On November 30, 2020 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTsTM), announced that, effective November 24, 2020, Steve Hoffman will remain in the role of Chairman of the board of directors and continue as the Company’s Chief Science Officer, after a successful tenure as Chief Executive Officer since 2015 (Press release, TYME, NOV 30, 2020, View Source [SID1234571993]). Richie Cunningham, former Icagen CEO and Boehringer Ingelheim executive, has been appointed as TYME’s next Chief Executive Officer.

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"We are fortunate to have been able to identify and bring on an individual with Mr. Cunningham’s significant experience in key facets sought by emerging biotech companies. His leadership and expertise in the biopharmaceutical industry, as well as his knowledge of efficient partnering strategies will be invaluable in helping TYME establish itself as a commercial organization with a pipeline of next-generation metabolic-based compounds," said Steve Hoffman, Chairman and Chief Science Officer of TYME.

Mr. Cunningham brings more than 20 years of successful leadership experience spanning from pre-IND drug discovery through the commercialization and launch of over a dozen therapies in oncology, rare disease, infectious disease, respiratory, neurology, cardiovascular and metabolic diseases. Richie brings to TYME an in-depth understanding of maximizing therapeutic lifecycles, enhancing efficiencies and outcomes in biotech business models, and most importantly a commitment to a values-driven culture.

Mr. Cunningham also brings significant experience in mergers & acquisitions, business development, strategy development, therapeutic launches, contracting, managed care, and sales & marketing. Most recently, Richie served as CEO at Icagen, leading the company through two transformational acquisitions, acquiring assets and talent out of Pfizer and Sanofi. While CEO at Icagen, he successfully negotiated and signed multiple licensing deals with Roche, Sanofi and the Cystic Fibrosis Foundation.

Prior to joining Icagen, Mr. Cunningham was an executive with one of the world’s largest pharmaceutical companies, Boehringer Ingelheim, where he held a variety of key strategic and operational roles, including the launch of Boehringer’s first entrance into the oncology market with Gilotrif (afatinib), an oral tyrosine kinase inhibitor, as a treatment for patients with non-small cell lung cancer.

In addition, Mr. Cunningham excelled in the National Football League holding All-Pro honors for the Dallas Cowboys. His career in the NFL spanned from 1994 until his retirement in 2002.

"TYME is positioned for success and I look forward to working with the leadership team and TYME employees to achieve its strategic short- and long-term objectives. I am excited about the prospects of making a positive impact in the lives of patients and enhancing the value for all stakeholders," said Richie Cunningham.

On November 30, 2020 Imago BioSciences, Inc., ("Imago") a clinical-stage biotechnology company developing innovative treatments for myeloid diseases, reported the expansion of its global Phase 2b clinical study evaluating bomedemstat (IMG-7289) for the treatment of advanced myelofibrosis (MF) into Hong Kong, where the first patient has now been enrolled and dosed at the Department of Medicine, Queen Mary Hospital and the University of Hong Kong (Press release, Imago BioSciences, NOV 30, 2020, View Source [SID1234571943]). Myelofibrosis is a rare bone marrow cancer that interferes with the production of blood cells.

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In addition to Hong Kong, the Phase 2b study continues to actively enroll patients in the U.S., U.K., and E.U. The study is in the final stages of completing enrollment and continues to dose patients to evaluate safety, tolerability and efficacy.

"Patients with myelofibrosis around the world are still in need of new treatment options," said Hugh Young Rienhoff, Jr. M.D., Chief Executive Officer, Imago BioSciences. "We are progressing well with enrollment and are pleased to continue expanding our global Phase 2 study into new geographies like Hong Kong. We are encouraged by the signs of clinical activity and safety of bomedemstat as a treatment alternative for patients who do not benefit from the current standards of care."

Bomedemstat is an inhibitor of lysine-specific demethylase 1 (LSD1), an epigenetic regulator critical for self-renewal of malignant myeloid cells and the differentiation of myeloid progenitors. Data presented at the 25th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress in June demonstrated that the first-in-class LSD1 inhibitor was well tolerated with no dose-limiting toxicities or safety signals. Furthermore, recent data demonstrates the potential of bomedemstat as a monotherapy in intermediate-2 and high-risk patients with myelofibrosis who have become intolerant of, resistant to or are ineligible for a Janus Kinase (JAK) inhibitor.

Bomedemstat was recently granted PRIME (PRIority MEdicines) designation by the European Medicines Agency (EMA) for the treatment of MF. The EMA reviewed bomedemstat non-clinical and clinical data from the ongoing Phase 2 study. The PRIME initiative was launched by the EMA in 2016 to provide proactive and enhanced support to the developers of promising medicines with the view of accelerating their evaluation to reach patients faster.

About Bomedemstat (IMG-7289)

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 therapeutic agents. Bomedemstat is an investigational agent currently being evaluated in ongoing clinical trials (ClinicalTrials.gov Identifier:
NCT03136185, NCT04262141, NCT04254978 and NCT04081220).

Bomedemstat has U.S. 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.

Bomedemstat is being evaluated in two open-label Phase 2 clinical trials for the treatment of advanced myelofibrosis (MF) and essential thrombocythemia (ET), bone marrow cancers that interfere with the production of blood cells. MF patients who are resistant to a Janus Kinase (JAK) inhibitor are eligible for the study of bomedemstat. ET patients who have failed one standard of care treatment are eligible for the bomedemstat ET study.

On November 30, 2020 Oasmia Pharmaceutical reported that it will publish its interim report for the second quarter of 2020 on December 9, 2020, at 08.00 am CET (Press release, Oasmia, NOV 30, 2020, View Source [SID1234571972]). The company will hold a conference call and an online presentation on the same day at 10.00 am CET. The call will be hosted by CEO Francois Martelet and Acting CFO Robert Maiorana. The presentation will be in English.

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On November 30, 2020 Shanghai Stock Exchange listed company HitGen Inc. ("HitGen") reported that it has entered into a research collaboration agreement with Cedilla Therapeutics, Inc. ("Cedilla"), a private biotechnology company developing targeted small molecules for the treatment of cancer and other diseases caused by protein dysregulation (Press release, HitGen, NOV 30, 2020, View Source [SID1234571994]). The companies will conduct joint research to identify and develop drug candidates directed to a validated, high-value target in oncology that has remained beyond the reach of previous efforts.

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HitGen is a world leading biotech company in DNA encoded library-screening, a high throughput compound screening technology, where more than 100,000 times larger libraries can be used than in traditional drug discovery. The platform thus enables faster identification of innovative drug candidates with improved target specificity and enhanced drug-like characteristics.

Pursuant to the terms of the collaboration agreement, HitGen has successfully applied its DEL technology and discovered program compounds that met certain criteria, and Cedilla has received an exclusive license to these compounds as well as associated IP for further development and commercialization. HitGen will be eligible for milestone payments and sublicensing income from Cedilla as the project progresses, in addition to research payments and upfront license fee.

"HitGen is a perfect partner for us in this program, with their cutting-edge DEL platform for screening. Their technology is well established and is now widely used by leading global pharmaceutical and biotech companies," said Dr. Alexandra Glucksmann, President and CEO of Cedilla. "With HitGen’s support, we are able to accelerate our ongoing efforts to pursue a breadth of high-value oncology targets that have eluded conventional therapeutic modalities. We are very pleased with the program compounds discovered by HitGen to date, are excited to advance these programs forward as we pursue our mission of delivering profound benefit to patients in areas of high unmet need."

"We are delighted to enter this collaboration with Cedilla, and believe their unique approach to identifying functionally-relevant proteoforms represents a powerful advance in how we think about treating diseases caused by protein dysregulation," said Dr. Jin Li, Chairman of the Board and Chief Executive Officer of HitGen. "We believe the collaboration will reinforce the role and reputation of HitGen’s platform in the rapidly developing field of DEL and further demonstrates the power of our DEL platform to discover novel small molecules against a variety of targets. We are working closely with Cedilla scientists and have seen early success towards generating new small-molecule lead compounds for their research programs to help bring transformative medicines to patients."

On November 30, 2020 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Robert M. Davis, chief financial officer and executive vice president, Merck Global Services, is scheduled to participate in a virtual fireside chat at the Evercore ISI 3rd Annual HealthCONx Conference on Dec. 2, 2020, at 9:40 a.m. EST (Press release, Merck & Co, NOV 30, 2020, View Source [SID1234571944]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at View Source