Arcellx Inc. signed a deal that could be worth almost $4 billion with Gilead Sciences Inc.’s unit Kite Pharma Inc. to push forward Arcellx's lead late-stage candidate CART-ddBCMA for relapsed or refractory multiple myeloma. The arrangement brings $225 million up front plus an equity investment of $100 million, along with as much as $3.9 billion in milestone payments. Arcellx CEO Rami Elghandour said the firm sorted through a number of suitors interested in the program. Data at the American Society of Clinical Oncology meeting “catalyzed a number of discussions and a broad set of interests. We felt of the possibilities out there, [Kite/Gilead is] the partner of choice in this space.” Read More
Erasca Inc. agreed to give Novartis AG $20 million cash up front and company shares (NASDAQ:ERAS) worth $80 million for an exclusive global license to naporafenib, a pan-RAF inhibitor for treating RAS/MAPK pathway-driven tumors, Erasca’s sweet spot. Erasca CEO Jonathan Lim told investors Dec. 9 that the therapy is complementary to the company’s portfolio, which includes 11 development programs targeting the pathway. Read More
Vaxxas Pty. Ltd. raised AU$34 million (US$23 million) to advance its needle-free COVID-19 vaccine program, which began in early November, and readouts from the study are expected in late February or early March, Vaxxas CEO David Hoey told BioWorld. The COVID-19 vaccine patch is based on the company’s high-density microarray patch technology that delivers Hexapro, a second-generation version of the spike protein used in all major U.S.-approved COVID-19 vaccines. Read More
MEI Pharma Inc. has discontinued the global development of its phosphoinositide 3-kinase (PI3K) delta inhibitor, zandelisib, outside Japan. “In light of FDA’s guidance, we no longer believe clinical development can be completed within a time period that would support further investment, or with sufficient certainty of the regulatory requirements to justify continued global development efforts,” said Daniel Gold, MEI’s president and CEO. Read More
We wrapped up 2022 and are preparing for 2023 on this BioWorld Insider podcast. Staff writer Lee Landenberger talked to four CEOs, visionaries of companies producing new science and drug development. The CEOs offered their insights into what happened this year and looked at the challenges and opportunities for next year. Read More
New and updated clinical data presented by biopharma firms at the San Antonio Breast Cancer Symposium, including: Astrazeneca, Context, Dantari, Exelixis, G1, Intensity. Read More
Biopharmas raising money in public or private financings, including: Aptorum, Biomebank, Certara, Eigen, Prometheus, Pure Tech, Replimune and Sonde. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Beigene, Corcept, Gilead, Hikma, Immunogen and Phanes. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akero, Bioxytran, Bloomsbury Genetic, Brim, Cerecin, Emmaus, In8bio, Liscure, Moderna, Molecular Targeting, Numinus, Quralis, Takeda, VBI, Visiox, Y-mabs. Read More