On July 23, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that its collaborator, Moffitt Cancer Center (Moffitt), has received approval by the U.S. Food and Drug Administration (FDA) of an individual patient Investigational New Drug Application (IND) to allow a second dose of its CAR-T therapy for a patient that may be demonstrating clinical activity to the initial treatment (Press release, Anixa Biosciences, JUL 23, 2024, View Source [SID1234645012]).

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Dr. Robert Wenham, Chair, Department of Gynecologic Oncology at Moffitt, and the principal investigator of the trial, stated, "In the first cohort and at the lowest dose administered, despite an initial increase in tumor size that met criteria for progression, one patient has remained off new therapy for many months with no new disease. Even her tumor marker that was initially elevating later began to fall. A biopsy demonstrated tumor with necrosis, inflammation and T cell infiltration by Immunohistochemistry (IHC). Based on these findings, we sought approval from the FDA to administer a second treatment to her, aiming to increase the likelihood of a partial or complete response. Recently, we received that approval from the FDA."

"I am pleased with the very long duration absent of any further disease and the possible response that my patient has exhibited with this innovative therapy, as she had no other realistic options. I look forward to evaluating her progress with successive dosing, as well as future patients who have no other alternatives," stated Dr. Monica Avila, the patient’s treating oncologist.

Dr. Amit Kumar, CEO of Anixa Biosciences commented, "We were somewhat surprised and quite encouraged to see such a notable response this early, given the low dose in the first cohort. We truly hope we can help this patient, as well as all other women fighting this terrible disease."

The Phase I clinical trial at Moffitt is treating recurrent ovarian cancer patients who have failed standard-of-care therapies. To date, six patients have been treated in the dose escalation trial, three in the first cohort and three in the second cohort. Dose escalation will continue after confirming the previous dosages are safe.

On July 23, 2024 Blue Earth Therapeutics, a Bracco company and emerging leader in the development of innovative next generation therapeutic radiopharmaceuticals, reported the signing of a clinical research collaboration with University College London (UCL) (Press release, Blue Earth Therapeutics, JUL 23, 2024, View Source [SID1234645028]). The collaboration is centered on a Phase 1/2 trial designed to evaluate the safety, tolerability, radiation dosimetry and anti-tumour activity of the company’s 225Ac-rhPSMA-10.1 in men with metastatic castrate-resistant prostate cancer who have previously responded to lutetium 177 (177Lu)-PSMA therapy. The work will be conducted at the UCL Cancer Institute in London, UK, by the Treatment Resistance Group under the leadership of Professor Gerhardt Attard, MD PhD FRCP. Professor Attard is the John Black Charitable Foundation Endowed Chair in Urological Cancer Research, and is a highly regarded prostate cancer clinical trialist.

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225Ac-rhPSMA-10.1 is the second compound in Blue Earth Therapeutics’ investigational pipeline. It is based on innovative radiohybrid PSMA technology, which allows for development of therapeutic radiopharmaceuticals that may be labelled with either beta- or alpha-emitting isotopes. The pharmacokinetic profile of rhPSMA-10.1 was carefully optimised during development to maximise the retention of radioactivity in tumour deposits whilst sparing normal tissue as far as possible. Pairing these properties with longer lived isotopes like 225Ac may allow the delivery of very high radiation doses to the cancer cells. Blue Earth Therapeutics has an ongoing clinical trial underway that uses the beta-emitting radioisotope lutetium 177 (177Lu) to radiolabel rhPSMA-10.1, and is building on that work by now radiolabelling the compound with the alpha-emitting radioisotope 225Ac.

"Our goal at Blue Earth Therapeutics is to deliver precise, targeted therapy specific to a patient’s condition," said David E. Gauden, D.Phil., Chief Executive Officer of Blue Earth Therapeutics. "This collaboration aims to rapidly translate alpha-labelled rhPSMA-10.1 from the laboratory to the clinic, with the hope to help patients who have advanced prostate cancer. We are delighted to collaborate with an illustrious academic institution such as UCL which is regularly ranked in the top 10 academic institutions globally, and look forward to working with Professor Attard and his group on this important UK clinical research initiative."

"We are pleased to enter into this broad research collaboration with UK-based Blue Earth Therapeutics, as both of our institutions share a vision to improve cancer treatment for patients," said Professor Attard, MD PhD FRCP. "Despite the development of several new therapeutic options for castration resistant prostate cancer in the last 20 years, treatment resistance is common and leads to thousands of premature deaths annually in the UK. Precision-delivered radiation therapy using radioligands provides an opportunity for selectively targeting resistant prostate cancer. We believe that delivery of radiation by means of alpha particles is a very promising area of research and we look forward to starting clinical testing of rhPSMA-10.1 for patients with aggressive, treatment-resistant prostate cancer."

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA) compounds consist of a radiohybrid ("rh") Prostate-Specific Membrane Antigen-targeted receptor ligand, which is internalised by prostate cancer cells, which can be radiolabelled with imaging isotopes for PET imaging, or with therapeutic isotopes for therapeutic use – providing the potential for creating a true theranostic technology. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Therapeutics and Blue Earth Diagnostics work closely on the development of 177Lu‐rhPSMA‐10.1 and 225Ac-rhPSMA-10.1. rhPSMA compounds for therapeutic use are investigational agents and have not received regulatory approval.

On July 23, 2024 Evogene Ltd. (Nasdaq: EVGN, TASE: EVGN) (the "Company" or "Evogene"), a leading computational biology company targeting to revolutionize life-science-based product discovery and development utilizing cutting edge computational biology technologies, across multiple market segments, reported that a reverse share split of its issued and outstanding Ordinary Shares, at a ratio of 1-for-10, is expected to be implemented after market close on July 24, 2024 (Press release, Evogene, JUL 23, 2024, View Source [SID1234645013]). The Company’s Ordinary Shares will begin trading on the Nasdaq Capital Market on a post-reverse split basis at the market open on July 25, 2024, and on the Tel Aviv Stock Exchange at the market open on July 28, 2024, in each case under the Company’s existing trading symbol "EVGN".

The reverse share split was approved by the Company’s shareholders at the Company’s Annual Meeting of Shareholders held on June 13, 2024, to be effected at the board of directors’ discretion within approved parameters.

Following the implementation of the reverse split, the Company’s registered share capital under the Company’s amended and restated articles of association, as currently in effect (the "Articles"), which as of the date hereof consists of NIS 3,000,000 divided into 150,000,000 Ordinary Shares of NIS 0.02 par value each, will be adjusted to consist of NIS 3,000,000 divided into 15,000,000 Ordinary Shares of NIS 0.2 par value each. The reverse split will adjust the number of issued and outstanding Ordinary Shares of the Company from approximately 50,790,000 Ordinary Shares to approximately 5,079,000 Ordinary Shares (subject to any further adjustments based on the treatment of fractional shares).

No fractional Ordinary Shares will be issued as a result of the reverse split. In accordance with the Company’s Articles, all fractional shares shall be rounded to the nearest whole ordinary share, such that only shareholders holding fractional consolidated shares of more than half of the number of shares which consolidation constitutes one whole share, shall be entitled to receive one consolidated share. No cash will be paid with respect to any fractional shares. In addition, proportionate adjustments will be made to the number of shares issuable upon the exercise of all outstanding options entitling the holders to purchase Ordinary Shares (with a reciprocal increase in the per share exercise price) and to the number of Ordinary Shares underlying outstanding Restricted Share Units (RSUs).

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On July 23, 2024 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported positive treatment updates from its Phase 2 clinical trial, THIO-101, evaluating THIO sequenced with the immune checkpoint inhibitor (CPI) cemiplimab (Libtayo) in patients with advanced non-small cell lung cancer (NSCLC) who failed two or more standard-of-care therapy regimens (Press release, MAIA Biotechnology, JUL 23, 2024, View Source [SID1234645029]).

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The trial’s therapeutic regimen is cycled every 3 weeks, with THIO 180mg administered in 60mg incremental doses on days 1, 2 and 3, followed by immune activation on day 4 (no dosing), and cemiplimab 350mg administered on day 5. As of the latest clinical cutoff date, June 12, 2024:

6 patients remain on treatment following at least 12 months of therapy.
Treatment with THIO followed by cemiplimab has been well tolerated throughout the trial, with much lower toxicity compared to standard-of care treatments.
Continuing treatment past 12 months demonstrates safety, efficacy and ongoing benefit from MAIA’s novel telomere targeting NSCLC therapy.
"Our longest treated patient so far has completed 21 cycles of THIO sequenced with a CPI, and 6 patients who have crossed the 12-month survival follow-up are continuing the treatment," said Vlad Vitoc, M.D., Chairman and Chief Executive Officer of MAIA. "With current therapies, second-line patients’ treatment duration is usually around 3-4 months1 and third-line is even lower than that. It is very encouraging to see that our patients can remain on treatment for much longer. The ongoing benefits of THIO in longer-term patients are particularly notable, signifying THIO’s potential as a durable and efficacious treatment for advanced NSCLC patients faced with limited options."

https://www.sciencedirect.com/science/article/pii/S0169500217304373

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with cemiplimab (Libtayo) followed by THIO has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

On July 23, 2024 Mendus AB ("Mendus" publ; IMMU.ST) reported that it has entered into a collaboration with Institut Bergonié, a leading cancer center in Bordeaux, France to study the Mendus’ intratumoral immune primer ilixadencel in soft tissue sarcomas as part of the REGOMUNE trial, a multicenter, prospective open-labeled phase 1/2 trial combining regorafenib and avelumab in solid tumors (Press release, mendus, JUL 23, 2024, View Source [SID1234645014]).

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Based on promising signs of clinical efficacy in a wide range of solid tumors and following the successful implementation of manufacturing process improvements, Mendus had previously communicated its decision to move the ilixadencel program forward in hard-to-treat solid tumors, with soft tissue sarcomas as a prioritized indication. Mendus announces today a collaboration with Institut Bergonié, Bordeaux, France to study ilixadencel as a novel immunotherapy in combination with the tyrosine kinase inhibitor (TKI) regorafenib and the immune checkpoint inhibitor avelumab as part of the REGOMUNE trial, which is coordinated by Institut Bergonié. Bayer AG supplies regorafenib and Merck KGaA supplies avelumab as study drug for the trial.

"To study ilixadencel in soft tissue sarcomas provides for the opportunity to assess the relevance of intratumoral immune priming with ilixadencel in hard-to-treat tumors that are poorly responding to currently available therapies", says Jeroen Rovers, Chief Medical Officer at Mendus. "Based on our completed clinical trials we are confident that ilixadencel can be safely combined and may act synergistically with tyrosine kinase inhibitors and immune checkpoint inhibitors. This provides for a solid basis to study the combination with regorafenib and avelumab in collaboration with Institut Bergonié as part of the REGOMUNE trial."

The REGOMUNE trial (ClinicalTrials.gov ID: NCT03475953) is a prospective open-labeled phase 1/2 trial combining regorafenib and avelumab in multiple solid tumors, led by Dr Sophie Cousin and Prof Dr Antoine Italiano. Following a phase 1b dose escalation study design, the combination of regorafenib with avelumab is being evaluated in 17 cohorts of advanced or metastatic tumors in independent phase 2 trials. The trial is recruiting patients in 7 specialized cancer hospitals throughout France. As part of the trial, Mendus will supply ilixadencel as study drug to treat up to 43 patients suffering from soft tissue sarcomas (STS).

Institut Bergonié is a comprehensive cancer center which, is the regional reference center for oncology in the Nouvelle-Aquitaine region of France. The center has a long history in cancer research and recently celebrated its centennial anniversary. Institut Bergonié is part of UNICANCER, a national hospital network of 20 French Comprehensive Cancer Centers (FCCC) which are entirely devoted to fighting cancer with the same unique model based on patient care, research and oncology education.

"Institut Bergonié is committed to provide access to all areas of cancer research to patients", says Prof Dr Antoine Italiano, principal investigator of the REGOMUNE trial and head of the Department of Medicine at Institut Bergonié. "Through our own research and in collaboration with external partners, we develop innovative treatments where they are most needed and the REGOMUNE trial is an excellent example of how we bring together promising new combination therapies to address hard-to-treat tumors. Based on its promising signs of efficacy and excellent safety profile, we look forward to add ilixadencel to the combination of regorafenib and avelumab for treatment of soft tissue sarcomas in the REGOMUNE trial."

Mendus and Institut Bergonié expect to complete the preparations for the ilixadencel treatment arm within the REGOMUNE trial in the second half of 2024 and first patient data to be available first half of 2026.

"Our continued research efforts and manufacturing process improvements allow us to bring ilixadencel back into clinical development and we feel privileged to work with Institut Bergonié as one of the leading cancer centers in Europe based on clinical and medical-scientific expertise", says Mendus CSO Alex Karlsson Parra. "A next wave of innovation in immuno-oncology is expected to come from novel combination approaches for tumors that are poorly responding to currently available therapies and this is where we have focused our preclinical and clinical research with ilixadencel. The REGOMUNE trial provides for an excellent opportunity to evaluate intratumoral immune priming with ilixadencel as a treatment which can have a meaningful impact in the lives of people suffering from hard-to-treat tumors."