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Nascent Biotech Receives Clearance from FDA to Begin Phase I Human Trials in Brain 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."

Y-mAbs Therapeutics Announces FDA Clearance of IND for its Bispecific GD2 Antibody

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.

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."

Biogen to Report Fourth Quarter and Year-End 2018 Financial Results January 29, 2019

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]).

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

CohBar Appoints Philippe P. Calais, Pharm.D., Ph.D. as Interim Chief Executive Officer

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.

"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.

Multiple Oncotype DX Study Presentations at the 2018 San Antonio Breast Cancer Symposium Reinforce Real-world Value of the Oncotype DX Breast Recurrence Score® Test in Patients Regardless of Age or Race

On December 10, 2018 Genomic Health, Inc. (NASDAQ: GHDX) reported results from multiple Oncotype DX Breast Recurrence Score (RS) presentations at the 2018 San Antonio Breast Cancer Symposium (SABCS), reinforcing the value of the Oncotype DX test in optimizing treatment and outcomes in patients with both node-negative and node-positive early-stage breast cancer (Press release, Genomic Health, DEC 10, 2018, View Source [SID1234532003]).

Among the data presented at SABCS are two presentations from investigators involved in the landmark TAILORx (Trial Assigning IndividuaLized Options for Treatment (Rx)) trial, which provided independent analysis using the Oncotype DX test to gain further information about chemotherapy benefit across ethnic groups and chemotherapy effect on quality of life. Other presentations included the first report of long-term outcomes from the Surveillance, Epidemiology, and End Results (SEER) registry program of the National Cancer Institute (NCI) on early-stage patients with node-positive disease not treated with chemotherapy and the first study specifically focused on the Oncotype DX test in women less than 40 years of age.

"With the practice-changing results of TAILORx and new real-world evidence in more the 80,000 patients, the Oncotype DX test is being increasingly used in the United States and around the world to contribute to smarter cancer care and improved outcomes for breast cancer patients," said Steven Shak, M.D., chief scientific officer and chief medical officer, Genomic Health.

Independent Analyses Reinforce TAILORx Conclusions
As follow-up to the TAILORx results that were published by the ECOG-ACRIN Cancer Research Group in the New England Journal of Medicine in June 2018, Kathy S. Albain, M.D., FACP, professor of medicine, Loyola University Chicago Stritch School of Medicine, evaluated outcomes among patients of different races and/or ethnic backgrounds. These findings reported at SABCS reinforce the original TAILORx results, showing that chemotherapy in early-stage breast cancer can be safely avoided if the Recurrence Score result is less than 26 in women of all races/ethnicities, including Black, Hispanic and Asian women.

Results of a separate TAILORx sub-study, presented at SABCS by Lynne I. Wagner, Ph.D., professor, Social Sciences and Health Policy at Wake Forest School of Medicine, provide additional evidence regarding the negative impact of chemotherapy on patient quality of life. These results underscore the value of the Oncotype DX Breast Recurrence Score in avoiding unnecessary chemotherapy in the majority of patients with node-negative breast cancer.

Additionally, real-world evidence from a more than 80,000 patient study based on an analysis of data from the SEER registry program of the NCI reinforced findings from multiple clinical trials, including TAILORx, and confirmed that the Oncotype DX Breast Recurrence Score result is predictive of chemotherapy benefit in patients with node-negative disease (p=0.009), with no chemotherapy benefit with RS results less than 26. In patients with node-negative disease and RS results less than 26 not treated with chemotherapy, the Breast Cancer Specific Survival (BCSS) was greater than 96 percent at nine years. In patients with node-positive disease not treated with chemotherapy and RS results less than 18, BCSS was greater than 97 percent at nine years.

"The SEER nine-year real-world evidence supports the new TAILORx-defined paradigm for Recurrence Score-guided chemotherapy treatment using the cutoff of 26," said Gabriel N. Hortobagyi, M.D., FACP, program director, Department of Breast Medical Oncology, Division of Susan G. Komen Interdisciplinary Breast Fellowship Program, The University of Texas MD Anderson Cancer Center. "Importantly, these long-term SEER results also support the option of hormone therapy alone for patients with one to three positive nodes and an Oncotype DX Recurrence Score less than 18."

Finally, investigators at Dana-Farber led a multi-center study to prospectively analyze Oncotype DX test results in 500 young women with node-positive and node-negative breast cancer. The findings showed very good outcomes for those with a RS of 0 to 25 who were not treated with chemotherapy. These results provide further evidence of the unique value of the Oncotype DX test to guide chemotherapy treatment decision-making in early-stage breast cancer in patients age 40 or younger.

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company’s flagship product, the Oncotype DX breast cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. With more than 950,000 patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeDX.com or www.MyBreastCancerTreatment.org.