Partnering News: J&J, BMS, Sandoz & MoreBy
A roundup of bio/pharmaceutical partnering news from Johnson & Johnson/Cellular Bio, Bristol Myers Squibb/Immatics and Sandoz/Adalvo.
* J&J, Cellular Bio In $245-M Oncology Pact for CAR-T Therapies
* BMS Opts in for T-Cell Therapy Pact with Immatics
* Sandoz, Adalvo in US Commercialization Pact for Six Medicines
J&J, Cellular Bio In $245-M Oncology Pact for CAR-T Therapies
Johnson & Johnson (J&J) has entered into a worldwide collaboration and license agreement with Cellular Biomedicine Group (CBMG), a Rockville, Maryland-based bio/pharmaceutical company, to develop, manufacture, and commercialize chimeric antigen receptor (CAR) T-cell therapies for the treatment of B-cell malignancies in a deal consisting of $245 million in upfront funding plus undisclosed milestone payments.
The companies report that the investigational CD20-directed autologous CAR-Ts under the agreement have demonstrated promising results in Phase I studies in patients with relapsed/refractory non-Hodgkin’s lymphoma in China, with the majority of study participants having diffuse large B-cell lymphoma (DLBCL), the most common type of aggressive lymphoma accounting for approximately one-third of B-cell lymphomas globally.
A key product under the agreement is C-CAR039, a bispecific CAR-T therapy targeting both CD19 and CD20 antigens, which has received US Food and Drug Administration (FDA) investigational new drug (IND) clearance, and regenerative medicine advanced therapy and fast-track designations for the treatment of patients with relapsed or refractory DLBCL.
Under the agreement, CBMG will grant J&J a worldwide license to develop and commercialize the CAR-T assets, except in Greater China. J&J and CBMG will negotiate an option for Janssen to commercialize the products in the China territory. J&J will make an upfront payment of $245 million that will be accounted for in the second quarter as a research and development expense. Additional future payments will be based upon the achievement of certain development, regulatory, and sales milestones, as well as tiered royalty payments on worldwide net trade sales, excluding Greater China.
The closing of the transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act, and is expected to close in the second quarter of 2023.
Source: Johnson & Johnson
BMS Opts in for T-Cell Therapy Pact with Immatics
Bristol Myers Squibb (BMS) has exercised its option and entered into an exclusive worldwide license for a T-cell receptor engineered T cell therapy (TCR-T) candidate from Immatics, a Tuebingen, Germany-based bio/pharmaceutical company.
Under the terms of the 2019 multi-target strategic collaboration agreement with BMS, which was expanded in 2022, Immatics is developing and validating four TCR-T targets and product candidates through the lead TCR candidate stage. BMS can exercise opt-in rights and assume sole responsibility for further worldwide development, manufacturing, and commercialization of the TCR-T cell therapies. This first opt-in is for a TCR-T product candidate against a target relevant in multiple solid tumor indications. Immatics is to receive an option exercise fee of $15 million.
The TCR-T programs developed within the collaboration are directed against solid tumor targets discovered by Immatics using its Xpresident technology combined with its Xceptor TCR discovery and engineering platform to identify specific TCRs against these targets. For each program, Immatics is eligible for up to $505 million in option exercise fee, regulatory, and commercial milestone payments, as well as additional tiered royalties on net sales of the licensed product.
Sandoz, Adalvo in US Commercialization Pact for Six Medicines
Sandoz, the generics and biosimilars business of Novartis, has signed a distribution and collaboration agreement with Adalvo, a Malta-based bio/pharmaceutical company, for exclusive rights to Sandoz to commercialize six products in the US across key therapeutic areas, including antifungal/antibiotic, oncology, and pulmonary.
Sandoz says that the products, which are slated for near- to mid-term launches beginning in 2024, have a total addressable market size of approximately $3 billion.