On November 18, 2019 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to support the initiation of a phase 1/1b clinical study of SRF617 (targeting CD39) (Press release, Surface Oncology, NOV 18, 2019, View Source [SID1234551411]). At an inaugural R&D day today, the Company will share progress across its portfolio including clinical development plans for SRF617 and SRF388 (IL-27), and preclinical data supporting its new development candidate, SRF813, which targets the recently identified checkpoint protein CD112R to promote natural killer (NK) and T cell activation.

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"We welcome this opportunity to dive into the compelling data underpinning our lead programs’ differentiated approaches to overcoming the immunosuppressive tumor microenvironment, as we work to break through and bring the benefits of immunotherapy to more patients suffering with cancer," said Jeff Goater, chief executive officer of Surface Oncology. "We look forward to furthering the incredible scientific work of our team with the initiation of our phase 1 clinical trials for both SRF617 and SRF388 in early 2020."

SRF617 is a fully human anti-CD39 antibody designed to promote anti-tumor immunity through a dual mechanism of reducing immunosuppressive adenosine and driving the extracellular accumulation of immunostimulatory ATP within the tumor microenvironment. Due to this dual mechanism, Surface Oncology believes CD39 is the most promising therapeutic target on the adenosine axis, a notable immunosuppressive pathway. The Company’s planned phase 1/1b study will evaluate SRF617 in patients with advanced solid tumors both as a monotherapy and in combination with other cancer therapies.

Surface Oncology also anticipates the filing of an IND for SRF388 before the end of 2019, with the subsequent initiation of a phase 1/1b clinical study in early 2020. The Company has identified particular tumor types, including hepatocellular and renal cell carcinoma, where IL-27 appears to play an important role in tumor progression. Furthermore, Surface Oncology has identified a potential biomarker associated with IL-27 that may be useful in helping identify patients most likely to respond to SRF388, which has the potential to be the first IL-27 targeted antibody to enter clinical trials.

"The Surface team is energized by the compelling preclinical datasets across our programs, and is excited about advancing SRF617 and SRF388 into clinical development," said Rob Ross, M.D., chief medical officer of Surface Oncology. "Both SRF617 and SRF813 have best-in-class potential related to targeting the adenosine axis and NK cells, respectively, and we believe SRF388 has the ability to inhibit the highly immunosuppressive cytokine IL-27, which gives it the potential to be a potent therapeutic. We look forward to providing clinical updates from the SRF388 and SRF617 programs in late 2020."

Surface Oncology’s preclinical data demonstrates that SRF813 increases NK and T cell activity, has strong, differentiated preclinical efficacy and promotes immunological memory. Currently, there are no

therapeutic strategies to overcome resistance to T cell checkpoint inhibitor blockade, and emerging data highlights the potential of NK cell-based therapies, such as SRF813, to overcome checkpoint inhibitor resistance.

Surface Oncology recently presented data from a number of its programs, including SRF388 and SRF617, at the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting in National Harbor, MD. These can be viewed on the Pipeline page of the Surface Oncology corporate website.

The R&D Day presentations and a live broadcast will be viewable from 8:15am ET at investors.surfaceoncology.com.

On November 18, 2019 Propanc Biopharma, Inc. (OTC: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, reported that the POP1 research and drug discovery program has made significant advancements towards producing synthetic versions of the two proenzymes, trypsinogen and chymotrypsinogen (Press release, Propanc, NOV 18, 2019, View Source [SID1234551410]). With the aim of producing large quantities of trypsinogen and chymotrypsinogen for commercial use, exhibiting minimal variation between lots and without sourcing the proenzymes from animals, the Company is undertaking a challenging research project in collaboration with the universities of Jaén and Granada, led by research scientist Mr. Aitor González, supported by Dr. Macarena Perán, Ph.D. and Dr. Julian Kenyon, M.D. as joint supervisors, representing the Universities and Propanc, respectively.

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"We are pleased with the recent advancements made through our research program, as we are able to produce synthetic recombinant versions of the two proenzymes, trypsinogen and chymotrypsinogen. The two active ingredients are currently naturally derived from animal sources, which combine to form our lead product candidate, PRP. Our vision is to further stabilize and enhance the effects of the proenzymes when administered to patients," said Dr. Julian Kenyon, Propanc’s Chief Scientific Officer.

Mr. James Nathanielsz, Propanc’s Chief Executive Officer said, "As we seek to expand our product pipeline, our vision is to create a new drug product class that provides a solution for the treatment and prevention of recurring and spreading malignant tumors, once perceived as untreatable. Through our PRP development and POP1 drug discovery programs, I am pleased to confirm that we continue to make positive steps towards achieving this vision."

So far, the Company’s scientific researchers have developed a novel expression system. At the research laboratories at the universities of Jaén and Granada, scientific researchers are in the process of optimizing conditions to achieve high titers of recombinant trypsinogen and chymotrypsinogen with this expression system. After western blotting analysis of cell extracts, they observed the cells are producing the proteins, and further sequence analysis will be completed in order to confirm the correct sequence of both proenzymes produced.

One specific objective of the project will be to synthesize by an in vivo system both proenzymes to produce crystalized proteins that could be maintained for long periods without suffering degradation, even in absence of refrigeration. This will be particularly useful for a longer shelf life as well as global distribution of the drug product, particularly in warmer climates and developing regions where refrigeration may not be available.

On November 18, 2019 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported the pricing of its previously announced public offering of 10,000,000 shares of its common stock, at a public offering price per share of $0.10, for gross proceeds of $1.0 million, before deducting placement agent fees and other offering expenses (Press release, Phio Pharmaceuticals, NOV 18, 2019, View Source [SID1234551409]). The offering is expected to close on or about November 19, 2019, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as exclusive placement agent for the offering.

Phio intends to use the net proceeds from this offering to fund the development of its immuno-oncology programs, for other research and development activities and for general working capital needs.

The shares of common stock described above were offered by Phio pursuant to a shelf registration statement on Form S-3 (File No. 333-224031) filed with the Securities and Exchange Commission (the "SEC") on March 29, 2018 and declared effective by the SEC on April 6, 2018. A preliminary prospectus supplement and accompanying prospectus related to the offering was filed with the SEC. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC. When available, electronic copies of the final prospectus supplement and accompanying prospectus may be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, via e-mail at [email protected] or via telephone at (646) 975-6996.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall 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 November 18, 2019 Heat Biologics, Inc. (NASDAQ:HTBX), a biopharmaceutical company developing immunotherapies designed to activate a patient’s immune system against cancer, reported that top line data from its ongoing Phase 2 trial of HS-110 will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy (Press release, Heat Biologics, NOV 18, 2019, View Source [SID1234551408]).

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The poster, titled "Viagenpumatucel-L (HS-110) plus nivolumab in previously-treated patients with advanced non-small cell lung cancer (NSCLC)," will be presented starting at 4:30PM Eastern Time on November 19, 2019.

The AACR (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy is being held at the Boston Marriott Copley Place in Boston on November 17-20, 2019.

About AACR (Free AACR Whitepaper) Special Conference on Tumor Immunology

The AACR (Free AACR Whitepaper) Special Conference on Tumor Immunology and Immunotherapy is designed to integrate multidisciplinary facets of basic cancer immunology and immunotherapy to broaden our understanding of ways to harness the immune system to treat cancer. The hallmark of this series is also to encourage the effective exchange of ideas between basic cancer immunologists, nonimmunologists, and clinical oncologists in order to develop approaches that translate to outcomes. This year’s program will feature international leaders in the field, who will expand our knowledge of the microbiome, adverse immunologic events, imaging and other new technologies, genetics and epigenomics of immuno-oncology, and immunologic signaling pathways. These world-renowned oncologists and researchers will offer their insights on novel cell therapies, biomarkers, vaccines, and adjuvants, all in the pursuit of understanding tumor evolution and creating better treatments.

On November 18, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that results from a number of studies from across its growing breast cancer portfolio will be presented at the San Antonio Breast Cancer Symposium (SABCS), from 10-14 December 2019 (Press release, Hoffmann-La Roche, NOV 18, 2019, View Source [SID1234551405]). These data include new results in HER2-positive breast cancer and studies of new molecules in hormone receptor-positive (HR-positive) breast cancer.

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"For the past three decades we have remained dedicated to improving outcomes for people with breast cancer," said Levi Garraway, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "This sustained commitment is exemplified by new data for our approved and investigational medicines across the spectrum of breast cancer being presented at SABCS this year."

Key presentations
New data will be presented from a second interim overall survival (OS) analysis of the phase III APHINITY trial evaluating Perjeta (pertuzumab) and Herceptin (trastuzumab) plus chemotherapy (the Perjeta-based regimen), compared to Herceptin and chemotherapy, as an adjuvant treatment for HER2-positive early breast cancer (eBC). This latest interim OS analysis also includes updated descriptive invasive disease-free survival (iDFS) and cardiac safety data.

Roche will also present data from the primary analysis of the phase III FeDeriCa study which evaluated a new investigational fixed-dose combination (FDC) of Perjeta and Herceptin administered as a single subcutaneous (SC) formulation in combination with intravenous (IV) chemotherapy. The FDC is administered under the skin in just minutes, significantly reducing the time spent receiving treatment and providing people with HER2-positive breast cancer a potential new treatment option for faster delivery of the Perjeta-based regimen.

Data will also be presented from studies in HR-positive breast cancer, including findings from early studies investigating Roche’s pipeline molecules GDC-9545, a selective oestrogen receptor degrader, and GDC-0077, a selective PI3Kα inhibitor.

Overview of Roche studies to be presented at SABCS 2019

About the APHINITY study1,2
APHINITY (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer, NCT01358877/ BO25126/ BIG 4-11) is an international, phase III, randomised, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta plus Herceptin and chemotherapy, compared to Herceptin and chemotherapy, as adjuvant therapy in 4,805 people with operable HER2-positive eBC. The primary efficacy endpoint of the APHINITY study is iDFS, which in this study is defined as the time a patient lives without return of invasive breast cancer at any site or death from any cause after adjuvant treatment. Secondary endpoints include cardiac and overall safety, OS, disease-free survival and health-related quality of life. The study will continue to follow participants for ten years.

About the FeDeriCa study3
FeDeriCa is an international, multi-centre, two-arm, randomised, open-label, phase III study evaluating the pharmacokinetics, efficacy and safety of SC injection of the FDC of Perjeta and Herceptin in combination with chemotherapy, compared with standard IV infusions of Perjeta and Herceptin in combination with chemotherapy, in people with HER2-positive eBC who are being treated in the neoadjuvant (before surgery) and adjuvant (after surgery) settings. The primary endpoint of the study is minimum levels of Perjeta in the blood during a given dosing interval (Ctrough). Secondary endpoints include safety; minimum levels of Herceptin in the blood during a given dosing interval (Ctrough); and total pCR, meaning there is no tumour tissue detectable at the time of surgery.

About Roche in breast cancer
Roche has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough innovations in HER2-positive breast cancer which have changed the natural history of the disease. As our understanding of breast cancer biology has rapidly evolved, we have expanded our focus to identify new biomarkers and approaches to treatment for other types of breast cancer, such as triple-negative and HR-positive disease, where there remains a significant unmet need.

Our HER2-targeted medicines Herceptin, Perjeta and Kadcyla continue to transform the treatment of early and advanced HER2-positive breast cancer and now, through our large clinical trial programmes with Tecentriq and ipatasertib and recent approvals for Tecentriq, we are bringing new treatment options to people with TNBC.