Ghent, Belgium – August 29, 2023 – Confo Therapeutics, a leader in the discovery of medicines targeting G-protein coupled receptors (GPCRs), today announced the appointment of Dieter Weinand as Independent Chairman of its Board of Directors. Mr. Weinand brings with him a wealth of experience with more than 35 years in the pharmaceutical industry and over 25 years as the leader of geographic and strategic business units and drug commercialization efforts across global organizations, including several years as the President, CEO and Chairman of the Board of Bayer Pharmaceuticals AG. He joins Confo as the company advances its pipeline and continues to leverage its proprietary GPCR drug discovery engine. Mr. Weinand succeeds John Berriman, who is retiring from his current position as Chairman of Confo’s Board of Directors.

“Dieter is an exceptional leader in the pharmaceutical industry with a proven track record across the spectrum of research and development to commercialization, bringing impactful medications to patients. A chairman of his caliber will be invaluable as we continue progressing as an organization with a truly innovative GPCR-targeting technology and a growing pipeline of novel drug candidates,” said Cedric Ververken, CEO of Confo Therapeutics. “On behalf of the Confo team, I sincerely thank John Berriman for his guidance over the past seven years and his contributions to Confo’s growth into a clinical-stage drug development company.”

“Confo is moving on an exciting trajectory, harnessing the momentum of a pivotal agreement with Eli Lilly for its first clinical program, CFTX-1554, and building out a robust pipeline of large and small molecules based on its unique platform,” added Dieter Weinand, Independent Chairman. “I look forward to working together with the Confo team to advance the company through its next stages of growth and to achieve its future strategic business and pipeline objectives.”

Mr. Weinand has had a highly successful career across all areas of pharmaceutical development, commercialization, and international organizational leadership. Most recently, he was Head of Global Primary Care Business at Sanofi where he led the optimization of the company’s portfolios. Before this, he was President, CEO, and Chairman of the Board of Bayer Pharmaceuticals AG, where he was responsible for integrating the R&D, manufacturing, and all commercial and support functions of the healthcare business of the Bayer AG corporation. Mr. Weinand held various senior management positions across international corporations including at Bristol-Meyers Squibb and Pfizer. He has been instrumental in the launch and marketing of some of the industry’s pivotal products including Lipitor®, Neurontin®, Abilify® and Cipro®. Mr. Weinand holds a B.A. in Biology from Concordia College, New York, and an M.S. in Pharmacology and Toxicology from Long Island University, New York. Mr. Weinand is Chairman of the Board of Nasdaq-listed Replimune (REPL), FORE Biotherapeutics, and ZielBio, among others.

BEVERLY, Massachusetts – August 17, 2023 – Quanta Dialysis Technologies^® today announced that it has completed enrollment of its Home Run study for at-home hemodialysis. The Home Run study is a prospective, multi-center, open-label trial to assess the efficacy and safety of the Quanta Dialysis System for home hemodialysis.  Results are expected to be announced in the second half of 2023.

“People with end-stage kidney disease on hemodialysis are currently limited as to options available.  Although frequent home hemodialysis is proven to deliver superior outcomes, for many, in-center dialysis treatment three times a week is the only viable option,” said Quanta Chief Medical Officer, Dr. Paul Komenda, MHA, FRCPC, FASN.  “We hope that FDA clearance of an additional home hemodialysis device will contribute to more patients having access to regular care in their home environment.   Enrollment completion is the first step forward in a potential new alternative for people with this life-threatening disease.”

Tuebingen, Germany and Houston, Texas, August 10, 2023 – Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today announced the initiation of a Phase 1/2 clinical trial with its proprietary Bispecific T cell engaging receptor (TCER®) IMA402. IMA402 is the second product candidate in Immatics’ TCER® pipeline of next-generation, half-life extended bispecific molecules to enter clinical development. It targets an HLA-A*02:01-presented peptide derived from PRAME, a clinically established cancer target frequently expressed in a large variety of solid tumors.

The Phase 1/2 clinical trial (NCT05958121) investigates TCER® IMA402 in HLA-A*02:01-positive patients with PRAME-expressing recurrent and/or refractory solid tumors. The dose escalation part of the study is designed as a basket trial in focus indications to accelerate signal finding. Initial focus indications are cutaneous and uveal melanoma, ovarian cancer, lung cancer, uterine cancer and synovial sarcoma, among others.

“The addition of IMA402 to our clinical pipeline is a truly exciting step and aligns with our strategic goal to harness the full potential of PRAME, one of the most promising cancer targets in solid tumors. With our half-life extended format, we believe IMA402 has the potential to be an attractive treatment option by enhancing efficacy, minimizing toxicities, and providing favorable dosing regimen for cancer patients.,” said Cedrik Britten, Chief Medical Officer at Immatics. “We are working with urgency to bring IMA402 to a broad patient population as quickly as possible and look forward to sharing first clinical data in 2024.”

Primary objectives of the IMA402 Phase 1/2 trial are to determine the maximum tolerated dose (MTD) and/or the recommended doses for trial extensions, as well as to characterize safety and tolerability of IMA402. Secondary objectives are to evaluate anti-tumor activity and assess pharmacokinetics of IMA402. The Phase 1a dose escalation will be followed by a Phase 1b dose expansion, with the plan then to initiate a Phase 2 with indication-specific cohorts and/or combination therapies. Immatics has implemented an adaptive design for the dose escalation with the goal of accelerating the clinical development timeline of IMA402. Pharmacokinetics data will be assessed throughout the trial and might provide an early opportunity for adjustment of the treatment interval based on the half-life extended TCER® format. The trial is initially planned to be conducted at approximately 15 sites in Europe, with extension into the US at dose expansion stage. The Phase 1a is designed to enroll approximately 45 patients.

The trial initiation is based on the comprehensive preclinical studies with IMA402 presented at the European Society for Medical Oncology (ESMO) Congress 2022.

TCER® IMA402 is the second Immatics clinical program targeting PRAME, with the first being ACTengine® IMA203, a TCR-T cell therapy which is currently being evaluated in a Phase 1b dose expansion. Both approaches, ACTengine® and TCER®, are distinct therapeutic modalities that Immatics believes to have the potential to provide innovative treatment options for a variety of cancer patient populations with different medical needs.

Quanta Dialysis System becomes first-in-class to perform three standard-of-care dialysis modalities in one device

BEVERLY, Mass., Aug. 3, 2023 /PRNewswire/ — Quanta Dialysis Technologies®, a medical technology company committed to making kidney care more accessible, today announced that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for an expanded indication of the Quanta Dialysis System, a compact and easy-to-use hemodialysis device, for two modalities of continuous renal replacement therapy (CRRT): continuous venovenous hemodialysis (CVVHD) and slow continuous ultrafiltration (SCUF). Under the new 510(k), the Quanta Dialysis System is the only dialysis device FDA-cleared to provide intermittent hemodialysis (IHD), sustained low efficiency dialysis (SLED) or bagless CRRT which creates dialysate on demand – all in a single machine.

The Quanta Dialysis System was originally designed to serve the more than two million people with end-stage kidney disease (ESKD) worldwide who receive treatment with dialysis or a kidney transplant. The latest addition of its Trinal Kidney Therapy™ (TKT) software provides a treatment solution for critically ill patients diagnosed with acute kidney injury (AKI) who require dialysis. It features dialysate flow rates from 50 to 500 mL/min and treatment times up to 24 hours of continuous delivery.

“This clearance is a true game-changer for acute care settings,” said Quanta Chief Executive Officer, Alejandro Galindo. “Hospitals are often constrained with limited space and nursing staff. The Quanta Dialysis System with TKT software provides an all-in-one solution for hospitals with an intensive care unit (ICU) looking to reduce their device footprint, maximize their operational efficiencies, reduce burden on nurses and substantially lower consumables expenses.”

Mortality for ICU patients with severe AKI who need dialysis has been reported to exceed 50% in patients often requiring intravenous life support to maintain a minimum blood pressure. CRRT offers a slower and gentler alternative to conventional dialysis; continuous dialysis runs 24 hours a day as compared to traditional hemodialysis which occurs over a four-hour period enabling better real time management of volume and biochemistry for patients.

“Critically ill patients that are hemodynamically unstable, such as those with severe AKI, are more challenging to manage in the ICU balancing volume status, inotropic support and ventilation requirements. Because of its slower rate of fluid removal, CRRT may cause less stress for the patient and enable more real-time decision making for clinical teams on a minute-to-minute basis,” said Quanta Chief Medical Officer, Dr. Paul Komenda, MHA, FRCPC, FASN. “However, once the hemodynamic status of the patient has improved, a transition to IHD or SLED may be the best option. A device than can perform all three modalities in one is ideal.”

Quanta is ready to commercialize the Quanta Dialysis System with TKT software and expects to officially launch the product at the 2023 American Society of Nephrology Annual Meeting.