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Moderna Announces New Supply Agreement with Israel for 2022

On April 20, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported a new supply agreement with Israel for 2022 (Press release, Moderna Therapeutics, APR 20, 2021, View Source [SID1234578267]). Under the terms of this agreement, Israel also retains an option to purchase doses of one of Moderna’s variant-specific vaccine candidates subject to regulatory approval. Today’s announcement follows two earlier agreements between Israel and Moderna to supply a total of 10 million doses of the COVID-19 Vaccine Moderna. The Israeli Ministry of Health authorized COVID-19 Vaccine Moderna for use on January 4, 2021.

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"We appreciate the continued confidence and collaboration with the Israel Ministry of Health with this new agreement," said Stéphane Bancel, Chief Executive Officer of Moderna. "This is an important moment for our company as the first firm order for 2022 supply and for the supply of our variant-specific booster vaccine candidates against COVID-19, currently being studied in human clinical trials. Recent preclinical results have shown that our variant-specific booster candidates were effective against COVID-19 variants of concerns, and we hope to continue to see positive results from the clinical studies."

About the COVID-19 Vaccine Moderna

The COVID-19 Vaccine Moderna (referred to in the U.S. as the Moderna COVID-19 Vaccine) is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the National Institutes of Health (NIH) on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of the Moderna COVID-19 Vaccine was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation. On May 29, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of the vaccine. On July 8, the Phase 2 study completed enrolment.

Results from the second interim analysis of the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine. On November 30, 2020, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases. On November 30, 2020, the Company also announced that it filed for Emergency Use Authorization with the U.S. FDA and a Conditional Marketing Authorization (CMA) application with the European Medicines Agency. On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has also received authorization for its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore, Qatar and Taiwan. Additional authorizations are currently under review in other countries and by the World Health Organization.

Preclinical data on the Company’s variant-specific booster vaccine candidates have been submitted as a preprint to bioRxiv and will be submitted for peer-reviewed publication. These variant-specific vaccine candidates include mRNA-1273.351, which is more specifically targeted against the SARS-CoV-2 variant known as B.1.351 first identified in the Republic of South Africa, and a multivalent booster candidate, mRNA-1273.211, which combines mRNA-1273 (Moderna’s authorized vaccine against ancestral strains) and mRNA-1273.351 in a single vaccine. The Company’s Phase 2 study to evaluate three approaches to boosting is ongoing.

Authorized Use

Moderna has received approval to import and market COVID-19 Vaccine Moderna in Israel under Regulation 29 (A)(9). COVID-19 Vaccine Moderna is approved as a two-dose series for patients 18 years of age and older.

JCRI-ABTS and USMI Successfully Complete Phase 1 Multi-Center Clinical Trial Using Canady Helios™ Cold Plasma for the Treatment of Cancer

On April 20, 2021 The Jerome Canady Research Institute for Advanced Biological and Technological Sciences, LLC (JCRI-ABTS) and US Medical Innovations, LLC (USMI) reported that they have successfully completed Phase 1 in their Clinical Trial using Canady Helios Cold Plasma (CHCP) for the treatment of recurrent and stage 4 solid tumors (IDE #G190195) (Press release, JCRI-ABTS, APR 20, 2021, View Source [SID1234578266]). The medical centers involved in the study were Rush University Medical Center in Chicago, Illinois (Principal Investigator, Steven Gitelis, MD) and Sheba Medical Center, in Tel HaShomer, Israel (Principal Investigator, Aviram Nissan, MD).

USMI is the first company in the world to integrate a high frequency electrosurgical generator and plasma gas to deliver a CHCP for the selective treatment of cancer. This novel non-thermal process (24-27o C) has been developed for treating solid cancerous tumors. After the surgeon removes the cancerous tumor during surgery, CHCP is subsequently sprayed at the surgical margins to target any remaining cancerous tissue or cells, thus reducing the chances of cancer recurrence.

According to Jerome Canady, MD and USMI’s CEO (Sponsor Investigator), "Our Primary Objective was to establish the safety and efficacy of our Canady Helios Cold Plasma (CHCP) on human neoplastic tissues."

"We are very happy to report that the first phase of the Clinical Trial has been successfully completed with no adverse effects and we expect this product to not only be proven safe, but also proven effective in ablating cancer cells in the surgical tumor margins and macroscopic tumor sites."

Dr. Canady continued, "Unlike Chemo and Radiation Therapy, the Canady Helios Cold Plasma Therapy has many advantages. It is performed during the surgical procedure. It is highly selective because it only targets cancer cells without damaging surrounding healthy tissue. And thirdly, CHCP is personalized for your specific cancer type."

Through 20 surgical cancer procedures, Canady Helios Cold Plasma has been used safely with no side effects and is expected to be one of the most promising cancer treatments developed in recent times.

Janux Therapeutics Closes $125 Million Series B Financing to Advance Next Generation T Cell Engager Immunotherapies into Clinical Trials

On April 20, 2021 Janux Therapeutics reported the closing of a $125 million Series B financing led by RA Capital Management and joined by new investors BVF Partners L.P., EcoR1 Capital, Hartford HealthCare Endowment, Janus Henderson Investors, Logos Capital, Samsara BioCapital and Surveyor Capital (a Citadel company) (Press release, Janux Therapeutics, APR 20, 2021, View Source [SID1234578265]). Janux’s existing investors, OrbiMed, Avalon Ventures, and Bregua, also participated. The proceeds of the financing will help support the advancement of Janux’s pipeline of next generation T cell engager immunotherapies, including a PSMA-TRACTr, EGFR-TRACTr, and TROP2-TRACTr, into initial proof of concept clinical trials.

"This commitment from a world-class syndicate of life science investors will help advance Janux’s proprietary pipeline of potentially transformative immunotherapies into clinical development, while leveraging our powerful TRACTr platform to identify and optimize new drug candidates," said David Campbell, Ph.D., President and CEO of Janux Therapeutics. "We intend to use the proceeds to advance PSMA-TRACTr, EGFR-TRACTr, and TROP2-TRACTr into the clinic as well as attract the talent needed to realize our vision of providing cancer patients with safe and effective drugs that direct their immune system to eradicate tumors to give them the best chance to overcome their disease."

T cell engagers are an emerging class of immunotherapies that bind to a tumor cell and recruit a patient’s T cells to eradicate tumor cells. Janux’s proprietary Tumor Activated T Cell Engager (TRACTr) technology is designed to overcome specific limitations of current T cell immuno-oncology therapies. Although previous therapies utilizing other technologies have displayed substantial anti-tumor activity, they have been constrained by dose-limiting toxicities, poor pharmacokinetic profiles, and attenuated efficacy. Janux’s TRACTr technology is designed to overcome these limitations by integrating tumor-specific activation with crossover pharmacokinetics to produce differentiated T cell engager therapeutics.

"RA Capital believes that Janux’s proprietary technology has the potential to unlock the next generation of immunotherapies, and we are excited about the significant potential that this platform holds for a breadth of highly prevalent solid tumors," said Jake Simson, Ph.D., partner at RA Capital Management. "We are impressed with the preclinical data from Janux’s wholly-owned TRACTr drug candidates showing the potential to harness the potent tumor-killing properties of T cells."

In preclinical studies, Janux TRACTr drug candidates have demonstrated comparable anti-tumor activity relative to standard T cell engagers but lack the associated liabilities related to cytokine release, healthy tissue toxicities, or systemic immune activation.

Illumina Remains Committed to GRAIL Acquisition to Accelerate Access to Breakthrough Multi-Cancer Early Detection Blood Test

On April 20, 2021 Illumina, Inc. (NASDAQ: ILMN), reported that it disagrees with the European Commission’s Directorate-General for Competition’s decision to review Illumina’s acquisition of GRAIL, a company founded to accelerate early screening of cancer (Press release, Illumina, APR 20, 2021, View Source [SID1234578264]). Illumina will continue to work with the Directorate-General to bring the investigation to conclusion. Illumina remains committed to the transaction, the impact of which would accelerate the adoption of a multi-cancer early detection blood test.

"Reuniting GRAIL and Illumina will allow us to bring GRAIL’s breakthrough early detection multi-cancer test to patients across the world faster and consequently save lives," said Francis deSouza, Chief Executive Officer of Illumina. "We do not believe that the European authorities have jurisdiction to review the GRAIL acquisition and look forward to resolving this matter expeditiously."

Illumina originally founded GRAIL five years ago and the two companies do not compete in any way. In reuniting the two organizations, Illumina will leverage its global scale of manufacturing and clinical capabilities, as well as its global regulatory and reimbursement expertise, to bring early-stage, multi-cancer testing to patients more quickly and more affordably, resulting in more lives being saved.

Illumina strongly believes that acquiring GRAIL is in the best interest of patients, is procompetitive, and benefits the multi-cancer early detection field as a whole. Together with GRAIL, Illumina looks forward to changing the course of cancer detection and treatment.

Tubulis appoints Günter Fingerle-Rowson as Chief Medical Officer to lead the clinical development of its new generation of ADCs

On April 20, 2021 Tubulis reported the appointment of Günter Fingerle-Rowson, MD, PhD, as Chief Medical Officer to complement the leadership team and to further build the company’s clinical expertise (Press release, Tubulis, APR 20, 2021, View Source [SID1234578263]). Dr. Fingerle-Rowson is an experienced hematologist and medical oncologist who brings to Tubulis more than two decades of academic, biotechnology and pharmaceutical industry experience. Moreover, he has a proven track record of advancing product candidates from early clinical phase through regulatory approval and into clinical practice. In this newly established role, he will use his extensive knowledge in the development of cancer therapeutics to oversee Tubulis’ clinical activities and advance the company’s Antibody Drug Conjugates (ADCs) towards clinical evaluation.

"Günter is an expert in developing successful clinical oncology programs that resulted in the regulatory approval of several monoclonal antibodies. His wealth of experience and his track record of execution will be a great asset to Tubulis as we transition towards becoming an established clinical-stage drug developer," said Dr. Dominik Schumacher, CEO and co-founder of Tubulis. "In addition, his background in translational research in immuno-oncology will further strengthen our team and our capabilities to rapidly deliver the benefits of our ADC approach to cancer patients."

Dr. Fingerle-Rowson commented: "I am thrilled to join Tubulis to be part of the team that brings ADC technology to a new level. The technological advancements that the company has made in a short period of time and the team’s clear vision to become a leader in the field of ADCs instantly drew my interest. I look forward to help shape the clinical development plan for Tubulis’ exciting technology platform and to bring its first candidate TUB-010 to patients in the near term. Tubulis´ proprietary ADC technology enables us to develop novel ADCs that have a better versability and an improved benefit/risk profile than current ADC options."

Prior to joining Tubulis, Dr. Fingerle-Rowson worked in Global Clinical Development at MorphoSys and F. Hoffmann-La Roche as well as in Medical Affairs at Janssen-Cilag, a J&J company. He has contributed to bring three drugs to patients with malignancies. In his latest role as VP, Global Product Head at MorphoSys, he steered the clinical development as well as the regulatory approval for Tafasitamab (MOR208, Monjuvi). From 2011-2018, he served as Associate Medical Group Director, Global Development Team Leader and Global Clinical Leader at F. Hoffmann-La Roche where he was responsible for the clinical development and regulatory approvals of Obinutuzumab (GA101, Gazyva). Dr. Fingerle-Rowson also worked as Medical Manager at Janssen-Cilag, and as academic physician in internal medicine, hemato-oncology at the University Hospitals in Cologne and Munich where he also led own research in the field of immuno-oncology. Dr. Fingerle-Rowson was a longstanding active member of the German CLL Study Group where he contributed to the approval of Rituximab. He is a board-certified hematologist/medical oncologist and holds an MD in Internal Medicine from Munich University, and a MD-PhD in Molecular Medicine from New York University.