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Natera to Present New Immunotherapy Monitoring Data at SABCS 2020

On December 8, 2020 Natera,Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, reported it will present new data on its personalized and tumor-informed circulating tumor DNA (ctDNA) assay, Signatera, at the 2020 virtual San Antonio Breast Cancer Symposium (SABCS) taking place December 8-11, 2020 (Press release, Natera, DEC 8, 2020, View Source [SID1234572463]).

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Natera will present two posters: one from the I-SPY2 Trial describing Signatera’s performance as a predictive biomarker for response to neoadjuvant immunotherapy, and the other from the Beyond BRCA study describing Natera’s plasma-based whole exome analysis as a tool for tracking clonal evolution and discovering new treatment resistance mutations.

Details about the presentations are as follows:

Poster #PD9-02 | Spotlight Poster Discussion
Presenter: Mark Jesus M. Magbanua, Ph.D.
Date: Dec 10, 2020 | 3:30 PM to 4:45 PM CT

Personalized ctDNA as a predictive biomarker in high-risk early stage breast cancer treated with neoadjuvant chemotherapy (NAC), with or without pembrolizumab

A study from the prospective, randomized I-SPY2 Trial exploring the predictive value of personalized ctDNA analysis, performed by Natera, in patients with early-stage breast cancer undergoing either standard NAC or NAC in combination with the immune checkpoint inhibitor pembrolizumab. Early clearance of ctDNA (three weeks after initiation of treatment) is significantly associated with achieving pathological complete response, and may serve as an early surrogate marker for response to therapy. Persistent presence of ctDNA after completion of NAC, but prior to surgery, is strongly correlated with poor disease-free survival.

"Just last week, the I-SPY investigators published a paper in Annals of Oncology validating Signatera’s performance in neoadjuvant treatment monitoring for patients with early-stage breast cancer," said Angel Rodriguez, M.D., Medical Director at Natera. "This new study presented at SABCS follows a different cohort of I-SPY2 patients who received NAC in combination with immunotherapy. The results from this new cohort further validate the initial finding that Signatera can be a powerful tool for neoadjuvant treatment response monitoring, regardless of the type of therapy, and can complement existing tools, such as pathology and imaging, to optimize decisions around the escalation or de-escalation of treatment."

Poster #PD10-12 | Spotlight Poster Discussion
Presenter: Joshua J. Gruber, M.D., Ph.D.
Date: Dec 11, 2020 | 1:00 PM to 2:15 PM CT

Genomic analysis from the Talazoparib Beyond BRCA clinical trial: homologous recombination deficiency (HRD) scores, loss-of-heterozygosity and mutations in non-BRCA 1/2 mutant tumors

A poster on the genomic characterization of treatment response and resistance to the PARP1 inhibitor, talazoparib, in non-BRCA 1/2 mutant tumors with mutations in other HRD-associated genes. Plasma-based whole exome sequencing of ctDNA, performed by Natera, provides a comprehensive view of tumor evolution over the course of treatment, wherein responders and nonresponders show distinct patterns, leading to the identification of novel mutations responsible for acquired resistance to talazoparib treatment.

"Drug resistance remains a significant challenge in the management of breast cancer," said Joshua J. Gruber, M.D., Ph.D., medical oncologist at Stanford University Medical Center and the lead author of the Beyond BRCA study. "The ability to non-invasively characterize the molecular evolution of tumors during treatment using ctDNA can guide further investigation of treatment resistance."

About Signatera
Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and in 2019, it was granted Breakthrough Device Designation by the FDA. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy; rather, it is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions. Signatera test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Signatera has been developed and its performance characteristics determined by Natera, the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). CAP accredited, ISO 13485 certified, and CLIA certified.

Caris Life Sciences Publishes New Data in Clinical Cancer Research Demonstrating 71% Difference in Overall Survival for mCRC Patients Using Its AI-Based MI FOLFOXai Predictor

On December 8, 2020 Caris Life Sciences, a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine, reported positive results from validation studies of MI FOLFOXai, the company’s Artificial Intelligence (AI)-based predictor intended to gauge a metastatic colorectal cancer (mCRC) patient’s likelihood of benefit from first-line treatment FOLFOX followed by FOLFIRI versus FOLFIRI followed by FOLFOX, both standard of care options (Press release, Caris Life Sciences, DEC 8, 2020, View Source [SID1234572462]). The studies demonstrated that the overall survival (OS) of patients treated in a manner consistent with the FOLFOXai prediction was 17 months longer than the OS of patients treated counter to the prediction. FOLFOXai is the first clinically validated machine-learning powered molecular predictor of chemotherapy efficacy in patients with mCRC. The results were published in Clinical Cancer Research December 8, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

"The clinical application of these findings could have a major impact on how FOLFOX and FOLFIRI are sequenced, both options are recognized standard of care in metastatic disease, for patients," said Heinz-Josef Lenz, M.D., FACP, Associate Director Clinical Science and Co-director of the Center for Cancer Drug Development at USC Norris Comprehensive Cancer Center. "Using this AI predictor, we saw a 71% difference in OS in patients treated with FOLFOX-FOLFIRI in whom we predicted would benefit from FOLFOX-FOLFIRI chemotherapy compared to those predicted to benefit from FOLFIRI-FOLFOX."

Across two independent validation studies, researchers determined a significant difference in OS based on the FOLFOXai-predicted increased benefit or decreased benefit with FOLFOX-FOLFIRI chemotherapy in combination with bevacizumab. A study using real-world evidence demonstrated a median OS of 42 months in patients expected to see an increased benefit compared to 24.5 months in patients expected to see a decreased benefit (Hazard Ratio [HR]=0.466, 95% Confidence Interval [CI]: 0.325-0.670, p<0.0001). Additionally, patients predicted to have a decreased benefit from FOLFOX-FOLFIRI chemotherapy had significantly better outcomes when treated with FOLFIRI-FOLFOX than those predicted to have an increased benefit and vice versa (HR=2.631, 95% CI: 1.041-6.649, p=0.034). Analysis of samples from the TRIBE2 randomized phase-3 study which compared standard chemotherapy with FOLFOX followed by FOLFIRI to the FOLFOXIRI combination, confirmed the ability of FOLFOXai to predict OS for both study arms.

"These studies validate the potential role of FOLFOXai to improve overall survival in patients with metastatic colorectal cancer who receive first-line standard of care options in the optimal order," said Alan P. Venook, M.D., FASCO, The Madden Family Distinguished Professor of Medical Oncology and Translational Research and Shorenstein Associate Director, Program Development, UCSF Helen Diller Family Comprehensive Cancer Center.

In addition to mCRC, exploratory analyses also found that FOLFOXai predicted a treatment benefit from oxaliplatin-containing regimens in patients with advanced esophageal/gastro-esophageal junction cancers (EC/GEJC) and pancreatic ductal adenocarcinoma (PDAC). These analyses demonstrated FOLFOXai was predictive of OS, with a median OS difference of 10.1 months in the increased benefit cohort compared to decreased benefit (21.4 months versus 11.3 months; HR=0.478, CI: 0.289 – 0.792, p=0.003) but not the nab-paclitaxel/gemcitabine cohort (median OS of 10.8 months for increased benefit versus 9.8 months for decreased benefit; HR=0.958, CI: 0.658 – 1.395, p=0.823). Similarly, data from 104 patients with advanced EC/GEJC demonstrated that FOLFOXai was predictive of efficacy of oxaliplatin containing regimens also in this clinical setting (median OS for increased benefit: 14 months versus 8.9 months for decreased benefit; HR=0.437, CI: 0.250 – 0.763, p=0.003).

"The results of these analyses demonstrate that precision medicine powered by AI has the potential to change how clinicians approach treatment for metastatic colorectal cancer and other cancers, given the selection of initial therapy has implications for improved treatment outcomes and disease progression," said W. Michael Korn, M.D., Chief Medical Officer at Caris Life Sciences. "Based on the results of this study, FOLFOXai should be considered as part of the initial therapeutic decision-making process in the clinical setting."

"Cancer is a complex genetic disease that results from perturbations in cell’s signaling pathways that make it virtually impossible for humans to interpret. Application of AI to truly comprehensive genomic profiling and outcome data of these systems has allowed us to make clinically impactful insights and improve patient care. Using our database of over 215,000 profiles and outcomes, we have begun to deconvolute the drivers of therapy resistance and tailor treatment strategies to each individual patient. This is one of many benefits patients receive automatically when they get profiled by Caris, as this is additional clinical insight from an already covered diagnostic test," said David Spetzler, M.S., MBA, Ph.D., President and Chief Scientific Officer at Caris Life Sciences.

"Application of AI to molecular data sets involves overcoming some significant computational challenges. The molecular data generated by MI Profile provides hundreds of thousands of data points per patient that had to be analyzed to derive a robust and generalizable set of features and algorithms," said Jim Abraham, Ph.D., Chief Data Officer at Caris Life Sciences. "We were able to deploy 318 different machine learning algorithms to solve these problems and validate the results in blinded, well controlled studies, and this is the first of many AI signatures to come."

Colorectal cancer is the third most common cancer globally, with more than 1.8 million patients diagnosed with the disease each year i. As many as 25% of colorectal cancer patients will present with Stage IV – or metastatic – disease, where the cancer has spread to other parts of the body, making the choice of treatment critical to the patient’s prognosis.

Precigen to Host R&D Update Virtual Event on December 15th to Share Latest Clinical Developments

On December 8, 2020 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported that the Company will host a virtual event on Tuesday, December 15, 2020 at 11:00 AM ET to provide an update on the latest progress for its clinical pipeline (Press release, Precigen, DEC 8, 2020, View Source [SID1234572461]).

The event will showcase data from several of the Company’s most advanced clinical programs, such as PRGN-3005 UltraCAR-T, PRGN-3006 UltraCAR-T and AG019 ActoBioticsTM. Precigen executives and key opinion leaders will participate in the event, including:

Helen Sabzevari, PhD, President and CEO of Precigen
Pieter Rottiers, PhD, CEO of Precigen ActoBio
Mary L. (Nora) Disis, MD, faculty member at the University of Washington and Fred Hutchinson Cancer Research Center and one of the lead investigators for the PRGN-3005 clinical study
Kevan Herold, MD, Professor of Immunobiology and of Medicine (Endocrinology) at Yale School of Medicine and one of the lead investigators for the AG019 clinical study
Participants may register and access the live webcast through Precigen’s investor relations website in the Press & Events section. An archived recording will be posted to the investor relations website following the event.

Applied BioMath, LLC Announces Collaboration with Antengene for Systems Pharmacology Modeling in Oncology

On December 8, 2020 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported a collaboration with Antengene Corporation for the development of a systems pharmacology modeling in immuno-oncology (Press release, Applied BioMath, DEC 8, 2020, View Source [SID1234572460]). Applied BioMath will develop a systems pharmacology model for a PDL1/41BB bispecific antibody, ATG-101, in immuno-oncology indications. The model will be used to predict clinical starting and efficacious doses for first-in-human studies. "Antengene Corporation is dedicated to developing first-in-class and/or best-in-class therapies in oncology," said Dirk Hoenemann, M.D., VP, Head of Medical Affairs for Asia Pacific Region (APAC) and Early Clinical Development. "We decided to collaborate with Applied BioMath in an effort to provide ourselves the highest likelihood possible of predicting accurate starting and efficacious doses which is a critical part of our first-in-human studies."

Applied BioMath employs a rigorous fit-for-purpose model development process which quantitatively integrates knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach employs proprietary algorithms and software that were designed specifically for systems pharmacology model development, simulation, and analysis. "Predicting starting and efficacious doses for first-in-human studies is non-trivial for complex therapeutics such as Antengene’s bispecific therapeutic," said Dr. John Burke, Ph.D., Co-Founder, President, and CEO of Applied BioMath. "We have developed algorithms and tools specifically for this purpose that have a proven track record of predicting such doses. We look forward to collaborating with Antengene to support them in this project."

Sutro Biopharma Announces Pricing of $126.0 Million Public Offering

On December 8, 2020 Sutro Biopharma, Inc. (Nasdaq: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer and autoimmune therapeutics, reported the pricing of an underwritten public offering of 6,000,000 shares of its common stock at a price to the public of $21.00 per share (Press release, Sutro Biopharma, DEC 8, 2020, View Source [SID1234572459]). The gross proceeds from this offering are expected to be $126.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by Sutro. Sutro has also granted the underwriters a 30-day option to purchase up to an additional 900,000 shares of common stock in connection with the public offering. All of the shares of common stock are being offered by Sutro. The offering is expected to close on or about December 11, 2020, subject to the satisfaction of customary closing conditions.

Cowen, Piper Sandler and Wells Fargo Securities are acting as joint book-running managers in the offering. Wedbush PacGrow and JMP Securities are acting as co-managers in the offering.

Sutro intends to use the net proceeds from the proposed offering, together with its existing cash, cash equivalents and marketable securities, to fund the continued clinical development of STRO-001 and STRO-002 and the remainder to fund the further development of its technology platform, including manufacturing, to broaden its pipeline of product candidates, and for working capital and general corporate purposes.

The shares are being offered by Sutro pursuant to registration statements filed and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to this offering have been filed with the SEC. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering, and when available, the final prospectus supplement, may be obtained from: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; 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 Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, New York 10001, by telephone at (800) 326-5897, or by email at [email protected]. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Sutro, 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 registration or qualification under the securities laws of any such state or jurisdiction.