On February 8, 2018 GlycoMimetics, Inc. (NASDAQ: GLYC) reported that it has entered into an agreement with the Haemato Oncology Foundation for Adults in the Netherlands (HOVON) group to initiate clinical trial startup activities (Press release, GlycoMimetics, FEB 8, 2018, View Source [SID1234523836]). In the planned clinical trial, HOVON researchers will evaluate GlycoMimetics’ drug candidate, GMI-1271, in adults with newly diagnosed acute myeloid leukemia (AML) but who cannot tolerate intensive chemotherapy, as well as in patients with myelodysplastic syndrome (MDS) with a high risk of leukemia. The HOVON Central Office has already approved a protocol concept, and this agreement enables HOVON to commit staff to the planned trial in order to finalize the protocol, start regulatory and ethics reviews, and begin development of the database. Separately, GlycoMimetics said it plans to announce the design details for its company-sponsored Phase 3 trial in relapsed/refractory AML patients as part of its fourth-quarter and year-end 2017 earnings call scheduled for March 6, 2018.

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"HOVON is one of the most prestigious collaborative clinical groups in Europe and is focused exclusively on improving clinical outcomes in patients with hematologic malignancies. HOVON’s interest in evaluating GMI-1271 in patients with previously untreated AML and MDS who are unable to tolerate intensive chemotherapy underscores the importance of the efficacy and safety data we’ve generated to date in clinical trials with GMI-1271," noted Helen Thackray, M.D., FAAP, GlycoMimetics Senior Vice-President, Clinical Development and Chief Medical Officer. "We believe GMI-1271 has the potential for broad utility in the treatment of hematologic malignancies, and this trial expands the scope of development across the continuum of care in AML and complements our own planned Phase 3 registration trial in patients with relapsed/refractory disease."

Professor Gerwin Huls, Principal Investigator at HOVON and Professor of Haematology at University Medical Centre Groningen, said, "With Breakthrough Therapy designation awarded by the U.S. Food and Drug Administration in patients with relapsed/refractory AML, GMI-1271 is clearly a promising agent. We look forward to generating data in this ‘unfit’ AML population to see if GMI-1271 can improve patient outcomes over what is achieved with decitabine alone."

The HOVON trial will be the first to evaluate GMI-1271 together with decitabine in this underserved population of AML and MDS patients, who are not considered by their physicians to be candidates for intensive chemotherapy; these two populations represent a significant potential label expansion opportunity for GMI-1271. HOVON intends to enroll approximately 140 patients in the clinical trial, including a control arm. Key efficacy endpoints will include complete remission rate, disease-free survival, and overall survival. The trial is expected to start this year and will be conducted in five countries across Europe.

About GMI-1271

GMI-1271 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 the Phase 1/2 clinical trial that has now completed enrollment, GMI-1271 was evaluated in both newly diagnosed elderly and relapsed/refractory patients with acute myeloid leukemia (AML). In both populations, patients treated with GMI-1271 together with standard chemotherapy achieved better than expected remission rates and overall survival based on historical controls, as well as lower than expected induction-related mortality rates. Importantly, treatment in this patient population was well tolerated with minimal adverse effects.

On February 8, 2018 ERYTECH Pharma (Euronext Paris: ERYP, Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that Gil Beyen, Chief Executive Officer, will present at the 2018 BIO CEO & Investor Conference, being held February 12-13, 2018 at the New York Marriott Marquis in New York City (Press release, ERYtech Pharma, FEB 8, 2018, View Source;p=RssLanding&cat=news&id=2331180 [SID1234523801]).

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Mr. Beyen will deliver ERYTECH’s presentation detailing the Company’s ERYCAPS platform and targeted treatment applications.

Details for the presentation are below:

Event: 2018 BIO CEO & Investor Conference

Date: Tuesday, February 13, 2018

Time: 2:00 pm ET

Presentation Room: Odets Room

Mr. Beyen, CEO, will be available for one-on-one meetings on February 13th, 2018. To arrange a meeting with management, please contact Naomi Eichenbaum at [email protected] or visit the BIO CEO One-on-One Partnering webpage to schedule a meeting directly.

On February 8, 2018 Eleven Biotherapeutics, Inc. (NASDAQ:EBIO), a late-stage clinical oncology company advancing novel product candidates based on its Targeted Protein Therapeutics (TPTs) platform, reported that Stephen Hurly, President and Chief Executive Officer, will present a company overview at the 2018 BIO CEO & Investor Conference, taking place February 12-13 in New York City (Press release, Eleven Biotherapeutics, FEB 8, 2018, View Source [SID1234523828]).

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Presentation Details
Date: Tuesday, February 13
Time: 9:00am Eastern Time
Location: New York Marriott Marquis, Odets Room
Webcast: www.elevenbio.com

An archived replay of the webcast will be available on the Company’s website for 90 days after the conference.

On February 8, 2018 The Medicines Company (NASDAQ:MDCO) reported that it will participate in the Leerink Partners 7th Annual Global Healthcare Conference on Wednesday, February 14, 2018, in New York City (Press release, Medicines Company, FEB 8, 2018, View Source;p=RssLanding&cat=news&id=2331467 [SID1234523871]). Clive Meanwell, M.D., Ph.D., Chief Executive Officer, will participate in a fireside chat at 9:00 a.m., Eastern Time.

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A live audio webcast will be available in the "Investors-Events/Presentations" section of The Medicines Company website. A replay of the fireside chat will be available for approximately 90 days.

On February 8, 2018 Innovation Pharmaceuticals Inc., (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, reported the closure of its Phase 2a clinical trial (see NCT03042702) of Kevetrin for the treatment of late-stage Ovarian Cancer (OC) (Press release, Innovation Pharmaceuticals, FEB 8, 2018, View Source [SID1234523838]). The Company initiated the trial for the purpose of demonstrating modulation of the key tumor-suppressor protein p53, which was achieved in analysis of the first patients at the lowest dose of Kevetrin (see December 27, 2017 press release).

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Throughout pre-clinical testing and two successful clinical trials, Kevetrin has demonstrated promising signs of efficacy as an anti-cancer agent and a favorable pharmacokinetic profile that includes a very short half-life and good bioavailability. It is believed that these characteristics make Kevetrin an ideal candidate for oral delivery (capsule or tablet), which will facilitate convenient and frequent dosing, perhaps even multiple times daily, to maximize the therapeutic benefit of the compound. With the positive observation of intra-tumor p53 modulation, the Company will now allocate resources to focus its efforts on completing development of an oral formulation, including performing bridging toxicology work.

The Company is adhering to a value-building strategy born from discussions with larger pharmaceutical companies interested in Kevetrin, one of the world’s most advanced p53 drug candidates. Securing the right development partner for Kevetrin remains an important objective.

"This study delivered multiple insights into how Kevetrin modulates the p53 protein and affects related molecular pathways," commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. "Moreover, if we successfully transition to oral dosing of Kevetrin, we believe the therapeutic effect will be maximized, providing important benefits to cancer patients in need—beyond the ultimate convenience of oral delivery. An effective orally-delivered p53-modulating drug has the potential to transform cancer care and we are proud to be at the forefront toward achieving this goal."

About Kevetrin and p53

Kevetrin is a small molecule that has demonstrated the potential of becoming a breakthrough cancer treatment by modulating p53, a protein frequently referred to as the "Guardian of the Genome" due to its critical role in controlling cell mutations. In the majority of cancers, and regardless of origin, type, and location, the p53 pathway is mutated, preventing the body from performing its natural anti-tumor functions. Conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center, a Phase 1 clinical trial (see NCT01664000) of Kevetrin in treating advanced solid tumors has been successfully completed, with patients showing good toleration and encouraging signs of potential therapeutic response (see ASCO (Free ASCO Whitepaper) 2015, ASCO (Free ASCO Whitepaper) 2013). Additional pre-clinical work supporting Kevetrin’s anti-cancer activity has recently been presented at scientific conferences (see EHA (Free EHA Whitepaper) 2017, AACR (Free AACR Whitepaper) 2017). The Company has initiated a Phase 2a trial of Kevetrin (see NCT03042702) in late stage, platinum-resistant/refractory ovarian cancer. Patients receive more frequent dosing (3 times per week) at higher levels and then receive standard of care treatment after trial conclusion. Efforts also are underway to develop Kevetrin as an oral anti-cancer agent that can be administered daily, potentially multiple times per day. The FDA has awarded Kevetrin Orphan Drug status for ovarian cancer, pancreatic cancer, and retinoblastoma, qualifying it for developmental incentives and a potential extra 7 years of market exclusivity upon drug approval. The FDA also has granted Kevetrin Rare Pediatric Disease designation for childhood retinoblastoma.