On October 1, 2020 ViewRay, Inc. (Nasdaq: VRAY) reported that the Company will host a virtual physician-led informational discussion for investors and analysts during the 2020 American Society of Radiation Oncology (ASTRO) Annual Meeting (Press release, ViewRay, OCT 1, 2020, View Source [SID1234567938]).

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Event:

Physician-led Webinar for Investors and Analysts at 2020 ASTRO Annual Meeting

Date:

Tuesday, October 27, 2020

Time:

9:00 a.m. – 10:00 a.m. MTN

Details:

Registration is required to attend and will close an hour prior to the start. Please register at View Source An archived replay of the meeting will be available within 24 hours on ViewRay’s investor relations website at View Source

Guest Speakers:

Dr. John Bayouth is a tenured professor and the Bhudatt Paliwal endowed chair of the Radiation Oncology Physics Division in the Department of Human Oncology at the University of Wisconsin in Madison, one of the nation’s premier radiation oncology physics programs. He is also the director of the UW–Madison Medical Physics Residency Program in Radiation Therapy. Dr. Bayouth has served in the presidential chair of both the American Association of Physics in Medicine (AAPM) and the Society of Directors of Academic Medical Physics Programs (SDAMPP) and within various committees of the American Society of Radiation Oncology (ASTRO), the Radiological Society of North America (RSNA), and the American Board of Radiology (ABR).

Daphne Haas-Kogan, MD, is Chair of the Department of Radiation Oncology at Dana-Farber/Brigham and Women’s Cancer Center (DFBWCC) and Boston Children’s Hospital. She is also the Willem and Corrie Hees Family Professor of Radiation Oncology at Harvard Medical School. As Department Chair, her vision includes supporting each member of the Radiation Oncology Department in fostering close collaborative ties with diagnostic radiologists, medical and pediatric oncologists, surgeons, pathologists, and basic science investigators to spearhead cutting edge science, translational investigations and clinical studies, all based on the depth and breadth of success that already permeates DFBWCC. Dr. Haas-Kogan is a member of the National Academy of Medicine.

A question and answer session will be held at the end of the presentation.

On October 1, 2020 Johnson & Johnson (NYSE: JNJ) reported it has successfully completed its acquisition of Momenta Pharmaceuticals, Inc. ("Momenta"), a company that discovers and develops novel therapies for immune-mediated diseases, in an all cash transaction for approximately $6.5 billion (Press release, Johnson & Johnson, OCT 1, 2020, View Source;johnson-completes-acquisition-of-momenta-pharmaceuticals-inc-301143938.html [SID1234567937]).

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"We’re delighted to welcome Momenta’s talented team to the Janssen Pharmaceutical Companies of Johnson & Johnson and to begin our work together to further advance patient care in autoantibody-driven diseases," said Jennifer Taubert, Executive Vice President, Worldwide Chairman, Pharmaceuticals, Johnson & Johnson. "We anticipate multiple launches, many of which would be first-in-class indications in rare diseases and areas of significant unmet need."

Johnson & Johnson’s tender offer for all outstanding shares of Momenta for $52.50 per share expired at 12:00 a.m. (midnight), New York City time, at the end of the day on September 30, 2020. American Stock Transfer & Trust Company, LLC, the depositary and paying agent for the tender offer, has advised Johnson & Johnson that approximately 100,595,118 shares of Momenta’s common stock were validly tendered and not validly withdrawn in the tender offer, representing approximately 79.4% of the outstanding shares of Momenta’s common stock on a fully diluted basis. All of the conditions to the tender offer have been satisfied, and on October 1, 2020, Vigor Sub, Inc. ("Vigor"), a wholly-owned subsidiary of Johnson & Johnson, accepted for payment, and will as promptly as practicable pay for, all shares validly tendered and not properly withdrawn in the tender offer.

The acquisition was completed on October 1, 2020 through a merger of Vigor with and into Momenta in accordance with Section 251(h) of the General Corporation Law of the State of Delaware without a vote of Momenta’s stockholders. Momenta now operates as a wholly-owned subsidiary of Johnson & Johnson. In connection with the merger, shares of Momenta that were not tendered in the tender offer were acquired by Johnson & Johnson and converted into the right to receive $52.50 per share. As a result of the completion of the merger, Momenta’s common stock will be delisted from the NASDAQ Global Select Market.

"The Momenta team has made excellent progress in developing its medicines for rare diseases, and we look forward to combining our expertise and resources with theirs to increase that scope," said Mathai Mammen, M.D., Ph.D., Global Head of Janssen Research & Development, Johnson & Johnson. "Our immunology pathways strategy creates an opportunity to create a ‘pipeline in a pathway,’ with multiple potential indications across autoimmune diseases with substantial unmet medical need in maternal-fetal disorders, neuroimmune disorders, rheumatology, dermatology and autoimmune hematology."

On October 1, 2020 Debiopharm (www.debiopharm.com), a Swiss biopharmaceutical company, reported the first patient dosed in their phase III clinical trial (TrilynX) with xevinapant, an orally available antagonist of IAPs (Inhibitor of apoptosis proteins) cancer therapy in combination with CRT for LA-SCCHN patients (Press release, Debiopharm, OCT 1, 2020, View Source;a-large-scale-phase-iii-clinical-trial-to-further-evaluate-xevinapant-in-the-treatment-of-head–neck-cancer-301143930.html [SID1234567935]). This prospective, randomized, double-blind, placebo-controlled, multicenter, 2-arm clinical trial is being conducted to demonstrate the superior efficacy of xevinapant vs. placebo when added to CRT in high risk head and neck patients including those affected in the throat and vocal chords (oropharynx -HPV-negative, hypopharynx and larynx). The TrilynX study is being launched worldwide in 25 countries in over 200 sites with the aim of enrolling approximately 700 patients.

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This trial launch follows the positive phase II results observed at 3-year follow-up analysis showing superior and statistically significant locoregional control, progression-free survival and overall survival vs. the placebo control group. Efficacy during phase III will be evaluated by multiple radiological and clinical variables including event-free survival, progression-free survival, and duration of response.

"The launch of the TrilynX trial follows several key 2020 milestones in the development of xevinapant including the FDA Breakthrough Designation in February and the recent presentation this fall of our clinically meaningful 3-year, phase II data at the ESMO (Free ESMO Whitepaper) (European Society of Medical Oncology) virtual congress. We expect that this large-scale trial will confirm the strong outcomes observed in phase II, bring us a step further towards positively impacting the lives of high-risk head & neck cancer patients." expressed Bertrand Ducrey, CEO of Debiopharm.

Worldwide, head and neck cancer accounts for more than 650,000 cases and 330,000 deaths annually1 making it the 6th most common cancer type worldwide. LA-SCCHN is a highly debilitating disease, gradually progressing impaired breathing, swallowing, and speech.2 Risk for the disease is linked with alcohol and tobacco abuse, largely due to exposure to carcinogens in the upper airways. Despite standard of care CRT, at least 50% of patients with LA-SCCHN develop locoregional or distant relapses, which are usually detected within the first 2 years of treatment,3,4 hence the need to identify new therapeutic solutions.

Debiopharm’s commitment to patients
Debiopharm, Swiss Biotech Award Winner 2020, develops innovative therapies that target high unmet medical needs in oncology and bacterial infections. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.

On October 1, 2020 Olema Oncology, a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers, reported the closing of a $85 million Series C financing (Press release, Olema Pharmaceuticals, OCT 1, 2020, View Source [SID1234567933]). Olema will use the financing proceeds to advance the clinical development of OP-1250, its lead product candidate in breast cancer, and expand ongoing research and development activities. OP-125 is currently being evaluated in a Phase 1/2 clinical trial in patients with recurrent, locally advanced or metastatic estrogen-receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer whose disease has progressed on endocrine therapy.

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Vivo Capital led the financing with participation by additional new investors, including Avoro Capital Advisors, funds and accounts managed by BlackRock, Deerfield Management Company, and OrbiMed, among other investors. All existing institutional investors – BVF Partners L.P., Logos Capital, Janus Henderson Investors, Cormorant Asset Management, Wellington Management Company, RA Capital Management, Venrock Healthcare Capital Partners, Surveyor Capital (a Citadel company), and Foresite Capital – also participated.

"We are pleased to have such strong support from our new and existing investors as we begin our next phase of growth as a clinical-stage company in pursuit of our mission to bring novel, potentially life-saving therapies to women affected by breast cancer," said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. "We recently strengthened our executive team and Board with the appointment of leading industry experts and initiated a Phase 1/2 trial of OP-1250."

Shane Kovacs, Chief Operating and Financial Officer of Olema, added, "The proceeds from this financing provide Olema with additional capital that will allow us to continue to build and execute our growth plans for OP-1250 as well as further invest in our research efforts to expand our pipeline and advance additional programs that could benefit women with breast and other hormone-positive cancers. The quality of this investor syndicate is a testament to the strength of our opportunity and the team we have been building."

Olema plans to conduct additional studies evaluating OP-1250 in combination with other targeted breast cancer therapies.

"With new treatments urgently needed for women living with breast cancer, we are thrilled to lead this Series C financing and help Olema and its experienced leadership team, now headed by biopharma veteran Sean Bohen, pursue its goal of changing the way breast cancer is treated," said Albert Cha, M.D., Ph.D., Partner at Vivo Capital. "We are impressed by OP-1250 and the opportunity it presents in women’s oncology. With its oral formulation and differentiated profile, OP-1250 is poised to potentially overcome the limitations of current endocrine therapies for metastatic ER+ breast cancer and potentially become the endocrine therapy of choice to treat women with this type of cancer."

Cowen served as exclusive placement agent for the Series C financing.

On October 1, 2020 Qualigen Therapeutics, Inc. (NASDAQ: QLGN) reported it has entered into an amended Sponsored Research Agreement with the University of Louisville (UofL) to advance development of Qualigen’s anticancer drug candidate AS1411-GNP, also known as ALAN (Aptamer-Linked Anti-Nucleolin) (Press release, Qualigen, OCT 1, 2020, View Source [SID1234567931]).

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The work being performed under the original Sponsored Research Agreement comprises animal studies to assess antitumor efficacy and safety of different ALAN compositions designed to treat pediatric and adult acute myeloid leukemia (AML). Under the amended Sponsored Research Agreement UofL will perform preclinical studies on AML and on additional indications including glioblastoma, a malignant brain cancer that is difficult to treat because most drugs cannot pass the blood-brain membrane, and non-small cell lung cancer, which comprises approximately 85% of the 1.6 million global lung cancer cases each year.

Additionally, Qualigen and UofL will study how ALAN may inhibit metastasis of cancer cells as a potential adjuvant therapy. The recurrence of cancer after initial treatment is the cause of approximately 90% of cancer deaths and represents a pressing unmet clinical need.

"Our expanded agreement with UofL should provide Qualigen with additional data to help us achieve our goal of advancing our ALAN cancer drug candidate into clinical trials against AML next year. We are especially interested in several new applications of this drug candidate, namely the treatment of pediatric cancers such as leukemia, the treatment of glioblastoma, the deadliest form of brain cancer and as an adjuvant therapy to stop the recurrence of cancer after initial treatment. We believe these paths will become a larger part of our clinical efforts and will accelerate the expansion of our product pipeline over the coming year, as they represent high unmet needs for critically important areas of cancer treatment," stated Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen.

ALAN is a combination of AS1411 plus a DNA-coated gold nanoparticle, which dramatically increases its potency. This cancer drug candidate has the potential to target and destroy tumor cells in a wide variety of cancer types with minimal side effects. The Company is aiming to commence Phase 1 human trials in 2021 for AML, its lead indication. Qualigen has an exclusive worldwide license agreement from the UofL for ALAN.

"We are pleased to continue our relationship with Qualigen Therapeutics to expand the development program for ALAN," added Paula Bates, PhD, Professor of Medicine at UofL, who will be leading the project at UofL in collaboration with Martin O’Toole, PhD, and Levi Beverly, PhD. "We look forward to conducting these studies, which have the potential to demonstrate ALAN’s broad applicability as an effective therapy for these difficult-to-treat cancers."