On June 18, 2021 Guardant Health reported that STUDY SHOWS GUARDANT REVEAL BLOOD-ONLY LIQUID BIOPSY TEST PREDICTS RISK FOR COLORECTAL CANCER RECURRENCE WITH INDUSTRY-LEADING SENSITIVITY (Press release, Guardant Health, JUN 18, 2021, View Source [SID1234584169]).

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For patients with early-stage colorectal cancer (CRC), the presence of circulating tumor DNA (ctDNA) or minimal residual disease (MRD) after curative intent treatment is becoming an important prognostic biomarker for cancer recurrence, and can also be used to evaluate the potential need for adjuvant treatment in post-surgical patients. Until recently, tests developed to detect MRD required tumor tissue to gain the necessary genomic information needed to accurately identify high-risk patients. A new study led by Massachusetts General Hospital Cancer Center and published in Clinical Cancer Research demonstrates that Guardant Reveal, the first blood-only liquid biopsy to identify MRD, identifies those patients most likely to recur, with industry-leading sensitivity, without the need for tumor tissue. 1,2

The single-center, prospective study evaluated the effectiveness of the Guardant Reveal liquid biopsy test to detect MRD in patients with stage I-IV colorectal cancer after curative intent therapy. Blood draws were taken one month after completion of definitive treatment, either surgery or adjuvant therapy, and at various surveillance or monitoring timepoints. Blood samples were analyzed using the Guardant Reveal test, which integrates both cancer-specific epigenomic signatures and genomic alterations, unlike standard MRD tests which analyze only genomic alterations.

In the primary landmark analysis (n=84), blood samples were taken from the curative intent patient population one month (median 31.5 days) after completion of definitive treatment. In the subset of patients with at least one year of clinical follow-up, all patients with detectable ctDNA recurred (100% PPV). Guardant Reveal test sensitivity and specificity were 55.6% and 100% respectively for this single timepoint. By incorporating longitudinal surveillance samples, sensitivity improved to 91%. Integrating epigenomic signatures increased test sensitivity by 36% versus using genomic alterations alone. Additionally, CEA tests, the traditional biomarker for colorectal cancer, did not predict recurrence in this patient cohort.

"The integration of cancer-specific epigenomic and genomic signatures allows Guardant Reveal to detect minimal residual disease in early-stage colorectal cancers with industry-leading performance and without the need for tumor tissue," said AmirAli Talasaz, Guardant Health president. "We believe that Guardant Reveal can be a powerful decision-making tool for oncologists managing patients with early-stage colorectal cancer. In addition, our blood-only approach offers a more streamlined workflow and faster turnaround time for clinical decision making."

"By detecting minimal residual disease after curative intent treatment, we can have a better understanding of which patients are at high-risk for recurrence and perhaps tailor additional therapy," said Aparna Parikh, MD, MPH, Gastrointestinal Oncologist at Massachusetts General Hospital and Assistant Professor of Medicine, Harvard Medical School. "This study demonstrates that the incorporation of epigenomic signatures with genomic alterations allows for Guardant Reveal to have high sensitivity and specificity, but without the need for tumor tissue."

Tissue-dependent MRD tests have previously reported sensitivities of 40%-50% with a single post-surgical blood draw. 1,3 When looking only at the subset of patients with stage II or III CRC in this study, Guardant Reveal had a sensitivity of 63% and a specificity of 100% for recurrence. These data show that Guardant Reveal can detect minimal residual disease from a simple blood draw. In addition, the sensitivity of the test increases with additional longitudinal blood draws, allowing for earlier detection of recurrence in the patient surveillance setting compared with standard imaging methods.

The Guardant Reveal test achieves industry-leading sensitivity (91%) 2 for detecting ctDNA by simultaneously interrogating genomic and epigenomic alterations. The test accurately identifies genomic alterations down to allele frequencies of 0.01% and effectively filters out biological noise sources such as mutations caused by clonal hematopoiesis. The incorporation of biologically relevant epigenomic signatures is essential to increasing test sensitivity in the post curative intent and surveillance patient populations.

The publication titled, "Minimal Residual Disease Detection using a Plasma-Only Circulating Tumor DNA Assay in Colorectal Cancer Patients" can be found here

On June 18, 2021 Privo Technologies, Inc. reported attends the BIO International Convention online from June 14-18, 2021 (Press release, Privo Technologies, JUN 18, 2021, View Source;utm_medium=rss&utm_campaign=bio-international-convention-2021 [SID1234586911]).

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Despite the conference being held online this year due to COVID-19, Bio International 2021 was
informative and enjoyable. The company connected with potential investors and industry partners in
discussing their PRV111 and PRV211 technology. In addition, the company discussed technology
collaborations with pipeline products.

On June 17, 2021 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents which includes checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported that the U.S. Food and Drug Administration (FDA) has accepted Agenus’ Biologics License Application (BLA) for balstilimab, an anti-PD-1 antibody, for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy (Press release, Agenus, JUN 17, 2021, View Source [SID1234584134]). The FDA has granted Priority Review to this submission, a designation for drugs which, if approved, may provide significant improvements in the safety or effectiveness of the treatment of serious conditions. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target action date of December 16, 2021.

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About Cervical Cancer
Nearly 14,000 women are expected to be diagnosed with invasive cervical cancer in the United States this year and more than 4,000 are expected to die.1 Cervical cancer remains one of the leading causes of cancer death in women globally, annually killing more than 300,000 women worldwide.2 Despite advances in routine medical examinations and HPV vaccines, cervical cancer remains prevalent. When left undetected, recurrent or metastatic cervical cancer often develops, for which there are limited treatment options and a low chance of survival. Current therapies for recurrent or metastatic cervical cancer are limited to a small subset of patients with limited benefit.

About balstilimab
Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. PD-1 is a negative regulator of immune activation that is considered a foundational target within the immuno-oncology market. Balstilimab is currently in clinical trials as monotherapy and in combination with Agenus’ anti-CTLA-4, zalifrelimab, in an ongoing Phase 2 study for recurrent/metastatic cervical cancer.

On June 17, 2021 OncoNano Medicine, Inc. reported the raise of an approximate $50 million Series B financing led by the healthcare investment team at Advantech Capital, a China-based cross border institutional investment fund (Press release, OncoNano Medicine, JUN 17, 2021, View Source [SID1234584156]). Proceeds of the financing will be used, in part, to support the Phase 3 clinical trials in the U.S. and Europe for pegsitacianine, an innovative real-time imaging agent used in intraoperative surgical resection of solid tumors, and accelerate the advancement of the company’s first therapeutic development program, ONM-501, a novel immune-therapeutic formulated with the company’s core delivery technology.

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"We are thrilled to welcome Advantech as an investor in OncoNano and look forward to continuing the momentum we’ve built with our lead development programs that utilize our proprietary pH-activated micelle platform," said Martin Driscoll, CEO at OncoNano Medicine, Inc. "We plan to initiate our pegsitacianine pivotal trial program in the U.S. and Europe and submit an IND for our first therapeutic development program in 2022. The funds from this Series B raise combined with the support of our partners from the Cancer Prevention & Research Institute of Texas (CPRIT) provide the resources to operate our company for several years, advance pegsitacianine further towards commercialization, and progress our novel immuno-oncology compound, ONM-501, through our Phase 1a/1b clinical program. With the inclusion of the new capital, we now have the capability to accelerate our development programs and work to achieve our goal of bringing novel interventions and treatments to cancer patients."

"We are impressed with the potential for OncoNano’s innovative core technology," said Benjamin Qiu, partner at Advantech Capital. "We see great promise in OncoNano and are excited to support the company through its further advancement of pegsitacianine into a pivotal clinical development program and its novel dual-activation STING agonist towards a first in human study to help address the persistent and challenging unmet needs in cancer surgery and treatment."

About Advantech Capital

Advantech Capital is a private equity investment fund, focusing on innovation-driven growth opportunities in China, mainly investing in TMT, pharmaceuticals, and healthcare.

About Cancer Prevention & Research Institute of Texas (CPRIT)

CPRIT has awarded $2.72 billion in grants to Texas research institutions and organizations through its academic research, prevention, and product development research programs. CPRIT has recruited 233 distinguished researchers, supported the establishment, expansion, or relocation of 42 companies to Texas, and generated more than $5.5 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 7.1 million life-saving cancer prevention and early detection services reaching Texans from all 254 counties. On November 5, 2019, Texas voters overwhelmingly approved a constitutional amendment providing an additional $3 billion to CPRIT, for a total $6 billion investment in cancer research and prevention efforts across Texas, one of the largest state funded research programs in United States history and the second largest source of funding for cancer research in the world.

On June 17, 2021 Anji Pharma ("Anji"), a global pharmaceutical company focused on tackling high-value drug targets validated by human genetics, reported that an Anji subsidiary has acquired worldwide development and commercialization rights to an MCL1 inhibitor program through a license from the Broad Institute of MIT and Harvard and will work to advance the program’s MCL1 inhibitors through clinical development (Press release, Anji Pharmaceuticals, JUN 17, 2021, View Source [SID1234584173]).

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MCL1 is a member of the Bcl-2 family, normally acting as a "brake" on the apoptosis pathway. In many human cancers, the Mcl-1 gene is highly amplified, shifting the balance from pro- to anti-apoptotic signals and promoting cancer cell survival and tumor formation. Molecules which selectively block MCL1 function induce rapid and specific killing of cancer cells in preclinical models when administered as single agent or in combination with other targeted therapy.

"MCL1 has always been at the top of our list for oncology mechanisms, given its pronounced amplification across tumor types and central role in orchestrating chemotherapy resistance," noted Dan Meyers, M.D., Chief Medical Officer of Anji. "We believe this specific class of MCL1 inhibitors has a unique profile that could offer a wider safety window and better outcomes for cancer patients."

"Our interest in this MCL1 program reaffirms our commitment to pursue compelling mechanisms – regardless of disease indication – and develop therapies that can help patients across the globe," added Brian Hubbard, Ph.D., Chief Executive Officer of Anji. "What matters to us most is whether it will work, and then we commit our clinical and regulatory experience to bring treatments to patients as safely and quickly as possible."

The MCL1 program is one of several programs pursued by the Center for Development of Therapeutics (CDoT) at the Broad Institute. CDoT is a highly collaborative team of professional scientists who work closely with Broad’s principal investigators to advance deep biological insights into therapeutics.