On April 23, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of uro-oncology, reported that it has entered into an agreement with Janssen Research & Development, LLC (Janssen) to conduct an early-stage feasibility evaluation in a therapeutic area of mutual interest (Press release, UroGen Pharma, APR 23, 2019, View Source [SID1234535329]). UroGen and Janssen will each conduct certain activities under the terms of the agreement.

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"We are excited to enter into this agreement with Janssen, an industry leader with a history of developing transformative therapies," said Liz Barrett, President and Chief Executive Officer of UroGen. "We maintain a strong commitment to bringing innovative treatments to patients in areas of unmet need."

On April 23, 2019 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported that it has entered into definitive agreements with institutional investors to purchase an aggregate of 9,375,000 units at a public offering price of $1.60 per unit in a registered direct offering (Press release, Moleculin, APR 23, 2019, View Source [SID1234535328]). Each unit is comprised of one share of common stock and 0.5 of a warrant to purchase one share of common stock.

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Each warrant will have an exercise price of $1.75 per share and is exercisable immediately. The warrants will expire five years from the date of issuance. The shares of common stock and the accompanying warrants included in the units can only be purchased together in this offering but will be issued separately and will be immediately separable upon issuance. The offering is expected to close on or about April 25, 2019, subject to customary closing conditions.

The gross proceeds of the offering are expected to be approximately $15.0 million, prior to deducting the placement agent fees and other estimated offering expenses.

Oppenheimer & Co. Inc. is acting as the sole placement agent for the offering. Roth Capital Partners, LLC and Maxim Group LLC are acting as financial advisors to the Company.

The Company intends to use the net proceeds of the offering to fund its planned clinical trials, preclinical programs, for other research and development activities and for general corporate purposes.

The securities described above are being offered pursuant to a prospectus supplement and an accompanying prospectus forming part of a shelf registration statement on Form S-3 (No. 333-219434) previously filed with and declared effective by the Securities and Exchange Commission (SEC). A final prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, by telephone at (212) 667-8055, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On April 23, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, reported a triple combination clinical trial of OncoSec’s TAVO, epacadostat, and KEYTRUDA in patients with squamous cell carcinoma head and neck (SCCHN) cancer (Press release, OncoSec Medical, APR 23, 2019, View Source [SID1234535327]). This study, the "TRIFECTA" study, will be conducted by the UCSF Helen Diller Family Comprehensive Cancer Center.

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TRIFECTA, formally entitled, "The Trifecta Study: Optimizing Antitumor Immunity Using Tavokinogene Telseplasmid with Electroporation, Pembrolizumab, and Epacadostat in Squamous Cell Carcinoma of the Head and Neck," will evaluate the combination use of OncoSec’s TAVO (intratumoral IL-12 tavokinogene telseplasmid), epacadostat (IDO inhibitor), and KEYTRUDA (pembrolizumab, an anti-PD1 monoclonal antibody) in patients with SCCHN cancer.

TRIFECTA will be an investigator-initiated clinical trial by UCSF otolaryngologist, Dr. Chase Heaton, to determine whether the triple combination can increase the overall response rate (ORR) in SCCHN compared with historical data for KEYTRUDA as a monotherapy. The costs of this clinical trial will be shared with others and will require minimal financial commitment from OncoSec.

The response rate in patients with unresectable SCCHN is very low when treated with anti-PD1 antibodies as a monotherapy, with only 13-16%1 2 durable remissions. Treatment failures are more common in patients whose tumors either lack anti-tumor immune cells or have an overabundance of regulatory immune cells that suppress effective anti-tumor immune responses. TAVO has previously demonstrated the ability to reverse this type of anti-PD-1 resistance in patients with metastatic melanoma.

"Effective anticancer immune responses require three steps, including immune priming and tumor infiltration with T cells; activation of partially exhausted TILs; and selective modulation of T cell populations to maximize the ratio of effector to regulatory immune cells," said Dr. Alain Algazi, Associate Professor of Clinical Medicine at UCSF and Clinical Strategic Advisor to OncoSec. "Based on this framework, we hypothesize that the combination of TAVO’s tumor infiltration mechanism, with pembrolizumab’s TIL technology and epacadostat’s T cell modulating capabilities will substantially increase the ORR to pembrolizumab in patients with SCCHN and that the combination will be well tolerated in this population."

TRIFECTA is a single-arm open-label clinical trial in which 35 evaluable patients will receive TAVO, pembrolizumab, and epacadostat. The primary endpoint of the study is overall response rate (ORR) by RECIST v1.1 and will be compared to historical data for pembrolizumab monotherapy in SCCHN and to existing data regarding the combination of pembrolizumab and epacadostat.

Melanoma patients in the anti-PD-1 refractory setting have found renewed clinical responses with the combination of KEYTRUDA with TAVO in the KEYNOTE-695 trial. TAVO’s mechanism of action may also enhance the activity of epacadostat as expression of IDO is driven by IFN-g, which, in TAVO-treated patients may create a broader target and therefore opportunity to limit this suppressive IDO axis. Due to its favorable safety profile, clinical activity and ability to trigger adaptive resistance (increases in both IDO and PD-L1 expression) via a robust IFN-g response, TAVO is a strong backbone for a combination strategy with epacadostat and Merck’s anti-PD-1 antibody, pembrolizumab.

"Supporting this investigator-initiated clinical is a very cost-effective way to learn if the three-way combination of TAVO, epacadostat and pembrolizumab can significantly improve the historical anti-PD-1 monotherapy durable remission response rate of 13-16%," said Daniel O’Connor, President and Chief Executive Officer of OncoSec. "Studies such as these continue to build on the body of clinical evidence in support of TAVO in a variety of combination therapies. We believe it is important to support investigator led studies such as this one, especially considering the prestige of the medical institution and the oncologists involved."

On April 23, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that it would present at the 2019 Bloom Burton & Co. Investor Conference (Press release, Oncolytics Biotech, APR 23, 2019, View Source [SID1234535326]). The presentation, by Dr. Matt Coffey, President & CEO of Oncolytics, will take place at 11:00 am ET, on Tuesday, April 30, 2019, at the Metro Toronto Convention Centre, Toronto, Ontario.

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A live audio link to the webcast session will be available on the Company’s website at View Source It is recommended that listeners log on 10 minutes in advance of the live session to register and download any necessary software. An audio replay will be accessible approximately two hours following the presentation on the Oncolytics website.

On April 23, 2019 Varian (NYSE: VAR) reported that The Nairobi West Hospital in Nairobi, Kenya is the first clinic in the country and in West, Central, and East Africa to begin treating cancer patients using the Halcyon radiotherapy system (Press release, Varian Medical Systems, APR 23, 2019, View Source [SID1234535324]). The Halcyon system simplifies and enhances virtually every aspect of image-guided volumetric intensity-modulated radiotherapy (IMRT), including improved patient comfort and shortening the time from installation to first-treatment without sacrificing quality. The system is well suited to treat a majority of cancer patients, offering advanced treatments for lung, prostate, breast, head & neck, and many other forms of cancer.

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The Halcyon system features a streamlined workflow that only requires nine steps from the start to the end of treatment compared to up to more than 30 steps with older technologies thereby reducing the total treatment time. To assist in the reduction of time and construction costs from installation to first patient treatment, Halcyon offers expedited commissioning, requires less shielding than traditional systems, can fit in the majority of existing small vaults, and can be installed in two weeks or less.

"The installation and treatments on the Halcyon system is a major achievement for patients and cancer care delivery in Kenya and in the region," said Sukhmeet Sandhu, chief executive officer, The Nairobi West Hospital. "The streamlined workflow and the advanced capabilities of the Halcyon system will have a positive impact on the increased number of cancer patients we can treat every year."

"At Varian we believe that by increasing access to advanced cancer care we can move closer to achieving a world without fear of cancer," said Jean-Luc Devleeschauwer, president, Varian Oncology Systems EMEIA. "We are proud of our collaboration with The Nairobi West Hospital on the installation of the Halcyon system. The whole process from our first meeting, to treatment room construction, to installation and staff training, only took nine months. I commend the Nairobi West Hospital and Varian teams for quickly bringing this advanced treatment capability to cancer patients in Kenya and the region."