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OSE Immunotherapeutics and the FoRT Foundation Announce Initiation of a Phase 2 Clinical Trial Evaluating Tedopi® in Combination with Opdivo® (nivolumab) in Non-Small Cell Lung Cancer

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

Mabwell, a Model Case of China’s Booming Biopharma Start-ups

On May 27, 2021 "In China, the biopharma industry has been entering a period of incredibly rapid development," says Dr. PC Zhu, Founder and CEO of ATLATL, the leading Innovation Center in Shanghai (Press release, Mabwell Biotech, MAY 27, 2021, View Source [SID1234580715]). "Scores of companies with rich pipelines and robust capabilities have listed or filed listing applications in the past few years, and the portfolio companies at our campus have raised tremendous funds, just like my previous incubator in Boston." Mabwell, a typical case of such a start-up company, reported that has raised $279 million (RMB ¥1.97 billion) from a series of investors, ranking in the Top 5 Venture Raises of 2020, and is currently preparing for listing on SSE STAR market.

Mabwell is representative of the success of Chinese biopharma start-ups, ranking 5th on the list of the Top 10 money raisers of 2020 around the world, as ranked by Fiercebiotech (released in Mar. 2021) and 2nd in the list of the Top 20 Venture Raises of 2020 in ex-US regions, as listed in LavoieHealthScience (released in Oct. 2020). Founded in 2017, Mabwell focuses on the discovery, development, manufacture, and commercialization of innovative biologics and has set-up 9 subsidiaries to accelerate the industrialization process. Currently, Mabwell has a pipeline of 15 biologics in the areas of immunology, oncology, metabolic diseases, ophthalmology, and infectious diseases, and 8 products in the clinical stage are expected to be commercialized by 2023-2026. The first product, Adalimumab biosimilar, is expected to be marketed in 2021. Earlier this year, Mabwell obtained the IND acceptance for an anti-ST2 monoclonal antibody, making it the first Chinese company to apply this target IND submission and receive acceptance.

For venture capital, pipeline and capability may be the most immediate concerns. A high value pipeline means a promising future and generous returns. In addition, a company with comprehensive capabilities guarantees smooth sailing in every process, especially clinical development, which is significant in the fierce, competitive field of drug development. With expansion of the local market and investment, and growing support from the Chinese government, an increasing number of biopharma start-ups in China are expected to raise more money to strengthen pipelines and improve capabilities. With this trend, it is easily foreseeable that Chinese biopharma companies will be even more competitive in the global market in the next decade.

Scholar Rock to Present at Upcoming Healthcare Conferences in June

On May 27, 2021 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported that management will participate in the following upcoming investor conferences (Press release, Scholar Rock, MAY 27, 2021, View Source [SID1234580714]):

Jefferies Virtual Healthcare Conference on Wednesday, June 2nd, 2021 at 11:00 a.m. ET.
Goldman Sachs Annual Global Healthcare Conference on Wednesday, June 9th, 2021 at 2:10 p.m. ET.
BMO Biopharma Day: Rare Disease Panel, Central Nervous System on Tuesday, June 22nd, 2021 at 10:30 a.m. ET.
A live webcast of presentations at the Jefferies and Goldman Sachs conferences may be accessed by visiting the Investors & Media section of the Scholar Rock website at View Source An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the presentation.

Dr. Thomas Cannell, President and CEO of Sesen Bio, to Participate in Fireside Chat at the 2021 Jefferies Virtual Healthcare Conference

On May 27, 2021 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported that Sesen Bio President and CEO Dr. Thomas Cannell will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on June 4, 2021 (Press release, Sesen Bio, MAY 27, 2021, View Source [SID1234580713]).

Event: Jefferies Virtual Healthcare Conference
Date: June 4, 2021
Time: 8:30 – 8:55 AM ET

A live webcast of the Company’s presentation will be accessible from the Investors & Media section of Sesen Bio’s website, www.sesenbio.com. An archived replay of the webcast will be available on the Company’s website for 60 days after the conference.

Cardinal Health and Telix Launch Gallium Awareness Campaign With Release of White-Paper: “Moving Beyond the Myth”

On May 27, 2021 As interest and demand for more accurate prostate cancer imaging grows, and with the approval of the first Ga-68 PSMA based prostate imaging agent late last year1, Cardinal Health Nuclear & Precision Health Solutions (Cardinal Health) and Telix Pharmaceuticals (US) Inc. (Telix) reported that they have developed an in-depth white-paper, entitled: "Moving beyond the Myth: Meeting the growing demand for Ga-68 radiopharmaceuticals (Press release, Cardinal Health, MAY 27, 2021, View Source [SID1234580712])." The paper shines a light on the pathways for radio-isotope production, distribution and clinical application, as well as highlighting the extensive systems already in place to help ensure potential demand for Ga-68 imaging products is met.

Despite major disruption caused by COVID-19, 2020 saw two new drug applications (NDA) and an approval by the U.S. Food and Drug Administration (FDA) for the first 68Ga- PSMA-11 product for prostate cancer imaging albeit restricted to use in two academic institutions1. Since then, interest has been building in anticipation of other gallium-based imaging options currently under review by the FDA.

"A key to satisfying the demand for this isotope lies in having a robust network of radiopharmacies like Cardinal Health," said Dr. Christian Behrenbruch, Chief Executive Officer of Telix Pharmaceuticals Limited. "There is a perception in the industry that supply chain issues may limit the availability of gallium-based radiopharmaceuticals. Whilst this may have been true historically, this is no longer the case. The strength and power of gallium lies in its flexibility, with production by either cyclotron or generator. This offers greater flexibility and opportunity for scale than other purely cyclotron-based isotopes. Subject to regulator approval, we look forward to offering state-of-the-art diagnostic imaging to U.S. men living with prostate cancer, and Cardinal Health’s radiopharmacy network and infrastructure will be vital in facilitating nationwide access."

Cardinal Health Nuclear & Precision Health Solutions offers an extensive network of over 130 pharmacies, of which more than 110 are licensed to process 68Ga. Besides distribution efficiencies, Cardinal Health’s Accutrac system tracks doses during transit from the pharmacy to the site of care, enabling a greater than 99% on-time delivery record to help ensure doses are delivered where they are needed, when they are needed. "Patient and physician satisfaction is our top priority," says Tiffany Olson, President of the Cardinal Health Nuclear & Precision Health Solutions business. "Telix Pharmaceuticals is developing gallium-based innovations to advance prostate cancer imaging, and Cardinal Health is ready to help meet that demand."