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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]).

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.

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.

GenFleet and Innovent Starts First-in-human Phase I/II Trial of KRAS G12C Inhibitor

On September 29, 2021 GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, and Innovent Biologics (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported that the first patient with KRAS G12C mutation has been dosed in the first-in-human trial of GFH925 (ClinicalTrials.gov, NCT05005234) (Press release, GenFleet Therapeutics, SEP 29, 2021, View Source [SID1234590486]).

Led by Professor Yilong Wu of Guangdong Provincial People’s Hospital, it is an open label, multicenter study treating advanced solid tumors patients with KRAS G12C mutation.

Designed to enroll over 100 patients with late stage NSCLC and gastrointestinal cancer, the study will evaluate the safety/tolerability/efficacy and characterize the pharmacokinetics profile of GFH925 administered orally to patients with KRAS G12C mutation. Moreover, this study will explore the potential mechanisms of primary and acquired resistance to KRAS inhibitors. Based on emerging data of GFH925 and other KRAS inhibitors including biomarkers, investigators will look to further optimize the precision treatment plans and the potential for combination therapies.

"KRAS mutation is widespread among patients of non-small cell lung cancer, pancreatic cancer, colorectal cancer, etc. Preclinical data has shown that GFH925 is differentiated from other KRAS G12C inhibiting products, and we look forward to positive results of GFH925’s safety/tolerability and efficacy to benefit patients with KRAS G12C gene mutation." said Professor Yilong Wu, Director of Guangdong Lung Cancer Institute.

"Current data demonstrates the higher response to selective KRAS G12C inhibitors in population of lung cancer patients with KRAS G12C mutation. The first patient with KRAS G12C mutation administrated after precision screening is a key milestone in the clinical development of GFH925. Thanks to our joint efforts with investigators from our sites, we have completed program initiation and began patient screening in a very short amount of time. We are also confident that our collaboration with Innovent, with its successful track records of developing and commercializing novel therapies, will speed up the study process in order to bring this life-saving treatment to patients across the globe." said Yu Wang, M.D./Ph.D., Chief Medical Officer of GenFleet Therapeutics.

"KRAS G12C is one of the most frequently mutated oncogenes in human cancer cells and RAS used to be an undruggable target over decades. So far there have been few treatments for patients with this mutation and we can see huge unmet medical needs. We are pleased to achieve the dosing of the first patient and it’s an important milestone in the development ofIBI351 (GenFleet R&D code: GFH925). Based on preclinical data, we believe that the clinical research of IBI351 in China will benefit more patients with KRAS G12C mutant lung cancer and other solid tumors and deliver more effective therapies for doctors in the world." said Hui Zhou, Senior Vice President of Clinical Development of Innovent.

About GFH925

Being developed by GenFleet Therapeutics, GFH925 is a novel, orally active, potent KRAS G12C inhibitor designed to effectively target the GTP/GDP exchange, an essential step in pathway activation, by modifying the cysteine residue of KRAS G12C protein covalently and irreversibly. Preclinical cysteine selectivity studies demonstrated high selectivity of GFH925 towards G12C. Subsequently, GFH925 effectively inhibits the downstream signal pathway to induce tumor cells’ apoptosis and cell cycle arrest.

GenFleet Therapeutics and Innovent Biologics entered into an exclusive license agreement in early September for the development and commercialization of GenFleet’s lead KRAS G12C candidate, GFH925 in China, including the Chinese mainland, Hong Kong, Macau and Taiwan with additional option-in rights for global development and commercialization.