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ImmixBio Approves 4 Additional Clinical Trial Sites for IMX-110 Clinical Trials, Complementing Existing Soft Tissue Sarcoma Lead Site

On October 18, 2022 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, reported that it has approved 4 additional clinical trial sites for IMX-110 clinical trials, complementing existing soft tissue sarcoma lead clinical trial site in California (Press release, Immix Biopharma, OCT 18, 2022, View Source [SID1234622129]). Historically, the lead high-enrolling site has enrolled 2-3 patients per month. Once dosing begins, patients will undergo CT scans every 8 weeks to assess tumor response to IMX-110; results are expected to be released on a rolling basis beginning in Q1 2023.

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"We are excited to select these 4 preeminent oncology sites to join our clinical site consortium from a larger group of interested centers. We are humbled by the enthusiasm from these key opinion leaders to bring IMX-110 to their patients," said Ilya Rachman, MD PhD, CEO of ImmixBio. "These KOLs are excited about both IMX-110 as a monotherapy, and in combination with BeiGene and Novartis’ anti-PD-1, tislelizumab."

About IMX-110

The U.S. Food and Drug Administration ("FDA") has approved orphan drug designation ("ODD") for IMX-110 for the treatment of soft tissue sarcoma. Additionally, the FDA has approved rare pediatric disease designation ("RPDD") for IMX-110 for the treatment of a life-threatening pediatric cancer in children, rhabdomyosarcoma. RPDD qualifies ImmixBio to receive fast track review and a priority review voucher (PRV) at the time of marketing approval of IMX-110. IMX-110 is currently being evaluated in a phase 1b/2a clinical trial in patients with advanced solid tumors. Learn more at www.immixbio.com/iMX-110

Immatics presented its Corporate presentation

On October 18, 2022 Immatics presented its Corporate presentation (Press release, Immatics, OCT 18, 2022, View Source [SID1234622128]).

Helsinn publishes new data evaluating chlormethine gel’s mode of action in Dermatology and Therapy

On October 18, 2022 Helsinn Group ("Helsinn"), a fully integrated global biopharma company with a diversified pipeline of innovative oncology assets, reported that research from an in vitro study of chlormethine gel has been published in the journal Dermatology and Therapy (Press release, Helsinn, OCT 18, 2022, View Source [SID1234622127]).

This article, "Chlormethine Gel for the treatment of Mycosis Fungoides Cutaneous T-Cell Lymphoma: In Vitro Release and Permeation Testing", evaluated part of the mode of action of chlormethine (CL) gel once applied to the skin. In a preliminary, proof-of-concept, in vitro study, the release profile of 0.016% chlormethine gel was evaluated compared to an ointment-based formulation of CL. The absorption profile of the CL gel was also evaluated in ex vivo healthy human skin using in vitro permeation testing (IVPT).

Results from the study indicate that the rate of chlormethine release from the CL gel formulation was statistically higher in comparison to the ointment formulation. In addition, data indicate that only a minimal amount of the CL can pass through the epidermis reaching the dermis, suggesting that most of the applied CL reacted within the epidermal layer. This finding is consistent with the lack of evidence of systemic absorption seen with CL gel(1,2) and further supports the notion that drug-drug interactions are very unlikely.

Details of the publication:

Title: "Chlormethine Gel for the treatment of Mycosis Fungoides Cutaneous T-Cell Lymphoma: In Vitro Release and Permeation Testing."
Authors: Claudio Giuliano, Stefano Frizzarin, Alessandro Alonzi, Virginia Stimamiglio and Pablo L. Ortiz-Romero
Link: View Source
Chlormethine gel 0.016%, also known as mechlorethamine gel, is approved in multiple countries, including the EU and US, and is marketed under the trade names LEDAGA and VALCHLOR. The authorized use for each country varies based on the design of the registrational trial and the individual health authority requirements. For more details, please refer to the approved product information for each respective jurisdiction.

Dr. Silvia Sebastiani, Group Head of Medical Affairs, commented: "Chlormethine is a well-established and effective topical therapy for treating lesions in patients with MF-CTCL and is available in a variety of formulations. Understanding CL gel’s mode of action and how it permeates through the skin is extremely important for its use in clinical practice."

Salarius Pharmaceuticals Announces Pause in New Patient Enrollment in its Phase 1/2 Trial of Seclidemstat in Ewing Sarcoma and FET-Rearranged Sarcomas

On October 18, 2022 Salarius Pharmaceuticals, a clinical-stage biopharmaceutical company using protein inhibition and protein degradation to develop cancer therapies for patients in need of new treatment options, reported that, as per protocol design, it is voluntarily pausing new patient enrollment in the company’s Phase 1/2 trial of seclidemstat as a treatment for Ewing sarcoma and FET-rearranged sarcomas (Press release, Salarius Pharmaceuticals, OCT 18, 2022, View Source [SID1234622124]).

The pause in new patient enrollment is due to a metastatic FET-rearranged sarcoma patient death that was classified as a suspected unexpected serious adverse reaction (SUSAR). Upon review of the SUSAR and available information by the company’s independent Safety Review Committee for the clinical trial, patients currently receiving seclidemstat treatment may continue treatment after consulting with their physician.

Salarius communicated the details of the SUSAR to the U.S. Food and Drug Administration (FDA) and intends to further analyze the available data with the goal of understanding how best to proceed and restart enrollment as soon as possible. Salarius continues to plan to release interim sarcoma clinical trial results later this year.

"Patient safety is our primary concern, and this is reflected in the design of our clinical trial protocol, which automatically paused enrollment based upon this SUSAR," said David Arthur, chief executive officer of Salarius. "Unfortunately, pauses to enrollment occur in early-stage drug development, but these pauses allow time to understand new data and adjust clinical protocols and development plans as needed. We plan to restart enrollment as soon as possible."

About the Phase 1/2 Ewing sarcoma and other FET-rearranged sarcomas trial
The Phase 1/2 trial currently is in its dose-expansion stage, which includes three patient arms. The first patient arm is enrolling up to 30 patients with Ewing sarcoma, a rare and deadly pediatric bone cancer, and will investigate seclidemstat in combination with topotecan and cyclophosphamide, a commonly used second- and third-line chemotherapy regimen. Salarius believes data released during ASCO (Free ASCO Whitepaper) 2021 demonstrated synergy in a Ewing sarcoma cell line when seclidemstat was used in combination with these agents. Salarius also believes this treatment combination and its use as a second- and third-line therapy could greatly expand the addressable patient population for seclidemstat and improve outcomes by allowing physicians to introduce seclidemstat earlier in the Ewing sarcoma continuum of care.

The trial’s second patient arm is investigating seclidemstat as a single agent in up to 15 patients with myxoid liposarcoma. The third patient arm is investigating seclidemstat as a single agent in up to 15 patients with select sarcomas that share a similar biology to Ewing sarcoma, also referred to as FET-rearranged or Ewing-related sarcomas. In data released at ASCO (Free ASCO Whitepaper) 2021, a subset of patients with advanced FET-rearranged sarcomas treated with single-agent seclidemstat resulted in stable disease and prolonged time to progression, which Salarius believes suggests disease control, a clinically relevant endpoint for soft tissue sarcomas.

All three patient arms are designed to evaluate safety and efficacy in patients with advanced disease. Per protocol design, new patient enrollment will be stopped, or paused, when 1) any death or life-threatening adverse experience deemed possibly or definitely related to the investigational product is observed, or 2) it is determined that the protocol precipitates multiple patient non-compliance beyond reasonably missed visits.

Exelixis to Release Third Quarter 2022 Financial Results on Tuesday, November 1, 2022

On October 18, 2022 Exelixis (Nasdaq: EXEL) reported that its third quarter 2022 financial results will be released on Tuesday, November 1, 2022 after the markets close (Press release, Exelixis, OCT 18, 2022, View Source [SID1234622121]). At 5:00 p.m. ET / 2:00 p.m. PT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 888-338-9509 (domestic) or 412-902-4281 (international) and ask to be joined into the Exelixis conference call to participate by phone.

A telephone replay will be available until 8:00 p.m. ET on November 3, 2022. Access numbers for the telephone replay are: 877-344-7529 (domestic) and 412-317-0088 (international); the passcode is 6992264. A webcast replay will also be archived on www.exelixis.com for one year.