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.

On November 21, 2019 Onco360, the nation’s largest independent Oncology Pharmacy, reported that it has been selected by BeiGene to be a specialty pharmacy network partner for BRUKINSA (zanubrutinib), a new oral treatment for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy (Press release, Onco360, NOV 21, 2019, View Source [SID1234551594]).

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"The approval of BRUKINSA as a second-line therapy option for patients with relapsed and refractory MCL is an important advancement in fighting this devastating disease"

"The approval of BRUKINSA as a second-line therapy option for patients with relapsed and refractory MCL is an important advancement in fighting this devastating disease," said Paul Jardina, President and CEO, Onco360. "As a specialty pharmacy dedicated to serving people with cancer, Onco360 is pleased to be one of a few pharmacies bringing this new innovative treatment to MCL patients."

According to the American Cancer Society, Mantle cell lymphoma is a type of non-Hodgkin’s lymphoma representing 3-10% of all non-Hodgkin’s lymphomas in the United States. By the time it is diagnosed, mantle cell lymphoma has usually spread to the lymph nodes, bone marrow and other organs. In relapsed lymphoma, the disease reappears or grows again after a period of remission, while in refractory lymphoma, the disease does not respond to treatment or responds only briefly.

BRUKINSA is manufactured by BeiGene, a global, commercial-stage, research-based biotechnology company, and was approved by the U.S. Food and Drug Administration (FDA) to treat adult patients with MCL on November 14, 2019. The FDA’s approval of BRUKINSA is based on efficacy results from two single-arm clinical trials, with independent review committee (IRC)-assessed ORR per 2014 Lugano Classification as the primary endpoint. Across both trials, BRUKINSA achieved an ORR, which is the sum of complete responses and partial responses, of 84%. For full prescribing information, visit BRUKINSA.com.

On November 21, 2019 Azeria Therapeutics (Azeria), a newly formed pioneer factor drug discovery company, reported a £32 million Series B financing in which Syncona has committed £29.5 million alongside existing investor the CRT Pioneer Fund (Press release, Azeria Therapeutics, NOV 21, 2019, View Source [SID1234551575]).

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Azeria was originally founded in 2017 by Sixth Element Capital, manager of the CRT Pioneer Fund and Cancer Research UK’s Commercial Partnerships team with the aim of building a world class pioneer factor1 oncology company, developing breakthrough treatments for hormone resistant breast cancer patients. It was based on the work of leading expert in the field, Professor Jason Carroll at the Cancer Research UK Cambridge Institute, University of Cambridge, UK, whose scientific insights have led to a new approach to target FOXA1 driven cancer.

FOXA1 is an essential pioneer factor which has been shown to be pivotal in the tumour growth, progression and maintenance of oestrogen receptor positive luminal breast cancer. This is an area of significant unmet patient need where approximately 30 per cent of patients progress to late stage endocrine resistant disease2 and where there is potential for new treatments to have significant impacts for patients not addressed by existing therapeutics. Extensive target validation and drug discovery work to date supports the lead programme, with a plan to take the programme into the clinic over the course of the Series B funding. Azeria is seeking to develop the programme to commercialisation and to explore a pipeline of further programmes in oncology.

Azeria received initial investment of £5.5 million in Series A financing from the CRT Pioneer Fund, which focuses on early stage investments in highly innovative oncology programmes. Syncona is the largest investor in the CRT Pioneer Fund and will now participate directly in the next stage of growth and development. Magda Jonikas and Martin Murphy of Syncona will now join the Board of Azeria.

Stephen Myatt, Chief Executive Officer of Azeria Therapeutics said:

"Azeria is the product of more than ten years of research by Professor Jason Carroll at Cancer Research UK’s Cambridge Institute, University of Cambridge and was created to accelerate research and development into pioneer factors, a completely new target class in oncology including FOXA1. We would like to thank Sixth Element Capital for their continued support and look forward to working closely with Syncona to accelerate the development of breakthrough treatments for hormone resistant breast cancer patients."

Martin Murphy, Chief Executive of Syncona Investment Management Limited, said:

"Azeria is an exciting company and a perfect fit for Syncona’s long term strategy building globally leading healthcare companies. Based on unique, proprietary scientific insight, with a world class academic founder and high-quality team, the company has an opportunity to develop and commercialise treatments which could make a significant difference for patients. The Sixth Element team did an excellent job in identifying and investing in this science to take it to the point where it became an exciting and appropriate opportunity for Syncona."

1 A pioneer factor is a specialised type of transcription factor, able to ‘open’ compacted DNA to which is a protein that can initiate the expression of genes to make sure they are expressed in the right cell at the right time. Changes in these specific expression patterns can drives certain cancers.