On October 31, 2023 Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, reported that it has received official meeting minutes from the Type A meeting with the United States Food and Drug Administration (FDA) held September 28, 2023 in which the FDA reiterated the need for an additional Phase 3 trial of avasopasem manganese (avasopasem) for radiotherapy-induced SOM (Press release, Galera Therapeutics, OCT 31, 2023, View Source [SID1234636528]). The Company also decided to halt the Phase 2b GRECO-2 trial of rucosopasem manganese (rucosopasem) in patients with locally advanced pancreatic cancer (LAPC) and the Phase 1/2 GRECO-1 trial of rucosopasem in patients with non-small cell lung cancer (NCSLC), following a futility analysis of the GRECO-2 trial. The Company believes this decision will enable the Company to conserve cash while it continues to assess potential strategic alternatives with the goal of maximizing shareholder value.

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In the Type A Meeting minutes, the FDA reiterated that results from an additional Phase 3 trial will be required to support resubmission of the Company’s New Drug Application (NDA) for avasopasem in radiotherapy-induced SOM.

"We are disappointed that the FDA did not find the data from our Phase 2b GT-201 and Phase 3 ROMAN trials sufficient for the approval of the NDA for avasopasem," said Mel Sorensen, M.D., Galera’s President and CEO. "After discussing the data with the FDA, it is clear that their position is another Phase 3 trial is required."

To optimize the Company’s resources, it conducted a futility analysis of the GRECO-2 trial to assess the likelihood of a successful outcome. The analysis indicated that the trial was unlikely to succeed as designed. GRECO-2 is a randomized, double-blind, placebo-controlled Phase 2b trial evaluating rucosopasem or placebo in combination with SBRT in patients with LAPC. Overall survival is the trial’s primary endpoint. The trial was designed to enroll 220 patients with final analysis at 120 events (deaths). The trial has enrolled 177 patients to date, and the futility analysis was conducted based on 35 deaths with a data cutoff of October 9, 2023.

Dr. Sorensen continued, "In light of our current resources and the results of the futility analysis, we have made the difficult decision to discontinue both GRECO trials. We will analyze the data collected to date to determine next steps for the asset, and we thank the patients and providers who participated in both trials."

The Company has engaged Stifel, Nicolaus & Company, Inc. to assist in reviewing strategic alternatives for the Company and its portfolio of dismutase mimetics with the goal of maximizing value for its shareholders. Such alternatives may include a merger, sale, divestiture of assets, licensing, or other strategic transaction. If the Company is unable to undertake any strategic alternative, it may be required to cease operations altogether.

Galera estimates that its balance of cash, cash equivalents and short-term investments as of September 30, 2023 was $28.4 million. This figure is preliminary and is subject to completion of the Company’s financial closing procedures. The Company plans to file its Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 on November 14, 2023.

On October 31, 2023 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in the development of AI-Immunology powered vaccines, reported initial results from the EVX-01 Phase 2 clinical trial, confirming previous successful Phase 1 findings (Press release, Evaxion Biotech, OCT 31, 2023, View Source [SID1234636526]). A comprehensive clinical update will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th annual meeting, taking place in San Diego, California, from November 1-5, 2023.

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Key highlights of the initial Phase 2 results for the first five metastatic melanoma patients treated with EVX-01 include:

Phase 2 data confirm the favorable safety profile of EVX-01 observed in the Phase 1 trial
Promising immunological and clinical outcomes align with the Phase 1 outcomes
Upon EVX-01 treatment, a pronounced and ongoing tumor reduction was observed in a patient with progressive disease
Phase 2 data confirms Evaxion’s AI-Immunology platform’s ability to identify therapeutically relevant cancer vaccine targets
Christian Kanstrup, CEO of Evaxion, stated, "We firmly believe that our AI-Immunology platform has the potential to revolutionize the field of oncology and infectious diseases. Today’s update underscores its promise in immuno-oncology, with our EVX-01 vaccine safely eliciting robust immune responses in all patients. Notably, a pronounced tumor reduction in a metastatic patient with initial progressive disease following EVX-01 treatment offers hope for those with life-threatening cancer. We are looking forward to discussing these results with potential partners."

Join us at the SITC (Free SITC Whitepaper) meeting to explore the poster titled "Effects of an AI-generated personalized neopeptide-based immunotherapy, EVX-01, in combination with pembrolizumab in patients with metastatic melanoma. A clinical trial update", presented on Saturday, November 4, between 9 a.m. – 8:30 p.m. PDT.

Additionally, don’t miss an in-depth presentation of Evaxion’s EVX-01 Phase 2 clinical results by joining an online webinar featuring the study’s principal investigator, Professor Adnan Khattak, held on November 8 at 11:30 a.m. EST. To register for the event, please follow this link.

Earlier this year, Evaxion reported a successful Phase 1 clinical trial for EVX-01 in combination with a checkpoint inhibitor. The trial demonstrated a 67% clinical response rate while meeting safety standards and reporting only mild adverse events. Further, high-quality neoantigens predicted by AI-Immunology were associated with longer progression-free survival. To learn more, please read here.

About EVX-01 Phase 2 Clinical Trial

EVX-01 is Evaxion’s lead clinical asset and constitutes a peptide-based personalized cancer vaccine. The Phase 2 clinical study is a self-sponsored open-label, single-arm, multi-center trial carried out in collaboration with Merck Sharp & Dohme LLC, and together with leading principal investigators and research centers from Italy and Australia aims at evaluating the efficacy and safety of EVX-01 vaccination in combination with anti-PD1 treatment (pembrolizumab) in treatment-naive patients with metastatic or unresectable malignant stage III or IV melanoma. More information can be accessed under clinical trial ID NCT05309421.

On October 31, 2023 EORTC reported that Acute myeloid leukaemia (AML) is a blood cancer that predominantly occurs in older patients. Intensive chemotherapy regimens have been used for decades to treat patients regarded as sufficiently fit to tolerate this treatment (Press release, EORTC, OCT 31, 2023, View Source [SID1234636524]). Allogeneic haematopoietic cell transplantation following treatment with chemotherapy drugs can reduce the risk of a relapse, thus offering the primary curative approach. However, many older patients with AML treated with intensive chemotherapy die or cannot undergo allogeneic haematopoietic cell transplantation due to toxicity caused by intensive chemotherapy.

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Hypomethylating agents are drugs that have significantly improved the prognosis of elderly patients regarded as unfit to receive intensive treatment. We hypothesised that replacing this intensive chemotherapy with a hypomethylating agent (decitabine) could improve outcomes of patients 60 years of age or older and fit to receive intensive chemotherapy. To investigate this hypothesis, the collaborative groups EORTC Leukaemia Group, GIMEMA and GMDS-SG joined forces to conduct the EORTC-1301-LG-AML21 phase III clinical trial (NCT02172872) in which we compared a 10-day decitabine monotherapy schedule with intensive chemotherapy in this patient population. The study was led by the EORTC Leukaemia Group and coordinated by Professor Gerwin Huls from University Medical Centre Groningen, Professor Michael Lübbert from the University Medical Centre Freiburg, and Professor Pierre Wijermans from the Haga Teaching Hospital (names of study coordinators provided in alphabetical order). Professor Adriano Venditti from the University of Rome Tor Vergata coordinated the GIMEMA activities.

The results, with 606 patients accrued at 54 centres in 9 European countries, were just published1 in one of the leading medical journals (The Lancet Haematology). They showed a comparable overall survival between the two treatment arms (HR 1.04, 95% CI 0.86-1.26; p-value 0.68). At 4 years, 26% of patients from the decitabine arm and 30% from the intensive chemotherapy arm were estimated to be alive. The proportion of patients who underwent allogeneic haematopoietic cell transplantation as a part of the study protocol was comparable as well (40% for decitabine, 39% for "3+7" at 4 years) and more than half of patients in both treatment arms underwent allogeneic haematopoietic cell transplantation at some timepoint. A notable difference between the treatment arms was observed regarding the incidence of severe adverse events during the treatment with decitabine as compared with intensive chemotherapy. Decitabine treatment showed lower incidences of severe infections (41% vs 53%), oral mucositis (2% vs 10%) and diarrhoea (1% vs 8%).

On October 31, 2023 Chimeric Therapeutics (ASX:CHM, "Chimeric" or the "Company"), an Australian leader in cell therapy, reported that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of CHM 2101, Chimeric’s first in class CDH17 CAR T cell therapy for gastrointestinal cancers (Press release, Chimeric Therapeutics, OCT 31, 2023, View Source [SID1234636521]).

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The company plans to investigate CHM 2101 in a multi center, open label Phase 1A/B clinical trial for patients with advanced Colorectal Cancer, Gastric Cancer and Neuroendocrine Tumours. CHM 2101 is a 3rd generation, novel CDH17 CAR T cell therapy that targets CDH17, a cancer target associated with poor prognosis and metastasis in the most common gastrointestinal tumors including Colorectal Cancer, Gastric Cancer and Neuroendocrine Tumours.

The clinical program for CHM 2101 builds upon the preclinical studies published in the preeminent scientific journal, Nature Cancer in March 2022 by leading immunotherapy scientist Xianxin Hua, MD, PhD, and his team at the Abramson Family Cancer Research Institute at the University of Pennsylvania. These experiments demonstrated that CHM 2101 was able to eradicate established tumours in seven cancer models with no toxicity to normal tissues.

"It is exciting to see the advancement from discovery of the CDH17 target and CAR T therapy in preclinical studies to the initiation of clinical trials in patients with GI-cancers and neuroendocrine tumors," said Xianxin Hua, MD, PhD, Professor of Cancer Biology in Penn’s Perelman School of Medicine, an investigator at the Abramson Family Cancer Research Institute and a Harrington Scholar Innovator. "This is a critical step forward in developing an entirely new CAR T therapy for GI-cancers and neuroendocrine tumors, providing new hopes for the cancer patients who are refractory to the existing therapies."

With the FDA IND clearance Chimeric will now begin the initiation of a phase 1 /2 multi-site clinical trial in patients with advanced Colorectal Cancer, Gastric Cancer and Neuroendocrine Tumours. The study is planned to begin patient enrollment in 2024. (ClinicalTrials.gov ID: NCT06055439)

"I am really excited about the planned Phase 1 clinical trial of CHM 2101 and the opportunity to bring a potentially transformative new investigational agent to cancer patients who need them most," said Michael R. Bishop, MD, Professor of Medicine and Director, The David and Etta Jonas Center for Cellular Therapy, University of Chicago.

On October 31, 2023 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported that pre-clinical data on MUC1-CAR T-cells to overcome key challenges of targeting solid tumors, will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 38th Annual Meeting (SITC 2023), that will take place on November 1-5, 2023 at San Diego Convention Center in San Diego (CA) (Press release, Cellectis, OCT 31, 2023, View Source [SID1234636520]).

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The data will be presented by Laurent Poirot, Ph.D., SVP Immunology of Cellectis, in a poster session that will be held November 4th 2023 from 9:00 a.m. to 8:30 p.m. PDT, at San Diego Convention Center, Hall A.

The poster is number 254 and it is entitled "TGF-Beta Blockade Combined with Activation-Induced IL12 Secretion Synergize to Optimize Potency of MUC1-CAR T-cells in Preclinical Targeting of Triple-Negative Breast Cancer".

While during SITC (Free SITC Whitepaper) 2022 Cellectis presented how TALEN-mediated gene editing allows programming of various functions addressing both safety and potency aspects of allogenic CAR T-cell therapy, this year the company’s presentation will focus on the synergistic benefits of ΔPD1-IL12 and TGFBR2-KO attributes in preclinical models of triple negative breast cancer.

"We demonstrate that combination of the ΔPD1-IL12 with TGFBR2 KO not only enhanced CAR-T cell activity but surprisingly limit their accumulation outside the tumor, therefore reducing the risks of off-tumor toxicity. These cells also show strong anti-tumor activity against distal tumors when infused intratumorally.", said Laurent Poirot, Ph.D., SVP Immunology at Cellectis.

These pre-clinical data highlight the capability of multi-armored allogeneic CAR T-cells to preserve their activity despite the immunosuppressive microenvironment, while mitigating potential safety concerns.