On September 15, 2022 Integral Molecular, the industry leader in discovering antibodies against complex membrane protein targets, reported that it has licensed a panel of monoclonal antibodies (MAbs) to CARTEXELL, enabling CARTEXELL to develop CAR-T cell therapies using Integral Molecular’s Claudin 18.2 (CLDN18.2) MAbs (Press release, Integral Molecular, SEP 15, 2022, View Source [SID1234623334]).

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Under the terms of the agreement, Integral Molecular will provide an exclusive worldwide license to CARTEXELL to use the panel of high-affinity, high-specificity, and fully humanized CLND18.2 MAbs for the development of CAR-T cell therapies against solid tumors including gastric, lung, pancreatic and esophageal cancers. CARTEXELL will be solely responsible for all research, development, and commercial activities.

The CLND18.2 MAbs were isolated using Integral Molecular’s MPS Antibody Discovery platform which is uniquely tailored to deliver high-specificity, high-affinity antibodies against the most structurally challenging membrane protein targets including GPCRs, ion channels, transporters, and tight junction proteins.

"Claudin 18.2 is an exciting target for oncology therapeutics since it’s highly expressed in cancers such as gastric and esophageal cancers that are difficult to treat", said Joseph Rucker, PhD, Vice President of R&D at Integral Molecular. "We look forward to the synergy of our high-specificity MAbs with CARTEXELL’s CAR-T cell therapy technology to bring new therapies to patients."

"CAR-T cell therapy has revolutionized treatment options for blood cancers, but has been ineffective for solid tumors", said Jehee Suh, CEO of CARTEXELL. "We are excited by the promise of these Claudin 18.2 antibodies for targeting our CAR-T 2.0 technology which uses engineered cells and vectors to overcome the tumor microenvironment and provide more effective therapies."

On September 15, 2022 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), reported that it will be conducting one-on-one virtual meetings with institutional investors as part of the Lytham Partners Fall 2022 Investor Conference (Press release, MediciNova, SEP 15, 2022, View Source [SID1234619617]). The event is taking place virtually on September 28 – 29, 2022.

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Yuichi Iwaki, MD, PhD, President and Chief Executive Officer, and Geoffrey O’Brien, JD/MBA, Vice President and Executive Officer, will be available for one-on-one meetings at this conference and investors may request a one-on-one meeting by contacting Joe Diaz of Lytham Partners by phone at (602) 889-9660, by email at [email protected] or by registering at View Source

On September 15, 2022, SELLAS Life Sciences Group, Inc. (the "Company") presented the corporate presentation (Filing, 8-K, Sellas Life Sciences, SEP 15, 2022, View Source [SID1234619614]).

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On September 15, 2022 Galvanize Therapeutics, Inc., a commercial-stage biomedical platform company operating at the convergence of engineering, biology and healthcare delivery, reported it has completed a $100 million Series B financing to advance and commercialize its unique AliyaTM Pulsed Electric Field (PEF) energy platform for the treatment of chronic bronchitis symptoms, cardiac arrhythmias, solid tumors, and for drug delivery (Press release, Galvanize Therapeutics, SEP 15, 2022, View Source [SID1234619611]). Galvanize was created and incubated by the life sciences venture capital firm ATP (Apple Tree Partners), originally as three companies—Gala Therapeutics, Galaxy Medical, and Galvanize Therapeutics—that recently merged into one company under the Galvanize Therapeutics name . The funding round was led by Fidelity Management & Research Company with participation by Intuitive Surgical, ATP, and Gilmartin Capital.

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Jonathan Waldstreicher, M.D., founder and CEO of Galvanize Therapeutics and a partner at ATP
Jonathan Waldstreicher, M.D., founder and CEO of Galvanize Therapeutics and a partner at ATP
"We are energized by this vote of confidence from our investors in our technology platform and team as we seek to bring transformative electrosurgical therapies to patients worldwide," said Jonathan Waldstreicher, M.D., founder and CEO of Galvanize Therapeutics and a partner at ATP. "We designed the customizable Aliya energy platform to serve patients in a variety of challenging disease categories, and the integration of our market-specific strategies and innovative products within Galvanize is an exciting milestone in the execution of our vision. We are investing meaningfully to prove safety and demonstrate enhanced outcomes in our initial clinical targets, and we continue to explore additional platform applications."

Centered on disease biology and how energy can alter cellular physiology, Galvanize developed the Aliya energy platform to produce high voltage, high frequency electrical current to interfere with cellular function in tissue. Unlike other ablation modalities, Aliya energy is non-thermal. The electrical waveforms are designed to be delivered through single monopolar electrodes to enable more consistent and predictable treatment zones with minimal muscle contraction that previously plagued high voltage technologies.

One Core Platform, Several Targets

Galvanize is developing and commercializing its energy platform for several indications, adapting its core technology for each application:

Chronic Bronchitis: The RheOx system is a minimally invasive bronchoscopic therapy that reduces the abnormal mucus-producing cells in the airways of chronic bronchitis patients. RheOx has CE Mark and recently launched in select hospitals in Italy, Switzerland, Denmark and Germany, with new customers adopting RheOx each week. Following Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA), the RheSolve pivotal clinical trial is enrolling in the United States and Europe to support a U.S. Premarket Approval (PMA) submission for RheOx.

Cardiac Arrhythmias: The CENTAURI system disrupts aberrant electrical signals in the heart which cause cardiac arrhythmias, including atrial fibrillation. CENTAURI delivers a novel proprietary waveform and is compatible with several marketed catheters and mapping systems. CENTAURI has CE Mark and currently is launching in Europe.

Soft Tissue Ablation: The Aliya system recently received 510(k) clearance from the U.S. FDA for soft tissue ablation. Through a single percutaneous electrode inserted in the target tissue, the physician delivers a pre-programmed dose of energy. Aliya is now launching at select U.S. hospitals.

Immuno-Oncology: The Aliya energy platform is being studied to treat solid tumors by combining PEF-mediated cell death and neoantigen creation, designed to stimulate the patient’s own immune system to activate against the tumor. Galvanize’s preclinical data and early clinical data from the INCITE-ES trial conducted outside the U.S. have demonstrated signals of immune activation.

Drug Delivery: A system for local delivery of therapeutic agents is under development.
RheOx and CENTAURI were developed in ATP portfolio companies Gala Therapeutics (founded 2015) and Galaxy Medical (founded 2020), respectively, both of which now are part of Galvanize Therapeutics.

"ATP makes investments to translate incredible science into treatments that can transform lives, and I believe the Galvanize PEF energy platform exemplifies the remarkable breakthroughs we can accomplish with our singular investment and incubation model," said Seth Harrison, M.D., ATP’s founder and managing partner. "ATP invested over a period of years to build an adaptable therapeutic device platform capable of addressing some of the most intractable medical problems that have not been solved yet by drugs, and it is gratifying to see the vision being realized. The Galvanize team has developed ingenious solutions for patients and their doctors that they are now delivering to healthcare systems every day."

Doug Godshall, president & CEO of Shockwave Medical, and chair of Saluda Medical, who previously was chair of Gala Therapeutics, has been appointed chair of the board of Galvanize Therapeutics. Mr. Godshall commented: "At Gala over the last few years, we observed the life-changing outcomes that RheOx can achieve in debilitated chronic bronchitis patients, and I am excited to work with the broader Galvanize team as they expand their efforts." He added:

"Galvanize is unique because of the way Jon and his talented team have created a single, highly sophisticated technology across three unique clinical applications. With a deep portfolio of clinical studies already under way, I am highly impressed by what the team has accomplished to-date and am quite enthusiastic about the significant impact Galvanize is going to have for a wide spectrum of patients."

On September 15, 2022 Mission Bio, Inc., the pioneer in high-throughput single-cell DNA analysis, reported new data supporting the use of its Tapestri Platform in clinical development, including clonal evolution patterns in patients with IDH1-mutated acute myeloid leukemia (AML) treated with Servier Pharmaceuticals’ TIBSOVO (ivosidenib tablets) plus azacitidine (Press release, Mission Bio, SEP 15, 2022, View Source [SID1234619603]). Data previously generated via single-cell DNA sequencing with Tapestri supported analyses for Servier’s ongoing pivotal phase 3 AGILE trial, the basis for U.S. Food and Drug Administration approval of the combination in newly diagnosed patients with IDH1-mutated AML in May 2022.

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AML is one of the most common and dangerous leukemias, as the majority of patients with AML eventually relapse after initial treatment – with poor prognoses. However, improving methods of molecular profiling has brought new hope by supporting the development and targeted use of precision therapies like TIBSOVO, the first FDA-approved IDH1 inhibitor. Researchers at Agios (later acquired by Servier) previously leveraged Tapestri to fully characterize the clonal architecture of AML at the single-cell level, revealing mechanisms of resistance to TIBSOVO monotherapy and enabling Servier to further explore the advantages of the combination therapy trial strategy.

Through their continuing collaboration, Servier has worked with Mission Bio’s Pharma Assay Development (PAD) services to utilize the Tapestri single-cell DNA sequencing technology to serially assess hundreds of samples from patients with IDH1-mutated AML who have been treated with TIBSOVO. At the World Clinical Biomarkers & CDx Summit this month, Servier will discuss Tapestri-powered findings revealing differences in the clonal evolution that occurs after TIBSOVO treatment in frontline and relapsed/refractory settings, both as a monotherapy and a combination therapy. This includes new insights into acquired resistance to TIBSOVO and azacitidine and the potential for serial molecular testing using single-cell analytics to enable physicians to dynamically sequence therapies to suppress emerging clones in AML.

"Targeted therapies play a key role in the continued evolution of precision cancer treatment, but it is critical to examine disease resistance in order to maximize the impact of these medicines," said Scott Daigle, Director of Translational Medicine at Servier. "Tapestri has shown that it can play an important role in helping drug developers discover insights that bring the right therapies to patients at the right time."

"The latest data on TIBSOVO, as well as the collaboration with Servier itself, is a great demonstration of Tapestri’s utility in retrospective studies. We are excited to see how this can potentially progress to prospective use of Tapestri in clinical trials for patient stratification, therapy monitoring, and measurable residual disease detection," said Todd Druley, Chief Medical Officer of Mission Bio. "Servier is again leading the pharmaceutical field, showing the potential for single-cell DNA sequencing to be used to predict relapse and help impact patient outcomes."

Servier is presenting a talk entitled "Clonal evolution underlying clinical responses and relapses in patients with IDH1-mutated AML treated with ivosidenib monotherapy or ivosidenib + azacitidine" at the 12th Annual World Clinical Biomarkers & CDx Summit at 4:15 p.m. on September 28th in Boston, Mass.

Visit Mission Bio during the World Clinical Biomarkers & CDx Summit from September 28-29 at booth 26.