On December 21, 2023 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported a new study published in Molecular Oncology comparing the performance of mean tumor molecules per milliliter (MTM/mL) against mean variant allele frequency (mVAF) for measuring circulating tumor DNA (ctDNA), using Signatera, Natera’s personalized and tumor-informed molecular residual disease (MRD) test (Press release, Natera, DEC 21, 2023, View Source [SID1234638769]). The full study can be found here.

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To date, mVAF and MTM/mL are the two main metrics that have been used to quantify ctDNA levels in the blood. Unlike mVAF, which is a fraction that can be confounded by changes in total background cfDNA, MTM/mL takes into account total cfDNA as well as plasma volume. The premise is that MTM/mL is therefore more representative of a patient’s true disease burden, a hypothesis that was validated in this study.

The study analyzed ctDNA data generated in 55,183 ctDNA-positive samples from 23,543 patients who underwent testing with Signatera for various cancer diagnoses, and it reported the correlation between MTM/mL and mVAF, as well as the correlations of each with patient outcomes.

Key findings include:

Among the 18,426 patients with longitudinal ctDNA measurements, 13.3% had discordant ctDNA trajectories (increase/decrease) when calculated using MTM/mL versus mVAF.
In patients with stage IV disease receiving immunotherapy (N=51), ctDNA dynamics measured in MTM/mL were more predictive of therapy response than those measured in mVAF, with a hazard ratio (HR) nearly 2x higher (MTM/mL HR 16, p<0.0001; mVAF HR 8.8, p<0.0001).
In a case study of a patient with metastatic triple-negative breast cancer, disease progression during systemic therapy was reflected in increasing MTM/mL values, while mVAF levels remained stable.
"We are pleased to see the publication of these important findings, in which MTM/mL provided a more accurate measure of ctDNA than mVAF, particularly for patients undergoing active therapy which can impact the levels of background cfDNA," said Minetta Liu, M.D., chief medical officer of oncology at Natera. "Clinicians need tools to enable reliable predictions of therapy response and clinical outcomes. As the only MRD test that uses MTM/mL, this study supports the utility of Signatera for ctDNA quantification, to measure treatment response at critical time points and inform decisions on how patients are managed."

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer (stage IIb and higher) and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 50 peer-reviewed papers.

On December 21, 2023 ImmunoScape, a biotechnology company focused on next-generation T Cell receptor (TCR)-based immunotherapies, reported a partnership with the Experimental Drug Development Centre (EDDC), Singapore’s national platform for drug discovery and development hosted by the Agency for Science, Technology and Research (A*STAR) (Press release, immunoSCAPE, DEC 21, 2023, View Source [SID1234638768]).

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ImmunoScape’s core antigen-specific T cell immune profiling technology was developed at A*STAR’s Singapore Immunology Network and is exclusively licensed from A*STAR. Since its spinout from A*STAR in 2016, ImmunoScape has developed a cutting-edge, high-throughput, TCR discovery platform that produces a broad and emerging portfolio of novel, safe, and efficacious TCRs against solid tumors.

In this new partnership, ImmunoScape will leverage its catalog of highly potent tumor-specific TCR candidates for the joint development of innovative off-the-shelf TCR-based bispecific molecules with EDDC. These molecules contain two distinct binding sites and are engineered to bind and activate T cells, redirecting them towards tumor sites for interaction with cells expressing the unique tumor-specific antigen through the TCR. This approach enables the patient’s own T cell repertoire to selectively eliminate cancer cells. EDDC will apply its expertise in therapeutic protein design and antibody engineering to develop these novel TCR-based bispecific molecules.

"The benefit of off-the-shelf TCR molecules is that they do not require engineering and manufacturing of the patients’ own T cells, which can make them accessible to a much broader patient population and further results in much lower production costs and shorter timelines for the patients to receive the drug," said Choon-Peng Ng, CEO of ImmunoScape. "By combining the power of our machine learning-augmented TCR discovery platform with EDDC’s broad expertise in the design of multifunctional constructs, we will aim to rapidly develop novel off-the-shelf TCR-based bispecific molecules that could overcome widespread challenges in cell therapy approaches against solid tumors."

"We are thrilled to join forces with ImmunoScape to design and produce TCR-based bispecific constructs that could lead to more effective treatments for solid tumors," said Damian O’Connell, CEO of EDDC. "Our deep expertise in progressing projects from discovery and production of antibodies to the design of multifunctional constructs, paired with ImmunoScape’s TCR discovery platform and library of tumor-specific TCRs, will allow us to jointly develop molecules for sensitive and effective tumor targeting in a T cell-independent manner."

The collaboration is set to commence in early 2024.

On December 21, 2023 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, reported the expansion of their clinical development pipeline in preparation for the commencement of a second Phase III trial (Press release, Renovorx, DEC 21, 2023, View Source [SID1234638767]). The CouGar Trial will evaluate RenovoGem in bile duct cancer, specifically unresectable locally advanced extrahepatic cholangiocarcinoma (eCCA).

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"We are pleased to engage our first clinical site for our second pivotal clinical trial. The CouGar Trial marks an important milestone for RenovoRx as we expand our clinical pipeline for RenovoGem into bile duct cancer, a difficult-to-treat solid tumor cancer," said Leesa Gentry, Senior Vice President of Clinical Operations at RenovoRx. "I’m extremely proud of our team and our collaborators for their tremendous work reinforcing our mission to improve patient lives by delivering innovative therapies that can potentially change the current paradigm of cancer care."

The pivotal Phase III CouGar study is a randomized study designed to evaluate the safety and efficacy of unresectable, locally advanced eCCA using intravenous cisplatin, gemcitabine, and durvalumab (all forms of chemotherapy) versus Trans-Arterial Micro-Perfusion via RenovoGem (delivery system and gemcitabine) with intravenous durvalumab. Oklahoma University (OU) Health is the first clinical site for the CouGar study.

"Unfortunately, bile duct cancer today has a poor prognosis for patients. Despite early diagnosis, the five-year survival rate is approximately 24%," said Paula Novelli, MD FSIR, CouGar National Principal Investigator, and Associate Professor of Radiology and Director of Interventional Radiology Research at the University of Pittsburgh Medical Center. "There are currently limited treatment options for patients diagnosed with this aggressive cancer, which only prolongs life by a few months. The CouGar study brings hope for a new treatment option. RenovoGem has the potential to meet the urgent clinical need for a safe and effective therapy in this important patient population."

Dr. David Geller, Director, UPMC Liver Cancer Center, Richard L. Simmons Professor of Surgery, University of Pittsburgh School of Medicine is the CouGar study’s Co-Investigator.

"The current standard of care for bile duct cancer is systemic (intravenous) chemotherapy, which has poor uptake and delivery since there are few blood vessels feeding this type of tumor," said Dr. Hassan Hatoum, Principal Investigator, Associate Professor and Hematologist and Oncologist at Oklahoma University Health Stephenson Cancer Center – Gastrointestinal Cancer Clinic. "RenovoRx’s clinical trial is evaluating targeted, trans-arterial delivery of chemotherapy that is locally directed to the tumor site. Our team looks forward to participating in the CouGar study to bring this novel therapy to patients."

RenovoGem received FDA Orphan Drug Designation for pancreatic cancer and bile duct cancer which provides 7 years of market exclusivity upon NDA approval.

On December 21, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that it has entered into a common stock purchase agreement with Baillie Gifford on behalf of accounts that it manages for the sale of 3,387,446 shares of its common stock in a registered direct offering at an offering price of $26.77 per share (Press release, Guardant Health, DEC 21, 2023, View Source [SID1234638766]).

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Gross proceeds are approximately $90.7 million, before deducting expenses payable by Guardant Health. Guardant Health intends to use the net proceeds from the offering primarily for general corporate purposes, including working capital, operating expenses and capital expenditures.

"We are proud to be supported by Baillie Gifford," said Helmy Eltoukhy, co-founder and co-CEO of Guardant Health. "At Guardant, we are driven by the impact our products have on patient outcomes each and every day, and look forward to Baillie Gifford’s continued support as we work to serve many more patients with our growing product portfolio."

"We have deep conviction in Guardant’s ability to execute on the opportunity ahead," said Brogan Harris at Baillie Gifford. "We look forward to a long-term partnership with Guardant’s team, as they work to continue to improve outcomes and transform patient lives across the continuum of care."

The shares of common stock are being offered by Guardant Health pursuant to an automatic shelf registration statement on Form S-3 that was previously filed with the U.S. Securities and Exchange Commission, or the SEC, and automatically became effective upon filing. A final prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and is available on the SEC’s website at www.sec.gov.

Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained when available, on the SEC’s website at View Source or by contacting Guardant Investor Relations, 3100 Hanover Street, Palo Alto, California 94304, by email: [email protected] or by telephone: (657) 254-5417.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, nor shall there be any sale of these securities in any state or 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 jurisdiction.

On December 21, 2023 AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving quality of life for patients, reported that Jim Clemmer, President and Chief Executive Officer, and Stephen Trowbridge, Executive Vice President and Chief Financial Officer, will present at the J.P. Morgan 42nd Annual Healthcare Conference at 9:00 a.m. PT (12:00 p.m. ET) on Thursday, January 11, 2024 in San Francisco, CA (Press release, AngioDynamics, DEC 21, 2023, View Source [SID1234638765]).

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A live webcast of the presentation will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following the event.