TRACON Pharmaceuticals Announces Initiation of Randomized Phase 2 Trial of TRC102 in Lung Cancer Sponsored by the National Cancer Institute

On February 2, 2022 TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics reported that the National Cancer Institute (NCI) has initiated a randomized Phase 2 trial of TRC102 in combination with chemoradiation in patients with stage III non-squamous non-small cell lung cancer (NCT05198830: View Source;draw=2&rank=3) (Press release, Tracon Pharmaceuticals, FEB 2, 2022, View Source [SID1234607611]).

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The open-label two arm trial will enroll 78 patients and assess the benefit of adding TRC102 to current standard of care treatment of pemetrexed, cisplatin, and radiation therapy followed by consolidative durvalumab. The primary endpoint of the trial is progression free survival (PFS) and the trial is designed to detect an improvement in PFS at one year from 56% to 75%. Enrollment is expected to begin in June 2022 and results are expected in 2024.

"We are pleased by the continued support of the National Cancer Institute for the development of TRC102 through our Cooperative Research and Development Agreement (CRADA), including sponsorship of the initial randomized trial of TRC102," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "The initiation of a randomized clinical trial of TRC102 marks an important milestone for the program."

The randomized trial builds upon positive data from a Phase 1 trial of TRC102 in combination with chemoradiation presented at ASCO (Free ASCO Whitepaper) 2020 that demonstrated a 100% response rate in 15 patients with Stage IIIA or Stage IV non-squamous non-small cell lung cancer, including three patients who had a complete response to treatment. These data compared favorably to historical data of the same combination of chemoradiation without TRC102 in advanced lung cancer from the PROCLAIM and the PACIFIC clinical trials.

About TRC102

TRC102 (methoxyamine) is a novel, small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA) and has orphan drug designation from the U.S. FDA in malignant glioma, including glioblastoma.

VBL Therapeutics to Participate in the Guggenheim Oncology Conference and the 2022 BIO CEO & Investor Conference

On February 2, 2022 VBL Therapeutics (Nasdaq: VBLT), a late-clinical stage biotechnology company developing first-in-class therapeutics for difficult-to-treat malignant solid tumors and immune or inflammatory indications, reported that Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics, will participate in a fireside chat at the Guggenheim Oncology Conference being held virtually on February 9 – 11, 2022 (Press release, VBL Therapeutics, FEB 2, 2022, View Source [SID1234607610]). Management will also attend the BIO CEO & Investor Conference being held as a hybrid event on February 14 – 17, 2022.

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Guggenheim Oncology Virtual Conference
Date: Thursday, February 10, 2022
Time: 10:00 a.m. ET
Format: Fireside Chat
Webcast: View Source

2022 BIO CEO & Investor Conference
Date: February 14 – 17
Registration details for investor meetings and the event can be found here.

A link to the webcast will also be available on the Events and Presentations page of the Investor Relations section on the Company’s website at www.vblrx.com.

Fate Therapeutics to Present at Upcoming February Investor Conferences

On February 2, 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 present at the following upcoming investor conferences (Press release, Fate Therapeutics, FEB 2, 2022, View Source [SID1234607609]):

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4th Annual Guggenheim Oncology Day available on demand on Wednesday, February 9, 2022 at 11:00 AM ET
SVB Leerink 2022 Global Healthcare Conference on demand on Wednesday, February 16, 2022 at 3:00 PM ET
A live webcast, if recorded, of each presentation 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 shortly after the event.

LEIDOS TO PARTICIPATE IN THE COWEN 43RD ANNUAL AEROSPACE/DEFENSE & INDUSTRIALS CONFERENCE

On February 2, 2022 Leidos (NYSE: LDOS), a FORTUNE 500 science and technology company, reported that it will participate in the Cowen 43rd Annual Aerospace/Defense & Industrials Conference webcast (Press release, Leidos, FEB 2, 2022, View Source;INDUSTRIALS-CONFERENCE/default.aspx [SID1234607608]).

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Roger Krone, Chief Executive Officer, will participate in a question and answer "fireside chat" on Tuesday, Feb. 8, 2022 at 1:30pm ET.

A live audio webcast of the event will be available on the Leidos Investor Relations website at View Source A replay of the webcast will be available following the presentation at the same link listed above for 90 days afterward.

SHINE Europe B.V. Designing Advanced Medical Isotopes Facility in the Netherlands

On February 2, 2022 SHINE Europe B.V. (SHINE Europe), a subsidiary of SHINE Technologies, LLC, (SHINE), a next-generation nuclear technology company, reported the company has secured funding to begin designing an advanced medical isotopes facility in Veendam, the Netherlands (Press release, Shine Medical Technologies, FEB 2, 2022, View Source [SID1234607602]). This new facility will leverage SHINE’s innovative production systems to safely produce medical isotopes including molybdenum-99 (Mo-99), which is currently used in millions of diagnostic imaging procedures each year to help diagnose various life-threatening diseases in patients across the globe. The new facility is expected to develop medical isotopes in a very reliable, environmentally-friendly and less wasteful process than the legacy methods, also without adding exponential taxpayer burden to construct new European reactors.

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"Once operational, SHINE Europe demonstrates an innovative EU initiative that delivers critical medical care through new technology," said Greg Piefer, SHINE founder and CEO. "It’s like comparing travel in Mercedes-Benz’s first gasoline-powered car in the 1880s to an innovative journey inside today’s Tesla. Simply, we believe our technology will provide a state-of-the art solution for producing medical isotopes. We believe that in just a few years, and with a significant portion of investment from private funding, SHINE Europe will be providing critical Mo-99 for millions of European patients without dependency on aging reactors."

SHINE Europe marks the second such nuclear facility for the company as SHINE’s Janesville, Wis (U.S.A.) plant also plans to begin the production of Mo-99. SHINE is also exploring potential production of additional isotopes such as iodine-131 and xenon-133, among others. Once SHINE Europe is fully operational, SHINE anticipates the two facilities’ combined output of Mo-99 can serve up to 70 percent of the global need for Mo-99 used in daily diagnostic imaging.

The current phase of SHINE’s European project is being funded by the Province of Groningen, and the Federal State of the Netherlands. SHINE’s other investors include leading global private and public entities such as Baillie Gifford, Koch Disruptive Technologies, Fidelity, Deerfield Management Company, and Oaktree Capital Management.

"We are very pleased to see this breakthrough technology in nuclear medicine coming to the Province of Groningen in the Netherlands, and especially with a cause to help so many Europeans with critical diagnostic procedures," said Commissioner of the King, René Paas. "SHINE Europe is a great community partner helping to bring global innovation and technology to Veendam."

The supply of Mo-99 to support millions of diagnostic imaging procedures continues to be a challenge. SHINE Europe’s innovative approach demonstrates an efficient path to help solve this challenge.

"Europe has consistently struggled with unstable, aging reactors leading to supply issues and shortages of Mo-99," said Harrie Buurlage, SHINE’ General Manager of European Operations. "We believe the SHINE Europe facility will greatly improve the supply chain, reduce potential shortages of various fission-based isotopes, and empower medical professionals to deliver a higher level of patient care. Delivering Mo-99 for millions of diagnostic procedures across Europe and beyond is at the core of SHINE’s efforts."

"We are delighted about the company’s plans to build another advanced facility, providing additional capacity and reliable consistent supply of critical diagnostic and therapeutic isotopes. This will help medical professionals caring for tens of thousands of heart and cancer patients every day across the globe" said Julia Casey, General Manager – Molecular Imaging of GE Healthcare, based in Europe.