On August 26, 2020 CohBar, Inc. (NASDAQ: CWBR) (the "Company"), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported the pricing of an underwritten public offering of 12,300,000 units at a price to the public of $1.22 per unit (Press release, CohBar, AUG 26, 2020, View Source [SID1234564049]). Each unit consists of one share of the Company’s common stock and one warrant to purchase 0.75 of a share of common stock at a per share exercise price of $1.44. Each warrant will be exercisable for five years from the closing date of the offering. The aggregate gross proceeds from this offering are expected to be approximately $15.0 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The offering is expected to close on or about August 28, 2020, subject to customary closing conditions. The Company has also granted the underwriters a 30-day option to purchase up to an additional 1,845,000 shares of common stock and/or warrants to purchase up to an additional 1,383,750 shares of common stock.

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Roth Capital Partners is acting as sole book-running manager for the offering and Brookline Capital Markets, a division of Arcadia Securities, LLC, and WBB Securities are acting as co-managers.

CohBar intends to use the net proceeds from the offering, together with its existing cash resources, for general corporate purposes, which may include funding preclinical and clinical development of its peptides, increasing working capital, operating expenses and capital expenditures.

The securities will be issued pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission (SEC) on November 22, 2017. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Roth Capital Partners, 888 San Clemente, Newport Beach, CA 92660, Attn: Prospectus Department, telephone: 800-678-9147.

This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction. Any offer, if at all, will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

On August 26, 2020 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapy, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported that data from two Phase 2 trials of balstilimab alone and in combination with zalifrelimab will be presented in an oral presentation at the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Conference on September 18, 2020 (Press release, Agenus, AUG 26, 2020, View Source [SID1234564048]).

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Data will be presented by Dr. David O’Malley, Professor of Obstetrics and Gynecology at The Ohio State University College of Medicine and the Director of the Division of Gynecologic Oncology at the James Cancer Hospital of The Ohio State University Comprehensive Cancer Center. Agenus remains on track to initiate rolling BLA submission for balstilimab monotherapy this quarter. Agenus also plans to have a completed data packet supporting BLA submission of balstilimab in combination with zalifrelimab by the end of this year.

Abstract title: Single-agent Anti-PD-1 Balstilimab or in Combination with Anti-CTLA-4 Zalifrelimab for Recurrent/Metastatic (R/M) Cervical Cancer (CC). Preliminary Results of Two Independent Ph2 Trials [LBA34]

Session: Gynaecological cancers

Date: September 18, 2020

On August 26, 2020 MD Anderson reported that Phase I/II trial finds targeted therapy effective in heavily pretreated patients and those with brain metastases (Press release, MD Anderson, AUG 26, 2020, View Source,researchers%20from%20The%20University%20of [SID1234564045])

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For patients with non-small cell lung cancers (NSCLC) marked by RET gene fusions, the targeted therapy selpercatinib was well tolerated and achieved durable objective responses, or tumor shrinkage, in the majority of participants in the Phase I/II LIBRETTO-001 trial, according to researchers from The University of Texas MD Anderson Cancer Center.

Among previously untreated patients, the objective response rate (ORR) was 85%, and those receiving at least prior platinum-based chemotherapy had an ORR of 64%. For patients with brain metastases, there was a 91% ORR in the brain.

Results from LIBRETTO-001, published today in the New England Journal of Medicine, led to the approval of selpercatinib in May by the Food and Drug Administration for RET-altered lung and thyroid cancers.

"Genome-guided precision oncology has altered the landscape of multiple kinase-driven tumors, with lung cancer being the poster child. However, we previously did not have any drug approved specifically for RET-fusion positive non-small cell lung cancer," said senior author Vivek Subbiah, M.D., associate professor of Investigational Cancer Therapeutics. "Moving from the first-in-human Phase I trial to FDA approval in less than three years is a testament to the fact that patients benefited a great deal from this treatment and had no effective options."

Evaluating selective RET inhibitor to answer significant unmet need

RET fusions occur when a portion of the chromosome containing the RET gene breaks and rejoins with another piece of chromosome, creating a fusion protein capable of fueling cancer growth. RET alterations occur in roughly 2% of NSCLC, 10-20% of papillary thyroid cancers (PTC) and the vast majority of medullary thyroid cancers (MTC). Up to half of all RET fusion-positive cancers metastasize to the brain.

Several targeted therapies, such as cabozantinib and vandetanib, have ancillary activity against RET alterations, but clinical trials found that NSCLC patients saw only limited benefit from these drugs, explained Subbiah, who is co-principal investigator of the trial.

The study reports findings from 144 patients with advanced NSCLC enrolled on the open-label, international trial. The primary endpoint was ORR assessed by an independent review committee, and secondary endpoints included safety, intracranial response, duration of response, and progression-free survival (PFS). Results from investigator assessments were not significantly different from that of independent reviewers.

The trial included previously untreated patients (39) and patients having received at least platinum-based chemotherapy (105). Previously treated patients had a median of three prior lines of therapy, including immune checkpoint blockade in more than half. Across both cohorts, trial participants were 57.6% Caucasian, 32.6% Asian, 5.6% Black, 2.8% other and 1.4% unknown. The median age was 61, with women accounting for 58.3% and men 41.7% of participants.

Among previously treated patients, 2% had a complete response, 62% had a partial response and 29% had stable disease. The median duration of response was 17.5 months and 63% of responses were ongoing at a median follow-up of 12 months. Median PFS was 16.5 months.

In previously untreated patients, 85% had a partial response and 10% had stable disease. At six months, 90% of responses were ongoing, and neither median duration of response nor median PFS has been reached at the time of analysis.

On the study, 11 patients had measurable brain metastases. Ten of these patients (91%) saw an objective response in the brain, including three complete responses. The median duration of CNS response was 10.1 months.

The most common adverse events of grade 3 or higher were hypertension (14%), increased aminotransferase (13%), increased aspartate aminotransferase (10%), hyponatremia (6%) and lymphopenia (6%). Four patients discontinued selpercatinib treatment due to treatment-related adverse events.

Strong response also reported in patients with thyroid cancers

In additional cohorts of LIBRETTO-001, selpercatinib also showed activity in RET-altered thyroid cancers, including MTC with RET mutations and papillary/anaplastic thyroid cancers with RET fusions, with a similar safety profile.

Among patients with MTC, there was a 73% ORR in previously untreated patients and 69% ORR in those receiving prior targeted therapies. In patients with previously treated papillary/anaplastic thyroid cancer, the ORR was 79%. These data also were published today in New England Journal of Medicine, with Subbiah and Maria Cabanillas, M.D., professor of Endocrine Neoplasia and Hormonal Disorders, as co-senior authors.

"The data show these patients benefit from this treatment and it is safe compared with multi-kinase inhibitors and chemotherapy," said Subbiah. "The continued implementation of a robust molecular screening strategy in frontline lung and thyroid cancers with the ability to detect RET and other gene fusions will be critical for identifying patients who may benefit from specifically targeted therapies like selpercatinib."

The study was supported by Loxo Oncology, a wholly owned subsidiary of Eli Lilly. A full list of co-authors and disclosures can be found with the full paper here.

On August 26, 2020 IMV Inc. ("IMV" or the "Corporation") (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, reported that the IMV’s executive management team will participate at four upcoming virtual investor conferences in September (Press release, IMV, AUG 26, 2020, View Source [SID1234564044]):

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LD Micro 500 Virtual Event
Date: Tuesday, September 1, 2020
Presentation Time: 3:00 p.m. Eastern Daylight Time

2020 Wells Fargo Virtual Healthcare Conference
Date: Wednesday, September 9, 2020
Presentation Time: 8:00 a.m. Eastern Daylight Time

H.C. Wainwright: 22nd Annual Global Investment Conference
Date: Monday, September 14, 2020
Presentation Time: 10:00 a.m. Eastern Daylight Time

2020 Cantor Virtual Global Healthcare Conference
Date: Wednesday, September 16, 2020
Presentation Time: 8:40 a.m. Eastern Daylight Time

A live webcast of these presentations will be available under "Events, Webcasts and Presentations" in the investors section of IMV’s website and a replay will be available approximately one hour after the presentation. Afterwards, it will be available for approximately 30 days.

On August 26, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported the first patient has been dosed in the Company’s investigator-sponsored phase 2 study of pelareorep-anti-PD-1 combination therapy in unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) (Press release, Oncolytics Biotech, AUG 26, 2020, View Source [SID1234564043]). The study, known as IRENE, is co-sponsored by Oncolytics, the Rutgers Cancer Institute of New Jersey, and Incyte. Participants in the multi-center study receive pelareorep in combination with Incyte’s anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012).

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The recently announced IRENE study builds on prior clinical data showing pelareorep-induced priming of an adaptive immune response in multiple breast cancer subtypes. In addition to investigating the safety and efficacy of pelareorep-anti-PD-1 combination treatment in TNBC patients, the study will also evaluate changes in PD-L1 expression and correlations between treatment outcomes and peripheral T cell clonality, a previously identified biomarker of pelareorep response that may enable the success of future registrational trials by facilitating study design and patient selection. The trial will take place at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.

Principal investigator Mridula George, M.D., Medical Oncologist, Rutgers Cancer Institute of New Jersey and Assistant Professor of Medicine, Rutgers Robert Wood Johnson Medical School, commented, "The paucity of treatment options in metastatic triple-negative breast cancer combined with its aggressive clinical behavior results in a poorer prognosis when compared to other subtypes of breast cancer. This is an exciting study to evaluate the role of immunomodulation in the tumor microenvironment as a treatment option. I’m looking forward to getting this study underway to potentially make an impact in the lives of patients affected with metastatic triple-negative breast cancer."

For more information about the IRENE study, refer to ClinicalTrials.gov (NCT04445844).

About IRENE
The IRENE (INCMGA00012 and the oncolytic virus pelareorep in metastatic triple-negative breast cancer) study is a single-arm, open-label, phase 2 study evaluating the combination of pelareorep and INCMGA00012 for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer. The study will enroll 25 patients and will be conducted at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.
Study participants will receive pelareorep intravenously on days 1, 2, 15, and 16 of 28-day treatment cycles. INCMGA00012 will be administered on day 3 of each cycle, with treatment cycles continuing until disease progression is observed. The co-primary endpoints of the study are safety and objective response rate. Secondary endpoints include progression free survival, overall survival, and duration of response. Exploratory endpoints include peripheral T cell clonality and pre- vs. post-treatment change in tumor PD-L1 expression.

About Breast Cancer
Breast cancer is the most common cancer in women worldwide, with over two million new cases diagnosed in 2018, representing about 25 percent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 85 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women globally, with an estimated 522,000 deaths.

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The malignant tumor (cancer) is getting worse when the cells grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.