On January 19, 2021 EDAP TMS SA (Nasdaq: EDAP) ("the Company"), the global leader in robotic energy based therapies, reported that Marc Oczachowski, President and CEO, will participate in a fireside chat at the B. Riley Securities Virtual Oncology Investor Conference on Wednesday, January 20, at 10:00 a.m. ET (Press release, EDAP TMS, JAN 19, 2021, View Source [SID1234574106]).

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An audio webcast of the presentation will be available on replay on the "Events and Presentations" section of the EDAP’s investor website, View Source The replay of the webcast will be available on the Company’s website for 90 days.

On January 19, 2021 Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancer, reported the online publication of an article in Nature Medicine, Volume 27, Issue 2, February, 2021, entitled: "The Androgen Receptor is a Tumor Suppressor in Estrogen Receptor-Positive Breast Cancer" (View Source or DOI # 10.1038/s41591-020-01168-7) by an international team headed by Drs (Press release, Veru, JAN 19, 2021, View Source [SID1234574197]). Theresa Hickey and Wayne Tilley at the University of Adelaide in collaboration with scientists at the Garvan Institute of Medical Research in Australia.

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In the Nature Medicine publication, Dr. Hickey and colleagues provide scientific evidence supporting a new discovery in breast cancer demonstrating that the androgen receptor acts like a tumor suppressor. Using human cell line and patient derived breast cancer models, they demonstrate that androgen receptor activation by androgens and enobosarm, a selective androgen receptor agonist, had potent antitumor activity in all ER positive breast cancer preclinical models tested including those that have become resistant to estrogen receptor targeted endocrine therapy as well as CDK 4/6 inhibitors, which are standard of care treatments for advanced, ER+ breast cancer. Further, enobosarm, by activating the androgen receptor, has demonstrated antitumor activity in both estrogen receptor targeted endocrine therapy resistant and CDK4/6 inhibitor resistant metastatic human breast cancer models. In contrast, androgen receptor inhibitors, like enzalutamide, had no effect. This study clears up the confusion in the scientific field regarding the role that the androgen receptor is playing in ER+ breast cancer.

"We provide compelling new experimental evidence that androgen receptor activating drugs, like enobosarm, can be more effective than existing (e.g., Tamoxifen) or new (e.g., Palbociclib) standard-of-care treatments and, in the case of the latter, can be combined to enhance growth inhibition. Moreover, enobosarm as a selective androgen receptor activating agent lacks the undesirable masculinizing side effects of natural androgens and has potential additional clinical benefits in women including promotion of bone, muscle and physical function, and mental health," said Professor Wayne Tilley, Director of the Dame Roma Mitchell Cancer Research Laboratories, and Associate Professor Theresa Hickey, Head of the Breast Cancer Group, who led the Nature Medicine study.

"This important new work establishes that the androgen receptor is a tumor suppressor and that enobosarm, as an AR targeted agent, has anti-tumor activity not only in AR+ ER+ metastatic breast cancer that has become resistant to estrogen receptor targeted endocrine and CDK4/6 inhibitor treatments, but also that enobosarm in combination with a CDK4/6 inhibitor (e.g. Palbociclib) restores CDK4/6 inhibitor sensitivity in ER+ breast cancer that has become resistant to CDK4/6 inhibition," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. "I would like to congratulate Dr. Tilley and his international team for this landmark study which provides deep scientific evidence for the novel therapeutic approach Veru has taken to address estrogen receptor targeted endocrine therapy and CDK4/6 inhibitor resistance in patients with AR+ ER+ metastatic breast cancer. We are excited to be advancing enobosarm, our AR activating targeted agent, into a Phase 3 registration ARTEST clinical trial scheduled for next quarter."

Enobosarm is an oral, first-in-class, new chemical entity, selective androgen receptor targeting agonist that activates the androgen receptor in AR+ER+HER2- metastatic breast cancer without unwanted masculinizing side effects and has potentially beneficial effects including increase in muscle mass and physical function and the promotion of bone strength and healing. Enobosarm is the first new class of targeted endocrine therapy for advanced breast cancer in decades. Last quarter the FDA agreed to the ARTEST Phase 3 registration clinical trial design to evaluate the efficacy and safety of enobosarm, a selective androgen receptor targeted agent, versus physician’s choice of either exemestane or tamoxifen as an active comparator for the treatment of metastatic ER+/HER2- breast cancer in approximately 240 patients who have failed a nonsteroidal aromatase inhibitor (anastrozole or letrozole), fulvestrant, and a CDK4/6 inhibitor. The primary endpoint is radiographic progression-free survival.

On January 19, 2021 Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (NYSE: LLY), and Merus N.V. (NASDAQ: MRUS), a clinical-stage oncology company developing multi-specific antibodies, reported a research collaboration and exclusive license agreement that will leverage Merus’ proprietary Biclonics platform along with the scientific and rational drug design expertise of Loxo Oncology at Lilly to research and develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies (Press release, Eli Lilly, JAN 19, 2021, View Source [SID1234574091]).

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Under the terms of the agreement, Merus will lead discovery and early stage research activities while Loxo Oncology at Lilly will be responsible for additional research, development and commercialization activities. Merus will receive an upfront cash payment of $40 million, as well as an equity investment by Lilly of $20 million in Merus common shares. Merus is also eligible to receive up to $540 million in potential development and commercialization milestones per product, for a total of up to approximately $1.6 billion for three products, as well as tiered royalties ranging from the mid-single to low-double digits on product sales should Lilly successfully commercialize a therapy from the collaboration.

"CD3-engaging bispecific antibodies are rapidly becoming one of the most transformative immune-modulating modalities used to treat cancer. We expect these therapies will become an important component of the Loxo Oncology at Lilly biologics strategy," said Jacob Van Naarden, chief operating officer of Loxo Oncology at Lilly. "Merus has built a differentiated platform and one that we believe can enable us to create bispecific antibody therapies with wider therapeutic indexes than those available today. We look forward to working closely with Merus to develop new potential medicines for patients with cancer."

"The collaboration with Loxo Oncology at Lilly and their world class research capabilities opens up exciting possibilities for Merus’ Biclonics platform," said Bill Lundberg, MD., President and Chief Executive Officer at Merus. "Our CD3 T-cell engager platform includes over 175 novel and diverse anti-CD3 common light chain antibodies across a wide range of affinities and attributes and enables functional screening of large libraries for optimal performance. We look forward to working together with Loxo Oncology at Lilly to define a new generation of medicines to treat cancer."

This transaction is subject to customary closing conditions. This transaction will be reflected in Lilly’s reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP). There will be no change to Lilly’s 2021 non-GAAP earnings per share guidance as a result of this transaction.

On January 19, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that senior leadership plans to present at the following virtual healthcare conferences (Press release, Iovance Biotherapeutics, JAN 19, 2021, View Source [SID1234574107]):

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B. Riley Oncology Investor Conference
Date/Time: Wednesday, January 20, 2021 at 1:00 p.m. ET
The live and archived webcast of the presentation will be available in the Investors section of the Iovance website at View Source
Guggenheim Healthcare Talks Oncology Days
Date/Time: Thursday, February 11, at 12:00 p.m. ET
The live and archived webcast of the presentation will be available in the Investors section of the Iovance website at View Source
7th Annual Immuno-Oncology 360° Conference – Event Information
Panel Title: Biotech CEO Leadership on the Business and Science of Cell and Gene Therapy
Date/Time: Tuesday, February 23, at 11:10 a.m. ET

Presentation Title: Tumor Infiltrating Lymphocyte Cell Therapy for Treatment of Solid Tumors
Date/Time: Tuesday, February 23, at 1:45 p.m. ET

On January, 19, 2021 miRagen Therapeutics, Inc. (NASDAQ: MGEN), a development-stage biotechnology company, reported its name change to Viridian Therapeutics, Inc. ("Viridian") (Press release, Viridian Therapeutics, JAN 19, 2021, View Source [SID1234639899]). Beginning tomorrow, Viridian will trade on NASDAQ under the ticker symbol "VRDN" and its common stock will trade under a new CUSIP number, 92790C104.

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The Company also announced today the appointment of Jonathan Violin, Ph.D., M.B.A. as President and Chief Executive Officer (CEO) and member of the Board of Directors. Dr. Violin, who previously served as Viridian’s President and Chief Operating Officer (COO), succeeds Lee Rauch as CEO and member of the Board of Directors. Ms. Rauch will remain as strategic advisor for the Company.

In addition, Viridian appointed internationally recognized neuro-ophthalmologist, Barrett Katz M.D ., M.B.A., as Chief Medical Officer (CMO). Dr. Katz comes to Viridian from BridgeBio Pharma, Inc. where he developed therapeutics to treat orphan eye diseases.

"The leadership team changes and Viridian Therapeutics name reflect the continuing evolution of the company and our patient-centric model of innovation," said Dr. Violin. "We’re leveraging proven biology and technology to efficiently allocate research and development resources, while addressing strategic gaps related to access, delivery, quality of life, and efficacy. We are thrilled to attract someone with Dr. Katz’s depth of expertise in serving patients and leading scientific and clinical programs."

During his tenure at BridgeBio, Dr. Katz held leadership positions in two subsidiaries, as President and CMO of Retinagenix and CEO of Fortify Therapeutics. Prior to BridgeBio, he was CMO at GenSight Biologics where he oversaw early- and late-stage clinical programs. He held the Francis DeJur Chair of Ophthalmology at the Montefiore Medical Center and Albert Einstein College of Medicine in New York , where he also served as Professor of Ophthalmology, Neurology and Neurosurgery, as well as the Executive Director of the Office of Clinical Trials . He previously served as CEO of Danube Pharmaceuticals , CMO of Fovea Pharmaceuticals and VP for Medical Affairs and Strategy at Eyetech. Dr. Katz received an M.D. from Case-Western Reserve University School of Medicine , an M.B.A. from the University of Rochester’s Simon School of Business , and an A.B. from Colgate University .

Prior to co-founding privately held Viridian Therapeutics, Dr. Violin had founded and served as CEO of two virtual drug discovery companies, Quellis Biosciences and Dianthus Therapeutics, and co-founded and held several executive positions at Trevena, Inc. He holds a Ph.D. in biomedical sciences from the University of California San Diego School of Medicine , an M.B.A. from the Fuqua School of Business at Duke University , and a B.S. from Duke University .

Viridian is developing multiple product candidates to treat patients who suffer from thyroid eye disease (TED), a debilitating orphan disease that can cause bulging eyes, or proptosis, as well as double vision and potential blindness. TED significantly impacts quality of life, imposing a high physical and mental burden on patients. There is currently one Food and Drug Administration (FDA)-approved treatment for TED, an intravenously administered monoclonal antibody that targets the insulin-like growth factor-1 receptor (IGF-1R).

"Patients with TED have limited treatment options," said Dr. Katz . "Viridian has a clear and compelling strategy to better serve these patients. I am delighted to help build upon the Company’s recent momentum and eager to design and implement robust clinical programs for our lead product candidates."

Viridian’s most advanced product candidate is VRDN-001, an intravenously administered anti-IGF-1R monoclonal antibody which, the Company expects to proceed directly to a phase 2 trial, pending feedback from the FDA. In October, the Company obtained exclusive worldwide rights from ImmunoGen, Inc. to develop and commercialize VRDN-001 for all non-oncology indications that do not use radiopharmaceuticals, including the treatment of TED.

VRDN-002 is the Company’s second-generation product candidate, incorporating half-life extension technology, and is intended for subcutaneous administration. Viridian holds exclusive rights to develop and commercialize antibody therapeutics targeting IGF-1R using the Xtend TM half-life extension technology developed and owned by Xencor, Inc.

In the second half of 2021, Viridian expects to file Investigational New Drug (IND) applications for both VRDN-001 and VRDN-002.