On June 8, 2022 Harbour BioMed ("HBM", HKEX: 02142) reported that China National Medical Products Administration (NMPA) had approved the investigational new drug (IND) application to commence phase I trial of its B7H4x4-1BB bispecific antibody (HBM7008) in China (Press release, Harbour BioMed, JUN 8, 2022, View Source [SID1234615792]). This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of HBM7008 in patients with solid tumors. It has successfully completed the dosing of first patient in the phase I trial of HBM7008 in Australia on 25 May 2022.

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HBM7008 is generated from HBM’s unique and innovative HBICE platform. It is a first-in-class bispecific antibody targeting B7H4 and 4-1BB. The bispecific antibody can engage and activate T cells by 4-1BB only in B7H4 positive tumor microenvironment. B7H4 is overexpressed on a variety of solid malignancies, including breast, ovarian, endometrial, and non-small cell lung cancers. With its crosslinking-dependent specificity on tumors and potent immune modulation activity, HBM7008 has shown excellent safety profile with strong anti-tumor efficacy in the pre-clinical study, including completed response observed in the mouse tumor model.

"4-1BB is one of the most promising anti-tumor immune targets, providing new solutions for cancer treatment. As the first-in-class bispecific antibody targeting B7H4 and 4-1BB, HBM7008 is expected to lead the development of next-generation immunotherapeutics. Based on preclinical study data, we are highly confident in B7H4x4-1BB bispecific antibody. We will efficiently promote this clinical study to provide a novel, effective and safe treatment for patients, so that more cancer patients can benefit from the innovative therapeutic." said Dr. Humphrey Gardner, CMO of Harbour BioMed.

About HBM7008

HBM7008 is a bispecific antibody targeting Tumor-Associated Antigen B7H4x4-1BB that not only displays high potency in the T cell co-stimulation and tumor growth inhibition, and potentially may also translate to better safety due to its strict dependency of TAA-mediated crosslinking T cell activation. HBM7008 is one of the fully human bispecific antibodies developed from the HBICE platform of the Company. It is the only bispecific antibody against these two targets globally. Its unique specificity on tumors and immune modulation activity makes it a promising therapeutic in PD-L1 negative or PD-1/PD-L1 resistant patients. It also has the potential to avoid 4-1BB liver toxicity risk observed in other products with the benefit of its innovative biology mechanisms and bispecific design.

On June 7, 2022 Immatics N.V. (Nasdaq: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, and Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome editing company, reported that the two companies have entered into a strategic research collaboration and licensing agreement to combine gamma-delta T cell adoptive cell therapies and gene editing to develop medicines for the treatment of cancer (Press release, Immatics, JUN 7, 2022, View Source [SID1234615687]). As part of the licensing agreement, Immatics gains non-exclusive rights to Editas Medicine’s CRISPR technology and intellectual property. Editas Medicine is the exclusive licensee of Harvard and Broad Institute’s Cas9 patent estates and Broad Institute’s Cas12a patent estate for human medicines.

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By combining Editas Medicine’s gene editing technology with Immatics’ ACTallo allogeneic, off-the-shelf adoptive cell therapy platform based on gamma-delta T cells, gamma-delta T cells can be redirected to cancer cell targets with the goal of creating cells with enhanced tumor recognition and destruction.

"Engineered cell therapies have the potential to significantly impact the treatment paradigm for cancer, and our partnership with the esteemed team at Editas Medicine will provide us with further versatility and flexibility in how we engineer our ACTallo cell therapies based on a specific tumor target," said Rainer Kramer, Ph.D., Chief Business Officer, Immatics. "It has always been our focus to deliver innovative science to cancer patients and this collaboration with Editas Medicine will enable us to access CRISPR technologies and apply them to our off-the-shelf gamma-delta T cell platform."

"We believe that our gene editing technology can modulate and enhance the potential of cell therapies to deliver transformative medicines for the treatment of cancer. We are excited to work with the team at Immatics to develop new experimental medicines with enhanced tumor fighting abilities to help patients with cancer," said Gilmore O’Neill, M.B., M.M.Sc., President and Chief Executive Officer, Editas Medicine.

Under the terms of the agreement, Editas Medicine will be eligible to receive an undisclosed upfront cash payment as well as additional milestone payments based on development, regulatory, and commercial milestones. In addition, Immatics will pay royalties on future net sales on any products that may result from this collaboration.

On June 7, 2022 Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ: FBRX), a biopharmaceutical company focused on autoimmune diseases reported that Dr. Hubert Chen, MD has joined the company as Chief Scientific Officer and President (Press release, Tocagen, JUN 7, 2022, View Source [SID1234615705]).

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"Dr. Chen is a very accomplished drug development scientist and physician and we are very fortunate that he has agreed to join the Forte team," said Paul Wagner, Ph.D., CEO of Forte Biosciences. "This is a very exciting time for Forte and having Dr. Chen join us in this important leadership position reinforces our confidence in the future of Forte."

Prior to joining Forte, Dr. Chen was the Chief Medical Officer of Metacrine, a clinical-stage company focused on the treatment of liver and gastrointestinal diseases. Prior, he was the Chief Scientific and Medical Officer of Pfenex, where he successfully designed and executed the clinical, nonclinical, and regulatory approval strategy for PF708, a teriparatide injectable for the treatment of high-risk osteoporosis, leading to NDA approval in 2019 and MAA approval in 2020. Additional experiences include serving as vice president of clinical development at Aileron Therapeutics, vice president of translational medicine at Regulus Therapeutics, and senior director of clinical research at Amylin Pharmaceuticals. Dr. Chen received his medical training at UCSF and Massachusetts General Hospital, M.D. from Columbia University, and B.A.S. in political science and biology from Stanford University.

On June 7, 2022 EpimAb Biotherapeutics, a clinical-stage biotechnology company specializing in bispecific antibody development, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for a Phase Ib/II study in patients with non-small cell lung cancer (NSCLC) evaluating the combination of EMB-01, a bispecific antibody designed to simultaneously target EGFR and cMET on tumor cells, and Tagrisso (osimertinib), AstraZeneca’s (LSE/STO/Nasdaq: AZN) third-generation EGFR-TKI (Press release, EpimAb Biotherapeutics, JUN 7, 2022, View Source [SID1234615723]). AstraZeneca is providing Tagrisso for this trial under a non-exclusive clinical trial collaboration agreement.

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"This is an important milestone for EpimAb as we continue on our trajectory to advance our bispecific pipeline and look to explore the potential of our assets for combination therapy," said Dr. Chengbin Wu, founder and CEO of EpimAb. "EMB-01 has demonstrated efficacy in multiple preclinical models as well as in our ongoing clinical trial program. We look forward to evaluating the potential synergies of this asset with Tagrisso in this study, alongside our ongoing global Phase I/II study of EMB-01 as a monotherapy."

"Non-small cell lung cancer is one of the most common oncology indications worldwide, yet there remains a huge unmet need among NSCLC patients with EGFR mutations who develop resistance to third-generation TKIs," said Dr. Bin Peng, CMO of EpimAb. "The combination of EMB-01 and Tagrisso has the potential to synergistically inhibit tumor growth, ultimately expanding treatment options for patients."

The planned Phase Ib/II trial will evaluate the safety and tolerability of EMB-01 in combination with Tagrisso in patients with NSCLC with EGFR mutations. Pharmacokinetics, immunogenicity, and the anti-tumor activity of EMB-01 combined with Tagrisso will also be assessed.

About EMB-01
EMB-01 is a novel bispecific antibody developed based on EpimAb’s proprietary FIT-Ig platform to simultaneously target EGFR and cMet on tumor cells. It is being studied in Phase I/II clinical trials in NSCLC as well as several GI indications in the U.S. and China.

On June 7, 2022, Olema Pharmaceuticals, Inc. ("Olema") and Aurigene Discovery Technologies Limited ("Aurigene"),reported that entered into an exclusive global license agreement (the "License Agreement") to research, develop and commercialize novel small molecule inhibitors of an undisclosed oncology target (Filing, 8-K, Olema Oncology, JUN 7, 2022, View Source [SID1234615809]).

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Under the terms of the License Agreement, Olema will make an upfront licensing payment of $8 million for rights to a pre-existing Aurigene program. Aurigene will also be eligible to receive up to $60 million in potential clinical development and regulatory milestones, up to $370 million in potential commercial milestones, and royalties ranging from the mid-single digits to the low teens based on annual net sales. During the initial research term, Olema will contribute funding to Aurigene to facilitate ongoing discovery efforts and the companies will jointly direct further preclinical work. Upon successful completion of the research term, Olema will lead clinical development as well as regulatory and commercial activities.

The foregoing description of the License Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the License Agreement, which will be filed as an exhibit to Olema’s Quarterly Report on Form 10-Q for the quarter ending June 30, 2022. Olema intends to redact certain portions of the License Agreement for confidentiality purposes.