HONG KONG – China’s I-Mab Biopharma Co. Ltd. has entered a strategic partnership with Indonesia’s PT Kalbe Genexine Biologics (KG Bio). Through the deal, KG Bio will receive the right of first negotiation to commercialize two I-Mab-discovered candidates in the ASEAN and MENA regions as well as Sri Lanka.

One of those candidates is I-Mab’s TJD-5, a highly differentiated anti-CD73 antibody in phase I development for advanced solid tumors.

“TJD-5 is differentiated from other clinical-stage CD73 antibodies by its novel epitope, which works through a unique intradimer binding mode, resulting in a complete inhibition of the enzymatic activity and avoiding the aberrant pharmacological property known as the ‘hook effect’,” Taylor Guo, the chief scientific officer for I-Mab, told BioWorld.

TJD-5 allosterically inhibits CD73 in a substrate noncompetitive manner, which results in a decrease in adenosine production and an increase of T-cell antitumor activity.

“By relieving the immunosuppression, TJD-5 is expected to enable the immune cells to fight cancer more aggressively,” said Guo.

The deal with KG Bio will help I-Mab cover markets in Southeast Asia and the Middle East. But there are also plans for other major markets, too.

Isaac Meng, the head of medical office for I-Mab, said that TJD-5 is being developed in the U.S. and China in parallel.

“In the U.S., we have partnered with Tracon Pharmaceutical to do a phase I study in cancer patients looking at the safety and tolerability of the drug and collecting information about whether it is working in the body, particularly in the tumor, as intended. We hope to finish collecting data before reporting our conclusions, hopefully in the third quarter, but suffice to say, the trial is progressing nicely,” Meng told BioWorld.

He added that I-Mab has also initiated a phase I trial in China focusing on lung cancer.

“In both U.S. and China trials, the plan is to quickly reach a safe dose for combination with other anti-PD-(L)1 antibodies and to decide which types of cancer patients are most likely to benefit from the combination therapy and thus to be recruited to subsequent trials,” said Meng.

For TJD-5, I-Mab would be eligible to receive from KG Bio an aggregate amount of up to approximately $340 million, including an up-front payment and subsequent payments. It would also receive tiered royalties in the low to midteen percentages on net sales from the regions KG Bio covers.

The second product included in the KG Bio is an undetermined candidate. It “will be selected from a panel of assets, ranging from preclinical to clinical in development stage, and will need to be agreed upon by both parties,” Jielun Zhu, the chief financial officer for I-Mab, told BioWorld.

KG Bio is the joint venture between PT Kalbe Farma Tbk, the largest publicly listed pharmaceutical company in Southeast Asia, and South Korean biotech firm Genexine Inc. It is I-Mab’s only partner for the ASEAN and MENA regions at the moment.

“Our partnership with KG Bio is precisely meant to be such a synergistic collaboration,” Zhu said. “We can leverage the extensive commercial resources of KG Bio, and by extension, Kalbe, in these regions. In return, KG Bio is able to enjoy early access to commercial rights to selected assets in our highly innovative proprietary pipeline. It is a genuine win-win arrangement,” he added.

I-Mab has also submitted an IND application to South Korea’s Ministry of Food and Drug Safety, to evaluate its TJM-2 in treating cytokine storm (CS) in severe and critically ill patients caused by the coronavirus.

TJM-2 is an I-Mab-discovered neutralizing antibody against human granulocyte-macrophage colony stimulating factor (GM-CSF), an important cytokine that plays a critical role in acute and chronic inflammation.

The proposed clinical trial in South Korea is a single-arm, open-label pilot study that will evaluate the effects of TJM-2 on reducing cytokine levels, including GM-CSF, in patients with severe COVID-19 disease.

I-Mab also announced a similar program in the U.S. on March 13.

“We are in close contact with FDA and they are reviewing our application under an expedited time frame,” Zhu said. “We are preparing clinical sites and expect to initiate the study when it’s approved by the agency.

“Since the disease’s spread in China has been better controlled now, we are currently considering initiating studies in selected European and Asian countries,” he added.

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