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Immunovia enters licensing agreement with JW BioScience for pancreatic cancer biomarkers

On September 13, 2021 Immunovia AB (publ) ("Immunovia"), a diagnostic company that develops and sells highly accurate blood tests for the early detection of cancer, reported that Immunovia has strengthened its patent protection for pancreatic cancer biomarkers by obtaining a global license from the South Korean company JW BioScience’s IP portfolio (Press release, JW Pharmaceutical, SEP 13, 2021, View Source [SID1234587649]).

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The license agreement gives Immunovia global commercial rights for two biomarkers for early detection of pancreatic cancer. The biomarkers are also part of Immunovia, Inc.’s IMMray PanCan-d biomarker signature. Immunovia discovered these pancreatic cancer biomarkers independently of JW BioScience and have now fully secured intellectual property rights.

The details and deal size of this contract are not disclosed as agreed by both parties.

Patrik Dahlen, CEO of Immunovia, said, "We are delighted to enter into this agreement that further secures relevant IP and validates our biomarker discovery approach. By entering into this agreement, Immunovia and JW BioScience will also evaluate possibilities for commercial collaboration to enable early detection of pancreatic cancer in the Korean market."

Eun-Kyung Hahm, CEO of JW Bioscience, said, "This contract is an important milestone for JW’s unique IP position and a recognition of the excellence of JW technology in the global market." She also added that, "JW will be able to further strengthen its commercial and technological competitiveness through the collaboration with Immunovia."

Immunovia has a strong and extensive IP portfolio consisting of seven patent families, covering biomarkers in pancreatic cancer.

GT Biopharma Advances GTB-3650, a Second-Generation Tri-Specific Killer Engager -TriKE®, Into IND-Enabling Studies

On September 13, 2021 GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager, TriKE protein biologic technology platform, reported the advancement of GTB-3650 into IND-enabling studies, with which it plans to supplant the ongoing Phase 1 program with GTB-3550 (Press release, GT Biopharma, SEP 13, 2021, View Source;trike-into-ind-enabling-studies-301374947.html [SID1234587648]).

Therapeutic and commercial advantages of GTB-3650 compared to GTB-3550 include:

Based on second generation camelid single-domain antibody technology that holds several advantages over traditional IgG monoclonal antibodies
Improved potency and enhanced binding affinity
Similar preclinical safety profile
Commercial manufacturing capabilities through arrangement with Cytovance
Proprietary patented molecule, which unlike GTB-3550, is wholly owned by GT Biopharma
"We look forward to advancing GTB-3650 toward the clinic" noted Greg Berk, M.D., GT Biopharma’s President of R&D and Chief Medical Officer. "This transition marks the next logical evolution of our TriKE platform. As the company focuses its resources on the most promising pipeline candidates, GTB-3650 will now be able to take advantage of the strong evidence gathered from our first-generation pilot TriKE program. Complementing this development advance, has been the transition of all manufacturing processes to Cytovance Biologics, a leading specialty cGMP contract manufacturing organization. We have now achieved another strategic milestone consistent with our mission to advance novel immuno-oncology drugs to patients with advanced cancers", commented Dr. Berk.

About Camelid Antibodies

Camelid antibodies are single domain antibodies (sdAbs) from the Camelidae family of mammals that include llamas, camels, and alpacas. These animals produce 2 main types of antibodies. One type of antibody camelids produce is the conventional antibody that is made up of 2 heavy chains and 2 light chains. They also produce another type of antibody that is made up of only 2 heavy chains and no light chain. This is known as heavy chain IgG (hcIgG). While these antibodies do not contain the CH1 region, they retain an antigen binding domain called the VHH region. VHH antibodies, also known as single domain antibodies, contain only the VHH region from the camelid antibody. Camelid antibodies have key characteristics, which include high affinity and specificity (equivalent to conventional antibodies), high thermostability, good solubility and strictly monomeric behavior, small size, relatively low production cost, ease of genetic engineering, format flexibility or modularity, low immunogenicity, and a higher penetration rate into tissues.

About GTB-3650

GTB-3650 is the Company’s lead second-generation Tri-Specific Killer Engager TriKE program currently in preclinical development for the treatment of relapsed/refractory acute myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS).

Palatin to Participate in H.C. Wainwright 23rd Annual Global Investment Virtual Conference

On September 13, 2021 Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor systems, reported that Carl Spana, Ph.D., President and Chief Executive Officer, will participate in the H.C. Wainwright 23rd Annual Global Investment Virtual Conference on September 13-15, 2021 (Press release, Palatin Technologies, SEP 13, 2021, View Source [SID1234587647]).

OncoHost Publishes Data Identifying Predictive Signature for Response to Immunotherapy in Lung Cancer Patients

On September 13, 2021 OncoHost, a global leader in next-generation precision oncology for improved personalized cancer therapy, reported that it has published a study identifying a predictive proteomic signature for patient response to immune checkpoint inhibitor (ICI) therapy in non-small-cell lung carcinoma (NSCLC) patients (Press release, OncoHost, SEP 13, 2021, View Source [SID1234587646]). The signature was discovered using OncoHost’s first-of-its-kind, AI-based platform, PROphet, and the study will be presented as a poster at the ESMO (Free ESMO Whitepaper) Virtual Congress 2021.

Immune checkpoint inhibitor (ICI)-based treatment has revolutionized the cancer therapy landscape, displaying a significant response in patients with advanced stage disease. However, only a small fraction of patients actually responds to this treatment, making it critical to identify reliable biomarkers for response and understand the mechanisms underlying resistance. OncoHost’s PROphet platform utilizes advanced machine learning and bioinformatics to analyze the complex tumor-patient-treatment biologic interplay, providing clinicians and their patients with a clinically actionable "disease navigator."

"This study has revealed that OncoHost’s bioinformatic analysis and host response evaluation based on proteomic data can help predict patient outcomes with very high accuracy," said Professor Yuval Shaked, founder and Chief Scientific Advisor at OncoHost, and Professor of Cell Biology and Cancer Science at the Technion – Israel Institute of Technology. "We are proud to be taking such strides in overcoming the challenge of non-responsiveness to immunotherapy and advancing the development of novel therapeutic strategies."

Researchers examined host-mediated effects occurring in response to ICI treatment, and their contribution to therapy resistance in stage IV NSCLC patients. Overall, 108 subjects participated in the study, of whom 80 were responders and 28 were non-responders. The research revealed that plasma proteome changes occur following immunotherapy, suggesting host (patient) response to ICI treatment. An analysis of differentially expressed proteins in the patients indicated therapy-specific mechanisms of resistance.

"Traditional precision medicine searches for biomarkers at the therapy-tumor axis. By adding the patient to the equation, OncoHost is fighting cancer through a distinctive, deep profiling of the patient-tumor interface," said Dr. Ofer Sharon, CEO of OncoHost. "Our research demonstrates the potential clinical utility of PROphet, offering physicians targeted treatment options for their patients and identifying previously unanticipated targets for future interventions and clinical trials."

The clinical study was conducted in collaboration with the Chaim Sheba Medical Center Institute of Oncology, the Technion Institute of Technology, Thomas Jefferson University and the University of Connecticut.

The virtual ESMO (Free ESMO Whitepaper) Congress 2021 will take place September 16-21.

Poster Title: A predictive signature for response to immunotherapy in non-small cell lung cancer based on plasma proteomics and clinical parameters.
Abstract #: 300
E-poster #: 74P

The abstract is available on the ESMO (Free ESMO Whitepaper) website here.

PharmAbcine to Participate in ACCESS CHINA Biotech Forum

On September 13, 2021 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next generation antibody therapeutics, reported that the Company will virtually participate in ACCESS CHINA Biotech Forum (Press release, PharmAbcine, SEP 13, 2021, View Source [SID1234587645]). The event will take place from September 23 – September 30, 2021.

ACCESS CHINA Biotech Forum is one of the largest corporate access events in China. It provides opportunities for business development, licensing deals, or commercial collaborations to global biopharmas. In the past event, more than 300 global companies that focus on oncology, cardiology, ophthalmology, orthopedics, pediatrics, and gastroenterology areas have participated to enter or expand their products in the Chinese market. For more information, please visit View Source

During the event, PharmAbcine’s pre-recorded presentation video will be made available to Chinese pharmas or biotechs that are looking to enrich their pipeline through in-licensing deals. In the presentation video, the Company will introduce its core technology and update the R&D progress of the main pipelines such as olinvacimab, PMC-403, and PMC-309.

Olinvacimab, an anti-VEGFR2 (Vascular Endothelial Growth Factor Receptor 2) fully human antibody, is the Company’s leading pipeline and is undergoing multiple global clinical trials. In early September 2021, PharmAbcine initiated a Phase II olinvacimab and pembrolizumab combo study for the treatment of mTNBC (metastatic Triple-Negative Breast Cancer) in Australia. Also, a Phase II olinvacimab mono study for bevacizumab-nonresponding rGBM (recurrent glioblastoma multiforme) patients at multiple sites in both US and Australia and two Phase Ib olinvacimab and pembrolizumab combo trials in mTNBC and rGBM in Australia are still ongoing.

PMC-403 is a novel TIE2-activating fully human antibody designed to stabilize and repair damaged blood vessels in a variety of diseases. PMC-403 is currently in development for treating AMD (Age-related Macular Degeneration), DME (Diabetic Macular Edema), and DR (Diabetic Retinopathy) which are common abnormal vascular-related eye diseases. The Company expects PMC-403 to enter global clinical trials for both ophthalmology and oncology in 2022.

PMC-309 is a novel anti-VISTA (V-domain Ig Suppressor of T cell Activation) antagonizing antibody in development for the treatment of various tumor types. VISTA plays a pivotal role in maintaining the immunosuppressive environment around the tumor cells and is expressed primarily on MDSC (Myeloid-Derived Suppressor Cells) and Tregs (regulatory T cells). Blocking VISTA pathways activates T cells’ immune responses and leads to better anti-tumor effects. PMC-309 is expected to enter a global clinical trial in 2022.