I-Mab attracts collaboration interest from big pharma following Gilead/FTSV deal – executives

10 March 2020

I-Mab, the China and US-based clinical stage biopharmaceutical company, has attracted big pharma for a potential partnership for its CD47-targeted candidate TJC4, with Gilead‘s USD 4.9bn takeover of Forty Seven unlocking the value of CD47, according to I-Mab’s CFO Jielun Zhu.

I-Mab, the China and US-based clinical stage biopharmaceutical company, has attracted big pharma for a potential partnership for its CD47-targeted candidate TJC4, with Gilead‘s USD 4.9bn takeover of Forty Seven unlocking the value of CD47, according to I-Mab’s CFO Jielun Zhu.

 

The company is flexible in terms of a partnership structure, which could range from an outright licensing deal to a co-development, as well as some form of equity investment, said Zhu, adding that it will make a timely disclosure regarding this.

With TJC4’s clinical trials in both the US and China showing varied results, I-Mab is in early discussions with potential partners on possible collaboration opportunities, said Zhu.

The company debuted on the NASDAQ on 17 January and is currently trading at USD 14 per share, with a market capitalization of USD 823m as of today (10 March).

I-Mab’s candidate TJC4 is an internally discovered antibody targeting CD47 with minimal red blood cell (RBC) binding, which could pose fewer risks of encountering severe anemia resulting from CD47’s overexpression of RBC, according to I-Mab’s prospectus.

 

The candidate is in Phase I safety trials in the US, according to CEO Joan Shen, adding that the company’s strategy is to validate its safety advantages in solid tumor and lymphoma cases.

 

“In the US, we are currently in an ongoing dose escalation study on 10mg/kg cohort, and have already completed two dose cohorts (1mg/kg and 3mg/kg),” said CEO Joan Shen. “So far, we have not seen severe hematologic adverse effects.”

 

“Once we have determined the recommended dose, we will continue to expand the study in solid tumor and lymphoma cases in combination with PD-1/PD-L1 antibody Keytruda in collaboration with MSD, or in combination with Roche’s rituximab, in the US,” added Shen.

 

According to I-Mab’s IPO prospectus, the study is expected to obtain single-agent safety data by mid-2020, according to Shen.

 

I-Mab is also about to initiate China trials for AML (myeloid leukemia) and MDS (myelodysplastic syndrome) soon, Shen noted.

Gilead’s USD 4.9bn bet on CD47

California-based Gilead made a USD 4.9bn binding offer for Forty Seven, the Menlo Park, California-based clinical-stage biotech firm, with a nearly 65% premium to the latter’s closing price on trading day before the 2 March announcement date, in a move to add the latter’s lead candidate, magrolimab, a CD47 targeted therapy, into its pipeline, according to Gilead’s press release.

The candidate has shown promising results in a Phase Ib study in patients with MDS and AML, with a first-in-class potential, as per the release.

According to local media reports, Forty Seven was bid by a number of big pharmas before the deal was inked.

“This (Gilead/FTSV deal) was a landmark transaction for the immune-oncology (I/0) space and for CD47 class specifically, “said Zhu. “It clearly demonstrated that CD47 has been validated as a promising I/O target.”

Further strategy

I-Mab has 16 candidates in the pipeline, eight of which are in clinical trials in both the US and China, said Shen.

The company is investing a lot of effirt into four clinical programs. Besides TJC4, TJD5, a CD73 antibody that treats multiple cancers, is in Phase I trials in the US and China, according to Shen.

TJ202, a CD38 antibody licensed from German biotech firm MorphoSys, is in Phase II studies in China and the company aims to file a biologic license application (BLA) for multiple myeloma by mid-2021, said Shen.

It is also planning to file for Phase III trials in China for its long-acting recombinant growth hormone (rhGH) candidate TJ101 this year, and aims to file for the BLA in 2024, she noted.

It will also build its translational medicine capability and expand collaboration with academia, physicians and hospitals to support its multiple clinical trials in both the US and China, added Shen.

 

At the same time, the company is reviewing a number of options to build manufacturing facilities in China, said Zhu. It will consider technical requirements, government support and investments to make a decision, he added.

 

The company is also building a core capability with a senior commercial leader in place soon to be announced. TJ202 and TJ101, scheduled to be launched as early as 2022, will be the priority of the company’s commercial strategy, said Zhu.

 

Founded by Chairman Zang Jingwu, the company raised USD 104m this January and is the first Chinese biotech to launch a US IPO in more than two years. Before the IPO, the company has received equity financing from a group of well-known strategic investors and funds, including Chinese biologic CDMO company WuXi Biologics, medical CRO provider Tigermed, Tianjin-based pharmaceutical group Tasly, as well as Hony CapitalHillhouse, CDH, Hopu Investments, Ally Bridge and C-Bridge Capital, since its establishment in 2015, according to its website.