On March 15, 2021 Peptomyc reported that the company has reached another major milestone obtaining the approval from the Spanish authorities (AEMPS) to initiate the First in Human Phase I/II trial with its first compound OMO-103 in patients with advanced solid tumors (Press release, Peptomyc, MAR 15, 2021, View Source [SID1234576695]). Peptomyc will soon start treating the first patients with this disruptive Myc inhibitor in selected clinical sites in Barcelona and Madrid. The company could achieve this key milestone thanks to an outstanding team, great collaborators and consultants.

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The Chief Medical Officer of Peptomyc, Manuela Niewel, MD, PhD, comments: "Now we will be able to translate the good preclinical results into hopefully great benefit for the patients".

On March 15, 2021 OSE Immunotherapeutics (FR0012127173) and the French cooperative group ARCAGY-GINECO reported that the French National Agency for Medicines and Health Products Safety (ANSM) and the French Central Ethic Committee (CPP) approved the initiation of a new Phase 2 clinical trial evaluating Tedopi in patients with recurrent ovarian cancer (the TEDOVA trial) (Press release, OSE Immunotherapeutics, MAR 15, 2021, View Source [SID1234646983]). Tedopi will be evaluated alone and in combination with Merck’s Keytruda (pembrolizumab), an immune checkpoint inhibitor, as maintenance treatment in ovarian cancer patients after chemotherapy.

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The three arm TEDOVA study will evaluate neo-epitope-based vaccine Tedopi as a maintenance treatment, alone or in combination with anti-PD-1 Keytruda, versus the best supportive care in platinum-sensitive recurrent ovarian cancer patients with controlled disease after platinum-based chemotherapy.

The clinical trial is sponsored by the "Association de Recherche sur les CAncers dont GYnécologiques (ARCAGY-GINECO)" on behalf of GINECO, lead group for the TEDOVA trial of the European Network for Gynaecological Trial Groups (ENGOT). It will be supported in part by a research grant from the Investigator-Initiated Studies Program of MSD (Merck Sharp & Dohme Corp), a subsidiary of Merck & Co., Inc.", which will provide Keytruda (pembrolizumab), and by OSE Immunotherapeutics which will provide Tedopi for the study as well as partial financial support.

Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics, comments: "This new clinical development program for Tedopi in ovarian cancer demonstrates the interest in exploring the potential of a PD-1-targeted checkpoint inhibitor combination strategy for combating oncology indications with significant unmet medical needs. We are very pleased to collaborate with the oncology group ARCAGY – GINECO to advance a new therapeutic pathway for patients suffering from a particularly aggressive cancer."

Dr Alexandra Leary, Chief Investigator of TEDOVA study from Gustave Roussy cancer center, adds: "Our patients with ovarian cancer do not respond to checkpoint inhibitors (ICI) alone because these tumors are ‘immune cold’. The objective of TEDOVA is to turn ovarian cancer into an ‘immune hot’ tumor using a combination of tumor associated neo-epitopes that have been optimized to break immunological selftolerance. TEDOVA is the first trial evaluating such an innovative approach in ovarian cancer and has received enthusiastic support from the international gynecological oncology community."

ABOUT OVARIAN CANCER
Worldwide, ovarian cancer is the seventh most common cancer and the eighth leading cause of cancer death in women. The five-year survival rate for ovarian cancer worldwide is 30-40%. In 2018, there were nearly 300,000 new cases diagnosed. Once the first relapse has occurred, ovarian cancer is managed as a chronic disease, requiring iterative lines of platinum-based chemotherapy. After 6 cycles, chemotherapy is stopped and one of the major priorities is to extend "chemotherapy-free" intervals for the patients by proposing maintenance strategies with targeted therapies (PARP inhibitors or bevacizumab). By the time patients with ovarian cancer present with first or second relapse, they will have received BOTH a PARP inhibitor and bevacizumab, thus patients progressing post-PARP inhibitors and bevacizumab represent an area of unmet medical need, they are offered chemotherapy alone with no maintenance strategy. The TEDOVA trial focuses on these women.

On March 15, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells directly within the patient’s body, reported that it will present at the virtual Oppenheimer 31st Annual Healthcare Conference being held March 16-18, 2021 (Press release, Cue Biopharma, MAR 15, 2021, https://cuebiopharma.gcs-web.com/news-releases/news-release-details/cue-biopharma-present-corporate-overview-and-clinical-progress [SID1234608283]).

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Cue Biopharma will provide a corporate update highlighting clinical progress with CUE-101, the lead Immuno-STAT (Selective Targeting and Alteration of T cells) platform-based therapeutic, in clinical trials for the treatment of patients with HPV+ recurrent/metastatic head and neck cancer. The presentation will also focus on the Company’s platform developments and pipeline progress including the CUE-400 series, a novel class of therapeutic molecules for broad applications in multiple autoimmune diseases.

Presentation Details

Oppenheimer 31st Annual Healthcare Conference
Date and Time: Thursday, March 18, 2021 at 9:20 a.m. EDT
Webcast link: View Source
A live and archived webcast of the presentation will be available in the Investors and Media section of the Company’s website at www.cuebiopharma.com. The webcast will be archived for 30 days.

On March 15, 2021 AVEO Oncology (Nasdaq: AVEO) reported that it will regain its rights to AV-203 outside of North America, its clinical-stage potent humanized IgG1 monoclonal antibody that targets ErbB3 (also known as HER3), following the voluntary termination of its collaboration and license agreement by CANbridge Life Sciences (Press release, AVEO, MAR 15, 2021, View Source [SID1234577596]). AVEO will regain rights to AV-203 in all territories outside of North America, and CANbridge has initiated the process to transfer all preclinical data and materials to AVEO. The transfer of rights and termination of the collaboration and license agreement will become effective on September 5, 2021.

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AV-203 is an IgG1 antibody designed to inhibit both ligand-dependent and ligand-independent ErbB3 signaling. ErbB3 is a receptor that is typically expressed in many human cancers, and AV-203 has demonstrated preclinical activity in multiple tumor models. To date, AVEO has completed a Phase 1, open-label, dose-escalation study of AV-203 in patients with advanced solid tumors (N=22). In this study, one patient had a dose limiting adverse event and the recommended phase 2 dose, or RP2D, is 20 mg/kg. One of two neuregulin positive (NRG1+) patients had a partial response. Neuregulin, the only known ligand for ErbB3, is a potential biomarker which may prove to be predictive of AV-203 anti-tumor activity.

"By reacquiring rights to AV-203 outside of North America, we add global rights to a third IgG1 antibody clinical candidate within our internally developed and diverse portfolio of oncology therapeutics," said Michael Bailey, president and chief executive officer of AVEO. "AV-203 has demonstrated early signs of activity in an NRG1+ patient that suggest it could have meaningful application in several areas of high unmet need in cancer. We look forward to advancing AV-203 in the clinic as part of our strategy for delivering long-term value from our pipeline programs. This strategy includes progress in our immunotherapy combination programs for FOTIVDA (tivozanib), potential initiation of a pivotal study of ficlatuzumab in head and neck squamous cell carcinoma, and the execution of our Phase 1 study of AV-380 for cancer cachexia."

Under their 2016 agreement, AVEO granted CANbridge Life Sciences worldwide rights, excluding the United States, Canada, and Mexico, to AV-203. CANbridge completed their manufacturing obligations under the agreement and AVEO received a $2 million development and regulatory milestone in August 2018 from CANbridge for regulatory approval from the National Medical Products Administration in China of an investigational new drug application for a clinical study of AV-203 in esophageal squamous cell cancer.

On March 15, 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, MAR 15, 2021, View Source [SID1234577317]). This programme is part of the overall share repurchase programme of up to DKK 17 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 3 February 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.0 billion in the period from 3 February 2021 to 3 May 2021.

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 42,011,629 B shares of DKK 0.20 as treasury shares, corresponding to 1.8% of the share capital. The total amount of A and B shares in the company is 2,350,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 17 billion during a 12- month period beginning 3 February 2021. As of 12 March 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 3,109,017 B shares at an average share price of DKK 446.14 per B share equal to a transaction value of DKK 1,387,052,209.