On October 10, 2018 Hemispherx Biopharma, Inc. (NYSE American: HEB) reported the signing of a clinical trial agreement with Roswell Park Comprehensive Cancer Center to evaluate Ampligen in combination with checkpoint inhibitors (CPIs) (Press release, Hemispherx Biopharma, OCT 10, 2018, View Source [SID1234530604]). The Phase IIa clinical trial will evaluate the immune-mediated effects of cytokine modulation in combination with CPIs in patients with primary resistance to CPI therapy. The protocol will seek to evaluate the combination of Ampligen and CPIs in patients with advanced urothelial carcinoma, renal cell carcinoma and melanoma. Ampligen is the Company’s investigational immune-enhancing TLR3 agonist that has demonstrated a robust anti-cancer effect in preclinical models when combined with CPIs. This new agreement expands the extensive prior clinical and preclinical work into the clinical checkpoint blockade arena and offers the opportunity to begin evaluation of this combination therapy in patients with a variety of solid tumors where large numbers of patients do not respond or progress following treatment with standard CPI-based therapy.

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The Phase IIa study will be led by Pawel Kalinski, MD, PhD, Vice Chair for Translational Research and Professor of Oncology in the Department of Medicine and Co-Leader of the Tumor Immunology and Immunotherapy Program at Roswell Park, in collaboration with Mateusz Opyrchal, MD, PhD, of the Roswell Park Department of Medicine. Additional details about trial design, implementation and timing will be disclosed upon approval by Roswell Park’s institutional review board.

"This event marks an important milestone for Hemispherx as we evaluate Ampligen in combination with CPIs in difficult-to-treat solid tumors and among a patient population that is largely relapsed and/or refractory to treatment," said Thomas K. Equels, Chief Executive Officer of Hemispherx. "Our expanded collaboration with Roswell Park offers an ideal setting for these early stage trials. We have developed a productive working relationship with this world-class team and look forward to beginning these important clinical trials."

On October 10, 2018 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported that the company is scheduled to present at the 2018 BIO Investor Forum Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported that the company is scheduled to present at the 2018 BIO Investor Forum. The Forum will be held on October 17th and 18th at the Westin St. Francis Hotel in San Francisco, California.

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Jeff Wolf, Founder and Chief Executive Officer of Heat Biologics, will provide an overview of the Company’s business during the live presentation and will be available to participate in one-on-one meetings with investors who are registered to attend the forum.

Presentation Date: Wednesday, October 17, 2018
Time: 3:45 PM, PT
Location: Elizabethan A Room

. The Forum will be held on October 17th and 18th at the Westin St. Francis Hotel in San Francisco, California.

Jeff Wolf, Founder and Chief Executive Officer of Heat Biologics, will provide an overview of the Company’s business during the live presentation and will be available to participate in one-on-one meetings with investors who are registered to attend the forum.

Presentation Date: Wednesday, October 17, 2018
Time: 3:45 PM, PT
Location: Elizabethan A Room

On October 10, 2018 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained a supplemental approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) on October 10, 2018, for the anti-cancer agent, pertuzumab (brand name: PERJETA I.V. Infusion 420 mg/14 mL) for the indication of "neoadjuvant and adjuvant therapy for HER2-positive early breast cancer (Press release, Chugai, OCT 10, 2018, View Source [SID1234529941])." In Japan, PERJETA is currently on the market and its approved indication is in "HER2-positive inoperable or recurrent breast cancer." With this supplemental approval, the indication of PERJETA has been broadened to "HER2-positive breast cancer."

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"The ultimate goal for early breast cancer treatment is to cure. Although treatment outcomes have improved over the years, unfortunately, some patients still have recurrence of cancer. By offering a new treatment option for HER2-positive early breast cancer with this approval, we hope that PERJETA can make an even greater contribution to the advancement of breast cancer treatments," said Dr. Yasushi Ito, Chugai’s Executive Vice President, Co-Head of Project & Lifecycle Management Unit. "Chugai will continue to focus on collecting and providing information for the proper use of PERJETA against the treatment of HER2-positive breast cancer."

This approval is based on the results from the APHINITY study (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer), a global phase III study, and several clinical studies. The APHINITY study is a global phase III study evaluating the efficacy and safety of PERJETA plus Herceptin and chemotherapy (anthracycline medicine followed by docetaxel or paclitaxel / docetaxel plus carboplatin) compared to Herceptin and chemotherapy as adjuvant (post-surgery) therapy in 4,805 patients (including 302 patients in Japan) with HER2-positive early breast cancer who have undergone curative surgery. The primary endpoint of the APHINITY study is invasive disease-free survival (IDFS), which is the time a patient lives without return of invasive breast cancer at any site or death from any cause after adjuvant therapy. PERJETA arm significantly reduced the risk of recurrence or death by 19% compared to control arm (HR=0.81, 95%CI 0.66-1.00, stratified log-rank test, p=0.0446). The safety profile of PERJETA was consistent with that seen in previous studies.

PERJETA was approved for neoadjuvant therapy for HER2-positive early breast cancer in September 2013 in the US and in July 2015 in Europe. In addition, PERJETA was approved for adjuvant therapy for HER2-positive early breast cancer in December 2017 in the US and in May 2018 in Europe.

As the leading pharmaceutical company in the field of oncology in Japan, Chugai believes that PERJETA will make a significant contribution to patients’ lives as a new treatment option for "HER2-positive early breast cancer."

Drug Information

The underlined descriptions are newly added and changed.

Product name: PERJETA I.V. Infusion 420 mg/14 mL

Generic name: pertuzumab (genetical recombination)

Indication: HER2-positive breast cancer

Dosage and administration: The usual adult dosage when used in combination with trastuzumab (genetical recombination) and other anticancer drugs is a loading dose of 840 mg of pertuzumab (genetical recombination) followed by 420 mg every three weeks given by intravenous infusion over 60 minutes. For neoadjuvant or adjuvant chemotherapy, however, treatment should be given for up to 12 months. The infusion time can be shortened to as little as 30 minutes from the second infusion onward if the first infusion is well tolerated.

On October 10, 2018 Gotham Therapeutics, a biotechnology company developing a novel drug class targeting RNA-modifying proteins, reported with a $54 million Series A financing co-led by founding investor Versant Ventures, Forbion and S.R. One (Press release, Gotham Therapeutics, OCT 10, 2018, View Source [SID1234550889]). The syndicate also included Celgene Corporation and Alexandria Venture Investments. Gotham is part of New York’s rapidly growing biopharma community with a subsidiary at one of Europe’s leading life science clusters near Munich, Germany.

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Versant created and seeded Gotham based upon the seminal discoveries of co-founder Samie Jaffrey, M.D. Ph.D., a pioneer in an exciting new field within RNA metabolism called epitranscriptomics. Dr. Jaffrey is a professor of pharmacology at Weill Cornell Medicine and a member of the Scientific Advisory Board for Gotham Therapeutics. His work has shed light on the role of post-transcriptional mRNA modifications in health and disease. These modifications and their biological effects are driven by protein complexes commonly described and categorized as writers, erasers and readers of the epitranscriptomic code.

With its seed funding, Gotham built a platform to assess the impact of RNA-modifying proteins on disease biology and developed small molecules against priority targets. The Series A proceeds will allow Gotham to establish clinical proof of concept and to invest broadly in a pipeline of preclinical candidates that have potential to treat diseases intractable to classical approaches.

"As we pursue several important targets, the information we glean will help us further validate and build our platform for increasingly broad applications. Our goal is to become the leader in drugging key proteins that modulate mRNA functionality, thereby impacting disease onset and progression," said Lee Babiss, Ph.D., CEO of Gotham.

"While academic research and the pharmaceutical industry focused initially on modifications of DNA, a growing body of evidence indicates that mRNA modifications help determine to which degree genes are translated into proteins. RNA modifications and their associated protein complexes therefore represent an untapped frontier that could yield new therapeutic approaches," added Dr. Jaffrey.

Gotham has assembled an experienced founding team led by Dr. Babiss, former President of Pharma Research at Roche. Dr. Babiss is an early adopter of RNA drug discovery approaches who has a track record of translating discoveries into therapeutic candidates. He also has served as CSO of PPD, and as Head of Human Genetics and Personalized Healthcare at Glaxo Wellcome.

"After following the developments in the RNA drug discovery field for a number of years, we felt this was the right time to build a company that could capitalize on translating the scientific discoveries into a whole new class of drug candidates," said Carlo Rizzuto, Ph.D., Partner at Versant. "With our initial investment, the Gotham team constructed a platform able to validate critical links between specific types of RNA modifications and disease biology. We look forward to advancing a number of drug candidates with this new round of financing."

"We are excited to invest in Gotham, one of the pioneers in the fast-emerging field of RNA metabolism, which could create a paradigm shift in both cancer therapy and other major diseases," commented Holger Reithinger, Ph.D., General Partner at Forbion. "Gotham represents the first investment by our recently announced Forbion IV fund. Our new fund aims to help build leading companies around exciting new science, proven teams or in-licensed assets."

Dr. Reithinger will join Dr. Babiss, Dr. Rizzuto and Jill Carroll, Principal, SR One, on Gotham’s Board of Directors. Jorge DiMartino M.D., Ph.D., Vice President, Translational Development Oncology at Celgene and Head of Celgene’s Epigenetics Thematic Center of Excellence, has joined the board in an observer role.

On October 10, 2018 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that it will hold its third-quarter 2018 sales and earnings conference call with institutional investors and analysts at 8:00 a.m. EDT on Thursday, Oct. 25 (Press release, Merck & Co, OCT 10, 2018, View Source [SID1234529843]). During the call, company executives will provide an overview of Merck’s performance for the quarter.

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Investors, journalists and the general public may access a live audio webcast of the call on Merck’s website at View Source A replay of the webcast, along with the sales and earnings news release and supplemental financial disclosures, will be available at www.merck.com.

Institutional investors and analysts can participate in the call by dialing (706) 758-9927 or (877) 381-5782 and using ID code number 2169459. Members of the media are invited to monitor the call by dialing (706) 758-9928 or (800) 399-7917 and using ID code number 2169459. Journalists who wish to ask questions are requested to contact a member of Merck’s Media Relations team at the conclusion of the call.