Legend Biotech announced that FDA and European Commision have approved Carvykti (cilta-cel) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor, and an immunomodulatory agent, and are refractory to lenalidomide.
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Carvykti was approved in the US and Europe for treatment of multiple myeloma
CLINICAL AND REGULATORY
Carvykti approved in the US and Europe as second line treatment of multiple myeloma
Carvykti is the first and only BCMA targeted therapy, including CAR-T therapies, bispecific antibodies, and ADCs, approved starting in the second-line of treatment for patients with multiple myeloma. The approvals are based on positive results from the CARTITUDE-4 study, which demonstrated that Carvykti resulted in statistically significant and clinically meaningful improvement of PFS compared to two standard of care treatment regimens, pomalidomide, bortezomib, and dexamethasone or daratumumab, pomalidomide, and dexamethasone, in adults with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.
DEALS AND FINANCING
Century Therapeutics announced acquisition of Clade Therapeutics
The acquisition of Clade strengthens Century’s position as a leader in allogeneic, iPSC-derived cell therapy through the enhancement of its next generation platform – including novel technology enhancing Century’s efforts on Allo-Evasion – and a newly expanded pipeline incorporating three additional preclinical-stage programs from Clade’s αβ iT platform spanning across cancer and autoimmune diseases. With favorable terms and synergies between these respective platforms, Century is well-positioned to drive further value in the cell therapy space in the near and long term. Century’s newly expanded and diversified pipeline incorporates additional next-generation iNK and iT programs spanning targets in cancer, and autoimmune diseases. These programs include CLDE-308, an αβ iT cell program targeting CD19 in autoimmune disease and B-cell malignancies, CLDE-361, an αβ iT cell program targeting BCMA in myasthenia gravis, and an undisclosed iT cell focused research program in solid tumors. The aggregate purchase price of the Clade acquisition is approximately $35 million in upfront consideration, comprising of a mix of cash and shares of Century common stock, with the shares of common stock issued based on a price per share representing a 16.7% premium to Century’s closing price on April 10, 2024. The merger is subject to customary closing conditions. An additional one-time milestone payment in an amount of $10 million, payable in cash, shares of Century’s common stock or a combination thereof, will be due upon the achievement of a future clinical milestone.
BMS and Cellares announced a $380 million supply agreement for manufacturing of CAR-Ts
BMS and Cellares, the first Integrated Development and Manufacturing Organization (IDMO) dedicated to clinical and industrial-scale cell therapy manufacturing, announced a worldwide capacity reservation and supply agreement for the manufacture of CAR T cell therapies in a transaction valued up to $380M in upfront and milestone payments. As part of the agreement, Cellares will optimize, automate, and tech-transfer select BMS CAR T cell therapies onto its automated and high-throughput manufacturing platform, the Cell Shuttle. Cellares will dedicate multiple Cell Shuttle and Cell Q™ systems with fully automated, high-throughput quality control for BMS’ exclusive use. The Cell Shuttles and Cell Qs will be deployed in Cellares’ Smart Factories in the US, EU, and Japan. Manufacturing cell therapies is both operationally and technically complex. Because cell therapies are rapidly transforming the way many different diseases are treated, the demand for these treatments is increasing significantly. This collaboration enables Bristol Myers Squibb to expand its manufacturing capacity, meeting the growing demand for its diverse range of cell therapies through a platform that is scalable and has the potential to improve turnaround time, bringing the promise of cell therapies to more patients faster. This agreement expands upon the existing collaborations between BMS and Cellares. In August 2023, BMS participated in Cellares’ Series C financing to launch the first IDMO Smart Factory in an effort to meet the demand for cell therapies globally. That same month, Bristol Myers Squibb joined Cellares’ Technology Adoption Partnership (TAP) Program to evaluate the Cell Shuttle’s automated manufacturing capabilities.
Genentech has terminated deal with Adaptimmune to develop allogeneic T-cell therapies
Adaptimmune announced that Genentech quits on their 2021 collaboration to develop allogeneic cell therapies derived from induced pluripotent stem cells to treat cancer. Adaptimmune received $150 million up front and was eligible for $150 million in payments over five years, plus up to $3 billion in milestones. Adaptimmune remains focused on launching afami-cel later this year with a PDUFA date of August 4th and developing its broader sarcoma franchise.
