On April 26, 2022 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported that it will report its first quarter 2022 financial results after market close on Tuesday, May 3, 2022 (Press release, Rigel, APR 26, 2022, View Source [SID1234612973]). Rigel senior management will follow the announcement with a live conference call and webcast at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the financial results and give an update on the business.

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The conference call will also feature a presentation by Key Opinion Leader and FORWARD trial investigator, Caroline Piatek, M.D., Associate Professor of Clinical Medicine, Jane Anne Nohl Division of Hematology at the Keck School of Medicine of the University of Southern California. Dr. Piatek will discuss the current treatment landscape, unmet medical need, patient journey, and how she may incorporate fostamatinib, if approved, into clinical practice in warm autoimmune hemolytic anemia (wAIHA).

Dr. Piatek’s clinical focus is in non-malignant hematology. Her research interests include immune thrombocytopenia (ITP), wAIHA, cancer-associated thrombosis, and paroxysmal nocturnal hemoglobinuria.

Participants can access the live conference call by dialing 877-407-3088 (domestic) or 201-389-0927 (international). The conference call and accompanying slides will also be webcast live and can be accessed from the Investor Relations section of the company’s website at www.rigel.com. The webcast will be archived and available for replay for 90 days after the call via the Rigel website.

About the FORWARD Phase 3 Study
Fostamatinib is currently being evaluated in a Phase 3 randomized, double-blind, placebo-controlled clinical study in 90 patients with wAIHA who have failed at least one prior treatment. The study will evaluate the efficacy of fostamatinib versus placebo in achieving a durable hemoglobin response, defined as a hemoglobin level ≥ 10 g/dL, with an increase from baseline and durability measure in hemoglobin level of ≥ 2 g/dL, with the response not being attributed to rescue therapy, on three consecutive available visits during the 24-week treatment period. Secondary endpoints include other measures of hemoglobin response, use of rescue medication, and safety. The pivotal trial is fully enrolled and topline data is expected in mid-2022.

The FDA has granted fostamatinib Orphan Drug and Fast Track designations for the treatment of patients with wAIHA.

Fostamatinib, commercially available in the U.S. under the brand name TAVALISSE (fostamatinib disodium hexahydrate) tablets, is the first and only FDA-approved SYK inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic ITP who have had an insufficient response to a previous treatment.

On April 26, 2022 Myovant Sciences (NYSE: MYOV) reported it will host a webcast and conference call to discuss corporate updates and financial results for its fourth fiscal quarter and fiscal year 2021, ended March 31, 2022 (Press release, Myovant Sciences, APR 26, 2022, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-host-fourth-fiscal-quarter-and-fiscal-year-2021 [SID1234612972]). The webcast and conference call will be held at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time on May 10, 2022.

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Investors and the general public may access a live webcast of the call by visiting the investor relations page of Myovant’s website at https://investors.myovant.com/. Institutional investors and analysts may also participate in the conference call by dialing 1-800-891-3840 in the U.S. or +1-785-424-1677 from outside the U.S. and reference password MYOVQ421.

A replay of the webcast, along with the earnings press release and presentation materials, can be found on Myovant’s investor relations website for a period of one year.

On April 26, 2022 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, reported that it will host a conference call on Tuesday, May 3rd, 2022, at 4:30 pm ET to report its financial results for the first quarter of 2022 (Press release, Infinity Pharmaceuticals, APR 26, 2022, View Source [SID1234612971]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live webcast of the conference call can be accessed in the Investors/ Media section of Infinity’s website at View Source and will be available on Infinity’s website for 30 days following the event.

On April 26, 2022 VBL Therapeutics (Nasdaq: VBLT), a late-clinical stage biotechnology company focused on developing first-in-class therapeutics for difficult-to-treat malignant solid tumors and immune or inflammatory indications, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for ofra-vec (ofranergene obadenovec or VB-111) in combination with paclitaxel for the treatment of platinum-resistant ovarian cancer (Press release, VBL Therapeutics, APR 26, 2022, View Source [SID1234612970]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are pleased to receive FDA Fast Track designation for ofra-vec in platinum-resistant ovarian cancer. The Fast Track designation can facilitate the process towards potential registration and, importantly, may help expedite the time to market for ofra-vec, if approved," said Prof. Dror Harats, M.D., chief executive officer of VBL Therapeutics. "The readout of the progression free survival primary endpoint in the OVAL trial will be an important milestone for VBL in the second half of this year. We believe that, if positive, this will support a Biologics License Application submission to the FDA."

Ofra-vec is VBL Therapeutics’ investigational anti-cancer, gene-based agent in development to treat a wide range of solid tumors. The lead clinical program for ofra-vec is the OVAL Phase 3 registration-enabling trial in recurrent platinum-resistant ovarian cancer patients. VBL recently completed patient enrollment of 409 patients in this global trial being conducted at centers in the United States, Europe, Israel and Japan. In addition, the Independent Data Safety Monitoring Committee (DSMC) unanimously recommended to continue the trial as planned, following review of unblinded data from 370 randomized patients.

About the OVAL Trial

OVAL (VB-111-701/GOG-3018) is an international Phase 3 randomized, pivotal registration-enabling clinical trial comparing a combination of ofra-vec (ofranergene obadenovec or VB-111) and paclitaxel to placebo plus paclitaxel, in adult patients with recurrent platinum-resistant ovarian cancer. The OVAL trial has two primary endpoints: progression free survival (PFS) and overall survival (OS). Successfully meeting either primary endpoint has the potential to support a Biologics License Application (BLA). Meeting the PFS endpoint, with a top-line readout anticipated in the second half of 2022, could accelerate BLA submission by approximately one year, subject to discussions with the U.S. Food and Drug Administration. A top-line readout of the OS primary endpoint is anticipated in 2023. OVAL is being conducted in collaboration with the GOG Foundation, Inc., an independent international non-profit organization with the purpose of promoting excellence in the field of gynecologic malignancies. For more information, refer to Clinicaltrials.gov NCT03398655.

About Ofra-Vec (ofranergene obadenovec; `VB-111`)

Ofra-vec is an investigational anti-cancer, gene-therapy agent in development to treat a wide range of solid tumors. Ofra-vec is a unique biologic agent designed to use a dual mechanism to target solid tumors. Its mechanism combines the blockade of tumor vasculature with an anti-tumor immune response. Ofra-vec is administered as an IV infusion once every 6-8 weeks. It has been observed in past clinical research to be generally well-tolerated in >300 cancer patients and demonstrated activity signals in an "all comers" Phase 1 trial as well as in three tumor-specific Phase 2 trials. Ofra-vec has received orphan designations for the treatment of ovarian cancer and for the treatment of glioma by the European Commission. The FDA granted ofra-vec orphan designation for the treatment of malignant glioma and fast track designation for the treatment of rGBM and the treatment of platinum-resistant ovarian cancer. Ofra-vec demonstrated proof-of-concept and survival benefit in Phase 2 clinical trials in radioiodine-refractory thyroid cancer (NCT01229865) and platinum-resistant ovarian cancer (NCT01711970).

On April 26, 2022 INOVIO (NASDAQ: INO) reported that first quarter 2022 financial results will be released after the market close on May 10, 2022 (Press release, Inovio, APR 26, 2022, View Source [SID1234612969]). Following the release, INOVIO will host a live conference call and webcast at 4:30 p.m. ET to discuss financial results and provide a general business update.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live and archived version of the audio presentation will be available online at View Source This is a listen-only event but will include a live Q&A with analysts.