On June 9, 2020 Promega Corporation reported CE marking for the OncoMate MSI Dx Analysis System (OncoMate MSI) as a new in vitro diagnostic (IVD) medical device in Europe (Press release, Promega, JUN 9, 2020, View Source [SID1234560942]). OncoMate MSI is a PCR-based, validated gold standard for determining microsatellite instability (MSI) status in solid tumors.1,2,3 It offers analytical sensitivity and unsurpassed specificity with a short turn-around time.4,5

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"European guidelines recommend MSI testing to assess deficient mismatch repair function of solid tumors for a spectrum of cancers, including colorectal cancer and endometrial cancer, in order to reduce morbidity and mortality," said Richard Hamelin, Ph.D., Research Director (Ret) at Inserm. "Data show that OncoMate MSI provides clinicians a valuable DNA-based MSI reading that is complementary to a standard MMR immunohistochemistry panel and can be used as an independent biomarker to predict response with immuno-oncology therapies."

Loss of mismatch repair (MMR) protein function results in tumor cells with DNA MSI.6 MSI testing is an important first step in the molecular characterization related to loss of MMR function, including Lynch Syndrome-related cancers.7,8 A study led by Hamelin shows accumulating evidence suggesting that MSI-High status identifies a subset of colorectal cancers with distinctive biological and clinical properties, emphasizing the importance of simple, accurate markers for detection.9 Using a pentaplex PCR system allows for accurate evaluation of tumor MSI status of DNA with high sensitivity and specificity.9

OncoMate MSI uses the most sensitive panel of markers for MSI status detection, as included in the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) guidelines. Screening cancer patients with these reliable markers can provide pathologists, oncologists, and patients with information that characterizes tumors to help guide care and treatment decisions.10

"Promega MSI technology demonstrates our commitment to developing precise and reliable tools for life scientists around the world," said Heather Tomlinson, Director of Clinical Diagnostics at Promega Corporation. "With the CE marking of OncoMate MSI, Promega aims to make MSI testing more broadly accessible to laboratories within Europe and to aid clinicians in making vital decisions in cancer patient care and treatment."

Promega MSI technology is one of the leading standard tests for MSI status detection in research laboratories and achieved innovation status and priority review by the National Medical Products Administration (NMPA) in China. It has been used extensively in clinical research for more than 15 years and is supported by more than 140 peer-reviewed publications. Promega continues to advance the promise of MSI technology globally and intends to seek regulatory clearance for OncoMate MSI in the United States and China.

To learn more about OncoMate MSI Dx Analysis System, visit: www.promega.com/OncoMateCEIVD

About OncoMate MSI Dx Analysis System

OncoMateTM MSI Dx Analysis System encompasses a complete workflow for MSI determination from DNA extraction to data analysis, offering an easy to use and standardized system. It includes the same validated and endorsed loci as the Promega Research Use Only MSI Analysis System Version 1.2 with the new advantages of a shorter turn-around time and GoTaq MDx DNA polymerase. OncoMate MSI is a fluorescent, multiplex PCR-based test to detect DNA sequence length changes in microsatellite regions of tumor cell DNA relative to the same regions from the patient’s normal cells thereby indicating microsatellite instability. OncoMate MSI targets seven microsatellite markers: five mononucleotide-repeat markers (BAT-25, BAT-26, NR-21, NR-24 and MONO-27) and two pentanucleotide-repeat markers (Penta C and Penta D). These mononucleotide-repeat markers are analyzed to determine MSI status and were selected for high sensitivity and specificity to alterations in repeat lengths in samples containing mismatch repair defects. MSI is a form of genomic instability caused by insertion or deletion of additional bases into DNA microsatellites, regions of repeating bases distributed throughout the human genome. During DNA replication, failure of the mismatch repair system to correct these errors causes MSI.

On June 9, 2020 Bolt Biotherapeutics, Inc., a private clinical-stage biotechnology company developing its Immune-Stimulating Antibody Conjugate (ISAC) platform technology to harness the power of the immune system to treat cancer, reported that the U.S. Patent and Trademark Office (USPTO) has issued U.S. Patent No. 10,675,358 entitled "Antibody Adjuvant Conjugates (Press release, Bolt Biotherapeutics, JUN 9, 2020, View Source [SID1234560927])." The patent provides protection for immunoconjugates of a piperazinyl imidazoquinoline adjuvant bound to any antibody, including Bolt’s BDC-1001 ISAC embodiment.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

BDC-1001 is being developed as a monotherapy for patients with HER2-expressing solid tumors. BDC1001 is an ISAC comprised of trastuzumab conjugated to a Bolt proprietary TLR7/8 agonist payload.

Michael N. Alonso, Ph.D., scientific co-founder and vice president of immunology and pharmacology of Bolt, stated "The development of Boltbody ISACs is motivated by the insatiable need to translate scientific discoveries into products that will help cancer patients become survivors. This patent issuance is an important milestone that provides protection for our BDC-1001 clinical asset and our Boltbody ISAC technology platform. Our dedicated and talented teams will continue to aggressively build a robust patent portfolio to protect our pipeline, our platform, and our commitment to patients."

About Bolt Biotherapeutics’ Immune-Stimulating Antibody Conjugate (ISAC) Platform Technology The Boltbody platform consists of Immune-Stimulating Antibody Conjugates (ISAC) that harness the ability of innate immune agonists to convert cold tumors into immunologically hot tumors thereby illuminating tumors to the immune system and allowing them to be invaded by tumor killing cells. Boltbody ISACs have demonstrated the ability to eliminate tumors following systemic administration in preclinical models and have also led to the development of immunological memory, which is predicted to translate into more durable clinical responses for patients. The company’s first Boltbody to enter clinical development, BDC-1001, is currently being evaluated in patients with HER2-expressing solid tumors

On June 9, 2020 C2i Genomics ("C2i"), a company dedicated to improving cancer patient lives and outcomes with a breakthrough tumor pattern recognition approach for liquid biopsy, reported that it has raised $12 million in its Series A financing (Press release, C2i Genomics, JUN 9, 2020, View Source [SID1234560943]). The financing was led by Casdin Capital and joined by additional new investors including NFX Capital, The Mark Foundation for Cancer Research and other investors. Proceeds from the financing will be used to fund the development and clinical validation of C2i Genomics’ personalized, real-time solution for monitoring recurrence and treatment response for various types of solid cancers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This Series A funding will allow us to take the next major step in our growth and advance our core technology into pilot and pivotal validation studies in several oncology indications," said Asaf Zviran, C2i Genomics’ co-founder, chief executive officer and chief scientific officer. "We believe that the improvement in sensitivity we’ve achieved will allow physicians to quantitatively monitor their patient treatment response and detect treatment failure or disease recurrence months and even years before they would do otherwise. We have built C2i on a solid scientific and technological foundation and are excited to work with our investors and other partners toward the deployment of our cloud-based platform for disease management. The great support of our clinical collaborators from the US, Europe and Asia highlights the global need that underlines our mission to support effective therapy decisions for millions of cancer patients around the world."

C2i Genomics’ innovative solution is based on research performed at the New York Genome Center (NYGC) and Weill Cornell Medicine (WCM) by Dr. Zviran, along with Dr. Dan Landau, core faculty member at the NYGC and assistant professor of Medicine at WCM, who serves as scientific co-founder and member of C2i’s scientific advisory board. C2i then welcomed Dr. Boris Oklander as chief technology officer, and Ezra Sofer as its general manager and chief financial officer, both of whom bring extensive executive leadership and management expertise and experience from their previous roles in the healthcare industry. The technology has been validated through longitudinal clinical cohorts in collaboration with cancer centers in New York and Boston and was recently published in Nature Medicine. This proof-of-concept research was supported by a 2017 grant from The Mark Foundation for Cancer Research.

"The C2i technology allows for the company to develop a bio-platform approach that works across cancer types and allows effective guidance of diverse treatment modalities from surgery and chemotherapy to immunotherapy and targeted therapies." said James Currier, managing partner of NFX Capital. "Such a data-based treatment management platform will produce a network effect, which will increase the value of C2i’s data and services over time. We predict that this is a unique opportunity to build a sector defining company."

Existing liquid biopsy methods focus on detecting specific mutations in targeted panels. Panel-based methods can have limited sensitivity and show only mutation-specific response which do not typically represent the full complexity of the cancer’s response due to tumor heterogeneity. C2i’s liquid biopsy analysis platform can detect and quantify very small amounts of residual disease in the patient’s blood by utilizing a personalized tumor "fingerprint" representing thousands of mutations for each individual patient. This novel genome-wide signature detection, coupled with proprietary mathematical inference models and machine learning techniques, provides ultra-sensitive quantification of the amount of circulating tumor DNA in the patient’s blood, accurately capturing the aggregate response of the heterogenic tumor.

Ultra-sensitive treatment monitoring holds promise to improve patient outcome while reducing the overall cost burden on the health system. Through effective monitoring, C2i technology also offers the opportunity to accelerate clinical trials, aiming to bring lifesaving treatments to the clinic.

"Genomic tools are bringing enormous benefit to the cancer patient treatment through more powerful and precise care and therapeutic development," said Eli Casdin, managing partner of Casdin Capital. "The C2i approach breaks through sensitivity limitations of current approaches by exploiting the team’s unique capabilities at the intersection of genomic and data sciences. The Series A financing catalyzes progress towards making an impact by supporting clinical development partnerships and collaborations with the biopharma industry."

On June 9, 2020 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, Zytiga-resistant prostate cancer and leukemia, reported initiation of its Expanded Access Program (EAP) for its investigational drug onvansertib, in combination with standard-of-care FOLFIRI and bevacizumab, for second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC) (Press release, Cardiff Oncology, JUN 9, 2020, View Source [SID1234560928]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to offer expanded access to our investigational drug for patients with KRAS-mutated mCRC who may benefit from treatment with onvansertib, but may not be able to participate in our clinical trial," said Dr. Mark Erlander, Chief Executive Officer of Cardiff Oncology. "The granting of Fast Track Designation coupled with the initiation of our Expanded Access Program underscores the medical need for a new therapeutic option to treat these patients who are facing a devastating prognosis. We are dedicated to advancing the clinical development of onvansertib so that many more patients will have access to treatment in our ongoing trials and through our compassionate use program."

The Expanded Access Program (or compassionate use) is a program recognized by the FDA as a follow-on to their granting Fast Track Designation to onvansertib. An EAP provides a potential pathway for patients with a serious or life-threatening condition to gain access to an investigational drug for treatment outside of a clinical trial, particularly when no comparable or satisfactory alternative therapy options are available. The Cardiff Oncology EAP is intended for use in combination with FOLFIRI and bevacizumab for the second-line treatment of patients with KRAS-mutated mCRC that have progressed on prior FOLFOX (with or without bevacizumab) therapy.

Requests for expanded access to onvansertib must be made by a U.S. licensed, treating physician. Physicians can learn more about the onvansertib expanded access program protocol at clinicaltrials.gov and can request access for a patient by sending an e-mail to [email protected]

The FDA’s Fast Track program facilitates the development of drugs intended to treat serious conditions and that have the potential to address unmet medical needs. A drug program with Fast Track status is afforded greater access to the FDA for the purpose of expediting the drug’s development, review and potential approval. In addition, the Fast Track program allows for eligibility for Accelerated Approval and Priority Review, if relevant criteria are met, as well as for Rolling Review, which means that a drug company can submit completed sections of its New

Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be submitted for review.

About the Phase 1b/2 Clinical Trial of Onvansertib in KRAS-Mutated mCRC
In this open-label, Phase 1b/2 trial, onvansertib in combination with standard-of-care FOLFIRI and Avastin (bevacizumab) is being evaluated for safety and efficacy for second-line treatment of patients with KRAS-mutated mCRC. The trial, A Phase 1b/2 Study of Onvansertib (PCM-075) in Combination with FOLFIRI and Bevacizumab for SecondLine Treatment of Metastatic Colorectal Cancer in Patients with a KRAS Mutation, will enroll up to 44 patients with a KRAS mutation and histologically confirmed metastatic and unresectable disease. In addition, patients must have failed treatment or be intolerant of FOLFOX (fluoropyrimidine and oxaliplatin) with or without bevacizumab. The trial is being conducted at two prestigious cancer centers: USC Norris Comprehensive Cancer Center and The Mayo Clinic Arizona.
About Onvansertib
Onvansertib is a first-in-class, third-generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK1) enzyme, which is over-expressed in multiple cancers including leukemias, lymphomas and solid tumors. Onvansertib targets the PLK1 isoform only (not PLK2 or PLK3), is orally administered and has a 24-hour half-life with only mild-to-moderate side effects reported.
Onvansertib has demonstrated synergy in preclinical studies with numerous chemotherapies and targeted therapeutics used to treat leukemias, lymphomas and solid tumor cancers, including irinotecan, FLT3 and HDAC inhibitors, taxanes and cytotoxins. Cardiff Oncology believes the combination of onvansertib with other compounds has the potential to improve clinical efficacy in acute myeloid leukemia (AML), metastatic castration-resistant prostate cancer (mCRPC), non-Hodgkin lymphoma (NHL), KRAS-mutated colorectal cancer and triple-negative breast cancer (TNBC), as well as other types of cancer.
Cardiff Oncology has three ongoing clinical trials of onvansertib: A Phase 2 trial of onvansertib in combination with Zytiga (abiraterone acetate)/prednisone in patients with mCRPC who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or asymptomatic) while currently receiving Zytiga (NCT03414034); a Phase 1b/2 Study of onvansertib in combination with FOLFIRI and Avastin for second-line treatment in patients with mCRC with a KRAS mutation (NCT03829410); and a Phase 2 clinical trial of onvansertib in combination with decitabine in patients with relapsed or refractory AML (NCT03303339).
Cardiff Oncology licensed onvansertib (also known as NMS-1286937 and PCM-075) from Nerviano Medical Sciences (NMS), the largest oncology-focused research and development company in Italy, and a leader in protein kinase drug development. NMS has an excellent track record of licensing innovative drugs to pharma/biotech companies, including Array/Pfizer, Ignyta/Roche and Genentech.

On June 9, 2020 IncellDx, Inc., a global leader in single-cell diagnostics, reported approval by the Costa Rican Ministry of Health of its Next Generation HPV/cervical cancer assay, OncoTect 3Dx (Press release, IncellDx, JUN 9, 2020, View Source [SID1234560944]). This novel assay is the only test to simultaneously detect and quantify 3 molecular markers of cervical cancer—overexpression of oncogenes (E6, E7 mRNA), proliferation, and aneuploidy. Using high throughput flow cytometry, 96 cervical cytology samples can be tested and resulted in less than 4 hours, without having to examine slides.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are thrilled to have received approval for the HPV OncoTect 3Dx assay, thanks to the perseverance of our team and our international collaboration with IncellDx," said Dr. Rodrigo Mora, Ph.D., Professor of Medical Virology, Faculty of Microbiology, University of Costa Rica. "We are so looking forward to start offering this test to women in Costa Rica who are currently at risk of over-treatment. Now, we will finally be able to distinguish and separate HPV infection from HPV disease to contribute to the health of our women and reduce the psychological burden associated with HPV."

Nearly 1.9 million women are at risk of cervical cancer in Costa Rica, and it is the 3rd most common female cancer in the country. Human Papillomavirus (HPV) infection has been directly linked to the development of cervical intraepithelial lesions and increased risk for cervical cancer. The HPV OncoTect 3Dx assay aids in the determination of which patients need to be further evaluated for the presence of high-grade cervical intraepithelial neoplasia.

Dr. Bruce Patterson, chief executive officer of IncellDx, added, "We appreciate the hard work done by Dr. Mora and his team in validating this assay for staging of cervical cancer using the only test in the world that combines three molecular biomarkers in a single assay in intact cells from a liquid-based cytology specimen. This assay is the next step after determining infection with a high-risk HPV genotype to determine the biological behavior of high-risk HPV infections when the overwhelming majority of these infections will not progress to cervical cancer."