On December 10, 2018 Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company focused on the development and commercialization of female-specific oncology products, reported that the U.S. Food and Drug Administration (FDA) accepted the company’s Investigational New Drug (IND) application, indicating that Sermonix may proceed directly to a Phase 2 clinical study in the personalized medicine arena involving its lead investigational drug, lasofoxifene (Press release, Sermonix Pharmaceuticals, DEC 10, 2018, View Source [SID1234532259]).

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The open-label, randomized, multi-center study is expected to begin enrollment in early 2019 and will evaluate the activity of oral lasofoxifene versus intramuscular fulvestrant for the treatment of postmenopausal women with locally advanced or metastatic estrogen receptor-positive (ER+)/HER2- breast cancer with an ESR1 mutation.

"We are delighted the IND application was favorably reviewed by the FDA and brings us ever closer to delivering a novel endocrine treatment option for these women in great need," said Sermonix Chairman Dr. Anthony Wild. "This marks an important milestone in Sermonix’s effort to develop lasofoxifene as a precision medicine for women with advanced breast cancer."

A large amount of clinical data from earlier non-oncology development, along with new, compelling preclinical data have enabled Sermonix to commence directly into the Phase 2 study. The study will include postmenopausal women with ESR1 mutations, identified using a liquid biopsy clinical trial assay, who have progressed after aromatase inhibitor and CDK 4/6 inhibitor therapy. ESR1 mutations occur in up to 40 percent of women with metastatic breast cancer and may confer a worse prognosis and poor response to currently available endocrine treatments1.

"As ESR1 mutations are highly prevalent in ER+ metastatic breast cancer, we look forward to demonstrating lasofoxifene’s potential promise in this area of significant unmet medical need," said Dr. David Portman, Sermonix founder and chief executive officer. "Acceptance of the IND application allows us to maintain momentum in the important effort to bring lasofoxifene to patients who desperately need more options for this incurable disease, so we are thrilled to receive this news from the FDA."

1 Chandarlapaty S et al, JAMA oncology 2016 Oct 1;2(10):1310-1315)

About Lasofoxifene

Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed from Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and has been studied in previous comprehensive Phase 1-3 non-oncology clinical trials in more than 15,000 postmenopausal women worldwide.

Lasofoxifene’s binding affinity and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance and ESR1 mutations, a common mutation in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was recently discovered and Sermonix has exclusive rights to develop and commercialize it in this area. A potent, well-characterized and bioavailable SERM, lasofoxifene, if approved, could play a critical role in the personalized treatment of advanced ER+ breast cancer.

On December 10, 2018 Nascent Biotech, Inc. (OTC: NBIO) reported that it Received US Food and Drug Administration (FDA) Clearance to begin Phase 1 Clinical Trials effective December 7th, 2018 (Press release, Nascent Biotech, DEC 10, 2018, View Source [SID1234532016]).

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Nascent CEO Sean Carrick stated, "On Friday December 7, 2018, Nascent Biotech received a letter from the FDA moving the Company’s IND filing from Full Clinical Hold to Partial Clinical Hold, which frees the Company to immediately begin Phase 1 Human Clinical Trials with its present drug lot." "There are additional product testing criteria required by the FDA, which we believe are very achievable and have already begun to respond," stated Executive Vice President Dr. Brandon Price.

Nascent founder, Dr. Mark Glassy, commented, "It is gratifying that the FDA will allow Nascent to test the value of Pritumumab in the treatment of advanced brain cancer – a disease with few treatment options and very poor outcomes."

On December 10, 2018 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer reported that the U.S. Food and Drug Administration ("FDA") has cleared the Investigational New Drug ("IND") application for a humanized bispecific GD2 antibody (Press release, Y-mAbs Therapeutics, DEC 10, 2018, View Source [SID1234532006]). It is anticipated that a Phase 1/2 clinical trial will soon be initiated to begin screening patients with relapsed/refractory neuroblastoma, high grade osteosarcoma and other GD2(+) solid tumors, where patients have relapsed or refractory disease that is resistant to standard therapy.

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This bispecific product candidate is a fully humanized IgG-scFv format antibody, licensed by Memorial Sloan Kettering to Y-mAbs, in which the anti-CD3 scFv is linked to naxitamab IgG1 and the Fc region is mutated to help prevent cytokine release as well as complement-mediated pain side effects. Y-mAbs expects that this bispecific GD2 antibody may have potential advantages over other bispecific antibodies, such as improved potency due to bivalency, binding to neonatal Fc receptor and longer serum half-life, which obviates continuous infusion and enables more convenient administration to the patient.

Y-mAbs Founder, President and Head of Business Development and Strategy, Thomas Gad said, "This is a novel bivalent tumor targeting bispecific antibody for the treatment of GD2 positive solid tumors in both pediatric and adult cancers. We believe that these bispecific antibodies have the potential to overcome many of the limitations associated with existing bispecific constructs."

Dr. Claus Møller, Chief Executive Officer further notes, "I am excited to see this bispecific antibody make its way towards the clinic, to establish the safety profile and to determine the maximum tolerated dose."

On December 10, 2018 Biogen Inc. (Nasdaq:BIIB) reported it will report fourth quarter and year-end 2018 financial results Tuesday, January 29, 2019, before the financial markets open (Press release, Biogen, DEC 10, 2018, View Source [SID1234532005]).

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Following the release of the financials, the Company will host a live webcast with Biogen management from 8:00-9:00 am ET. To access the live webcast, please go to the investors section of Biogen’s website at View Source Following the live webcast, an archived version of the call will be available on the website

On December 10, 2018 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat age-related diseases, reported that it has appointed Philippe P. Calais, Pharm.D., Ph.D. as its interim Chief Executive Officer, effective December 7, 2018 (Press release, CohBar, DEC 10, 2018, View Source [SID1234532004]). Dr. Calais will continue to serve on the company’s Board of Directors, which he joined in June 2018. CohBar is currently engaged in search activities for a successor CEO, for which Dr. Calais is considered a leading candidate, as well as for an additional independent director to join CohBar’s Board.

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"We are very pleased that Philippe has agreed to contribute his extensive biopharmaceutical leadership experience to our management team at this important time for CohBar," said Albion J. Fitzgerald, Chairman of the Board of Directors. "We anticipate the coming year will be instrumental to the ongoing development of our lead clinical candidate, CB4211, for the treatment of NASH and obesity, as well as to the advancement of our preclinical pipeline of mitochondria based therapeutics targeting other large-population diseases with underlying metabolic dysfunction. We believe Philippe’s broad range of management experience and extensive therapeutic expertise, spanning all aspects of drug development, financing, partnering and commercialization, make him particularly well-suited to lead the company."

"On behalf of the Board, I would like to thank Simon Allen for his contributions and leadership during CohBar’s evolution to a clinical stage NASDAQ listed biotechnology company, and for his support through this transition," Mr. Fitzgerald concluded.

"I joined CohBar’s Board earlier this year with a firm belief in the potential of the company’s discoveries and intellectual property to be developed as mitochondria based therapeutics to improve clinical outcomes for large and growing patient populations suffering from age-related diseases," commented Dr. Calais. "My tenure as a director has strengthened my belief in the CohBar team’s ability to translate these discoveries into a new class of therapeutics for the potential benefit of patients and shareholders alike. I look forward to working with the management team to efficiently advance the company’s clinical and preclinical pipeline, while continuing to explore strategic partnership and funding opportunities."

Dr. Calais brings to the CohBar team more than 30 years of large and small-cap biopharmaceutical experience in product development and commercialization, partnerships, collaborations and financings. He most recently served as Chief Executive Officer of Isarna Therapeutics B.V., a developer of oligonucleotide therapeutics, where he led the company through a successful Phase 1 study of ISTH0036 in advanced glaucoma, and was responsible for a number of strategic licensing, partnering and asset sale transactions during his tenure. Prior to Isarna, Dr. Calais led several clinical stage biopharmaceutical companies in Canada and in Europe, and headed Univalor LTD, a large technology transfer organization focused on commercializing innovations from the University of Montreal. Earlier in his career, he had multiple roles of increasing responsibility over a ten year period at F. Hoffmann-La Roche, ultimately becoming Global Head of its Anti-Infectives, Dermatology and Anti-Fungals Business Unit, with direct responsibility over strategy, marketing, and licensing transactions. Dr. Calais received his bachelor’s degree in pharmacy and his doctor of pharmacy from the Université François-Rabelais in Tours, France.

Details for Conference Call

Date: December 11, 2018
Time: 5:00 p.m. Eastern Time

Dial-in U.S. and Canada: (800) 239-9838
Dial-in International: (323) 794-2551
Conference ID Number: 1003502
We kindly request that you call into the conference audio approximately 10 minutes before the start time so that we can begin promptly.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on December 11, 2018, through 11:59 p.m. Eastern Time on January 1, 2019. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 1003502. The audio replay will also be available at www.cohbar.com from December 11, 2018, through January 1, 2019.

About CB4211

CohBar’s lead program is based on CB4211, a first-in-class mitochondria based therapeutic (MBT) that has demonstrated significant therapeutic potential in preclinical models of nonalcoholic steatohepatitis (NASH) and obesity. CB4211 is a novel and improved analog of MOTS-c, a naturally occurring mitochondrial-derived peptide (MDP) which was discovered in 2012 by CohBar founder Dr. Pinchas Cohen and his academic collaborators and has been shown to play a significant role in the regulation of metabolism. In July 2018, CB4211 entered a Phase 1a/1b clinical trial which includes a potential activity readout relevant to NASH and obesity. In November 2018, the company announced the temporary suspension of the trial to address mild injection site reactions that were unexpectedly persistent. NASH has been estimated to affect as many as 12% of adults in the U.S., and there is currently no approved treatment for the disease.