On September 14, 2022 Qurient Co. Ltd. (KRX: 115180), a clinical-stage biotech company based in Korea, reported that the company has entered into a clinical collaboration agreement with MSD (Merck & Co., Inc., Rahway, NJ., USA), for clinical study of Q901, a selective CDK7 inhibitor in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) (Press release, Qurient Therapeutics, SEP 14, 2022, View Source [SID1234619564]).

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Under this agreement, Qurient will conduct a phase 1/2 study in the U.S. to evaluate safety and efficacy of Q901 in combination with KEYTRUDA for the treatment of selected advanced solid tumors.

"We are pleased to collaborate with MSD to evaluate Q901 in combination with KEYTRUDA for advanced solid tumors where limited treatment options are currently available. Q901 shows very effective tumor growth inhibition through cell cycle regulation and triggers genomic instability, which may set synthetic lethality for anti-PD-1 therapy. The Q901 and anti-PD-1 antibody combination showed beneficial effect in preclinical models, and we expect the same clinical benefits," said Kiyean Nam, Ph.D., CEO of Qurient. "The clinical collaboration with MSD on Q901-KEYTRUDA combination follows on clinical collaboration on Q702-KEYTRUDA combination agreement announced in November 2021, and they are important milestones for patients who have had few treatment options, and Qurient’s two lead oncology assets."

Terms of the collaboration were not disclosed.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme, LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About Q901

Q901 is a highly selective cyclin dependent kinase 7 (CDK7) inhibitor that only inhibits CDK7 in the human kinome. CDK7 is a master regulator of cell cycle checkpoints and an essential component of transcription machinery. Selective inhibition of CDK7 by Q901 specifically kills cancer cells with aberrant cell division cycle or transcriptional regulation. In animal studies, Q901 exerts tumor growth inhibition in a number of murine cell-derived and patient-derived xenograft models, including breast, ovarian, prostate, pancreatic, small-cell lung, and colorectal cancers. Qurient licensed the CDK7 inhibitor program at the discovery research stage from Lead Discovery Center (LDC) and the Max-Planck Society and further optimized the program, completed the IND-enabling studies, and received FDA clearance of investigational new drug (IND) application.

On September 14, 2022 Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315) reported a strategic collaboration with Guangzhou FineImmune Biotechnology Co., LTD. ("FineImmune") to co-develop cell-based therapeutic drugs targeting intracellular tumor-associated antigens (Press release, Biocytogen, SEP 14, 2022, View Source [SID1234619563]). Biocytogen will use its proprietary TCR-mimic antibody platform to discover fully human antibody sequences that will be further developed using FineImmune’s unique cell therapy platform.

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Biocytogen’s TCR-mimic antibody development platform utilizes its proprietary fully human antibody RenMice (RenMab and RenLite mice) that have been further engineered to express a human leukocyte antigen (HLA) gene. Antibodies against intracellular tumor-associated antigens are subjected to advanced high-throughput antibody screening technologies to discover antibodies with high specificity and affinity.

"Most tumor antigens are intracellular, and our TCR-mimic platform provides a solution for developing antibodies against these valuable targets," said Dr. Yuelei Shen, Founder, Chairman and CEO of Biocytogen. "TCR-mimic antibodies generated by our TCR-mimic platform have potentials to be developed into multiple drug modalities such as T cell engagers, bispecific/multispecific antibodies and CAR-T therapies. We are pleased to collaborate with FineImmune to explore the application of our antibodies in the field of cell therapies."

FineImmune is a pioneering T cell therapy company, and has solved multiple critical barriers in the microenvironment of solid tumors by using multiple proprietary technology platforms, such as GSOP for T-cell engineering, HAP for TCR identification, CMP for personalized TCR-T cell production and in vivo T-cell delivery platform (TDP). FineImmune’s product pipelines include TCR-T, CAR-T, TAL, TIL, etc. The company developed the first personalized neoantigen-specific TCR-T cell therapy, which is in phase I clinical trial now. In addition, FineImmune possesses technologies for the precision prediction of the efficacy and side effects of immunotherapy, enabling healthcare professionals to provide effective and safe immunotherapy to patients with common malignant tumors.

"T cells play an important role in treating cancers. Biocytogen’s advanced TCR-mimic platform makes it possible for us to develop T cell therapies against crucial but low-expressed intracellular tumor antigens," said Dr. Penghui Zhou, Founder and Chief Technology Officer of FineImmune. "We focus on providing efficient and safe immunotherapy using advanced technologies. This collaboration will promote the development of new cell therapeutic drugs and the expansion of the potential of immunotherapy to benefit patients."

About the TCR-Mimic Platform

Biocytogen’s T Cell Receptor (TCR)-Mimic platform utilizes HLA-expressing fully human antibody mice (HLA/RenMice) to generate antibodies to intracellular tumor-associated antigens when immunized with MHC-antigen-peptide complexes. Subsequently, Biocytogen’s high-throughput antibody screening platform aims to swiftly identify TCR-mimic antibodies with higher specificity and affinity than endogenous TCRs derived from patients. Currently, antibody sequences against multiple intracellular targets have been obtained, and their efficacies have been verified in vitro and in vivo. Fully human antibody sequences obtained from the TCR-mimic platform can empower the development of T cell engagers, bispecific/multispecific antibodies, and CAR-T therapies.

On September 14, 2022 bioAffinity Technologies, (NASDAQ: BIAF, BIAFW), a biotechnology company that develops noninvasive, early-stage diagnostics to detect cancer and diseases of the lung, reported publication of its research in high-throughput flow cytometry analysis of sputum (Press release, BioAffinity Technologies, SEP 14, 2022, View Source [SID1234619562]). The journal PLOS ONE, published Sputum analysis by flow cytometry; an effective platform to analyze the lung environment reporting on results of analyzing sputum by flow cytometry as the basis for high-throughput diagnostic tests to determine the health of the lung.

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"The PLOS ONE paper presents our unique method for determining the health of an individual’s lungs"

"The PLOS ONE paper presents our unique method for determining the health of an individual’s lungs," bioAffinity President and CEO Maria Zannes said. "Flow cytometry allows for analysis of whole cells and cell populations that make up the lung environment. Our research provides a better understanding of how disease changes the lung environment and how flow cytometry can be used as a diagnostic tool by analyzing sputum. Flow cytometry is successfully used to diagnose blood cancers, particularly at early stage. In the paper, we describe an innovative and highly efficient method to analyze sputum for the presence of lung cancer, with the potential to focus on other diseases such as COPD and asthma."

bioAffinity Technologies is addressing the need for noninvasive diagnosis of early-stage cancer and diseases of the lung, and targeted cancer treatment. The Company develops proprietary noninvasive diagnostic tests using technology that preferentially targets cancer cells and cell populations indicative of a diseased state. The Company’s first product, CyPath Lung, is a non-invasive test that has shown high sensitivity and specificity for the detection of early-stage lung cancer. The test is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Services. Research and optimization of the Company’s platform technologies are conducted in its laboratories at The University of Texas at San Antonio.

About CyPath Lung

CyPath Lung is a noninvasive test for the early detection of lung cancer which uses flow cytometry to count and characterize cells in a person’s sputum, or phlegm. The test’s automated analysis of the flow cytometry data detects cell populations that indicate cancer is present. CyPath Lung has the potential to increase overall diagnostic accuracy of lung cancer diagnosis leading to increased survival while lowering the number of unnecessary invasive procedures, reducing patient anxiety, and lowering medical costs. CyPath Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Services.

On September 14, 2022 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), developer of treatments for rare and orphan indications, including Parkinson Disease and DIPG, reported that the Company will have two poster presentations at the upcoming 2022 Society for Neuro-Oncology (SNO) Annual Meeting on November 16-20, 2022, Tampa Bay, Florida (Press release, Oncotelic, SEP 14, 2022, View Source [SID1234619561]).

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Abstract Number: DDEL-16

Title: Delivery of OT-101 – TGF-2 Antisense- for the treatment of glioblastoma
Session Date: Friday November 18, 2022
Presentation Time: 7:30 PM – 9:30 PM
Abstract Number: RTID-04

Title: Clinical potential of targeting transforming growth factor beta 2 with OT-101 for post-radiation consolidation in diffuse intrinsic pontine glioma
Session Date: Friday November 18, 2022
Presentation Time: 7:30 PM – 9:30 PM
"There is no standard treatment for progressive DIPG after the failure of radiation therapy and no salvage regimen has been shown to extend survival. Therefore, there is an urgent need for therapeutic innovations for treatment of DIPG. We believe that OT-101 may offer hope for salvage therapy of pediatric DIPG patients who have this rare and fatal disease." said Dr. Vuong Trieu, CEO Oncotelic. "Now that JVCo is completed with the formation of Sapu Bioscience, we are accelerating clinical development of OT-101 for DIPG. Looking forward to providing updates on this important program".

About Dr. Fatih Uckun, DIPG Lead

The Chief Medical Officer of Oncotelic, Dr. Fatih Uckun MD, PhD, is an internationally renowned KOL in pediatric cancer research and treatment. Dr. Uckun is an elected Member of the American Society for Clinical Investigation (ASCI), an honor society for physician-scientists, and an active member of several professional organizations. He received numerous awards for his work on monoclonal antibodies, recombinant cytokines and fusion proteins, radiation sensitizers, kinase inhibitors and targeted therapeutics for difficult-to-treat cancers, including the Stohlman Memorial Award of the Leukemia Society of America (now known as Leukemia and Lymphoma Society), the highest honor given to a Leukemia Society Clinical Scholar. Dr. Uckun completed his residency training in pediatrics, clinical fellowship training in Hematology/Oncology/Blood and Bone Marrow Stem Cell Transplantation as well as postdoctoral research training in immunology at the University of Minnesota. Dr. Uckun has more than 30 years of professional experience in developmental therapeutics with a special emphasis on targeted therapeutics/precision medicines and biopharmaceuticals against childhood cancer. Dr. Uckun worked as a Professor of Pediatrics, Therapeutic Radiology-Radiation Oncology, Pharmacology, as well as Director of the Biotherapy Institute at the University of Minnesota (1986-1997), where he became the first recipient of the highly prestigious Endowed Hughes Chair in Biotherapy, and as a Professor of Pediatrics and Head of Translational Research in Leukemia and Lymphoma of the Children’s Center for Cancer and Blood Diseases at the University of Southern California (2009-2015). From 2012-2015, Dr. Uckun served as chair of the Biotargeting Working Group and a Member of the Coordination and Governance Committee of the NCI Alliance for Nanotechnology in Cancer. Prior to joining Oncotelic, Dr. Uckun served as Head of Immuno-Oncology at Ares Pharmaceuticals and Executive Medical Director and Strategy Lead in Global Oncology and Hematology at Syneos Health. Prior to this, he was Chief Scientific Officer of Jupiter Research Institute and, before that, held senior-level scientific and research positions at Parker Hughes Institute and its cancer center, Paradigm Pharmaceuticals, and the Children’s Cancer Study Group, an NCI-funded cooperative clinical trials consortium that coordinated pediatric leukemia trials at 120 institutions in the US, Canada, Australia and Europe. As a Vice Chair of the New Agents Committee as well as Member of the Leukemia Steering Committee of the Children’s Cancer Study Group, Dr. Uckun has helped design and direct several Phase I-III studies in pediatric cancer patients.

On September 14, 2022Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") and machine learning ("M.L.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that it will present positive preclinical data on the in vivo efficacy of its drug candidate LP-184 for pancreatic cancer at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference for Pancreatic Cancer, Sept 13-16th, 2022, in Boston, MA (Press release, Lantern Pharma, SEP 14, 2022, View Source [SID1234619560]).

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LP-184 is a small molecule drug candidate and next generation acylfulvene that preferentially damages DNA in cancer cells that harbor mutations in DNA damage repair (DDR) genes and that overexpress the enzyme PTGR1. Pancreatic cancer cells are expected to be sensitive to LP-184 treatment as around 25% of these cancers harbor both elevated levels of PTGR1 and mutations in DDR genes.

The AACR (Free AACR Whitepaper) poster, which is being presented in collaboration with Igor Astsaturov, M.D., Ph.D. at The Marvin and Concetta Greenberg Pancreatic Cancer Institute at Fox Chase Cancer Center, shows that LP-184 treatment has potent anti-tumor effects in mouse models of pancreatic cancer that harbor mutations in the DDR genes ATR or BRCA1. After two rounds of LP-184 treatment, the ATR and BRCA1 pancreatic cancer mouse models had tumor growth inhibitions of 140% and 112%, respectively. In these mice, LP-184 treatment was generally well-tolerated and minimal differences were observed in body weight and blood counts relative to treatment control groups.

The AACR (Free AACR Whitepaper) presentation will show additional data demonstrating that LP-184 can act synergistically in vitro and in vivo with several standard of care or FDA approved agents, including spironolactone and radiation therapy. These results continue to demonstrate LP-184’s potential as a therapeutic agent for pancreatic cancer as a monotherapy or in combination with other approved therapies.

LP-184 has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of pancreatic cancer, malignant gliomas, and ATRT, and was also granted a Rare Pediatric Disease Designation for ATRT. These designations and continued positive preclinical data will help to accelerate LP-184 towards a targeted IND submission in Q1 2023 and Phase 1 clinical trials anticipated to commence in Q2 2023.

Details of the poster presentation are listed below and can be found on the AACR (Free AACR Whitepaper) conference website. A full version of the poster will be available on Lantern’s website on September 19th, 2022.

Title: LP-184, a tumor site activated small molecule synthetic lethal therapeutic, is synthetically lethal in pancreatic cancers with DNA damage repair defects
Date and Time: September 14, 2022, 4:00pm ET
Poster Number: B033
Presenter: Aditya Kulkarni, Ph.D., Lantern Pharma

About Lantern Pharma

Lantern Pharma (NASDAQ: LTRN) is a clinical-stage oncology-focused biopharmaceutical company leveraging its proprietary RADR A.I. and machine learning platform to discover biomarker signatures that identify patients most likely to respond to its pipeline of genomically-targeted therapeutics. Lantern is currently developing four drug candidates and an ADC program across nine disclosed tumor targets, including two phase 2 programs. By targeting drugs to patients whose genomic profile identifies them as having the highest probability of benefiting from the drug, Lantern’s approach represents the potential to deliver best-in-class outcomes.