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.

On June 7, 2022 Catalent, the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, and MigVax, an Israeli biopharmaceutical company developing an oral subunit vaccine against COVID-19, reported that they have signed a development agreement to leverage Catalent’s proprietary Zydis Bio orally disintegrating tablet (ODT) technology for delivering the MigVax-101 vaccine (Press release, Catalent, JUN 7, 2022, https://www.catalent.com/catalent-news/catalent-and-migvax-sign-agreement-to-develop-an-orally-disintegrating-freeze-dried-tablet-vaccine-against-covid-19/ [SID1234615689]).

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MigVax’s lead oral vaccine program, MigVax-101, has shown positive results in preclinical tests, and in November 2021. As an oral formulation, MigVax-101 could offer significant potential advantages in low-and middle-income countries over today’s first-generation injected vaccines, including ease of administration, transport and storage, the potential to tackle future variants, and applicability to a broader population. In addition, MigVax’s oral approach may allow for mucosal protection, a benefit that may prove important in preventing infection.

Zydis technology creates a freeze-dried tablet that disperses almost instantly in the mouth without water, and is recognized as one of the world’s best-performing ODTs, offering multiple advantages over conventional oral dosage forms, including improved patient compliance, adherence, and convenience. Utilizing the Zydis ODT technology, Catalent’s innovative Zydis Bio facilitates the oral delivery of macromolecules. Under the terms of the agreement, Catalent will undertake a feasibility study to formulate MigVax-101 into a Zydis Bio ODT dose form and evaluate its preclinical performance and stability properties. Work will be carried out at Catalent’s Zydis facility in Swindon, U.K.

"We are excited to collaborate with Catalent to simplify the transportation, storage and administration of our MigVax oral Covid-19 vaccine," commented Mr. Ran Amir, MigVax’s CEO. "Once our vaccine can be transported using the Zydis Bio technology, in unrefrigerated vehicles and stored in standard warehouses, it will be much easier and cost-effective for countries everywhere to roll out mass-vaccination programs. We believe this is a major step forward that will help society cope with the viruses in our midst as we continue returning to the ‘new normal’."

"Zydis Bio technology offers numerous potential benefits to this program, and has previously been used to successfully deliver antigens to the oral mucosae," commented Jonathan Arnold, President of Oral and Specialty Delivery at Catalent. He added, "In addition, the ease of administration and the potential for removal of the need for cold chain storage and transport means that the oral vaccine would have significantly fewer restrictions in terms of global distribution, compared with current cold chain injectable vaccines."

Catalent’s 250,000-square-foot site in Swindon, U.K., houses the company’s Zydis development and manufacturing operation, which produces over one billion ODTs annually.

On June 7, 2022 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that Jeff Baxter, VBI’s President and CEO, will participate in an analyst-led fireside chat at the Jefferies Healthcare Conference on Wednesday, June 8, 2022 (Press release, VBI Vaccines, JUN 7, 2022, View Source [SID1234615706]).

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Presentation Details

A live webcast of the presentation will also be available on the Investors page of VBI’s website at: View Source A replay of the webcast will be archived on the Company’s website following the presentation.