On October 1, 2020 Imago BioSciences, Inc. ("Imago") a clinical-stage biopharmaceutical company developing innovative treatments for myeloid diseases, reported that the first patient has been dosed in the first Imago-sponsored Phase 2b clinical trial of bomedemstat (IMG-7289) for the treatment of essential thrombocythemia (ET) (Press release, Imago BioSciences, OCT 1, 2020, View Source [SID1234567853]).

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"We are excited to start this study. There are many patients with essential thrombocythemia in need of alternatives to the current standards of care. Bomedemstat has the potential to serve as a new option for such patients," said Hugh Young Rienhoff, Jr. MD, CEO, Imago BioSciences.

This Phase 2b multi-center, open-label study is designed to assess the safety, efficacy, and pharmacodynamics of bomedemstat, an oral inhibitor of the epigenetic enzyme lysine-specific demethylase 1 (LSD1) (www.clinicaltrials.gov Identifier NCT04254978). Eligible patients aged 18 or older with ET who have failed at least one standard therapy and require treatment in order to lower their platelet count will be considered for participation in this study. Exploratory assessments include the serial measurement of mutant allele frequencies and changing plasma cytokine profiles. The trial is being conducted in the United States, the United Kingdom, Europe, New Zealand, and Australia.

About Bomedemstat (IMG-7289)

In addition to the ET study, bomedemstat is being evaluated in an open-label Phase 2 clinical trial for the treatment of advanced myelofibrosis (MF), a bone marrow cancer that interferes with the production of blood cells. MF patients who are resistant to, intolerant of, or ineligible for a Janus Kinase (JAK) inhibitor are eligible for the study of bomedemstat as monotherapy. The endpoints include spleen volume reduction and symptom improvement at 12 and 24 weeks of treatment. Preliminary results have been presented at meetings of the European Hematology Association (EHA) (Free EHA Whitepaper) and the American Society of Hematology (ASH) (Free ASH Whitepaper).

Bomedemstat is an orally available small molecule discovered and developed by Imago BioSciences that inhibits lysine-specific demethylase 1 (LSD1 or KDM1A), an enzyme shown to be vital in cancer stem/progenitor cells, particularly neoplastic bone marrow cells. In non-clinical studies, bomedemstat demonstrated robust in vivo anti-tumor efficacy across a range of myeloid malignancies as a single agent and in combination with other chemotherapeutic agents. Bomedemstat is an investigational agent currently being evaluated in ongoing clinical trials (ClinicalTrials.gov Identifier: NCT03136185, NCT04262141 and NCT04081220). Bomedemstat has FDA Orphan Drug and Fast Track Designation for the treatment of myelofibrosis and essential thrombocythemia, Orphan Drug Designation for treatment of acute myeloid leukemia and PRIME designation by the European Medicines Agency for the treatment of MF.

On October 1, 2020 Covis Group S.à r.l. ("Covis") and AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) reported that they have entered into a definitive agreement under which Covis will acquire AMAG for $13.75 per share in cash, or approximately $498 million on a fully diluted basis and approximately $647 million on an enterprise basis, including debt obligations expected to be assumed or repaid net of cash (Press release, AMAG Pharmaceuticals, OCT 1, 2020, View Source [SID1234567886]). The offer represents a premium of approximately 46% to the closing price of AMAG’s common stock on September 30, the last full trading day prior to the announcement.

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Commenting on the transaction, Covis CEO Michael Porter said, "AMAG’s category leading treatments are strong strategic complements to our existing therapeutic portfolio. Through this combination, we believe we will be able to unlock value for all of our stakeholders, employees and patients through the effective and efficient management of these products, coupled with our two companies’ longstanding commitment to expanding patient access to therapy and putting patient interests first. At Covis, we never lose sight that our patients are our paramount concern. We look forward to engaging with the talented team at AMAG as we work together to plan the integration of our two organizations."

AMAG CEO Scott Myers added, "In the beginning of 2020, AMAG announced that the company had undertaken a strategic review of our product portfolio and strategy, the guiding principles of which included driving near- and long-term profitability and enhancing shareholder value. This strategic review resulted in the company pursuing and accomplishing the divestiture of its women’s health assets, and other efforts to streamline and strengthen the core business to position AMAG for the future. Following this initial transformation, our Board of Directors and management team, together with independent legal and financial advisors, thoroughly evaluated the transaction with Covis as well as other strategic options and concluded that it represents the most compelling opportunity for shareholders, providing them certain and immediate cash value. We believe Covis is the right partner for AMAG, especially in light of Covis’ shared commitment to ensuring that our therapies will reach patients in need. We are confident the work we’ve done will continue to thrive under Covis’ leadership."

The completion of the tender offer is subject to customary closing conditions, including the tender of at least a majority of the outstanding shares of AMAG’s common stock, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and other customary conditions. Following the successful completion of the tender offer, an indirect, wholly owned subsidiary of Covis will merge with AMAG (the "merger") and the outstanding AMAG shares not tendered in the tender offer will be converted into the right to receive the same $13.75 per share in cash paid in the tender offer. The tender offer is expected to commence in October 2020. Covis plans to finance the transaction with cash on hand, and a combination of committed debt and equity financing. There is no financing condition to the obligations of Covis to consummate the transaction.

As part of the transaction, Covis intends to enter into an amended and restated credit facility with its current lenders (the "Lenders"), pursuant to which the Lenders will provide up to a $460 million senior secured incremental term loan and a $55 million secured revolver (the "Covis Debt Financing"). The proceeds from the Covis Debt Financing, plus equity commitments from Covis’ equity sponsor, will be used to pay the cash purchase price for the transaction and repay any of the existing AMAG debt that is not assumed. The Covis Debt Financing amount will be added to Covis’ current $450 million term loan facility with the Lenders. As the merger will result in a change of control under the terms of AMAG’s Indenture governing its 3.25% Convertible Senior Unsecured Notes Due 2022 (the "Convertible Notes"), the holders of the Convertible Notes will have the right to put at par the Convertible Notes held by them for a period of twenty business days following the closing of the merger.

All Board members and executive officers of AMAG have agreed to tender their shares in favor of the transaction. The transaction, which has been unanimously approved by the Board of Directors of each company, is expected to close in November 2020, pending Hart-Scott-Rodino (HSR) approval and the conditions to the tender offer being satisfied.

Goldman Sachs & Co. LLC is acting as exclusive financial advisor, and Goodwin Procter LLP is acting as legal advisor to AMAG. Paul, Weiss, Rifkind, Wharton and Garrison LLP is acting as legal advisor to Covis.

On October 1, 2020 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that Manuel Litchman, M.D., President and Chief Executive Officer, will participate in a fireside chat at Chardan’s Virtual 4th Annual Genetic Medicines Conference 2020 on Monday, October 5, 2020, at 1:00 p.m. EDT (Press release, Mustang Bio, OCT 1, 2020, View Source [SID1234567913]).

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A live webcast of the fireside chat will be available on the Events page of the Investor Relations section of Mustang’s website: www.mustangbio.com. An archived replay of the webcast will be available for approximately 30 days following the fireside chat.

On October 1, 2020 Genenta Science, a clinical-stage biotechnology company pioneering the development of a hematopoietic stem cell gene therapy for cancer (Temferon), reported that it will present new preliminary data from the Phase I/II TEM-GBM study of Temferon in patients affected with glioblastoma multiforme, at the 4th Virtual Annual Genetic Medicines Conference, hosted by Chardan on 5th and 6th of October 2020 (Press release, Genenta Science, OCT 1, 2020, View Source [SID1234567855]).

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Pierluigi Paracchi, Chairman and Chief Executive Officer at Genenta Science and Dr. Carlo Russo, Chief Medical Officer and Head of Development, will present the data along with an overview of the company’s pipeline and development of Temferon in two solid tumor indications.

Presentation Details:
Date: Tuesday, October 6
Time (EDT): starting from 2:30pm

Registration at: View Source

On October 1, 2020 SOPHiA GENETICS, global leader in Data-Driven Medicine, reported the closing of a $110 million financing round to enter into the next stage of its expansion, with a focus on supporting the growing clinical and biopharma demand for Data-Driven Medicine worldwide (Press release, Sophia Genetics, OCT 1, 2020, View Source [SID1234567888]).

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This Series F round was led by aMoon, a leading health-tech & life sciences venture fund based in Israel, and Hitachi Ventures, a venture arm of Japanese Hitachi Group. The company also received the trust of prime financial institutions Credit Suisse and the Pictet group. Existing investors Swisscom Ventures, Endeavour Vision, Generation Investment Management, Alychlo, and Eurazeo Growth participated in the round, as well as newcomers ACE & Company and Famille C Invest.

Having established the world’s largest Data-Driven Medicine community network through its universal and collaborative AI platform, SOPHiA GENETICS supports healthcare professionals by translating multiple sources of complex medical data into valuable clinical insights. The SOPHiA Platform is used by over 1’000 healthcare institutions and has analyzed 600’000 genomic profiles; up to 17’000 new profiles a month. Through continual learning and network effects, experts worldwide are empowered to act with confidence for better patient management.

The new funding round will boost the company’s penetration in both the US and Asian markets. Proceeds will also be dedicated to increasing the platform multimodal capabilities and its adoption by healthcare institutions worldwide. Leveraging this momentum, SOPHiA GENETICS will be best positioned to power biopharma’s effort to optimize and accelerate the development of new targeted therapies.

As SOPHiA enters this new phase of rapid expansion, Didier Hirsch, former CFO at Agilent, joins the company’s Board of Directors. He will also chair the company’s Audit Committee, ushering SOPHiA GENETICS toward its next important milestones.

"The overall demand for Data-Driven Medicine is rapidly growing, and the next step is to successfully combine multiple sources of data to better address clinicians’ needs," said Dr. Tomer Berkovitz, Partner & CFO of aMoon. "With this shift, more complex data will be generated, and we believe that SOPHIA’s decentralized model will play a pivotal role in empowering health organizations to offer better patient care".

Keiji Kojima, Executive Vice President and General Manager of Hitachi’s Smart Life Business Division, added: "Over the years, SOPHiA GENETICS has emerged as a leader in Data-Driven Medicine and we look forward to supporting the company expand its footprint in the Japanese market and beyond."

"SOPHiA has established an impressive track record of disrupting healthcare and enabling a decentralized approach. This new funding round will further strengthen SOPHiA’s already unique offering, performance, and life-changing impact on patients and targeted therapies," said Troy Cox, Chairman of the Board of Directors of SOPHiA GENETICS.

"Since inception, we knew that leveraging a wide range of data modalities powered by cutting-edge technologies was key to sustainably deliver better outcomes to the global healthcare community", concluded Jurgi Camblong, CEO and Founder at SOPHiA GENETICS. "Now, with this new funding round, we can embark on the next stage of our development and take our collaborative approach further, delivering intelligent medicine, together."