On May 27, 2021 OSE Immunotherapeutics (Paris:OSE) (ISIN: FR0012127173; Mnemo: OSE) and the FoRT Foundation (Fondazione Ricerca Traslazionale) reported that the Italian Medicines Agency (AIFA) and the Italian Ethics Committee approved the initiation of a new Phase 2 clinical trial evaluating Tedopi in combination with Opdivo or chemotherapy as second-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) (Press release, OSE Immunotherapeutics, MAY 27, 2021, View Source [SID1234580716]).

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This three-arm Phase 2 study will evaluate neo-epitope-based vaccine Tedopi in combination with Bristol Myers Squibb’s Opdivo (nivolumab), an immune checkpoint inhibitor, or Tedopi plus chemotherapy or chemotherapy alone as second-line treatment in HLA-A2 positive patients with metastatic NSCLC after first-line chemo-immunotherapy.

The clinical trial will be sponsored by the Italian oncology Foundation FoRT. It will be supported by Bristol Myers Squibb, which will provide Opdivo, and by OSE Immunotherapeutics, which will provide Tedopi for the study as well as a partial financial support.

Federico Cappuzzo, M.D., Ph.D., Director Medical Oncology at Cancer Institute Regina Elena, Roma, Italy, and Chief Investigator of the study, comments: "Checkpoint inhibitors are now often used in first-line settings in combination with chemotherapy. For patients who have disease progression after checkpoint inhibitors, the standard second-line option remains chemotherapy. In particular for NSCLC patients with disease progression, we need additional second-line combinations of immuno-therapeutic agents to provide these patients with new options. The trial will evaluate a new treatment strategy with the combination of therapeutic vaccine Tedopi which, by activating T lymphocytes, might efficiently optimize a checkpoint inhibitor or chemotherapy treatment."

Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, comments: "We are very pleased to collaborate with Dr Federico Cappuzzo and FoRT to evaluate Tedopi in combination with Opdivo in second-line treatment of NSCLC patients after chemo-immunotherapy. This additional development program of Tedopi in NSCLC will expand the product’s clinical data in this indication for a patient population who needs innovative treatment options. Tedopi was evaluated as monotherapy post-checkpoint failure in NSCLC and already demonstrated positive results for the Step-1 of its Phase 3 Atalante trial, as presented at the 2020 ESMO (Free ESMO Whitepaper) congress*."

* OSE Immunotherapeutics presented positive results of Step-1 of its Phase 3 Atalante 1 clinical trial, including a significant increase in overall survival in NSCLC patients after failure with checkpoint inhibitor (survival rate at 12 months in the patients treated with Tedopi versus standard of care). Today, OSE Immunotherapeutics intends to discuss with the regulatory health authorities, the U.S. Food and Drug Administration and the European Medicines Agency, to determine the best options to continue development of Tedopi and to maximize the data obtained in terms of risk / benefit ratio

On May 27, 2021 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that management will participate in two upcoming virtual conferences (Press release, BioMarin, MAY 27, 2021, View Source [SID1234583249]). An audio webcast of the presentations will be available live. You can access the webcast at: View Source An archived version of the remarks will also be available through the Company’s website for a limited time following the conference.

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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.

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 May 27, 2021 Aptose Biosciences Inc. ("Aptose") (NASDAQ: APTO, TSX: APS), a clinical-stage company developing highly differentiated therapeutics targeting the underlying mechanisms of cancer, reported that the company management team will provide a corporate update for the investment community on Friday, June 11th, at 8:00 AM ET, in conjunction with participation at the EHA (Free EHA Whitepaper)2021 Virtual Congress (Press release, Aptose Biosciences, MAY 27, 2021, View Source [SID1234580666]). The event will include an up-to-date review of clinical data available for Aptose’s clinical programs: luxeptinib (CG-806), Aptose’s oral, first-in-class FLT3 and BTK kinase inhibitor in two Phase 1 a/b trials, one in patients with relapsed or refractory acute myeloid leukemia (AML) and another in patients with relapsed or refractory B cell malignancies; and APTO-253, a first-in-class small molecule MYC repressor in a Phase 1 a/b trial in patients with relapsed or refractory AML or high risk myelodysplastic syndromes (MDS).

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Aptose Corporate Update Details

Date & Time: Friday, June 11th, 8:00 AM ET

Participant Webcast Link: LINK

The slides will be available on Aptose’s website here and a recording of the presentation will be archived shortly after the conclusion of the event.

Early clinical data for luxeptinib (CG-806) and APTO-253 also will be presented in posters at the EHA (Free EHA Whitepaper)2021 Virtual Congress, to be held virtually June 9 – 17, 2021. All e-posters will be made available in the Virtual Congress platform on Friday, June 11 at 09:00 CEST / 03:00 ET. The posters also will be available on the presentations page of Aptose website here.

Poster Presentation Details

Title: A Phase 1a/b dose escalation study of the mutation agnostic BTK/FLT3 inhibitor luxeptinib (CG-806) in patients with relapsed or refractory B cell malignancies
Topic: Chronic lymphocytic leukemia and related disorders – Clinical
Final Abstract Code: EP643
Poster Date & Time: Friday, June 11 at 09:00 CEST

Title: A Phase 1a/b dose escalation study of the MYC repressor APTO-253 in patients with relapsed or refractory AML or high-risk MDS
Topic: Acute myeloid leukemia – Clinical
Final Abstract Code: EP452
Poster Date & Time: Friday, June 11 at 09:00 CEST
Abstract Only

Title: A Phase 1a/b dose escalation study of the mutation agnostic BTK/FLT3 inhibitor luxeptinib (CG-806) in patients with relapsed or refractory acute myeloid leukemia
Topic: Acute myeloid leukemia – Clinical
Final Abstract Code: PB1391