Category Archives: Cell Therapy

Wilmington, Delaware, United States, Oct. 12, 2022 (GLOBE NEWSWIRE) -- Transparency Market Research Inc. The solutions in the global CAR T-cell therapy market are increasingly being hailed as cutting-edge innovations in the field of cancer treatments. Clinical trials conducted by players in the global CAR T-cell therapy market are displaying promising results, particularly in end stage patients suffering from acute lymphocytic leukemia. The success of these trials is translating into substantial revenue grab opportunities for market players. As per a recent professional survey report, the global CAR T-cell therapy market is estimated to grow at a CAGR of 30.6% over the forecast period of 2021 to 2031.

Players in the global CAR T-cell therapy market are working closely with research institutes and hospitals to develop cost-effective solutions, as the high cost of CAR T-cell therapies remains a major barrier for the adoption of these solutions. Chimeric Antigen Receptors or CAR are protein constructs that have been genetically engineered to be incorporated into patients cytotoxic T cells for aiding them in fighting cancer cells by efficiently recognizing them. Players in the global CAR T-cell therapy market offer various types of novel products, including tisagenlecleucel, lisocabtagene maraleucel, axicabtagene ciloleucel, brexucabtagene autoleucel, and idecabtagene vicleucel, among others.

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CAR T-cell Therapy Market Key Findings of the Report

CAR T-cell Therapy Market Growth Drivers

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CAR T-cell Therapy Market Key Players

Some of the key companies operating in the global CAR T-cell therapy market include Novartis AG, Amgen, Inc., Johnson & Johnson Services, Inc., Merck & Co., Inc., Pfizer, Inc., Bristol-Myers Squibb, Sorrento Therapeutics, Inc., Gilead Sciences, Inc., and bluebird bio, Inc., among others. Some of the noteworthy expansion strategies employed by these players include acquisitions, strategic alliances, geographical expansion, new product launches, and distribution agreements.

Furthermore, leading players in the global CAR T-cell therapy market are also focusing on research and development to design and develop new types of CAR T-cell therapy products intended for treating different types of cancer. Stakeholders in the global CAR T-cell therapy market are complying with various research and health policy frameworks in order to adhere to stringent regulations put forth by governments across the world.

CAR T-cell Therapy Market Regional Growth Assessment

In 2020, North America region held the dominant share of the global CAR T-cell therapy market. This leading industry positioning of the North America region can be attributed to the presence of a large number of leading international players, rising healthcare spending, and early adoption of new medical technologies and techniques. Furthermore, rising number of research activities in the region is also boosting growth within the North America CAR T-cell therapy market. In coming years, Asia Pacific is also expected to witness significant growth in the global market.

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CAR T-cell Therapy Market: Segmentation

CAR T-cell Therapy Market, by Product Type

CAR T-cell Therapy Market, by Indication

CAR T-cell Therapy Market, by End User

CAR T-cell Therapy Market, by Region

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CAR T-cell Therapy Market Riding on the Wave of Growth and will Grow at a CAGR of 30.6% to 2031 | TMR Study - GlobeNewswire

Allogene Therapeutics has begun the first pivotal test of an off-the-shelf cell therapy for cancer.

The biotechnology company, which has been at the forefront of a push in recent years to develop such treatments, known as allogeneic therapies and derived from donor cells, announced the start of two trials on Thursday. One will test a blood cancer drug known as ALLO-501A, while the other will evaluate a regimen Allogene uses to prepare patients for treatment. Assuming positive results, Allogene expects the studies will support approval applications for both of them.

The studies represent milestones for allogeneic cell therapies, which are meant to be more convenient alternatives to the personalized CAR-T treatments that have come to market for a handful of blood cancers. Allogene, spun out of Pfizers cell therapy work in 2018, is the largest and most advanced among the companies advancing them. Its run by former executives of Kite Pharma, which successfully developed the cell therapies now sold by Gilead Sciences.

Allogene raised more than a half a billion dollars in private financing and an initial public offering to fund its work. The company has had a bumpy ride since then, however. Its cell therapies, including ALLO-501A, have shown promise, but also face lingering questions about their durability and effectiveness compared to CAR-T treatments. The field has also gotten more competitive, with an emerging group of companies advancing therapies using different types of cells and CAR-T moving into earlier lines of care.

Additionally, Allogenes research was delayed by the unexpected finding of a chromosomal abnormality in a treated patient. The companys treatment was exonerated, but the FDA froze Allogenes programs for months during the investigation. Longtime partner Servier cut ties with the company last month as well.

The company now has the chance to prove how its technology stacks up. ALLO-501A is being tested in a Phase 2 study in patients with relapsed or refractory large B cell lymphoma, a setting for which multiple CAR-T treatments are already available.

In a research note, RBC Capital Markets analyst Luca Issi noted that its trial, ALPHA2, mimics the design of the studies underlying approvals of those treatments for lymphoma. Its a single-arm study of about 100 patients whove previously received at least two prior treatments, but not a CAR-T therapy. The study will be judged by ALLO-501As ability to induce a response. Allogene didnt disclose a bar for success, but Issi, after speaking with management, said executives believe efficacy needs to be in the range of approved CAR-T therapies.

Notably, the company is testing a single dose of the treatment, not a repeat-dosing regimen Allogene has been experimenting with to strengthen the effects of ALLO-501A. Issi indicated the decision was made for ease and convenience.

Allogenes other study, EXPAND, is a registrational trial for ALLO-647, an antibody drug the company is using to prepare patients for treatment. That study will enroll about 70 patients and have a control arm that doesnt receive Allogenes drug. Updates are expected by the end of the year, Allogene said.

Allogene shares climbed 12% in pre-market trading Friday, though at about $11, shares still trade well below their highs of about $54 apiece in 2020.

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Allogene starts first pivotal trials of an 'off-the-shelf' cell therapy for cancer - BioPharma Dive

Collaboration brings together Avectas' breakthrough cell engineering technology and Inceptor Bio's CAR-T platform

MORRISVILLE, N.C. and DUBLIN, Oct. 12, 2022 /PRNewswire/ --Inceptor Bio, acell therapy biotechnology company and Avectas, a cell engineering technology leader, announce their collaboration to improve the development and manufacturing of next-generation CAR-T cell therapies for the treatment of solid tumors.

Under the agreement, Inceptor will utilize Avectas' SOLUPORE technology as an alternative to electroporation for engineering T cells with the goal to yield a healthier T cell product. Avectas' SOLUPORE technology is well suited to Inceptor Bio's CAR-T cell process, which aims to improve the quality of the engineered T cells, and ultimately, enhance their durability in the tumor microenvironment. By combining Avectas' SOLUPORE delivery with Inceptor Bio's CAR-T cell therapy platform, the engineered cells have the potential for improved performance and efficacy.

Avectas has developed the non-viral SOLUPORE technology to overcome the limitations of current delivery modalities to enable cell engineering, including complex editing, by efficiently delivering cargoes into cells. SOLUPORE technology permeabilizes the target cell membrane so that molecular cargoes can be delivered while retaining high cell viability and functionality levels.

"Inceptor Bio is committed to building and advancing a pipeline of programs based on diversified cell therapies, including CAR-M, CAR-T, and CAR-NK. This collaboration with Avectas is part of our strategy of advancing Inceptor Bio's next-generation cell therapy platform focused on multiple novel mechanisms to address solid tumors," saidShailesh Maingi, Founder and CEO of Inceptor Bio. "The aim for our proprietary CAR-T platform is to transform how solid tumors are treated."

"Avectas is delighted to collaborate with Inceptor Bio to leverage the benefits of the SOLUPORE delivery platform for solid tumor CAR-T cell therapies," said Michael Maguire, PhD, CEO of Avectas. "Excellent cell health and functionality, after complex editing, are critical to the success of these next-generation therapies".

About Avectas

Avectas is a cell engineering technology business that has developed a unique delivery platform to enable theex vivomanufacture of gene-modified cell therapy products that retain highin vivofunctionality. Our vision is to position the non-viral SOLUPOREcell engineering technology to be integrated into manufacturing processes, including complex gene editing, for multiple autologous and allogeneic therapies and commercialized through development and license agreements. For more information, please visit the company's websiteatwww.avectas.com.

About Inceptor Bio

Inceptor Bio is a biotechnology company developing multiple next-generation cell therapy products to deliver cures for underserved and difficult-to-treat cancers. Inceptor Bio is developing CAR-T, CAR-M, and CAR-NK platforms to generate a diversified pipeline to strategically treat a broad range of solid tumors. Inceptor Bio is headquartered in the Research Triangle Park area in Morrisville, North Carolina. More information is available at http://www.inceptor.bio.

Media contacts:

For Inceptor BioAbe Maingi[emailprotected]

For Avectas

InternationalSue Charles, Charles Consultants+44 7968 726585 [emailprotected],com

IrelandRay Gordon, Gordon MRM+353 87 2417373 [emailprotected]

SOURCE Avectas

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Inceptor Bio and Avectas Announce Collaboration to Improve Manufacturing of CAR-T Cell Therapies for the Treatment of Solid Tumors - PR Newswire

NEW YORK Bristol Myers Squibb is advancing a larger, multi-center trial of its investigational GPRC5D-targeting CAR T-cell therapy after a proof-of-principle trial in heavily treated multiple myeloma patients yielded encouraging response rates.

Meanwhile, based on the activity seen in this early-stage study, researchers are also exploring the potential of dual CAR T-cell therapy simultaneously targeting GPRC5D and BCMA in multiple myeloma.

The data that enticed BMS and researchers came from a single-center trial and was recently published in the New England Journal of Medicine, showing a 71 percent response rate among multiple myeloma patients who received the autologous CAR T-cell therapy, dubbed MCARH109, after five or more prior treatments. BMS gained the rights to develop the CAR T-cell therapy in 2019, when it acquired Celgene, which had previously acquired Juno Therapeutics. Juno bought the rights to develop CAR T-cell therapies using antibodies targeting GPRC5D from Memorial Sloan Kettering in 2016.

In the Phase I trial published in NEJM, patients were treated at MSK, and their autologous T cells were engineered to target the GPRC5D protein in MSK's Cell Therapy Cell Engineering Facility. The trial enrolled 17 multiple myeloma patients, all of whom had received at least three prior therapies, but most of whom received more than that. The median number of prior treatment lines was six, and eight patients had already received BCMA-directed autologous CAR T-cell therapy.

Across all four dose levels of the GPRC5D-directed CAR T-cell therapy, 71 percent of patients responded, and 35 percent experienced a complete response or stringent complete response. After a median follow-up of 10.1 months, 50 percent of the patients who experienced at least a partial response remain progression-free, and the therapy was generally safe with side effects comparable to those seen with B-cell maturation antigen (BCMA)-directed CAR T-cell therapies.

According to Renier Brentjens, the deputy director of the Roswell Park Comprehensive Cancer Center and a co-senior author on the Phase I study, one of the most encouraging findings was that of the eight patients who'd already received BCMA-targeted CAR T-cell therapy, 75 percent responded to MCARH109.

"That was key, because it means that with this type of technology, you get more than one chance at bat," said Brentjens, who worked at MSK at the start of the trial. "If you don't get long-term remission, but you get a year of disease-free survival out of one [CAR T-cell therapy], then we know that we still have another option in our back pocket."

The finding that GPRC5D-directed CAR T-cell therapy could be effective for multiple myeloma patients who have already received BCMA-directed CAR T-cell therapy comes on the heels of US market approval of two multiple myeloma CAR T-cell therapies that target BCMA. Last year, the US Food and Drug Administration approved 2seventy Bio (formerly Bluebird Bio) and BMS's Abecma (idecabtagene vicleucel) as a fifth-line treatment for relapsed or refractory multiple myeloma patients, and in March, Janssen and Legend Biotech netted approval for Carvykti (ciltacabtagene autoleucel) for the same patient population. These drugs are approved in Europe in this setting, too.

The arrival of CAR T-cell therapy in multiple myeloma has been encouraging for patients whose cancers haven't responded to prior treatment regimens. Abecma and Carvykti both led to high response rates in pivotal trials, and many patients have benefited from the autologous therapies since they've entered the US and European markets. But as Brentjens and colleagues wrote in their recent NEJM paper, these therapies "have not generated survival curves with a plateau in patients with multiple myeloma, and most patients are likely to have an eventual relapse."

When, eventually, most patients do experience disease progression following BCMA-directed CAR T-cell therapy, the treatment options are limited, highlighting a significant need for a next-line therapy like MCARH109.

Possible dual-targeting approach

Beyond the possibility that MCARH109 might offer multiple myeloma patients another option after BCMA-directed CAR T-cell therapy, Brentjens suggested there might be a role for combined CAR T-cell infusions that target both BCMA and GPRC5D.

"The idea is that, if the tumor can somehow dodge one CAR T cell by, for example, decreasing or losing expression of BCMA well, it's a lot more difficult to get rid of both targets at the same time," Brentjens said. "If target antigen loss is a reason why patients get relapsed disease, one would predict that that would occur less frequently than if you're going after two targets rather than one on the tumor cell."

Clinical trials evaluating this approach are already underway in the academic setting, Brentjens said. He and his colleagues at MSK have recently begun enrolling patients into a Phase I trial combining BCMA- and GPRC5D-targeted CAR T-cell therapy for relapsed or refractory multiple myeloma patients after at least three prior treatment lines.

Investigators exploring the dual receptor targeting approach will need to be extra careful about patient toxicity, Brentjens acknowledged. "You would think that the toxicity would be additive, so the toxicity you see with one therapy would be seen at the same time as the toxicity you see with the other but biology can sometimes surprise us," he said. "You need to be vigilant to look at whether there is a synergistic degree of toxicity if you get both [CAR T-cell therapies] at the same time."

As far as the efficacy of the dual-targeting approach goes, Brentjens said that the data he and colleagues have generated to date "certainly justifies trying both at the same time."

"I'm very excited about it," he said of the new combined CAR T-cell trial. "I think we're one of the first to try to see if this approach might be feasible, and hopefully we'll see that the remissions are longer term when compared to one or the other treatment alone."

Brentjens also suggested he could see a future situation in which patients could have their cells analyzed prior to undergoing CAR T-cell therapy, and a higher expression of one versus the other target be it BCMA or GPRC5D could determine which therapy a patient receives. That said, because BCMA-targeted CAR T-cell therapy is currently FDA approved whereas GPRC5D-directed CAR T-cell therapy is not, the prospect of that sort of biomarker-directed approach to sequencing cell therapies is not right around the corner; clinical trials would first need to provide enough support for MCAR109 to score regulatory approval.

This may well be on the horizon, though. BMS has recently launched a dose-escalation study of MCARH109 at nine sites across the country and is planning to enroll 77 relapsed or refractory multiple myeloma patients. Participants in this trial must have three or more prior therapies, though prior BCMA-targeted CAR T-cell therapy is not a requirement for enrollment.

BMS did not provide further information about this trial or its overall approach to studying MCARH109.

See more here:
Early Data on GPRC5D-Directed CAR T-Cell Therapy Open Doors for New Myeloma Treatment Strategies - Precision Oncology News

The recently published report entitled Cell Therapy Technologies Market 2022: By Types, Applications, Size, Share, Key Players & Regions Forecast Analysis till 2030 by Polaris Market Research covers unique insights into the Cell Therapy Technologies market that are contributing to the growth of the overall industry.

According to the research report, the global cell therapy technologies market was valued at USD 3.86 billion in 2021 and is expected to reach USD 12.27 billion by 2030, to grow at a CAGR of 14.5% during the forecast period.

The report can help stakeholders gain knowledge about the competitive environment and design profound strategies to help them increase their revenue. The report includes comprehensive information on the market size of Cell Therapy Technologies, its volume, share, recent trends and developments, demand, and growth rate. The report guides readers about the current status of the industry and its future prospects. It analyzes the market by type of component, end-user, company, and region. Also, market size (value and volume), share, and growth rate by types and applications in estimated and included in the report.

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The report focuses on the current status, competitor landscape, changing dynamics, detailed cost analysis, supply chain, marketing channels, and geographical overview. The study sheds light on crucial information on critical dynamics such as drivers, restraints, opportunities, and challenges. Recommendations and business advice are given that will help the readers ensure success in the market. It offers a qualitative and quantitative analysis of the overall industry. Facts and data are represented through graphs, pie charts, diagrams, and other graphical representations.

Product and Application Segment Analysis

Based on product segment, the report estimates sales, revenue, price, market share, and the growth rate by type. Then, it focuses on the application of Cell Therapy Technologies by evaluating the status and outlook for major applications/end users, consumption (sales), market share and growth rate for each application, consumption, and the growth rate of each application. Growth prospects are given in terms of sales and revenue forecast, and regional forecast. It also makes projections of the market by type and application. Overall, segment analysis helps in understanding the key factors that support the markets growth.

Top Market Players Profiles Covered in This Report:

Competitive Scenario

The report emphasizes leading players of the Cell Therapy Technologies market covering their information such as production, company profiles, revenue, product images, as well as specification, price, capacity, price, and contact information. Upstream raw materials, instruments as well as downstream demand survey is also mentioned in this report. This section also helps to analyze the strategies, developments, and collaborations made by key players.

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Regional Scope of the Market

The report analyzes and examines various factors that determine the regional growth of a particular region. Analysts have studied the data on revenue, production, and manufacturers of each region. This section conducts an in-depth analysis and overview of the market development of the key countries on national, regional, and international levels. Market share assessments for the regional and country level segments are delivered in this report.

The report aims to assist the reader in developing business expansion plans. In this document, SWOT analysis and Porters five forces analysis are used, which help in providing the precise direction of the market. It further sheds light on the factors driving the Cell Therapy Technologies industry growth coupled with those expected to hamper the development of the market in the coming years. Analysts have evaluated the growing investments in manufacturing activities as well as product innovation that are likely to impact these segments. Further, the research explains the massive movements in this market for the predicted timeline.

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Cell Therapy Technologies Market Expected to Reach US ~$12.27 Billion and CAGR 14.5% by 2030 Polaris Market Research - Digital Journal

BORDEAUX, France, Oct. 11, 2022 /PRNewswire/ --TreeFrog Therapeutics,a biotechnology company developing stem cell-derived therapies in regenerative medicine and immuno-oncology based on the biomimetic C-Stemtechnology platform, and Invetech, a global leader in the development and production ofautomated manufacturing solutionsfor cell and advanced therapies, today announced the delivery of a GMP-grade cell encapsulation device using the C-Stemtechnology. The machine will be transferred in 2023 to a contract development and manufacturing organization (CDMO) to produce TreeFrog's cell therapy candidate for Parkinson's disease, with the aim of a first-in-human trial in 2024.Over 2023, Invetech will deliver three additional GMP encapsulation devices to support TreeFrog's in-house and partnered cell therapy programs in regenerative medicine and immuno-oncology.

Blending microfluidics and stem cell biology, TreeFrog's C-Stemtechnology generates alginate capsules seeded with induced pluripotent stem cells (iPSCs) at very high speed. Engineered to mimic the in vivo stem cell niche, the capsules allow iPSCs to grow exponentially in 3D, and to differentiate into ready-to-transplant functional microtissues. And because alginate is both porous and highly resistant, encapsulated iPSCs can be expanded and differentiated in large-scale bioreactors without suffering from impeller-induced shear stress.

"TreeFrog Therapeutics introduces a breakthrough technology for cell therapy, which impacts scale, quality, as well as the efficacy and safety potential of cellular products. Automating this disruptive technology and turning it into a robust GMP-grade instrument is a tremendous achievement for our team. This deliverable is the result of a very fruitful and demanding collaboration with TreeFrog's engineers in biophysics and bioproduction over the past four years. We're now eager to learn how the neural microtissues produced with C-Stemwill perform in the clinic." Anthony Annibale, Global VP Commercial at Invetech.

Started in 2019, the collaboration between TreeFrog and Invetech led to the delivery of a prototype in October 2020. With this research-grade machine, TreeFrog demonstrated the scalability of C-Stem, moving within six months from milliliter-scale to 10-liter bioreactors. In June 2021, the company announced the production of two single-batches of 15 billion iPSCs in 10L bioreactors with an unprecedented 275-fold amplification per week, striking reproducibility and best-in-class cell quality. The new GMP-grade device delivered by Invetech features the same technical specifications. The machine generates over 1,000 capsules per second, allowing to seed bioreactors from 200mL to 10L. However, the device was entirely redesigned to fit bioproduction standards.

"With the GMP device, our main challenge was to minimize the learning curve for operators, so as to facilitate tech transfer. Invetech and our team did an outstanding job in terms of automation and industrial design to make the device both robust and easy to use. As an inventor, I am so proud of the journey of the C-Stemtechnology. Many elements have been changed and improved on the way, and now comes the time to put the platform in the hands of real-world users to make real products." Kevin Alessandri, Ph.D., co-founder and chief technology officer, TreeFrog Therapeutics

"In October 2020, we announced that we were planning for the delivery of a GMP encapsulation device by the end of 2022. Exactly two years after, we're right on time. I guess this machine testifies to the outstanding execution capacity of TreeFrog and Invetech. But more importantly, this machine constitutes a key milestone. Our platform can now be used to manufacture clinical-grade cell therapy products. Our plan is to accelerate the translation of our in-house and partnered programs to the clinic, with a focus on immuno-oncology and regenerative medicine applications." Frederic Desdouits, Ph.D., chief executive officer, TreeFrog Therapeutics

About Invetech

Invetech helps cell and gene therapy developers to visualize, strategize and manage the future. With proven processes, expert insights and full-spectrum services, we swiftly accelerate life-changing therapies from the clinic to commercial-scale manufacturing. Through our ready-to-run, preconfigured systems, our custom and configurable technology platforms and automated production systems, we assure predictable, reproducible products of the highest quality and efficacy. Our integrated approach brings together biological scientists, engineers, designers and program managers to deliver successful, cost-effective market offerings to more people, more quickly. Working in close collaboration with early-stage and mature life sciences companies, we are committed to advancing the next generation of vital, emerging therapies to revolutionize healthcare and precision medicine.invetechgroup.com

About TreeFrog Therapeutics

TreeFrog Therapeutics is a French-based biotech company aiming to unlock access to cell therapies for millions of patients. Bringing together over 100 biophysicists, cell biologists and bioproduction engineers, TreeFrog Therapeutics raised $82M over the past 3 years to advance a pipeline of stem cell-based therapies in immuno-oncology and regenerative medicine. In 2022, the company opened technological hubs in Boston, USA, and Kobe, Japan, with the aim of driving the adoption of the C-Stemplatform and establish strategic alliances with leading academic, biotech and industry players in the field of cell therapy.www.treefrog.fr

Media ContactsPierre-Emmanuel GaultierTreeFrog Therapeutics+ 33 6 45 77 42 58[emailprotected]

Marisa ReinosoInvetech+1 858 437 1061[emailprotected]

SOURCE Invetech; Treefrog Therapeutics

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BREAKTHROUGH TECHNOLOGY FOR IPS-DERIVED CELL THERAPIES TURNED INTO GMP PLATFORM BY TREEFROG THERAPEUTICS & INVETECH - PR Newswire

Cabaletta Bio

Company has obtained exclusive worldwide license for a fully human CD19 binder with clinical tolerability data that support potential clinical development in autoimmune diseases

CABA-201 Investigational New Drug (IND) application planned for the first half of 2023 with initial clinical data expected by the first half of 2024, pending IND clearance

Clinical development plans being informed by exclusive translational research partnership with Georg Schett, M.D., senior author of the Nature Medicine publication reporting clinical and serologic disease remission and potential immune system reset in CD19-CAR T treated refractory systemic lupus erythematosus (SLE) patients and a global leader in the application of CD19-targeting cell therapies in autoimmunity

PHILADELPHIA, Oct. 11, 2022 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced CABA-201, a newly designed, fully human CD19 chimeric antigen receptor (CAR) containing a 4-1BB co-stimulatory domain. Cabaletta has obtained an exclusive, worldwide license for the CD19 binder in CABA-201. The CD19 binder is integrated into a dual targeting CAR T therapy that has been evaluated in approximately 20 cancer patients to date in an investigator-initiated trial.We believe the tolerability data generated in these patients support clinical development in patients with autoimmune diseases. In addition, Cabaletta has established an exclusive translational research partnership with Dr. Georg Schett, a pioneer and global leader in the application of CD19-targeting cell therapies in autoimmunity. The collaboration is focused on generation of additional translational data to gain deeper understanding of the immunologic mechanisms of response and clinical insights from ongoing and continued clinical studies in multiple autoimmune disease indications. The construct utilized in these studies has a similar design to CABA-201, sharing the 4-1BB costimulatory domain and the binding region on the CD19 antigen with a fully human binder. With the addition of CABA-201 to its cell therapy pipeline, Cabaletta can potentially address a broad range of autoimmune diseases in indications such as SLE, rheumatoid arthritis, myositis and systemic sclerosis, among others where B cells contribute to disease pathogenesis.

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On the heels of the seminal publication in Nature Medicine last month reporting initial clinical activity and tolerability data from a 4-1BB-containing CD19-CAR T in patients with SLE who experienced durable drug-free clinical and serologic remission with the one-time therapy, we are excited to announce our new pipeline candidate, CABA-201. We believe CABA-201 is favorably designed for patients with autoimmune diseases given its fully human CD19 binder and 4-1BB co-stimulatory domain. Our exclusive translational research partnership with Professor Schett, which is designed to leverage the deep experience and expertise of Cabaletta scientists in autoimmune cell therapy, has the potential to provide us with important and timely insights into patients enrolled in his breakthrough clinical studies, said Steven Nichtberger, M.D., Chief Executive Officer and Co-founder of Cabaletta. We have a sufficient cash runway that will allow us to advance CABA-201 in parallel with the DesCAARTes and MusCAARTes trials employing our chimeric autoantibody receptor (CAAR) technology, with the potential to generate important clinical data readouts for each program. Accelerated by our teams proven experience in developing cell therapies for patients with autoimmune diseases in logistically complex trials, our next anticipated milestones for CABA-201 are an IND submission in the first half of 2023, and pending FDA clearance of the IND, initial clinical data by the first half of 2024. We believe CABA-201 has the potential to transform treatment of several common autoimmune diseases by providing clinical and serologic remission and a potential to reset the immune system, furthering our mission to develop therapies that deliver deep, durable, and potentially curative responses for patients with autoimmune diseases.

Data published by Professor Schett and his colleagues in Nature Medicine on September 15, 2022, demonstrate that a CD19-CAR T cell therapy with a 4-1BB co-stimulatory domain following lymphodepletion with fludarabine and cyclophosphamide induced persistent and deep clinical responses in five out of five patients with severe, refractory SLE, with up to 17 months of follow up. The safety profile demonstrated only mild cytokine release syndrome (CRS), with grade 1 CRS observed in three out of five patients, and no neurotoxicity (immune effector cell-associated neurotoxicity syndrome, or ICANS) of any grade observed. New B cells repopulated within five months of CD19-CAR T infusion in all patients, with no evidence of disease recurrence or autoantibodies following repopulation.

There is significant unmet need in SLE and other autoimmune diseases, where we believe there is strong potential for CD19-targeting cell therapies to provide meaningful responses for patients. The team at Cabaletta has deep expertise in translational research relating to cell therapy in autoimmune patients, which will be complementary to my teams efforts. Together, through our exclusive translational research partnership, we can more efficiently address questions critical to advancing CD19-targeting cell therapy strategies for patients, stated Georg Schett, M.D., Professor and Head of the Department of Internal Medicine 3, and Vice President of Research, Friedrich-Alexander University, Erlangen-Nurnberg, Erlangen, Germany.

CABA-201 includes a fully human CD19 binder that was exclusively in-licensed from Nanjing IASO Biotherapeutics, Co., Ltd. (IASO Bio), which currently utilizes the binder in its CT120 product candidate, a 4-1BB-containing tandem CD19xCD22-CAR T cell therapy that has been evaluated in approximately 20 patients with promising tolerability data in an investigator-initiated trial. CT120 is currently in a Phase I clinical trial in China for non-Hodgkins Lymphoma.

Transaction Terms with IASO BioUnder the terms of the agreement, Cabaletta will receive an exclusive, worldwide license to IASO Bios CD19 binder for use in autoimmune and alloimmune indications in humans. IASO Bio is eligible to receive up to $162 million in aggregate payments, including an upfront payment and payment upon the achievement of specified development and commercial milestones, along with tiered mid-single digit royalties on future net sales for products that may result from this collaboration agreement.

About Cabaletta BioCabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on the discovery and development of engineered T cell therapies that have the potential to provide a deep and durable, perhaps curative, treatment for patients with autoimmune diseases. The CABA platform encompassing chimeric antigen receptor T cells for autoimmunity (CARTA: CABA-201, a 4-1BB-containing CD19-CAR T) and Cabaletta Bios proprietary chimeric autoantibody receptor T cells (CAART: multiple candidates including DSG3-CAART for mucosal pemphigus vulgaris, MuSK-CAART for MuSK myasthenia gravis) provides multiple opportunities to treat broad and challenging autoimmune diseases. Cabaletta Bios headquarters are located in Philadelphia, PA. For more information, visitwww.cabalettabio.com and follow us on LinkedIn and Twitter.

Forward-Looking StatementsThis press release contains forward-looking statements of Cabaletta Bio within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including without limitation, express or implied statements regarding expectations regarding: Cabalettas ability to grow its autoimmune-focused pipeline; the ability to capitalize on and potential benefits resulting from the translational research partnership with Professor Georg Schett and the exclusive license agreement with IASO Bio; the companys business plans and objectives; the timing of our planned submission of an investigational new drug application (IND) for CABA-201 to the FDA and generation of initial clinical data for CABA-201; statements regarding regulatory filings regarding its development programs; the expectation that Cabaletta Bio may improve outcomes for patients suffering from mPV, MG, or other autoimmune diseases; the progress and results of its DesCAARTes Phase 1 trial, including Cabalettas ability to enroll the requisite number of patients, dose each dosing cohort in the intended manner, and progress the trial; plans to initiate patient dosing in an open-label Phase 1 clinical trial to evaluate MuSK-CAART safety and tolerability in MuSK MG patients in 2022; the ability to accelerate Cabalettas pipeline and develop meaningful therapies for patients, including in collaboration with academic and industry partners; and the anticipated contribution of the members of Cabalettas executives to the companys operations and progress.

Any forward-looking statements in this press release are based on managements current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that signs of biologic activity or persistence may not inform long-term results; Cabalettas ability to demonstrate sufficient evidence of safety, efficacy and tolerability in its preclinical studies and clinical trials of CABA-201; risks related to clinical trial site activation or enrollment rates that are lower than expected; risks related to unexpected safety or efficacy data observed during clinical studies; risks related to the impact of public health epidemics affecting countries or regions in which Cabaletta has operations or does business, such as COVID-19; risks related to Cabalettas ability to protect and maintain its intellectual property position; uncertainties related to the initiation and conduct of studies and other development requirements for its product candidates; the risk that any one or more of Cabalettas product candidates will not be successfully developed or commercialized; and the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Cabalettas actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in Cabalettas most recent annual report on Form 10-K as well as discussions of potential risks, uncertainties, and other important factors in Cabalettas other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Cabaletta undertakes no duty to update this information unless required by law.

Contacts:

Anup MardaChief Financial Officerinvestors@cabalettabio.com

Sarah McCabeStern Investor Relations, Inc.sarah.mccabe@sternir.com

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Cabaletta Bio Announces CABA-201, a Newly Designed CD19-Targeting CAR T Cell Therapy Engineered to Address a Broad Range of Autoimmune Diseases -...

Women have always been told to be aware of lumps in the breast. Routine self-examination of breasts is considered important for the early identification of lumps and subsequent investigations to rule out cancer. Once considered deadly, advances in treatments have ensured increased survival rates in women with breast cancer. Nonetheless, it remains the number one cancer among Indian women.

Before understanding more about breast cancer, let us first understand what is cancer. Dr. Pradeep Mahajan, Regenerative Medicine Researcher, StemRx Bioscience Solutions Pvt. Ltd., Navi Mumbai, explains cancer as the uncontrolled multiplication of cells, which is something the immune system cannot handle effectively. What makes matters worse is that cancer cells are capable of hiding from the immune system. He added that this is the reason why recent advances in cancer therapy have attempted to focus on training the immune cells in order to attack cancer cells.

Dr Mahajan explains that conventional cancer therapies are associated with hair loss, weight loss, general malaise etc. The reason behind this is that treatments such as chemotherapy/radiotherapy not only target cancer cells but also normal cells. Our body has natural healing mechanisms, which are suppressed by these treatments, resulting in undesirable side effects.

Immunotherapy and other advances in cancer therapy are target-specific; thus, prolong the survival of the patient while maintaining their quality of life. Further helping us understand more about immunotherapy and its role in breast cancer, Dr Mahajan says, In breast cancer (and other cancers), immunotherapy aims to educate the front-line immune cells (dendritic cells, natural killer cells, T-cells) of the body to target the cancer cells specifically. The treatment is minimally invasive. It is mostly a laboratory procedure to prepare the cells for transplantation in the patients bodythink of it like a vaccine. Obtaining blood and transplanting the cells is via intravenous injection, which is similar to that done while taking blood tests. Immunotherapy simply enhances the natural healing mechanisms of the body to fight cancer, which is overwhelmed by the load of the disease.

Another treatment is using stem cells to reconstruct defects left after surgery for cancer. In breast cancer specifically, fat-derived stem cells have shown promise in improving/maintaining the volume of the breast tissue, and have shown positive effects on improving blood circulation, reducing swelling/inflammation and scar tissue.

We need treatments that enable a patient to go about his/her routine independently for as long as possible and not just prolong survival. Immunotherapy and stem cell treatments improve the quality of life of patients with breast cancer along with reducing the side effects of conventional treatments, concludes Dr. Mahajan.

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Breast cancer treatment: These targeted therapies are a ray of hope for patients - Health shots

SALT LAKE CITY, Oct. 11, 2022 /PRNewswire/ --DiscGenics, Inc., a clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced that Matthew F. Gornet, MD, Board Certified Spine Surgeon at The Orthopedic Center of St. Louis, will present two-year follow-up data from the Company's first-in-human clinical study of its allogeneic discogenic progenitor cell therapy (IDCT) for lumbar disc degeneration at the North American Spine Society (NASS) 37th Annual Meeting to be held October 12 15, 2022 at McCormick Place West in Chicago.

DiscGenics previously announced the primary efficacy endpoint of the study was achieved with statistically significant improvement in low back pain observed in the high dose IDCT group at the one-year timepoint. High dose IDCT also produced clinically meaningful, statistically significant improvements in function and quality of life by 12 weeks following intradiscal injection with durability sustained at the one-year interim readout.

Dr. Gornet will present final two-year clinical data for three key patient-reported outcome measures of pain, function, and quality of life, as well as MRI results across four study groups: low dose IDCT (n=20), high dose IDCT (n=20), vehicle (n=10) and saline placebo (n=10).

"We are thrilled to have Dr. Gornet, a world-renowned spine surgeon, present this data," said Kevin T. Foley, MD, Chief Medical Officer of DiscGenics and Chairman of Semmes-Murphey Neurologic & Spine Institute. "Dr. Gornet was the highest enroller in our study and provides tremendous perspective on the IDCT data given his years of surgical experience and clinical trial involvement in concert with SPIRITT Research in St. Louis."

The study is an FDA-approved, prospective, randomized, double-blinded, controlled, multicenter study designed to evaluate the safety and preliminary efficacy of IDCT for the treatment of symptomatic lumbar degenerative disc disease versus vehicle and saline controls. For more information on the study, visit: https://clinicaltrials.gov/ct2/show/NCT03347708.

Dr. Gornet's presentation will take place on Wednesday, October 12 at 1:06PM Central Time during the Lumbar Degenerative Pathology Abstract Presentations in Room W471ab.

DiscGenics is a sponsor of NASS 2022 and will host Booth# 5040 in the Exhibit Hall.

In attendance from DiscGenics will be Flagg Flanagan, Chief Executive Officer and Chairman, Dr. Kevin Foley, Chief Medical Officer, Bob Wynalek, Chief Operating and Commercial Officer, and Lindsey Saxon, Communications and Business Development.

About DiscGenics

DiscGenics is a privately held, clinical-stage biopharmaceutical company developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine. DiscGenics's first product candidate, IDCT (rebonuputemcel), is an allogeneic, injectable discogenic progenitor cell therapy for symptomatic, mild to moderate lumbar disc degeneration. IDCT is a mixture of live Discogenic Cells, which are a unique progenitor cell population derived from donated adult human intervertebral disc tissue, and a viscous carrier. As the only company in the world to develop an allogeneic cell therapy derived from intervertebral disc cells to treat diseases of the disc, DiscGenics has a unique opportunity to offer a non-surgical, potentially regenerative solution for the treatment of patients suffering from the debilitating effects of back pain. For more information, visit discgenics.com.

SOURCE DiscGenics, Inc.

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Two-Year Clinical Data for DiscGenics's Progenitor Cell Therapy for Lumbar Disc Degeneration to Be Presented at NASS 2022 - PR Newswire

Roughly 620,000 new cases of lymphoma were diagnosed worldwide, according to the World Cancer Research Fund International's 2020 report. Survival rates have improved as advances develop in treatment, such as chimeric antigen receptor-T cell therapy (CAR-T cell therapy).

CAR-T cell therapy is a personalized treatment giving hope to patients diagnosed with various lymphomas.

"Lymphoma in plain terms is essentially a cancer of your immune system," says Dr. Madiha Iqbal, a Mayo Clinic hematologist and oncologist.

Patients who are newly diagnosed with lymphoma are offered a combination of chemotherapy and antibody-based treatments. But for those who do not respond to two or more lines of such treatments, CAR-T cell therapy may be an option.

"Prior to the advent of CAR-T cell therapy, patients who had failed two lines of chemotherapy had a very poor survival of around six months," says Dr. Iqbal.

Receiving CAR-T cell therapy can take a few weeks as a patient's T cells, which normally help fight off infections, are collected and genetically engineered to target lymphoma.

After low-dose chemotherapy, the modified cells are infused back into the patient. These cells can then attack and destroy the lymphoma.

"Patients who had a very poor prognosis can now potentially be cured of their disease," says Dr. Iqbal.

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Mayo Clinic Minute: What is CAR-T cell therapy? - Finger Lakes Times