Citius Signs Exclusive Option with Novellus to License Novel Stem-Cell Therapy for Acute Respiratory Distress Syndrome (ARDS) Associated with COVID-19…

CRANFORD, N.J., April 1, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today signed an exclusive six-month option agreement to in-license a stem-cell therapy for acute respiratory distress syndrome (ARDS) from a subsidiary of Novellus, Inc., a preclinical-stage biotechnology company based in Cambridge, MA.

Novellus's patented process uses its exclusive non-immunogenic synthetic messenger ribonucleic acid (mRNA) molecules to create induced pluripotent stem cells (iPSCs) that, in turn, generate mesenchymal stem cells (MSCs) with superior immunomodulatory properties. MSCs have been shown to be safe in over 900 clinical trials and to be safe and effective in treating a number of inflammatory diseases, including ARDS.

"ARDS is the most common cause of respiratory failure and mortality in COVID-19 patients. Currently, there is no proven treatment for ARDS. Literature supports the use of counter-inflammatory MSCs for ARDS, and papers published in China have shown that at least seven COVID-19 patients with ARDS responded to MSC therapy. Clearly this is an avenue that shows promise and should be pursued as a potential treatment for ARDS. We believe Novellus is at the forefront of creating allogeneic, iPSC-derived MSCs. These cells have the potential to overcome the limitations of MSCs derived from adult donors, which are telomere shortened and introduce variability into the manufacturing process," said Citius Chief Executive Officer Myron Holubiak.

Novellus Chief Science Officer Matt Angel, PhD, stated, "Using our mRNA-based cell-reprogramming technology, Novellus can provide a near-unlimited supply of MSCs for treating patients with ARDS, including those critically ill from COVID-19. These will be allogeneic ('off-the-shelf') cells that in vitro have demonstrated much greater expansion potential and much higher immunomodulatory protein expression than donor-derived MSCs. We are excited to employ our technology to such an urgent medical crisis and believe that our MSCs represent an ideal source of cells to be used in this extremely important development effort."

Holubiak added, "No effective pharmacotherapy for ARDS exists, and ARDS-related morbidity and mortality are high. MSCs have been studied in the treatment of lung injury, and we aim to build upon this work with Novellus's iPSC-derived MSCs to improve the immunomodulatory response in humans. We have assembled a team of experts who are dedicated to advancing this project to an Investigational New Drug (IND) application as quickly as possible."

About ARDSAcute respiratory distress syndrome (ARDS) is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. ARDS is a rapidly progressive disease that occurs in critically ill patients most notably now in those diagnosed with COVID-19. ARDS affects approximately 200,000 patients per year in the U.S., exclusive of the current COVID-19 pandemic, and has a 30% to 50% mortality rate. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain, particularly while inhaling, and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

About Citius Pharmaceuticals, Inc.Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. For more information, please visit http://www.citiuspharma.com.

About Novellus, Inc.Novellus is a pre-clinical stage biotechnology company developing engineered cellular medicines using its non-immunogenic mRNA, nucleic-acid delivery, gene editing, and cell reprogramming technologies. Novellus is privately held and is headquartered in Cambridge, MA. For more information, please visit http://www.novellus-inc.com.

Safe HarborThis press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition, and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: the risk of successfully negotiating a license agreement with Novellus within the option period; our need for substantial additional funds; the estimated markets for our product candidates, including those for ARDS, and the acceptance thereof by any market; risks associated with conducting trials for our product candidates, including those expected to be required for any treatment for ARDS and our Phase III trial for Mino-Lok; risks relating to the results of research and development activities; risks associated with developing our product candidates, including any licensed from Novellus, including that preclinical results may not be predictive of clinical results and our ability to file an IND for such candidates; uncertainties relating to preclinical and clinical testing; the early stage of products under development; risks related to our growth strategy; our ability to obtain, perform under, and maintain financing and strategic agreements and relationships; our ability to identify, acquire, close, and integrate product candidates and companies successfully and on a timely basis; our ability to attract, integrate, and retain key personnel; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions, or circumstances on which any such statement is based, except as required by law.

Contact:Andrew ScottVice President, Corporate Development(O) 908-967-6677ascott@citiuspharma.com

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Citius Signs Exclusive Option with Novellus to License Novel Stem-Cell Therapy for Acute Respiratory Distress Syndrome (ARDS) Associated with COVID-19...

Cellect Biotechnology Reports Fourth Quarter and Full Year 2019 Results – Yahoo Finance

Achieved Primary Investigational New Drug (IND) Approval in the U.S.; Positioned to Commence Patient Enrollment

Maintained Clinical Progress in Israel and Nearing Completion of Phase 1/2 Trial

Strategic Commercial Agreement with Canndoc Anticipated to Generate Significant Revenue; Closing of Merger Transaction Progressing as Planned

TEL AVIV, Israel, April 3, 2020 /PRNewswire/ -- Cellect Biotechnology Ltd. (Nasdaq: APOP), a developer of a novel stem cell production technology, today announced operating and financial results for the fourth quarter and full year ended December 31, 2019.

"We achieved a number of strategic priorities in 2019, including the IND approval to commence our first-ever trial in the U.S.," commented Dr. Shai Yarkoni, Chief Executive Officer."We plan to begin enrolling patients for this trial and completing the trial in Israel when the COVID-19 pandemic is mitigated. While these near-term events are value-enhancers, I believe that our recently announced prospective partnership with Canndoc could be a game-changer for Cellect and change our growth trajectory. It has the potential to significantly enhance our short and long term business prospects and shareholder value. As a player in the fast-growing pain management market, we would anticipate significant revenue opportunities already this year."

Recent Strategic Development

As previously announced, on March 4, 2020, the Company entered into a commercial binding Letter Of Intent (LOI) with Canndoc Ltd, a leading pharma grade medical cannabis pioneer and a wholly owned subsidiary of publicly-traded Intercure Ltd. (TASE: INCR),to acquire from Canndoc all rights to the use and sell Canndoc products for the reduction of opioid usage, including accumulated data, as well as on-going and pipeline of clinical trials. This commercial arrangement is subject to negotiation and approval by each company's board of directors and definitive agreements.

Additionally, the two companies signed a non-binding LOI for a full merger. Under preliminary details, Cellect will acquire from Intercure all of Canndoc outstanding shares, in exchange for additional Cellect ADRs to be in total ~95% (~93% on a fully diluted basis) of the merged company. The proposed merger is subject to independent valuation of both companies, fairness opinion by a third party, negotiation of a definitive agreement, approval of the agreement by the Company's Board of Directors and shareholders, internal approvals by Canndoc and Intercure, and customary closing conditions, including the approval of the IMCA (Israeli Medical Cannabis Agency). Upon the closing of the merger, Cellect and Canndoc will aim to fulfill all of the requirements to ensure the Company's ADRs and warrants continue trading on the Nasdaq Stock Market (Nasdaq) and, for this purpose, Intercure would commit to invest a cash sum of at least $3.0 million in any public offering that is undertaken by the Company, at a price of not less than $4.50 per ADR.

Based on the progress to date, the Company continues to expect the commercial and merger transactions will close in the second quarter of 2020.

Additional Operating Highlights:

Clinical Progress Update:

Due to the ongoing COVID-19 pandemic, the Company is experiencing clinical disruption such as:

The Company continues to take all the necessary precautions advised by global health officials to ensure the health and safety of its employees and partners. The Company is unaware of any impact on employees from pandemic related exposure or illness and is continuing to perform in-house research, including in the opioid/pain management area.

Fourth Quarter and Full Year 2019 Financial Results:

Balance Sheet Highlights:

For the convenience of the reader, the amounts have been translated from NIS into U.S. dollars, at the representative rate of exchange on December 31, 2019 (U.S. $1 = NIS 3.456).

About Cellect Biotechnology Ltd.

Cellect Biotechnology (NASDAQ: APOP) has developed a breakthrough technology, for the selection of stem cells from any given tissue, that aims to improve a variety of stem cell-based therapies.

The Company's technology is expected to provide researchers, clinical community and pharma companies with the tools to rapidly isolate stem cells in quantity and quality allowing stem cell-based treatments and procedures in a wide variety of applications in regenerative medicine. The Company's current clinical trial is aimed at bone marrow transplantations in cancer treatment.

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Forward Looking Statements

This press release contains forward-looking statements about the Company's expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as "believe", "expect", "intend", "plan", "may", "should", "could", "might", "seek", "target", "will", "project", "forecast", "continue" or "anticipate" or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss Cellect's intent regarding the future potential of Cellect's technology. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the Company's history of losses and needs for additional capital to fund its operations and its inability to obtain additional capital on acceptable terms, or at all; the Company's ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; the Company's ability to obtain regulatory approvals; the Company's ability to obtain favorable pre-clinical and clinical trial results; the Company's technology may not be validated and its methods may not be accepted by the scientific community; difficulties enrolling patients in the Company's clinical trials; the ability to timely source adequate supply of FasL; risks resulting from unforeseen side effects; the Company's ability to establish and maintain strategic partnerships and other corporate collaborations; the scope of protection the Company is able to establish and maintain for intellectual property rights and its ability to operate its business without infringing the intellectual property rights of others; competitive companies, technologies and the Company's industry; unforeseen scientific difficulties may develop with the Company's technology; and the Company's ability to retain or attract key employees whose knowledge is essential to the development of its products. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in Cellect Biotechnology Ltd.'s Annual Report on Form 20-F for the fiscal year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, http://www.sec.gov, and in the Company's periodic filings with the SEC.

Cellect Biotechnology Ltd

Consolidated Statement of Operation

Convenience

translation

Twelve months

ended

Twelve months ended

Three months ended

December 31,

December 31,

December 31,

2019

2019

2018

2019

2018

Unaudited

Audited

Audited

Unaudited

Unaudited

U.S. dollars

NIS

(In thousands, except share and pershare data)

Research and development expenses

3,508

12,122

13,513

2,571

4,040

General and administrative expenses

2,954

10,210

15,734

2,378

4,733

Operating loss

6,462

22,332

29,247

4,949

8,773

Financial expenses (income) due towarrants exercisable into ADS

(2,032)

(7,022)

(7,719)

998

(4,784)

Other financial expenses (income), net

433

1,498

(1,415)

129

(238)

Total comprehensive loss

4,863

16,808

20,113

6,076

3,751

Loss per share:

Basic and diluted loss per share

0.023

0.079

0.155

0.027

0.029

Weighted average number of sharesoutstanding used to compute basic anddiluted loss per share

212,642,505

212,6432,505

129,426,091

224,087,799

130,274,953

Cellect Biotechnology Ltd

Consolidated Balance Sheet Data

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Cellect Biotechnology Reports Fourth Quarter and Full Year 2019 Results - Yahoo Finance

Fate inks $100M J&J pact for ‘off-the-shelf’ cancer cell therapies – BioPharma Dive

Dive Brief:

First-generation autologous CAR-T therapies involve genetically edited immune cells taken directly from patients in a lengthy, logistically challenging and costly procedure. Fate is one of a group of companies advancing an "off-the-shelf" cell therapy approach, which utilizes cells taken from healthy donors.

It's an emerging field of research that's still in its early stages. Only slivers of human data have been published thus far. These companies have yet to prove off-the-shelf approaches can match, or surpass, what has been seen with CAR-T without triggering serious or potentially deadly immune reactions.

But pharma has made notable investments in the work, which could lead to treatments that are quicker and less costly to produce than their autologous counterparts. Among them: Pfizer's wide-ranging deal with Allogene Therapeutics in 2018 as well as Bayer's buyout of BlueRock Therapeutics and investment in Century Therapeutics last year.

Entering this year, the allogeneic field looked set to take some steps forward. As analyst firm Jefferies noted in March, Precision,AllogeneTherapeutics and CRISPRTherapeutics, which each use different off-the-shelf approaches, could all produce notable human data this year.

The coronavirus pandemic, however, has threatened clinical research timelines across the industry, disrupting study enrollment and treatment.

Fate is in the mix, too, though it acknowledged COVID-19 could impact its plans. In announcing the J&J deal, Fate also warned of coronavirus-related "delays or disruptions in patient enrollment and site initiation" that will affect the timing of its clinical trials. It didn't provide specific details.

The J&J partnership does give Fate some breathing room. The San Diego biotech is getting $100 million to produce up to four new therapies that J&J will have the option to license, while J&J covers the associated R&D costs. Fate could receive another $3 billion in various conditional payments tied to regulatory and sales milestones if all goes to plan, though those payments may never materialize.

"From speaking to management, we think this is exactly the type of deal [Fate] was looking for," wrote Cantor Fitzgerald analyst Alethia Young, referring to a back-loaded agreement that gives the company the chance to keep some rights to the programs in the alliance.

Young wrote the deal is also "a strong validation" of Fate's approach, which draws from stem cell and CAR-T technologies.Fate turns cells from donors into induced pluripotent stem cells, which in turn can be re-engineered into a variety of different cells. In their partnership, for instance, Fate and J&J aim to create certain types of immune cells natural killer, or NK cells, and T cells that can hunt down tumors.

The partnership doesn't include any of the other treatments currently in Fate's pipeline. Shares climbed about 20%, to around $25 apiece, in pre-market trading Friday.

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Fate inks $100M J&J pact for 'off-the-shelf' cancer cell therapies - BioPharma Dive

ReNeuron assessing potential of emerging cell technology in the coronavirus fight – Proactive Investors UK

It has developed a line of the human exosomes that can deliver a medically relevant payload; viral vaccines, for example

() has said it is assessing the potential of an emerging celltechnology to help in the fight against the coronavirus (COVID-19).

It has developed a line of the human exosomes that can deliver a medically relevant payload; viral vaccines, for example.

Previously presented, unpublished data show that ReNeuron's exosomes can be loaded with biologically active cargo and delivered preferentially to certain specific sites in the body, the company said in a statement.

This research is in its initial stages, the goal being to establish whether an increase in the potency of SARS-CoV-2 coronavirus vaccines in development can be enhanced in this way, utilising ReNeuron's established expertise in exosome isolation, modification and manufacture at scale.

The insight was provided alongside a wider update on progress in the face of the COVID-19 outbreak, which has led to wholesale lockdowns on both sides of the Atlantic.

The stem cell specialist said the disruption will inevitably lead to delays in the recruitment of patients to trials of its treatments for people with stroke disability and a degenerative eye condition called retinitis pigmentosa.

It said it will update on how this will affect the release of top-line data from the two studies once it knows the full impact of the restrictions.

ReNeurons priority internal research, meanwhile, is progressing to current timelines. The firm said it is adhering to safety guidelines in the labs with a rota system and, where possible, work is being done from home.

The safety of employees, suppliers, clinical trial participants and all other people with whom the company interacts is of over-riding importance to the company, investors were told.

Finally, ReNeuron's exclusive licensing partner in China, Shanghai Fosun, has recently filed to open clinical sites to take part in the ongoing PISCES III clinical trial in stroke disability.

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ReNeuron assessing potential of emerging cell technology in the coronavirus fight - Proactive Investors UK

Celularity and Infectious Disease Research Institute will try out COVID-19 cell therapy – GeekWire

Celularitys subsidiary, LifebankUSA, maintains a repository of placental and cord blood, containing stem cells for potential therapeutic use. (LifebankUSA / Robert Hariri via Twitter)

Seattles Infectious Disease Research Institute and a New Jersey company called Celularity have been cleared by the Food and Drug Administration to start trials of an experimental cell-based therapy for COVID-19.

The immunotherapy treatment makes use of natural killer cells, or NK cells, which play a key role in the bodys natural defense against viral infections. Celularitys NK cell product, known as CYNK-001, is derived from placental stem cells for treating viral diseases as well as some types of blood cancers and tumors.

CYNK-001 has been safely given to patients in early trials for treating leukemia and multiple myeloma. Now the FDA has given investigational new drug clearance for its use to be extended to COVID-19, the disease caused by the coronavirus outbreak.

To date, efforts to treat COVID-19 cases have been primarily focused on antiviral medications, Corey Casper, who is CEO of the Infectious Disease Research Institute as well as a clinical professor of global health at the University of Washington, explained in a news release.While these are important, patients with serious disease may not respond completely to antiviral medications because they are experiencing damage already inflicted on the bodys vital organs.

About 80 to 100 patients diagnosed with pneumonia due to a COVID-19 infection will be enrolled at medical centers in the U.S., potentially including sites in Washington state. Participants in the study will be provided with infusions of CYNK-001.

The hypothesis is that administering NK cells to patients with moderate to severe COVID-19 will allow the immune cells find the sites of active viral infection, kill the virus, and induce a robust immune response that will help heal the damage and control the infection, Casper said. Beyond its promise as a critically needed treatment for COVID-19, the biology of NK cells indicates a possibility that this immunotherapy could be used as an off-the-shelf treatment for future pandemic infections.

Initial results are expected about 30 to 60 days after the first patients receive the cells. If the results are encouraging, a more rigorous clinical trial would follow.

Last weekend, Rudy Giuliani, President Donald Trumps personal attorney, touted the treatment on Twitter, saying that this therapy has real potential. This week, the FDA gave its clearance for the preliminary tests on an expedited basis.

In a statement issued today, Celularitys chairman and CEO, Robert Hariri, thanked the FDAs Center for Biologics Evaluation and Research for their tireless effort to guide us through the process of clearing the drugs use for COVID-19.

The New York Times quoted Paul Knopfler, a stem cell researcher at the University of California at Davis, as saying that Celularitys approach carried some risk. Its conceivable that the NK cells could exacerbate problems by massive killing of the patients respiratory cells, he told the Times.

The FDA has cleared testing of several other therapies for COVID-19, including use of the drugs hydroxychloroquine and remdesivir as well as blood plasma from recovered patients. In addition, the first U.S. clinical trial of a COVID-19 vaccine is underway at Seattles Kaiser Permanente Washington Research Institute.

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Celularity and Infectious Disease Research Institute will try out COVID-19 cell therapy - GeekWire

Pinprick Blood Test To Identify Antibodies In Patients Approved By FDA – Kaiser Health News

The blood tests are important for a variety of reasons, including the fact that those with antibodies might be able to act as the first wave of people to re-start the economy. In other treatment news: an unproven stem cell therapy gets the green light, an oral antiviral spray shows promise to protect health workers, experts warn there's no "magic pill" to cure the virus, and the man behind a cocktail of drugs that's been criticized as giving Americans false hope.

The New York Times:F.D.A. Approves First Coronavirus Antibody Test In U.S.The Food and Drug Administration on Thursday approved a new test for coronavirus antibodies, the first for use in the United States. Currently available tests are designed to find fragments of viral genes indicating an ongoing infection. Doctors swab the nose and throat, and amplify any genetic material from the virus found there. The new test, by contrast, looks for protective antibodies in a finger prick of blood. It tells doctors whether a patient has ever been exposed to the virus and now may have some immunity. (Mandavilli, 4/2)

The Associated Press:Coronavirus Survivor: 'In My Blood, There May Be Answers'Tiffany Pinckney remembers the fear when COVID-19 stole her breath. So when she recovered, the New York City mother became one of the countrys first survivors to donate her blood to help treat other seriously ill patients. It is definitely overwhelming to know that in my blood, there may be answers, Pinckney told The Associated Press. Doctors around the world are dusting off a century-old treatment for infections: Infusions of blood plasma teeming with immune molecules that helped survivors beat the new coronavirus. (Neergaard and Ritzel, 4/3)

The New York Times:Unproven Stem Cell Therapy Gets OK For Testing In Coronavirus PatientsAn experimental stem cell therapy derived from human placentas will begin early testing in patients with the coronavirus, a New Jersey biotech company said Thursday. The treatment, being developed by the company Celularity, has not yet been used on any patients with symptoms of Covid-19, but it has caught the attention of Rudy Giuliani, President Trumps personal lawyer. Mr. Giuliani recently featured an interview with the company founder on his website and said on Twitter that the product has real potential, while also criticizing the Food and Drug Administration for not moving more quickly to approve potential remedies. (Thomas, 4/2)

Cincinnati Enquirer:Coronavirus: Oral Antiviral Spray To Be Tested For Infection PreventionAn antiviral oral spray that has been available over the counter since 2012 will undergo a clinical trial by University Hospitals in northeastern Ohio to see if it prevents front-line health care workers from becoming infected with the new coronavirus.We have every reason to believe it will be effective, said Dr. Robert A. Salata, chairman of the department of medicine at University Hospitals Cleveland Medical Center and principal investigator for the study. (Futty, 4/2)

Politico:No 'Magic Pill': The Fight Over Unproven Drugs For CoronavirusThe Food and Drug Administrations rush to greenlight unproven malaria medicines to fight the coronavirus may derail clinical trials of other potential cures for the deadly virus. Right now, dozens of potential therapies from antivirals to antibodies taken from the blood of coronavirus survivors are being tested in people. The first results from these studies could come within months if drugmakers enroll the thousands of patients needed to complete the research. (Owermohle, 4/2)

The New York Times:Touting Virus Cure, Simple Country Doctor Becomes A Right-Wing StarLast month, residents of Kiryas Joel, a New York village of 35,000 Hasidic Jews roughly an hours drive from Manhattan, began hearing about a promising treatment for the coronavirus that had been rippling through their community. The source was Dr. Vladimir Zelenko, 46, a mild-mannered family doctor with offices near the village. Since early March, his clinics had treated people with coronavirus-like symptoms, and he had developed an experimental treatment consisting of an antimalarial medication called hydroxychloroquine, the antibiotic azithromycin and zinc sulfate. (Roose and Rosenberg, 4/2)

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Pinprick Blood Test To Identify Antibodies In Patients Approved By FDA - Kaiser Health News

Is There a New CAR T-Cell Treatment for Mantle Cell Lymphoma? – AJMC.com Managed Markets Network

Maggie L. Shaw

Mantle cell lymphoma is a type of B-cell non-Hodgkin lymphoma with a typically poor prognosis. Even with an allogeneic stem cell transplant, patients can become resistant to chemotherapy. Most do not survive 4 or 5 years after diagnosis, and the 10-year survival rate hovers between 5% and 10%.

Chimeric antigen receptor (CAR) T-cell therapy has been making great inroads as targeted treatment for many types of cancers highly resistant to other treatments, by prolonging patient survival and increasing their quality of life. Until now, similar results have not been seen in patients with MCL. However, with their successful phase 2 ZUMA-2 trial results just published in the New England Journal of Medicine, a group of researchers led by Michael Wang, MD, from The University of Texas MD Anderson Cancer Center, are able to show that these patients can benefit from the specialized therapy.

In this study conducted in the United States and Europe, the patient population had relapsed/refractory progressive disease despite receiving Brutons tyrosine kinase (BTK) inhibitor therapy and from 3 to 5 prior therapies.

BTK inhibitor therapy has greatly improved outcomes in patients with relapsed or refractory mantle cell lymphoma, yet patients who have disease progression after receiving the treatment are likely to have poor outcomes, with median overall survival of just 6 to 10 months, the authors said.

The median patient age was 65 years (range, 38-79). They were evaluated for response to a single infusion of KTE-X19, an anti-CD19 CAR T-cell therapy, that was dosed at 2106 CAR T cells/kg of body weight. Seventy-four patients were enrolled between October 24, 2016, and April 16, 2019; the treatment was manufactured for 71 and ultimately administered to 68.

There was a follow-up after 60 patients were monitored for 7 months, at which time a primary efficacy analysis was conducted. The primary endpoint was objective response (complete [CR] or partial [PR]), which was confirmed via bone marrow evaluation and positron emission tomography-computed tomography.

Overall, 85% of the entire study cohort of 74 patients was able to reach an objective response to KTE-X19, 59% of whom had a CR. These numbers were even higher among the group of 60 patients. Ninety-three percent (95% CI, 84%-98%) achieved an objective response, which was evaluated by an independent radiologic review committee. And of this group, 67% (95% CI, 53%-78%) had a CR.

The median times to response were impressive, with there being 1 month (range, 0.8-3.1) to initial response and 3 months (range, 0.9-9.3) to CR. In addition, of the 42 patients who initially had a PR or stable disease (SD), 24 (21 who had a PR, 3 who had SD) progressed to a CR in a median 2.2 months (range, 1.8-8.3).

Progression-free (PFS) and overall survival (OS) results also show promise to treatment with KTE-X19. As of the data cutoff date, there was evidence of remission in 78% patients who had a CR, with similar results seen in 57% of patients from the primary efficacy analysis. Overall, at 12 months, the PFS and OS were 61% and 83%, respectively.

Common adverse events to the treatment of grade 3 or higher included cytopenias (94%) and infections (32%). Ninety-one percent also experienced cytokine release syndrome, with a median time to onset of 2 days (range, 1-13) for any grade and 4 days (range, 1-9) for at least grade 3, but none died as a result. According to the study authors, most symptoms were reversible.

ZUMA-2 is the first multi-center, phase 2 study of CAR T-cell therapy for relapsed/refractory mantle cell lymphoma, and these efficacy and safety results are encouraging, stated Wang. Although this study continues, our reported results, including a manageable safety profile, point to this therapy as an effective and viable option for patients with relapsed or refractory mantle cell lymphoma.

Reference

Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-Cell therapy in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2020;382;1331-1342. doi: 10.1056/NEJM0a1914347.

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Is There a New CAR T-Cell Treatment for Mantle Cell Lymphoma? - AJMC.com Managed Markets Network

CytoDyn CEO Dr. Pourhassan to Appear on Fox Business Network Friday, April 3, 2020 at 2:00 pm ET to Discuss Leronlimab Treatment of 10 Severely Ill…

Both Phase 2 and Phase 2b/3 trials for COVID-19 patients will be discussed

VANCOUVER, Washington, April 03, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that Nader Pourhassan, Ph.D., President and Chief executive Officer of CytoDyn will appear on Fox Business Network on the Making Money with Charles Payne program. The program will air from 2:00 pm ET to 3:00 pm ET (11:00 am PT to 12 noon PT) and is also available via live streaming at https://www.foxbusiness.com/shows/making-money-with-charles-payne.

The Companys investigational new drug, leronlimab, has been administered to 10 severely ill patients with COVID-19 at a leading medical center in the New York City area under an emergency IND recently granted by the FDA. The Company recently initiated enrollment in a Phase 2 trial for leronlimab treatment of COVID-19 patients with mild-to-moderate indications and under the same IND, is now proceeding with its second COVID-19 clinical, a Phase 2b/3 trial for the treatment of critically ill patients.

About Coronavirus Disease 2019SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

Story continues

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in April of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

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CytoDyn CEO Dr. Pourhassan to Appear on Fox Business Network Friday, April 3, 2020 at 2:00 pm ET to Discuss Leronlimab Treatment of 10 Severely Ill...

PharmAbcine Announces Acceptance of Phase Ib Olinvacimab and Pembrolizuamb Combination Trial in rGBM Patients Abstract at the 2020 ASCO Annual Meeting…

PharmAbcine Inc. (KOSDAQ: 208340) announced today that the abstract summarizing interim data on its phase Ib trial of olinvacimab in combination with Mercks anti-PD-1 antibody Keytruda for recurrent glioblastoma multiforme (rGBM) patients has been accepted at the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting.

Phase Ib study is to evaluate the safety of the combination therapy of two agents for rGBM patients and to explore appropriate clinical dose levels of the two agents as in a combination regimen. During the study, 200 mg of Keytruda was administered to patients every three weeks while 12 or 16 mg/kg of olinvaciamb was administered on a weekly basis. From the phase Ib study, there was no DLT (dose limiting toxicity) observed, and among 9 patients, 4 patients had SD (stable disease) and 5 patients experienced disease progression (PD).

rGBM is a rare tumor and there are only a few treatment options available to date. It is known to have the worst prognosis among any other types of cancers/tumors and the life expectancy of rGBM patients is less than 4 months upon diagnosis. There have been multiple clinical trials using immuno-oncology drugs to treat rGBM but the promising results have not been reported yet.

Previously Olinvacimab from its phase IIa clinical study in rGBM patients ascertained its significant improvement of brain edema and shrinkage of tumor. Now its use is being investigated in a phase II study for Avastin-refractory rGBM patients in US and Australia.

An ASCO annual meeting is a global conference, annually accommodating 40,000 people from 76 different countries.

About PharmAbcine Inc.

PharmAbcine is a clinical-stage biotech company focusing on the development of fully human antibody therapeutics to treat neovascular disorders and tumors by targeting molecules involved in angiogenesis and immune checkpoints, which are responsible for hindrance in immune response to tumors. Our innovative discovery technology coupled with dedicated R&D staff have enabled us to provide superlative therapeutic antibodies for a wide array of indications in oncology, immuno-oncology, ophthalmology, and renal pathology.

PharmAbcines HuPhage library and innovative selection system are priceless proprietary assets that can generate antibodies with greater diversity than 10^11.

PharmAbcines advanced 3G expression system accommodates high levels of antibody production with high reproducibility. With our highly advanced technology platforms, we provide high-quality antibody generation services.

PharmAbcines advanced evaluation platforms can facilitate the pipeline development by assessing its anti-tumor effects with greater precision and accuracy. Through the collaboration with Samsun Medical Centre, We have more than 300 patients-derived cancer stem cell libraries and a PDX (patient-derived xenograft) animal model system to evaluate internal pipeline development.

Additional information about PharmAbcine can be found on our website at http://www.pharmabcine.com

Contacts

Yohan Jung

82-42-863-2017

yohan.jung@pharmabcine.com

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PharmAbcine Announces Acceptance of Phase Ib Olinvacimab and Pembrolizuamb Combination Trial in rGBM Patients Abstract at the 2020 ASCO Annual Meeting...

North Jersey hitting the surge – Politico

This shouldnt come as a surprise given what New Jerseyans are seeing right across the river. But Im still a little taken aback with how little people are talking about it.

Yesterday, Health Commissioner Judith Persichilli said "It looks like the surge is beginning to occur in the northern part of the state.

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Gov. Murphy acknowledged New Jersey will soon need refrigerated trucks for the bodies of coronavirus victims.

I dont have a specific day, but soon, Murphy said yesterday. The fact that were having this conversation, folks, means this is real.

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QUOTE OF THE DAY: There's no greater intervention, period, full stop, none, than physical distancing. California Gov. Gavin Newsom on CNN. (I bet you thought it was someone else)

WHERES MURPHY?: In Secaucus at 10 a.m. to tour the field hospital at the Meadowlands Exposition Center, then in Trenton for his daily briefing at 1 p.m.

HAPPY BIRTHDAY: My cousin Amanda, Princetons Brent Colburn, MBIs Michele Jaker, Environment New Jerseys Doug OMalley, Optimus Partners David Vitali

CORONAVIRUS TRACKER: The latest: 3,649 newly-diagnosed cases in New Jersey for a total of 22,255 since the pandemic hit. Ninety-one new deaths, for a total of 355.

Sign up for POLITICO Nightly: Coronavirus Special Edition, your daily update on how the illness is affecting politics, markets, public health and more.

THE ANTI-CHRISTIE In New Jersey, a quieter alternative to Cuomo leads the pandemic response, by POLITICOs Matt Friedman: In a matter of hours last month, New Jersey Gov. Phil Murphy went from dealing with the biggest personal health crisis of his life to overseeing the biggest health crisis his state has faced in more than a century. On March 4, Murphy reported to a New York City hospital at dawn for a surgical procedure in which doctors removed a cancerous tumor from his left kidney. Fourteen hours later, while recovering in his hospital bed, Murphy approved a statement from his office announcing New Jerseys first known case of the coronavirus. Since then, New Jersey has seen more than 22,000 of its residents test positive for Covid-19 and more than 350 die as the state is now the second-biggest hot spot in the nation behind New York. While New York Gov. Andrew Cuomo has become the national medias go-to governor as he deals with that states outbreak with tough talk and sometimes harsh, sometimes cajoling words for President Donald Trump, Murphy known locally more for his taste in Allbirds footwear and dad jokes than for being a disciplinarian has maintained a gentler, folksier style as he manages the crisis from the other side of the Hudson River.

STATEHOUSE REPORTERS LOOK FORWARD TO HARD CIDER DURING NEGOTIATION STAKE OUTS New Jersey to extend tax filing deadline to July 15, budget deadline to Sept. 30, by POLITICOs Katherine Landergan: New Jersey will extend the tax filing deadline to July 15 and the deadline for passing a state budget to Sept. 30, Gov. Phil Murphy and legislative leaders announced Wednesday morning. The state budget is typically due June 30, but that date is being pushed back three months to deal with severe financial disruptions caused by the coronavirus pandemic. The ongoing COVID-19 pandemic has caused hardships, financial strain, and disruptions for many New Jerseyans and New Jersey businesses. As part of our response, we have reached agreement that the state income tax filing deadline and the corporation business tax filing deadline will be extended from April 15 to July 15, Murphy, Senate President Steve Sweeney and Assembly Speaker Craig Coughlin said in a statement. Additionally, as part of the whole-of-government effort that is going into fighting COVID-19, we have agreed that the state fiscal year should be extended to September 30th, the statement said. This will allow the Administration and the Legislature to focus fully on leading New Jersey out of this crisis, and to allow for a robust, comprehensive, and well-informed budget process later in the year.

WHO COULDVE PREDICTED A DANGEROUS VIRUS COULD CAUSE PROBLEMS? Coronavirus in NJ: State was warned in 2015 about 'catastrophic' impact a flu-like disease could have, by The Asbury Park Press Michael L. Diamond: The New Jersey Department of Health updated its emergency influenza plan in 2015, predicting a devastating impact on the state if it were to get hit by a disease similar to the Spanish flu a century ago. It said nearly a third of the population would contract the illness, 277,000 would need to be hospitalized and 5,000 would die. Put into motion by the coronavirus, though, the blueprint has exposed shortfalls in preparation that have forced government and health leaders to improvise, leaving health care workers and patients at risk. In hindsight, we all should have paid attention" to the plan, said state Sen. Declan O'Scanlon, R-Monmouth. 'But without any frame of reference, it would have been hard to do.

BUILD THE WALL To stop coronavirus, Murphy wants to keep the 'lowest common denominator' out of NJ, by The Records Charles Stile: Coronavirus has converted Phil Murphy into a close-the-border hardliner. The liberal New Jersey governor, who daily invokes a 'One New Jersey family' slogan of solidarity, inclusiveness, now wants to keep 'the lowest common denominator' from traveling into the Garden State. By that he means people traveling in from other states that have been slow to take the threat seriously by refusing to close their beaches during spring break or shut down mega-churches where faith supersedes science. Murphy said he fears out-of-staters will restart the fire; or spark a second wave of infections and deaths when New Jersey life begins returning to normal his remarks are also puzzling that they come only two days after President Trump floated his own an unenforceable and constitutionally questionable travel ban of New Jersey, New York and Connecticut residents."

LUXURY APARTMENTS ARE ESSENTIAL Some NJ construction workers fear virus exposure as they continue to work, by News 12s Walt Kane: While most of New Jersey is under a stay at home order, construction workers across New Jersey are on the job. And some tell Kane In Your Corner the situation has them concerned for their safety, There's no social distancing at all, a construction worker says. I don't know why this is still going on. He's one of the hundreds who report to a job site in Jersey City each morning. Like all construction projects in the state, it's been deemed essential by Gov. Phil Murphy. But the project in question is Jersey Squared, a large, luxury high-rise complex in Journal Square that's been under construction, in stages, for years. The worker says he doesn't think it's essential at all. Other states, including New York, have taken a different approach to construction, shutting down all but essential projects.

SORRY ABOUT THAT BUT THANKS FOR THE REVENUE Pandemic isolation, shift to online gambling set up 'perfect storm,' experts say, by The Press of Atlantic Citys David Danzis: Gov. Phil Murphy ordered the indefinite closing of Atlantic Citys nine casinos March 16 but permitted online gaming to continue. Industry experts expect an escalation in online gaming activity because of the retail casino closings, and the anticipated growth in internet play has gambling addiction professionals worried. We believe every risk factor for gambling problems is increasing right now, said Keith Whyte, executive director of the National Council on Problem Gambling. The social distancing measures recommended by government health officials exacerbate conditions such as loneliness, isolation and depression that lead to problem behaviors, Whyte said.

HCQ OR CIALIS? In my bone of bones, I think this works: Pennacchio on HCQ, by InsiderNJs Fred Snowflack: Joe Pennacchio is no stranger to plunging ahead to make a point. He did that 26 years ago with a long shot primary challenge to Dean Gallo, a popular congressman. Now a state senator from Montville (LD-26) and also a co-chair of Donald Trumps New Jersey reelection effort, Pennacchio is energetically championing another and much more important cause a treatment for COVID-19. A dentist by profession, the man who called himself Jersey Joe during an unsucessful U.S. Senate bid more than a decade ago, has been firing off regular press statements praising the drug, hydroxychloroquine, or HCQ, as a treatment for the virus. The drug is not unknown. It is used to treat lupis, rheumatoid arthritis and malaria. In my bone of bones, I think this works, Pennacchio said this morning.

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A HARIRI SITUATION Rudy Giuliani wants FDA to fast-track a stem cell therapy for Covid-19; critics see political meddling, by STATs Adan Feuerstein: In recent days, Giuliani has used his Twitter account and podcast to tout the stem cell treatment being developed by a New Jersey biotech company, Celularity, despite scant evidence to date that its therapy will benefit Covid-19 patients. The company is currently seeking permission to start a clinical trial for the treatment. Giuliani, for his part, has been critical of the FDA, accusing it of standing in the way of important treatments. The general reputation of the FDA and I dont mean to be critical at a time like this but it is very slow, Giuliani said in an interview on his podcast with Bob Hariri, Celularitys founder and CEO Experts fear his argument could resonate with Trump, who has not only made Giuliani a close confidant but has long expressed impatience with the FDAs drug approval process. Giuliani could not be reached for comment.

You may remember Dr. Hariri, a Christie donor and former Celgene executive, from this.

PERIOD. LATE START Murphy hits back at Trump claim New Jersey was very late in coronavirus response, by POLITICOs Sam Sutton: New Jersey Gov. Phil Murphy pushed back Wednesday on President Donald Trumps assertion that the state got off to a very late start on coronavirus containment and mitigation, arguing that the Garden State was one of the first to begin preparing for the possibility of a coronavirus outbreak in January. I don't think that theres any state in America that was on this earlier than we were, Murphy said at his coronavirus press briefing, adding that Washington state where the first domestic case of coronavirus was discovered in January also responded rapidly. The facts dont support that. Period, full stop. At Tuesdays White House coronavirus briefing, Trump said that while he believes Murphy and New York Gov. Andrew Cuomo responded effectively to the public health crisis, they got off to a very late start" on containment.

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IM CONFIDENT HELL SURVIVE THE VIRUS, BUT CAN HE SURVIVE NOT GOING TO THE TURTLE BACK ZOO? Essex County Executive Joe DiVincenzo is latest N.J. official to test positive for coronavirus, by NJ Advance Medias Anthony G. Attrino: Essex County Executive Joseph N. DiVincenzo Jr., who has been self-quarantined for more than a week, has tested positive for the coronavirus, he announced Wednesday. I decided to get tested after experiencing a fever for several days and have been self-quarantined since March 21, DiVincenzo, 67 said in a Facebook post. DiVincenzo said his symptoms have been mild and that he feels OK.

SHOT Coronavirus in Lakewood: the pandemic has 'changed the way we live and celebrate', by The Asbury Park Press Gustavo Martnez Contreras: After seeing and hearing all the negativity targeting Lakewood in this novel coronavirus pandemic, a Howell man decided to take a drive and see for himself. The video travelogue that 28-year-old Boruch Perlowitz created reveals a township that is ostensibly on lock down, its residents sheltering in place and steering clear of favorite places, sometimes denied by chained and locked doors. As Perlowitz depicts it, usually bustling Lakewood is as sleepy as any other town in New Jersey. I said, let me find out the truth for my neighbors and friends, said Perlowitz. I wanted to do complete honest reporting. If places were open, I would say that places are open. Perlowitz's video aims to counter a narrative in social media that paints Lakewood as a lawless place where residents openly defy Gov. Phil Murphy's executive order shuttering businesses, barring large gatherings and requiring social distancing. Perlowitz said that narrative has engendered enmity toward the town's largely Orthodox Jewish community.

CHASER 10 charged at Lakewood engagement party in violation of coronavirus lockdown, cops say

Heres why large gatherings keep happening in Lakewood, as the coronavirus rages in N.J.

From News 12 anchor Kurt Sieglin on his Lakewood school bus tweets, which I included in Playbook earlier this week: In vetting a story, I screwed up yesterday. There were many reasons the tweets went out, but the responsibility is ultimately with me. Its my account. I have a brand to protect. I regret it. Im sorry for any pain or distrust the tweets created for residents who saw it. Much morehere

R.I.P. Five residents dead at New Milford nursing home, 16 test positive for coronavirus, by The Records Lindy Washburn: A nursing home in New Milford where at least five residents have died of complications of coronavirus is Bergen Countys first major outbreak at a long-term care facility. The disease already has nearly filled area hospitals. Sixteen residents and six staff members at Care One New Milford, known as Woodcrest, have tested positive for coronavirus and others are being tested, the company said late Tuesday night. Additional deaths at the facility also are being investigated to see if the residents had coronavirus.

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100% THAT DISH Lizzo sends food to N.J. hospital, says were praying for you everyday, by NJ Advance Medias Bobby Olivier: After a hefty food donation from a pop superstar, Community Medical Center is hopefully feeling 'Good As Hell.' Lizzo, the breakout 'Truth Hurts' singer, sent food to the Toms River hospital Monday to thank the medical staff for their hard work battling the coronavirus outbreak. Hello Toms River! Lizzo said in a video posted by RWJBarnabas Monday. Thank you for working so hard for us. I wanted to show a token of my appreciation and just drop off some food, I hope you enjoy the meals.

R.I.P. Fountains of Waynes Adam Schlesinger Dead at 52 From Coronavirus, by Rolling Stone's Jon Blistein: "Adam Schlesinger, co-founder of the New Jersey power-pop group Fountains of Wayne and Emmy- and Grammy-winning songwriter for film, television, and theater, died Wednesday from complications related to COVID-19. He was 52."

R.I.P. N.J. ER doctor who twice survived cancer dies a week after developing coronavirus symptoms

Losing your job overnight: How NJ's LGBTQ community is affected by the coronavirus

Manahan: Coronavirus update: Wake up, N.J.! Florida is trying to kill us (and pin the blame on us)

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North Jersey hitting the surge - Politico