Cullinan Therapeutics, Inc.

HBM7020 has yet to enter the clinic, although Harbour BioMed secured the green light from Chinese authorities to take the asset into a phase 1 cancer study. \n Aiming T-cell engagers at autoimmune diseases continues to be a red-hot dealmaking target, as evidenced by Otsuka Pharmaceutical’s decision to pay $47 million upfront for the ex-China rights to Harbour BioMed’s BCMAxCD3 bispecific candidate.The therapy, dubbed HBM7020, has yet to enter the clinic, although Harbour secured the green light from Chinese authorities back in 2023 to take the asset into a phase 1 cancer study. The theory behind HBM7020 is that dual anti-BCMA binding sites enhance the therapy’s ability to target cancer cells specifically while monovalent-optimized CD3 activity minimizes cytokine release syndrome, according to a June 22 release.As well as the upfront fee, Harbour will be eligible to receive up to $623 million in development and commercial milestone payments as well as tiered royalties on future net sales.The deal “establishes a foundation for potential future partnerships between the two companies in the T-cell engager area,” Harbour said in the release.Rather than focus on cancer, Otsuka’s plans are to target HBM7020 at autoimmune conditions. In fact, the two companies said today’s licensing deal also marked the start of “a global strategic collaboration … to advance BCMAxCD3 bispecific T-cell engagers for the treatment of autoimmune diseases.”“This collaboration underscores the strength of Harbour BioMed\'s proprietary Harbour Mice and HBICE technology platforms, which enable the rapid development of fully human bispecific antibodies with optimized safety and efficacy profiles,” Harbour CEO Jingsong Wang, M.D., Ph.D., said. “By leveraging our unique capabilities, we are well-positioned to advance next-generation biotherapeutics that can make a meaningful difference in patients\' lives worldwide,” the CEO added.Otsuka should have the space to develop HBM7020, having cleared out a clutch of cancer candidates from its pipeline earlier this year.The Japanese company is using the antibody-drug conjugate and small-molecule platforms of its Visterra and Jnana Therapeutics subsidiaries, respectively, to expand further into autoimmune disease, Otsuka’s President Makoto Inoue explained in the release.“HBM7020 is expected to demonstrate efficacy in a broad range of autoimmune diseases in which B cells play a major role in disease pathogenesis, and we hope to contribute further to the field of specialized autoimmune diseases and thereby benefit patients,” Inoue added.Earlier this month, Cullinan Therapeutics paid $20 million upfront to get its hands on another BCMAxCD3 bispecific T-cell engager that the biotech also plans to use for autoimmune disease when paired with its own CD19 candidate.

Otsuka Pharmaceutical inked a licensing agreement with Harbour BioMed valued up to $670 million, bagging ex-China rights to the latter’s BCMAxCD3 bispecific T-cell engager (BiTE) HBM7020 for treating autoimmune conditions.As part of the deal announced Sunday, Otsuka gains worldwide development and commercialisation rights for HBM7020, excluding Mainland China, Hong Kong, Macau and Taiwan. Harbour is set to receive $47 million in upfront and near-term payments, with eligibility for additional milestone payments of up to $623 million, plus tiered sales royalties.HBM7020 — developed using Harbour’s HBICE and Harbour Mice platforms — features dual anti-BCMA sites for precise targeting and monovalent CD3 binding to reduce cytokine release risk. The bispecific antibody has previously demonstrated potent cytotoxicity with therapeutic potential across immunology and oncology. It was granted IND clearance by China's National Medical Products Administration in 2023, enabling Phase I testing for cancer indications within Greater China.“HBM7020 is expected to demonstrate efficacy in a broad range of autoimmune diseases in which B cells play a major role in disease pathogenesis, and we hope to contribute further to the field of specialised autoimmune diseases," said Makoto Inoue, president of Otsuka.Drugmakers globally are increasingly looking at Chinese biotechs for attractive ventures, particularly in the oncology and autoimmune space. Earlier this month, Cullinan Therapeutics secured ex-China rights to Genrix Bio’s BCMAxCD3 BiTE, while Juri Biosciences tapped EpimAb Biotherapeutics' investigational T-cell engager for prostate cancer last month.

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