WuXi Biologics and OncoC4 Establish Exclusive CDMO Partnership

On May 27, 2021 WuXi Biologics ("WuXi Bio") (2269.HK) reported that the companies have entered into an exclusive contract development and manufacturing partnership for OncoC4’s full pipeline of biologics including its late-stage project, ONC-392, a next generation CTLA-4 antibody which is under phase I clinical trials in the U.S. and China (Press release, WuXi Biologics, MAY 27, 2021, View Source [SID1234611486]).

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Per the agreement, WuXi Biologics, as the exclusive CDMO partner will provide biologics development and cGMP manufacturing services for OncoC4’s products from early R&D and preclinical activities to post commercialization. OncoC4 will leverage WuXi Biologics’ process development and manufacturing capabilities and expertise in cell line development, formulation development as well as drug substance and drug product manufacture.

The two companies expand the strategic collaboration by using the proprietary WuXiBody; bispecific antibody platform to research and develop certain bispecific antibodies. Under the terms of the agreement, OncoC4 has rights to use the WuXiBody; platform to research and develop bispecific antibodies. For any potential bispecific antibody products commercialized from the WuXiBody; platform, in addition to an upfront payment, WuXi Biologics will receive development and commercialization milestones as well as tiered royalties on net sales of such bispecific antibody.

These new agreements build on the companies’ successful multi-year relationship. Since 2017, WuXi Biologics has been providing services to OncoC4 (formerly known as OncoImmune), including comprehensive and integrated CMC services for the ONC-392 clinical program.

Dr. Yang Liu, Chairman, CEO and Founder of OncoC4, commented, "This long-term supply agreement is another significant step forward in our relationship with WuXi Biologics. It allows OncoC4 to leverage world-class manufacturing capacity to meet the challenges associated with the production of our best-in-class and first-in-class biologics, that include bispecific antibodies and antibody-drug conjugates that target innate and adaptive immune checkpoints for cancer treatment."

Dr. Chris Chen, CEO of WuXi Biologics, commented, "We are honored to be OncoC4’s exclusive CDMO partner for its full therapeutic pipeline, which is another great example of our follow and win the molecule strategy. This partnership is a strong validation of our premier quality and project execution excellence. We are looking forward to enabling OncoC4 to make innovative life-saving biologics more available and affordable to patients across the globe."

Tempest Therapeutics to Present at the Jefferies Healthcare Conference

On May 27, 2021 Tempest Therapeutics, Inc., a clinical-stage oncology company developing first-in-class therapeutics that combine both precision and immune-mediated mechanisms, reported that management will be presenting at the Jefferies Healthcare Conference on Thursday, June 3, 2021 at 3:00 p.m. ET (Press release, Tempest Therapeutics, MAY 27, 2021, View Source [SID1234585164]).

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To access the archived recording of the company presentation, please visit the Tempest website at www.tempesttx.com.

Lupin Announces Achievement of Key Milestones for its Clinical Stage MEK Inhibitor Compound

On June 17, 2021 Global pharma major Lupin Limited (Lupin) reported the achievement of key milestones for Lupin’s MEK inhibitor compound (LNP3794) that is planned for development by Boehringer Ingelheim in combination as potential targeted therapy for patients with difficult-to-treat cancers(Press release, Lupin, MAY 27, 2021, View Source [SID1234584116]).

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As part of the agreement, Lupin has received payment of USD 50 million from Boehringer Ingelheim for achievement of key milestones.

Lupin and Boehringer Ingelheim inked a licensing, development and commercialization agreement in 2019 for Lupin’s novel oncology compound to treat KRAS-driven cancers. Lupin’s MEK inhibitor developed as part of its oncology pipeline had previously shown pre-clinical activity as a single agent as well as in combination.

Lupin’s New Chemical Entity Research team is focused on building a pipeline of highly differentiated and innovative new chemical entities, primarily in the oncology space. Lupin’s NCE activities were started with the vision to use cutting-edge research in bringing novel molecules that address unmet medical needs in multiple therapeutic areas to market globally.

VAXIMM to Attend International Scientific and Industry Events

On May 27, 2021 VAXIMM AG, a Swiss/German biotech company focused on developing an oral plug and play DNA vaccination technology to stimulate patients’ cytotoxic T-cells targeting a wide range of cancer-related antigens, reported that the Company will attend several international scientific and industry events in the coming months (Press release, Vaximm, MAY 27, 2021, View Source [SID1234583290]).

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Dr. Heinz Lubenau, Chief Executive Officer of VAXIMM, and the management team will participate in the following conferences:

American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2021
June 4-8, 2021, Virtual Event
• To schedule a meeting with the Company, please contact [email protected].

BIO KOREA
June 9-11, 2021, Virtual and Live Event (COEX, Seoul)
• To request a meeting with Dr. Lubenau, please sign up through the event’s online partnering system.

BIO Digital
June 10-11 & June 14-18, 2021, Virtual Event
• Company presentation.
• To request a meeting, please sign up through the event’s BIO one-on-one partnering system.

Paris Immuno-Oncology Conference
July 1-2, 2021, Virtual Event
• To schedule a meeting with the Company, please contact [email protected].

For updates, please see the Events section of the Company’s website.

AIM ImmunoTech Announces Two Year Extension of Agreement with Shenzhen Smoore Technology Limited to Develop and Test a New Inhalation Delivery Device for Ampligen

On May 27, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported that it has entered into a two-year extension of its Material Transfer and Research Agreement with Shenzhen Smoore Technology Limited (Smoore), a subsidiary of Smoore International Holdings Limited (HKEX: 6969), with the goal of developing Ampligen as a potential inhalation therapy for COVID-19 and potentially other respiratory viral diseases (Press release, AIM ImmunoTech, MAY 27, 2021, View Source [SID1234583284]).

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AIM entered into the agreement on April 1, 2020, to study the utilization of an innovative Smoore inhalation delivery device and Ampligen as a potential treatment approach for the SARS-CoV-2 pandemic. On parallel paths, over the past year, Smoore has focused on the development of a personal inhalation device designed to administer Ampligen, given temperature parameters of dsRNA. Contemporaneously, AIM has studied the safety and efficacy of Ampligen using an ex vivo 3D model in primary human respiratory epithelial cells at Utah State University, which showed that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels, and conducted intranasal safety testing. AIM hopes to commence inhalation safety testing before year-end.

"With Smoore’s concept for an Ampligen inhalation delivery device ready to be developed, and Ampligen’s track record of both safety and efficacy, we believe AIM is well positioned to move forward with our goal of developing Ampligen as a potential inhalation therapy for COVID-19 and potentially other respiratory viral diseases," said AIM CEO Thomas K. Equels. "We are in the process of planning a Phase 1/2 inhalation clinical study on a parallel track with Smoore’s device development testing."

‘Application of vaping technology in healthcare and pharmaceutical fields is one of our R&D focus. We are really happy to partner with AIM to explore applications of advanced atomization technology in medical inhalation therapy," Dr. Zhiqiang Shi, Chief Scientist and Director of Global R&D of Smoore, commented. "We will coordinate our device development work along with our partner’s plan and the regulation needs to move into next phase testing on schedule.’