On May 17, 2021 Refuge Biotechnologies, Inc. ("Refuge"), a synthetic biology company developing intelligent cell therapeutics for cancer immunotherapy, and The University of Texas MD Anderson Cancer Center reported a strategic collaboration to advance new cell therapies for potential treatment of solid tumors (Press release, Refuge Biotechnologies, MAY 17, 2021, View Source [SID1234580119]). The agreement pairs Refuge’s innovative technologies with the experience and industrial capabilities of MD Anderson’s Biologics Development platform, within the Therapeutics Discovery division.

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Under the agreement, MD Anderson will possess exclusive rights to apply Refuge’s proprietary platform for next-generation cell engineering to its tumor infiltrating lymphocyte (TIL) programs. MD Anderson also will co-develop Refuge’s RB-340, a HER-2 targeted CAR T-cell therapy with context dependent inducible down-regulation of PD-1, including Investigational New Drug (IND) filing, Good Manufacturing Practice (GMP) production and Phase I/II clinical trials.

"MD Anderson has extensive expertise in developing and manufacturing innovative cell therapies, including groundbreaking work with TILs," said Bing Wang, Ph.D., chief executive officer and co-founder of Refuge Biotechnologies. "We look forward to working closely with MD Anderson researchers to apply our technology to this promising field of research, while also advancing development of our lead intelligent cell therapy program."

Using Refuge’s platform for programming cells to selectively react to tumor cells through direct modulation of gene expression utilizing CRISPR interference and activation, RB-340 is designed to conditionally and smartly down-regulate expression of PD-1 on approaching tumor cells, reducing T cell exhaustion and increasing T cell persistence and proliferation, thus creating better efficacy against solid tumors. Treatment with RB-340 in preclinical models has shown a clear survival benefit compared to conventional CAR T-cell therapy. IND filing is anticipated in the first half of 2022, with clinical development of RB-340 focused in solid tumors.

Through its Biologics Development platform, MD Anderson is advancing research into therapeutic applications for TILs – naturally occurring lymphocytes that can recognize cancer cells and penetrate a tumor. MD Anderson and Refuge will explore the use of Refuge’s platform to engineer TILs for enhanced anti-tumor activity.

"It is my belief that TILs are poised for a significant impact in the field of cancer therapy, and engineering improved TILs is a vital part of advancing this modality," said Jason Bock, Ph.D., vice president of Therapeutics Discovery and head of Biologics Development at MD Anderson. "We have been encouraged by the data coming from Refuge’s applications of its next generation, context dependent and inducible cell engineering platform, and we look forward to incorporating its potential into our TIL programs."

MD Anderson’s Biologics Development platform is built around an experienced team focused on pioneering impactful biologic therapeutics, including antibodies and cell therapies. With a state-of-the-art GMP cell therapy manufacturing facility, the platform unites MD Anderson research with industrial therapeutic development.

On May 17, 2021 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported its financial results for the first quarter ended March 31, 2021 (Press release, CohBar, MAY 17, 2021, View Source [SID1234580118]).

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"I am excited about the potential of CohBar’s mitochondria based therapeutic programs to make a significant difference in the lives of patients," stated Dr. Joseph Sarret, Chief Executive Officer. "We look forward to the Phase 1b data from our trial of CB4211 for the treatment of NASH and obesity in early July 2021. In parallel, we are continuing to advance our preclinical pipeline, most notably initiating IND-enabling studies with CB5138-3 for fibrotic diseases, including IPF, putting us on track for our goal of having at least 2 clinical-stage programs in 2022."

First Quarter 2021 and Recent Highlights

Completed last subject visit in the Phase 1b stage of the clinical study of CB4211 under development for nonalcoholic steatohepatitis (NASH) and obesity: The ongoing study evaluates CB4211 in subjects with non-alcoholic fatty liver disease (NAFLD) and obesity with at least 10% liver fat. The primary endpoints are safety and tolerability, with a secondary endpoint of pharmacokinetics, and exploratory endpoints of changes in liver fat, body weight, and biomarkers relevant to NASH, obesity, and metabolic disease. The company expects to release topline data in early July 2021.
Nominated CB5138-3 as lead clinical candidate for Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic diseases and initiated IND-enabling activities: In March, the company announced the selection of CB5138-3 for advancement into IND-enabling activities, with the goal of starting clinical studies in 2022. In addition, the company is continuing to evaluate the efficacy of CB5138 Analogs in models of other fibrotic diseases.
Signed a Non-Clinical Evaluation Agreement (NCEA) with the National Institute of Allergy and Infectious Diseases (NIAID) to evaluate the potential of CB5064 Analogs for the treatment of COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS): In January, the company announced it will be utilizing the non-clinical and pre-clinical services program offered by the NIAID, a division of the National Institutes of Health (NIH). NIAID will be responsible for any study conducted under the NCEA, including an evaluation using the golden Syrian hamster SARS-CoV-2 model, which has been used in the assessment of other COVID-19 therapeutics.
Appointed Joseph J. Sarret, M.D., J.D. as Chief Executive Officer and Director: In April, the company announced the appointment of Joseph J. Sarret, M.D., J.D. as Chief Executive Officer and Director, effective May 3, 2021. Dr. Sarret is a seasoned executive with a track record of success in biotechnology.
Gained additional bank research coverage: Recently, Wall Street banks Aegis Capital and Maxim Group initiated coverage on CohBar and issued research reports on the company.
Founders’ Update

During the first quarter and subsequent period, CohBar’s founders, Dr. Pinchas Cohen, Dean of the USC Leonard Davis School of Gerontology, and Dr. Nir Barzilai, Director of the Institute for Aging Research at Albert Einstein College of Medicine, continued to present and publish on the study of mitochondrial science, aging and age-related diseases.

Dr. Cohen and his colleagues published three landmark papers on the role of MOTS-c in human health. The first, "MOTS-c is an exercise-induced mitochondrial-encoded regulator of age-dependent physical decline and muscle homeostasis," published in Nature Communication, outlined the exercise mimetic actions of MOTS-c, and described the fitness- and health-enhancing effects of this hormone. The second paper, entitled "MOTS-c reduces myostatin and muscle atrophy signaling," published in the American Journal of Physiology, described a key mechanism for MOTS-c action, namely its effect on suppressing the myokine myostatin in animal models, which has implications for possible utility in diseases like frailty and sarcopenia. The third paper, entitled "A pro-diabetogenic mtDNA polymorphism in the mitochondrial-derived peptide, MOTS-c," published in the journal Aging, described the effects of a mutation in the MOTS-c gene, found in up to 8% of Japanese, Koreans and Northern Chinese. This mutation results in a "bio-inactive" variant of MOTS-c that is unable to induce the insulin-sensitizing and weight-loss effects the "wild-type" form elicits in male animals. Men who carry this mutation have elevated levels of (inactive) MOTS-c, increased abdominal fat and an elevated risk for type-2 diabetes; this risk is further increased in the subset of these men who are also sedentary, providing additional support for the relationship between MOTS-c and exercise.

Dr. Barzilai was featured at several conferences related to aging, including the "Annual Aging Research and Drug Discovery 2020: From aging mechanisms to interventions" symposium and publication. In addition, he was featured at the National University of Singapore Yong Loo Lin School of Medicine’s Healthy Longevity series in a webinar titled "Age Later: Lessons for This Pandemic and the Next". Dr. Barzilai was a keynote speaker at the Annual International (bio)Medical Students Meeting (AIMS) Meeting and the Geneva Science and Diplomacy Anticipator. He was also a panelist on the "Living Healthily to 120 and Beyond" session at the Fifth International Vatican Conference.

First Quarter 2021 Financial Highlights

Cash and Investments: CohBar had cash and investments of $17.8 million as of March 31, 2021, compared to $21.0 million as of December 31, 2020. The cash burn for the quarter ended March 31, 2021, was approximately $4.2 million.

R&D Expenses: Research and development expenses were $2.7 million for the three months ended March 31, 2021, compared to $1.5 million in the prior year quarter. The increase in research and development expenses was primarily due to the investment in the company’s research programs focused on the continued development of its peptides, and an increase in clinical trial costs due to the timing of those expenses, partially offset by a decrease in stock-based compensation costs.

G&A Expenses: General and administrative expenses were $1.4 million for the three months ended March 31, 2021, compared to $1.8 million in the prior year quarter. The decrease in general and administrative expenses was primarily due to lower stock-based compensation costs.

Net Loss: For the three months ended March 31, 2021, net loss, which included $0.4 million of non-cash expenses, was $4.0 million, or $0.07 per basic and diluted share. For the three months ended March 31, 2020, net loss, which included $1.8 million of non-cash expenses, was $4.2 million, or $0.10 per basic and diluted share.
First Quarter Investor Call:

Date: May 17, 2021
Time: 5:00 p.m. ET (2:00 p.m. PT)

Conference Audio Only

Dial-in U.S. and Canada: (877) 451-6152
Dial-in International: (201) 389-0879
Conference ID No.: 13718702
An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on May 17, 2021, through 11:59 p.m. Eastern Time on June 7, 2021. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 13718702. The audio recording will also be available at www.cohbar.com during the same period. For this call there will not be a slide presentation

On May 17, 2021 Clovis Oncology, Inc. (NASDAQ:CLVS) reported that it has filed a prospectus supplement with the U.S. Securities and Exchange Commission ("SEC"), under which it may offer and sell, from time to time, shares of its common stock having an aggregate offering price of up to $75,000,000 million through an "at-the-market" equity offering program (the "ATM Program") (Press release, Clovis Oncology, MAY 17, 2021, View Source [SID1234580117]). The timing and amount of any sales will be determined by a variety of factors considered by Clovis Oncology.

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Shares of Clovis Oncology common stock will be offered through J.P. Morgan Securities LLC ("JPM") and BofA Securities, Inc. ("BofA Securities"), who are serving as the distribution agents. JPM and BofA Securities may sell the shares of our common stock by any method deemed to be an "at-the-market offering" defined by Rule 415(a)(4) of the Securities Act of 1933, as amended, including without limitation, sales in ordinary brokers’ transactions, including directly on the Nasdaq Global Select Market or into any other existing trading market for the shares, or to or through a market maker, in block transactions or by any other method permitted by law, including negotiated transactions and to JPM and BofA Securities as principals for their own account. Sales may be made at market prices prevailing at the time of a sale or at prices related to prevailing market prices or at negotiated prices. As a result, sales prices may vary.

Clovis Oncology intends to use the net proceeds from any sales of its common stock under the ATM Program for general corporate purposes, including funding of its development programs, sales and marketing expenses associated with Rubraca (rucaparib), repayment, repurchase or refinance of its debt obligations, payment of milestones pursuant to its license agreements, general and administrative expenses, acquisition or licensing of additional product candidates or businesses and working capital.

Clovis Oncology’s prospectus supplement filed today with the SEC supplements information contained in the accompanying prospectus contained in the shelf registration statement on Form S-3 (File No. 333-253485), as amended for the offering. Prospective investors should read the prospectus in that registration statement, the prospectus supplement and all other documents that Clovis Oncology has filed with the SEC for more complete information about Clovis Oncology, including information pertaining to the ATM Program and the risks associated with investing in Clovis Oncology. Copies of the prospectus supplement and related prospectus may be obtained from J. P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email to [email protected], or from BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte NC 28255-0001, Attn: Prospectus Department or by email to [email protected]. You may also obtain these documents free of charge when they are available by visiting EDGAR on the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On May 17, 2021 Cernostics (View Source) a pioneer in delivering spatialomics to the clinic, reported that new results from clinical studies on the TissueCypher Barrett’s Esophagus Assay will be presented at Digestive Disease Week (DDW) 2021 taking place May 21-23 (Press release, Cernostics, MAY 17, 2021, View Source;utm_medium=rss&utm_campaign=digestive-disease-week-2021-to-showcase-the-tissuecypher-barretts-esophagus-assay [SID1234580116]).

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Clinical studies by Mayo Clinic, and Academic Medical Center in The Netherlands, two of the world’s leading academic institutions in the area of diagnosis and treatment of Barrett’s esophagus (BE) and esophageal cancer prevention, will be presented during the oral lecture session focused on predicting progression to esophageal cancer in patients with BE.

"New data accepted for presentation at this year’s DDW point to the value of TissueCypher for improving prevention of esophageal cancer, particularly to help physicians and patients make more informed management decisions based on the unique biology of individual patients’ esophageal biopsies," said Mike Hoerres, Cernostics’ chief executive officer. "We believe such data demonstrate the value of precision medicine testing with the TissueCypher Barrett’s Esophagus Assay, and greatly appreciate the Barrett’s esophagus clinical experts who led and participated in these studies."

Below are the details of the presentations on TissueCypher at DDW 2021:

TissueCypher Objectively Risk Stratifies Barrett’s Esophagus Patients with Low Grade Dysplasia (lecture presentation)

Presenter: Nicola Frei, MD (AMC, Amsterdam, Netherlands)

Session Title: Prediction of Progression in Barrett’s Esophagus

Session Date/Time: May 21, 2021, 10:00 AM to 11:30 AM EDT (UTC –4)

Prediction of Progression in Barrett’s Esophagus Using a Tissue Systems Pathology Test: A Pooled Analysis of International Multicenter Studies (lecture presentation)

Presenter: Prasad Iyer, MD (Mayo Clinic)

Session Title: Prediction of Progression in Barrett’s Esophagus

Session Date/Time: May 21, 2021, 10:00 AM to 11:30 AM EDT (UTC –4)

The AMC study, led by Professor Jacques Bergman, MD, PhD, evaluated the performance of the TissueCypher Barrett’s Esophagus Assay versus the independent scoring of expert and generalist pathologists in the USA and Europe in a cohort of 155 patients previously diagnosed with Low-Grade Dysplasia (LGD) in the community practice setting. TissueCypher demonstrated higher sensitivity and provided more objective risk stratification than the 12 participating pathologists, as well as identified a subset of progressor patients who had been down-staged to Non-dysplastic BE (ND BE) upon expert review.

The Mayo Study, led by Dr Prasad Iyer, MD, analyzed four independent clinical validation studies (475 patients, including 152 progressors) to assess the performance of TissueCypher in independently predicting incident progression. The results demonstrated TissueCypher outperformed the expert pathologist as well as commonly-used clinical variables in risk stratifying patients for progression. Importantly, this study also demonstrated that TissueCypher can identify high-risk progressor patients diagnosed with ND BE, and therefore can be missed by the standard of care.

Due to the dangers of esophageal cancer and the challenges in identifying those patients who will likely progress to it, the management of Barrett’s esophagus and predicting progression are two of the major Education Tracks in DDW 2021. Objectively and accurately predicting progression from ND BE to High-Grade Dysplasia (HGD) or esophageal adenocarcinoma (EAC) is critical as the incidence of esophageal cancers is growing at one of the fastest rates of all cancers, and once diagnosed, has extremely low survivability.

About Cernostics and TissueCypher Barrett’s Esophagus Assay

Cernostics applies spatial biology and biologically aware AI to tissue diagnostics, delivering precision diagnostic testing to patients and gastroenterologists. This technology was used to develop the TissueCypher Barrett’s Esophagus Assay, the world’s first precision medicine test that predicts future development of esophageal cancer in patients with Barrett’s esophagus. TissueCypher is a proprietary Laboratory Developed Test (LDT) with its own unique CPT PLA code (0108U), available only from Cernostics’ CLIA-certified pathology laboratory. TissueCypher has been on the Medicare Clinical Laboratory Fee Schedule since January 2021.

On May 17, 2021 Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare and orphan diseases, reported that members of its senior management team will participate in three upcoming virtual investor conferences (Press release, Cerecor, MAY 17, 2021, View Source [SID1234580115]).

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2021 RBC Capital Markets Global Healthcare Virtual Conference
Date: Tuesday, May 18, 2021
Time: 8:35 AM ET

Oppenheimer Rare & Orphan Disease Summit
Date: Friday, May 21, 2021
1×1 meetings only

Jefferies Virtual Healthcare Conference
Date: Wednesday, June 2, 2021
Time: 1:00 PM ET

A live webcast of the presentation at the 2021 RBC Capital Markets Global Healthcare Virtual Conference and the Jefferies Virtual Healthcare Conference can be accessed under the "News/Events" page in the Investors section of the Company’s website at www.cerecor.com.