Kyowa Kirin has decided to discontinue all clinical development of its OX40 drug after two new cancer cases emerged. Sanofi is committing up to $1.5 billion for global rights to Sino Biopharm's first-in-class JAK/ROCK inhibitor, which has potential in graft-versus-host disease. With strong early-stage data in prostate cancer, BioNTech is moving a DualityBio-licensed B7-H3 antibody-drug conjugate into phase 3. And more.
1. New cancer cases prompt Kyowa to discontinue late-stage autoimmune disease program
Kyowa Kirin has decided to discontinue all clinical development of its anti-OX40 drug about a month after Amgen exited a partnership around the candidate, rocatinlimab. Two new cases of Kaposi’s sarcoma—one confirmed and one suspected—were reported on top of a previous case, drawing a “potential mechanistic link to OX40 pathway modulation,” according to the company.
2. Sanofi strikes $1.5B global licensing deal for Sino Biopharm's first-in-class JAK/ROCK asset
Sanofi will pay $135 million upfront to obtain global rights to Sino Biopharm’s first-in-class JAK/ROCK inhibitor rovadicitinib, which was just approved in China in myelofibrosis. The drug’s “core value,” according to the seller, is in its potential in chronic graft-versus-host disease. The deal includes up to $1.395 billion in potential milestones.
3. BioNTech advances DualityBio ADC into phase 3 with half the patients of Merck-Daiichi rival
BioNTech’s DualityBio-partnered B7-H3 antibody-drug conjugate showed median radiographic progression-free survival of 11.3 months among heavily pretreated patients with metastatic castration-resistant prostate cancer, including some who had failed on Novartis’ Pluvicto. BioNTech is moving the drug, BNT324, into a phase 3 that’s half the size of a competing program 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 bispecific, partner Pfizer is aiming to beat the competition based on breadth of research, speed and novel combinations, the pharma’s oncology chief said. In less than a year since the agreement, Pfizer will have started 12 clinical trials of the drug, Pfizer’s Jeff Legos, Ph.D., told Fierce. Pfizer’s first phase 3 trials look similar to its competitors’, but the company is evaluating new combinations, including with its ADCs, he added.
5. UCB enters TCE space with $1.1B deal for Chinese biotech's autoimmune candidate
UCB is paying $80 million upfront for rights to a CD19xCD3 T-cell engager made by Antengene. The drug is slated to enter phase 1 testing in China and Australia by the end of March. Antengene is responsible for completing first-in-human studies before UCB takes over. The Chinese biotech is eligible to receive up to $1.1 billion in milestone payments.
6. Roche pumps $480M into South Korea biopharma industry to establish global trial 'ecosystem'
Roche signed a memorandum of understanding with the South Korean government for the Swiss pharma to spend about $484 million in South Korea’s biopharma industry. The partnership will strengthen the country’s competitiveness “by establishing an ecosystem for global clinical trials and enhancing R&D capabilities for innovative medicines,” a Roche spokesperson said.
Other News of Note:
7. Padcev-Keytruda combo aces another bladder cancer trial as MIBC landscape becomes more complex
8. Ono's Deciphera drops early-stage solid tumor drug for strategic reasons
9. Merck KGaA drops pipeline assets from SpringWorks buyout, Hengrui licensing deal
10. BioDuro enters Taiwan joint venture, adding commercial API plant to production network
11. TCE biotech Candid scores Nasdaq listing via reverse merger with rare-disease-focused Rallybio
12. Earendil pens $885M pact to use WuXi XDC's linker tech for next-gen ADCs
13. GLP-1 player QL Biopharm raises $73M in series C (Fundraising tracker)
14. Daiichi Sankyo pens pact with Germany's Gaia to sell digital therapeutic for high cholesterol