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HOOKIPA to Present a Trial in Progress Poster on its Prostate Cancer Phase 1/2 Clinical Trial at ASCO

On April 26, 2023 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported that a Trial in Progress poster on its ongoing Phase 1/2 clinical study (NCT05553639) of HB-300 in prostate cancer has been accepted for presentation at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 2-6, 2023 (Press release, Hookipa Biotech, APR 26, 2023, View Source [SID1234630524]).

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"We’re excited to present an overview of our ongoing HB-300 Phase 1/2 clinical trial at ASCO (Free ASCO Whitepaper)," said Joern Aldag, Chief Executive Officer at HOOKIPA. "HB-300 is our second oncology immunotherapy program currently in the clinic. We look forward to sharing more about this novel compound as we seek to address unmet clinical needs in prostate cancer."

Details of the presentation are:

HB-300, a novel arenavirus-based cancer immunotherapy in patients with metastatic castration-resistant prostate cancer
Abstract #TPS5108; Poster Session: Genitourinary Cancer – Prostate, Testicular, and Penile
Saturday, June 3, 2023; 8:00-11:00 am CT
The full abstract will become public at 5:00 pm ET on Thursday, May 25.

About HB-300
HB-300 is an alternating, 2-vector replicating arenaviral immunotherapy for metastatic castration-resistant prostate cancer (mCRPC). HB-300 uses the lymphocytic choriomeningitis virus (LCMV) and pichinde virus (PICV) as arenaviral backbones, with each expressing two well-defined antigens of prostate cancer, prostatic acid phosphatase (PAP) and prostate-specific antigen (PSA). HOOKIPA’s approach is designed to focus the immune response against the target antigens and has demonstrated the ability to induce potent antigen-specific T cells responses and anti-tumor activity in preclinical and clinical settings.

GlycoMimetics to Report First Quarter 2023 Financial Results on May 3, 2023

On April 26, 2023 GlycoMimetics, Inc. (Nasdaq: GLYC), reported that it will host a conference call and webcast to report first quarter 2023 financial results on Wednesday, May 3, 2023, at 8:30 a.m. ET (Press release, GlycoMimetics, APR 26, 2023, View Source [SID1234630523]).

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.

Geron Announces Upcoming Oral Presentation at 2023 American Society of Clinical Oncology Annual Meeting of Imetelstat Data from IMerge Phase 3 Lower Risk MDS Trial

On April 26, 2023 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported that data from the pivotal IMerge Phase 3 clinical trial evaluating the Company’s first-in-class telomerase inhibitor, imetelstat, in lower risk myelodysplastic syndromes (MDS), was accepted for oral presentation at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Geron, APR 26, 2023, View Source [SID1234630522]). The data in the ASCO (Free ASCO Whitepaper) abstract will be embargoed per ASCO (Free ASCO Whitepaper) guidelines until May 25, 2023 at 5 p.m. Eastern Time. ASCO (Free ASCO Whitepaper) is taking place in Chicago, IL from June 2-6, 2023.

Details for the oral presentation are as follows:

Title: IMerge: Results from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Imetelstat in Patients (pts) With Heavily Transfusion Dependent (TD) Non-Del(5q) Lower-Risk Myelodysplastic Syndromes (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis Stimulating Agents (ESA).

Presenter: Amer Methqal Zeidan, Yale School of Medicine

Abstract number: 7004

Date: Friday, June 2, 2023

Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

About IMerge Phase 3

The Phase 3 portion of the IMerge Phase 2/3 study is a double-blind, 2:1 randomized, placebo-controlled clinical trial to evaluate imetelstat in patients with IPSS Low or Intermediate-1 risk (lower risk) transfusion dependent MDS who were relapsed after, refractory to, or ineligible for, erythropoiesis stimulating agent (ESA) treatment, had not received prior treatment with either a HMA or lenalidomide and were non-del(5q). To be eligible for IMerge Phase 3, patients were required to be transfusion dependent, defined as requiring at least four units of packed red blood cells (RBCs), over an eight-week period during the 16 weeks prior to entry into the trial. The primary efficacy endpoint of IMerge Phase 3 is the rate of RBC-TI lasting at least eight weeks, defined as the proportion of patients without any RBC transfusion for at least eight consecutive weeks since entry to the trial (8-week TI). Key secondary endpoints include the rate of RBC-TI lasting at least 24 weeks (24-week TI), the duration of TI and the rate of hematologic improvement erythroid (HI-E), which is defined as a rise in hemoglobin of at least 1.5 g/dL above the pretreatment level for at least eight weeks or a reduction of at least four units of RBC transfusions over eight weeks compared with the prior RBC transfusion burden. A total of 178 patients were enrolled in IMerge Phase 3 across North America, Europe, Middle East and Asia.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic malignancies. Data from non-clinical studies and clinical trials of imetelstat provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells in myeloid hematologic malignancies resulting in malignant cell apoptosis and potential disease-modifying activity. Imetelstat has been granted Fast Track designation by the U.S. Food and Drug Administration for both the treatment of adult patients with transfusion dependent anemia due to Low or Intermediate-1 risk MDS that is not associated with del(5q) who are refractory or resistant to an erythropoiesis stimulating agent, and for adult patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus associated kinase (JAK) inhibitor treatment. Geron plans to submit a New Drug Application (NDA) in the U.S. in mid-2023 and a Marketing Authorization Application (MAA) in the EU in the second half of 2023 in the lower risk MDS indication.

Galera to Present One-Year Reductions in Cisplatin-Related Chronic Kidney Disease Data from ROMAN Trial at 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

On April 26, 2023 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported that a prespecified analysis from the Phase 3 ROMAN trial detailing one-year reductions in cisplatin-related chronic kidney disease in patients with head and neck cancer treated with avasopasem will be presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 2-6, 2023, in Chicago, IL (Press release, Galera Therapeutics, APR 26, 2023, View Source [SID1234630521]).

Presentation Details:

Title: One-year reductions in cisplatin-related chronic kidney disease (CKD) in patients with head and neck (HNC) cancer treated with avasopasem manganese: A prespecified analysis from the phase 3 ROMAN trial
Abstract Number: 6066
Session Title: Head and Neck Cancer
Session Date and Time: Monday, June 5, 2023, 1:15 PM – 4:15 PM ET

The titles of the abstracts are currently available in the ASCO (Free ASCO Whitepaper) digital program, with the full abstracts scheduled to be published on May 25, 2023, at 5 p.m. ET. The presentation will be available on Galera’s website at the start of the poster session at View Source

G1 Therapeutics to Release First Quarter 2023 Financial Results and Provide Business Update on May 3, 2023

On April 26, 2023 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that it will host a webcast and conference call to provide a financial and corporate update for the first quarter 2023 on Wednesday May 3, 2023, at 8:30 a.m. ET (Press release, G1 Therapeutics, APR 26, 2023, View Source [SID1234630520]).

Please note that there is a new process to access the call via telephone. To register and receive a dial in number and unique PIN to access the live conference call, please follow this link to register online. While not required, it is recommended that you join 10 minutes prior to the start of the event. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.