Akeso and Summit Therapeutics' ivonescimab showed strong efficacy against Merck's Keytruda in a phase 3 trial in China. The BIOSECURE Act sailed through a full House vote despite some objections. Candid Therapeutics amassed $370 million in series A funds with two T-cell engagers licensed from China. And more.
Akeso and Summit Therapeutics’ PD-1/VEGF bispecific ivonescimab cut the risk of disease progression or death by 49% over Merck’s Keytruda in a Chinese phase 3 trial in first-line PD-L1-positive non-small cell lung cancer. Consistent benefits were seen across key patient subgroups. While the drug showed strong data, it still has some proving to do before it can become the new cancer immunotherapy king.
2. After BIOSECURE Act passes in House, targeted Chinese companies say they're 'deeply' concerned
The U.S. House of Representatives voted 306-81 in favor of the BIOSECURE Act. Nearly all “no” votes came from Democrats. WuXi AppTec, one of the companies that could be excluded from the U.S. market if the bill eventually becomes law, said the legislation “pre-emptively and unjustifiably” designates the company without due process. The bill’s path at the Senate remains uncertain.
3. With $370M debut, Candid Therapeutics is upfront about goal to lead a coming T-cell engager wave
Candid Therapeutics has emerged with $370 million from a series A round co-led by Venrock Healthcare Capital Partners, Fairmount, TCGX and venBio Partners, plus two T-cell engagers obtained from Chinese companies. The two candidates are BCMAxCD3 and CD20xCD3 bispecific antibodies that Candid is now developing for autoimmune diseases. Former RayzeBio chief Ken Song, M.D., is at the helm of the biotech.
4. AstraZeneca, Daiichi unpack Dato-DXd's overall survival fail ahead of FDA decision
Detailed data from the TROPION-Lung01 trial showed a numerical 2.3-month improvement in median overall survival for AstraZeneca and Daiichi Sankyo’s Dato-DXd compared with docetaxel in a subgroup of patients with nonsquamous non-small cell lung cancer. The death risk reduction in the patient group was 16%, which doesn’t bear statistical significance.
AZ, with the help of artificial intelligence, has devised a new biomarker for Dato-DXd called normalized membrane ratio of TROP2 by quantitative continuous scoring (NMR-QCS). The marker incorporates both the membrane and cytoplasm expression of TROP2. With this effort, AZ's ambition is to explain why Dato-DXd appears to work only in nonsquamous patients and to differentiate the drug from competitors.
6. AbbVie slaps BeiGene with another blood cancer lawsuit, this time on BTK degrader trade secrets
AbbVie has brought another lawsuit against BeiGene, accusing the latter company of trade secrets theft related to BTK degraders. AbbVie argued that BeiGene lured a former scientist to work on its competing program and therefore obtained confidential information. BeiGene told Fierce that its candidate was “independently discovered” and that the company plans to “vigorously defend” itself.
Other News of Note:
7. J&J bolsters Rybrevant-Lazcluze's case against AZ's Tagrisso with survival analysis
8. Merck, Daiichi repeat early success in small cell lung cancer with updated ADC data
9. FDA issues Form 483s to Japanese, Indian drugmakers in wake of plant inspections
10. India's Zydus hit with warning letter as FDA flags glass contamination concerns and more
11. Connect reduces China workforce, mulls strategy for potential Dupixent rival
12. FDA sends warning letters to 2 Chinese lab service providers for device makers (release)