1stOncology™: Cancer Intelligence Service – Page 6176 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

FDA accepts HOOKIPA’s Investigational New Drug Application for HB-300 for the treatment of metastatic castration-resistant prostate cancer

On July 25, 2022 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapies based on its proprietary arenavirus platform, reported that it has received U.S. Food and Drug Administration (FDA) acceptance of its Investigational New Drug (IND) application for HB-300, a novel arenaviral immunotherapy for the treatment of metastatic castration-resistant prostate cancer (Press release, Hookipa Pharma, JUL 25, 2022, View Source [SID1234616904]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

Schedule Your 30 min Free Demo!

"FDA acceptance of our IND application for HB-300 is a key milestone as we expand and diversify our oncology pipeline and arenavirus platform from viral antigens to self-antigens," said Joern Aldag, Chief Executive Officer at HOOKIPA. "With the concurrent acceptance of the Drug Master File, we have reduced cycle time between completion of preclinical studies and clinical entry of our pipeline projects."

About HB-300
HB-300 is an alternating, 2-vector replicating arenaviral immunotherapy for metastatic castration-resistant prostate cancer. It uses the Lymphocytic Choriomeningitis Virus and Pichinde Virus as arenaviral backbones, with each expressing two well-defined antigens of prostate cancer, PAP and PSA. Subsequent clinical development may include addition of arenaviral therapeutics expressing a third antigen, PSMA. HOOKIPA’s approach is designed to focus the immune response against the target antigens. The technology has demonstrated the ability to induce potent antigen-specific T cell responses and anti-tumor activity in preclinical tumor models.

About the Drug Master File
A Drug Master File (DMF) is a voluntary submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The information contained in the DMF may be used to support additional INDs and other submissions. The FDA accepted HOOKIPA’s submission of a Type II Master File to the FDA’s Center for Biologics Evaluation and Research to present data specific to HOOKIPA’s proprietary replicating arenavirus platform.

About prostate cancer
Prostate cancer is the most diagnosed cancer and fifth leading cause of death from cancer in men. There are several stages of prostate cancer, and prostate cancer cells usually need androgen hormones, such as testosterone, to grow. Treatment for early-stage prostate cancer often aims to lower testosterone levels to stop or slow growth. Metastatic castration-resistant prostate cancer is when the cancer has spread, or metastasized, to other parts of the body including the lymph nodes, bones, rectum, liver and lungs. Metastatic castration-resistant prostate cancer does not respond to hormone therapy. Currently, there are limited treatment options for people with metastatic castration-resistant prostate cancer and only 30 percent will survive beyond five years.

Guardant Health Applauds Congressional Letter Calling for HHS Action to Improve USPSTF Process to Increase Access to Cancer Screenings

On July 25, 2022 Guardant Health, a leading precision oncology company, reported that applauds Congresswoman Anna Eshoo (D-CA) and Energy and Commerce Chairman Frank Pallone (D-NJ) for raising important questions in a letter to U.S. Health and Human Services (HHS) Secretary Xavier Becerra on how the United States Preventive Services Task Force (USPSTF) process can be improved to increase patient access to essential preventive services such as early cancer screening tests (Press release, Guardant Health, JUL 25, 2022, View Source [SID1234616903]).

The USPSTF is an independent, volunteer advisory board that issues evidence-based recommendations on which clinical preventative services Americans should receive.1 Services that receive an "A" or "B" grade from the Task Force are covered with $0 cost-sharing for insured patients.2 Under its current structure, the USPSTF aims to review and update existing recommendations every five years, though multi-year delays are common.3,4

"The Task Force guidelines play a key role in ensuring people have access to preventative services like early cancer screening however, the current USPSTF five-year update cycle doesn’t reflect today’s pace of innovation," said AmirAli Talasaz, Guardant Health co-CEO. "We thank Reps. Eshoo and Pallone for their action, and hope that HHS leadership will take the necessary steps to improve the USPSFT process so that innovative technologies like blood-based cancer screening tests can be accessible to patients upon FDA approval."

The Congressional letter outlines how a new blood test to screen asymptomatic, average-risk patients for colorectal cancer (CRC) may not be accessible to patients right away under the current USPSTF process. The most recent USPSTF review of CRC screening was completed in May 20215 and the next recommendation is not expected until 2026. Therefore, should FDA approval be granted for CRC blood-based screening tests, it may still be years until the USPSTF releases its next recommendation to include blood tests.

The inability to provide access to the latest innovations in cancer screening technology has far-reaching implications. More than 75% of people who die from CRC today are not up to date with recommended screening.6 Blood tests have the potential to overcome many of the access barriers associated with current CRC screening methods by incorporating these tests into routine medical care. Timely access to innovative new cancer screening technologies like blood tests can lead to improved compliance, early detection and diagnosis.

For more information on how Guardant Health is advocating for access to modern cancer screenings visit View Source

Transactions in connection with share buy-back program

On July 25, 2022 Genmab A/S reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, JUL 25, 2022, View Source [SID1234616902]).

The share buy-back program is expected to be completed no later than August 31, 2022 and comprises up to 370,000 shares.

The following transactions were executed under the program from July 18, 2022 to July 22, 2022:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 417,583 shares as treasury shares, corresponding to 0.63% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 22 dated June 17, 2022.

FibroGen to Report Second Quarter 2022 Financial Results

On July 25, 2022 FibroGen, Inc. (NASDAQ: FGEN) reported that it will announce its second quarter 2022 financial results on Monday, August 8 after the market close. FibroGen will also conduct a conference call on that day at 5:00 p.m. ET (2:00 p.m. PT) with the investment community to further detail the company’s corporate and financial performance (Press release, FibroGen, JUL 25, 2022, View Source [SID1234616901]).

Conference Call and Audio Webcast
Interested parties may access a live audio webcast of the conference call via the "Investor Relations" page of the Company’s website at www.fibrogen.com. To access the call by phone, please go to this link (registration link), and you will be provided with dial in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. A replay of the webcast will also be available for a limited time at the following link (webcast replay).

Fate Therapeutics to Webcast Conference Call Reporting Second Quarter 2022 Financial Results

On July 25, 2022 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, reported that the Company will host a conference call and live audio webcast on Wednesday, August 3, 2022 at 5:00 PM ET to report its second quarter 2022 financial results and provide a corporate update (Press release, Fate Therapeutics, JUL 25, 2022, https://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-webcast-conference-call-reporting-second-7 [SID1234616900]).

In order to participate in the conference call, please dial (877) 545-0320 (domestic) or (973) 528-0002 (international) and refer to conference ID 687045. The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.