On September 15, 2021 Guardant Health, Inc. (Nasdaq: GH), along with leading academic institutions and pharmaceutical companies, reported that share data highlighting molecular targets of importance, treatment resistance patterns, and advantages of using the Guardant360 liquid biopsy test to help improve the management of advanced solid cancers at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2021 virtual congress on September 16-21 (Press release, Guardant Health, SEP 15, 2021, View Source [SID1234587760]).

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"While precision oncology has made a meaningful difference in improving clinical outcomes for highly prevalent cancers, such as non-small cell lung, colorectal, and breast, there remains a subset of patients who don’t respond to currently available treatments," said Craig Eagle, MD, Guardant Health Chief Medical Officer. "It is gratifying to be able to work with the oncology community to analyze the molecular information generated from our liquid biopsy tests to continue to increase our understanding of possible new targets and more personalized treatments which can potentially improve overall survival of these hard-to-treat cancers in a more meaningful way."

Guardant INFORM Liquid Biopsy Dataset Shows No Clear Standard of Care and Unmet Need for Patients with HER2+ Metastatic Colorectal Cancer

Title

ePoster

Presenter

Characteristics and treatment patterns among patients with HER2-amplified advanced/metastatic colorectal cancer (mCRC): A clinical-genomic database study

439P

John Strickler

Guardant360 Liquid Biopsy Reveals Molecular Insights Impacting Outcomes in Patients with Unresectable and Early-Onset (<50 years) Metastatic Colorectal Cancer

Title

ePoster

Presenter

Molecular features in liquid biopsy of early (EO) and late-onset colorectal cancer (LO)

500P

Julia Alcaide-Garcia

Mutational landscape in synchronous unresectable metastatic colorectal cancer (mCRC) according to upfront primary tumour resection (UPTR)

503P

Manuel Benavides

Guardant360 Liquid Biopsy Reveals Treatment Resistance Patterns and Therapeutic Targets for the Management of Advanced Cancers Including Non-Small Cell Lung and Pancreatic

Title

ePoster

Presenter

First-results of the CLIMB360 study, a prospective molecular screening program across multiple cancer types based on circulating tumor DNA (ctDNA)

92P

Javier Garcia-Corbacho

Pre-existing and acquired mechanisms of resistance to lorlatinib in previously treated patients (pts) with ALK+ advanced non-small cell lung cancer (NSCLC)

1196P

Ben J. Solomon

Cell-free DNA dominant clone allele frequency associates with poor outcomes in advanced pancreatic cancer

1483P

Pedro Uson Junior

On September 15, 2021 T-Cure Bioscience, Inc., a privately held company focused on developing autologous T cell receptor therapy (TCR-T) products for the treatment of solid tumors, reported that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to initiate a Phase I clinical study evaluating a TCR-based product candidate for the treatment of tumors expressing Kita-Kyushu lung cancer antigen 1 (KK-LC-1), such as gastric, cervical, lung, breast cancers and other KK-LC-1 positive epithelial cancers (NCT05035407) (Press release, T-Cure Bioscience, SEP 15, 2021, View Source [SID1234587759]). T-Cure acquired the KK-LC-1 TCR therapy under an exclusive, worldwide license with the National Cancer Institute (NCI) in 2020. This Phase I Clinical Study will be conducted and sponsored by the NCI, part of the National Institutes of Health, where Dr. Scott Norberg and Dr. James Gulley will be the main PIs for this investigator-initiated trial. The trial will be done under a Cooperative Research and Development Agreement (CRADA) that T-Cure has in place with the NCI.

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Last year, T-Cure entered into an exclusive, worldwide license with the NCI for intellectual property related to autologous TCR-T treatment of tumors expressing KK-LC-1, such as gastric, lung, triple negative breast and cervical cancers.

KK-LC-1 is a cancer germline (CG) antigen that has restricted expression in healthy tissues and frequent expression in epithelial cancers including lung cancer, gastric cancer, triple negative breast cancer, cervical cancer and others. Adoptive T-cell therapy is one potentially powerful treatment for cancer that genetically modifies natural T cells to make them tumor-specific and to improve their ability to destroy tumor cells. TCR-T cell therapy targeting CG antigens has been shown to induce objective responses without autoimmunity or off-target toxicity in patients with melanoma, synovial sarcoma and cervical carcinoma.

"TCR-T cell therapy is a promising new treatment modality that has demonstrated clinical activity in a subset of solid tumors." stated Scott Norberg, D.O., Assistant Research Physician, Genitourinary Malignancies Branch, of CCR NCI and Principal Investigator of the study. "Our hope is that KK-LC-1 TCR-T cell therapy can be effective against common epithelial cancers, which account for 80-90% of all human malignancies."

"We are excited that NCI has obtained the regulatory approval from FDA to initiate a first-in-human trial against a very important target in multiple solid tumors." stated Gang Zeng, Ph.D., Chief Executive Officer of T-Cure Bioscience. "Dr. Norberg and Dr. Gulley have extensive experiences in developing novel adoptive T-cell therapies for cancer and they will be invaluable as we advance this program."

Of note, the TCR was isolated from the tumor-infiltrating lymphocytes of a patient who had a complete response to an immunotherapy without any toxicities. As a result, it may hold great promise for engineering patients’ immune cells to effectively target and destroy cancer cells without harming healthy tissue.

On September 15, 2021 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported that the Company will host a virtual Investor Event on Monday, September 20, 2021 at 8:30 a.m. ET / 5:30 a.m. PT (Press release, Mirati, SEP 15, 2021, View Source [SID1234587757]).

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Company executives will discuss:

A top-line update from the Phase 2 registrational cohort of the KRYSTAL-1 study in previously-treated patients with KRASG12C-mutated non-small cell lung cancer (NSCLC)
Findings from the colorectal cancer (CRC) cohort of the Phase 1/2 KRYSTAL-1 study evaluating adagrasib as monotherapy and in combination with cetuximab in patients with heavily pretreated CRC harboring the KRASG12C mutation, as presented at the 2021 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress
Results from the Phase 2 MRTX-500 study evaluating sitravatinib combined with nivolumab in patients with non-squamous NSCLC who progressed on or after prior checkpoint inhibitor therapy, to be presented at the 2021 ESMO (Free ESMO Whitepaper) Congress
Investors and the general public are invited to register and listen to a live webcast of the event through the "Investors and Media" section on Mirati.com. A replay of the event will be available shortly after the conclusion of the event.

Mirati studies at ESMO (Free ESMO Whitepaper) Congress 2021 include:
*All times noted are Central European Summer Time (CEST)

Presentation Title: KRYSTAL-1: Adagrasib (MRTX849) as Monotherapy or Combined with Cetuximab in Patients With Colorectal Cancer Harboring a KRASG12C Mutation
Author: Jared Weiss
Abstract Number: LBA6
Session: Presidential Symposium II
Presentation Date/Time: Sunday, September 19, 2021 at 15:47-16:02 CEST | Channel 1

Presentation Title: MRTX-500: Phase 2 Trial of Sitravatinib (Sitra) + Nivolumab (Nivo) in Patients (Pts) With Nonsquamous (NSQ) Non–Small-Cell Lung Cancer (NSCLC) Progressing on or After Prior Checkpoint Inhibitor (CPI) Therapy
Author: Ticiana A. Leal
Abstract Number: 1191O
Session: NSCLC Proffered Paper Session II
Presentation Date/Time: Monday, September 20, 2021 at 14:10-14:20 CEST | Channel 4

On September 15, 2021 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase" or the "Company"), a biotechnology platform company Drugging the Genome to address disease at the base level using a new class of precision genetic medicines, reported that Dietrich A. Stephan, Ph.D., Chief Executive Officer of NeuBase, will present a corporate overview at the virtual Oppenheimer Fall Healthcare Life Sciences & MedTech Summit being held September 20 – 23 (Press release, NeuBase Therapeutics, SEP 15, 2021, View Source [SID1234587756]).

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Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

Date: Tuesday, September 21st
Time: 3:45 p.m. ET
Location: Webcast Link – or at the company’s website (click here)

On September 15, 2021 aTyr Pharma, Inc. (Nasdaq: LIFE), a clinical stage biotherapeutics company engaged in the discovery and development of innovative medicines based on novel biological pathways, reported that it has commenced an underwritten public offering of shares of its common stock (Press release, aTyr Pharma, SEP 15, 2021, View Source [SID1234587755]). In addition, aTyr expects to grant the underwriters a 30-day option to purchase additional shares of its common stock. All of the shares to be sold in the offering are to be sold by aTyr. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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Piper Sandler and RBC Capital Markets are acting as joint book-running managers for the offering.

The proposed offering is being made pursuant to a shelf registration statement on Form S-3, including a base prospectus, filed by aTyr that was declared effective by the Securities and Exchange Commission ("SEC") on August 23, 2021. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. An electronic copy of the preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the website of the SEC at www.sec.gov. Copies of the preliminary prospectus supplement, when available, and the accompanying prospectus relating to the offering may be obtained by contacting Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, by telephone at (800) 747-3924 or by email at [email protected]; or RBC Capital Markets, LLC, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, New York 10281, by telephone at (877) 822-4089 or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.