New Study Finds Freenome’s Multiomics Approach Successful in Detecting Pancreatic Cancer

On September 29, 2021 Freenome, a privately-held biotech company, reported that new research today at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pancreatic Cancer (Press release, Freenome, SEP 29, 2021, View Source [SID1234590493]). The data demonstrated the potential of extending Freenome’s multiomics approach into other cancers, such as pancreatic cancer, with biomarkers already embedded in the existing platform.

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Freenome’s platform uses a routine blood test to detect cancer.

"An accurate blood-based test like this could be a powerful tool for early diagnosis and treatment, impacting so many patients," said Randall Brand, M.D., professor of Medicine and Human Genetics at the University of Pittsburgh School of Medicine, and co-author of the study. "We are hoping to further validate the findings through additional studies, which are already underway."

Pancreatic cancer is one of the deadliest cancers, with an overall five-year survival rate of 11%. If detected at an early stage, the five-year survival rate increases to 42%.[1] The only FDA-authorized test for pancreatic cancer is the carbohydrate antigen 19-9 (CA19-9), which is only cleared for monitoring response to therapy.

This retrospective study of 75 participants evaluated whether Freenome’s multiomics approach of combining methylation and CA19-9 signals together (as a subset of existing analytes in the platform) detected pancreatic cancer in stages II, III and IV with higher sensitivity than either alone.

Across all stages studied, Freenome’s approach achieved a sensitivity of 93% at a nominal specificity of 96%. At an identical specificity, the sensitivity of methylation or CA19-9 alone was 74% and 87%, respectively. In stages II, III and IV, the multiomics approach achieved a sensitivity of 82%, 89%, and 100%, respectively.

This new study demonstrates that Freenome’s platform can be used to detect pancreatic cancer in addition to colorectal cancer (CRC). Last year, Freenome presented data showing a sensitivity of 94% at a specificity of 94% for early-stage (I/II) CRC using their multiomics platform.[2] Freenome’s CRC test is currently undergoing analytical and clinical validation.

"We’re demonstrating success in detecting CRC and advanced adenomas in blood. We’re now expanding our platform to detect additional cancers," said Mike Nolan, chief executive officer, Freenome. "Our goal is to transform the way cancer of all types is managed by enabling early detection, and this data on pancreatic cancer is an important step in that direction."

EpicentRx Announces Completion of First Cohort in Phase 1 "BETA PRIME" Trial with AdAPT-001

On September 29, 2021 EpicentRx Inc., a leading-edge drug and device company with cancer and inflammatory disease-targeted platforms, reported the completion of patient enrollment in the first cohort of a Phase 1 trial called BETA PRIME for its TGF-beta (TGFß) trap-enhanced cancer targeting adenovirus (Press release, EpicentRx, SEP 29, 2021, https://www.prnewswire.com/news-releases/epicentrx-announces-completion-of-first-cohort-in-phase-1-beta-prime-trial-with-adapt-001-301387822.html [SID1234590491]).

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AdAPT-001 Mechanism of Action
The study, which has successfully enrolled three patients in the first cohort, is evaluating the safety, tolerability, optimal dose level and immunogenicity for single and multiple doses of AdAPT-001 both alone and in combination with a checkpoint inhibitor when administered to advanced cancer patients.

TGFß, a protein that inhibits the activity of the immune system as a safeguard against severe inflammation and autoimmunity, is hijacked by cancer cells to escape immune elimination. Therapeutically resistant cancer is an area of high unmet medical need, which this triple combination strategy involving the AdAPT-001 cancer targeting virus armed with a TGFß trap and a checkpoint inhibitor intends to address.

The AdAPT-001 Phase 1 multi-center clinical trial is conducted in three parts starting with a single dose escalation that is followed by an expansion cohort at the highest tolerable dose prior to combination with a checkpoint inhibitor.

EpicentRx’s proprietary platform of next-generation oncolytic viruses that preferentially infect and kill cancer cells has been developed with over two decades of oncolytic virus research by EpicentRx’s CEO, Dr. Tony Reid, MD, PhD and VP of Viral Therapy, Dr. Christopher Larson, MD, PhD. EpicentRx’s discovery pipeline of multiple differentiated oncolytic virus candidates are potent and tumor-selective.

"The completion of enrollment in cohort 1 of the BETA PRIME trial is the first step for EpicentRx on its journey to bring a first-in-class treatment to the millions of patients in America and ultimately around the world that are afflicted with resistant cancer," said Dr. Tony R. Reid, Chief Executive Officer of EpicentRx. "To date, we have seen no serious adverse events in the trial. To defeat cancer what is needed are therapeutic agents like AdAPT-001 that are not only as genetically sophisticated as the tumor itself but also that are minimally toxic."

The trial is titled "A First in Human Study of AdAPT-001 in Subjects With Refractory Solid Tumors." Trial design details can be found at View Source

Bexion Pharmaceuticals Receives Study May Proceed Letter from FDA for a Phase 1b/2 Clinical Trial of BXQ-350 in Newly Diagnosed Metastatic Colorectal Carcinoma

On September 29, 2021 Bexion Pharmaceuticals, Inc. reported that a Study May Proceed letter has been received from the US Food and Drug Administration (FDA) for the Investigational New Drug Application (IND) for BXQ-350 to initiate a Phase 1b/2 clinical trial in newly diagnosed stage 4 metastatic colorectal cancer patients (Press release, Bexion, SEP 29, 2021, View Source [SID1234590489]).

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Bexion recently completed Phase 1 studies in both adults and children with advanced solid tumors utilizing BXQ-350 as monotherapy. These studies demonstrated that BXQ-350 has a tolerable safety profile with no dose limiting toxicity (DLT) at the highest administered dose and showed in some patients preliminary evidence of anti-tumor activity (including in advanced colorectal cancers).

Additional pre-clinical and anecdotal data suggest that BXQ-350 may play a role in decreasing oxaliplatin-induced sensory neurotoxicity, a common result of colorectal cancer standard of care.

"BXQ-350 with its proven safety profile, potential efficacy and possible neuropathy benefit makes it a worthwhile candidate to use in combination with standard of care treatment for metastatic colorectal cancer (mCRC), stated Dr. Ray Takigiku, CEO and President of Bexion. "We are hoping to not only enhance the standard treatment of mCRC, but to potentially alleviate the side effects related to oxaliplatin-induced sensory neurotoxicity."

Quest Diagnostics To Release Third Quarter 2021 Financial Results On October 21

On September 29, 2021 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report third quarter 2021 financial results on Thursday, October 21, 2021, before the market opens (Press release, Quest Diagnostics, SEP 29, 2021, View Source [SID1234590488]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "7895081." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-360-7722 for domestic callers or 203-369-0174 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on October 21, 2021 until midnight Eastern Time on November 4, 2021.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

Flamingo Therapeutics to Present at the Chardan Virtual 5th Annual Genetic Medicines Conference

On September 29, 2021 Flamingo Therapeutics., a biotechnology company pioneering RNA-targeting therapies in oncology, reported that Mike Garrett, Chief Executive Officer and Rob MacLeod, Chief Scientific Officer, will participate in a fireside chat at the Chardan Virtual 5th Annual Genetic Medicines Conference on Monday, October 4th, 2021 at 5:30 pm ET (Press release, Flamingo Therapeutics, SEP 29, 2021, View Source [SID1234590487]). The Flamingo management team will also participate in one-on-one meetings with investors during the conference.

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