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Deals and Financings

Shanghai AlphaGen Therapeutics and ArtBio of Cambridge MA, two targeted radioligand therapy (RLT) companies, forged a far-reaching agreement to expand ArtBio’s market and develop new RLTs (see story). AlphaGen will have China rights to use ArtBio’s AlphaDirect isotope isolation technology to generate 212Pb, a unique isotope without a global supply.

It will also have a license to develop AB001, a clinical-stage alpha RLT targeting prostate-specific membrane antigen (PSMA), in Greater China. And AlphaGen will have the right to use ArtBio’s AlphaDirect platform to develop 212Pb RLTs against additional targets. ArtBio will have a minority equity interest in AlphaGen as part of the agreement. 

Biocytogen Pharma (Beijing) signed an antibody evaluation/option agreement with Gilead Sciences (GILD), granting access to Biocytogen’s fully human antibody library aimed at a wide range of therapeutic targets (see story). Over a three-year period, Gilead will nominate targets of interest and evaluate the corresponding antibodies, with an option to acquire global rights for promising antibodies.

Biocytogen will receive a payment to enable Gilead’s evaluation of antibodies for a specific target, and it will be eligible to receive option exercise fees along with milestone payments for each selected antibody, plus single-digit royalties on net sales. Specific details of the agreement were not disclosed. 

Trials and Approvals

Legend Biotech (LEGN) reported Europe’s CHMP recommended approval of its lead CAR-T drug, Carvykti, for a new indication: second-line therapy for adult patients with relapsed and refractory multiple myeloma (see story). Carvykti (ciltacabtagene autoleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy. It is currently indicated to treat adult M/M patients as a fifth-line therapy.

The filing was conducted by a subsidiary of Janssen, Legend’s partner on the drug. Legend was spun out of Nanjing’s GenScript, though it now lists Somerset, NJ as its global headquarters while continuing to operate in Nanjing as well. 

Nanjing Simcere Pharma (SMHGF) reported data from a Phase III trial of Sanbexin sublingual tablets for acute ischemic stroke were published in an online Journal of American Medical Association•Neurology publication (see story). Sanbexin is an edaravone-dexborneol combination that Simcere is developing with Nanjing’s NeuroDawn Pharma, a CNS company.

Simcere expects the Sanbexin sublingual tablets will become a sequential therapy with Simcere's marketed Sanbexin (Edaravone and Dexborneol Concentrated Solution for Injection), allowing patients to complete their treatment at home. In June 2023, China’s NMPA accepted Simcere’s NDA filing for the combination therapy. 

Suzhou Innovent (IVBXF) reported that IBI31, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, met its endpoint in China Phase III trial in patients with Thyroid Eye Disease (TED) (see story). TED is an autoimmune disease that causes bulging eyes.

A rare disease, the condition usually occurs in patients with Graves' disease (GD), and is the most common orbit-related (problems with the muscles and structures of the eye) disease in adults. TED occurs in approximately 25 to 50% of GD patients. Innovent, which developed the candidate for TED, plans to file an NDA for IBI311 in China.

Jacobio Pharma (JBPHF) was approved to start a China Phase III clinical trial of glecirasib, a KRAS G12C inhibitor, combined with the SHP2 inhibitor JAB-3312 as a first-line therapy for non-small cell lung cancer patients with KRAS G12C mutations (see story). The company said JAB-3312 is the first SHP2 inhibitor to begin a Phase III study globally in combination with an KRAS G12C inhibitor.

The combination will be compared to the current standard of care, a combination of an PD-1 antibody and chemotherapy. Jacobio, a Beijing-San Francisco biopharma, is developing the KRAS G12C inhibitor for several solid tumor cancers. 

Immunofoco was approved to begin a US Phase I trial of IMC001, an EpCAM-targeting autologous CAR-T cell product to treat EpCAM-positive advanced gastrointestinal tumors (see story). The company was already approved to start China trials of the candidate.

The US trial will enroll patients with advanced gastric cancer and gastroesophageal junction adenocarcinoma. EpCAM is a biomarker for circulating tumor cells, which are highly expressed in both primary and metastatic lesions of gastrointestinal tumors, while having only low expression in normal tissues. Immunofoco develops cell therapy products for solid tumors. 

Shanghai’s Mabwell was approved to start US clinical trials of its B7-H3 targeting ADC for advanced malignant solid tumors (see story). The company describes 7MW3711 as a next-gen antibody-drug conjugate comprised of an innovative antibody molecule, novel linker, and novel payload (topoisomerase I inhibitor) that was developed on its drug conjugate platform IDDC.

B7-H3 is overexpressed in most cancer types, but expressed at a low level in normal tissues. In malignant tissues, B7-H3 inhibits tumor antigen-specific immune responses. The company has already started a 7MW3711 clinical trial in China.

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