Kyowa Kirin has decided to halt all clinical development of its OX40 drug following the occurrence of two new cancer cases. Sanofi has committed up to $1.5 billion for worldwide rights to Sino Biopharm’s first-in-class JAK/ROCK inhibitor with potential for graft-versus-host disease. Based on strong early-stage data in prostate cancer, BioNTech is advancing its B7-H3 antibody-drug conjugate licensed from DualityBio to Phase 3.
1. New cancer cases prompt Kyowa to cancel late-stage autoimmune disease program
Kyowa Kirin has decided to halt all clinical development of its anti-OX40 drug, approximately one month after Amgen terminated its partnership with the company regarding its drug candidate, locatinlimab. The company said two new cases of Kaposi’s sarcoma (one confirmed and one suspected) were reported in addition to the previous cases, showing a “potential mechanistic link to OX40 pathway regulation.”
2. Sanofi signs $1.5 billion worldwide license agreement for Sino Biopharm’s first-in-class JAK/ROCK assets
Sanofi will pay $135 million upfront for worldwide rights to Sino Biopharm’s first-in-class JAK/ROCK inhibitor lovacitinib, which was just approved in China to treat myelofibrosis. According to the seller, the drug’s “core value” lies in its potential in chronic graft-versus-host disease. The deal includes potential milestones of up to $1.395 billion.
3. BioNTech advances DualityBio ADC to Phase 3, captures half of Merck First competitor’s patients
BioNTech’s B7-H3 antibody-drug conjugate in partnership with DualityBio demonstrated a median radiographic progression-free survival of 11.3 months in heavily pretreated patients with metastatic castration-resistant prostate cancer, including those who did not respond to Novartis’ Pluvicto. BioNTech is moving its drug, BNT324, into Phase 3, which is half the size of competing programs from Merck & Co. and Daiichi Sankyo.
4. Pfizer’s oncology R&D strategy: Jeff Legos on speed, breadth and novel combinations
With 3SBio’s PD-1xVEGF bispecificity, partner Pfizer aims to beat the competition based on breadth of research, speed and novel combinations, said the company’s head of oncology. Pfizer’s Dr. Jeff Legos told Fierce that less than a year after the deal, Pfizer would begin 12 clinical trials of the drug. He added that Pfizer’s initial Phase 3 trials are similar to those of its competitors, but that the company is evaluating new combinations, including combinations with ADCs.
5. UCB enters TCE space with $1.1 billion deal with Chinese biotech’s autoimmune candidate
UCB has paid $80 million upfront for the rights to Antengene’s CD19xCD3 T-cell engager. The drug is expected to enter phase 1 trials in China and Australia by the end of March. Antengene will be responsible for completing the first-in-human study before UCB takes over. Chinese biotech companies are eligible to receive up to $1.1 billion in milestone payments.
6. Roche pumps $480 million into South Korea’s biopharmaceutical industry to establish global clinical trial ‘ecosystem’
Roche has signed a memorandum of understanding with the South Korean government under which the Swiss pharmaceutical company will spend approximately $484 million in the Korean biopharmaceutical industry. A Roche spokesperson said the partnership would strengthen the country’s competitiveness “by establishing a global clinical trial ecosystem and strengthening innovative medicine research and development capabilities.”
Other notable news:
7. Padchev and Keytruda combination therapy begins new bladder cancer clinical trial as MIBC landscape becomes more complex
8. Ono Pharmaceutical’s Decifera discontinues early solid tumor treatment drug for strategic reasons
9. Merck KGaA sells pipeline assets from SpringWorks acquisition and Henrui license agreement
10. BioDuro joins Taiwan joint venture, adds commercial API factory to production network
11. TCE biotechnology company Candid achieves NASDAQ listing through reverse merger with rare disease specialist Rallybio
12. Earendil signs $885 million agreement to use WuXi XDC’s linker technology in next-generation ADCs
13. GLP-1 player QL Biopharm raises $73 million in Series C (fundraising tracker)
14. Daiichi Sankyo signs agreement with Germany’s Gaia to sell digital treatment for high cholesterol
