Hyaluronidase

-Treatment with VCN-01 in combination with durvalumab demonstrated an acceptable safety profile and encouraging biological activity- ROCKVILLE, Md., Sept. 05, 2022 (GLOBE NEWSWIRE) -- Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, today announced a presentation of initial data from a Phase 1 investigator-sponsored study evaluating VCN-01 in combination with durvalumab for patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC). Data will be featured in a poster presentation at the European Society for Medical Oncology (ESMO) Congress, being held both virtually and in Paris from September 9-13, 2022. “We are encouraged by the acceptable safety profile seen in the sequential arm of this study as well as the biological activity observed in R/M HNSCC patients previously treated with anti-PD(L)-1 agents, which speak to the promise of VCN-01-based combination approaches for devastating cancers with high unmet need,” said Manel Cascallό, Ph.D., General Director of Synthetic Biologics’ European Subsidiary. “Further, these results provide valuable dose-finding context and build upon our compelling foundation of data that highlight VCN-01’s differentiated mechanism of action that may transform cancer therapy. We look forward to leveraging our findings as we advance VCN-01 through clinical development and we remain on track to deliver on several value-driving milestones, including the initiation of our Phase 2 study in patients with metastatic pancreatic adenocarcinoma in the fourth quarter of 2022 and our Phase 2/3 study in retinoblastoma in the second half of 2023.” Key data and conclusions featured in the ESMO presentation include: Safety: Treatment with VCN-01 had an acceptable safety profile when administered with durvalumab in the sequential regimen (single dose of VCN-01 administered 14 days prior to the first dose of durvalumab; n=14). The most common treatment-related adverse events (TRAEs) were pyrexia, flu-like symptoms and increases in liver transaminases.TRAEs were dose-dependent, reversible and consistent with TRAEs previously described for other adenovirus-based products. Pharmacokinetics (PK) and pharmacodynamics (PD): Based on toxicology and PK/PD analysis the recommended Phase 2 dose is 1x1013 viral particles (vp)/patient.Biological activity: Sustained blood levels of VCN-01 viral genomes and increased serum hyaluronidase levels were maintained for over six weeks. Observed an increase in CD8 T cells, a marker of tumor inflammation and an upregulation of PD-L1 in tumors.Analysis of serial tumor biopsies revealed differential gene expression profiles and downregulation of matrix-related pathways after VCN-01 administration. The full abstract (#1231P) is accessible on the ESMO Congress portal and the e-Poster will be available on-demand starting Saturday, September 10 at 9:00 a.m. CEST. Additional details of the poster are provided below. Title: Phase I Study to Evaluate the Safety, Tolerability, and Efficacy of VCN-01 in Combination With Durvalumab (MEDI4736) in Subjects With Recurrent/ Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M HNSCC)Presenting Author: Dr. Ricard Mesia (Head of the Medical Oncology Department at Institut Català d'Oncologia- Barcelona, Spain)Poster Session Date and Time: Monday, September 12 at 12:00 p.m. CEST About Synthetic Biologics, Inc. Synthetic Biologics, Inc. (NYSE American: SYN) is a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need. The Company advanced into oncology through the acquisition of VCN Biosciences, S.L. (VCN), who have developed a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company's lead candidates are: (1) VCN-01, an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment; (2) SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent (a) microbiome damage, (b) Clostridioides difficile infection (CDI), (c) overgrowth of pathogenic organisms, (d) the emergence of antimicrobial resistance (AMR), and (e) acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients, and (3) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases. For more information, please visit Synthetic Biologics' website at www.syntheticbiologics.com. Forward-Looking Statement This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases forward-looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates," "intends," "plans," "believes," "estimates," and similar expressions, and include statements regarding the promise of VCN-01-based combination approaches for devastating cancers with high unmet need, VCN-01’s differentiated mechanism of action transforming cancer therapy, leveraging findings as VCN-01 is advanced through clinical development, and remaining on track to deliver on several value-driving milestones, including the initiation of our Phase 2 study in patients with metastatic pancreatic adenocarcinoma in the fourth quarter of 2022 and our Phase 2/3 study in retinoblastoma in the second half of 2023. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, VCN-01’s differentiated mechanism of action transforming cancer therapy, Synthetic Biologics' and VCN’s ability to reach clinical milestones when anticipated including initiation of a Phase 2 study in patients with metastatic pancreatic adenocarcinoma in the fourth quarter of 2022 and a Phase 2/3 study in retinoblastoma in the second half of 2023 , Synthetic Biologics' ability to successfully combine and operate the business of Synthetic Biologics and VCN, Synthetic Biologics' and VCN's product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results; the ability to complete clinical trials on time and achieve the desired results and benefits, continuing clinical trial enrollment as expected; the ability to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Synthetic Biologics' and VCN's ability to promote or commercialize their product candidates for the specific indications, acceptance of product candidates in the marketplace and the successful development, marketing or sale of Synthetic Biologics' and VCN's products, developments by competitors that render such products obsolete or non-competitive, Synthetic Biologics' and VCN's ability to maintain license agreements, the continued maintenance and growth of Synthetic Biologics' and VCN's patent estate, the ability to continue to remain well financed, and other factors described in Synthetic Biologics' Annual Report on Form 10-K for the year ended December 31, 2021 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and current reports on Form 8-K. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law. For further information, please contact: Investor Relations: Chris Calabrese LifeSci Advisors, LLC ccalabrese@lifesciadvisors.com 917-680-5608

DUBLIN, June 22, 2022 /PRNewswire/ -- The "Breast Cancer Monoclonal Antibodies Global Market Report 2022: By Product, By End-User" report has been added to ResearchAndMarkets.com's offering. The global breast cancer monoclonal antibodies market is expected to grow from $15.37 billion in 2021 to $16.67 billion in 2022 at a compound annual growth rate (CAGR) of 8.5%. The market is expected to reach $21.47 billion in 2026 at a CAGR of 6.5%. Major players in the breast cancer monoclonal antibodies (mAbs) market are Amgen, Mylan, Merck, Novartis, GlaxoSmithKline, Daiichi Sankyo, Biocad, Boehringer Ingelheim, Bristol-Myers Squibb and Array BioPharma. The breast cancer monoclonal antibodies (mAbs) market consists of sales of monoclonal antibodies by entities (organizations, sole traders and partnerships) that produce breast cancer monoclonal antibodies used as therapy for breast cancer either as monotherapy or combination therapy. The revenue generated includes the sales of naked mAbs and conjugated mAbs. The companies engaged in the breast cancer monoclonal antibodies market are primarily focused on the research, development, and production of monoclonal antibodies that are used in early-stage and advanced breast cancer, ductal carcinoma in-situ, triple-negative breast cancer, inflammatory breast cancer, and others. The main types of breast cancer monoclonal antibodies are naked mAbs and conjugated mAbs. Naked mAbs are antibodies that are free of any drugs or radioactive materials. They are self-contained. The most prevalent type of mAb used to fight cancer is this one. The different types of treatments include chemotherapy, surgery & radiation therapy, targeted therapy, biologic therapy, hormone therapy and is used in various sectors such as hospitals, retail pharmacies. Alternative treatment methods and natural remedies are increasingly becoming popular globally and this is expected to impact the revenues of breast cancer monoclonal antibodies manufacturing companies. Treatments in the fields of homeopathy, Ayurveda, yoga, acupuncture, sujok therapy are gaining popularity and slowly replacing some traditional hospital practices. For instance, ayurvedic medicine, an ancient Indian system of medicine uses a range of techniques and treatments for cancer. Many herbs used in Ayurveda have anti-cancer properties. According to the World Health Organization (WHO), some nations are still responding to plant-based treatment as their main medicine source and developing nations are using the benefits of natural compounds for therapeutic purposes, affecting the sales of oncology drugs. Also, the global homeopathic product market is projected to reach $18.6 billion by the end of 2027. The National Institute of Cancer indicated the promising results of vaccines in HER2-positive cancer including breast, ovarian, lung, colorectal, and gastroesophageal cancers, wherein they have used patients' immune cells to treat their HER2-positive cancers by genetically modifying them to customize personalized vaccine. These factors are expected to continue during the forecast period and limit the demand for the breast cancer monoclonal antibodies market. Companies in the breast cancer monoclonal antibodies market are investing in targeted and combination therapy, which has proven to be more effective and less toxic than the traditional treatment options. Targeted cancer therapies are drugs or substances that block the growth of cancer by interfering with molecules that are more specifically involved in cancer cell progression than in normal cell activity. The goal of these therapies is to eliminate cancerous cells in the body while leaving normal cells unharmed. By focusing on changes in the cell that are specific to cancer, this therapy may prove to be more effective than traditional chemotherapy and radiotherapy. Combination therapy uses a treatment method in which a patient is given two or more drugs (or other therapeutic agents) for a single disease. In February 2019, the FDA approved the combination of a mAb trastuzumab with hyaluronidase-oysk for SC administration in HER2-positive early breast cancer wherein hyaluronidase is an enzyme that helps the body to use trastuzumab. In 2020, The American Society of Clinical Oncology published the success of combination therapy of a targeted monoclonal antibody atezolizumab with chemotherapy with improved progression-free survival in patients with triple-negative breast cancer. It resulted in the progression-free survival of 7.2 months for patients receiving the combination therapy, compared with 5.5 months for those who received placebo plus nab-paclitaxel (chemotherapy). Promising results with targeted therapies and combination therapies are expected to raise the focus on these therapies in the breast cancer monoclonal antibodies market. In March 2019, AstraZeneca, a UK-based global biopharmaceutical company that discovers, develops and commercializes prescription drugs in therapy areas such as oncology, cardiovascular, renal & metabolism and respiratory, entered into a collaboration with Daiichi Sankyo Company, Limited with an upfront payment of $1.35 billion. The collaboration agreement is about the global development and commercialization of trastuzumab deruxtecan (DS-8201), which is an exclusive antibody-drug conjugate (ADC) and potential new targeted cancer therapy. Except in Japan (exclusive rights for Daiichi Sankyo), the companies will jointly develop and commercialize trastuzumab deruxtecan. Daiichi Sankyo Company Limited is a Japan-based global pharmaceutical company that creates innovative new and generic medicines and new methods of drug discovery and delivery. Key Topics Covered: 1. Executive Summary 2. Breast Cancer Monoclonal Antibodies Market Characteristics 3. Breast Cancer Monoclonal Antibodies Market Trends And Strategies 4. Impact Of COVID-19 On Breast Cancer Monoclonal Antibodies 5. Breast Cancer Monoclonal Antibodies Market Size And Growth 5.1. Global Breast Cancer Monoclonal Antibodies Historic Market, 2016-2021, $ Billion 5.1.1. Drivers Of The Market 5.1.2. Restraints On The Market 5.2. Global Breast Cancer Monoclonal Antibodies Forecast Market, 2021-2026F, 2031F, $ Billion 5.2.1. Drivers Of The Market 5.2.2. Restraints On the Market 6. Breast Cancer Monoclonal Antibodies Market Segmentation 6.1. Global Breast Cancer Monoclonal Antibodies Market, Segmentation By Product, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion Naked Mabs Conjugated Mabs 6.2. Global Breast Cancer Monoclonal Antibodies Market, Segmentation By End-User, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion Hospitals Retail Pharmacies 6.3. Global Breast Cancer Monoclonal Antibodies Market, Segmentation By Treatment, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion Chemotherapy Surgery & Radiation Therapy Targeted Therapy Biologic Therapy Hormone Therapy 7. Breast Cancer Monoclonal Antibodies Market Regional And Country Analysis 7.1. Global Breast Cancer Monoclonal Antibodies Market, Split By Region, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion 7.2. Global Breast Cancer Monoclonal Antibodies Market, Split By Country, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion Companies Mentioned Amgen Mylan Merck Novartis GlaxoSmithKline Daiichi Sankyo Biocad Boehringer Ingelheim Bristol-Myers Squibb Array BioPharma Celldex Therapeutics Celltrion Roche Immunomedics MacroGenics Pfizer Sun Pharmaceutical Industries Teva Pharmaceuticals Puma Biotechnology Seattle Genetics AstraZeneca Eddingpharm Eisai Galena Biopharma ImmunoGen For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 SOURCE Research and Markets