On November 23, 2020 RGENIX, Inc., a clinical stage biopharmaceutical company developing first-in-class small molecule and antibody cancer therapeutics, reported that CEO Masoud Tavazoie, M.D., Ph.D., will present at the 32nd Annual Piper Sandler Virtual Healthcare Conference (Press release, Rgenix, NOV 23, 2020, View Source [SID1234571578]).

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This virtual presentation will be available online here from November 23, 2020 at 10:00 AM EST to December 3, 2020.

A link to an archived version of this presentation will also be available on RGENIX’s website within the News section.

Rgenix will also be participating in one-on-one meetings with investors on November 30 and December 1, meetings may be requested exclusively via Piper Sandler.

On November 23, 2020 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the publication of a second abstract at the San Antonio Breast Cancer Symposium (SABCS), jointly authored by Professor Mothaffar F. Rimawi, the Global Principal Investigator of the GP2 Phase III clinical trial, and the Executive Medical Director and Co-Leader of the Breast Cancer Program at the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine, and Professor C. Kent Osborne, Tina and Dudley Sharp Chair in Oncology and the founding Director of the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine (Press release, Greenwich LifeSciences, NOV 23, 2020, View Source [SID1234571595]). The abstract will be displayed as the Company’s second poster on Wednesday, December 9, 2020 in a virtual format with an introductory audio track.

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The abstract highlights the design of the planned Phase III clinical trial. The trial is designed as a single registration trial that will include an interim analysis seeking conditional marketing approval from the FDA upon the interim analysis data read out followed by submission of a Biologics Licensing Application. The Phase III clinical trial aims to reproduce the Phase IIb study which concluded that completion of the first 6 intradermal injections of GP2 + GM-CSF safely elicited a potent immune response and reduced recurrence rates to 0% in HER2/neu 3+ patients, who received a standard course of trastuzumab after surgery.

Snehal Patel, CEO of Greenwich LifeSciences, commented, "The participation of Baylor College of Medicine as the Phase III clinical trial lead site further validates the significance of our Phase IIb data. Reducing the recurrence of breast cancer rates to 0% gives us great confidence as we try to reproduce this data in the Phase III clinical trial. We are addressing a potential market of up to $5 billion in a disease that affects 1 in 8 women, who if recur, will likely face metastatic breast cancer."

"We are very excited to be working with such prominent key opinion leaders. Professor Rimawi’s leadership of our Phase III clinical trial will complement the positive Phase IIb clinical trial results with the research and clinical expertise of Baylor College of Medicine. Due to GP2’s efficacy and safety profile, GP2 immunotherapy may provide clinicians with an option to reduce the use of other toxic and expensive treatments. We look forward to sharing our Phase IIb clinical trial data and Phase III clinical trial design with breast cancer leaders attending SABCS and to discussing the participation of their clinical sites in our trial," Patel concluded.

The Phase III clinical trial will explore the use of GP2 + GM-CSF as adjuvant therapy to prevent the recurrence of breast cancer in HER2/neu positive and HLA 2+ patients, post-surgery and following the first year of treatment with any trastuzumab-based therapy.

The Phase III clinical trial is a prospective, randomized, double-blinded, multi-center study. After 1 year of trastuzumab-based therapy or an approved biosimilar, treatment with GP2 + GM-CSF or placebo will be administered intradermally for the 6 primary immunization series over the first 6 months and 5 subsequent boosters over the next 2.5 years for a total of 11 injections over 3 years of treatment. The participant duration of the trial will be 3 years of treatment plus 2 years of follow-up for a total of 5 years following the first year of treatment with trastuzumab-based therapy or approved biosimilar. An interim analysis is planned and patients will be stratified based on prior and current treatments, among other factors.

The majority of breast cancer patients will be HER2/neu positive and HLA 2+, disease-free, conventionally treated node-positive, post breast tumor removal surgery and following the first year of treatment with trastuzumab-based therapy.

Abstract OT-13-03 is entitled: A prospective, randomized, multicenter, double-blinded, placebo-controlled Phase III trial of the HER2/neu peptide GP2 + GM-CSF versus bacteriostatic saline/WFI placebo as adjuvant therapy after any trastuzumab-based therapy in HER2-positive women with operable breast cancer. The full abstract can be viewed here on page 912.

About SABCS

The 43rd annual SABCS has grown to be the industry’s premier breast cancer conference for basic, translational, and clinical cancer research professionals. It is well-known for presenting the latest breast cancer data from all over the world. More than 7,500 health care professionals from more than 90 countries attend annually. Baylor College of Medicine became a joint sponsor of SABCS in 2005. The Cancer Therapy & Research Center at UT Health Science Center San Antonio and American Association for Cancer Research (AACR) (Free AACR Whitepaper) began collaborations with SABCS in 2007. For more information, please visit the conference website at: View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On November 23, 2020 The South Korean biotech company Y-Biologics and the French pharmaceutical group Pierre Fabre reported their plans to form a strategic partnership in the field of immuno-oncology research (Press release, Y-Biologic, NOV 23, 2020, View Source [SID1234571628]). The decision has been acknowledged through a letter of intent signed by both parties and will be confirmed in the coming months through a detailed agreement. The collaboration is set to run for three years, with the possibility of a two-year extension.

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Y-Biologics, which specializes in the discovery of monoclonal antibodies, and the Pierre Fabre group, France’s second-largest private pharmaceutical laboratory, plan to combine their areas of expertise with the aim of identifying and developing novel therapeutic monoclonal antibodies targeting key immunosuppressive mechanisms activated within solid tumors.

It has been shown that key cellular components of the tumor microenvironment play an important role in helping the tumor thwart the body’s immune response. Cancer immunotherapies work by specifically reactivating the immune system so that it can destroy the tumor cells. The partnership between Pierre Fabre and Y-Biologics aims to provide patients with novel therapies based on the use of therapeutic monoclonal antibodies that are capable of reprogramming some cell types to stimulate and/or restore the anti-tumoral response exerted by the immune system.

Under the terms of this agreement, Y-Biologics will contribute through its human antibody display platforms to generate therapeutic and diagnostic monoclonal antibodies directed against key molecular targets designated by Pierre Fabre. For its part, Pierre Fabre will contribute its expertise in immuno-oncology leveraging the skills of its teams located at the Pierre Fabre Immunology Centre (CIPF) in Saint-Julien-en-Genevois (discovery and validation of immunosuppressive targets, targeted biotherapies) and at the Pierre Fabre R&D Centre on the Oncopole campus in Toulouse (translational medicine, pharmacology, toxicology, clinical development).

Young Woo Park, CEO of Y-Biologics, stated : « Utilizing Y-Biologics’ human antibody display platform, we are extremely pleased to have entered into the joint study and optional license agreement for antibody discovery for novel immuno-oncology targets proposed by Pierre Fabre. We take great pride in enabling Pierre Fabre, an important stakeholder in oncology, to recognize our antibody discovery platform and expand our technology globally. Y-Biologics hope that the candidates we have discovered can step forward into preclinical and clinical stage by Pierre Fabre and we are all very pleased to see that this partnership broadens the opportunities for subsequent co-development. We look forward to continuing our strong relationship with Pierre Fabre through this project. »

«Innovation in oncology is one of our strategic priorities, therefore we are very excited to partner with Y-Biologics in the discovery and development of cutting-edge monoclonal antibodies. The agreement with Y-Biologics is another testimony of Pierre Fabre´s commitment to accelerate identification of innovative therapies for patients who are refractory or resistant to current treatments » added Jean-Luc Lowinski, Medical Care Business Unit CEO at Pierre Fabre.

Under the planned partnership, Pierre Fabre would have the option to acquire all rights on the antibodies that will be developed under the collaboration. These rights will be subject to payments of discovery fees, milestones and royalties to Y-Biologics.

On November 22, 2020, Baudax Bio, Inc., (the "Company"), reported that it entered into a Securities Purchase Agreement (the "Purchase Agreement") with an institutional investor named therein (the "Purchaser"), pursuant to which the Company agreed to issue and sell, in a registered direct offering (the "Offering"), 2,850,000 shares (the "Shares") of the Company’s common stock, par value $0.01 per share (the "Common Stock") and warrants exercisable for an aggregate of 10,126,583 shares of Common Stock (the "Series A Warrants") at a combined offering price of $1.185 per share (Filing, 8-K, Baudax Bio, NOV 22, 2020, View Source [SID1234572278]). The Series A Warrants have an exercise price of $1.20 per share. Each Series A Warrant is exercisable for one share of Common Stock and will be immediately exercisable and will expire five years from the issuance date.

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The Company also offered and sold to the Purchaser pre-funded warrants to purchase an aggregate of 7,276,583 shares of Common Stock (the "Series B Warrants" and, together with the Shares and the Series A Warrants, the "Securities"), in lieu of shares of Common Stock at the Purchaser’s election. Each Series B Warrant is exercisable for one share of our Common Stock. The purchase price of each Series B Warrant is $1.175, and the exercise price of each pre-funded Series B Warrant is $0.01 per share. The Series B Warrants are immediately exercisable and may be exercised at any time until all of the Series B Warrants are exercised in full.

A holder (together with its affiliates) may not exercise any portion of such holder’s Series A Warrants or Series B Warrants to the extent that the holder would own more than 4.99% (or 9.99%, at the holder’s election) of the Company’s outstanding Common Stock immediately after exercise, except that upon notice from the holder to the Company, the holder may decrease or increase the limitation of ownership of outstanding stock after exercising the holder’s Series A Warrants or Series B Warrants up to 9.99% of the number of shares of the Company’s Common Stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Series A Warrants and Series B Warrants, provided that any increase in such limitation shall not be effective until 61 days following notice to the Company.

The Purchase Agreement contains customary representations and warranties and agreements of the Company and the Purchaser and customary indemnification rights and obligations of the parties. The closing of the Offering is expected to occur on November 25, 2020. The Company is expected to receive gross proceeds of approximately $11.9 million in connection with the Offering, before deducting placement agent fees and related offering expenses.

As compensation to H.C. Wainwright & Co., LLC (the "Placement Agent") as placement agent in connection with the Offering, the Company agreed to pay to the Placement Agent a cash fee of 6.0% of the aggregate gross proceeds raised in the Offering, plus a management fee equal to 1.0% of the gross proceeds raised in the Offering and reimbursement of certain expenses and legal fees. The Company will also issue to designees of the Placement Agent warrants to purchase up to 6.0% of the aggregate number of shares of Common Stock sold in the transactions, or warrants to purchase up to 607,595 shares of Common Stock (the "Placement Agent Warrants"). The Placement Agent Warrants have substantially the same terms as the Series A Warrants, except that the Placement Agent Warrants have an exercise price equal to 125% of the offering price per share (or $1.48125 per share).

The foregoing summaries of the Purchase Agreement, the Series A Warrants, Series B Warrants and the Placement Agent Warrants do not purport to be complete and are subject to, and qualified in their entirety by, the forms of such documents attached as Exhibits 10.1, 4.1, 4.2 and 4.3, respectively, to this Current Report on Form 8-K (the "Report"), which are incorporated herein by reference.

The Securities in the Offering and the Placement Agent Warrants were offered by the Company pursuant to a registration statement on Form S-3 (File No. 333-243488), which was filed with the Securities and Exchange Commission on August 10, 2020 and was declared effective by the Commission on October 2, 2020 (the "Registration Statement"). A copy of the opinion of Troutman Pepper Hamilton Sanders LLP relating to the legality of the issuance and sale of the Securities in the Offering is attached as Exhibit 5.1 hereto. This Report shall not constitute an offer to sell or the solicitation of an offer to buy securities, nor shall there be any sale of securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On November 20, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, reported that the results of the Phase 3 ORIENT-32 study were released in a late-breaking proffered oral presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia ("ESMO Asia") Virtual Congress 2020 (Press release, Innovent Biologics, NOV 22, 2020, View Source [SID1234571528]).

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ORIENT-32 is the first randomized Phase 3 study reporting the efficacy and safety of an anti-PD-1 antibody-based combination therapy versus sorafenib as the first-line treatment in patients with advanced unresectable hepatocellular carcinoma (HCC). A total of 571 patients were enrolled in the trial. Based on an interim analysis conducted by the study’s Independent Data Monitoring Committee (IDMC), TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection) demonstrated significantly improved overall survival (OS) and Independent Radiographic Review Committee (IRRC) progression-free survival (PFS) versus sorafenib. Compared to sorafenib, TYVYT (sintilimab injection) plus BYVASDA (bevacizumab biosimilar injection) demonstrated a 43.1% decreased risk of all-cause mortality (HR 0.569, 95%CI: 0.431-0.751, P<0.0001); the median OS was not reached in the TYVYT (sintilimab injection) plus BYVASDA (bevacizumab biosimilar injection) arm versus 10.4 months in the sorafenib arm. TYVYT (sintilimab injection) plus BYVASDA (bevacizumab biosimilar injection) also demonstrated 43.5% decreased risk of progression as assessed by IRRC (HR 0.565 95%CI: 0.455-0.701, P<0.0001); median PFS was 4.6 months in the TYVYT (sintilimab injection) plus BYVASDA (bevacizumab biosimilar injection) arm versus 2.8 months in the sorafenib arm.

The significantly improved OS and PFS benefits brought by TYVYT (sintilimab injection) plus BYVASDA (bevacizumab biosimilar injection) over sorafenib were generally consistent across all subgroups. The combination regimen showed an acceptable safety profile with no new safety signals. With these results, TYVYT (sintilimab injection) plus BYVASDA (bevacizumab biosimilar injection) could potentially provide a new option for the first-line treatment of patients with advanced HCC.

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, stated: "In China, HCC is the fourth most common malignancy with the second highest mortality rate. More than half of new and fatal cases of HCC in the world occur in China every year. Despite the challenges and impact from the COVID-19 pandemic, the ORIENT-32 study was carried out smoothly and successfully under the joint efforts of all investigators and patients with their families. We are very pleased to see that the ORIENT-32 study demonstrated significant prolongation of OS and PFS in advanced HCC patients in China. With these encouraging results，we will apply to the National Medical Products Administration for the new drug application of TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection). We look forward to this potentially becoming a new treatment regimen that could help more patients with HCC to live longer without their disease worsening."

About ORIENT-32 Trial

ORIENT-32 is a Phase 3 randomized, open-label，multi-center study to evaluate the efficacy and safety of TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection) compared to sorafenib in the first-line treatment of patients with advanced hepatocellular carcinoma（ClinicalTrials.gov, NCT 03794440）. The primary endpoints of the trial are overall survival (OS) and progression-free survival (PFS) as assessed by Independent Radiographic Review Committee (IRRC) based on RECIST v1.1.

Enrolled patients were randomly assigned 2:1 to receive TYVYT (sintilimab injection) combination with BYVASDA (bevacizumab biosimilar injection) or sorafenib, until disease progression, unacceptable toxicity, withdrawal of consent, death, or other reasons stated in the protocol, whichever occurs first.

About Hepatocellular Carcinoma (HCC)

Primary liver cancer（PLC）is a common malignancy of the digestive system worldwide, among which about half new cases and deaths occur in China. The main pathological types of liver cancer are hepatocellular carcinoma (HCC), accounting for 85 to 90 percent, and a small number of cases of intrahepatic cholangiocarcinoma（ICC） and HCC-ICC mixed liver cancer. In China, HCC is primarily caused by hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection.

About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection), an innovative drug with global quality standards jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT (sintilimab injection) is the only PD-1 inhibitor included in the new Catalogue of the National Reimbursement Drug List (NRDL). In April 2020, the NMPA accepted the sNDA for TYVYT (sintilimab injection) in combination with ALIMTA (pemetrexed) and platinum chemotherapy as first-line therapy for the treatment of patients with nonsquamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT (sintilimab injection) monotherapy met the primary endpoint of overall survival in the Phase 2 ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma. In August 2020, the NMPA accepted the sNDA for TYVYT (sintilimab injection) in combination with GEMZAR (gemcitabine for injection) and platinum chemotherapy as first-line therapy in squamous NSCLC. In September 2020, TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection) as a first-line treatment in advanced hepatocellular carcinoma met the predefined primary endpoints of overall survival and progression-free survival in an interim analysis of the Phase 3 ORIENT-32 study.

TYVYT (sintilimab injection) is a fully human immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies for TYVYT (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. This includes global clinical research studies on TYVYT (sintilimab injection).

About BYVASDA (Bevacizumab Biosimilar Injection)

BYVASDA is a bevacizumab biosimilar and a recombinant humanized anti-VEGF monoclonal antibody drug. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF selectively with high affinity and blocks its binding to VEGF receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. BYVASDA produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. Since the launch of bevacizumab, it has been approved for the treatment of patients with multiple malignant tumors globally, including non-small cell lung cancer, metastatic colorectal cancer, glioblastoma, renal cell carcinoma, cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. The efficacy and safety of bevacizumab have been well recognized worldwide.