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AVEO Oncology Announces $2M Milestone Payment From EUSA Pharma Related To Commercialization of FOTIVDA® in Spain

On April 23, 2019 AVEO Oncology (NASDAQ:AVEO) reported the triggering of a $2 million milestone payment to AVEO from EUSA Pharma (Press release, AVEO, APR 23, 2019, View Source [SID1234535332]). The milestone payment relates to the reimbursement approval and commercial launch in Spain of FOTIVDA (tivozanib) as a first line treatment of adult patients with advanced renal cell carcinoma (RCC). Commercial launch in Spain is the third of five EU5 country launches to trigger a $2 million payment under the terms of AVEO’s license agreement with EUSA Pharma. In the European Union, Norway and Iceland, tivozanib is indicated for the first line treatment of adult patients with RCC and for adult patients who are vascular endothelial growth factor receptor (VEGFR) and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for RCC. Tivozanib is an oral, once-daily, potent and highly-selective vascular endothelial growth factor receptor tyrosine kinase inhibitor.

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"We are pleased to see Spain recognize the benefit of patient access to FOTIVDA and continued expansion of the FOTIVDA commercial footprint in Europe," said Michael Bailey, president and chief executive officer of AVEO. "We continue to work toward reporting more mature interim overall survival results from our TIVO-3 study in the fourth quarter of 2019, and remain confident in the significant commercial potential for a VEGF therapy that has demonstrated activity and tolerability in all lines of RCC therapy, including highly refractory patients with prior exposure to PD-1 therapy."

EUSA Pharma is the licensee for tivozanib in Europe, North and South Africa, Latin America and Australasia. Under the terms of their December 2015 agreement, EUSA Pharma has agreed to pay AVEO up to $382 million in future research and development funding and milestone payments, assuming successful achievement of specified development, regulatory and commercialization objectives, as well as a tiered royalty ranging from a low double-digit up to mid-twenty percent on net sales of tivozanib in the agreement’s territories. Thirty percent of milestone and royalty payments received by AVEO, excluding research and development funding, are due to Kyowa Hakko Kirin (KHK) as a sublicensing fee in Europe. In the United States, the royalty obligation to KHK would range from the low- to mid-teens on net sales upon approval and commercialization.

About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Hakko Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal and breast cancers. In addition, a new formulation of tivozanib is in pre-clinical development for the treatment of age-related macular degeneration.

Personalis, Inc. to Present at European NeoAG Summit 2019

On April 23, 2019 Personalis, Inc., a leader in advanced genomics for cancer, reported that the company will present at European NeoAG Summit 2019 in Amsterdam on April 24th at 2:30 PM CEST (Press release, Personalis, APR 23, 2019, View Source [SID1234535331]).

The presentation, entitled "ImmunoID NeXT Platform: Improving Neoantigen Prediction, TME Assessment, and ctDNA Detection for Vaccine Development," will introduce Personalis’ new universal cancer immunogenomics platform, ImmunoID NeXT. In addition to an overview, the presentation will highlight innovative genomics methods for more comprehensive assessment of neoantigens, which include improving neoantigen-to-MHC binding prediction and ranking and assessing TME/TCR and tumor escape mechanisms that may impact vaccine response.

ImmunoID NeXT is the first platform to provide comprehensive analysis of both a tumor and its immune microenvironment from a single sample. The platform can be used to investigate the key tumor- and immune-related areas of cancer biology, consolidating multiple oncology biomarker assays into one. This maximizes the biological information that can be generated from a precious tumor specimen.

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

GlycoMimetics Announces Enrollment of First Patient in NCI-Sponsored Phase 3 Trial of Uproleselan in AML

On April 23, 2019 GlycoMimetics, Inc. (NASDAQ: GLYC) reported dosing of the first patient in a Phase 3 clinical trial being conducted under the auspices of a Cooperative Research and Development Agreement (CRADA) between GlycoMimetics and the National Cancer Institute (NCI), part of the National Institutes of Health (Press release, GlycoMimetics, APR 23, 2019, View Source [SID1234535330]). The second in a series of trials designed to evaluate uproleselan across the continuum of care in AML, this NCI-sponsored study is evaluating the addition of uproleselan to a standard cytarabine/daunorubicin regimen (7&3) in older adults with previously untreated AML who are suitable for intensive chemotherapy. A third trial, to be conducted by the European HOVON consortium, is expected to initiate later this year.

"The initiation of the NCI-sponsored trial is an important milestone for our uproleselan program, a drug candidate with the potential to address significant unmet treatment needs across the spectrum of AML," noted Helen Thackray, M.D., FAAP, GlycoMimetics Senior Vice President, Clinical Development, and Chief Medical Officer. "Along with our global pivotal Phase 3 clinical trial testing the investigational drug in patients with relapsed/refractory acute myeloid leukemia, this trial will facilitate our growing understanding of how uproleselan may fit into the continuum of care for individuals living with AML."

GlycoMimetics is collaborating with both the NCI and the Alliance for Clinical Trials in Oncology to conduct the trial, which is led by Geoffrey Uy, M.D., Associate Professor of Medicine, Bone Marrow Transplantation and Leukemia, Washington University School of Medicine in St. Louis. The primary endpoint will be overall survival, with a planned interim analysis based on event-free survival (EFS) after the first 250 patients have been enrolled in the study. More information on this clinical trial can be found at www.clinicaltrials.gov.

New data on uproleselan-treated high-risk patients with both relapsed/refractory and newly diagnosed AML were presented at an oral session during the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2018. An analysis of clinical outcomes from the Phase 1/2 clinical study showed that uproleselan (GMI-1271) resulted in the majority of evaluable patients achieving a stringent level of measurable residual disease (MRD) negativity, an effect which translated into extended survival relative to matched, historical controls.

About Uproleselan (GMI-1271)

uproleselan (yoo’ pro le’ sel an) is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed/refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better than expected remission rates and overall survival compared to historical controls, which have been derived from results from third party clinical trials evaluating standard chemotherapy, as well as lower than expected induction-related mortality rates. Treatment in these patient populations was generally well tolerated, with fewer than expected adverse effects. The U.S. Food and Drug Administration (FDA) has granted uproleselan Breakthrough Therapy Designation for the treatment of adult AML patients with relapsed/refractory (R/R) disease. GlycoMimetics is implementing a comprehensive development program across the clinical spectrum of AML.

UroGen Pharma Announces Early Stage Feasibility Agreement with Janssen

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.

"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."

Moleculin Announces $15.0 Million Registered Direct Offering

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.

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.