On January 11, 2022 Dren Bio, Inc. ("Dren Bio" or the "Company") reported it has entered into a research collaboration and license agreement with Pfizer Inc (Press release, Dren Bio, JAN 11, 2022, View Source [SID1234598599]). The strategic collaboration will focus on the discovery and development of therapeutic bispecific antibodies for select oncology targets using Dren Bio’s proprietary Targeted Myeloid Engager and Phagocytosis Platform.

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!

Under the terms of the agreement, Pfizer made an upfront cash payment of $25 million to Dren Bio, with the Company eligible to potentially receive more than $1 billion of cash in total, including payments for the achievement of future development, regulatory, and commercial milestones. Dren Bio and Pfizer will work together to advance the selected oncology target programs through clinical candidate selection, at which point Pfizer will assume full responsibility for all remaining development, manufacturing, regulatory and commercialization activities. For each target-specific product that is globally licensed by Pfizer, Dren Bio will be eligible to receive tiered royalties on all future net sales during the term of the Agreement. Additionally, under the terms of the agreement, Pfizer also has the right to reserve and subsequently nominate additional oncology targets to license from Dren Bio, subject to additional cash payments and future royalties. Excluding products developed for targets licensed to Pfizer, Dren Bio will retain exclusive global rights for the platform including all other therapeutic targets currently in development as part of its own internal pipeline.

"This agreement highlights Dren Bio’s expertise in therapeutic antibody development and marks the first collaboration using our proprietary platform to harness myeloid cells in disease, offering a differentiated approach with the potential to provide revolutionary therapies to patients across a broad array of therapeutic areas, starting with cancer," said Nenad Tomasevic, Ph.D., Chief Executive Officer of Dren Bio. "Pfizer’s unwavering commitment to deliver innovative therapies makes them an ideal strategic partner to help us achieve this vision."

"Building on Pfizer’s established leadership position in oncology research, we are excited to work alongside Dren Bio on a novel strategy focused on the engagement of myeloid cells to treat cancer," said Jeff Settleman, Ph.D., Senior Vice President and Chief Scientific Officer for Oncology Research and Development at Pfizer. "Together we hope to develop potential breakthrough treatments for cancer patients."

The Company’s proprietary Targeted Myeloid Engager and Phagocytosis Platform is a bispecific antibody-based technology that engages a receptor selectively expressed on myeloid cells, including monocytes, macrophages, and dendritic cells. Certain myeloid cells, such as Tumor-Associated Macrophages (TAMs), are part of the tumor microenvironment where they can be immunosuppressive and are therefore often associated with poorer clinical outcomes. By repolarizing TAMs and engaging them together with dendritic cells to execute targeted phagocytosis, antigen presentation, and subsequent T cell activation, the Company’s platform antibodies may expand the therapeutic benefit of immunotherapy while also potentially promoting durable clinical responses.

Data generated to date using platform antibodies from the Company’s pipeline demonstrate a differentiated, multi-pronged mechanism of action that encompasses (i) direct coupling of myeloid cells with tumor cells, (ii) stimulation of myeloid cells causing the release of key cytokines responsible for repolarizing TAMs in order to mitigate the immunosuppressive tumor microenvironment, (iii) targeted phagocytosis of tumor cells and (iv) cross-presentation of tumor neoantigens to promote the future activation of tumor-specific T cells to potentially promote a long-lasting immunological memory response. The unique biology of the novel phagocytic receptor targeted by the Company’s platform antibodies enables controlled myeloid cell activation only in the presence of the target antigen, resulting in localized cytokine release for potentially greater therapeutic indexes and safety profiles. In addition to the pharmacodynamic effect demonstrated in preclinical non-human primate studies to date, the observed tolerability and safety profile support the potential utilization of future platform candidates at higher or broader dose levels, which may provide an important benefit when compared to competing technologies such as T or NK cell engagers and antibody drug conjugates.

Dren Bio’s internal development pipeline for the platform currently includes multiple antibodies targeting both liquid and solid tumor types. In addition to the initial focus on developing therapies for the treatment of cancer, the Company has also generated data using platform antibodies against targets associated with non-oncology indications, including forms of amyloidosis and Alzheimer’s disease. This data further supports the vast potential of the platform for developing multiple successful product candidates.

On January 11, 2022 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported 2022 corporate priorities and anticipated clinical development and research milestones (Press release, Xencor, JAN 11, 2022, View Source [SID1234598598]).

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 plug-and-play nature of Xencor’s XmAb Fc domains and our protein engineering expertise have enabled a broad portfolio of bispecific antibody and engineered cytokine drug candidates, as well as a multitude of partnerships, which have thus far produced three marketed products," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "In 2022, we expect emerging clinical data to continue to support our own mid-stage development plans for vudalimab and plamotamab, and we will continue to initiate new studies with potential to present new data that may define a path to registration for these programs. Additionally, we remain excited by the opportunities to use our technological competitive advantage to address challenging areas of biology and continually grow our portfolio, now with multiple reduced-potency cytokines and CD3 and CD28 T cell engagers in development, both internally at Xencor and with our partners."

Execute on development plans for mid-stage XmAb bispecific antibody programs

Vudalimab (PD-1 x CTLA-4), designed to activate intra-tumoral T cells
Xencor presented updated Phase 1 expansion cohort data in November 2021 and is enrolling a Phase 2 study in patients with metastatic castration-resistant prostate cancer (mCRPC), where vudalimab is being evaluated as a monotherapy or in combination depending on the tumor’s molecular subtype. Xencor plans to:

Initiate a second Phase 2 study, evaluating vudalimab in patients with advanced pelvic tumors, including clinically defined high-risk mCRPC and certain gynecologic malignancies.
Present initial data from the Phase 2 study in mCRPC, in the second half of 2022.
Plamotamab (CD20 x CD3), for B-cell malignancies
Xencor presented updated Phase 1 dose-escalation data in December 2021 and is currently recruiting non-Hodgkin lymphoma patients in expansion cohorts of plamotamab monotherapy at the Phase 2 recommended dose. Xencor entered a global collaboration and license agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to expand the Company’s strategy to develop plamotamab as part of multiple highly active chemotherapy-free regimens across B-cell cancers. Xencor plans to:

Initiate potentially registration-enabling Phase 2 study, evaluating plamotamab in combination with tafasitamab and lenalidomide, in patients with relapsed or refractory DLBCL.
Incorporate subcutaneous administration into the ongoing Phase 1 monotherapy study.
Present data from Phase 1 expansion cohorts, in the second half of 2022.
Develop B-cell targeted CD28 bispecific antibodies to selectively enhance T-cell cytotoxic activity in combination with plamotamab.
Advance multiple potency-reduced XmAb cytokine programs in oncology and autoimmune disease

Xencor’s engineered, potency-reduced cytokines are designed to expand select immune cell populations, to have longer circulating half-life and to be tolerable, active and easy to administer. XmAb cytokines incorporate Xtend extended half-life technology.

XmAb306, potency-reduced IL15/IL15Rα-Fc fusion protein
Recently, Xencor announced encouraging initial dose-escalation data from an ongoing Phase 1 study in patients with advanced solid tumors, in which the preliminary safety profile, biological activity and signs of anti-tumor activity provide initial validation for the Company’s approach to engineering cytokine therapeutics. Xencor plans to:

Announce new clinical studies of XmAb306 in combination with other agents, such as NK- or T-cell recruiting therapies in collaboration with the Company’s co-development partner.
XmAb564, potency-reduced IL2-Fc fusion targeting regulatory T cells in autoimmune disease
Xencor plans to:

Present tolerability, durability and biomarker data from the ongoing Phase 1 single-ascending dose study in healthy volunteers.
Identify development indications and initiate a multiple-ascending dose study in select patient populations.
XmAb662, potency-reduced IL12-Fc fusion protein designed to increase tumor immunogenicity
Xencor plans to:

Submit an investigational new drug (IND) application in 2022, and initiate a Phase 1 study in patients with advanced solid tumors in 2023.
Xencor plans to present preclinical data from additional cytokine-Fc programs in 2022.

Expand the Company’s portfolio with the first internally developed XmAb 2+1 CD3 and XmAb CD28 bispecific antibodies advancing into Phase 1 clinical studies

XmAb819 (ENPP3 x CD3), XmAb 2+1 bispecific antibody for renal cell carcinoma (RCC)
The multivalent XmAb 2+1 bispecific antibody format enables greater selectivity for tumor cells compared to normal cells, which also express ENPP3 at lower levels. Xencor plans to:

Initiate a Phase 1 study evaluating XmAb819 in patients with RCC in the first half of 2022.
XmAb808 (B7-H3 x CD28), tumor-selective, co-stimulatory CD28 bispecific antibody
CD28 is a key immune co-stimulatory receptor on T cells; however, the ligands that activate T cells through CD28 are usually not expressed on tumor cells. Targeted CD28 bispecific antibodies may provide conditional co-stimulation of T cells, for example, to T cells recognizing neoantigens or in concert with CD3 T-cell engaging bispecific antibodies. XmAb808 targets the broadly expressed tumor antigen B7-H3. Xencor plans to:

Submit an IND application in the first half of 2022, and initiate a Phase 1 study in patients with advanced solid tumors in the second half of 2022.
Cash Position and Financial Guidance

Xencor ended the fourth quarter of 2021 with unaudited cash, cash equivalents, receivables and marketable debt securities totaling approximately $660 million. Based on current operating plans, Xencor expects to have sufficient cash resources to fund research and development programs and operations through 2025.

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]).

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!

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.

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!

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]).

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 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.