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Phio Pharmaceuticals Announces Pricing of $1.0 Million Public Offering of Common Stock

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.

Heat Biologics Announces Additional Top Line Phase 2 Data of HS-110 plus Nivolumab in Advanced NSCLC Patients at AACR Tumor Immunology and Immunotherapy Conference

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]).

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.

Roche to present new and updated data for seven approved and investigational medicines across multiple types of breast cancer at the 2019 San Antonio Breast Cancer Symposium

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.

"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.

3SBio Selects Verseau’s PSGL-1-targeted Antibody VTX-0811 as First Partnered Macrophage Checkpoint Modulator in Immuno-Oncology Collaboration

On November 17, 2019 3SBio Inc. ("3SBio") (HKEX:1530) and Verseau Therapeutics, Inc. ("Verseau") reported the selection of VTX-0811, a monoclonal antibody targeting PSGL-1, as the first licensed program under their partnership agreement focused on the development and commercialization of novel monoclonal antibodies in the field of immuno-oncology for a broad range of cancers (Press release, 3SBio, NOV 17, 2019, View Source [SID1234551402]).

By targeting PSGL-1, an adhesion molecule that is highly expressed on tumor-associated macrophages across most tumor types, VTX-0811 reprograms macrophages to a pro-inflammatory state, activates T cells and attracts other immune cells to generate a coordinated and powerful antitumor response. Verseau’s PSGL-1 antibodies demonstrate a greater inflammatory response compared to current immunotherapies in both PD-1 responsive tumors and non-responsive tumors. PSGL-1 is the first unblinded target from Verseau’s pipeline of macrophage checkpoint modulators (MCMs). Verseau’s MCMs reprogram macrophages to be more inflammatory or more tolerogenic depending on the disease context.

"We are pleased to have achieved our first licensing milestone in our collaboration with 3SBio. Their decision to select VTX-0811 as the first program for development validates that PSGL-1 is an important and novel immuno-oncology target with the potential to expand the number of patients benefitting from immunotherapy," said Dr. Christine Bunt, Chief Executive Officer of Verseau. "Our innovative partnership is enabling Verseau to advance our industry-leading pipeline of macrophage checkpoint modulators with first-in-class potential across a broad range of cancer therapies."

"Early data in patient-derived primary tumors suggests that PSGL-1 antibodies could generate a greater anti-tumor inflammatory response compared to current immunotherapies in both PD-1 responsive and non-responsive tumors," said Dr. Jing Lou, Chairman and Chief Executive Officer of 3SBio. "By partnering with Verseau,we are now at the forefront of one of the most promising areas of innovation within immuno-oncology and are making timely progress toward our goal of bringing novel cancer therapies to patients in China. We are eager to begin development on the first program selected under our partnership and look forward to future programs around novel macrophage targets identified by Verseau’s all human translational platform."

Under the terms of the agreement, 3SBio received an exclusive license to develop and commercialize a selected number of MCM antibodies for all human oncology indications in Greater China, including mainland China, Taiwan, Hong Kong and Macau ("Territory"). Verseau retains global rights to all MCM programs outside of Greater China. Verseau is responsible for discovery and optimization of MCM antibodies for each program. 3SBio will fund and conduct antibody development, GMP manufacturing and commercialization in the Territory. Verseau and 3SBio will be eligible to receive certain milestone payments and royalties on product sales both in the Territory and globally. The selection of the first program for co-development under the partnership triggers an undisclosed milestone payment to Verseau. Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., a subsidiary of 3SBio, will be responsible for the development and commercialization of VTX-0811 in the Territory.

About PSGL-1

PSGL-1 (P-selectin glycoprotein ligand-1) is an adhesion molecule that is involved in immune cell trafficking in response to tissue injury or inflammation. Verseau discovered that modulation of PSGL-1 can lead to macrophage reprogramming. Proprietary PSGL-1 monoclonal antibodies induce tumor microenvironment activation, T-cell activation and naïve immune cell recruitment amounting to a coordinated immune attack on tumors. In patient-derived primary tumors, PSGL-1 antibodies demonstrate a greater inflammatory response compared to current immunotherapies in both PD-1 responsive and non-responsive tumors. Given the prominent role of PSGL-1 in many tumor types, Verseau has selected PSGL-1 as the lead macrophage checkpoint modulator (MCM) program for clinical development.

About Macrophage Checkpoint Modulators

Verseau is broadening the therapeutic potential of immunotherapy by developing macrophage checkpoint modulators (MCMs) that regulate the functional shift to make macrophages more inflammatory or more tolerogenic depending on the disease context. While many patients benefit from PD-1 inhibitor therapies, they are only effective in the ~25% of cancers that involve T cell infiltration. By targeting modulation of macrophages, which are present in ~75% of human cancers, Verseau aims to significantly expand the therapeutic benefit of immunotherapy. MCMs cause tumors to turn highly inflammatory and stimulate multiple immune cell types, including T cells. Verseau’s therapies have the potential to significantly expand the number of patients benefitting from immunotherapy, including those unresponsive to PD-1 inhibitor therapies. Through its proprietary all-human translational system Verseau has validated more than two dozen targets amenable to different therapeutic modalities, including monoclonal antibodies.

Personalis, Inc. to Present New Data at the AACR Tumor Immunology and Immunotherapy Conference

On November 17, 2019 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that the company will participate in the AACR (Free AACR Whitepaper) Tumor Immunology and Immunotherapy conference at the Boston Marriott Copley Place in Boston, MA, November 17-20, including poster presentations on November 18th and 19th (Press release, Personalis, NOV 17, 2019, View Source [SID1234551401]).

The company will showcase ImmunoID NeXT, the first platform to enable comprehensive analysis of both a tumor and its immune microenvironment from a single sample. ImmunoID NeXT can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one and maximizing the biological information that can be generated from a precious tumor specimen.

Following is a list of abstracts that will be presented at the meeting.

Scientific Poster Presentations

Poster Number

Title & Presenter

Day & Time

Location

A19

HLA allele-specific loss of heterozygosity detection
using augmented exome capture approach

Presenter: Rachel Marty Pyke, Ph.D.

November 18:
12:30 PM – 3:00 PM

Back Bay

B18

Exome scale liquid biopsy monitoring of putative
neoantigens and genomic biomarkers in patients
on anti-PD-1 therapy in squamous cell carcinoma of
the head and neck

Presenter: Charles Abbott, Ph.D.

November 19:
4:30 PM – 7:00 PM

Back Bay

Personalis will also be exhibiting during the conference (Exhibit # 10). Representatives will be available to answer questions about the company’s cancer immunogenomics services.