On October 10, 2018 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported that new data relating to its molecule WP1122 will be presented at the upcoming Society for Neuro-Oncology Annual Scientific Meeting (Press release, Moleculin, OCT 10, 2018, View Source [SID1234529841]).

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"We continue to make progress in the development of our inhibitor of glycolysis, WP1122," commented Dr. Donald Picker, Moleculin’s Chief Science Officer. "We believe that we have discovered new data during our IND-enabling research with animals that confirms a highly beneficial metabolism of WP1122 and significant organ accumulation of the inhibitor of glycolysis in the brain and also in the pancreas. This is especially significant because both brain and pancreatic tumors are highly dependent upon glucose for survival and WP1122 appears to have the ability to inhibit glycolysis, the process by which these tumors convert glucose into energy."

Walter Klemp, Moleculin’s Chairman and CEO added, "Metabolic inhibition of tumors is conceptually a very important approach, and we believe we have a clear translational focus. We have been pushing hard to prepare WP1122 for Investigational New Drug (IND) status. It is encouraging to have discoveries during this process that appear to confirm the initial premise and give us more hope that WP1122 could become an important new way to deal with difficult cancers like glioblastoma and pancreatic cancer."

The Society for Neuro-Oncology is a multidisciplinary organization dedicated to promoting advances in neuro-oncology through research and education. Now in its twenty fourth year, the Society continues to grow and mature as the premier North American organization for clinicians, basic scientists, nurses and other health care professionals whose focus is central nervous system tumors in children and adults. This year’s Annual Scientific Meeting will be held November 15 – 18, 2018 at the Marriott Hotel in New Orleans, Louisiana.

On October 10, 2018 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnémo: OSE) reported the submission of a clinical trial application to initiate a Phase 2 clinical trial of Tedopi in advanced or metastatic pancreatic cancer (Press release, OSE Immunotherapeutics, OCT 10, 2018, View Source [SID1234529889]). The trial will compare Tedopi, 10 neoepitopes associated to activate cytotoxic T-lymphocytes, in combination with nivolumab, an immune checkpoint inhibitor releaving the brakes that prevent optimal T lymphocyte activation versus maintenance standard of care treatment with Folfiri.

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The clinical trial application has been submitted in France to the ANSM (the French National Agency for Medicines and Health Products Safety) and to the central Ethics Committee by the oncology cooperative group GERCOR, who is sponsoring the clinical trial as part of PRODIGE intergroup. The Company expects activation of the trial and opening of clinical centers in early 2019.

The Phase 2 clinical trial, named TEDOPaM, aims to evaluate Tedopi as a maintenance therapy, alone or in combination with immune checkpoint inhibitor nivolumab, and evaluated versus Folfiri, a combination chemotherapy with folinic acid, fluorouracil and irinotecan and the standard of care. The study will be completed in HLA-A2 positive patients with stable disease who have received four months of first line standard-of-care chemotherapy Folforinox, a combination chemotherapy with folinic acid, fluorouracil, irinotecan and oxaliplatin.

"This new step marks the expansion of the development of Tedopi, already under evaluation in a Phase 3 study in advanced lung cancer, to an additional oncology indication, a particularly aggressive cancer for which new therapeutic options are strongly needed. With this new clinical development program evaluating Tedopi in combination with the PD-1 inhibitor nivolumab, a checkpoint inhibitor, in advanced pancreatic cancer, we are broadening our exploration of new pathwaysin immuno-oncology," commented Alexis Peyroles, chief executive officer of OSE Immunotherapeutics.

"The study’s rationale is based on the interest of a combination of immunotherapies that stimulate cytotoxic T-cells with Tedopi, whose antigens are overexpressed in pancreatic tumor, and a PD-1 checkpoint inhibitor nivolumab, whose preclinical data available to date in this cancer plead in favor of a combination with a neoepitope-type immunotherapy, likely to potentiate its activity. Our network of clinicians is now mobilizing to start this Phase 2 trial," concluded Professor Christophe Louvet, president of GERCOR.

Tedopi is a combination of 10 neoepitopes selected and optimized from five tumor associated antigens able to generate a specific response against cytotoxic T-cells expressing at least one of these tumor associated antigens and an associated helper T-cell response.

ABOUT GERCOR
GERCOR is an association of physicians whose purpose is to improve the care of patients affected by cancer by developing clinical research in the scope of an independent, multidisciplinary and multi-focused group. GERCOR
concentrates its efforts on only one mission: clinical research. Thanks to its network, GERCOR offers patients easy
access to its up-to-date treatments. To achieve this goal, GERCOR stimulates the inclusion into its network of the
greatest number of physicians involved in the treatments it is conducting, offers vital logistical assistance to research
physicians whose job is to direct and monitor the application of the treatments to patients.

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.