Ivonescimab

Summit Therapeutics' unsatisfactory global phase 3 readout, Bristol Myers Squibb's big bet on PD-L1/VEGF, Enhertu's first-line breast cancer data and Regeneron's obesity deal with Hansoh Pharma made our news this week. The PD-(L)1xVEGF field had a roller coaster week marked by an imperfect readout and a potentially $11 billion deal. AstraZeneca and Daiichi Sankyo trotted out Enhertu's detailed data in first-line breast cancer. Regeneron signed on a GLP-1/GIP candidate from China's Hansoh Pharma. And more.1. Akeso, Summit's ivonescimab delayed progression of certain lung cancers in first global phase 3 readoutBristol Myers inks $11B BioNTech deal to join bispecific gold rush, leaping ahead of Merck and PfizerSummit Therapeutics unveiled the first global phase 3 readout from Akeso’s PD-1xVEGF bispecific ivonescimab, saying the drug reduced the risk of progression or death by 48% in previously treated EGFR-mutated nonsquamous non-small cell lung cancer. But, because the HARMONi trial did not meet the overall survival endpoint at the current analysis, the company’s stock price tanked.But the PD-(L)1xVEGF field quickly got an injection of confidence when Bristol Myers Squibb announced a potentially $11.1 billion deal to co-develop and co-commercialize BioNTech’s PD-L1xVEGF candidate BNT327. The deal includes $1.5 billion upfront and $2 billion in unconditional anniversary payments through 2028. BioNTech got the drug recently from purchasing its then-partner, Chinese biotech Biotheus, for $800 million upfront.2. ASCO: AstraZeneca, Daiichi flex Enhertu's muscles in first-line breast cancer as they drop new phase 3 gastric cancer dataAstraZeneca and Daiichi Sankyo’s Enhertu, used in combination with Roche’s Perjeta, significantly reduced the risk of progression or death by 44% versus the standard THP regimen in first-line HER2-positive breast cancer. Experts suggested that the result, from the Destiny-Breast09 trial, makes the Enhertu combo a new first-line standard treatment option, although some questions such as treatment duration remained.3. Regeneron pens $2B pact for Hansoh's potential obesity rival to Lilly's ZepboundRegeneron is paying China’s Hansoh Pharma $80 million upfront for ex-China rights to a GLP-1/GIP receptor agonist coded HS-20094. The deal includes up to $1.93 billion in potential milestone payments. The drug is currently undergoing a phase 2b in diabetes and a phase 3 in obesity in China.4. Astellas aspires to strike CLDN18.2 gold again with ADC licensing deal worth up to $1.34BAstellas has doubled down on the Claudin18.2 field by in-licensing an antibody-drug conjugate from Chinese biotech Evopoint Biosciences in a deal potentially worth up to $1.34 billion. Evopoint is testing the agent, XNW27011, in a phase 1/2 solid tumor trial covering gastric, pancreatic, colorectal, ovarian and other cancers. Astellas already has the first FDA-approved Claudin18.2 agent, Vyloy.5. Cullinan pens $700M pact for BCMA bispecific to pair with another autoimmune T-cell engagerCullinan Therapeutics, which is already working on a CD19 bispecific for autoimmune diseases, is getting a BCMA T-cell engager. For $20 million upfront and nearly $700 million in potential milestones, Cullinan is getting ex-China rights to Genrix Bio’s BCMAxCD3 candidate velinotamig. Last year, researchers reported a deep remission in a woman with aggressive refractory systemic lupus erythematosus who received Johnson & Johnson’s BCMA bispecific Tecvayli.6. Kelun-Biotech raises $250M with 6M share placement (release)After its Hong Kong IPO in 2023, China's Kelun-Biotech has raised about $250 million in a new share placement. The company sold about 5.92 million shares at HK$331.80 per share, according to a press release. Kelun said the placement was "multiple times oversubscribed" with support from various types of investors, leading the biotech to expand a previous fundraising target of $200 million. Kelun plans to use the money to fund R&D operations, regulatory interactions, manufacturing infrastructure and more. Other News of Note:7. Ascletis scores phase 3 win for daily acne pill, prepares push to Chinese regulators8. ASCO: Kura, Kyowa reveal 23% remission rate behind oral leukemia drug's phase 2 win9. BioAge inks option agreement for Chinese biotech's obesity asset on heels of earlier APJ agonist setback10. Astellas organizes action week to connect patients to advocacy groups11. Fujifilm, Coherus, ViGeneron unveil rebrands to better reflect ongoing work

London: Bristol Myers Squibb will pay $1.5 billion upfront to partner with Germany's BioNTech on an experimental cancer drug, the U.S. company said on Monday, in a deal that could eventually exceed $11 billion in value for BioNTech. The deal provides a boost for the German company's ambition to continue its costly long-term focus on experimental cancer treatments, and show that its success as Pfizer's COVID-19 vaccine partner was not a one-off achievement. BioNTech's Germany-listed shares surged 13.1% by 1117 GMT to a one-month high. Bristol said it will co-develop and co-commercialize BioNTech's drug, BNT327 , for multiple solid tumour types. The deal underscores the industry's focus on a new dual mechanism of action in oncology . BNT327 is designed to activate the immune system, similar to an established drug class including Merck & Co's Keytruda, but also to cut a tumour's blood supply. "We are impressed by the innovation that BioNTech has achieved to date and we look forward to partnering to accelerate existing clinical trials and time to market, while expanding the number of potential indications," Bristol Myers CEO Chris Boerner said in a statement. Shares in Instil Bio, which is working with ImmuneOnco on a similar compound, soared 41% in U.S. premarket trade. Summit Therapeutics and Akeso have formed another partnership in the development race with a drug candidate called ivonescimab. BioNTech took full ownership of BNT327 through the acquisition of China's Biotheus earlier this year for $800 million upfront and up to $150 million contingent on development achievements. It previously held certain rights in the drug under a 2023 collaboration deal. In addition to the initial payment, Bristol plans to pay BioNTech up to $2 billion more in non-contingent anniversary payments through 2028. BioNTech may also earn up to $7.6 billion more in development, regulatory and commercial milestones, Bristol said. The companies will share global profits and losses from the drug equally, and joint development and manufacturing costs will also be shared on a 50/50 basis, subject to some exceptions. BNT327, part of a drug category known as bispecific antibodies, is currently being tested as a first-line treatment in extensive stage small cell lung cancer and non-small cell lung cancer. More than 1,000 patients have been treated with the drug to date. (Reporting by Michael Erman and Ludwig Burger; Editing by Jacqueline Wong and Susan Fenton)