On February 2, 2023 Promontory Therapeutics Inc., a clinical stage pharmaceutical company advancing small molecule immunotherapies in oncology, reported that it will present a poster on its clinical trial in progress of PT-112, its lead therapeutic candidate, in patients with late-stage metastatic castration-resistant prostate cancer, to be held at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Genitourinary Cancers (ASCO GU) Symposium. ASCO (Free ASCO Whitepaper) GU will take place in San Francisco and online on Feb. 16-18, 2023 (Press release, Promontory Therapeutics, FEB 2, 2023, View Source [SID1234626774]).

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Poster Session Details
Title: A phase 2 study of immunogenic cell death inducer PT-112 in patients with metastatic castration-resistant prostate cancer.
Abstract Number: TPS292
Session Information: Trials in Progress Poster Session A: Prostate Cancer
Session Date: Thursday, Feb. 16, 2023
Speaker/Lead Author: Alan Bryce, MD

Abstracts will be published online on the ASCO (Free ASCO Whitepaper) GU website at 5:00 p.m. EST on Monday, Feb. 13.

For more information about PT-112 and Promontory Therapeutics’ clinical pipeline visit www.PromontoryTx.com. Further details on the PT-112 clinical trial in prostate cancer (NCT02266745) can be found at clinicaltrials.gov.

About PT-112

PT-112 is the first small-molecule conjugate of pyrophosphate in oncology, and possesses a unique pleiotropic mechanism of action that promotes immunogenic cell death (ICD), through the release of damage associated molecular patterns (DAMPs) that bind to dendritic cells and lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents a highly potent inducer of this immunological form of cancer cell death. Further, PT-112 harbors a property known as osteotropism, or the propensity of the drug to reach its highest concentrations in certain areas of the bone, making it a candidate for treatment of patients with cancers that originate in, or metastasize to, the bone. The first in-human study of PT-112 demonstrated an attractive safety profile and evidence of long-lasting responses among heavily pre-treated patients and won "Best Poster" within the Developmental Therapeutics category at the ESMO (Free ESMO Whitepaper) 2018 Annual Congress. The combination Phase 1b dose escalation study of PT-112 with PD-L1 checkpoint inhibitor avelumab in solid tumors was reported in an oral presentation at the ESMO (Free ESMO Whitepaper) 2020 Virtual Congress and the Phase 2a dose confirmation cohort in non-small cell lung cancer (NSCLC) patients was reported at ESMO (Free ESMO Whitepaper) I-O 2022. The Phase 1 study in patients with relapsed or refractory multiple myeloma presented at ASH (Free ASH Whitepaper) 2020 is the third completed Phase 1 study of PT-112. Monotherapy Phase 2 development is ongoing in mCRPC, and includes the Phase 2 proof of concept study in thymic epithelial tumors under the company’s formal CRADA with the NCI.

On February 2, 2023 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that members of management will present at the following upcoming investor conferences (Press release, Mersana Therapeutics, FEB 2, 2023, View Source [SID1234626772]).

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Guggenheim Oncology Conference
Format: Fireside Chat
Date/Time: Wednesday, February 8, 2023, at 2:10 p.m. Eastern Time

SVB Securities Global Biopharma Conference
Format: Fireside Chat
Date/Time Wednesday, February 15, 2023, at 1:00 p.m. Eastern Time

Cowen 43rd Annual Health Care Conference
Format: Panel Discussion
Date/Time: Wednesday, March 8, 2023, at 9:10 a.m. Eastern Time

Oppenheimer 33rd Annual Healthcare Conference
Format: Presentation
Date/Time: Tuesday, March 14, 2023, at 12:00 p.m. Eastern Time

Live webcasts of these events will be available on the Investors & Media section of Mersana’s website at www.mersana.com. Archived replays will be available for approximately 90 days following the events.

On February 2, 2023 Leidos (NYSE: LDOS), a FORTUNE 500 science and technology leader, reported that it will participate in the Cowen 44th Annual Aerospace/Defense & Industrials conference being held in Arlington, VA (Press release, Leidos, FEB 2, 2023, View Source;Industrials-Conference/default.aspx [SID1234626771]).

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Roger Krone, Chief Executive Officer, will engage in a question and answer "fireside chat" on February 15, 2023, at 2:05 p.m. 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 30 days afterward.

On February 2, 2023 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that Fred Schwarzer, Chief Executive Officer, will participate in a fireside chat at the Guggenheim 2023 Oncology Conference on Thursday, February 9, 2023, at 1:35 p.m. EST in New York (Press release, IGM Biosciences, FEB 2, 2023, View Source [SID1234626770]).

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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 30 days following the presentation.

On February 2, 2023 Guardant Health Inc. (Nasdaq: GH), a leading precision oncology company, and AnHeart Therapeutics, a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapeutics, reported a strategic collaboration on the development, regulatory approval and commercialization of the Guardant360 CDx and Guardant360TissueNext assays as companion diagnostics for taletrectinib in the United States and European Union (Press release, Guardant Health, FEB 2, 2023, View Source [SID1234626769]). Taletrectinib is an investigational ROS1 inhibitor for the treatment of adult patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).

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AnHeart received U.S. Food and Drug Administration Breakthrough Therapy Designation (BTD) for taletrectinib on August 1, 2022, for the treatment of adult patients with advanced or metastatic ROS1-positive NSCLC who are ROS1 tyrosine kinase inhibitor treatment naïve or previously treated with crizotinib. BTD is intended to expedite the development and regulatory review of investigational treatments for serious or life-threatening conditions when preliminary clinical evidence indicates that the drug has the potential to substantially improve clinical outcomes compared with available therapies. The collaboration will focus on the use of the Guardant tests for comprehensive genomic profiling to identify patients with the specific tumor mutations that are targeted by taletrectinib.

"We are very excited to partner with Guardant Health, a global leader in oncology companion diagnostics, to identify NSCLC patients with ROS1 fusion mutations who may benefit from taletrectinib. There is a critical need to improve access to high quality diagnostics to help guide treatment decisions for patients," said Junyuan (Jerry) Wang, Ph.D., chief executive officer of AnHeart Therapeutics. "With our BTD recently granted by FDA, we are committed to advancing taletrectinib for adult patients with advanced or metastatic NSCLC and improving access to convenient biomarker testing in patients who will benefit from our targeted therapy."

The Guardant360 CDx test is FDA-approved to provide comprehensive genomic profiling results from ctDNA in plasma to guide treatment in all solid tumors, including NSCLC. Guardant360 TissueNext provides oncologists with another option to obtain comprehensive genomic profiling results using tissue. Sequencing a broad number of genes to understand the molecular drivers of a patient’s cancer is critical, as the number of genomic alterations associated with targeted treatments continues to grow.

"Our tissue- and blood-based assays play an essential role in the diagnosis of cancers by revealing actionable mutations that can help oncologists quickly match patients to the right targeted treatment," said Helmy Eltoukhy, Guardant Health co-CEO. "We are proud to partner with AnHeart on this important endeavor to help identify lung cancer patients who may benefit from taletrectinib."

About Taletrectinib

Taletrectinib is a novel potential best-in-class next-generation ROS1 inhibitor designed to effectively target ROS1 fusions with potential to treat both TKI-naïve and pre-treated patients. ROS1 rearrangement is estimated to be an oncogenic driver in approximately 1 to 2 percent of patients with NSCLC. ROS1 fusions are also observed in several other cancers such as cholangiocarcinoma, glioblastoma, ovarian, gastric, and colorectal cancers.

Taletrectinib has demonstrated excellent potency against crizotinib resistance, good brain penetration and intracranial antitumor activity, and favorable safety profiles in ROS1 fusion-positive NSCLC patients. In these patients, few neurological adverse events were observed, which likely benefits from the selective inhibition of ROS1 over TRKB by taletrectinib.

Taletrectinib has received FDA Breakthrough Therapy Designation (BTD) for the treatment of adult patients with advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who are ROS1 tyrosine kinase inhibitor (TKI) treatment naïve or previously treated with crizotinib.

More information about the ongoing China TRUST (Taletrectinib ROS1 LUng STudy) phase 2 trial and the global TRUST-II phase 2 trial may be found by searching clinical trial identifiers NCT04395677 and NCT04919811, respectively at View Source For questions about the ongoing trials, please contact [email protected].