Exploring The Donor-Derived CAR T-Cell Therapy, ALLO-501A – Targeted Oncology

Michael T. Tees, MD, an associate member physician at the Colorado Blood Cancer Institute and part of the Lymphoid and Autoimmune Disease Groups, discusses chimeric antigen receptor (CAR) T-cell therapies, including ALLO-501A, and its use for patients with relapsed or refractory large B-cell lymphoma (LBCL).

ALLO-501A is an anti-CD19 allogeneic CAR T-cell product with a disrupted TCR gene and an edited CD52 gene. Based on early research, the agent may reduce the risk of graft-versus-host disease, and allow the use of the humanized anti-CD52 mAb, ALLO-647 to decrease the number of host T cells for patients.

The agent was first evaluated in the ALPHA1 study (NCT03939026) where no dose modifications or dose-limiting toxicities were observed, and the most common adverse events (AEs) reported consisted of anemia, leukopenia, neutropenia, and thrombocytopenia (73%), and lymphopenia (64%). Then, the ALPHA2, (NCT04416984) study continued to explore the safety and efficacy of ALLO-501A in patients with relapsed/refractory LBCL.

TRANSCRIPTION:

0:08 | CAR T-cell therapy has been around for quite some time. It's been about 5 years since the first CAR T product was approved by the FDA, which was an autologous product. It's the patient's own cells that are genetically re-engineered to recognize that the cancer is foreign. Typically, it's CD19.

0:37 | ALLO-501A is a clinical trial evaluating not autologous CAR T cells, but allogeneic CAR T cells using cells from a donor population to achieve the same effect as using your own cells. [There are multiple reasons] why this is important to investigators. Primarily, there is a lag time between when we need to collect those donor cells and send them away for re-engineering until we can do the treatment for the patient. That lag time can be dangerous and potentially deadly for those patients who have refractory diseases. Having an off-the-shelf product ready to go, if it's safe, is key. We would not have the potential 3-to-4-week lag time of the processing and collection, which is extremely important.

1:54 | What we're also seeing now is a backlog for the products that are commercially available because they can't keep up with that demand. With this agent, the product is ready to go from a different donor with comparable benefit and efficacy, and ideally, an even better safety profile would make this the ideal situation.

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Exploring The Donor-Derived CAR T-Cell Therapy, ALLO-501A - Targeted Oncology

Rich Insights into the Heart Failure Clinical Trial Analysis Featuring … – PR Newswire

Currently, much research is ongoing to develop new and effective therapeutic drugs for the treatment of Heart failure. The treatment of HF is dependent on angiotensin-converting enzyme inhibitor, angiotensin receptor II blocker, beta-blockers, and diuretics. Additionally, other therapies, such as aldosterone antagonists, amiodarone, antiaggregants, anticoagulants, calcium antagonists, diuretics, nitrates, among others are used for the treatment of patients affected by heart failure. Biomarkers provide a low cost, low risk, and quick turnaround method to confirm or exclude a HF diagnosis, help to establish prognosis in the diagnosis, and more fundamentally, may provide substantial information on the complex pathophysiology that defines the syndrome of HF.

LAS VEGAS, April 4, 2023 /PRNewswire/ --DelveInsight's 'Heart Failure Pipeline Insight 2023'report provides comprehensive global coverage of available, marketed, and pipeline heart failure therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the heart failure pipeline domain.

Key Takeaways from the Heart Failure Pipeline Report

Request a sample and discover the recent advances in heart failure drug treatment @ Heart Failure Pipeline Report

The heart failure pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage heart failure drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the heart failure clinical trial landscape.

Heart Failure Overview

Heart failure is a syndrome caused by structural and functional defects in the myocardium that impair ventricular filling or blood ejection. Reduced left ventricular myocardial function is the most common cause of heart failure. Increased hemodynamic overload, ischemia-related dysfunction, ventricular remodeling, excessive neuro-humoral stimulation, abnormal myocyte calcium cycling, excessive or inadequate extracellular matrix proliferation, accelerated apoptosis, and genetic mutations are major pathogenic mechanisms leading to heart failure. Heart failure can significantly reduce a patient's functional capacity and increase the risk of death. Diagnosing and treating the disease effectively is critical to avoid recurrent hospitalizations, improve quality of life, and improve patient outcomes.

Heart failure treatment necessitates a multifaceted approach that includes patient education, an optimal medical regimen to improve cardiac contractility, and the prevention/limitation of exacerbations. The primary heart failure symptoms are dyspnea and fatigue, which can limit exercise tolerance and lead to pulmonary and splanchnic congestion and peripheral edema. Heart failure is still a difficult problem and is now regarded as the most difficult challenge in cardiovascular medicine and surgery.

Find out more about drugs for heart failure @ New Heart Failure Drugs

A snapshot of the Heart Failure Pipeline Drugs mentioned in the report:

Drugs

Company

Phase

MoA

RoA

Tirzepatide

Eli Lilly and Company

Phase III

Gastric inhibitory polypeptide receptor agonists; Glucagon like peptide 1 receptor agonists

Subcutaneous

Finerenone (BAY94-8862)

Bayer

Phase III

Mineralocorticoid receptor antagonists

Oral

Firibastat

Quantum Genomics

Phase II

Glutamyl aminopeptidase inhibitors

Oral

HU 6

Rivus Pharmaceuticals

Phase II

Metabolism stimulants

Oral

Elamipretide

Stealth BioTherapeutics

Phase II

Cardiolipin modulators; Free radical scavengers; Mitochondrial permeability transition pore inhibitors

Subcutaneous

TN-301

Tenaya Therapeutics

Phase I

HDAC6 protein inhibitors

Oral

Learn more about the emerging heart failure pipeline therapies @ Heart Failure Clinical Trials

Heart Failure Therapeutics Assessment

Theheart failure pipelinereport proffers an integral view of heart failure emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration.

Scope of the Heart Failure Pipeline Report

Dive deep into rich insights for new drugs for heart failure treatment; visit@ Heart Failure Medications

Table of Contents

1.

Heart Failure Pipeline Report Introduction

2.

Heart Failure Pipeline Report Executive Summary

3.

Heart Failure Pipeline: Overview

4.

Analytical Perspective In-depth Commercial Assessment

5.

Heart Failure Clinical Trial Therapeutics

6.

Heart Failure Pipeline: Late Stage Products (Pre-registration)

7.

Heart Failure Pipeline: Late Stage Products (Phase III)

8.

Heart Failure Pipeline: Mid Stage Products (Phase II)

9.

Heart Failure Pipeline: Early Stage Products (Phase I)

10.

Heart Failure Pipeline Therapeutics Assessment

11.

Inactive Products in the Heart Failure Pipeline

12.

Company-University Collaborations (Licensing/Partnering) Analysis

13.

Key Companies

14.

Key Products in the Heart Failure Pipeline

15.

Unmet Needs

16.

Market Drivers and Barriers

17.

Future Perspectives and Conclusion

18.

Analyst Views

19.

Appendix

For further information on the heart failurepipeline therapeutics, reach out @ Heart FailureDrug Treatment

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Heart FailureEpidemiology Forecast

Heart Failure Epidemiology Forecast 2032report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and heart failureepidemiology trends.

Advanced Heart Failure Pipeline

Advanced Heart Failure Pipeline Insight 2023report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the keyadvanced heart failurecompanies, including Sana Biotechnology, Salubris Biotherapeutics, Roche, Rivus Pharmaceuticals, Ribomic, Renova Therapeutics, Relaxera, among others.

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Acute Heart Failure Pipeline

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Rich Insights into the Heart Failure Clinical Trial Analysis Featuring ... - PR Newswire

Timing is everything – ASBMB Today

Congratulations on the acceptance of your manuscript.

It was strange to read this, since the project almost never happened.

Two years and seven months earlier, only sunlight illuminated the dim, silent hallway and adjoining quiet lab spaces. I hastened down the hall, slowing only to glance at flyers advertising seminars from March 2020. A month outdated, they were a relic from the time before COVID-19 froze academic life, despite the initial drumbeat of We will remain open.

Teisha Rowland

Much of the work Teisha Rowland, left, did to guide her student Ashlynn through her undergraduate research project had to be done remotely.

As the stem cell centers director, Id become what the university termed an essential worker, tasked with minding the centers frozen cell bank. While checking the cryogenic tank, I glanced at Ashlynns empty desk.

Ashlynn was an impressive undergraduate assistant; we wanted to start a research project. It would use human induced pluripotent stem cells, or iPSCs the centers specialty to investigate whether the extracellular matrix impacts cardiomyocyte differentiation.

Like many labs, we were pivoting. We were thrilled that Ashlynns summer research proposal had been approved but chose to delay funding until fall 2020.

We decided a remote literature review project would be best, helping prepare Ashlynn for bench research in the fall. This is going to be an incredible learning experience for me, Ashlynn raved.

With few funding options as a director, I was grateful for departmental professional development funds for her stipend.

Over the summer, Ashlynn made great progress on the literature review. We met twice a week via Zoom and exchanged many emails to discuss papers and flesh out the manuscript. At the summers end, we passed the manuscript torch to another undergraduate researcher, Tessa.

Ashlynn meanwhile attended one of the centers iPSC training workshops and then dug into her research in the lab that fall. Armed with a protocol we reviewed remotely, she finally tried the differentiation.

I remember going into the lab, excited to check on her cells. Carefully taking the plate from the incubator, I set it on the microscope and searched for cells. My heart may have skipped a beat when I saw Ashlynns cardiac cells contracting. She had successfully executed the protocol, on her own, on her first try.

By April 2021, research was mostly back to normal, but now our clock was ticking. After two years as the centers founding director, I was ready for new career adventures, but Ashlynns project was unfinished.

We selected extracellular matrix proteins and planned out our best-shot experiment.

And it worked. Sitting with Ashlynn in the centers dark, cozy fluorescence microscopy room, I gave her a crash course on collecting images. She continued collecting images after I left that day. With those and her detailed notes, it would have to be enough and amazingly, it was.

Ashlynn graduated in spring 2022 with an honors thesis built upon these experiments. That fall, we wrapped up the literature review, including Ashlynns data, and after peer review, it was published.

I was honored that, despite a pandemic, I published with an undergraduate listed as first author.

(The manuscript Teisha Rowland writes about here with multiple undergraduate co-authors was published in the journal Bioengineering.)

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Timing is everything - ASBMB Today

One Stem Cell Injection to Target Inflammation Slashed Risk of … – Good News Network

Dr. Perin holds up the stem cell treatment Texas Heart Institute

A large trial showed that a single injection of a patients own stem cells into their heart was able to reduce inflammation and risk of heart attack and stroke by 58% if they had heart failure.

6 million Americans have clinical diagnoses of heart failure, a condition designated by a lack of ability for the heart to pump blood sufficiently.

For the first time, weve discovered that stem cells can successfully treat the inflammation that causes heart failure, study lead author Dr. Emerson Perin, told the European Pharmaceutical Review.

Its the largest clinical trial of cell therapy for heart disease to date and demonstrated several positive results. Before understanding the cure, its worth taking a moment to understand the problem.

When less than 40% of the blood inside the heart is pumped out into the body, an individual has heart failure, and could in theory at any moment suffer a cardiovascular event like a heart attack. This is called left ventricular ejection fraction (LVEF), with a healthy persons fraction being 55%-70%.

Because inflammation is closely associated with heart diseaseboth arise from the same poor lifestyle patterns which cause the majority of cases of heart diseasecardiologists at the Texas Heart Institute designed a treatment that could address the inflammation.

What they selected were stem cells taken from a patients bone marrow called mesenchymal precursor cells, which are replicated in a lab via proprietary methods developed by a pharmaceutical company called Mesoblast, and injected straight into the heart.

MORE NEWS ON STEM CELLS: Sound Waves Convert Stem Cells Into Bone in Regenerative Breakthrough

First and foremost, the treatment, called rexlemestrocel-L, was well-tolerated and didnt cause additional inflammation in any patients who received it. Secondly, the treated patients showed increased performance of LVEF; their hearts were pumping out more blood volume.

We are very encouraged by these study data that indicate the potential of our allogeneic cellular therapy to address the major areas of unmet need in heart failure patients where conventional treatments are not effective, said Mesoblast CEO Dr. Silviu Itescu in a statement.

MORE NEWS ON STEM CELLS: Yale Scientists Successfully Repair Injured Spinal Cords Using Patients Own Stem Cells

Improvement in LVEF at 12 months may be a functional surrogate endpoint for rexlemestrocel-Ls subsequent benefits on long-term MACE outcomes and survival in this high-risk patient population with chronic heart failure.

The trial was a phase 3, double-blinded, placebo-controlled trial, i.e. the gold standard for medicine, and it should open up the door to future trials of the same kind and turn the research into real treatments for thousands of people.

SHARE This Encouraging Study Result With Your Friends

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One Stem Cell Injection to Target Inflammation Slashed Risk of ... - Good News Network

BioCardia Announces Issuance of Two Patents Related to … – BioSpace

SUNNYVALE, Calif., April 04, 2023 (GLOBE NEWSWIRE) -- BioCardia, Inc.[Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced the issuance of two patent grants related to enabling technologies for delivery of its investigational autologous and allogeneic cell therapies.

The United States Patent Office issued BioCardia Patent Number 11,716,859, entitled Multi-Directional Steerable Catheter, with a patent term that will expire in 2035. The patent claims a fundamental design for steerable introducer sheaths, such as those used for BioCardias autologous and allogeneic cell therapy procedures, and for transseptal procedures for the treatment of cardiac arrhythmias. The design enables the tensioning elements in the catheter to rotate around the catheter shaft, allowing consistent catheter performance in any direction. This design is intended to enable smooth navigation and prevent whip, when a catheter in the heart suddenly jumps from one orientation to another due to the build-up of mechanical forces in the device. This patented design is incorporated in the Companys FDA-cleared Morph DNA product, a 5 French sheath equivalent, and in the Companys FDA-cleared Avance product, an 8.5 French introducer sheath indicated for transseptal procedures.

The Indian Patent Office granted the Company Patent Number 424579, entitled Steerable Endoluminal Devices and Methods for Use, with a patent term that will expire in late 2031. The patent claims a fundamental design for steerable introducer sheaths. The design is for a coil with a braid disposed coaxially about the coil, all embedded within the wall of an introducer sheath. The coil enables a robust, kink-resistant design with enhanced column support, while the braid in the catheter shaft provides for excellent torque transmission. This patent design feature has demonstrated excellent performance in the Companys Morph Access Pro product family and has been used to treat approximately 10,000 patients to-date, ranging from a two-year-old girl to a 90-year-old man.

This positive experience with the Morph DNA, Avance, and Morph AccessPro underlies our understanding of catheter navigation that informs the delivery of our higher-value biotherapeutic interventions, where we utilize steerable guide sheaths in every procedure, said BioCardia CEO Peter Altman, PhD. The acquisitions of Baylis by Boston Scientific for $1.5 billion and the acquisition of the Acutus sheath portfolio by Medtronic for $87 million last year were focused on enabling transseptal access devices, like these, that enable ablation therapies to treat cardiac arrhythmias. These acquisitions show that these steerable catheter assets are nontrivial to develop and that the intellectual property that underlies these assets has the potential to enable large market opportunities and be quite valuable.

These new patents are anticipated to strengthen the protection of BioCardias efforts with respect to its cardiovascular therapeutic approaches and provide enhanced value for all therapies developed with the Helix biotherapeutic delivery system product family.

ABOUT BIOCARDIABioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP autologous and NK1R+ allogeneic cell therapies are the Companys biotherapeutic platforms that enable four product candidates in development. The CardiAMP Cell Therapy Heart Failure Trial investigational product has been granted Breakthrough designation by the FDA, has CMS reimbursement, and is supported financially by the Maryland Stem Cell Research Fund. The CardiAMP Chronic Myocardial Ischemia Trial also has CMS Reimbursement. The Company's current products include the Helix Transendocardial Biotherapeutic Delivery System, which it partners selectively with other biotherapeutic companies requiring local delivery to the heart. For more information visit:www.BioCardia.com.

FORWARD LOOKING STATEMENTSThis press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to development and value of steerable access catheter products and intellectual property and statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardias business and product development plans, the ability to enter into licensing and partnering arrangements, and overall market conditions. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.

We may use terms such as believes, estimates, anticipates, expects, plans, intends, may, could, might, will, should, approximately or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardias Form 10-K filed with the Securities and Exchange Commission on March 29, 2023, under the caption titled Risk Factors. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

Media Contact: Anne Laluc, MarketingEmail:alaluc@BioCardia.comPhone: 650-226-0120

Investor Contact: David McClung, Chief Financial OfficerEmail:investors@BioCardia.comPhone: 650-226-0120

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BioCardia Announces Issuance of Two Patents Related to ... - BioSpace

Dr. Narine Sarvazyan Has Been Named to the AUA William Frazer Endowed Professorship – Armenian News by MassisPost

YEREVAN The American University of Armenia (AUA) is pleased to announce that Dr. Narine Sarvazyan has been named to the AUAWilliam Frazer Endowed Professorship. Endowed by AUA Trustee Emeritus and longtime benefactor Edward Avedisian, this professorship was created in honor of Professor William Frazer, University of California (UC) Provost and Senior Vice President Emeritus, Academic Affairs, and Professor Emeritus, UC Berkeley Department of Physics. Dr. Frazer served as the inaugural Chairman of the Board of AUA Corporation, UC Provost and Senior Vice President of Academic Affairs, Acting Provost of UC San Diegos Third College, and research scientist at the Institute for Advanced Study, Princeton, New Jersey.

Dr. Sarvazyan started her career at Moscow State University, where she received her bachelors and masters degrees in physics and biophysics, respectively, and later joined the Yerevan Institute of Experimental Biology (now called the Institute of Molecular Biology NAS RA), where she received a Ph.D. in biological sciences. Within a few months after defending her dissertation, she left Armenia to pursue postdoctoral research first in Europe and later in the United States. She then joined the faculty of Texas Tech University Health Science Center, followed by her appointment as a tenured professor at the George Washington (GW) University School of Medicine and Health Sciences, where she led an interdisciplinary program at the intersection of medicine, physics, and engineering.

Dr. Sarvazyans research interests range from free-radical-mediated cardiotoxicity of anticancer drugs to the adverse effects of plasticizers, hyperspectral imaging, novel medical devices, stem cell therapy, 3D bioprinting, and tissue engineering. Her scientific discoveries have been published in several prestigious journals, includingNature, Journal of Clinical Investigation, Tissue Engineering, Stem Cell Reviews, Circulation, PLoS One, American Journal of Physiology,among others. She is the recipient of a number of prestigious research and teaching awards, and has repeatedly received funding from the U.S. National Institutes of Health, the National Science Foundation, and the American Heart Association.

Asked what initially led her to her profession, Dr. Sarvazyan remarks that the decision came naturally. Raised in Pushchino, Russia, a center of biological science back in the Soviet era, she was interested in science from early childhood years. My father led a lab in biophysical acoustics, so from early childhood, I was exposed to science, she recalls, I used to visit his lab, which was a very natural environment for me to be in. I never once regretted my decision. I love what I do.

Professor of pharmacology and physiology, Dr. Sarvazyan likes challenges. Science is always a challenge because you have a hypothesis, you try, and in 90% of the cases, you are not right. So you have to pivot all the time to find answers, she says, adding, Nowadays, with the mass involvement of hundreds of thousands of people in science and technology, just finding those niches where you can make a difference is itself a challenge. Thats challenge number one. Challenge number two is getting funding for pursuing your ideas. And then comes challenge number three, that is, to actually discover something new. All these challenges are difficult to solve, but they are also inspiring, and I love to solve them.

Dr. Sarvazyan has joined AUA to bring her expertise in research and education to Armenia. Under her leadership, the University is planning to establish the Akian BioScience Laboratory. Dr. Sarvazyan is currently based at the Akian College of Science and Engineering, and starting Fall 2023, she will be introducing new hands-on courses focusing on biomedical research. The classes will be limited to 10-12 students because all of them will be project-based and will involve supervised experimentation. She is excited to start working with AUA students, who she believes possess great potential and curiosity, I encourage those interested in biomedical research to contact me directly or come to my office to talk because enrollment will be very limited, she adds.

Having founded and leading a lab, Dr. Sarvazyan has been engaged in a variety of research projects. Her team at the Sarvazyan Lab at GW School of Medicine and Health Sciences works at the intersection of biology, physiology, physics, and instrumentation. I have always had students from different professional backgrounds and walks of life, which has enhanced the interaction among them because everyone has learned something from someone else. I hope to create a similar environment here, she says.

Science is not easy: you have to be ready to fail many times and still have enough energy and excitement to keep going, so you can get your experiments working, Dr. Sarvazyan remarks. She believes that only by actually doing something with their hands in the lab students can discover their passion for experimental science. She looks forward to starting such a hands-on classroom. Students learn much better through trial and error and by doing things with their hands. And based on my experience, that is what they also enjoy the most.

Dr. Sarvazyan is positive about the future of science in Armenia. She cautions that the resources needed to conduct competitive biomedical science are enormous, but with strong commitment of the government, local businesses, and the diaspora, she believes, it is possible to create the right environment. We can start by creating regional biomedical research centers to fill in the gaps its not an easy task, but its doable. Its important to first identify the areas where we can be competitive and start to build on it. What I currently have in mind is hyperspectral imaging technology, which I believe is a very promising tool for many medical applications. This is just one of the projects I would like to implement here. It is a relatively new direction and I think its possible to make it successful in Armenia, she elaborates.

Successful in her academic and professional career, Dr. Sarvazyan considers balancing family and academic career to be her most outstanding accomplishment. The fact that I managed to stay married for 40 years and raised two successful children while creating a research environment that helped many outstanding students achieve their career goals I think its a pretty good accomplishment, she smiles.

Apart from sharing her professional expertise with AUA students, Dr. Sarvazyan, together with her husband, Dr. Artur Petrosian, AUAs former Computer Science department chair, also have financially invested in education they areAUA pillars. We have always felt a strong connection with Armenia. We both believe that science, education, and research are what make a country stronger. I think many people would agree that AUA does a great job educating the new generation of Armenian youth. We believe that this institution really can benefit from our input and investment. By giving back to Armenia, were investing in our future, she remarks.

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Dr. Narine Sarvazyan Has Been Named to the AUA William Frazer Endowed Professorship - Armenian News by MassisPost

BrainStorm Cell Therapeutics Announces Full Year 2022 Financial … – PR Newswire

Biologics License Application for NurOwn for the treatment of ALS to be discussed in an upcoming FDA Advisory Committee Meeting

Conference call and webcast at 8:00 a.m. Eastern Time today

NEW YORK, March 30, 2023 /PRNewswire/ --BrainStorm Cell Therapeutics Inc.(NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for the fiscal year ended December 31, 2022 and provided a corporate update.

"Our priority in 2023 is to advance NurOwn through the regulatory process as expeditiously as possible, including making preparations for our upcoming Advisory Committee Meeting," said BrainStorm's President and Chief Executive Officer (CEO) Chaim Lebovits and Co-CEO Dr. StacyLindborg in a joint statement. "The ADCOM will provide an invaluable opportunity for an open and thoughtful discussion among BrainStorm, regulators, ALS experts, and other key stakeholders on both the urgent need for new ALS therapies and the robust and intricate dataset that we believe supports NurOwn's approval. As we move towards this important event, our clinical trial results and experienced team give us confidence in our ability to secure a successful outcome and execute on our mission of improving the lives of individuals with ALS."

Fourth Quarter 2022 and Recent Highlights

U.S. Food and Drug Administration (FDA) notified BrainStorm in a written communication that the Agency will hold an Advisory Committee Meeting (ADCOM) to review the company's Biologics License Application (BLA) for NurOwn for the treatment of amyotrophic lateral sclerosis (ALS).

Financial Results for the Year Ended December 31, 2022

Cash, cash equivalents, and short-term bank deposits were approximately $3 million as of December 31, 2022, compared to $22 million as of December 31, 2021.

Research and development expenses for the twelve months ended December 31, 2022, and 2021 were approximately $14 million and $15.2 million, respectively.

General and administrative expenses for the twelve months ended December 31, 2022, and 2021 were approximately $10.9 million and $9.3 million, respectively.

Net loss for the twelve months ended December 31, 2022, was approximately $24.3 million, as compared to a net loss of approximately $24.5 million for the twelve months ended December 31, 2021.

Net loss per share for the twelve months ended December 31, 2022, and 2021 was $0.66 and $0.68, respectively.

Conference Call and Webcast

March 30, 2023, at 8:00 a.m. Eastern Time

Participant Numbers:Toll Free: 877-545-0523International: 973-528-0016Entry Code: 943129

Webcast URL: https://bit.ly/40EuACf

Those interested in listening to the conference call live via the internet may do so by using the webcast link above or by visiting the "Investors & Media" page of BrainStorm's website athttps://ir.brainstorm-cell.com/events-and-presentationsand clicking on the conference call link.

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

Replay Numbers:

Toll Free: 877-481-4010International: 919-882-2331Replay Passcode: 47908

About NurOwn

The NurOwn technology platform (autologous MSC-NTF cells) represents a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells are designed to effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression.

BrainStorm filed the BLA for ALS on September 9, 2022. BrainStorm received a Refusal to File letter from FDA on November 8, 2022, and requested a Type A meeting on December 9, 2022, which was held on January 11, 2023. The perspective shared by the FDA review team reflected what was in the previously issued RTF letter. Conversations with the FDA continued, following the Type A meeting, on the best pathway to resolve the outstanding questions that remained. During these discussions, BrainStorm was presented with multiple options to return the BLA to regulatory review, which included the regulatory procedure to File over Protest. With the commitment by FDA to accept amendments that were filed to address items raised in the FTF letter, BrainStorm notified the FDA on February 6, 2023 of our decision to request the FDA to file the NurOwn BLA for ALS over Protest.

AboutBrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug designation status from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has completed a Phase 3 pivotal trial in ALS (NCT03280056); this trial investigated the safety and efficacy of repeat-administration of autologous MSC-NTF cells and was supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). BrainStorm completed under an investigational new drug application a Phase 2 open-label multicenter trial (NCT03799718) of autologous MSC-NTF cells in progressive MS and was supported by a grant from the National MS Society (NMSS).

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding BrainStorm's Type A meeting with the FDAandthe clinical development of NurOwnas a therapy for the treatment of ALS, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "intend," "should," "could," "will," "believe," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, management's ability to successfully achieve its goals, BrainStorm's ability to raise additional capital, BrainStorm's ability to continue as a going concern, prospects for future regulatory approval of NurOwn, whether BrainStorm's future interactions with the FDA will have productive outcomes, the impacts of the COVID-19 pandemic on our clinical trials, supply chain, and operations, and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available athttp://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations, and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements.

CONTACTS

Investor Relations:John MullalyLifeSci Advisors, LLCPhone: +1 617-429-3548 [emailprotected]

Media:Lisa Guiterman[emailprotected]

BRAINSTORM CELL THERAPEUTICSINC.

CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

(Except share data)

December31,

2022

2021

U.S.$inthousands

ASSETS

Current Assets:

Cash and cash equivalents

$

772

$

18,856

Short-term deposit (Note8)

2,211

3,238

Other accounts receivable

91

86

Prepaid expenses and other current assets (Note 4)

32

1,100

Total current assets

$

3,106

$

23,280

Long-Term Assets:

Prepaid expenses and other long-term assets

$

23

$

27

Operating lease right of use asset (Note 5)

4,389

4,781

Property and Equipment, Net (Note 6)

933

1,189

Total Long-Term Assets

$

5,345

$

5,997

Total assets

$

8,451

$

29,277

LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)

Current Liabilities:

Accounts payables

$

6,224

$

3,700

Accrued expenses

84

83

Operating lease liability (Note 5)

1,427

1,461

Other accounts payables

1,065

1,073

Total current liabilities

$

8,800

The rest is here:
BrainStorm Cell Therapeutics Announces Full Year 2022 Financial ... - PR Newswire

Celebrating Oncology Nursing Day – Hamilton Health Sciences

April 4 is Oncology Nursing Day, and this years theme is Oncology Nursing: Strength Within.

Our patients are wonderful people, and so appreciative. They fill my cup.

It takes a special kind of person to work in cancer care. In celebration of Oncology Nursing Day on April 4, were pleased to introduce you to five Hamilton Health Sciences (HHS) oncology nurses from our Juravinski Hospital and Cancer Centre (JHCC).

Our JHCC is the only hospital in the region where patients can be treated for all forms of cancer, with more than 26,000 cancer patients supported each year.

Tracey Mullen

Registered nurse Tracey Mullen is an oncology nurse case manager who coordinates care for patients of two malignant hematologists. (Malignant hematologists are doctors who specialize in caring for blood cancer patients.)

These case managers work as a team with doctors to support patients who are visiting for appointments at diagnosis, and during and after their cancer treatment.

The case manager assesses and updates information from the patient to share with the doctor. This can include medication changes, new symptoms, and treatment side effects such as nausea from chemotherapy.

Im usually the first face they see before meeting with their doctor, says Mullen.

Oncology nursing can be quite complex, since cancer patients may have other health and social issues that need to be considered when planning and delivering their treatment, says Mullen. We have to apply all of our nursing knowledge, including understanding how cancer treatment plans might affect other health conditions.

Mullen especially enjoys developing relationships with patients and their families. Our patients are wonderful people, and so appreciative. They fill my cup.

Ewa Sawicki

Diane Boyd

Registered nurse Diane Boyd and registered practical nurse Ewa Sawicki are bedside nurses who care for patients admitted to hospital. Boyd cares for blood cancer patients while Sawicki supports patients who are recovering from surgery for cancers including include colon, breast, liver, gynecological and urologic.

After 25 years of dealing with cancer patients, working directly with patients at the bedside has always been the job Ive enjoyed the most, says Boyd, who joined the hematology team just over a year ago. Prior to this, Boyd worked in other areas of cancer care including the chemotherapy suite, and as an oncology nurse case manager.

While cancer is a frightening word, its not all doom and gloom, adds Boyd. In hematology, especially right now with all of the research, advancements and new treatment options, we can give many patients much more hope.

Boyd also welcomes opportunities to mentor new nurses. I really enjoy working with young nurses who are so keen on learning. They inspire me with their excitement and they keep me young.

Sawicki is also passionate about bedside care. When people think of oncology, they think of chemotherapy and radiation, she says. However, many oncology patients have to undergo extensive surgeries that leave them with new wounds, ostomies, or drains that they must learn to manage. I love being a nurse and supporting them in this learning.

Megan Mantel

Registered nurse Megan Mantel is a nurse transplant coordinator, working with hematology patients needing an allogeneic stem cell transplant. An allogeneic transplant refers to stem cells from a donor.

The donor could be a family member, or someone living halfway around the world, says Mantel, who uses a worldwide database to search for the best possible match.

Mantel also supports patients in the weeks leading up to their transplant, so they know what to expect and can take all the necessary steps and tests to prepare.

Our JHCC is a top hospital in Canada for hematology, with one of the largest hematology divisions in the country. Hamilton is also a national leader in terms of stem cell transplants and cellular therapy.

Hematology is an ever-evolving area of cancer care, says Mantel. There have been so many advances in recent years, which is very motivating to me as an oncology nurse. Theres always something new to learn, and something new to offer to our patients.

Fatima Chuong

Registered nurse Fatima Chuong works with blood cancer patients visiting the hospital for day treatments including CAR-T cell therapy, plasma exchange, as well as stem cell collections and transplants.

A nurse for seven years, she discovered a passion for oncology back when she was a nursing student doing her placement at JHCC. I was really inspired by the nurses, and the care and comfort they provided to patients, says Chuong, who finds working in hematology fascinating due to rapid advancements in hematologic cancer care.

But the greatest feeling, hands-down, is hearing from blood cancer patients who got their lives back thanks to the care they received at JHCC, says Chuong.

We sometimes receive updates and photos from former patients, letting us know what theyve been doing since they left the hospital. Learning how theyve gone on to lead their best lives is so inspiring. Its absolutely the best part about being a nurse, and its the greatest feeling in the world.

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Celebrating Oncology Nursing Day - Hamilton Health Sciences

UM Today | Faculty of Graduate Studies | 3MT winner is full of heart – UM Today

April 3, 2023

Keshav Narayan Alagarsamy, a PhD candidate in the department of physiology and pathophysiology at Max Rady College of Medicine, won first place at UMs Three Minute Thesis (3MT) final on March 30.

He was chosen from a group of 12 finalists in a competition that challenges graduate students to summarize their thesis in just three minutes. The goal is to effectively communicate complex research to a non-specialized audience in an engaging manner.

Passionate about the ability of machines and materials to heal humans, Alagarsamy is combining stem cell technology with nanotechnology to create personalised heart cells that can regenerate a damaged heart after a heart attack.

One of the most rewarding aspects of my 3MT experience was the exhilarating challenge of delivering a flawless presentation despite experiencing nerves on multiple occasions, explains Alagarsamy.

This journey played a significant role in building my self-confidence and enhancing my understanding of my project.I am immensely grateful to my advisor, Dr. Sanjiv Dhingra, for his unwavering support and encouragement throughout my project. I also extend my heartfelt thanks to my labmates, colleagues at the St. Boniface Research Center, friends, and family for their assistance in overcoming my fears and instilling the confidence I needed to excel in the 3MT challenge.

Alagarsamy received $2,500 for his first place win, which was watched by over 700 people in person and online.

The event was hosted by CTVs Colleen Bready in front of a panel of esteemed UM alumni: Anita Wortzman, President, The Asper Foundation; Destiny Seymour, Founder, Indigo Arrows; and James Schellenberg, Founder & CEO, Cubresa Inc.

Every year I am impressed by the passion and poise that our graduate students bring to this amazing event, said Dr. Kelley Main, Acting Dean, Faculty of Graduate Studies. This event is such an important highlight of the work our graduate students do at UM.

Three other graduate students also received prizes in the 3MT final:

UM Retirees Association presents Akshi Malik with her second place trophy.

With one in four cancer patients developing heart failure due to chemotherapy drugs, Malik is working to eliminate this trade-off in cancer treatment. Her research focuses on understanding the mechanisms through which Doxorubicin, a chemotherapy drug, affects the hearts of cancer patients, as well as looking for a cardioprotective agent that can prevent Doxorubicin-induced heart failure.

I will forever cherish the moment when I was on stage and did my best. The happy high I felt after the talk was incomparable to any presentation I have given before. I would do it again in a heartbeat.I hope to graduate soon and work in the field of scientific outreach and communication. There is a lot of impactful research being done that the general public is not aware of and I would like to make science more accessible through my presentation skills and enthusiasm for science.

Dr. Diane Hiebert-Murphy, Provost and Vice-President (Academic) presents Shayna Giesbrecht with her third place trophy.

Giesbrechts research seeks to establish methods to use wastewater for tracking the incidence of sexually transmitted blood-borne infections, which will contribute meaningful information to infection outbreak prevention and response in the future. She was inspired by Manitoba leaders during the pandemic who put the health of Manitobans first and is driven to continue working in disease prevention at the government level helping smaller communities respond to infectious disease outbreaks.

One of my favourite things about 3MT that is not necessarily available in other research settings is getting to learn about advanced research and its impacts in really accessible language. 3MT is so audience friendly that my grandparents were able to watch online!I feel so honoured to have been chosen as the third place winner for this year. This years competition was incredibly strong, so to be chosen as a winner is a massive privilege.

Dr. Kelley Main, Acting Dean, Faculty of Graduate Studies presents Olubukola Olatosi with the Peoples Choice award.

With a greater focus on promoting early childhood oral health, Olubukolas research goal is to see a reduction in the incidence of early childhood caries among Indigenous Canadian children. Her research focuses on determining the strategies to implementing the novel Canadian Caries risk assessment tool and to provide guidelines for implementation to improve the oral health of Indigenous children.

The 3MT competition was a great experience for me, it was very competitive and I enjoyed the support from the community. This program helped me to sharpen my communication skills. It gave me a platform to disseminate my research focus.I wish to congratulate everyone who took part in this competition. I enjoyed the great support we gave each other. It was fun!

As the first place winner, Alagarsamy will go on to represent the University of Manitoba at the Western Regional 3MT Competition at the University of Saskatchewan on May 25, 2023.

Research at the University of Manitoba is partially supported by funding from the Government of Canada Research Support Fund.

See the article here:
UM Today | Faculty of Graduate Studies | 3MT winner is full of heart - UM Today