Adicet Bio today sharedpositive interim results from its Phase I study on a potential treatment for B-cell Non-Hodgkin's Lymphoma.

ADI-001, an investigational allogeneic gamma delta CAR T cell therapy, generated positive early responses from three of four evaluable participants, two of whom achieved complete responses (CR) while one had a partial response (PR) that researchers logged as "near complete."

As of the November 22 cutoff, six patients had been enrolled in the trial, though two did not reach the 28th day and were considered not evaluable to test the drug's efficacy. All participants had already received a median of five lines of systemic therapy prior to the trial.

One patient who had already gotten autologous CD19 CAR T therapy reported CR after a single infusion of the drug at the lowest dose. Of the four evaluable patients, three received ADI-001 at a level one dose, or 30 million CAR+ cells, while the fourth was given a level-two dose at 100 million CAR+ cells. Of the three who achieved PR or better, one had diffuse large B-cell lymphoma with five prior lines of therapy, one had follicular lymphoma that turned into a large B-cell tumor with four prior lines, and the third was diagnosed with mantle cell lymphoma with five prior lines of treatment.

ADI-001 works by targeting malignant B-cells through an anti-CD20 CAR and gamma delta innate and T-cell endogenous cytotoxicity receptors. In preclinical models, gamma delta T cells engineered with anti-CD20 CAR showed positive antitumor activity. So far, all the infusions were well-tolerated, with no reports of graft vs host disease, dose-limiting toxicities, grade 3 or higher cytokine release syndrome, and immune effector cell-associated neurotoxicity syndrome. This suggests a wide therapeutic potential for ADI-001.

"The preliminary safety and efficacy data from low-dose ADI-001 collected to date indicate the potential for a broad therapeutic window. Without the need for gene editing and its associated safety concerns, our platform is designed to preserve the natural innate and adaptive anti-tumor activity of gamma delta CAR T cells, which we believe may lead to better durability," said Francesco Galimi, M.D., Ph.D., the senior vice president and chief medical officer of Adicet Bio, in a statement.

The trial is still in its early stages and is expected to enroll around 75 patients. The primary objectives are to determine the drug's tolerability, safety, pharmacodynamics, and pharmacokinetics. The research also intends to find out the optimal dosing if it is used as monotherapy. Details of the study are available with the U.S. National Library of Medicine.

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In approaching the end of another full year within the COVID-19 pandemic, there's still much being learned about the dangerous respiratory virus that has seized the world. Developments in the last 12 months include greater confirmation that wearing masks do help to stop the spread, the virus can affect even the healthiest individuals long-term, and the first available vaccines offer extensive, but not complete, protection.

For certain populations, the protection offered by receiving a vaccine is even more limited. This year, rheumatologists found this to be the case for their patients who are on immunosuppressants or immunomodulatory treatmentsa realized concern 1 year after learning the severity by which immunosuppressed patients can be affected by COVID-19.

An array of studies have been performed in hopes of gaining a better understanding on this topic. The research revealed some great insight, but an important takeaway was that patients who are on immunosuppressants or immunomodulatory treatments still benefit from receiving the vaccine, even if it's not as effective as it is in the general population.

Earlier this year, Ruth Fernandez-Ruiz, MD, MS, Division of Rheumatology, Department of Medicine, New York University Grossman School of Medicine, conducted a study that evaluated the immune response and disease status in patients with systemic lupus erythematosus (SLE) which was presented at the American College of Rheumatology 2021 Convergence.

In an interview with HCPLive, Fernandez-Ruiz explained that all the phase 3 trials that were performed for the COVID-19 vaccines excluded patients who were taking immunosuppressants or immune-modifying drugs within 6 months from the time of enrollment.

At the time we initiated the study, Fernandez-Ruiz said, the data on rheumatic disease patients was virtually absent.

Previous research looked at this phenomenon with other vaccines, like the flu vaccine, and found that taking immunosuppressants did impact vaccine efficacy.

Prior to this study, Fernandez-Ruiz also collaborated on research that examined antibody responses in patients with lupus who had natural infection of SARS-COV-2.

We found that most patients were able to generate and maintain an antibody response after COVID-19 disease, Fernandez-Ruiz said. So overall, it wasnt really clear how our patients were going to respond to the COVID-19 vaccine, and there was a real need to study rheumatic disease patients.

Charalampos Papagoras, MD, PhD, Assistant Professor of Rheumatology at Department of Medicine, Democritus University of Thrace, led research on the outcomes of COVID-19 in vaccinated patients compared with unvaccinated patients who have systemic rheumatic diseases.

His study concluded that the severity of breakthrough COVID-19 cases depended on the vaccination status of the patient.

Aside from vaccination status, there were no differences in demographics, systemic rheumatic disease type, treatment or comorbidities between the 3 groups. However, hospitalization and mortality rates were higher in the unvaccinated group (29.3% and 4.1%, respectively), even when compared with the partially vaccinated group (21% and 0%).

Of course, patients who were fully vaccinated had the best outcome when faced with a COVID-19 breakthrough infection (10.3% and 0%).

The CDC was unclear if there were any disease-specific factors that could play a role in vaccine responses, Fernandez-Ruiz mentioned. Therefore, the team of investigators were compelled to focus particularly on the lupus population.

Their results showed approximately 30% of patients with lupus had a decrease in COVID-19 antibody responses and microneutralization titers compared to controls. Additionally, a correlation was found between circulating antibody levels against the spike protein and interfering gamma production by immune cells.

A low vaccine response was defined as less than or equal to 100 units per ml, which is the lowest value seen in controls.

After a patients vaccine response level was defined, the investigators further compared the 26 lupus patients who had a low response to the 64 lupus patients who had adequate response.

We found that a normal anti-double stranded DNA antibody, and taking any immunosuppressant medication, other than antimalarials like hydroxychloroquine, were associated with a decreased vaccine response, Fernandez-Ruiz said,

This particular study she led didnt have a large enough sample size to look at the effect of each individual medication, but Fernandez-Ruiz emphasized that research in this area has grown.

We do know now, she said, that other studies have shown that medications like methotrexate, mycophenolate mofetil, B-cell depleting agents like rituximab, and systemic steroids are likely playing a major role in blunting antibody response to the vaccine.

A study led by Jean Liew, MD, MS, Assistant Professor, Rheumatology, Boston University School of Medicine, found that most of the patients with rheumatic disease who had to be hospitalized for COVID-19, despite being vaccinated, were the patients taking B-cell depletion therapy medication.

The results of the trial, SARS-COV-2 Infections Among Vaccinated Individuals with Rheumatic Disease: Results from the COVID-19 Global Rheumatology Alliance Provider Registry, noted that of the 87 fully-vaccinated patients with rheumatic disease, 22 of them had breakthrough cases so severe they needed to be hospitalized.

Liew said in an interview with HCPLive that these results werent exactly surprising because they were in line with other laboratory-based studies she read.

While the findings are meaningful, the other side to these data are equally enlightening. B-cell depleting medications like rituximab, and antimetabolites like mycophenolate appeared as treatments in the hospitalized group, but what about the treatment options that were absent from this group?

Overall, the results should be reassuring, Liew explained, that other medication classes that are immunomodulatory that we use for rheumatic disease patients, like TNF inhibitors and other biologics that target specific cytokines, theyre not really represented in the people who were hospitalized after they were fully vaccinated.

For the highest risk patients, its imperative to continue to look at other prophylactic strategies pre or post exposure, like monoclonal antibodies or the potential antiviral oral medication, according to Liew.

Patients in this particular high-risk population, and the providers that treat them, have to walk a thin line.

For them, the only option for treatment is ultimately limited to the immunomodulatory or immunosuppressive medication that leaves them vulnerable to a breakthrough COVID-19 infection.

Adjusting or switching to another treatment simply wouldnt be effective at maintaining control of the disease and would then leave the patient vulnerable to a disease flare, which in turn could lead to poor outcomes if they were to be infected with COVID-19.

Theres not really an alternative therapy for these people, Liew said, which makes the implication here that we need to think about what other things we can do in addition to vaccinating them.

Fernandez-Ruizs study monitored for disease flare and found that 11% of vaccinated patients had a lupus flare.

Only 1 of these patients had a severe flare, she explained, which means that this was overall rare, and these findings really support the safety of the COVID-19 vaccine in patients with lupus.

The line may be thin, but it can be walked.

The American College of Rheumatology continuously updates their guidelines surrounding the COVID-19 vaccines with new data that arise. They recommend withholding most immunosuppressant medications after vaccination for a period of time.

Fernandez-Ruiz emphasized that these are guidelines, and rheumatologists have to make individualized decisions with each patient. The patients disease, the medication theyre on, the disease activity at the time, are all factors that need to be considered when discussing this with a patient.

Ive encountered situations where the disease activity, or the specific manifestations were treating, theyre life-threatening or theyre organ-threatening, so we cant have the luxury of just simply holding the medication, she said.

Its a process to be taken step-by-step. And Fernandez-Ruiz is already working on the next one.

Along with a team of investigators, Fernandez-Ruiz said she is currently studying the frequency and severity of breakthrough infections.

We also need to better understand whether holding immunosuppressants post-vaccination, and administering an additional dose of the vaccines, actually leads to improved humoral and cellular immunity to these vaccines, she said.

Even though approximately 30% of patients showed a relatively low response, we dont know if that response is enough to protect them from very poor outcomes of COVID-19. We think about infection prevention in general as an ideal outcome but also preventing hospitalization, oxygen requirement, ICU admission, intubation, these are all great things that we should aim for.

This year, we have certainly expanded our knowledge and understanding on the various ways COVID-19 has affected our lives and were on the path to continue doing so.

You can see it either way, Fernandez-Ruiz said. We saw 30% of patients had a low-vaccine response, but 70% of patients had a pretty good response, and this is without the booster or third dose shot, the additional dose that were recommending now, so thats actually pretty good.

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UC San Francisco has launched the Baszucki Lymphoma Therapeutics Initiative to increase the effectiveness and availability of chimeric antigen receptor T-cell (CAR T) therapy for lymphoma patients. Jan Ellison Baszucki and her husband, Roblox CEO David Baszucki, gifted $6 million over five years to support the initiative. After witnessing Jans father recover from a near-fatal lymphoma thanks to treatment with CAR T therapy, the couple wanted to help accelerate progress in the field so more families can benefit.

An emerging approach to immunotherapy, CAR T therapy has dramatically increased survival rates for patients with certain hard-to-treat blood cancers. It also shows promise for treating some solid tumors as well as diseases beyond cancer, including autoimmunity and neurodegeneration. The therapy involves harvesting T cells from a patients blood and genetically engineering them to kill cancer cells by detecting specific molecular targets, called antigens, on the cancer cells surface. The engineered T cells are then cultured to increase their numbers and infused back into the patients bloodstream, where they act as a living therapeutic against the cancer cells.

In cancer, we dont often use the big C word cure but CAR T therapy really does seem to lead to miracle cures after no other therapies have worked, says Babis Andreadis, MD, MSCE, a lymphoma specialist and professor of clinical medicine at UCSF who will direct the new initiative.

Since 2017, the US Food and Drug Administration (FDA) has approved five CAR T therapies for acute lymphoblastic leukemia (ALL), multiple myeloma, and several lymphomas. Andreadis ran some of the first clinical trials of CAR T therapies for non-Hodgkins lymphoma, which have shown complete remission rates of around 50 percent in patients who have failed multiple prior treatments.

In cancer, we dont often use the big C word cure but CAR-T therapy really does seem to lead to miracle cures after no other therapies have worked.

Babis Andreadis, MD, MSCE

The Baszucki Lymphoma Therapeutics Initiative will expand research underway at UCSF aimed at understanding who will benefit from CAR T therapy and developing new therapeutic targets for lymphoma patients who dont respond to current CAR T therapies.

Our goal is to reach a point when cancer medicine is completely personalized and every patient can get a therapy designed specifically for their own disease, says Alan Ashworth, PhD, FRS, president of the UCSF Helen Diller Family Comprehensive Cancer Center and the E. Dixon Heise Distinguished Professor of Oncology. Jan and Davids commitment to helping realize this vision exemplifies their remarkable foresight and generosity.

The Baszuckis, who live in San Francisco with their four children, are veterans of the Bay Area technology industry. Jan was the director of marketing at Infinity Financial Technology before becoming an award-winning writer and novelist. David is a software engineer and co-founder of Roblox Corporation, which develops Roblox, an online gaming platform that allows users to create and play their own games.

After the company went public, in March 2021, the couple launched the Baszucki Group to create foundational change through philanthropy, impact investing, community building, and other initiatives. One of the organizations first projects was establishing the Baszucki Brain Research Fund, which supports scientists and innovators pursuing breakthrough treatments that promote vitality, stability, and well-being in people at risk for or living with bipolar disorder. This year, the fund has invested more than $13 million in research grants, including a competitive program that will fund 45 grants to support pilot research in therapeutic discovery and translational research for bipolar disorder.

Our goal with Baszucki Group is to direct resources toward the greater good, Jan Baszucki says. Were interested in big, bold moves that will leapfrog current treatments rather than make incremental progress. Its obvious that CAR T therapy fits into that category.

One of the exciting things about CAR T is its not just one product, David Baszucki adds. Its a revolutionary therapeutic platform that offers infinite avenues for innovation, and Dr. Andreadis is one of those brilliant researchers who can use it to make CAR T therapy a reality for more families like ours.

The new initiative will also further the goals of the UCSF Living Therapeutics Initiative (LTI), which launched in June. By uniting many established UCSF programs, the LTI seeks to propel research in living therapeutics a broad category of medicines that use human or microbial cells to treat disease and speed promising therapies to clinical trials for patients who lack effective treatment options.

UCSF is laying the groundwork for the next frontier in pharmaceutical medicine, says Sam Hawgood, MBBS, UCSF chancellor and the Arthur and Toni Rembe Rock Distinguished Professor. We are deeply grateful to the Baszucki family and other philanthropic partners who inspire everyone engaged in our mission to treat patients compassionately and equitably with the best therapies they can get anywhere in the world.

The Baszuckis first met Andreadis in October 2020, after Jans father, Todd Ellison also an award-winning novelist, who writes under the pen name E.T. Ellison had endured three years of chemotherapy while only growing sicker. I was told I had no options left, Ellison says. Thats when his oncologist, who had trained at UCSF, referred him to Andreadis.

Earlier that fall, Andreadis had launched a study to test the viability of administering CAR T therapies manufactured in a university setting. Clinical researchers have previously partnered with pharmaceutical companies to use CAR T products already on the market or in development for commercialization. These products typically are manufactured by research contractors or by the companies themselves because they require specialized clean rooms, called current good manufacturing practice (cGMP) facilities, to ensure that the drugs are safe and of the highest quality.

However, some universities recently have begun making CAR T and other cell-based therapies in house. In June of this year, as part of the LTI, UCSF announced a strategic alliance with Thermo Fisher Scientific Inc. to build and manage a cGMP facility in leased space on UCSFs Mission Bay campus. The new facility will allow clinicians to offer cell therapies to more patients, including those who may be ineligible for or cant afford commercial products. In-house manufacturing also will allow researchers to optimize production specifications and doses and develop new therapeutic targets that drug companies might not pursue.

The CAR T products available today are designed for generic targets, Andreadis says, adding that while this approach maximizes the number of patients who are likely to respond to a particular CAR T product, it also means that patients whose cancers express low levels of these targets might not benefit.

Andreadiss study is a phase I trial to test the safety and appropriate dose of CAR T cells manufactured under custom protocols to target a common FDA-approved antigen known as CD19. (Until the cGMP facility at UCSF is operational, Andreadiss team is making the cells at a facility at UC Davis.) Ellison was the first patient to enroll. When he arrived here, he was seriously ill, Andreadis says.

Within a week of starting the treatment, however, Ellison began to improve. We kept waiting for him to get worse, but he just got better and better, Jan Baszucki recalls. And there were zero side effects, none at all, Ellison adds. By December 2021, his lymphoma was gone, and he remains cancer-free. (Not all CAR T patients have the same experience; some patients may experience short- or long-term side effects, including cytokine release syndrome and neurotoxicity.)

We are beyond grateful to Dr. Andreadis and his staff for the incredible care given to my father, Jan Baszucki says.

Andreadiss team has since treated five more patients in the phase I trial, several of whom had lymphomas that couldnt be treated with commercial CAR T products or who would not have qualified for insurance coverage because they were too sick. With the Baszuckis support, the team can now expand the study to enroll more patients with various lymphomas, including rare subtypes. They also plan to use patients blood samples to begin investigating new disease targets for the next generation of CAR T therapies.

Beyond improving treatment options for lymphoma patients, Andreadis predicts, this pioneering work will help set the stage for the development of in-house CAR T products for other cancers and diseases. Clinicians and scientists around the world will be able to use the infrastructure we are creating here at UCSF to customize CAR T therapies for a broad range of applications, he says.

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NEW YORK and SOMERSET, N.J., Dec. 7, 2021 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, and Catalent (NYSE: CTLT), a global leader in enabling biopharma, cell, gene and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, today announced that the technology transfer for NurOwn manufacturing at Catalent's facility has been finalized. NurOwn is BrainStorm's autologous cellular therapy being developed for the treatment of amyotrophic lateral sclerosis (ALS), progressive multiple sclerosis (PMS) and other neurodegenerative diseases.

Catalent entered into a partnership with Brainstorm in 2020 to provide CGMP clinical supply of NurOwn, in anticipation of the product candidate's potential regulatory approval. NurOwn will be manufactured at Catalent's world-class 32,000 square-foot cell therapy manufacturing facility in Houston, Texas.

"The successful completion of this technology transfer with Catalent is an important step in establishing manufacturing preparedness for NurOwn," said Chaim Lebovits, Chief Executive Officer, Brainstorm Cell Therapeutics. "The manufacturing of cellular therapies such as NurOwn is complex, and requires careful planning and very specific expertise. We are very pleased with the progress we have made with our partner Catalent, which has industry-leading capabilities in this area."

Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy, said, "Our extensive experience in cell therapy development and scale-up was key to the completion of this technology transfer to our state-of-the-art cell therapy facility in Houston, Texas. We look forward to continuing our partnership with BrainStorm and are committed to enabling the advancement of their autologous stem cell therapy product candidate toward a potential future commercial launch."

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.

About Catalent

Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world.

With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of more than 7,000 products to over 1,000 customers annually.

Catalent's expert workforce exceeds 17,000, including more than 2,500 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated $4 billion in revenue in its 2021 fiscal year. For more information, visitwww.catalent.com.

About BrainStorm 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 NurOwntechnology 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 multiple sclerosis (MS) and was supported by a grant from the National MS Society (NMSS).

For more information, visit the company's website atwww.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future NurOwnmanufacturing and clinical development plans, 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 "may," "should," "would," "could," "will," "expect,""likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, the prospects for regulatory approval of BrainStorm's NurOwntreatment candidate, the initiation, completion, and success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwntreatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture, or to use third parties to manufacture, and commercialize the NurOwntreatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation; 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:

Brainstorm Contacts

Investor Relations:John MullalyLifeSci Advisors, LLCPhone: +1 617-429-3548jmullaly@lifesciadvisors.com

Media:Mariesa Kemblekemblem@mac.com

Catalent Media Contact:Chris HallingPhone: +44 (0)7580 041073 chris.halling@catalent.com

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SOURCE Brainstorm Cell Therapeutics Inc

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BrainStorm Cell Therapeutics and Catalent Announce Completion of Technology Transfer for NurOwn Manufacturing - BioSpace

Nobel laureate Shinya Yamanaka will step down as director of Kyoto Universitys Center for iPS Cell Research and Application (CiRA) by the end of March to focus on my own research.

The university announced on Dec. 8 that Jun Takahashi, a CiRA professor who studies Parkinsons disease treatments using induced pluripotent stem (iPS) cells, will become the next CiRA director.

Yamanaka, who won the Nobel Prize in Physiology or Medicine in 2012 for his groundbreaking research on iPS cells, will continue his studies as a professor at CiRA.

In the past few years, I have wanted more and more to focus on my own research, Yamanaka said in a statement released on Dec. 8. As a basic researcher, I will do my best to contribute to the development of iPS cell research, medicine and biology.

According to the university, Yamanaka was considering retiring at the end of his current term and recommended Takahashi as his successor at a meeting of the CiRA Faculty Council on Dec. 2.

Takahashi was elected the next director by a majority vote at the meeting.

Using this (iPS cell) technology and other technologies, I will promote research and medical applications with CiRA faculty, staff and students to contribute to future medicine and life sciences, Takahashi said in a statement issued on Dec. 8.

Yamanaka, now in his sixth term, has served as director of CiRA since it was established in 2010.

Takahashis term as director will start in April and continue until the end of March 2024.

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