On January 23, 2023 BillionToOne, Inc., a next-generation molecular diagnostics company, is excited to reported the appointment of Dr. Gary Palmer as Chief Medical Officer (CMO), Oncology, and the launch of its Northstar liquid biopsy assays for commercial use (Press release, BillionToOne, JAN 23, 2023, View Source [SID1234626467]). Dr. Palmer brings significant expertise both as a clinical oncologist and as a high-level executive at several national laboratories. His prior industry roles include CMO at Tempus Labs, VP of Medical Affairs at Foundation Medicine, and VP of Medical Affairs at Genomic Health. Dr. Palmer’s deep clinical knowledge and empathy for patients coupled with his vast industry experience make him the perfect fit to guide BillionToOne in launching Northstar Select and Northstar Response.

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!

The Northstar liquid biopsy assays are available now for patients with late stage (III/IV) solid tumors. They have been uniquely developed to work together. Northstar Select is an 81-gene next generation sequencing (NGS)-based panel to guide therapy selection. As demonstrated in internal validation testing, Northstar Select has detected single nucleotide variants (SNVs) / indels and fusions down to two mutated molecules (i.e., 0.02-0.04% allele fraction equivalent at the average DNA inputs [15-30ng] level) in the specimen.1

Northstar Response is designed to help clinicians understand if a patient is responding to therapy. This methylation-based assay is tumor-naive and only requires a blood sample. Powered by BillionToOne’s Quantitative Counting TemplatesTM (QCTTM), the Northstar Response assay measures on average 10 times more informative loci (90 loci vs 9 loci) as compared to current SNV-based circulating tumor DNA (ctDNA) monitoring assays.2 Serial quantification of this methylated signal may provide an early indication of response or progression of the cancer to systemic therapy, complementing information provided by routine assessments, such as CT scans.

Analytical data show Northstar Response can accurately distinguish 0.2% changes in tumor fraction across cancer types. In further studies, Northstar Response showed consistent ability to detect changes in tumor fraction across 10 different cancer types, in some cases as much as 6 months earlier than indicated by scans.3 The results will be presented at upcoming oncology conferences and published in peer-reviewed journals in the coming months.

"I am excited about the vast potential of BillionToOne’s molecular counting technology and its application to oncology," said Dr. Palmer. "The Northstar assays may help revolutionize the way we treat cancer, and I’m honored to be a part of this innovative team." "We are thrilled to have Dr. Palmer join us as our Chief Medical Officer," said Oguzhan Atay, Ph.D., CEO of BillionToOne. "His extensive experience as an oncologist in clinical practice and as an executive launching diagnostics that have changed the standard of care will be invaluable as we continue to deliver our differentiated assays to physicians and patients."

On January 23, 2023 Agenus (Nasdaq: AGEN), an immuno-oncology company with a pipeline of immunological agents targeting cancer and infectious disease, reported clinical data from the MSS CRC (microsatellite stable colorectal cancer) 70 patient cohort of a Phase 1b study of botensilimab (multifunctional Fc-enhanced anti-CTLA-4) in combination with balstilimab (anti-PD-1) in patients with chemotherapy and/or immunotherapy-resistant tumors (Press release, Agenus, JAN 23, 2023, View Source [SID1234626465]). The larger dataset continues to demonstrate that this combination offers superior efficacy and durability compared to what has been reported for standard of care and other investigational therapies in third line metastatic MSS CRC. The data were presented in the opening late-breaking oral session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) – Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, CA on Saturday Jan 21 2023.

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 data highlight the deep and durable responses achieved with botensilimab and balstilimab in advanced MSS CRC, underscoring remarkable benefit for these patients who have failed standard of care or other investigative therapies. With over 300 patients enrolled to date, botensilimab alone and in combination with balstilimab have demonstrated durable clinical responses across nine cold and treatment-resistant cancers," said Steven O’Day, MD, Chief Medical Officer at Agenus. "Our top priority is to advance this combination in global randomized trials with the intent to bring this important treatment to patients expeditiously."

"MSS CRC accounts for over 95% of metastatic CRC cases and is characterized by tremendous unmet need, as available treatments have reported single digit responses rates," said Anthony El-Khoueiry, MD, Phase I Program Director and Associate Director for Clinical Research at the USC Norris Comprehensive Cancer Center, Keck Medicine of USC, and the Principal Investigator for the study. "The 23% response rate demonstrated by botensilimab plus balstilimab in this study supports rapid development of this combination in MSS CRC."

Study Design and Highlights:

A total of 70 evaluable patients with refractory metastatic MSS CRC received either 1 or 2 mg/kg botensilimab every 6 weeks and 3 mg/kg balstilimab every 2 weeks.

Patient Demographics:

Heavily pre-treated, with a median of 4 prior lines of therapy
31% had received prior immunotherapy

Objective responses:

23% overall response rate
Other PD-(L)1 + CTLA-4 combinations in comparable patient populations have reported 1-5% response rates1,2
69% of objective responses were ongoing at data cut-off
76% disease control rate (complete response + partial response + stable disease)

Survival:

12-month overall survival of 63%
Reported 12-month overall survival for standard of care is ~25%
Median overall survival has not been reached

Tolerability:

Manageable gastrointestinal toxicity with a differentiated overall safety profile
Presentation Details:

Abstract Title: Results from a phase 1a/1b study of botensilimab (BOT), a novel innate/adaptive immune activator, plus balstilimab (BAL; anti-PD-1 antibody) in metastatic heavily pretreated microsatellite stable colorectal cancer (MSS CRC) (NCT03860272)

Abstract Number: LBA8

Presenting Author: Anthony El-Khoueiry, MD, Phase I Program Director at the USC Norris Comprehensive Cancer Center, Keck Medicine of USC

On January 23, 2023 Redx (AIM:REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported that Dr. Simon Woodcock, Vice President, Oncology at Redx Pharma, will present at the 2nd Annual Wnt & β-Catenin Pathway Targeted Drug Development Summit (24-26 January, Boston, MA) (Press release, Redx Pharma, JAN 23, 2023, View Source [SID1234626464]).

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!

In the presentation, which will take place on Thursday 26 January at 10:30 (EST), Dr. Woodcock will discuss the challenges of genetic selection in defined patient populations and how this relates directly to Wnt/β-Catenin Biomarkers in patient selection for clinical studies of targeted therapies, such as Redx’s RXC004.

RXC004 is a clinical stage, highly potent and selective, orally active Porcupine inhibitor being developed as a targeted therapy for Wnt-ligand dependent cancer. It is currently being evaluated in Phase 2 proof-of-concept clinical studies as a monotherapy and in combination with anti-PD-1, Nivolumab, in genetically selected metastatic colorectal cancer (MSS mCRC) (clinicaltrials.gov NCT04907539), as monotherapy in genetically selected pancreatic cancer, and as a monotherapy and in combination with anti-PD-1, Pembrolizumab, in biliary tract cancers (clinicaltrials.gov NCT04907851).

On January 23, 2023 Qu Biologics Inc., a clinical stage biopharmaceutical company developing Site Specific Immunomodulators (SSIs), a novel platform of immunotherapies designed to restore innate immune function, is pleased to reported the appointment of Matt Cahill MBA JD PhD, as Chief Operating Officer (Press release, Qu Biologics, JAN 23, 2023, View Source;utm_medium=rss&utm_campaign=dr-matt-cahill-appointed-chief-operating-officer-of-qu-biologics [SID1234626463]).

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!

"I am excited to join Qu as the company prepares to initiate multiple phase 2 randomized placebo-controlled studies," said Dr. Cahill. "The Qu platform has the potential to make a profound impact in indications across oncology, inflammation, and infectious disease, and I look forward to supporting the growth of the organization and the expansion of our clinical pipeline."

Prior to joining Qu, Matt was a founding employee of Deep Genomics – a biotechnology company focused on the application of artificial intelligence in drug development. He played a central role in crafting and operationalizing the company’s strategy, helped build the executive team, and led a variety of functions including finance, legal, HR, and business development. During his tenure, the company formed its first Pharma partnerships and raised more than USD$200M through multiple rounds of financing.

Matt received his JD and MBA from the University of Toronto with an emphasis on biotechnology, entrepreneurship, and strategy. He received his PhD from the University of Cambridge, where he studied the genomes of bacteria using novel sequencing technologies.

"The Qu team and I are delighted to welcome Matt as COO at this critical time in Qu’s history, and we look forward to working together," said Dr. Hal Gunn, CEO of Qu Biologics. "His post-graduate degrees in science, law, and business and his past demonstrated success leading biotech finance, business development, and operations make him an excellent match for our needs as we enter the important next phase of our mission to realize the full potential of SSIs."

For more information about Qu Biologics and the science behind SSIs, please visit www.qubiologics.com.

Please subscribe here to receive future news and updates from Qu Biologics.

On January 23, 2023 Philogen reported its attendance at the European Bispecific and Multispecific Antibody congress in Amsterdam (Press release, Philogen, JAN 23, 2023, View Source [SID1234626462]).

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!

Dr. Roberto De Luca (Head of Antibody Therapeutics at Philochem) is giving a lecture on the 23rd of February 2023 entitled "Engineering Antibody-Cytokine Fusion proteins for Cancer Therapy".
Please follow the link below for more information
View Source