CSPC Innovation Pharmaceutical Co., Ltd.

CRB-701 is now being assessed in a Phase I dose escalation clinical trial to treat advanced solid tumours in China. Credit: CDC / Unsplash. Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). CSPC Megalith is a subsidiary of CSPC Pharmaceutical Group . Under the deal, Corbus Pharmaceuticals will have exclusive rights to develop and commercialise CRB-701 in Canada, Australia, the UK, the EU (including the European Free Trade Area), and the US, while CSPC will retain SYS6002’s rights in the remaining markets. The next-generation ADC targets the Nectin-4 expression on cancer cells for releasing a cytotoxic payload. According to the agreement, CSPC will receive a $7.5m upfront payment and eligible for royalties on net sales. It will also receive potential development and regulatory milestone payments of up to $130m along with potential commercial milestone payments of $555m. Corbus chief scientific officer Rachael Brake said: “CRB-701 has several key features that support a differentiated profile. “These include site specific conjugation chemistry that leads to low payload release in plasma, a novel Fc-enabled antibody with an improved pharmacokinetic profile and toxicology data that suggests that there is an ability to achieve higher exposures with CRB-701. “We look forward to working with CSPC to advance clinical development of this asset and realise its full potential.” The US Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for CRB-701. Currently, CSPC is investigating CRB-701 in a Phase I dose escalation clinical trial to treat advanced solid tumours in China. Corbus intends to connect the Phase I trial data to support a study in the US, which is planned to commence next year. Together, both companies will execute CRB-701’s clinical development, with Corbus handling the clinical development of the ADC in the US and other licensed territories.

As interest grows in antibody drug conjugates, another small player is jumping into the space with sights set on an increasingly popular target. On Wednesday, Elevation Oncology licensed an ADC for gastric and pancreatic cancer from Chinese biotech CSPC Megalith Biopharmaceutical. The deal gives Elevation rights to develop the drug outside of China, Taiwan, Hong Kong, and Macau. CSPC Megalith will get $27 million upfront, with an additional $148 million in future milestones. Notably, the ADC candidate, dubbed SYSA1801, is currently in a Phase I study in China, which is estimated to finish by the end of 2023. In order to fund the deal, Elevation Oncology took out a $50 million loan from K2 HealthVentures. An initial $30 million of the loan is available immediately, which Elevation said it would be putting towards the upfront payment to CSPC. By licensing the ADC, Elevation adds an additional drug to its arsenal, which currently consists of its lead candidate seribantumab. Elevation revived seribantumab from Merrimack in 2020, and is testing it in patients with tumors that have an NRG1 mutation. In a note, SVB securities analysts commented that the deal represents growing interest in the Claudin18.2 target, and is reminiscent of other recent deals. In May, Turning Point licensed an anti-Claudin18.2 ADC from LaNova Medicine, and AstraZeneca licensed Harbour BioMed’s anti-Claudin18.2xCD3 bispecific with exclusive global rights. The analysts also pointed out some concerns: In June, Bristol Myers bought Turning Point for $4.1 billion, largely based on promising data the biotech had posted on its lead lung cancer drug, repotrectinib. They also spell concerns regarding how similar SYSA1801 and Turning Point’s ADC are, since both use a construct developed by Seagen, which only further pits Elevation up against the Big Pharma. “Some investors may also question Elevation’s ability to compete with [Bristol Myers Squibb] given the large pharma’s infrastructure, finances and experience,” the analysts reiterated.