On February 10, 2020 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), reported that Dr. Steven M. Fruchtman, President and Chief Executive Officer, will present a company update at NobleCon16 – Noble Capital Markets’ Sixteenth Annual Investor Conference, February 17-18, 2020, being held in Hollywood, FL (Press release, Onconova, FEB 10, 2020, View Source [SID1234554090]). Dr. Fruchtman and members of management will be available for 1×1 meetings during the conference.

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Presentation details
Date/Time: Monday, February 17th, 10:30 AM
Venue: Seminole Hard Rock Hotel & Casino, Hollywood, FL
Terrace Ballroom D
Presenter: Steven Fruchtman, CEO
A video webcast of the presentation will be available the following day on the Company’s website at View Source, and as part of a complete catalog of presentations available on Noble Capital Markets’ Conference website: www.nobleconference.com and on Channelchek: www.channelchek.com, the investor portal created by Noble. The webcast will be archived on the company’s website, the NobleCon website, and on Channelchek.com for 90 days following the event.

On February 10, 2020 FerGene, a newly created gene therapy company committed to revolutionizing the treatment of bladder cancer, reported it will present research at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium taking place February 13-15 in San Francisco, California (Press release, FerGene, FEB 10, 2020, View Source [SID1234554108]).

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FerGene will present two posters on high-grade, Bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC), including an analysis of real-world utilization and outcomes of bladder preservation therapies as well as safety and efficacy results from the Phase 3 study of nadofaragene firadenovec, the company’s investigational intravesical gene therapy in development for patients with high-grade, BCG-unresponsive NMIBC.

Details for the presentations are as follows:

Poster (Abstract 442)

Title: Safety and efficacy of intravesical nadofaragene firadenovec for patients with high-grade, BCG unresponsive nonmuscle invasive bladder cancer (NMIBC): Results from a Phase III Trial

Presented by Stephen A. Boorjian, MD; Professor of Urology, Vice Chair of Research for the Department of Urology, and the Director of the Urologic Oncology Fellowship at Mayo Clinic

Time: Friday, February 14, 2020, 7:20AM – 7:25AM (Rapid Abstract Presentation) and 12:15PM – 1:45PM PST

Poster (Abstract 453)

Title: Disease progression among patients who receive available bladder preservation therapies after failure of BCG therapy in the SEER-Medicare data

Senior Author: Ashish Kamat, MD; Professor of Urology and Director of Urologic Oncology Fellowship at MD Anderson Cancer Center

Time: Friday, February 14, 2020, 12:15PM – 1:45PM PST

About nadofaragene firadenovec

Nadofaragene firadenovec (rAd-IFN/Syn3) is an investigational intravesical gene therapy being developed as a treatment for patients with high-grade, BCG-unresponsive NMIBC. It is an adenovirus vector-based gene therapy containing the gene for interferon alfa-2b, administered by catheter into the bladder once every three months. The virus is designed to enter the cells of the bladder wall, where it breaks down, releasing the active gene to do its work. The internal gene/DNA machinery of the cells ‘picks up’ the gene and translates its DNA sequence, resulting in the production of high and durable quantities of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This novel gene therapy approach thereby uses the patient’s own bladder wall cells to produce interferon, enhancing the body’s natural defenses against the cancer.

A Biologics License Application for nadofaragene firadenovec has been submitted to the U.S. Food and Drug Administration (FDA) for the treatment of patients with high-grade, BCG-unresponsive NMIBC. The application was granted Priority Review, and nadofaragene firadenovec previously received Fast Track and Breakthrough Therapy Designations. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of May 2020.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

NMIBC is an early form of bladder cancer which is present in the superficial layer of the bladder and has not invaded deeper into the bladder or spread to other parts of the body.1 It is estimated that there will be approximately 81,000 new cases of bladder cancer in the U.S. in 2020; more than 70% of these cases present as NMIBC.2,3 In patients with high-grade NMIBC, intravesical BCG is the recommended treatment; however, between 30% and 50% of cases with high-grade disease will recur.4 The outcome for BCG-unresponsive patients is poor, with total cystectomy (complete removal of the bladder) often being the recommended next treatment option.5

On February 10, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that the Company will release its fourth quarter and full year 2019 financial results on Thursday, February 20, 2020 before the U.S. financial markets open (Press release, Compugen, FEB 10, 2020, View Source [SID1234554124]). Management will host a conference call and webcast to review the results and provide a corporate update at 8:30 AM ET.

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To access the live conference call by telephone, please dial 1-888-407-2553 from the U.S.,
or +972-3-918-0610 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

On February 10, 2020 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported the availability of updated results from the Phase II CALYPSO study of the savolitinib / Imfinzi (durvalumab) combination in a cohort of patients with metastatic papillary renal cell carcinoma ("PRCC"), an investigator initiated study led by Professor Thomas Powles, Lead for Solid Tumour Research at Barts Cancer Centre, and sponsored by Queen Mary University of London (Press release, Hutchison China MediTech, FEB 10, 2020, https://www.chi-med.com/calypso-data-in-prcc-at-2020-asco-gu/ [SID1234554069]).

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Full data from the PRCC cohort of the CALYPSO study will be presented on Saturday, February 15, 2020, in oral and poster presentations at the annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium ("ASCO GU") in San Francisco, CA.

Further details from the presentation are as follows:

Presentation Title: Overall survival results for durvalumab and savolitinib in metastatic papillary renal cancer
Presenting Author: Cristina Suarez Rodriguez, Vall d’Hebron University Hospital and Institute of Oncology, Barcelona, Spain
Other Authors: Thomas Powles, James M. G. Larkin, Poulam Patel, Begoña Pérez-Valderrama, Alejo Rodriguez-Vida, Hilary Glen, Fiona Thistlethwaite, Christy Ralph, Srinivasan Gopalakrishnan, Maria Jose Mendez-Vidal, Kelly Mousa, Aaron Prendergast, Laura Vosper, Wing-Kin Liu
Abstract #: 619 / Board D5
Oral Presentation: Rapid Abstract Session C: Renal Cell Cancer
Date & Time: Saturday, February 15: 11:35 AM-12:30 PM PST
Poster Presentation: Session C: Renal Cell Cancer
Date & Time: Saturday, February 15: 7:00 AM-7:55 AM PST
Preliminary results of this study (cut-off date of September 25, 2018) were first presented on February 16, 2019 at ASCO (Free ASCO Whitepaper)-GU.[i]

About PRCC in the CALYPSO study
PRCC is a subtype of kidney cancer that is unusually difficult to treat, with low response rates from current treatment options and no treatments approved for this specific indication. The CALYPSO study is an independently sponsored open-label Phase II study of Imfinzi in combination with several drug candidates in the treatment of renal cell carcinoma in the U.K. and Spain. Several arms of CALYPSO are evaluating the treatment of PRCC and clear cell renal carcinoma (ccRCC) with savolitinib, a highly selective inhibitor of the MET receptor tyrosine kinase, both as a monotherapy and in combination with Imfinzi (durvalumab), AstraZeneca’s anti-programmed death-ligand 1 (PD-L1) antibody. CALYPSO enrolls an all-comer PRCC population with planned retrospective molecular profiling. For further details, please refer to clinicaltrials.gov number NCT02819596.

About Savolitinib
Savolitinib is a potential first-in-class inhibitor of MET, an enzyme which has been shown to function abnormally in many types of solid tumors. Chi-Med designed savolitinib to be a potent and highly selective oral inhibitor, which, through chemical structure modification, addresses human metabolite-related renal toxicity, the primary issue that halted development of several other selective MET inhibitors. In clinical studies to date, involving over 1,000 patients, savolitinib has shown promising signs of clinical efficacy in patients with MET gene alterations in multiple tumor types with an acceptable safety profile. Chi-Med is currently testing savolitinib in global partnership with AstraZeneca, both as a monotherapy and in combination with immunotherapy, targeted therapy and chemotherapy drugs.

On February 7, 2020, OncoSec Medical Incorporated (the "Company") reported the closing (the "Closing") of its previously announced strategic transaction (the "Transaction") with Grand Decade Developments Limited, a direct, wholly-owned subsidiary of China Grand Pharmaceutical and Healthcare Holdings Limited, a company formed under the laws of the British Virgin Islands ("CGP"), and its affiliate, Sirtex Medical US Holdings, Inc., a Delaware corporation ("Sirtex" and, together with CGP, the "Buyers") (Filing, 8-K, OncoSec Medical, FEB 10, 2020, View Source [SID1234554091]). On October 10, 2019, the Company and the Buyers entered into Stock Purchase Agreements (as amended, the "Purchase Agreements") pursuant to which the Company agreed to sell and issue to CGP and Sirtex 10,000,000 shares and 2,000,000 shares, respectively, of the Company’s common stock for a total purchase price of $30 million.

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As contemplated by the Purchase Agreements, and in connection with the Closing, on February 7, 2020, the Company entered into Registration Rights Agreements with each of CGP and Sirtex (the "Registration Rights Agreements"), pursuant to which, among other things, CGP and Sirtex will each have the right to deliver to the Company a written notice requiring the Company to prepare and file with the Securities and Exchange Commission a registration statement with respect to resales of shares of some or all of the common stock of the Company held by CGP and Sirtex.

The description of the Registration Rights Agreements does not purport to be complete and is subject to, and qualified in its entirety by the full text of the Registration Rights Agreements, copies of which are filed as Exhibits 4.1 and 4.2 to this Current Report and are incorporated by reference herein.

Concurrently with the execution and delivery of the Purchase Agreements, the Company and CGP entered into a License Agreement (the "License Agreement"), which became effective upon the Closing. In addition, the Company and Sirtex entered into a Services Agreement (the "Services Agreement") which also became effective upon the Closing. For a full description of both the License Agreement and Services Agreement, see the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 11, 2019.