On November 21, 2019 Clover Biopharmaceuticals, a global clinical-stage biotechnology company focused on developing novel and transformative biologic therapies, reported that the first patient was dosed in a Phase I trial of SCB-313, an investigational fully-human TRAIL-Trimer fusion protein, in Australia for the treatment of cancer patients with malignant pleural effusions (MPE) (Press release, Clover Biopharmaceuticals, NOV 21, 2019, View Source [SID1234551590]). There are now five clinical studies evaluating SCB-313 open to recruiting patients in China and Australia across three oncology indications (malignant ascites, peritoneal carcinomatosis, and malignant pleural effusions).

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"MPE has historically posed significant challenges for both patients and clinicians, and it remains a high unmet medical need for many cancer patients worldwide," said Dr. Y. C. Gary Lee, Director of Pleural Medicine at Sir Charles Gairdner Hospital, Perth, Australia.

The Phase I, open-label, dose escalation trial in Australia is designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of intrapleural administered SCB-313 for the treatment of MPE. Several sites in Australia, including Dr. Lee’s unit, are participating in this study.

"We are excited to work with these world-class investigators and sites participating in this study," said Dr. Min Dong, Executive Vice President, Global Clinical Development at Clover. "Now that Clover has successfully initiated clinical studies evaluating SCB-313 in multiple countries, we hope to bring this novel and potentially first-in-class therapy to patients worldwide."

"TRAIL has long been considered a tantalizing target for cancer therapy because it can induce apoptosis in a tumor-specific manner across many different tumor types. SCB-313, which utilizes our proprietary Trimer-Tag© technology, is able to potently and uniquely target this trimerization-dependent pathway," said Dr. Peng Liang, co-founder, Chairman and President of Clover. "We believe that SCB-313 has the potential to be a best-in-class TRAIL-based therapy based on our R&D results to date, and in the months ahead, we look forward to initiating multiple new clinical studies for the treatment of intracavitary cancers."

On November 21, 2019 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that the company will present at the NeoAg Summit US 2019 in Boston on November 21st at 9:15 AM EST (Press release, Personalis, NOV 21, 2019, View Source [SID1234551591]).

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The presentation, entitled "ImmunoID NeXT: A Comprehensive Platform for Improving Neoantigen Prediction, Tumor Escape Mechanism Reporting, TME Assessment, and Tumor Heterogeneity Profiling for Immuno-Oncology," will provide an overview of Personalis’ newly-launched cancer immunogenomics platform, specifically highlighting innovative machine learning-based methods for the comprehensive identification of neoantigens and the detection of emerging and novel biomarkers of response and resistance to immunotherapy.

ImmunoID NeXT is 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.

The presentation will be delivered by Sean M. Boyle, PhD, Sr. Director, Bioinformatics Applications for Personalis.

Personalis will also be exhibiting during the conference (Exhibit #9). Representatives will be available to answer questions about the company’s cancer immunogenomics capabilities.

On November 21, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with a focus on myelodysplastic syndromes (MDS), reported they have entered into a Distribution, License and Supply Agreement with Knight Therapeutics Inc. ("Knight"), a Canadian-based specialty pharmaceutical company focused on acquiring, in-licensing, selling and marketing innovative prescription and over-the-counter pharmaceutical products, whereby Knight shall have the exclusive rights to commercialize rigosertib in Canada (Press release, Onconova, NOV 21, 2019, View Source [SID1234551573]). In addition, Onconova may be entitled to receive clinical, regulatory and sales-based milestone payments up to CAD 33.95 million and tiered double-digit royalties on net sales.

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"We are pleased to add Knight to our roster of global partners for rigosertib," said Dr. Steven Fruchtman, President and Chief Executive Officer of Onconova. "We are eager to work with Knight’s team, which has successfully partnered with a number of biotechnology companies to commercialize innovative medicines in Canada."

"Patients with high-risk MDS have limited treatment options after first-line hypomethylating agents such as azacitidine fail," said Jonathan Ross Goodman, Chief Executive Officer of Knight. "If approved, rigosertib would address this unmet need and we look forward to the results of the ongoing phase III INSPIRE trial of IV rigosertib."

About Myelodysplastic Syndromes

MDS is a group of blood disorders that affect bone marrow function, whereby the bone marrow cells appear dysplastic and their capacity to produce cells is defective. As a result, patients with MDS have low blood cell counts and require frequent blood transfusions. In approximately one-third of patients, higher-risk MDS can progress to acute myelogenous leukemia (AML).

The Leukemia and Lymphoma Society of Canada estimates that there are between 1,800 and 5,900 new cases of MDS diagnosed in Canada each year. MDS is typically diagnosed in older individuals, and most patients diagnosed with the disease are over the age of 60. Approximately 23% of cases can be classified as having high risk or very high risk MDS as per the revised International Prognostic Scoring System (IPSS-R)1.

About Rigosertib

Rigosertib, Onconova’s lead candidate, is a proprietary Phase 3 small molecule. A key publication in a preclinical model demonstrated rigosertib’s ability to block cellular signaling by targeting RAS effector pathways (Divakar, S.K., et al., 2016: "A Small Molecule RAS-Mimetic Disrupts RAS Association with Effector Proteins to Block Signaling." Cell 165, 643). Onconova is currently in the clinical development stage with oral and IV rigosertib, including clinical trials studying single agent IV rigosertib in second-line higher-risk MDS patients (pivotal Phase 3 INSPIRE trial) and oral rigosertib plus azacitidine in first-line and refractory higher-risk MDS patients (Phase 2). Patents covering oral and injectable rigosertib have been issued in the US and are expected to provide coverage until at least 2037.

About the INSPIRE Phase 3 Clinical Trial

The clinical trial INternational Study of Phase 3 IV RigosErtib, or INSPIRE, was finalized following guidance received from the U.S. Food and Drug Administration and European Medicines Agency. INSPIRE is a global, multi-center, randomized, controlled study to assess the efficacy and safety of IV rigosertib in higher-risk MDS (HR-MDS) patients who had progressed on, failed to respond to, or relapsed after previous treatment with a hypomethylating agent (HMA) within nine cycles over the course of one year after initiation of HMA treatment. This time frame optimizes the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines. Patients are randomized at a 2:1 ratio into two study arms: IV rigosertib plus Best Supportive Care versus Physician’s Choice plus Best Supportive Care. The primary endpoint of INSPIRE is overall survival. The trial continued beyond the pre-specified interim analysis and is nearing its conclusion. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443).

On November 21, 2019 BostonGene Corporation (BostonGene), a Boston-based biomedical software company, reported that as a result of its collaborations, multiple abstracts have been accepted for presentation at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition to be held December 7-10, 2019 in Orlando, Florida (Press release, BostonGene, NOV 21, 2019, View Source [SID1234551593]). In addition, BostonGene will exhibit at booth #152 in Hall B.

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The presentations will provide results demonstrating the role of the tumor microenvironment in cancer classification and treatment outcomes. By combing whole exome and transcriptome sequencing analysis, the significance of stromal and immune compartments of microenvironment in therapeutically relevant categories of Mantle Cell Lymphomas and Diffuse Large B-Cell Lymphoma (DLBCL) is identified.

POSTER PRESENTATION

Sunday, December 8, 2019: 6:00 PM – 8:00 PM in Hall B, Level 2

Title: Tumor Microenvironment Molecular Signatures That Define Therapeutic Resistance in Mantle Cell Lymphoma (Abstract 2762)
Presenter: Krystle Nomie, The University of Texas MD Anderson Cancer Center
Session: 621. Lymphoma—Genetic/Epigenetic Biology: Poster II
ORAL PRESENTATION

Monday, December 9, 2019: 10:45 AM in Tangerine 2 (WF2), Level 2

Title: Microenvironmental Signatures Reveal Biological Subtypes of Diffuse Large B-Cell Lymphoma (DLBCL) Distinct from Tumor Cell Molecular Profiling (Abstract 656)
Presenter: Leandro Cerchietti, MD, Weill Cornell Medicine
Session: 622. Lymphoma Biology—Non-Genetic Studies: Tumor Microenvironment
Additional information on abstracts for the ASH (Free ASH Whitepaper) Annual Meeting can be found here: View Source

"We are excited to share our success as a strategic collaborator with two of the leading cancer centers in the world at this year’s ASH (Free ASH Whitepaper) event. We look forward to showcasing our innovative platform that will ultimately impact and improve cancer patients’ chances for survival," said Andrew Feinberg, President & CEO at BostonGene.

On November 21, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with a focus on myelodysplastic syndromes (MDS), reported that it has priced a public offering of an aggregate of 55,000,000 shares of Onconova’s common stock (or common stock equivalents), together with accompanying common stock warrants, at a public offering price of $0.20 per share and associated warrant (Press release, Onconova, NOV 21, 2019, View Source [SID1234551574]). Each share of common stock (or common stock equivalent) was sold in the offering together with a common warrant to purchase one share of common stock at an exercise price of $0.20 per share. The common stock warrants are exercisable immediately and will expire five years from the date of issuance. The offering was led by healthcare dedicated funds and included officers and directors of Onconova.

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

The gross proceeds to Onconova from this offering are expected to be $11.0 million, before deducting the placement agent’s fees and other estimated offering expenses payable by Onconova, assuming none of the warrants to be issued in this offering are exercised. The offering is expected to close on or about November 25, 2019, subject to the satisfaction of customary closing conditions.

Onconova anticipates using the net proceeds from the offering to fund the development of its clinical and preclinical programs, for other research and development activities and for general corporate purposes, which may include capital expenditures and funding working capital needs.

The securities described above are being offered by Onconova pursuant to a registration statement (File No. 333-234360) previously filed with and declared effective by the Securities and Exchange Commission (the "SEC") on November 21, 2019. A preliminary prospectus relating to the securities being offered was filed with the SEC on November 21, 2019 and is available on the SEC’s website at View Source Electronic copies of the final prospectus relating to the offering may be obtained, when available, by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source

This announcement is neither an offer to sell, nor a solicitation of an offer to buy, any of these securities and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such offer, solicitation or sale is unlawful. Any offer, if at all, will be made only by means of the prospectus forming a part of the effective registration statement.