Image Source: Pixabay

Deals and Financings

Shionogi (SGIOF), an Osaka innovative pharma, has signed an option agreement with Cilcare of Montpellier, France to in-license two drug candidates aimed at hearing loss in a deal worth up to $445 million (see story).

Shionogi optioned rights for two candidates targeting cochlear synaptopathy, including one that is poised to start a Phase II trial. In preclinical tests, CIL001 showed efficacy, restoring full activity of the auditory nerve and repairing the synapses. Shionogi will make an upfront payment of EUR15 million and, if it exercises the option, be responsible for milestones of EUR400 million, plus royalties. 

XtalPi, a Shenzhen-Boston AI drug discovery company, raised $126.8 million in a Hong Kong IPO, the third-largest Hong Kong IPO of the year (see story). XtalPi was initially backed by China’s Tencent and has raised over $780 million in venture capital, with the last $400 million round at a $2 billion valuation.

Established in 2015 by three postdoctoral physicists at MIT, XtalPi combines quantum physics, AI, cloud computing, and large-scale robotics to provide R&D discovery services for small molecule and biologic drugs. XtalPi's formal name is QuantumPharm.

Takeda (TAK) entered a $100 million option agreement to acquire global rights (ex-China) to Suzhou Ascentage’s (ASPHF) lead drug, olverembatinib, a third-gen BCR-ABL tyrosine kinase inhibitor (TKI) (see story). Ascentage will be responsible for all clinical development of olverembatinib until the option is exercised, and Takeda will make an equity investment of unspecified size in Ascentage.

Takeda is also responsible for an option exercise fee and additional milestone and royalty payments. Further details of the agreement were not disclosed. Olverembatinib is already launched in China for two three chronic myeloid leukemia (CML) indications. 

Australia’s EnGeneIC, a company developing a targeted nanocell technology for cancer therapies, announced financial partnerships with two Singapore entities, Singapore Institute of Advanced Medicine Holdings (SAM) and Singapore Medical Incorporation (SMI) (see story). Although the investment amount was not disclosed, the financing was called “significant.”

The funding will be used to advance EnGeneIC’s proprietary technology, EnGeneIC Dream Vector, for oncology and infectious diseases. The first-in-class EDVTM nanocell is the basis of an antibody nanocell drug conjugate platform for delivering therapeutic payloads -- drugs, siRNAs, miRNAs, adjuvants – via antibody-targeting of a cancer cell’s surface with minimal toxicity. 

Company News

Tokyo’s Kyowa Kirin (KYKOF) will invest up to $530 million to build a biologics manufacturing plant in Sanford, North Carolina, an area known as The Research Triangle (see story). The facility will be a 15,951 square meter (171,700-square-foot), two-bioreactor facility that is scheduled to break ground in Q3 of 2024.

Kyowa Kirin said the new facility will accelerate the development and production of biologic therapies for patients with debilitating diseases that have unmet medical needs. The company’s research interests include next-gen antibodies, small molecule drugs, nucleic acid drugs, and regenerative medicine products. Kyowa Kirin already has two manufacturing facilities in Japan. 

Asia Scientific Global, a company developing inhaled forms of existing drugs, has built a laboratory in Taiwan, and it will establish a second facility in Singapore later this year (see story). The new lab will develop 505(b)2 new dosage drugs targeting four key areas: antibiotics, erectile dysfunction, respiratory health, and the central nervous system.

For most of its products, Asia Scientific Global will use dry powder inhalers that deliver medication via the respiratory tract. Asia Scientific Global revealed recently that Beta1, a novel drug aimed at erectile dysfunction, has completed toxicology testing and will start clinical trials soon. 

Trials and Approvals

Vancouver’s Zymeworks (ZYME) announced that its BLA for zanidatamab, a HER2-targeted bispecific antibody, was accepted for review by China’s CDE as a second-line treatment for HER2-positive biliary tract cancer (BTC) (see story). Zanidatamab can simultaneously bind two non-overlapping epitopes of the HER2 receptor, known as biparatopic binding.

In 2018, BeiGene (BGNE) acquired Asia Pacific rights to zanidatamab and several other Zymeworks candidates in a $1.1 billion agreement. Following a Phase IIb trial, Zymeworks and BeiGene filed the BLA, which triggered an $8 million milestone from to Zymeworks. 

Shanghai Junshi Bio said toripalimab (Tuoyi), its anti-PD-1 mAb, met the progression free survival endpoint as a first-line treatment for advanced hepatocellular carcinoma (see story). Toripalimab was administered along with bevacizumab (Avastin), Genentech’s anti-VGFR.

The toripalimab-bevacizumab combination offered better progression free survival and overall survival compared to the current standard of care, sorafenib (Nexavar). Junshi will submit a supplemental NDA for the latest toripalimab indication soon; it is already approved for eight indications in China. 

Suzhou Ascentage Pharma was approved to start a China Phase III trial of olverembatinib (HQP1351) as a second-line therapy for succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) (see story). Olverembatinib is an orally-available novel third-generation TKI developed by Ascentage Pharma.

It its latest trials, olverembatinib achieved a clinical benefit rate of 92.3% in SDH-deficient GIST patients. With a median age of diagnosis of 21 years, the disease is more common in women. It arises primarily in the gastric area with a high propensity to metastasize. 

Nanjing Biosion presented positive data from a Phase II proof-of-concept trial of Bosakitug, a high potency anti-TSLP mAb, in subjects with atopic dermatitis (see story). 94% of the patients in the trial had an EASI response of 75%, and 25% reported a 100% response.

Bosakitug, Biosion’s lead drug candidate, has also started trials for severe asthma and chronic rhinosinusitis with nasal polyps, and it is in preclinical development for COPD. Biosion partnered China rights for Bosakitug with CTTQ and the US rights with Taiwan’s OBI Pharma. 

More By This Author: