BEIJING – Suzhou, China-based Innovent Biologics Inc. is known in China as one of the first drugmakers to launch a PD-1 monoclonal antibody. Now, the company is moving to expand its product portfolio and enhance efforts in developing bispecific antibodies and cell therapies in a potential multibillion-dollar deal with pharma giant Roche Holding AG.
On June 9, the two companies entered a strategic research and development collaboration to take aim at hematological and solid cancers. Under the terms, Innovent will pay undisclosed up-front development and commercial milestone payments and royalties to Roche for accessing some of its technologies nonexclusively. Those technologies will be used to enable the discovery and development of specific 2:1 T-cell bispecific antibodies and the universal CAR T platform. With the help of those technologies, Innovent plans to carry out the development and commercialization of the product candidates by itself.
Roche, however, retains an option right to license those product candidates for development and commercialization outside of China. In that case, Roche would pay $140 million to exercise the option as well as additional development, approval and sales milestone payments of up to $1.96 billion if all candidates are successfully developed and commercialized. Roche will also pay royalties from the double-digit up to the midteen percentage on each product.
“Innovent first entered the cellular therapy space a few years ago, and with this partnership with Roche we are taking a much bolder step forward as we build upon Roche’s novel, universal CAR T-cell technology to enhance our cellular therapy discovery platform, and on Roche’s 2:1 T-cell bispecific antibody platform for selected targets to discover, develop and commercialize new proprietary bispecific molecules,” said Innovent CEO Michael Yu.
He added that Innovent will rapidly advance Roche’s technologies to the proof-of-concept stage in China.
Blake Salisbury, vice president of business development at Innovent, told BioWorld that Innovent will develop up to five universal CAR T products by incorporating the Roche’s technology into its process.
“Innovent is always monitoring the latest development in cancer treatment. Cell therapy is one of the possible future development in cancer treatment,” he added.
On the CAR T front, Innovent is co-developing a novel fully human anti-BCMA CAR T therapy known as IBI-326 with Nanjing Iaso Biotherapeutics Co. Ltd. In September 2019, China’s NMPA granted a trial approval for the evaluation of the therapy candidate in relapsed or refractory multiple myeloma (r/r MM). In the same year, the company presented clinical data for IBI-326 that showed an overall response rate of 100% and complete response of more than 72% in patients with r/r MM in major conferences, such as the American Society of Clinical Oncology (ASCO), the European Hematology Association meeting and the American Society of Hematology (ASH) meeting.
Innovent aims to initiate a pivotal phase II trial in r/r MM, with the first patients being enrolled this year, and intends to report the results of extended follow-up at ASH 2020 in December.
Bispecifics in the pipeline
Meanwhile, the company already has in its pipeline a few bispecific products, which are largely PD-1-based.
One is a PD-1/PD-L1 bispecific antibody known as IBI-318 co-developed with Eli Lilly and Co. In April 2019, the first patient was dosed in a phase I trial in patients with advanced malignancies in China.
Innovent reported the preliminary results of the phase Ia study at ASCO earlier this month. Among 15 patients that enrolled in the phase Ia dose-escalation phase, 11 subjects experienced treatment-related adverse events (TRAEs) but there were no grade 3 or higher TRAEs. Three subjects experienced an objective response. Researchers said IBI-318 has an acceptable safety profile.
Second is IBI-315, a first-in-class PD-1/HER2 bispecific antibody co-developed with South Korean pharma Hanmi Pharmaceuticals Co. Ltd. The first patient was dosed in a phase I trial in advanced malignancies in China in November 2019.
The third is IBI-322, a first-in-class anti-CD47/PD-L1 bispecific antibody. Innovent received IND approvals from both the NMPA and FDA in January, and it is now preparing to start clinical trials in China and in the U.S.
Last but not least is IBI-302, a potential first-in-class anti-VEGF/complement bispecific fusion protein. The first patient was dosed in a phase I trial in China for wet age-related macular degeneration (AMD) in April 2019. It expects to enroll the first patient in a phase Ib study in China in wet AMD this year.
Innovent’s Roche’s deal follows a recent spate of Chinese partnerships with global pharma giants.
On June 5, Abbvie Inc. said it is joining Harbour Biomed Therapeutics Ltd.’s joint effort with Utrecht University and the Erasmus Medical Center to develop a novel antibody therapeutic to prevent and treat COVID-19. Known as 47D11, this fully human, neutralizing antibody targets the conserved domain of the spike protein of SARS-CoV-2.
A few days before that, Abbvie unveiled its collaboration with Beijing-based Jacobio Pharmaceuticals Co. Ltd. to develop two SHP2 inhibitors, JAB-3068 and JAB-3312, discovered by Jacobio. Financial terms were not disclosed.
Meanwhile, Shanghai Junshi Biosciences Co. Ltd. also unveiled recently its collaborations with Eli Lilly to advance SARS-CoV-2 JS-016 neutralizing antibodies and with Merck KGaA to investigate its PD-1 inhibitor in combination with Merck’s Erbitux (cetuximab).