Morphic Announces Closing of Initial Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On July 1, 2019 Morphic Holding, Inc. ("Morphic"), a biopharmaceutical company discovering and developing oral small-molecule integrin therapeutics, reported the closing of its initial public offering of 6,900,000 shares of its common stock at a price to the public of $15.00 per share, which includes 900,000 shares sold upon full exercise of the underwriters’ option to purchase additional shares of common stock (Press release, Morphic Therapeutic, JUL 1, 2019, View Source [SID1234537349]). The shares began trading on The Nasdaq Global Market on June 27, 2019 under the symbol "MORF." Morphic received gross proceeds, before deducting underwriting discounts and commissions and other estimated offering expenses, of approximately $103.5 million.

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Jefferies LLC, Cowen and Company, LLC, BMO Capital Markets Corp. and Wells Fargo Securities, LLC acted as joint book-running managers for the offering.

Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on June 26, 2019. The offering was made only by means of a prospectus. A copy of the final prospectus relating to the offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 877-821-7388 or by email at [email protected], from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by telephone at (631) 592-5973 or by email at [email protected]; from BMO Capital Markets Corp. at 3 Times Square, New York, NY 10036, Attention: Equity Syndicate Department, by telephone at (800) 414-3627 or by email to [email protected]; or from Wells Fargo Securities, LLC 375 Park Avenue, New York, New York 10152, Attention: Equity Syndicate Department, or by calling (800) 326-5897, or by emailing [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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.

Foundation Medicine Expands Indication for FoundationOne®CDx as a Companion Diagnostic for LYNPARZA® (Olaparib)

On July 1, 2019 Foundation Medicine, Inc. reported it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx to be used as a companion diagnostic for LYNPARZA (Olaparib) for first line maintenance therapy in BRCA-mutated advanced ovarian cancer (Press release, Foundation Medicine, JUL 1, 2019, View Source [SID1234537348]). FoundationOne CDx is an FDA-approved comprehensive genomic profiling (CGP) test for all solid tumors that incorporates multiple companion diagnostics. FoundationOne CDx detects tumor BRCA1 and BRCA2 mutations including both germline (inherited) and somatic (acquired) mutations.i FoundationOne CDx may help identify more women who could benefit from Lynparza as compared to conventional testing methods that only identify germline BRCA mutations. Germline-only BRCA1/2 testing identifies approximately half of all BRCA1/2 mutations.ii,iii

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"Foundation Medicine is proud to receive FDA approval for another important companion diagnostic on FoundationOne CDx, our broad companion diagnostic test that is clinically and analytically validated for all solid tumors," stated Brian Alexander, M.D., M.P.H. Foundation Medicine’s Chief Medical Officer. "It is imperative that women with advanced ovarian cancer receive rigorous testing for BRCA1/2 mutations such as FoundationOne CDx, which includes both germline and somatic mutations, to determine if they are a candidate for PARP inhibitors."

In December of 2018, AstraZeneca (LSE/STO/NYSE: AZN) and Merck & Co., Inc. announced that the FDA approved Lynparza for use as maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy.

Foundation Medicine, AstraZeneca and Merck have an ongoing collaboration to support the development of companion diagnostics for Lynparza in prostate cancer.

About FoundationOne CDx
FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. FoundationOne CDx is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit View Source

Amphivena’s Human Proof-of-Concept Data for AMV564 in Relapsed/Refractory AML Updated at the European Hematology Association Annual Meeting

On July 1, 2019 Amphivena Therapeutics highlighted initial data from the dose-escalation portion of the First-in-Human Phase 1 trial evaluating AMV564 in patients with relapsed or refractory acute myeloid leukemia (AML, AMV564-101, NCT03144245) in an oral presentation June 15 at the 24th European Hematology Association (EHA) (Free EHA Whitepaper) meeting in Amsterdam (Abstract S877) (Press release, Amphivena Therapeutics, JUL 1, 2019, View Source [SID1234537347]). The oral presentation of data from 33 patients treated within 9 cohorts demonstrated that AMV564 is active in relapsed or refractory AML and expanded upon the data from 26 patients presented at the Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2018. AMV564 is a bivalent, bispecific (2:2) T cell engager that binds CD33 and CD3 resulting in T cell directed lysis of leukemic blasts and myeloid-derived suppressor cells (MDSCs) without affecting monocytes and neutrophils.

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Gail Roboz, M.D., Professor of Medicine, Director of the Leukemia Program, and a member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center and a Principal Investigator for the study, presented on behalf of the study team. "While this is a Phase 1 study," she said, "we believe that AMV564 has demonstrated promising monotherapy activity, including a CR, CRi and PR and evidence of durability in a high risk, older patient population on a 14-day dosing regimen. The data show that AMV564 is well-tolerated with no dose limiting toxicities through 250 mcg and only Grade 1 and Grade 2 cytokine release syndrome distinguishing the safety of AMV564 from other drugs in development for myeloid malignancies."

"AMV564 has demonstrated novel clinical activity for a T cell engager by rapidly and selectively eliminating leukemic blasts and rare immature, granulocytic and monocytic MDSCs while sparing normal CD33-expressing cells, including neutrophils and monocytes. High levels of circulating MDSCs are associated with poor prognosis for cancer patients. Our drug’s ability to selectively eliminate MDSCs rather than modulating MDSC pathways provides a unique opportunity to evaluate the role of these immune suppressive cells in cancer," said Jeanmarie Guenot, Ph.D., Amphivena Chief Executive Officer and President.

Dr. Roboz has served as a consultant for Amphivena, Celgene, Bayer, Otsuka, Pfizer, Astellas Pharmaceuticals, Argenx, Astex Pharmaceuticals, Hoffman-La Roche, Janssen, Novartis, AbbVie, Sandoz, Eisai, Jazz Pharmaceuticals, Celltrion, Orsenix and Daiichi Sankyo.

About AMV564-101

AMV564-101 is a First-in-Human dose escalation and dose expansion Phase 1 trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AMV564 in patients with relapsed or refractory AML after 1-2 prior induction regimens (with a standard anthracycline-based regimen or hypomethylating agent) and no more than 2 prior salvage regimens. The Phase 1 study is currently open at Washington University School of Medicine, MD Anderson Cancer Center, NewYork-Presbyterian/Weill Cornell Medical Center and Weill Cornell Medicine, Fred Hutchinson Cancer Research Center, The Ohio State University Wexner Medical Center, University of Pennsylvania Medical Center, Northwestern Memorial Hospital, and The Johns Hopkins Hospital.

Genprex Provides Update on Development of its Oncoprex Immunogene Therapy in Combination with Immunotherapy for Non-Small Cell Lung Cancer

On July 1, 2019 Genprex, Inc. (NASDAQ: GNPX), a clinical stage gene therapy company, reported an update on development of its lead drug candidate, Oncoprex immunogene therapy, in combination with immunotherapy for the treatment of non-small cell lung cancer (NSCLC) (Press release, Genprex, JUL 1, 2019, View Source [SID1234537346]).

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In July 2018, the company entered a Sponsored Research Agreement with The University of Texas MD Anderson Cancer Center ("MD Anderson") to fund a research study entitled, "A Novel Therapeutic Approach for the Treatment of Cancer Using a Combination of the Multifactorial Tumor Suppressor Gene TUSC2 and Immunotherapy." The TUSC2 gene is the active agent in Genprex’s Oncoprex immunogene therapy. The study was budgeted to cost $2.03 million.

The study aimed to develop a novel therapeutic approach for the treatment of cancer using a combination of the tumor suppressor gene TUSC2 and immunotherapy, including immune checkpoint inhibitors and anti-PD1 and/or anti-CTLA-4 antibodies. A specific objective of the study was to validate therapeutic efficacy of the TUSC2 and immune checkpoint blockade combination in humanized cancer mouse models. This milestone was completed with positive results presented in a poster by Genprex’s collaborators from MD Anderson at the American Association of Cancer Research Meeting in April 2019, which is available on the company’s website.

Research under the Sponsored Research Agreement is continuing. Further aims of the research include evaluating TUSC2 in combination with immunostimulatory adjuvants and targeted small molecule drugs. Additional goals of the study also include identification of biomarkers that predict response to TUSC2-immunotherapy combinations

Based on data from this study and data from prior clinical and pre-clinical studies, Genprex is working with its Scientific Advisory Board and outside consultants to design a clinical trial for the study of Oncoprex in combination with a checkpoint inhibitor for treatment of non-small cell lung cancer, with the goal of being in a position to enroll patients in the first quarter of 2020.

"Recent studies have shown that less than half of cancer patients qualify for approved immunotherapies based on the patient’s PD-1 or PD-L1 protein expression level," said Julien Pham, President and Chief Operating Officer of Genprex. "Current immunotherapy treatment is only benefitting a small number of cancer patients. We are working to fill this gap by combining our lead drug candidate with approved immunotherapies to give patients more treatment options. The preclinical studies have shown encouraging data that this combination could be a viable treatment option for late-stage non-small cell lung cancer."

Synergys Announces Second Phase 1 SBIR Funding From National Institutes of Health

On July 1, 2019 Synergys Biotherapeutics, a preclinical stage biotherapeutics company developing Vasculogenic Mimicry (VM)-blocking antibody fusion drugs for cancer treatment reported the granting of its second Phase 1 Small Business Innovation Research (SBIR) award by the National Cancer Institute (NCI) (Press release, Synergys Biotherapeutics, JUL 1, 2019, View Source [SID1234537345]). This award will support the development for ovarian cancer an anti-HER2 antibody fusion candidate that contains a highly anti-angiogenic dimeric mutant endostatin as its fusion partner. The uniqueness of the fusion is its ability to inhibit both vasculogenic mimicry, which is the direct formation of vascular channels by tumor cells, as well as angiogenesis, i.e. the development of new vasculature by endothelial cells. Synergys was awarded its first SBIR grant for the development of an anti-EGFR-endostatin mutant fusion that is currently being developed for the treatment of Triple Negative Breast Cancer (TNBC).

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The fusion candidates were derived from A-TAP (Antibody-Targeted Anti-vascularization Payload) system that was pioneered by Drs. Joseph Rosenblatt, M.D., Professor and Chief of the Hematology Division and Seung-Uon Shin, Ph.D., Research Associate Professor, Department of Medicine, Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL. Synergys has established a long-term collaboration with Drs. Rosenblatt and Shin in developing the fusion candidates and exploring the molecular mechanism of VM inhibition in decreasing tumor burden and metastasis inhibition in cancer.

Regarding the award, Dr. Rosenblatt notes, "As a co-PI of the project, I am excited to note that our pioneering work on vasculogenic mimicry inhibition in cancer is being recognized by the SBIR review boards for its therapeutic potential, first for TNBC and now again for ovarian cancer. We look forward to continuing our collaboration with Synergys for the development of the antibody fusion molecules as new targeted therapeutics for various cancers."

Dr. Rathin Das, PhD, CEO of Synergys said, "Receiving our second SBIR award from the NCI is both validation and endorsement of the VM-blocking A-TAP platform thereby providing significant impetus for utilizing it for the development of breakthrough treatment modalities for a variety of solid cancers."