On May 6, 2019 Magenta Therapeutics, Inc. (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplant to more patients, reported that it has launched a proposed public offering of 4,250,000 shares of its common stock (Press release, Magenta Therapeutics, MAY 6, 2019, View Source [SID1234535786]).

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All shares of common stock will be offered by Magenta. Magenta expects to grant the underwriters a 30-day option to purchase up to an additional 637,500 shares of common stock. Magenta intends to use the net proceeds of the offering to advance its lead conditioning programs through preclinical studies and into Phase 1 clinical trials; to advance its first-line mobilization program, MGTA-145, through Phase 1 and into Phase 2 clinical trials; and to advance its cell therapy program, MGTA-456, through Phase 2 and into Phase 3 clinical trials. The remainder of the net proceeds will be used for research and development, working capital, and general corporate purposes. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the proposed offering.

J.P. Morgan, Goldman Sachs & Co. LLC and Cowen are acting as joint book running managers for the offering. Wedbush PacGrow is acting as lead manager for the offering.

The proposed offering will be made only by means of a prospectus. A preliminary prospectus supplement and accompanying prospectuses relating to and describing the terms of this offering has been filed with the U.S. Securities and Exchange Commission (the "SEC"). When available, copies of the preliminary prospectus may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 866-803-9204; Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, telephone: 631-274-2806.

Important Information

A registration statement relating to these securities has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any offer or sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On May 5, 2019 UroGen Pharma Ltd. (Nasdaq: URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, reported findings from a secondary analysis from the pivotal Phase 3 OLYMPUS trial which showed that UGN-101 (mitomycin gel) for instillation, an investigational mitomycin formulation, demonstrated a 59 percent complete response rate in a subset of patients with endoscopically unresectable low-grade upper tract urothelial cancer (UTUC) (Press release, UroGen Pharma, MAY 5, 2019, View Source [SID1234535721]). Findings were presented by Seth Paul Lerner, M.D., FACS, Professor of Urology at Baylor College of Medicine, in an oral presentation during the plenary session at the 114th American Urological Association (AUA) Annual Meeting in Chicago.

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The analysis showed that in the OLYMPUS intent-to-treat population, 71 patients had undergone PDE at the time of the analysis and 42 of the 71 patients (59 percent) achieved a CR. Forty-one patients entered follow-up. Of the evaluated complete responses to date, 27 patients have undergone a six-month evaluation, and 24 out of 27 patients (89 percent) have remained disease free at six months. Overall, 5 of 41 patients who achieved a CR have relapsed at any time during the study.

Of these 71 patients, 34 were initially characterized by the treating physician as having endoscopically unresectable tumor at baseline, and 20 of 34 of these patients (59 percent) achieved a CR at the PDE.

*Forty-one patients entered follow-up. At the time of the analysis, 66 percent (27/41) of patients have completed a six-month evaluation.

The most common adverse events observed were urinary tract infection, ureteral narrowing and stricture formation. The majority of ureteral events were reported as mild to moderate and have resolved.

"The results from the OLYMPUS trial continue to be compelling for new and recurrent LG UTUC, as well as for those who have unresectable tumors and would be immediate candidates for kidney removal. For this typically elderly patient population, kidney preservation is paramount, and these findings provide evidence-based support for the concept of chemoablation with UGN-101 as an initial kidney-sparing treatment option for low-grade UTUC," said Mark P. Schoenberg, MD, Chief Medical Officer at UroGen. "The analysis also advances our understanding of durability of response, which we are pleased to see has remained consistent as the number of patients who reach the six-month follow-up timepoint increases."

The Company initiated its rolling submission of the UGN-101 New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in December 2018. The FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to UGN-101 for the treatment of UTUC. If approved, UGN-101 would be the first drug approved for the non-surgical treatment of LG UTUC.

About The Phase 3 OLYMPUS Trial

OLYMPUS (Optimized DeLivery of Mitomycin for Primary UTUC Study) is a pivotal, open-label, single-arm Phase 3 clinical trial of UGN-101 (mitomycin gel) for instillation to evaluate the safety, tolerability and tumor ablative effect of UGN-101 in patients with low-grade UTUC. The trial enrolled 71 patients at clinical sites across the United States and Israel. Study participants were treated with six weekly instillations of UGN-101 administered via a standard catheter. Four to six weeks following the last instillation, patients underwent a primary disease evaluation (PDE) to determine response, the primary endpoint of the study. PDE involved a ureteroscopy and wash cytology, a standard microscopic test of cells obtained from the urine to detect cancer. Patients who achieved a complete response at the PDE timepoint were then followed for up to 12 months to determine the durability of disease control with UGN-101.

About UGN-101

UGN-101 (mitomycin gel) for instillation is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of low-grade upper tract urothelial cancer (LG UTUC). Utilizing the RTGel technology platform, UroGen’s proprietary sustained release, hydrogel-based formulation, UGN-101 is designed to enable longer exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-101 is delivered to patients using standard ureteral catheters. The Company initiated its rolling submission of the UGN-101 New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in December 2018. The FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to UGN-101 for the treatment of UTUC. If approved, UGN-101 would be the first drug approved for the non-surgical treatment of LG UTUC.

On May 5, 2019 Harbour BioMed and Chia Tai Tianqing Pharmaceutical Group Ltd. (CTTQ) reported they are entering into a strategic alliance to discover, develop and commercialize next-generation biologics for multiple therapeutic targets in oncology and immunology (Press release, Harbour BioMed, MAY 5, 2019, View Source [SID1234535722]).

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The collaboration will combine Harbour BioMed’s discovery capabilities, including its transgenic mouse technologies for generating fully human antibodies, with CTTQ’s preclinical development resources and expertise. The companies will be responsible for clinical development and commercialization of therapeutic candidates emerging from the collaboration in their respective regions. Harbour BioMed will be responsible for the United States, Japan, and the rest of the world outside, while CTTQ will have responsibility for Greater China and Europe. The companies will pay royalties to each other based on sales in their respective territories. Additional financial terms were not disclosed.

"The agreement with CTTQ, is part of our strategy to build a robust therapeutic pipeline for global markets through co-discovery, development and commercialization partnerships that capitalize on our patented platforms for generating fully human antibodies," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. "CTTQ, a well-known pharmaceutical company that is making strategic investments in therapeutic innovation in oncology and immunology, is a strong partner in that effort and directly complements our internal discovery programs," added Dr. Wang. It is expected that both sides will jointly own the IP and development and commercialization rights for the new drugs coming out of this collaboration.

"CTTQ will be committed to bring valuable treatment agents for diseases with unmet need. The collaboration with Harbour BioMed is well aligned with CTTQ’s strategy for innovative biological medicine development, it also marks significant progress to strengthen our capability of R&D of innovative therapeutic antibodies," said Shanchun Wang, President of CTTQ. CTTQ currently has several monoclonal antibody drugs, including a PD-L1 inhibitor, which have progressed into Phase 2 and Phase 3 clinical development.

On May 4, 2019 ESSA Pharma Inc. (Nasdaq: EPIX; TSX-V: EPI), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported new preclinical data on ESSA’s lead Investigational New Drug ("IND") candidate at the 2019 American Urological Association ("AUA") Annual Meeting (Press release, ESSA, MAY 4, 2019, View Source [SID1234535723]).

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In an oral poster presentation, "A New Generation of N-terminal Domain Androgen Receptor Inhibitors in Castration-Resistant Prostate Cancer Models", a deeper preclinical characterization of EPI-7386 was presented. The studies demonstrate that, pre-clinically, EPI-7386:

Displays similar in vitro IC50 potency compared to the ‘lutamide class of antiandrogens in an in vitro androgen receptor (AR) inhibition assay.
Shows in vitro activity in several enzalutamide-resistant prostate cancer cell models in which enzalutamide is resistant.
Exhibits a favorable metabolic profile across three preclinical animal species, which suggests that EPI-7386 will have high exposure and a long half-life in humans.
Provides similar antitumor activity to enzalutamide in the enzalutamide-sensitive LNCaP prostate cancer xenograft model.
Provides superior antitumor activity to enzalutamide, as a single agent or in combination with enzalutamide, in the enzalutamide-resistant VCaP prostate cancer xenograft model.
AR inhibition with both an N-terminal domain inhibitor (EPI-7386) and a ligand binding domain inhibitor (enzalutamide), induces deeper and more consistent anti-tumor responses in the enzalutamide-resistant VCaP xenograft model.
"The variety of in vitro and in vivo studies examining both antiandrogen sensitive models and antiandrogen-resistant xenograft mouse models show a favorable preclinical profile of EPI-7386. From this and an aggregate of other preclinical data, we nominated EPI-7386 as the IND candidate to be used in the clinic in mCRPC patients failing current antiandrogen therapy. EPI-7386 represents a novel approach to targeting the androgen receptor, one of the most validated targets in oncology," said Dr. David R. Parkinson, President & Chief Executive Officer. "We look forward to providing further details of the preclinical profile of EPI-7386 later in the year as we move close to our anticipated IND filing in the first quarter of 2020."

On May 3, 2019 Corcept Therapeutics Incorporated (NASDAQ: CORT) reported it will report first quarter financial results and provide a corporate update on May 9, 2019 (Press release, Corcept Therapeutics, MAY 3, 2019, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announce-first-quarter-financial-results-4 [SID1234535692]). The company will also host a conference call that day at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time).

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Conference Call Information

To participate, dial 1-800-347-6311 from the United States or 1-323-994-2132 internationally approximately ten minutes before the start of the call. The passcode will be 4773625.