On June 10, 2024 Green Data Center Real Estate has entered into a letter of intent to acquire Israeli biotech firm Vaxil Bio (Press release, Vaxil BioTherapeutics, JUN 10, 2024, View Source [SID1234648511]).

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Vaxil Bio is currently listed on the stock exchange and will divest all existing assets except cash to unrelated third parties.

The transaction is subject to regulatory approval and is due to close before the end of June. Other details related to the transaction have yet to be disclosed.

In connection with the acquisition, Green Data will also secure a loan, amounting to a minimum of C$2 million ($1.46m). The financing will be used for general corporate purposes and to fund the development of pipeline projects, said the company.

Green Data is a data center provider, that creates renewable generation and battery energy storage systems. The company was previously known as NuYen Enterprise Hosting and NuYen Blockchain before that, and currently has data centers in operation or under construction in Murphysboro, Illinois; New Mexico; and Canada.

Green Data is headed up by Jason Bak, the former CEO and chairman of Finavera Renewables and Solar Alliance.

Vaxil Bio is now headquartered in Toronto, Ontario, having been founded in Israel in 2007. The company almost closed on a similar merger with a copper mining company earlier this year. At the time Vaxil said: "The company will continue to actively explore other strategic options for maximizing shareholder value, including the continued development of Vaxil’s existing assets."

Prior to the letter of intent, Vaxil Bio specialized in immunotherapy of cancer and infectious diseases. The company’s lead product ImMucin was being developed to treat and prevent tuberculosis and Covid-19.

5X Capital Management is acting as the financial advisor to Green Data.

On June 10, 2024 Pacylex Pharmaceuticals Inc. (Pacylex) is a clinical-stage pharmaceutical company developing N-myristoyltransferase (NMT) inhibitors to treat hematologic cancers and solid tumors, reported the publication of Phase 1 clinical trial results in the journal Investigational New Drugs (Press release, Pacylex Pharmaceuticals, JUN 10, 2024, View Source [SID1234645047]). The report, titled: "A First-in-Human Phase I Trial of Daily Oral Zelenirstat, a N-myristoyltransferase Inhibitor, in Patients with Advanced Solid Tumors and Relapsed/Refractory B-cell Lymphomas," describes effects of zelenirstat at various doses on cancer patients who exhausted all other therapeutic options.

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Myristoylation is a fatty acid modification critical to targeting certain proteins to cell membranes where they participate in activities essential to cancer cell survival and proliferation. Zelenirstat works by the unique mechanism of inhibiting the myristoylation required for the assembly, translocation, and function of EGFR, VEGFR, and the B-cell receptor. Last month Pacylex published in the Journal of Translational Medicine that zelenirstat also blocks Complex I formation in mitochondria of cancer cells to shut down oxidative phosphorylation, an energy generation process needed for metastases and cancer stem cell survival.

The Phase 1 dose escalation safety and tolerability study was conducted in 29 patients with refractory/relapsed (r/r) lymphoma and refractory solid tumors who averaged 4 lines of prior therapy. Zelenirstat, administered as a once daily oral medication, was well-tolerated in Phase 1 patients up to the recommended Phase 2 dose (RP2D) with no dose limiting toxicities observed in 6 dose levels. The most common treatment related adverse events were mild to moderate gastrointestinal side effects which were self-limiting and occurred in a minority of patients.

The study was designed and sponsored by Pacylex Pharmaceuticals and was conducted at the Cross Cancer Institute, Edmonton, AB, under the direction of Principal Investigator Dr. Randeep Sangha; the British Columbia Cancer Centre for Lymphoid Cancer, Vancouver, BC, by Dr. Laurie Helen Sehn; Princess Margaret Cancer Centre, Toronto, ON by Dr. John Kuruvilla; and Université de Montréal’s hospital affiliated research centre, the CRCHUM, QC by Dr. Rahima Jamal.

The 7 patients receiving the recommended Phase 2 dose had significantly better progression free and overall survival than the 17 treated at lower doses; 57% had stable disease or better for six months or longer, including patients with ovarian, appendiceal, and colorectal cancer. The sole person with colorectal cancer receiving the RP2D had experienced only short-term benefit from any of the 6 prior lines of therapy, but continues to receive the zelenirstat 450 days after starting therapy and had reductions of approximately 50% in CEA (carcinoembryonic antigen) and tumor volumes.

"These Phase 1 results are as encouraging as any cancer study I have run with an oral cancer therapy", said Dr. Randeep Sangha. "The safety profile was consistent with long-term therapy and considering how many prior lines of therapy these patients had received, the signals of potential efficacy in several different types of solid tumor cancers was surprising."

"Given the outstanding safety of zelenirstat in Phase 1 and the prolonged stable disease or better seen in patients with refractory ovarian, appendiceal and colorectal cancer who received the RP2D, we are advancing zelenirstat into two Phase 2a studies that have begun dosing patients with refractory and relapsed B-cell non-Hodgkin’s lymphoma, and advanced refractory colorectal cancer", said Dr. John Mackey, CMO of Pacylex Pharmaceuticals.

"Zelenirstat is a very unique approach to treating cancer – it inhibits proteins that have been hijacked in cancer cells for survival and proliferation signaling, tumor blood supply, cell surface receptor recycling, and energy production, all with one drug", said Dr. Michael Weickert, CEO of Pacylex. "This explains how zelenirstat has potential as an important therapeutic option across many different cancers."

About zelenirstat (PCLX-001)

Zelenirstat (formerly identified as PCLX-001) is a first-in-class, oral, small molecule NMTi being developed to treat patients with leukemia, lymphoma, and solid tumors. Zelenirstat selectively killed cancer cells in vitro and in animal models has been shown to fully regress hematologic malignancies and inhibit the growth of lung and breast cancer tumors. In AML models, zelenirstat preferentially killed leukemic stem enriched cell populations and reduced the bone marrow leukemic burden.

About zelenirstat Phase 1 and 2 studies

Pacylex completed the dose escalation phase of a Phase 1 multiple ascending dose safety, tolerability, and pharmacokinetics study on zelenirstat in people with relapsed/refractory lymphoma and refractory solid tumors (NCT04836195). A recommended Phase 2 dose was determined. Zelenirstat demonstrated an acceptable safety and tolerability profile, pharmacokinetics consistent with once daily oral dosing, and early signs of efficacy.

Zelenirstat is currently being studied in a Phase 2a open-label study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and clinical activity of zelenirstat in patients with relapsed/refractory B-cell non-Hodgkin Lymphoma (NHL) and a separate Phase 2a cohort in patients with refractory metastatic colorectal cancer that has progressed despite all available standard therapies.

On June 10, 2024 NH TherAguix (NHT), a phase II clinical-stage biotechnology company specializing in the development of novel nanomedicine solutions applicable to precision radiotherapy in oncology, reported the publication in the peer-reviewed journal Scientific Reports, part of the Nature group, of an article describing a method for quantifying its next-generation radio-enhancer, AGuIX, after tumor targeting (Press release, NH TherAguix, JUN 10, 2024, View Source [SID1234644425]). The article highlights the MRI biomarker properties of AGuIX in addition to its radio-enhancing properties when combined with radiotherapy.

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The article, entitled "Quantifying gadolinium-based nanoparticle uptake distributions in brain metastases via magnetic resonance imaging", can be found on the Scientific Reports website: Link.

AGuIX nanoparticles offer a breakthrough in radiotherapy, addressing a key challenge by increasing efficacy while preserving surrounding healthy organs. Prior to treatment, AGuIX serves as a biomarker visible on MRI, allowing for dose customization and image-guided irradiation to precisely target tumors and optimize therapy delivery. With its gadolinium-based structure, AGuIX provides strong contrast imaging properties, while its capacity to amplify X-ray doses at the tumor site further enhances radiotherapy effectiveness.

The recently published article in Scientific Reports highlights AGuIX’s potential as a biomarker in a study involving 23 patients with brain metastases. Each patient received either a 100 mg/kg intravenous dose of AGuIX or a placebo, with subsequent biodistribution and quantification analyses conducted. This investigation is part of the ongoing randomized Phase II NANOBRAINMETS trial at theDana Farber Brigham Cancer Centre in Boston, USA. The trial aims to evaluate the efficacy of AGuIX combined with stereotactic radiotherapy compared to stereotactic radiotherapy alone in patients with brain metastases. Quantification of AGuIX on MRI images revealed that patients who received AGuIX had nanoparticle concentrations in their brain metastases ranging from 0.012 to 0.17 mg/ml, with a mean concentration of 0.055 mg/ml. Patients receiving placebo showed no significant absorption in their brain metastases. These results confirm AGuIX ability to infiltrate brain tumors in significant quantities.

Additionally, these data indicate that AGuIX uptake by brain metastases was 35% higher than data from the Phase I NANORAD-1 trial previously conducted by NH TherAguix on 15 patients. In this trial, only 3 of the 15 patients had received the highest dose of 100 mg/kg, confirming a dose effect.

"We are very pleased that our collaboration with the Dana Farber teams is regularly expanding and confirming the clinical evidence data for AGuIX in the best possible conditions," said Olivier de Beaumont, CMO of NH TherAguix. "This publication is an acknowledgement of the research efforts made by the Dana Farber Cancer Institute teams, in collaboration with NHT teams, for the clinical development of our innovative nanomedicine. I would like to thank the Dana Farber Cancer Institute teams for the confidence they have shown in our project from the outset, as well as for their collaborative spirit, enabling us to enrich our knowledge of AGuIX."

The AGuIX radio-enhancer is currently being evaluated in four Phase II trials in several types of solid tumors, in combination with radiotherapy. Three of these studies are expected to produce significant results by the end of 2024.

Although radiotherapy has experienced significant advancements in recent years, numerous challenges persist in providing patients with the most effective and precise treatment available. This publication, alongside our recent Fast Track designation by the US FDA, underscores the potential of our nextgeneration radio-enhancer for treating brain metastases and glioblastoma, among the most lethal cancers globally. We firmly believe that the forthcoming results from our clinical trials, anticipated later this year, will chart a new course in therapeutic approaches for these medically urgent conditions," concluded Vincent Carrère, CEO of NHT.

On June 10, 2024 Lixte Biotechnology Holdings, Inc. (the "Company") reported to have entered into a Clinical Trial Agreement (the "Agreement") with the Netherlands Cancer Institute ("NKI") to conduct a Phase 1b/2 clinical trial of the Company’s protein phosphatase inhibitor, LB-100, combined with atezolizumab, a PD-L1 inhibitor, the proprietary molecule of F. Hoffman-La Roche Ltd. ("Roche"), for patients with metastatic colon cancer (Filing, 8-K, Lixte Biotechnology, JUN 10, 2024, View Source [SID1234644326]). Under the Agreement, the Company will provide its lead compound, LB-100, and under a separate agreement between NKI and Roche, Roche will provide atezolizumab and financial support for the clinical trial. The Company has no obligation to, and will not provide any reimbursement of clinical trial costs. Pursuant to the Agreement and the protocol set forth in the Agreement, the clinical trial will be conducted by NKI at NKI’s site in Amsterdam by principal investigator Neeltje Steeghs, MD, PhD, and NKI will be responsible for the recruitment of patients. The Agreement provides for the protection of the respective intellectual property rights of each of the Company, NKI and Roche.

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This Phase 1b clinical trial will evaluate the side effects and optimal dose of LB-100 combined with atezolizumab for the treatment of patients with metastatic microsatellite stable colorectal cancer. Immunotherapy using monoclonal antibodies like atezolizumab can enhance the body’s immune response against cancer and hinder tumor growth and spread. LB-100 has been found to improve the effectiveness of anticancer drugs in killing cancer cells by inhibiting a protein called PP2A on cell surfaces. Blocking PP2A increases stress signals in tumor cells expressing the PP2A protein. Accordingly, combining atezolizumab with LB-100 may enhance treatment efficacy for metastatic colorectal cancer, as cancer cells with heightened stress signals are more vulnerable to immunotherapy.

This study comprises a dose escalation phase and a dose expansion phase. The objective of the dose escalation phase is to determine the recommended Phase 2 dose (RP2D) of LB-100 when combined with the standard dosage of atezolizumab. The dose expansion phase will further investigate the clinical activity, safety, tolerability, and pharmacokinetics/dynamics of the LB-100 and atezolizumab combination. The clinical trial is scheduled to open by June 30, 2024. Patient accrual is expected to take up to 24 months, with a maximum of 37 patients with advanced colorectal cancer to be enrolled in this study.

Additional information on the clinical trial is available on the clinicaltrials.gov website at View Source

The foregoing description of the terms of the Agreement does not purport to be complete and is subject to and qualified in its entirety by reference to the Agreement, a copy of which is filed with this Form 8-K and incorporated by reference.

On June 10, 2024 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC), reported the publication of its scholarly article, "Lasofoxifene as a Potential Treatment for Aromatase Inhibitor-Resistant ER-Positive Breast Cancer," in the peer-reviewed journal Breast Cancer Research (Press release, Sermonix Pharmaceuticals, JUN 10, 2024, View Source [SID1234644286]). The paper discusses positive findings observed during a preclinical study examining the effects of oral lasofoxifene, Sermonix’s lead investigational drug, on aromatase inhibitor-resistant, estrogen receptor-positive (ER+) breast cancer in the absence of ESR1 mutations.

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The study investigated the activity of lasofoxifene in a letrozole-resistant breast tumor model that did not have ESR1 mutations. Letrozole-resistant, MCF7 LTLT cells tagged with luciferase-GFP were injected into the mammary duct inguinal glands of NSG mice (MIND model; 6 mice/group). The mice were randomized to vehicle – lasofoxifene alone or plus palbociclib, fulvestrant alone or plus palbociclib, or palbociclib alone – two to three weeks after cell injections. Tumor growth and metastases were monitored with in vivo and ex vivo luminescence imaging, terminal tumor weight measurements and histological analysis. The experiment was repeated with the same design and eight to nine mice in each treatment group.

Western blot analysis showed that the MCF7 LTLT cells had lower ERα and higher HER2 expressions compared with normal MCF7 cells. Lasofoxifene alone or combined with palbociclib, but not fulvestrant, significantly reduced primary tumor growth versus vehicle as assessed by in vivo imaging of tumors at study ends. Percent tumor area in excised mammary glands was significantly lower for lasofoxifene plus palbociclib versus vehicle. Ki67 staining showed decreased overall tumor cell proliferation with lasofoxifene alone or combined with palbociclib. The lasofoxifene plus palbociclib combination was also associated with significantly fewer bone metastases compared with vehicle. Similar results were observed in the repeat experiment.

"We previously demonstrated that lasofoxifene effectively inhibits breast tumor growth in tumors bearing an ESR1 mutation that are resistant to endocrine therapy," said Dr. Geoffrey Greene, M.D., Ph.D., chair of the Ben May Department for Cancer Research at the University of Chicago. "In this aromatase-resistant breast tumor model, we now show that lasofoxifene inhibits tumor growth in the absence of an ESR1 mutation and with low ESR1 expression, suggesting that lasofoxifene can be an effective therapy option for all hormone-treatment resistant breast tumors."

Evidence of lasofoxifene’s antitumor activity in breast cancers with ESR1 mutations was previously demonstrated during the first two Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) trials. During ELAINE-1, lasofoxifene as a monotherapy led to numerically longer progression-free survival than fulvestrant (5.6 vs. 3.7 months; P=0.138) in patients with endocrine therapy-resistant, ESR1-mutated mBC who had prior CDK4/6i exposure. In ELAINE-2, the combination of lasofoxifene and abemaciclib was associated with a median progression-free survival of approximately 13 months.

ELAINE-3, A global registrational Phase 3 study, is currently enrolling, with clinical trial sites across the U.S., Europe, Asia-Pacific, Israel and Canada. ELAINE-3 is assessing the efficacy of oral lasofoxifene and Eli Lilly and Company’s CDK4/6 inhibitor abemaciclib (Verzenio) compared to fulvestrant and abemaciclib in 400 pre- and post-menopausal subjects with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation.

"The results of this new study demonstrate, for the first time, lasofoxifene’s anti-tumor activity in mouse models of ER-resistant breast cancer in the absence of ESR1 mutations, broadening its potential to become a valuable therapy regardless of ESR1 status," said Barry Komm, Ph.D., Sermonix chief scientific officer and co-author of the article. "As we remain focused on completing the ELAINE-3 trial, we are excited to further examine this new avenue of investigation and the potentially broader promise of lasofoxifene."

The open-access paper can be accessed online here.