Calidi Biotherapeutics Announces Exclusive License Agreement with City of Hope and the University of Chicago for Novel Oncolytic Virotherapy…

Details Category: DNA RNA and Cells Published on Monday, 16 August 2021 17:11 Hits: 487

LA JOLLA, CA, USA I August 16, 2021 I Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company with novel allogeneic stem cell platforms for delivery of oncolytic viruses, together with the University of Chicago and City of Hope, a world renowned NCI-Designated Comprehensive Cancer Center, based in Duarte, California, have entered into an exclusive worldwide licensing agreement for patents covering cutting edge therapies using an oncolytic adenovirus in combination with a clinical grade allogeneic neural stem cell line.

City of Hope (COH) scientists, led by Dr. Karen Aboody in collaboration with Dr. Maciej Lesniak's team at University of Chicago, and later Northwestern University, have used COHs exclusive GMP grade immortalized, clonal human neural stem cell line, to selectively deliver an oncolytic adenovirus to tumor sites. Dr. Aboody and Dr. Lesniak, together with Dr. Rachael Mooney at COH, have spent 13 years in a passionate effort to translate promising pre-clinical results into the clinic, attaining FDA approval for commencing a first-in-human Phase-1 trial in recurrent glioma patients.

We are very excited about the partnership and collaboration with Calidi Biotherapeutics. Their deep understanding and expertise using allogeneic stem cells as a delivery platform to protect, deliver, amplify, and potentiate oncolytic virotherapy, can potentially result in a significantly more effective treatment for cancer patients with invasive tumors, commented Dr. Karen Aboody, Professor, Department of Developmental and Stem Cell Biology, City of Hope National Medical Center & Beckman Research Institute.

The first wave of Oncolytic Viruses were novel, but lacked the ability to efficiently deliver the virus to tumor sites, due to the human complement immune system inactivating the viruses, usually within one hour of patient injection, thus resulting in a lack of efficacy, stated Allan Camaisa, Co-Founder, Chairman and CEO of Calidi Biotherapeutics. We believe this collaboration with City of Hope will allow us to implement Calidis proprietary techniques together with City of Hopes novel approach to glioblastoma and other malignant tumors, using neural stem cells combined with an oncolytic adenovirus. This FDA approved Investigational New Drug (IND), planned for patient trials in the first quarter of 2022, increases Calidis drug pipeline and gives our company a tumor-tropic stem cell line to use for oncolytic virus delivery in cancer patients.

This exclusive license agreement, which was executed by the University of Chicagos Polsky Center for Entrepeneurship and Innovation, transferred the COH/University of Chicago IND to Calidi for the commercial development of a licensed product. The agreement grants to Calidi commercial exclusivity in using neural stem cells with the adenovirus known as CRAd-pk-S-7 for oncolytic virotherapy.

Calidis scientific and medical teams are very excited to contribute in the development of this promising technology that has significant potential to help many patients with advanced tumors, said Boris Minev, MD, President, Medical and Scientific Affairs at Calidi Biotherapeutics. We are delighted to collaborate with the outstanding researchers and clinicians who developed this novel oncolytic virotherapy approach.

About Calidi Biotherapeutics

Calidi Biotherapeutics is a clinical-stage immuno-oncology company with proprietary technology that is revolutionizing the effective delivery of oncolytic viruses protected by stem cells for targeted therapy against difficult-to-treat cancers. Calidi Biotherapeutics is advancing a potent allogeneic stem cell and oncolytic virus combination for use in multiple oncology indications. Calidis off-the-shelf, universal cell-based delivery platform is designed to protect, amplify, and potentiate oncolytic viruses currently in development leading to enhanced efficacy and improved patient safety. Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit http://www.calidibio.com.

About University of Chicago

The University of Chicago is a leading academic and research institution that has driven new ways of thinking since its founding in 1890. As an intellectual destination, the University draws scholars and students from around the world to its campuses and centers around the globe. The University provides a distinctive educational experience and research environment, empowering individuals to challenge conventional thinking and pursue field-defining research that produces new understanding and breakthroughs with global impact.

The Polsky Center for Entrepreneurship and Innovation applies world-class business expertise from the University of Chicago Booth School of Business to bring new ideas and breakthrough innovations to market. Home of the Universitys technology transfer office, the Polsky Centers dedicated team of professionals with deep technical expertise enabling technology commercialization perform market analysis, manage intellectual property, identify partners, and negotiate partnerships and licenses for discoveries and inventions developed by faculty, researchers, and staff. Learn more at polsky.uchicago.edu and follow us on Twitter @polskycenter.

About City of Hope

City of Hope is an independent biomedical research and treatment center for cancer, diabetes and other life-threatening diseases. Founded in 1913, City of Hope is a leader in bone marrow transplantation and immunotherapy. City of Hopes translational research and personalized treatment protocols advance care throughout the world. Human synthetic insulin, monoclonal antibodies, and numerous breakthrough cancer drugs are based on technology developed at the institution. Translational Genomic research (TGen) became a part of City of Hope in 2016. AccessHope, a wholly owned subsidiary, was launched in 2019, dedicated to serving employers and their health care partners by providing access to City of Hopes exceptional cancer expertise. A National Cancer Institute-designated comprehensive cancer center and a founding member of the National Comprehensive Cancer Network, City of Hope is ranked among the nations Best Hospitals by U.S. News & World Report. Its main campus is located in Pasadena, California, near Los Angeles, with additional locations throughout Southern California and in Arizona. For more information about City of Hope, follow us on Facebook, Twitter, YouTube, or Instagram.

SOURCE: Calidi Biotherapeutics

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Calidi Biotherapeutics Announces Exclusive License Agreement with City of Hope and the University of Chicago for Novel Oncolytic Virotherapy...

LSU Health Shreveport Vaccine Clinic at 2726 Linwood Avenue to Begin Administering Third Doses of Vaccine Tomorrow for Those Who Meet CDC Requirements…

Shreveport LSU Health Shreveport will begin administering the third dose (booster) vaccines starting tomorrow from 10am to 6pm, Monday through Friday at 2627 Linwood Avenue/former Chevyland. Third doses will be administered based on CDC guidelines and recommendations by the Louisiana Department of Health.

In an effort to minimize wait times, it is suggested that those seeking the third dose of the vaccine do so based on the following schedule.

Last name begins with letters:

A F should get third vaccine on Tuesday, August 17

G-L should get third vaccine on Wednesday, August 18

M-S should get third vaccine on Thursday, August 19

T-Z should get third vaccine on Friday, August 20

If you are unable to come on suggested date, please feel free to come when you are available. Appointments are not required for third dose of vaccine.

Third doses will be available for people whose immune systems are compromised moderately to severely and are fully vaccinated with an mRNA COVID-19 vaccine. This action is being taken as those who are moderately to severely immunocompromised are especially vulnerable to COVID-19 because they are at a higher risk of serious, prolonged illness. As of Friday, August 13, 2021, CDC now recommends that people with moderately to severely compromised immune systems receive an additional dose of mRNA COVID-19 vaccine at least 28 days after their second dose of Pfizer-BioNTech COVID-19 vaccine orModerna COVID-19 vaccine. CDC doesnotrecommend additional doses or booster shots for any other population at this time.

Patients will self-attest to their condition by completing and signing this formhttps://ldh.la.gov/assets/oph/Center-CP/HANs/HANS21-58Attachment-3rdDoseAttestationForm.pdf.

Who Needs an Additional COVID-19 Vaccine?

Currently, CDC is recommending that moderately to severely immunocompromised people receive an additional dose. This includes people who have:

Been receiving active cancer treatment for tumors or cancers of the blood

Received an organ transplant and are taking medicine to suppress the immune system

Received a stem cell transplant within the last 2 years or are taking medicine to suppress the immune system

Moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)

Advanced or untreated HIV infection

Active treatment with high-dose corticosteroids or other drugs that may suppress your immune response

Other conditions which cause moderate or severe immunosuppression similar to the above conditions

People should talk to their healthcare provider about their medical condition, and whether getting an additional dose is appropriate for them.

Prescription or notation from a physician or other prescriber is not necessary at this time.Patients with one of the above conditions who wish to receive an additional dose of Pfizer or Moderna vaccine may self-attest to their condition by completing and signing this form.

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LSU Health Shreveport Vaccine Clinic at 2726 Linwood Avenue to Begin Administering Third Doses of Vaccine Tomorrow for Those Who Meet CDC Requirements...

Eagle County begins offering third vaccine doses to the immunocompromised – Vail Daily News

Eagle County hit the ground running in its effort to provide third doses of COVID-19 vaccine to immunocompromised residents who wish to receive them, offering the first doses at clinics mere days after a federal advisory committee recommended the booster shots.

On Friday, an advisory committee to the Centers for Disease Control and Prevention approved an additional dose of the two mRNA vaccines Pfizer and Moderna for moderately to severely immunocompromised people.

By Monday, the MIRA Bus, an RV that travels the county offering public health services, was offering third doses at a mobile clinic in Avon. Colorado Mountain Medical will offer the third shots to qualifying individuals at its Eagle campus every Thursday from 8 a.m. to 4 p.m.

We know the third dose booster with this population provides more protection for them and is recommended on a disease severity piece that theyll have more protection, said Chris Lindley, Vail Healths chief population health officer. So, we dont want to wait, even though the guidance is not as clear as we would like it.

The CDC outlined six categories of people that will qualify as immunocompromised in this first phase, an eligibility group much smaller than the definition of immunocompromised used in the initial vaccine rollout earlier this year, Eagle County Public Health Director Heath Harmon said.

In the spring, the immunocompromised priority group contained about 20,000 Eagle County residents, but this new group is likely much smaller, Harmon said.

During the initial vaccine rollout, everybody was vulnerable to the illness at that time, he said. So now, when were looking at third doses, we do have access to a lot of data, especially relative to individuals that may have already received two doses of an mRNA vaccine. So, its really helpful to be more specific in terms of who can benefit most from that third dose.

Among the eligible are those receiving active cancer treatment for tumors or cancers of the blood as well as people who have received an organ transplant and are taking medication that suppresses the immune system, according to the CDC.

Anyone who received a stem cell transplant within the past two years, is currently taking immunosuppressant medication or has a moderate or severe primary immunodeficiency is also eligible, according to the guidance.

The last two groups included are those with advanced or untreated HIV or who are actively receiving treatment with high-dose corticosteroids or other drugs that may suppress your immune response.

The relatively vague language of some of these groups leaves a little bit to be desired, Lindley said, and the guidance does not say anything about requiring proof of eligibility from a medical provider, so Vail Health and Colorado Mountain Medical will not do so at this time.

The guidance also does not provide a booster option for immunocompromised people who received the single-shot Johnson and Johnson vaccine. Currently, there is no additional shot available for the Johnson and Johnson vaccine, and it cannot be mixed with Pfizer or Moderna.

To those in that situation, we hear you, Harmon said. We understand that you have some questions, and we just ask for patience. We would expect for guidance to be available from our federal partners in the not-too-distant future.

The most important thing is that Eagle County now has one more prevention tool in its belt to help protect its most vulnerable residents, Harmon said.

Colorado Mountain Medicals Thursday clinics will continue to offer first and second doses of the COVID-19 vaccine to anyone who has yet to receive it, in addition to the third doses, said Shannatay Bergeron, director of specialty care services for Colorado Mountain Medical.

The clinics will be walk-in only and demand for third shots may be high, especially at first, so Bergeron cautioned residents to prepare for a wait. The MIRA Bus will be at the Eagle Colorado Mountain Medical location Thursday providing additional vaccination capacity, she said.

Eligible residents should bring a form of identification proving their age along with their vaccination card. More information on the Thursday clinics, as well as other COVID-19 and vaccination updates, can be found at vailhealth.org/COVID-19/vaccines.

Eagle County Public Health is also offering third doses at its locations in Eagle and Avon, Harmon said Tuesday.

Though the third shots were made available beginning Monday, Harmon said he did not think anyone had received one yet. More information on the countys clinics can be found at EagleCountyCOVID.org.

Vail Healths aggressive approach to offering the third shots as soon as possible is on par with how Eagle County has handled the entire pandemic thus far, Lindley said with pride.

It has always been our objective in dealing with COVID to be as aggressive and quick in the response as we possibly can, he said. We did it with testing by standing up the first drive-thru test center in the state. We were the first hospital to receive the mass vaccination distribution from the state of Colorado.

Once we heard whispers that this was likely coming, aligning with that aggressive approach, we started planning, staffing, we ordered more vaccine and supplies so we had it all on hand by last week so we would be ready to go, Bergeron said.

Part of the reason why Colorado Mountain Medical was able to mobilize so quickly was due to the significant surplus of vaccine doses in Eagle County, but also across the United States, Lindley said.

The United States has millions and millions, hundreds of millions, of doses of vaccine that are available, he said. Theres no shortage of vaccine in the United States of America.

The third shot has not been recommended for the broader population quite yet but, based upon murmurings about an announcement from the CDC and President Joe Bidens administration, guidance for the general public is likely to come soon, Lindley said.

Harmon said he cannot be sure whether a subsequent priority group will be announced or if eligibility for the third doses will be opened to all.

I would imagine that theyll continue to look at data and still look first and foremost at whos going to benefit most from receiving third doses, he said. We may see an additional tier 2 group for immunocompromised individuals in the future.

Lindley urged residents to continue following local, state and federal public health guidance and to get a third shot as they are eligible to maintain their immunization against COVID-19 as community spread of the Delta variant continues to rise.

Just like the annual influenza vaccines, I think we should all prepare to get annual or even more frequent COVID-19 vaccines, Lindley said. COVID is here to stay. I do not believe there will be a time in our lives that we will be alive that COVID is not here.

Theres six very common circulating COVID viruses that have been around for hundreds of years. Its our common cold. This is just another dimension of it, he continued. Its going to continue to mutate, so, we need to learn to deal with it, to protect ourselves and to do that immunization is our best tool. So, stay immunized, stay protected.

Email Kelli Duncan at kduncan@vaildaily.com

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Eagle County begins offering third vaccine doses to the immunocompromised - Vail Daily News

CDC: Third Dose Of COVID-19 Vaccine Recommended For Moderately & Severely Immunocompromised Individuals Only – KSST

CHRISTUS Mother Frances Hospital Sulphur Springs Business News August 17, 2021 CHRISTUS Mother Frances Hospital Sulphur Springs has ONE mission: To Extend the Health Ministry of Jesus Christ. By Holly Ragan, Senior Market Development, CHRISTUS Mother Frances Hospital Sulphur Springs, [emailprotected] Thank you for your patience!

Due to a sharp increase in Emergency Room visits as a result of the spike in COVID-19, please expect longer wait times than normal. Rest assured we are doing everything we can to provide high quality care in a timely manner. Thank you in advance for allowing us to provide for your healthcare needs, while extending grace to our staff.

CHRISTUS Mother Frances Hospital Sulphur Springs will host a COVID Vaccine Clinic every Friday morning from 9am to 11am in the main lobby of the hospital until further notice. The available vaccines include Moderna (2-doses, ages 18 and older), Pfizer (2-doses, ages 12 and older) and Johnson & Johnson (1-dose, ages 18 and older), Appointments not required, but parent/guardian must accompany anyone 17 and younger.

News from the Texas Department of State Health Services:

On Aug. 12, 2021, the Food and Drug Administration (FDA) revised both Pfizer and Moderna COVID-19 Vaccine Emergency Use Authorization fact sheets to include guidance on administering an additional dose in certain immunocompromised individuals.

Yesterday, the Centers for Disease Control and Preventions Advisory Committee on Immunization Practices (ACIP) recommended that people whose immune system are moderately to severely compromised receive an additional dose of mRNA COVID-19 vaccine at least 28 days after an initial two-dose mRNA series (Pfizer or Moderna).

ACIPs recommendation includes people with a range of conditions, such as recipients of organ or stem cell transplants, people with advance or untreated HIV infection, active recipients of treatment for cancer, people who are taking some medications that weaken the immune system, and others. A full list of conditions can be found on CDCs website: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html.

The additional dose should be the same vaccine product as the initial two-dose mRNA COVID-19 vaccine series (Pfizer-BioNTech or Moderna). If the mRNA COVID-19 vaccine product given for the first two doses is not available, the other mRNA COVID-19 vaccine product may be administered. A person should not receive more than three mRNA COVID-19 vaccine doses.

Its important to note that an additional dose is only recommended for individuals who are moderately or severely immunocompromised CDC does not recommend additional doses or booster shots for any other population at this time.

Currently, there are insufficient data to support the use of an additional mRNA COVID-19 vaccine dose after a single-dose Janssen COVID-19 vaccination series in immunocompromised people. FDA and CDC are actively working to provide guidance on this issue.

Immunocompromised individuals may discuss with their health care provider whether getting an additional dose is appropriate for them. If their health care provider is not at a site administering vaccines, these individuals can self-attest and receive the additional dose wherever vaccines are offered.For more information, please visit: https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html.

The Carter BloodCare Bus will be parked in the front parking lot of our hospital in Sulphur Springs on Wednesday, August 18, 2021, from 9 a.m. until 2 p.m. Our local blood supply is at an all-time low creating a serious supply issue.

To sign up to give blood, or for questions, please call Yeon Mi Kim at 903.438.4380 or call/text Carter Bloodcare at 800.366.2834. All donors will receive a free t-shirt.

FREE Saturday Athletic Injury Clinic for student athletes of all ages is here! Saturday sports clinic will be held every Saturday from 9 a.m. to 11 a.m., on August 21 through November 13. Athletes will get an exam and free x-ray to determine a plan of care to treat their injury. The location will be the CHRISTUS Trinity Clinic Orthopedic Office at 103B Medical Circle in Sulphur Springs.

For more information about our Sports Medicine program, or Orthopedic services, please call our office at 903.885.6688.

With COVID cases rapidly increasing in our community, the hospital requires all visitors to wear a mask while in the facility. There is no entry into the hospital without a mask. Visitors may wear a cloth or medical mask. Thank you for your continued support of the safety of our patients and associates.

While some hospitals are on divert due to a critical COVID surge, CHRISTUS Mother Frances Hospital continues to serve patients, and has available hospital beds, both for COVID and non-COVID diagnoses.

Please note the following guidelines for hospital visitation:

The CHRISTUS Urgent Care hours of operation are as follows:

The Urgent Care is located at 1339 S. Broadway, and the phone number to call is 903.951.1001.

CHRISTUS Trinity Mother Frances Health System includes CHRISTUS Mother Frances Hospitals Tyler, South Tyler, Jacksonville, Winnsboro and Sulphur Springs; the CHRISTUS Trinity Mother Frances Louis and Peaches Owen Heart Hospital Tyler; CHRISTUS Trinity Mother Frances Rehabilitation Hospital, a partner of Encompass Health; Tyler Continue CARE Hospital at CHRISTUS Mother Frances Hospital, a long-term acute care facility; and CHRISTUS Trinity Clinic.

CHRISTUS Trinity Clinic is the areas preferred multi-specialty medical group, with more than 400 Physicians and Advanced Practice Providers representing 36 specialties in 34 locations serving Northeast Texas across 41 counties.

For more information on services available through CHRISTUS Trinity Mother Frances Health System, visit christustmf.org

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CDC: Third Dose Of COVID-19 Vaccine Recommended For Moderately & Severely Immunocompromised Individuals Only - KSST

New CEO, check. $172M round, check. Wugen’s off-the-shelf cell therapies are ready for takeoff – FierceBiotech

When Dan Kemp was plottinghis next move after Takeda, he was blown away by data from Wugen, a biotech working on off-the-shelf natural killer (NK) cell therapies. Now, after four months in the CEO seat, hes ready to take those treatments to the next level with a $172 million financing.

The proceeds will bankroll the development of the companys memory NK cell platform and advance its lead program, WU-NK-101, through a phase 1/2 trial in acute myeloid leukemia (AML) and into new studies in solid tumors. The funding will also support Wugens broader pipeline, including an allogeneic CAR-T treatment for T-cell leukemia and lymphoma.

Wugen is one of several biotechs pursuing NK cell therapies to go where CAR-T treatments cannot. Despite its success in blood cancers, CAR-T has faced challenges in solid tumors. And all four of the FDA-approved CAR-T treatments are autologous, meaning theyre made from a patients own cells, which stops them from being widely available.

RELATED: Catamaran Bio sets sail with $42M to create off-the-shelf CAR-NK treatments

The biggest differentiator [of NK cell treatments] from CAR-T is the fact that there is this continual concern around safety. Cytokine release syndrome or neurotoxicity appear to be unavoidable consequences of CAR-T cell therapy, Kemp said, referring to side effects of CAR-T that happen when the treatment activates the immune system too strongly.

T-cell therapy developers have learned to expect these effects and try to manage them rather than avoid them. But NK cell treatments may become a safer alternative.

On the NK side of things, weve seen no toxicity at all; its a pristine safety profile, Kemp said. Thats consistent with other NK cell products that are in the clinic as well.

And thats not allWugen reckons its approach could have an advantage over other NK cell treatments. Its platform generates memory NK cells, which are better at killing cancer cells and last longer in the body than conventional NK cells.

RELATED: Sanofi inks $358M Kiadis takeover to acquire NK-cell platform

Conventional NK cells, like those derived from stem cells, cord blood or peripheral blood, must be engineered to provide sufficient potency to drive any clinical efficacy, Kemp said. Memory NK cells and WU-NK-101 have shown significant efficacy in AML without any engineering at all.

We essentially prime the cells into a superpotent phenotype and expand them so we can actually leverage the innate ability of NK cells themselves to have true clinical potency, he added.

That said, the company plans to combine its NK cell treatments with other cancer-fighting drugs and make engineered NK cell products that could work even better, Kemp said.

Moving forward, Wugen will start a global, multicenter study for WU-NK-101 and file an IND for its CAR-T program in T-cell leukemia and lymphoma later this year, Kemp said. Trials of WU-NK-101 in solid tumors will follow in 2022. As it ramps up its pipeline, the company will aggressively build its team. It currently has 40 staffers across sites in St. Louis and San Diego.

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New CEO, check. $172M round, check. Wugen's off-the-shelf cell therapies are ready for takeoff - FierceBiotech

Arbor Strengthens Focus on Therapeutics with Key Additions to Leadership Team – Yahoo Finance

- Pam Stetkiewicz, Ph.D., Appointed Chief Operating Officer - Kathryn McCabe, Ph.D., Named SVP, Head of Business Development

CAMBRIDGE, Mass., July 20, 2021 (GLOBE NEWSWIRE) -- Arbor Biotechnologies, an early-stage life sciences company discovering and developing the next generation of genetic medicines, announced today the appointments of Pam Stetkiewicz, Ph.D., as Chief Operating Officer, and Kathryn McCabe, Ph.D., as SVP, Head of Business Development. These appointments further expand Arbors leadership team and strengthen its focus on therapeutics.

Bringing Pam and Katy on at this time represents a significant milestone for Arbor as we drive our genetic medicines portfolio to the clinic and partner with leading companies to bring engineered cell therapies to patients, said Devyn Smith, Ph.D., CEO, Arbor Biotechnologies. Their scientific expertise, business acumen, and extensive experience in cell therapy and gene editing will help us execute on this strategy to develop therapeutics with our tailored library of CRISPR-based genetic editors and modifiers.

Pam Stetkiewicz is joining Arbor from Flagship Pioneering, where she was Senior Vice President, Global Program Leader at Flagship Pioneering Medicines. Dr. Stetkiewicz brings more than 20 years of extensive life-sciences pharmaceutical experience with recent experience at Editas Medicine as Vice President, Program and Alliance Management. At Editas, she led the team that filed the first IND for an in vivo CRISPR therapeutic (EDIT-101 for LCA10). Prior to Editas, Dr. Stetkiewicz worked at Novartis Institute of Biomedical Research for 13 years, in a variety of roles across science, alliance, project and portfolio management. Her last role at Novartis was as Executive Director, in Strategic Alliances which involved early business development and collaborations with external companies. She received her Ph.D. from Johns Hopkins University and a B.S. from the University of Rhode Island.

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Im thrilled to be joining Arbor at this exciting time, said Dr. Stetkiewicz. The company has made significant progress in the discovery and development of innovative therapies, particularly in the genetic medicines space, and I am looking forward to helping fulfill the therapeutic promise of Arbors already impressive discoveries.

Kathryn (Katy) McCabe is joining Arbor from Roche where she was Senior Director of Business Development based in Cambridge, MA. Over the last 20 years, she has combined her scientific knowledge, entrepreneurial spirit, and business experience to help transform novel modalities into new medicines at Roche, Lilly, Baxalta and GSK. Dr. McCabe has focused much of her attention on cell and gene therapy and has closed deals for CAR-T, diabetes cell therapy, in vivo gene editing, and gene therapy as well as led large strategic initiatives in these areas. In addition, she has had close interactions with a number of venture funds as the scientific lead for Lillys limited partnerships. Early in her career, Dr. McCabe led a team of senior scientists to develop stem cells for retina and corneal transplantation. She was a Postdoctoral Fellow in Dr. Marianne Bronners lab at Caltech, received her Ph.D. in Neuroscience and Behavior from the University of Washington, and her B.A from the University of Pennsylvania.

I look forward to finding partners that share our vision of bringing curative therapies to patients, said Dr. McCabe.

About Arbor Biotechnologies Arbor Biotechnologies is an early-stage life sciences company discovering and developing the next generation of genetic medicines. Co-founded by Feng Zhang and David Walt, Arbor uses its proprietary discovery engine to uncover unique CRISPR-based genetic modifiers with differentiated genetic editing and delivery capabilities. Following its strategic partnership with Vertex Pharmaceuticals to accelerate the path to the clinic for Arbors technologies, Arbor recently announced an agreement with Lonza. These partnerships further validate the breadth of applications of Arbors gene editing platform that can be custom tailored to address the underlying pathology of each genetic disease. Arbors pipeline of genetic medicines is focused on bringing curative therapies to all patients with genetic disease.

Media Contact: Kelly Friendly press@arbor.bio

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Arbor Strengthens Focus on Therapeutics with Key Additions to Leadership Team - Yahoo Finance

For Patients with HIV and Cancer, a Multidisciplinary Treatment Approach is Critical – Targeted Oncology

As a medical oncologist with a particular interest in the intersection of HIV and cancer, I have seen how cultural taboos as well as economic and demographic forces can still affect care. I have treated patients who dont wish to disclose that they have HIV, and who are willing to drive a hundred miles or more to refill medications in a different town or state to ensure their anonymity. Economically disadvantaged patients often dont have a complete care network, instead relying on their primary care physician and/or a cancer specialist for their treatment.

In 2018, the National Comprehensive Cancer Network (NCCN) published new NCCN Clinical Practice Guidelines in Oncology intended to help make sure people living with HIV who also receive a cancer diagnosis receive safe, necessary treatment.1 The guidelines highlight the disparities in cancer care for people living with HIV and point to the special considerations these patients require.

At Miami Cancer Institute, part of Baptist Health South Florida, we have opened a new HIV/Cancer Clinic to provide these particularly complex patients with better access to new clinical trials as well as coordinated, multidisciplinary care in one location. The program has also been accepted to the AIDS Malignancy Consortium (AMC), which is funded by the National Cancer Institute, to support our clinical trials and enhance our information sharing with other AMC members.

At various points during their treatment, patients at the Miami Cancer Institute HIV/Cancer Clinic will encounter a full spectrum of specialists including oncologists, infectious disease specialists, pharmacists specialized in oncology and infectious disease, nurse practitioners, clinical nurses, medical assistants, palliative care specialists, oncology dentists, psychologists, social workers and case managers. Our cancer clinics operate under one roof so that patients can see multiple specialists and caregivers in one visit. The team essentially assumes the role of primary care provider for the patient, coordinating every aspect of care and meeting periodically as a team to review the patients status.

Physicians who wish to refer HIV-positive patients for cancer care should seek out centers that have the expertise and capabilities to deal with complex cases. For example, Miami Cancer Institute has already performed an allogeneic stem cell transplant on a patient who has both HIV and an aggressive form of plasmablastic lymphoma. The procedure involved finding a matching donor who also had a specific mutation in a gene that offers resistance to HIV infection. Typically, it can take up to two years before a patient such as this can be declared cured, however, the patient is currently doing well six months after transplantation.

Lastly, I recommend that referring physicians look for centers that have a robust clinical trials program. At Miami Cancer Institute, we are presently recruiting HIV patients for seven clinical trials soon to increase to ten for various conditions including Kaposis Sarcoma, lymphomas, cervical cancer, and lung cancer. Even patients with very aggressive lymphomas may be good candidates for a clinical trial.

Reference:

Reid E, Suneja G, Ambinder R, et al. Cancer in people living with HIV, Version 1.2018, NCCN Clinical Practice Guidelines in Oncology.J Natl Compr Canc Netw. 2018;16(8):986-1017. doi. 10.6004/jnccn.2018.0066.

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For Patients with HIV and Cancer, a Multidisciplinary Treatment Approach is Critical - Targeted Oncology

Keeping the physical appointment was critical, the show of support appreciated by Renville County Commissioner – West Central Tribune

When he called the Olivia Hospital and Clinic to postpone his physical, he was urged to keep it. Physicals are important, he was reminded.

Keeping that date proved to be a lifesaving decision.

The physical went well, and shortly after he told his daughter that he was as fit as a horse.

But Dr. Jon Kemp, his primary physician who had urged him to keep the date for the physical, noticed a slight abnormality in a standard blood test. He recommended further testing.

On Dec. 20 Kramer was diagnosed with multiple myeloma.

Thanks to the early diagnosis, Kramer, age 62, has the means of keeping this disease at bay. Its a cancer of the plasma cells in bone marrow, and is the second most common blood cancer.

He is about to undergo a stem cell transplant this week as part of his treatment.

He learned that hes not alone on the journey ahead.

At Tuesdays meeting of the Renville County Board of Commissioners, fellow board members came wearing T-shirts proclaiming: In this county, nobody fights alone.

Organizers of the surprise sold 76 of the T-shirts to show support for Kramer and raise funds for the Renville County Walk in the Park campaign. More than 40 T-shirt wearing supporters joined the meeting via Zoom. Staff in the health department sang a song to express their support, and staff members told him they would keep him in their thoughts and prayers.

Thank you, said Kramer. He told the West Central Tribune that he was totally surprised by the display of support.

He has lots of support from family and friends, and its all-important. Kramer farms in eastern Renville County. He has lined up plenty of helping hands while he undergoes the stem cell transplant, which will sideline him for at least six weeks.

He said doctors are confident the stem cell transplant can knock the cancer into remission. They will be harvesting bone marrow cells and freezing a portion of them to make it possible to perform at least two more transplants in future years as well.

The decision to keep the date of that routine physical made all the difference. Absolutely, said Kramer.

Health providers told him that in too many cases, multiple myeloma is not diagnosed until a patient comes in with a broken leg or other bone, and wondering why. The cancer carves holes and weakens bones as it progresses unbeknownst to the person.

Thanks to the early diagnosis, Kramer said they found only pinholes in his bones, having caught the disease in the first of its three stages. He began chemotherapy in early January, and it has proven effective, he added.

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Keeping the physical appointment was critical, the show of support appreciated by Renville County Commissioner - West Central Tribune

Appia Bio aims for a new kind of off-the-shelf CAR-T with $52M raise – FierceBiotech

Nobel Prizewinner David Baltimore, Ph.D.has always dreamed of turning Los Angeles into a biotech hub. He tried to help it along as president of the California Institute of Technology some 20 years ago, but the idea didnt seem to stick. Now, hes getting another crack at it with a new cancer cell therapy company co-founded with a group of Caltech and Kite Pharma alums.

Appia Bio launches with $52 million to develop off-the-shelf cell therapies for cancer based on hematopoietic, or blood-forming, stem cells. Its platform, dubbed ACUA, allows the programming of stem cells to become invariant natural killer T (iNKT) cells, a powerful subtype of T cell that some folks think of as a hybrid between a natural killer (NK) cell and a T cell, said JeenJoo JJ Kang, Ph.D., CEO of Appia Bio.

Though everybody has iNKT cells in their body, these cells are exceedingly rare. They make up just a fraction of white blood cells found in the peripheral blood, so its hard to produce them in the traditional way, which is to draw blood and expand those cells, Kang said.

[iNKT] cells have multiple tumor cell-killing mechanisms through the natural killer and T cell pathway, she added. Were going to engineer them with a CAR and we think that is positive because it can address more heterogeneous tumor antigen presentations and get around antigen loss.

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Antigen loss or antigen escape is a process in which cancer cells stop expressing the antigen the CAR-T is designed to hunt down, such as CD19. Targeting more than one antigen could disrupt that escape mechanism and prevent relapse. It could also improve the odds of cell therapy working in solid tumorsa major pain point.

Besides solving these problems, Appia also hopes to address the barrier of access. Autologous cell therapiesthat is, those made from a patients own cellsare complex, expensive and time-consuming to make. Some patients dont have enough T cells or T cells of good enough quality to make those treatments.

Producing large amounts of iNKT cells from stem cells that can be stored until theyre needed could make cell therapy available to more patients and at a lower cost.

Being able to mass-produce a cell therapy product that can be dosed to thousands of patients out of a single manufacturing run can significantly affect the economics of what the viable price point is, Kang said. That is another aspect that is a part of our goals: to bring that price down.

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The ACUA technology is based on research out of the laboratory of co-founder Lili Yang, Ph.D., an associate professor at the University of California, Los Angeles who worked under Baltimore as a student and postdoc at Caltech.

Appias founding team also includes Pin Wang, Ph.D., of the University of Southern California and Kite alums Edmund Kim, Ph.D., and Jeff Wiezorek, M.D. Kim, who led corporate development at Kite, is Appias chief operating officer. Wiezorek,who led cell therapy development at Kite, is Appias chief medical officer.

Gilead acquired Kite in 2017, the same year its first CAR-T therapy, Yescarta, scored FDA approval. Later on, Wiezorek and Kims search for their next project coincided with the maturation of Yangs technology at UCLA.

Bringing the two together made a lot of sense, so we did that, Baltimore said. Kang came on board from The Column Group, the VC shop she joined in 2015 after completing her Ph.D. atyou guessed itCaltech.

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With the series A round in the bank, the team will turn to company building and advancing its lead programs in blood cancers and solid tumors, with plans to be in the clinic by the end of 2023, Kang said. 8VC led the financing, while Two Sigma Ventures, Sherpa Healthcare Partners and Freeflow Ventures also chipped in.

The company is setting up shop in Los Angeles County.

Im overjoyed that were getting space in Culver City and the people that we found really appreciate Los Angeles, Baltimore said. Maybe we can make it a biotech hubwe'll seebut at least we can get this company going."

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Appia Bio aims for a new kind of off-the-shelf CAR-T with $52M raise - FierceBiotech

Experimental treatments risk further medicalisation of menopause – The BMJ

Many women experience debilitating menopause symptoms. Fledgling interventions aimed at delaying menopause or treating symptoms are attracting commercial interest, but robust evidence of potential benefit and harms for patients is lacking. Sally Howard reports

Ovarian tissue cryopreservation and transplantation (OTCT)surgical procedures successfully used to restart ovarian function in young women who have undergone chemotherapy1are being offered to healthy women in the United Kingdom with a view to reinstate their pre-menopausal endocrine function. But robust evidence of effectiveness and safety in this indication is lacking, and some experts see this as overmedicalisation of menopause.

The private Birmingham based clinic Profam charges healthy women between 7000 and 11000 (8000-12500; $9500-$15000) for OTCT. Before menopause, a slice of oocyte rich ovary is laparoscopically resected, cryopreserved, and then regrafted into the pelvis or subcutaneously in the forearm after menopause.

Meanwhile, patients in Canada are being advertised a proposed surgical treatment for early menopause that would involve transferring newly recognised germline stem cells from the ovarian lining to the ovary despite limited knowledge of their development into new oocytes.2 Fertility CARE: The IVF Center, a clinic based in Florida, US, markets the treatment OvaPrime as a means of stopping your biological clock, which is on the cusp of being approved for mainstream use just over the northern border.3

Were seeing something like the commercial big bang that happened with IVF in the 1990s, says Evelyn Telfer, a biologist at the University of Edinburgh who researches the clinical potential of germline oocyte precursor cells. Private IVF clinics have proliferated since the 1990s, and some now sell a plethora of non-evidence based add-on interventions. This risks what we saw with IVFpatients paying a lot of money for treatments not ready to be rolled out, she says.

ProFams cofounder Simon Fishel, an IVF scientist,

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Experimental treatments risk further medicalisation of menopause - The BMJ