On August 3, 2022 Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), reported topline results that neither the primary endpoint of Overall Response Rate (ORR) nor the key secondary endpoint in Progression Free Survival (PFS) achieved statistical significance in the multi-center, international Phase III AGENT Study of arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab in metastatic colorectal cancer (mCRC) (Press release, Isofol Medical, AUG 3, 2022, View Source [SID1234617377]).

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The information in the press release is intended for investors.

The AGENT Study is the first to evaluate a meaningful alternative to the standard of care for all patients with mCRC since 2004. In the AGENT study, patients with non-resectable mCRC treated with arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab did not achieve a statistically significant overall response rate of ≥ 10% as compared to patients treated with the standard of care (leucovorin + 5-FU, oxaliplatin and bevacizumab).

"We are all surprised and disappointed in the results as we invested so much hope into improving the treatment for patients suffering mCRC. I would like to thank all the patients, clinical investigation sites and other participants that contributed to the study," said Ulf Jungnelius, CEO of Isofol. "We will complete the data analysis before confirming next steps and look forward to working with regulatory agencies to consider alternative paths forward. Decisions related to Isofol’s clinical program will be on hold until we’ve consulted with relevant regulatory bodies which is tentatively planned during the first half of 2023."

The AGENT Study will be completed in accordance with applicable regulations and the full data set will be published in order to enable the scientific community to fully take advantage of learnings. Sub-group analyses, gene expression and safety data is expected to be available in the final study report in Q4 2022. Pending results of further analyses, patients remaining on treatment in the experimental arm of the study will be offered to move to the standard of care treatment arm.

Audiocast, August 4, at 10:00 a.m. CEST
In connection to this announcement Isofol invites investors, analysts, and media to an audiocast with a Q&A-session. The presentation will be held in English by Isofol’s CEO Ulf Jungnelius and CMO Roger Tell and will conclude with a Q&A session. Questions can be asked on the telephone conference or in written form through the audiocast. No preregistration is needed.

This is information that Isofol Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 15:30 CEST on August 3, 2022.

About the AGENT Study
The Phase III AGENT Study is the first to evaluate a meaningful alternative to the standard of care for most patients with metastatic colorectal cancer (mCRC) in 20 years and involves approximately 90 clinics in the U.S., Canada, Europe, Australia, and Japan. The Phase III randomized, controlled, multi-center study of 490 patients assessed the efficacy and safety of arfolitixorin, [6R]-5,10 methylene-THF (MTHF), compared to leucovorin, both used in combination with 5-U, oxaliplatin, and bevacizumab, in first line mCRC patients.

The study was designed to show superiority for arfolitixorin over leucovorin. Patients were randomized in a 1:1 ratio with the primary endpoint being an overall response rate (ORR) >10 percent improvement vs. the control arm. The key secondary endpoint is a clinically meaningful positive trend in progression free survival (PFS). Other secondary endpoints include duration of response (DOR), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumor cells.

On August 3, 2022 Immunocore Holdings plc (Nasdaq: IMCR) ("Immunocore" or the "Company"), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases, reported that it will report second quarter earnings, before the US markets open on Wednesday, August 10, 2022 (Press release, Immunocore, AUG 3, 2022, View Source [SID1234617376]). Following the announcement, the Company will host a live teleconference and webcast at 8:00 a.m. EDT (1:00 p.m. BST) to discuss their financial results and provide a business and portfolio update.

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Audio webcast
The call will be made available via webcast by visiting the Events & Presentations section on Immunocore’s website. A replay of this webcast will be available for 90 days.

On August 3, 2022 Imago BioSciences, Inc. ("Imago") (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, reported that Hugh Young Rienhoff, Jr., MD, CEO of Imago BioSciences, will participate in an analyst led Fireside Chat at the 2022 Wedbush PacGrow Healthcare Conference on August 10, 2022, at 1:10 pm Eastern Time / 10:10 am Pacific Time (Press release, Imago BioSciences, AUG 3, 2022, View Source [SID1234617375]).

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Interested parties can access the live webcast of the Fireside Chat by visiting the Investor Relations section of the company’s website at ir.imagobio.com. A webcast replay will be available after the conclusion of the event for approximately 90 days.

On August 3, 2022 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the following (Press release, Greenwich LifeSciences, AUG 3, 2022, View Source [SID1234617374]):

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As previously disclosed, clinical trial contracts and budgets have been executed at multiple hospitals and the largest oncology network in the US. Clinical site initiation visits to train clinicians, nurses, coordinators, and pharmacists are underway, after which sites will be activated and the Flamingo-01 Phase III clinical trial will commence. We continue to actively recruit and prepare additional US clinical sites.
The Company is continuing to make progress to initiate clinical sites in Europe through oncology networks, potentially including networks in Germany, Spain, and France.
Following site activation, patients will be screened, tested for HLA type, randomized, and enrolled into any of 3 clinical trial arms, and treatment of the first patients will begin. Certain aspects of each arm will be open label, and the 3rd arm exploring HLA types that are not HLA-A02 will be entirely open label.
Patients who are interested in participating in the trial can contact the Company by email at [email protected] and can keep up to date with the progress of the trial or can obtain clinical site contact information to contact sites directly on clinicaltrials.gov with identifier NCT05232916 (view here).
Pharmacy process testing is nearing completion, which is anticipated to be the final testing required to commence Flamingo-01 and to start treating patients.
Dr. Jaye Thompson, VP Clinical and Regulatory Affairs, commented, "Our team has been very busy preparing for, scheduling, and conducting clinical site initiations. We have begun shipping clinical trial supplies to sites. All plans, procedures, and electronic systems are in place to allow the clinical trial to commence. We are excited to be at this stage in study start-up with Flamingo-01."

CEO Snehal Patel commented, "With our previously disclosed financial strategy, including our cash position, which should fund us through the coming years, and our ATM with one of the leading biotech investment banks, we are poised to opportunistically use the ATM at our discretion. To date, we have not used the ATM."

Mr. Patel further added, "We look forward to commencing Flamingo-01, to sharing more information about the clinical sites, key opinion leaders, clinical networks, and countries participating in the Phase III trial, and to publishing the open label Phase III data during the trial. Initial Phase III data could be available before the end of this year. We anticipate dovetailing our use of the ATM with these major milestones and validating events as we compare the Phase III trial progress to our Phase IIb trial results. Our goal is to reproduce the Phase IIb clinical trial results, which showed no metastatic breast cancer recurrences in patients treated with GLSI-100 over 5 years of follow-up, if the patients were treated, followed, and remained disease free over the first 6 months."

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2/neu positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial will be led by Baylor College of Medicine and will include US and international clinical sites from university-based hospitals and cooperative networks. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 100 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently registered on clinicaltrials.gov and can be seen here. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On August 3, 2022 GlycoMimetics, Inc. (Nasdaq: GLYC) reported its financial results and highlights for the second quarter ended June 30, 2022 (Press release, GlycoMimetics, AUG 3, 2022, View Source [SID1234617373]). Cash and cash equivalents as of the end of the quarter were $60.2 million.

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"During second quarter, we made strides in advancing our transformation from a research company to a commercially focused organization and are encouraged by the continued progress of our pivotal Phase 3 trial of uproleselan in relapsed/refractory AML," said Harout Semerjian, Chief Executive Officer. "Clearance by the FDA of the IND for GMI-1687 demonstrates our ability to create and advance innovative drug candidates for clinical development. GMI-1687 is now ideally suited for partnership and we are actively pursuing a licensing agreement for continued development of this novel molecule in sickle cell disease."

Operational Highlights

Uproleselan

GlycoMimetics continued efforts to clean the data received from the 70 sites in the U.S., Europe, Canada, and Australia that enrolled a total of 388 patients in the Company’s pivotal Phase 3 trial in relapsed/refractory AML. Progress to date now enables the Company to share a comparison of the demographics of those 388 patients against the patient demographics from the Company’s completed phase 2 study with respect to age, severity of AML, prior stem cell transplantation rate, and distribution of relapsed and refractory patients (Table 1). The Company has previously disclosed and will continue to update its projection of mid-year 2023 for the overall survival events trigger, with disclosure of top-line data results shortly thereafter.
The National Cancer Institute (NCI) continues to prepare for its planned interim analysis of event free survival of the 267 patients in its Phase 2/3 clinical trial evaluating uproleselan in newly diagnosed older adults with AML who are fit for chemotherapy. The Company intends to publicly share the outcome of the NCI’s analysis of the Phase 2 data.
Investigator-sponsored clinical trials to evaluate expanded indications for uproleselan continue to progress at the University of California-Davis, Washington University at St. Louis, MD Anderson Cancer Center, and the University of Michigan.
GMI-1687

In June, GlycoMimetics received clearance from the FDA of an IND application for clinical development of GMI-1687 in SCD.
GMI-1687 is a highly potent E-selectin antagonist initially targeted for development to treat acute vaso-occlusive crises (VOCs) in SCD with potential to address a high unmet medical need.
E-selectin is believed to play a major role in the cascade of events leading to clots and blockages that cause patients’ VOCs. The administration of GMI-1687 via subcutaneous injection may have the potential to offer a treatment option at the onset of pain crisis.
The Company is actively seeking a licensing partner to continue clinical development of this drug candidate.
Second Quarter 2022 Financial Results:

Cash position: As of June 30, 2022, GlycoMimetics had cash and cash equivalents of $60.2 million as compared to $90.3 million as of December 31, 2021.

Revenue: There was minimal revenue recognized during the three months ended June 30, 2022 and 2021.

R&D Expenses: The Company’s research and development expenses decreased to $8.0 million for the quarter ended June 30, 2022, as compared to $10.2 million for the same period in 2021. The decreased expenses were primarily due to lower clinical trial and development costs related to our ongoing global Phase 3 clinical trial of uproleselan in individuals with relapsed/refractory AML as patient enrollment ended in November 2021.

G&A Expenses: The Company’s general and administrative expenses increased to $5.5 million for the quarter ended June 30, 2022, as compared to $4.2 million for the first quarter of 2021 primarily due to commercial start-up expenses for uproleselan.

Shares Outstanding: Shares of common stock outstanding as of June 30, 2022, were 52,423,944.

The Company will host a conference call and webcast today at 8:30 a.m. ET. To access the call by phone, please go to this registration link and you will be provided with dial in details. Participants are encouraged to connect 15 minutes in advance of the scheduled start time.

A live webcast of the call will be available on the "Investors" tab on the GlycoMimetics website. A webcast replay will be available for 30 days following the call.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted inhibitor 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. FDA and from the Chinese National Medical Products Administration 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 within the bone marrow microenvironment.

About GMI-1687

Discovered and developed by GlycoMimetics, GMI-1687 is a potent E-selectin antagonist that has been shown in animal models to be fully bioavailable following subcutaneous administration. It is a second-generation compound that may be able to be developed to address certain challenges of IV therapies for SCD. E-selectin is believed to play a major role in the cascade of events leading to clots and blockages that cause pain crises in people living with SCD. The administration of GMI-1687 via subcutaneous injection may have the potential to offer a treatment option at the onset of pain crisis.