AstraZeneca and Daiichi Sankyo's Enhertu delivered a massive advantage over Roche's rival antibody-drug conjugate Kadcyla at slowing tumor progression in HER2-positive breast cancer. Biogen and Samsung Bioepis snagged an FDA nod for the U.S.' first ophthalmology biosimilar, a copycat referencing Roche and Novartis' Lucentis. With positive efficacy data, Clover Biopharmaceuticals will seek China, EU and World Health Organization authorizations for its COVID-19 vaccine.
The HER2 antibody-drug conjugate fight has found a winner. In second-line treatment of HER2-positive metastatic breast cancer, AstraZeneca and Daiichi Sankyo’s Enhertu cut the risk of disease progression or death by a huge 71.6% over Roche’s Kadcyla, data from the DESTINY-Breast03 trial showed. Enhertu also more than doubled the response rate compared with Kadcyla, and its rate of the side effect interstitial lung disease appeared better than in a previous trial in late-line treatment.
Biogen and its Samsung Biologics joint venture, Samsung Bioepis, have won FDA approval for Byooviz, the first biosimilar to Roche and Novartis’ eye med Lucentis. The copycat drug earned go-aheads in the EU and the U.K. last month. Through a licensing deal signed in 2019, Biogen will handle U.S. marketing.
Clover Biopharmaceuticals’ adjuvanted protein vaccine SCB-2019 showed strong efficacy in a phase 2/3 trial. Across the entire 30,000-person study, vaccine efficacy reached 67% against COVID-19 disease. Importantly, its efficacy was 79% against the currently dominant delta variant, though the efficacy dropped to 59% for the mu variant. The company will use the data to seek approvals in China and the EU as well as a listing with the World Health Organization.
Daiichi Sankyo offered an early look at first-in-human data from its fourth antibody-drug conjugate program, the B7-H3-targeting drug DS-7300. The dose-escalation stage of a phase 1/2 trial returned 15 partial responses plus another 32 patients with stable disease. A treatment-related death happened in the 16-mg/kg dose cohort after the patient developed interstitial lung disease.
Just two weeks after a Delaware judge said his court didn’t have the jurisdiction to order Takeda to abide by its Lupron supply agreement with AbbVie, the judge issued a separate ruling that the Japanese pharma had breached contract in failing to supply its partner with the prostate cancer drug. The legal battle came after the FDA slapped a warning letter on a Takeda plant making Lupron.
Hong Kong diagnostics company Prenetics is going public on Nasdaq through a SPAC merger with Artisan Acquisition, which was founded by Adrian Cheng, CEO of the Chinese conglomerate New World Development. Prenetics is slated to raise $459 million in cash, including $120 million from private investment. The transaction values the combined firm at $1.7 billion, featuring a rapid, portable COVID-19 test.
Serum Life Sciences, a subsidiary of Serum Institute of India, made a $68.2 million investment for a 3.9% share in Oxford Biomedica. The money will be used to upgrade an 84,000-square-foot manufacturing facility in Oxford. The U.K. company helps make AstraZeneca’s COVID-19 vaccine plus lentiviral vector-based products.
In the fight against Johnson & Johnson’s Erleada for supremacy in prostate cancer treatment, Pfizer and Astellas rolled out a final patient survival analysis for their Xtandi in metastatic hormone-sensitive disease. Adding Xtandi to androgen deprivation therapy (ADT) reduced the risk of death by 34% in the phase 3 ARCHES trial. At the four-year mark, 70.6% of Xtandi patients were alive, versus 57% for ADT alone.
Other news of note:
9. Cytiva invests $54.5M in Korea to expand vaccine manufacturing capacity over 3 years (Korea Biomedical Review)