On January 11, 2022 Perimeter Medical Imaging AI, Inc. (TSX-V:PINK) (OTC:PYNKF) (FSE:4PC) ("Perimeter" or the "Company"), a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address high unmet medical needs, reported the expansion of its ongoing pivotal study to include an additional clinical trial site at Baylor College of Medicine in Houston, TX, under the direction of Dr. Alastair Thompson, Principal Investigator of the study (Press release, Perimeter Medical Imaging AI, JAN 11, 2022, View Source [SID1234598597]).

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A multi-center, randomized, two-arm clinical trial is underway to measure the effectiveness of the Perimeter B-Series OCT imaging platform combined with ImgAssist artificial intelligence (AI) technology in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment. Approximately 300 patients undergoing breast conservation surgery across eight U.S. clinical sites are expected to participate in the pivotal trial, with study completion anticipated by the end of 2022.

Dr. Alastair Thompson, Professor, Section Chief of Breast Surgery, and Olga Keith Wiess Chair of Surgery at Baylor College of Medicine and Co-associate Director for Clinical Research at the Dan L Duncan Comprehensive Cancer Center, stated, "Failure to get clear margins in breast cancer surgery is a critical problem that can lead to further complications for patients due to re-operations and higher costs to the overall healthcare system. This pioneering technology allows surgeons to examine an excised tissue sample and identify areas of concern to support ‘real-time’ margin assessment during a surgery."

Dr. Thompson continued, "Having participated in earlier stages of Perimeter’s ATLAS AI project – including contributing to the collection of breast tumor images in order to develop and train the artificial intelligence algorithm – I am excited to act as principal investigator of this pivotal study."

Jeremy Sobotta, Perimeter’s Chief Executive Officer stated, "We are proud to partner with leading cancer centers like Baylor to enable the late-stage clinical development of our breakthrough-device-designated Perimeter B-Series OCT platform that includes AI-assisted software. We are also grateful for the grant funding that we received from the Cancer Prevention and Research Institute of Texas (CPRIT), which has supported our ATLAS AI project across multiple stages, culminating in this important pivotal study now underway. We believe our technology has the potential to help breast cancer surgeons improve outcomes for patients and we look forward to analyzing the data from this study, which is expected to be completed by the end of the year."

About the Clinical Development of Perimeter B-Series OCT with ImgAssist AI

Perimeter is advancing the clinical development of its proprietary, next-gen "ImgAssist" artificial intelligence (AI) technology under its ATLAS AI project, which is made possible, in part, by a US$7.4 million grant awarded by the Cancer Prevention and Research Institute of Texas (CPRIT). The U.S. FDA granted Breakthrough Device Designation for Perimeter B-Series OCT + ImgAssist AI, which has the potential to aid surgeons in identifying regions of interest on scanned samples, enabling them to make key decisions on margin status real-time intraoperatively. Perimeter B-Series + ImgAssist AI is currently approved for "Investigational Use Only" in the U.S., which means that at this time, only select surgeons have access to this technology by participating in the ongoing pivotal clinical trial.

About Perimeter S-Series OCT

Cleared by the U.S. FDA with a general tissue indication, Perimeter S-Series Optical Coherence Tomography (OCT) is a novel medical imaging system that provides clinicians with cross-sectional, real-time margin visualization (1-2 mm below the surface) of an excised tissue specimen. Giving physicians the ability to visualize microscopic tissue structures "real time" in the operating room has the potential to result in better long-term outcomes for patients and lower costs to the healthcare system.

On January 11, 2022 Lucence, a precision oncology company using liquid biopsy to bring clarity to cancer care, reported the availability of an expanded version of its flagship LiquidHALLMARK liquid biopsy assay that includes both cell-free DNA (cfDNA) and cell-free RNA (cfRNA) profiling (Press release, Lucence Diagnostics, JAN 11, 2022, View Source [SID1234598596]). LiquidHALLMARK cfDNA and cfRNA is currently available to US oncologists as a laboratory developed test and is being utilized by physicians at NCI-designated centers across the country.

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Most liquid biopsies available today interrogate cell-free DNA (cfDNA) as the sole analyte. However, for the detection of certain fusions, including those that have long intronic regions such as NTRK and NRG1, incorporation of RNA sequencing can be advantageous. Gene fusions like NTRK and NRG1 have emerged as clinically significant and actionable biomarkers that can help guide physicians to matched targeted therapies. Ryma Benayed and co-authors demonstrated that adding targeted RNA sequencing to DNA sequencing to tissue testing could obtain an additional 14% yield of clinically actionable alterations.

An internal validation study conducted by Lucence also supports this approach. Out of 112 non-small cell lung cancer (NSCLC) samples, 29 fusions were detected with a combined cfDNA and cfRNA approach in plasma, compared with 20 fusions from cfDNA alone.

"Including cfRNA in a liquid biopsy assay has a significant impact on the detection of clinically relevant fusions. This solves a major known limitation of cfDNA-only assays, which have more limited fusion detection capabilities. For example, NTRK fusions which have corresponding approved TRK inhibitors, and NRG fusions which have multiple emerging therapies, are best detected by a combination of both DNA and RNA testing. This is an exciting opportunity to help more cancer patients through broader and more accurate targeting," said Professor Gilberto Lopes, Chief of Medical Oncology at Sylvester Cancer Center at the University of Miami.

"Lucence’s experience using AmpliMark for SARS-CoV-2 as part of the fight against the COVID-19 pandemic gave us the experience with RNA to be able to expand our assay to detect fusions in cancer. It’s a great example of how R&D developed to fight COVID can now be used for ultrasensitive cancer diagnostics," said Dr. Min-Han Tan, MBBS, PhD, Founding CEO and Medical Director of Lucence.

Lucence’s LiquidHALLMARK cfDNA and cfRNA panel combines cfRNA profiling of 27 actionable and emerging fusions with cfDNA profiling of mutations in 80 genes, fusions in 10 genes, and somatic variants in 15 cancer types. LiquidHALLMARK is powered by AmpliMark, the Company’s proprietary amplicon-based sequencing technology, which uses a unique molecular barcode and error-correction technology to ensure test sensitivity across multiple mutation types for single nucleotide variants and fusion genes.

On January 11, 2022 Aligos Therapeutics, Inc. (Nasdaq: ALGS) a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, reported that it has expanded its ongoing collaboration agreement with Merck to discover and develop oligonucleotide therapies for non-alcoholic steatohepatitis (NASH) (Press release, Aligos Therapeutics, JAN 11, 2022, View Source [SID1234598595]).

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"We believe that one of our strengths as a company is our technical know-how in several areas of oligonucleotide research and development," said Lawrence Blatt, Ph.D., MBA, Chairman and Chief Executive Officer of Aligos. "We are pleased to broaden our collaboration where we may be able to contribute to creating effective, targeted therapies for NASH together with Merck."

Under the original agreement, Merck and Aligos committed to applying Aligos’ oligonucleotide platform technology to discover, research, optimize and develop oligonucleotides directed against a certain undisclosed non-alcoholic steatohepatitis (NASH) target and up to one additional target of interest in the cardiometabolic/fibrosis space. That agreement has now been expanded to include the in-license by Merck of an early-stage program with respect to a second undisclosed NASH target on which Aligos has previously been working independently and separately from Merck. In addition, under this expanded arrangement, Merck has the ability of adding an additional third target of interest in the cardiometabolic/fibrosis space to the collaboration.

"We are encouraged by the progress made to date in our ongoing collaboration with Aligos and look forward to applying Aligos’ technology towards a second target moving forward," said Dr. Ajay Chawla, Vice President, Cardiometabolic Disease Discovery, Merck Research Laboratories.

Under the expanded agreement, Aligos will receive a payment from Merck for the in-license of the program directed at a second undisclosed NASH target. Additionally, Aligos will receive an additional payment upon designation of a third target for the collaboration. With respect to each target in the collaboration, Aligos will be eligible to receive up to ~$460M in development and commercialization milestones as well as tiered royalties on net sales. Aligos is primarily responsible for designing, synthesizing and evaluating the oligonucleotide candidates and delivering optimized lead molecules. Thereafter, Merck is responsible for subsequent research, clinical development and commercialization.

On January 11, 2022 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported the company has entered into a strategic research collaboration with Pepscan Therapeutics B.V. (Pepscan) to discover novel, peptide-based radiopharmaceuticals for the treatment of various solid tumors (Press release, Fusion Pharmaceuticals, JAN 11, 2022, View Source [SID1234598593]).

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"Fusion’s internal research and develop capabilities combined with expertise in radiopharmaceuticals allow us to create novel targeted alpha therapies (TATs) using a variety of classes of targeting molecules, including antibodies, small molecules and peptides – all of which have been used successfully in radiopharmaceutical development," said Fusion Chief Executive Officer John Valliant, Ph.D. "We are pleased to work with Pepscan who has a proprietary platform for peptide discovery that will enable us to create novel, peptide-based targeted alpha therapies (TATs), further augementing our pipeline of radiopharmaceuticals."

Under the agreement, Fusion has global rights to develop and commercialize any peptides discovered under the collaboration.

On January 11, 2022 Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing novel T cell engagers, reported a pipeline milestone update on its TriTAC development programs (Press release, Harpoon Therapeutics, JAN 11, 2022, View Source [SID1234598592]).

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"We are excited to begin 2022 with a catalyst rich year that will be driven by our multiple TriTAC clinical programs, including advancing our HPN217 program into the next phase of development," stated Julie Eastland, President and CEO, Harpoon Therapeutics. "We also expect to submit our first IND for HPN601, targeting EpCAM, from our ProTriTAC technology platform as well as advance an additional preclinical candidate into IND enabling studies as we continue to build out our future clinical pipeline."

Anticipated 2022 Milestones

TriTAC Clinical Programs

HPN328 – Continue dose escalation to determine RP2D by year-end 2022

HPN217 – Select the RP2D and initiate dose expansion cohort during the first half of 2022

HPN536 – Complete dose escalation by year-end 2022

HPN424 – Complete dose escalation during the second half of 2022
Platform Technologies and Next Clinical Candidate

HPN601 – IND submission by year-end 2022

Platform technologies – Advance a clinical candidate into IND enabling studies during the second half of 2022
Corporate Update Events

Harpoon will host an R&D Day during the first half of 2022