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Deals and Financings

Shanghai Argo Biopharma entered two agreements with Novartis (NVS), out-licensing four next-gen RNAi therapeutics for $185 million upfront and a total value of $4.2 billion (see story). In the first agreement, Argo granted Novartis exclusive global licenses to develop and commercialize a Phase 1 stage program. In addition, Argo will perform discovery and optimization on two Novartis-chosen cardiovascular targets, with Novartis owning an option to acquire a global license.

In the second agreement, Argo granted Novartis an exclusive ex-Greater China license to a Phase I/IIa clinical-stage program for a cardiovascular therapy. Based on its cutting-edge RNAi platform, the assets offer promising efficacy and durability according to Argo. 

San Diego’s Ambrx Biopharma (AMAM) will be acquired by Johnson & Johnson (JNJ) for $2 billion, a 105% premium to its previous closing price (see story). Ambrx is a US-China company that is developing a portfolio of four antibody drug conjugates. Johnson & Johnson said it would accelerate the Phase I/II study of ARX517 in advanced prostate cancer, while advancing Ambrx’s entire ADC pipeline.

Ambrx has two China subsidiaries, and it has sold China rights for two of its candidates to China biopharmas. In 2015, Ambrx was bought by a consortium of four China companies, though none of them seem active in Ambrx. 

GSK (GSK) plans to acquire Aiolos Bio, a San Francisco-London startup, for $1 billion upfront and up to $400 million in regulatory milestones (see story). Aiolos’ major asset is AIO-001, a long-acting mAb for asthma in Phase II trials.

In August, Aiolos acquired global ex-China rights to the candidate from Jiangsu Hengrui Medicine for $21.5 million upfront and over $1 billion in milestones plus royalties. AIO-001 targets the thymic stromal lymphopoietin (TSLP) cytokine, a driver of inflammation. Aiolos expects AIO-001 to require dosing only every six months. 

Hong Kong’s Insilico Medicine sold global rights for its small molecule KAT6A inhibitor to Stemline Therapeutics, an oncology subsidiary of Italy’s Menarini Group, in a $500 million ($12 million upfront) agreement (see story). Insilico, an AI drug discovery company, said the candidate targets hormone sensitive cancers and other oncology indications. 

Overexpression of KAT6A is associated with poor clinical outcomes in patients with ER+/HER2- breast cancer, the most common subtype of the disease. In preclinical studies, the candidate showed inhibition against KAT6A in multiple CDX and PDX models with good efficacy and safety. 

Tenacia Biotechnology (Shanghai) acquired greater China rights to a clinical-stage therapy for essential tremor from Boston’s Praxis Precision Medicines (PRAX) in a $279 million agreement (see story). Praxis says ulixacaltamide is a differentiated, highly selective small molecule inhibitor of T-type calcium channels, currently in Phase II trials.

It is designed to block abnormal neuronal burst firing in the Cerebello-Thalamo-Cortical circuit that is correlated with tremor activity. Tanacia, a CNS company, paid $15 million upfront, consisting of a $5 million initially and a $10 million investment in Praxis. It will pay up to $264 million in milestones, plus royalties. 

Chengdu Kanghua Biological Products (Kangh) out-licensed global (ex-China) rights for its norovirus vaccine candidate to Boston’s HilleVax (HLVX) in a $270 million agreement (see story). Norovirus is the leading cause of gastroenteritis (vomiting and diarrhea). HIL-216 includes virus-like particles (VLPs) for six of the most common norovirus genotypes.

In 2021, HilleVax, was formed by Japan’s Takeda Pharma (TAK) to develop another norovirus vaccine candidate, HIL-214 (formerly TAK-214), outside of Japan. Kangh will receive $15 million up front and up to $255.5 million in milestones, plus single-digit tiered royalties. 

German’s Bayer AG (BAYRY) joined with RTW Investments of New York City to make a $162 million D round investment into Ji Xing Pharma, an innovative Shanghai drug development company (see story). In exchange for its $35 million share of the funding, Bayer will have privileged rights to negotiate products from RTW’s portfolio of cardiovascular and ophthalmology candidates.

Bayer said the investment has the potential to expand its already strong portfolio in cardiovascular and ophthalmology, along with its China presence. Founded in 2019, Ji Xing is backed by RTW and partners with global biotechnology companies to develop innovative therapeutics for cardiovascular and ophthalmology indications. 

OnCusp Therapeutics, a New York City-Shanghai biopharma, completed an oversubscribed $100 million Series A financing round from China investors (see story). The company plans to advance in-licensed cancer assets from pre-IND studies to proof of concept, considering this stretch to be the largest value inflection point in drug development.

OnCusp will use the proceeds to advance CUSP06, an ADC targeting CDH6, toward clinical proof-of-concept. OnCusp acquired global rights (ex-China) to CDH6 from Multitude Therapeutics, a Shanghai-Redwood City ADC company. OnCusp’s A round was co-led by Novo Holdings, OrbiMed, and F-Prime Capital. 

Shanghai Henlius Biotech acquired China rights to a novel clinical-stage breast cancer therapy developed by Sermonix Pharma of Columbus, Ohio (see story). Henlius will have rights to develop, manufacture, and commercialize lasofoxifene for at least two estrogen receptor-positive (ER+)/HER2- breast cancer indications in China.

It made an upfront payment to Sermonix and will pay up to $58 million in milestones, plus royalties. Sermonix develops novel drugs that treat metastatic breast cancers harboring ESR1 mutations. Lasofoxifene is a novel endocrine therapy that has shown robust target engagement as an ESR1 antagonist for breast cancer. 

Shanghai WuXi Biologics signed a research service agreement with Germany’s BioNTech (BNTX) to discover investigational monoclonal antibodies for two undisclosed targets (see story). WuXi Bio will receive $20 million upfront in exchange for exclusive rights to these mAbs, and it is eligible to receive payments for R&D along with milestones and tiered royalties.

BioNTech, which developed one of the two original siRNA vaccines for COVID-19 (and partnered it with Pfizer), is using its cash to expand into oncology therapies, with a goal of having ten candidates in registrational trials by the end of 2024. 

Beijing Biocytogen Pharma sold an option for a first-in-class anti-HER2/TROP2 bispecific antibody-drug conjugate to Radiance Biopharma of Boston (see story). If Radiance exercises the option, it will have rights to the bispecific ADC for all human indications worldwide.

HER2 and TROP2 are two tumor-associated antigens commonly expressed in multiple solid tumor cancers. Biocytogen will be entitled to receive option and licensing fees, milestone payments and single-digit royalties on net sales. It will also receive a share of any sublicensing fee. Biocytogen applies its gene editing technology to create animal models for antibody drug discovery.

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