On October 1, 2020 Simbec-Orion reported a charter agreement between the Oncodistinct Network and Simbec-Orion. The agreement strengthens the relationships between Simbec-Orion and the Oncodistinct network of oncology sites, who partner in operations and scientific expertise in the design and conduct of international early phase oncology trials (Press release, Simbec-Orion, OCT 1, 2020, View Source [SID1234567953]).

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"As a full-service agile Oncology CRO, dedicated to high quality delivery, the partnership between the Oncodistinct Network and Simbec-Orion provides benefits to both sponsors and patients," says Fabrice Chartier CEO at Simbec-Orion.

The Oncodistinct network is committed to accelerating oncology drug development and innovative strategies in clinical and translational research.

"This partnership with Simbec-Orion aligns with our network’s principles and activities, and underscores our commitment to innovative clinical research" says Professor Ahmad Awada from Oncodistinct.

The benefits of this agreement will include:

Streamlining of process and communication between sites, Simbec-Orion and sponsors to drive efficiencies in the setup and delivery of trials including the reduction of administrative burden in confidentiality agreements, feasibility efforts and contract negotiation
Commitment to fast-track feasibility within five working days of receipt
Expert and strategic advice on study design, protocol review and development

On October 1, 2020 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, reported that the Company’s GMP manufacturer partner NCK A/S, received a Certificate of Analysis (CoA) for its Active Pharma Ingredient (API), clearing it for use in the production of Berubicin (Press release, CNS Pharmaceuticals, OCT 1, 2020, View Source [SID1234567943]).

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As previously announced, CNS signed a contract with NCK A/S for the large-scale production of Berubicin, its lead drug candidate for the treatment of glioma brain tumors. NCK A/S is a GMP manufacturer of complex drugs located in Farum, Denmark, and the previous producer of Berubicin for Reata Pharmaceuticals. NCK A/S production of Berubicin should ensure drug availability through the end of Phase 2 clinical trials for glioblastoma.

"We believe the execution of this critical manufacturing milestone positions the company advantageously ahead of our expected U.S. Phase 2 trial," stated John Climaco, CEO of CNS Pharmaceuticals. "Our partnerships have proven instrumental in further progressing the manufacturing process necessary to continue the clinical development of our lead candidate. We look forward to continuing the work underway and to initiating our U.S. Phase 2 trial in Q1 of 2021."

On October 1, 2020 Biocept, Inc. (Nasdaq: BIOC), a leading commercial provider of molecular diagnostic assays, products and services designed to provide physicians with clinically actionable information to improve patient outcomes, reported the upcoming presentation of results from a prospective study using its Target Selector testing of the cerebrospinal fluid in patients with non-small lung cancer (NSCLC) (Press release, Biocept, OCT 1, 2020, View Source [SID1234567940]). The study results will be discussed in a poster presentation at the International Association for the Study of Lung Cancer (IASLC) Virtual Lung Cancer Hot Topic Meeting: Liquid Biopsy by David Berz, MD, PhD, MPH of the Beverly Hills Cancer Center, on October 2 from 2:30-3:30 p.m. Eastern time.

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Central nervous system involvement by metastasis occurs in 3% to 4% of patients with NSCLC and 9% of NSCLC patients with EGFR mutations. Involvement of the lepto-meninges, thin membranous connective tissue layers with blood vessels that surround the brain and spinal cord, accounts for deteriorating neurologic function, mental status changes and poor prognosis in these patients, but can be difficult to diagnose with current methods.

This prospective study evaluated results from Biocept’s combined circulating tumor cell (CTC) and circulating tumor DNA (ctDNA) liquid biopsy testing compared to conventional cytology examination, the current standard-of-care, for confirming the diagnosis of leptomeningeal metastases in patients with EGFR-mutated NSCLC undergoing treatment with Tesevatinib, an experimental EGFR tyrosine kinase inhibitor (NCT02616393).

"Testing the cerebrospinal fluid of patients for metastases to the central nervous system is a key component of our oncology testing business," said Michael Nall, President and CEO of Biocept. "We are excited that Dr. Berz, a national thought leader in lung malignancies and personalized oncology treatment, will present these results at the IASLC conference which features the latest developments in cancer treatment including liquid biopsy clinical utility."

About the IASLC 2020 Lung Cancer Hot Topic Meeting: Liquid Biopsy

There have been numerous advances in liquid biopsy since this event’s advent in 2018, and the concept of a "blood-first" approach—superseding or replacing tissue biopsy—is a current topic of much debate and discussion. This innovative virtual conference will bring together international and multidisciplinary experts in the field of liquid biopsy in lung cancer to present and discuss current technology and best practices for clinical applications based on available data.

About the IASLC

The International Association for the Study of Lung Cancer (IASLC) is the only global organization dedicated solely to the study of lung cancer and other thoracic malignancies. Founded in 1974, the association’s membership includes nearly 9,000 lung cancer specialists across all disciplines in over 100 countries, forming a global network working together to conquer lung and thoracic cancers worldwide. The association also publishes the Journal of Thoracic Oncology, the primary educational and informational publication for topics relevant to the prevention, detection, diagnosis and treatment of all thoracic malignancies. Please visit www.iaslc.org for more information.

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."