On June 14, 2022 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported that it has advanced a partnership with Invicro LLC (Invicro), a global, industry-leading imaging CRO, and part of REALM IDx, Inc., to develop an artificial intelligence (AI) platform to accompany Telix’s PSMA-PET imaging agent, Illuccix (kit for the preparation of gallium Ga 68 gozetotide) – known as TelixAI (Press release, Immudex, JUN 14, 2022, View Source [SID1234615957]).

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!

TelixAI seeks to increase the efficiency and reproducibility of clinicians’ imaging assessments using advanced analysis capabilities with an initial focus on prostate cancer. The platform is designed to do this by automatically separating healthy versus abnormal tracer uptake and then classifies lesions as either visceral (soft tissue) or bone lesions.

Invicro has a depth of experience in AI, machine learning and algorithm development for medical imaging. Its industry leading medical image analyst team consists of over fifty medical image processing scientists. The commercial objective of the development partnership is the submission to the United States Food and Drug Administration (FDA) 510(K) approval for software as a medical device.

A demonstration of the TelixAI was presented this week at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting being held in Vancouver, BC from June 11-14.

Telix Chief Scientist, Dr. Michael Wheatcroft said, "We are pleased to be advancing the TelixAI platform with Invicro, which aims to further enhance the utility of molecular imaging starting with Illuccix. Our investment in TelixAI is expected to extend into multiple applications for Telix’s late-stage imaging assets, including TLX250-CDx, which is currently completing a Phase III pivotal trial in renal cancer imaging."

CEO of Invicro, Matt Silva, Ph.D., continued, "Invicro is delighted to bring our deep expertise in PET imaging, AI and machine learning and take this collaboration with Telix’s Research and Innovation team into the next stage. We are excited about the possibility of bringing this software to realization with Illuccix and for the potential impact on clinicians’ decision-making and patient outcomes with Telix’s broad theranostic pipeline."

On June 14, 2022 CDx Diagnostics, Inc. reported that it has signed an agreement with laboratory benefits management provider Avalon Healthcare Solutions, Inc. of Tampa, Fla (Press release, CDx Diagnostics, JUN 14, 2022, View Source [SID1234615974]). The agreement means that CDx will be an in-network specialty anatomic pathology laboratory of Avalon client BlueCross BlueShield of South Carolina, and builds on Avalon’s positive medical policy for CDx’s proprietary diagnostic platform, WATS3D.

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!

Short for wide-area transepithelial sampling with three-dimensional analysis, WATS3D utilizes enhanced tissue acquisition, 3D imaging with AI-powered analysis, and expert pathologists to reliably detect Barrett’s esophagus (BE) and esophageal dysplasia. Effectively immediately, the agreement makes WATS3D available to the 565,000 members of BCBS of South Carolina with all commercial and Medicare Advantage plans.

"At CDx, we’re driven to empower physicians to preempt esophageal cancer and improve patient lives," said Bill Huffnagle, CEO of CDx Diagnostics. "This new agreement with Avalon brings modern, proven diagnostic technology to more than half a million more members. We will work together to bring this potentially lifesaving technology to additional payors and the members they serve."

WATS3D technology helps clinicians overcome the limitations associated with traditional upper endoscopy screening and surveillance methods, by combining a specially designed brush, unique 3D imaging powered by AI, and a team of trained GI pathologists. In large multicenter clinical studies, WATS3D has been found to significantly increase the detection rate of BE and esophageal dysplasia, both treatable precursors to esophageal cancer, one of the fastest growing and most fatal cancers in the United States.

On June 14, 2022 Prestige BioPharma Group, comprising Singapore-based biopharmaceutical company Prestige BioPharma Limited. and biopharmaceutical CDMO company Prestige Biologics Co., Ltd., reported that the Group is participating in the BIO International Convention 2022, taking place in San Diego from June 13 to 16, 2022 (Press release, Prestige BioPharma, JUN 14, 2022, View Source [SID1234616226]).

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 Group aims to partner with global players for its core pipelines and secure clients for its CDEMO business at the world’s largest event for the biotechnology and pharmaceutical industries. After 2 years of online conventions, this year’s event is back in-person, thus expected to gather a high number of participants including around 3,000 companies from all over the world.

At booth #1421 in Bioprocess Zone, Hall B2, Prestige BioPharma Group showcases its technological platform for bioprocessing value chain, ranging from drug discovery to commercialization, which enhances productivity and cost-effectiveness. In particular, Prestige BioPharma introduces its biosimilar and antibody portfolio and share current progress on each pipeline to discusses partnership in development or commercialization. Prestige Biologics concentrates on securing clients and business contracts of its CDEMO services that provide customized manufacturing suites as well as development and engineering solutions.

Michael Ruppert, Director of International Business Development at Prestige BioPharma, said: "Our goal here is to build global network and partnership to enter the global market. In addition to biosimilars and first-in-class antibody drugs, we also look forward to discussing collaborations in research and development of vaccines against next-generation infectious diseases."

Jae-young Yang, CEO of Prestige Biologics, said: "In the competitive CDMO market, we have armed ourselves with state-of-the-art biomanufacturing facilities and patent technologies that ensures high quality and productivity. We will seize this opportunity to raise Prestige Biologics’ profile worldwide and secure new clients for CDEMO business."

On June 14, 2022 Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), reported that the company invites investors, analysts, and media to a live-streamed R&D Event with a subsequent question and answer session on June 20 at 12:30 CEST (Press release, Isofol Medical, JUN 14, 2022, View Source [SID1234615958]).

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!

Isofol will shortly present top-line results from the multi-center, global Phase III AGENT study investigating arfolitixorin in combination with 5-FU, oxaliplatin and bevacizumab in advanced, metastatic colorectal cancer (mCRC). The purpose of the event is to provide investors, analysts, and media with a better understanding of the current treatment landscape; medical need for colorectal cancer patients; clinical, regulatory and market access demands; and an update on the AGENT study. Speaking at the R&D Event will be Isofol´s CEO Ulf Jungnelius MD, CMO/CSO Roger Tell MD, and Professor Sebastian Stintzing MD, Charité Universitätsmedizin, Division of Hematology, Oncology and Tumor Immunology. The event will be held in English.

Agenda for the R&D Event

The AGENT study – its design, patient population, endpoints, and an update including the current status of the study and upcoming topline results
The medical need for colorectal cancer patients
The current colorectal cancer treatment landscape and the clinical use of current treatments
Clinical, regulatory, and market access demands for introducing new treatments for colorectal cancer
Q&A-session
The event will be livestreamed and can be followed via a link that will be published on Isofol’s webpage shortly

Questions can be asked prior to the event by sending an email to [email protected] or during the webcast via a chat function. The webcast will also be available on demand on Isofol’s corporate website after the event.

Date and time
June 20, 2022, from 12:30-14:00 p.m. CEST

Webcast link
A link to the webcast will be published on Isofol’s webpage shortly.

On June 14, 2022 AVM Biotechnology, a clinical stage company advancing AVM0703 in the treatment of Non-Hodgkin’s Lymphoma (NHL)/Leukemia, reported that it has been awarded a Phase II Small Business Innovative Research (SBIR) grant (Press release, AVM Biotechnology, JUN 14, 2022, View Source [SID1234615975]). This $2 million National Cancer Institute (NCI) grant will assist in the continuation of the company’s existing clinical trial (AVM0703 for Treatment of Leukemia or Lymphoma, NCT04329728).

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 Phase II grant has been awarded for continued support of the adaptive-design, expansion cohort clinical trial of AVM0703 for "no-option," Relapsed/Refractory (R/R) NHL/Leukemia patients. The study is currently enrolling at City of Hope, UCLA, Norton Cancer Institute, and the University of Texas Southwestern. Additional sites are being brought on-line.

AVM0703:

is a small molecule which triggers the production and release of endogenous bispecific gamma delta TCR+ invariant TCR+ Natural Killer T-like cells (AVM-NKT).
induces AVM-NKT cells rapidly in the blood following a single dose.
is currently the subject of an adaptive design expansion cohort clinical trial with the dose escalation phase nearing completion and the efficacy phase projected to commence soon.
In the ongoing dose escalation phase, which included 11 highly refractory patients who had been heavily pretreated averaging 5.3 prior lines of therapy with 6 of 11 having failed hematopoietic stem cell transplantation (HSCT) or CAR-T, results included:

100% clinical response at 18 mg/kg target Ph II dose, with durable partial response/stable disease ongoing out to greater than 9 months in 1 patient.
Of 10 evaluable patients from the dose-escalation; 4 experienced partial response and 2 other patients subsequently reached complete remission.
An additional 20% achieved stable disease or significant clinical response including durable vision restoration in 1 patient.
One heavily pretreated patient with T-cell lymphoma who did not meet inclusion/exclusion criteria received AVM0703 under an FDA-approved Compassionate Use Program. That patient has experienced a very good partial response.

The drug has been well-tolerated with no reported Dose Limiting Toxicities (DLTs) or grades 4 or 5 adverse events. AVM0703 also potentiates chemotherapy and CAR-T response in pre-clinical models.

NHL is the 7th most common cancer in the US with over half of the 77,240 diagnosed annually over the age of 65. Even with treatment, disease recurs or relapses in approximately 50% of these patients and many become refractory to additional treatment. Patients can undergo many lines of various therapies including chemotherapy, radiation, CAR-T and HSCT which can be associated with significant toxicities and poor outcomes with many relapsing and requiring additional treatment. Based on its strong safety profile and clinical response, AVM0703 presents an appealing alternative to these therapies.

"AVM0703 represents an exciting new treatment option for NHL patients who have failed other therapies or who do not qualify for further chemotherapy, radiation, or cell therapies, including CAR-T. In addition to improvement in disease status, several patients treated with AVM0703 in the dose-escalation phase of the study have qualified for other treatments they had formerly been excluded from accessing," said Joe Luminiello, CEO.

AVM Biotechnology previously received a Phase I NCI grant from the National Institutes of Health (NIH) to study the use of AVM0703 as a preconditioning agent to allow safe and efficient delivery of therapeutic immune cells for cancer treatment. The company has requested breakthrough therapy designation and plans for accelerated approval for commercial launch in mid 2024.