On May 26, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that that clinicians at Washington University School of Medicine in St. Louis have dosed the first patient in an investigator-sponsored trial (IST) evaluating uproleselan as a prophylactic agent to reduce gastrointestinal (GI) toxicities associated with high-dose melphalan in autologous hematopoietic cell transplantation (auto-HCT) for multiple myeloma (MM) (Press release, GlycoMimetics, MAY 26, 2021, View Source [SID1234580614]). Dr. Keith Stockerl-Goldstein, M.D., Professor of Medicine, Division of Oncology, Section of Bone Marrow Transplantation, Washington University School of Medicine, is the clinical trial’s principal investigator.

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"GI side effects are the dose-limiting toxicities of high-dose melphalan in autologous hematopoietic stem-cell transplantation. Preclinical data have demonstrated a protective effect of uproleselan against mucosal damage and, in the GlycoMimetics Phase 2 trial reported at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in 2018, uproleselan demonstrated the potential to mitigate severe mucositis in relapsed and refractory acute myeloid leukemia (AML) patients undergoing intensive chemotherapy," said Eric J. Feldman, M.D., GlycoMimetics’ Chief Medical Officer. "With this background, Washington University clinicians at Siteman Cancer Center will be the first to look closely at the potential of uproleselan to attenuate GI toxicities in multiple myeloma patients undergoing transplant. If this placebo-controlled study demonstrates positive improvements, we believe it will underscore the unique properties of our compound and the potential safety benefits of adding uproleselan to a range of other standard blood cancer therapies where toxicity and durability of response are concerns."

About the Phase 2 Study

The study led by Washington University is a Phase 2, single-center, randomized, double-blind, and placebo-controlled IST designed to evaluate whether prophylactic uproleselan plus standard of care (SOC) compared to placebo plus SOC can reduce diarrhea severity in patients receiving high-dose melphalan conditioning in preparation for auto-HCT in MM. Clinicians will observe for oral mucositis severity and other GI toxicities as secondary endpoints. Exploratory endpoints will also assess minimal residual disease at 100 days post-HCT; soluble E-selectin levels at pre-dose and post-conditioning time points; progression free survival; and overall survival.

Eligible patients undergoing first auto-HCT with melphalan conditioning (200mg/m2) for MM will be randomized in a 1:1 allocation to receive either prophylactic uproleselan plus SOC or placebo plus SOC. Randomization will be stratified by age ≥65 years and <65 years, due to increased frequency of GI toxicity in elderly populations. GlycoMimetics anticipates a data readout from the trial in mid-2022.

Siteman Cancer Center, based at Barnes-Jewish Hospital and Washington University School of Medicine, is a top-ranked National Cancer Institute (NCI)-designated Comprehensive Cancer Center and recently received the NCI’s highest possible rating of "Exceptional" for its research programs.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted antagonist of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy designation from the U.S. Food and Drug Administration and the Chinese Health authority for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan 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

On May 26, 2021 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients, reported that Michel Detheux, PhD, President and Chief Executive Officer, will present at the Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021 at 8:00 a.m. ET (Press release, iTeos Therapeutics, MAY 26, 2021, View Source [SID1234580630]).

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A live webcast of the presentation will be available on the Investors section of the company’s website at View Source An archived replay will be available for approximately 30 days following the presentation.

On May 26, 2021 Foresee Pharmaceuticals (6576.TWO), ("Foresee") reported that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for CAMCEVI 42 mg, a ready-to-use 6-month subcutaneous depot formulation of leuprolide mesylate, as a treatment of advanced prostate cancer (Press release, Foresee Pharmaceuticals, MAY 26, 2021, View Source [SID1234580646]).

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"The approval of CAMCEVI 42 mg is a significant step toward our mission in improving the standard of care and the lives of patients," said Dr. Ben Chien, founder and Chairman of Foresee. "It also demonstrates the success of Foresee’s pioneering Stabilized Injectable Formulation (SIF) technology. We want to thank the tireless work from the team and all stakeholders, which has made this approval possible.

The FDA approval was based on a successful Phase 3 study in 137 Advanced Prostate Carcinoma patients, where treatment with CAMCEVI 42 mg injection every 6 months was demonstrated to be effective, safe and well tolerated (most common adverse events listed below in ISI). The primary efficacy end point was the percentage of subjects with suppression of serum testosterone (≤50 ng/dl) by day 28 and from day 28 to day 336 in the intent-to-treat (ITT) population. The primary efficacy endpoint was successfully achieved in 97% of subjects, with mean testosterone concentration suppressed below castrate levels to 17.6 ng/dL on day 28.

CAMCEVI 42 mg injection is exclusively licensed to Accord BioPharma in the U.S. for commercialization. "Camcevi 42mg is an important addition to of the rapidly expanding Accord Biopharma oncology portfolio and provides clinicians an important option for the treatment of advanced prostate cancer," Said Chrys Kokino, U.S. President Accord BioPharma specialty products.

Important Safety Information for the U.S.

CAMCEVI 42 mg subcutaneous injection is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of adult patients with advanced prostate cancer. CAMCEVI is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs, or the components of CAMCEVI.

Patients may develop tumor flare during the first few weeks of treatment, which is a transient worsening of bone pain, uretral obstruction, spinal cord compression, or the occurrence of additional signs and symptoms of prostate cancer. Monitor patients closely and manage symptoms.

Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH agonists. Blood glucose levels should be monitored and managed according to current clinical practice.

Increased risk of myocardial infarction, sudden cardiac death, and stroke has been reported in men receiving GnRH agonists. Patients should be monitored for cardiovascular disease and according to current clinical practice.

Androgen deprivation therapy may prolong the QT interval. Consider periodic monitoring of electrocardiograms and electrolytes.

Convulsions have been reported in patients receiving GnRH agonists, like CAMCEVI. Patients experiencing convulsions should be managed according to the current clinical practice.

Based on findings in animal studies and mechanism of action, CAMCEVI may cause fetal harm.

The most common (≥10%) adverse reactions were hot flush, hypertension, injection site reactions, upper respiratory tract infections, musculoskeletal pain, fatigue, and pain in extremity.

Please see the full prescribing information for CAMCEVI 42 mg for more information.

On May 26, 2021 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported its partipation in the following investor conferences in the month of June (Press release, ERYtech Pharma, MAY 26, 2021, View Source [SID1234580699]).

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Jefferies Virtual Healthcare Conference – June 1- 4, 2021

Gil Beyen, Chief Executive Officer, will be participating in a fireside chat followed by a virtual Q&A session on Friday June 4th at 10am (ET).

WEBCAST LINK

A replay of the session will be on the Jefferies conference website, as well as on ERYTECH’s website, under the "Investors" section at investors.erytech.com, for 30-days following the conference. For more information please visit the Conferences & Events section of the Jefferies website.

JMP Securities Life Sciences Conference – June 16 & 17, 2021

Gil Beyen, Chief Executive Officer, will present a company overview followed by a virtual Q&A session on Wednesday June 16th at 2pm (ET).

WEBCAST LINK

A link to the live audio webcast as well as the replay of the webcast will be available on ERYTECH’s website, under the "Investors" section at investors.erytech.com. For more information about the JMP Securities Life Sciences Conference, please refer to the JMP conference website

Spring European Midcap Event – June 24 & 25, 2021

Gil Beyen, Chief Executive Officer and Eric Soyer Chief Financial Offier will participate in one-on-one meetings on Thursday June 24th.

For more information about the Spring European Midcap Event, please refer to the CF&B conference website

If you are interested in arranging a one-on-one meeting, please contact your conference representative.

On May 26, 2021 Precision BioSciences Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS genome editing platform, reported that Derek Jantz, Ph.D., Chief Scientific Officer and co-founder, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference being held from June 1-4, 2021 (Press release, Precision Biosciences, MAY 26, 2021, View Source [SID1234580599]).

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Details for the fireside chat are below:

Jefferies Virtual Healthcare Conference
Date: Wednesday, June 2, 2021
Time: 1:30 PM ET

A live webcast of the fireside chat will be accessible on the Company’s website www.precisionbiosciences.com, under the Investors & Media section. An archived replay of the webcasts will be available for approximately 30 days.