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."

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.

On May 27, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its participation at three upcoming virtual investor conferences (Press release, TG Therapeutics, MAY 27, 2021, View Source [SID1234580694]). Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, is scheduled to participate in the following:

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Jefferies Virtual Healthcare Conference: Fireside chat scheduled to take place on Tuesday, June 1, 2021, at 2:00 PM ET
Goldman Sachs 42nd Annual Global Healthcare Conference: Fireside chat scheduled to take place on Tuesday, June 8, 2021, at 1:20 PM ET
Raymond James Human Health Innovation Conference: Presentation scheduled to take place on Tuesday, June 22, 2021, at 10:00 AM ET
A live webcast of each presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source Following each event, an archive file will be available for thirty days.

On May 27, 2021 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, reported that Chris Martin, Chief Executive Officer, will present at the Jefferies Virtual Healthcare Conference on Thursday, June 3, 2021, at 8:30 a.m. ET (Press release, ADC Therapeutics, MAY 27, 2021, View Source [SID1234580711]).

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A live webcast of the presentation will be available via the Events & Presentations page in the Investors section of ADC Therapeutics’ website, ir.adctherapeutics.com. A replay of the webcast will be available for approximately 30 days.

On May 27, 2021 enGene Inc., a clinical-stage biotechnology company developing non-viral gene therapies for local administration into mucosal tissues enabled by its proprietary DDX platform, reported the dosing of the first patient in the LEGEND study, a first-in-human Phase 1/2 clinical trial of EG-70 in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) (Press release, enGene, MAY 27, 2021, View Source [SID1234583245]).

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Based on enGene’s DDX platform, EG-70 is a non-viral gene therapy encoding two RIG-I agonists to stimulate the innate immune system, and IL-12 to stimulate the adaptive immune system. By stimulating both arms of the immune system, intravesically administered EG-70 yields remarkable tumor regression in preclinical models of bladder cancer, with induction of effective immunological memory and minimal signs of toxicity.

"Initiating our first clinical study of EG-70 is an important milestone for enGene, validating the potential of our platform to develop novel therapeutics towards clinically meaningful outcomes," said Jason Hanson, Chief Executive Officer at enGene. "This is the first time a non-viral gene therapy directly activating both innate and adaptive immunity is being evaluated as an anti-tumor agent in humans, and we are excited about the outcome of this trial towards positively impacting the lives of patients battling difficult-to-treat cancers."

"Patients with BCG-unresponsive high risk NMIBC have limited treatment options other than radical cystectomy which is associated with significant morbidity and quality of life alterations. Based on our understanding of high grade bladder cancer, the mechanism of BCG resistance/relapse, and the EG-70 mechanism of action, I strongly believe that this novel intravesical therapy has the potential, with few side effects, to make a meaningful difference for patients," said Dr. Gary Steinberg, Professor and Director at the Perlmutter Cancer Center Goldstein Urology Bladder Cancer Program of NYU Langone Health, and lead Principal Investigator for the EG-70 Phase 1/2 study.

The LEGEND study, both first-in-human and first-in-class, is an open-label, monotherapy, multi-center, dose-escalation trial evaluating safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of EG-70 administered by intravesical instillation. To learn more about the first-in-human clinical trial of EG-70 in BCG-unresponsive NMIBC, please visit ClinicalTrials.gov.