Week In Review: BeiGene And Bristol-Myers Squibb Close BeiGene-Celgene PD-1 Partnership

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Deals and Financings

Beijing’s BeiGene (BGNE) and Bristol-Myers Squibb have formally completed the breakup of the BeiGene-Celgene partnership, returning 23.3 million ordinary BeiGene shares to BeiGene, worth about $340 million (see story).

In 2017, the two companies announced a $1.4 billion cooperation agreement that sent ex-Asia rights for BeiGene’s PD-1 to Celgene, while BeiGene acquired marketing rights to three Celgene products in China. In 2020, Chinese authorities banned BeiGene-Celgene’s Abraxane because of manufacturing errors. BeiGene hasn’t sold the drug since then.

Soon after the 2017 deal, Celgene was acquired by BMS, which already had a blockbuster PD-1, Opdivio. BMS returned the PD-1 rights to BeiGene along with a $150 million termination payment. 

Gracell Biotechnologies (GRCL), a Suzhou-San Diego CAR-T company, raised $100 million in a private placement that could rise to $150 million if participants exercise options for additional shares (see story).

Gracell is developing a portfolio of CAR-T candidates based on its FasTCAR platform, which features next-day delivery of autologous CAR-T therapies, and its TruUCAR off-the-shelf technology platform. Gracell said the capital will support the company into the second half of 2026. The private placement priced the company’s ADSs at $3.60, and the warrants will purchase an ADS at $5.58. 

Shanghai Antengene out-licensed China commercialization rights for its XPO1 inhibitor, an approved therapy for multiple myeloma in China, to Hansoh Pharma in a deal worth up to $101 million in upfront and milestone payments (see story). Antengene will continue to conduct all development work of Xpovio, including distribution.

Hansoh will be responsible for commercialization, for which it will charge a service fee based on sales. Antengene will be eligible to receive $28 million in upfront payments and $73 million in milestones, plus it will record revenues from the drug. Hansoh Group is based in Shanghai. 

Neurophth Therapeutics, a Wuhan-San Diego company, closed a $95 million Series C+ financing to advance its portfolio of gene therapy ophthalmology therapies and expand its R&D operations (see story). In early 2023, Neurophth's lead therapy, NR082 (rAAV2-ND4), finished enrolling patients in a China Phase III trial as a therapy for Leber's hereditary optic neuropathy (LHON), a rare disease.

The company has also enrolled the first patient for Phase I/II clinical trials of NR082 in the US. The round was co-led by Yangtze River-CMB International Industry Fund, Wuhan Optical Valley Financial Holding Group, and other companies. 

Shanghai Inventisbio (SHA: 688382) out-licensed China rights for its KRAS G12C inhibitor to Nanjing Chia-Tai Tianqing Pharma, a division of Sino Biopharm. D-1553 is aimed at treating non-small cell lung cancer, colorectal cancer, and other cancers with the KRAS G12C mutation (see story).

Inventisbio says D-1553 is approved to start a China Phase II trial for NSCLC patients with the mutation. Financial details of the agreement were not disclosed, but Chia-Tai Tianqing is eligible to receive royalties on ex-China D-1553 revenues based on data sharing from its China trials. 

Duality Biologics (Suzhou) added a third antibody-drug conjugate candidate to its partnership with BioNTech, the German mRNA COVID vaccine company (see story). BioNTech will now have global rights (ex-China) to DB-1305, a third generation Trop2 ADC molecule that has shown clinical efficacy in NSCLC and other solid tumors.

In April, BioNTech in-licensed global (ex-China) rights for two ADC candidates from Duality in a $1.7 billion deal ($170 million upfront). In the latest agreement, Duality will receive an upfront payment and be eligible for milestones and royalties, though specific details were not disclosed. 

Tianjin CanSino Biologics (CASBF), a vaccine company, extended its research alliance with AstraZeneca (AZN), agreeing to provide contract development and manufacturing services for AstraZeneca’s messenger RNA (mRNA) vaccine program (see story). CanSino, which said it would manufacture and supply unspecified mRNA products to AstraZeneca, has an mRNA candidate that has completed China Phase II trials for COVID-19.

AstraZeneca said the deal would support investigational mRNA vaccines in its early pipeline. In November 2022, the two companies announced they were collaborating to bring rare disease therapies to the China market. Financial details of the latest agreement were not disclosed.


Trials and Approvals

AceLink Therapeutics started a China Phase II trial of its lead drug, a proposed treatment for males with previously untreated Fabry disease. AL01211 is a novel oral, non-brain penetrant glucosylceramide synthase (GCS) inhibitor (see story). The GCS inhibitor catalyzes the first step in the synthesis of glycosphingolipids to reduce the synthesis of glycosphingolipids, the cause of Fabry and Gaucher diseases.

AceLink positions AL01211 as an alternative to frequent IV infusions of enzyme replacement therapy. AceLink, which is supported by China venture capital companies, is located in the San Francisco Bay area. 

BioCity Biopharma of WuXi, China was cleared to start a US Phase I study of BC3448, a CD3/EGFR bispecific antibody that will enroll patients with advanced solid tumors (see story). The candidate recruits T cells to tumors cells with high EGFR expression, killing the tumor cells.

To reduce the possibility of cytokine release syndrome, BC3448 is designed to have differential binding affinities for EGFR and CD3, with a stronger binding affinity for EGFR than CD3. The candidate is being developed for solid tumors with high EGFR expression, including NSCLC, HNSCC, mCRC, and ESC. BayCity has already started a similar trial of BC3448 in China. 

Jacobio Pharma (JBPHF), a Beijing oncology company, reported its KRAS G12C inhibitor glecirasib was granted breakthrough therapy designation in China as a second-line therapy for pancreatic cancer patients with a KRAS G12C mutation (see story). The BTD was based on efficacy and safety data from ongoing glecirasib clinical trials.

In late 2022, glecirasib was granted BTD for non-small cell lung cancer (NSCLC) patients with the KRAS G12C mutation, also as a second-line therapy. Jacobio has recently started a pivotal trial of glecirasib for pancreatic cancer, which the company says is the first global pancreatic cancer KRAS G12C registrational clinical study.


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