On January 24, 2022 MaaT Pharma (EURONEXT: MAAT – the "Company"), a French clinical-stage biotech and a pioneer in the development of microbiome-based ecosystem therapies dedicated to improving survival outcomes for patients with cancer, reported that positive interim engraftment data from the first four cohorts of the CIMON trial with MaaT033, the Company’s high-richness, high-diversity, Microbiome Ecosystem Therapy for oral administration (Press release, MaaT Pharma, JAN 24, 2022, View Source [SID1234606708]). These results represent the first confirmation of MaaT033’s mechanism of action in humans. MaaT033 is the company’s second product in clinical development and is intended to improve survival in patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT), which represents approximately 22,000 patients every year in the 7 major markets. Its oral formulation, designed for targeted delivery in the intestine, may support long-term, ambulatory use.

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In this dose-ranging study, data from four out of five intended cohorts showed satisfactory safety and good microbiome engraftment, which is characterized by the presence of microbial OTUs[1] in the gut as a result of product administration and that were not present at treatment start.

Based on this positive data, the Company will close the CIMON trial to enable faster than planned completion and evaluation of the full data from the trial, in order to advance MaaT033 towards a planned Phase 2/3 trial, which could start in the second half of 2022. Complete results from the Phase 1b CIMON trial are expected in the first half of 2022.

"These interim results are an important milestone for MaaT Pharma as MaaT033 is our second product, and our first oral formulation, to demonstrate proof of engraftment in humans. This expands the potential of our proprietary Microbiome Ecosystem Therapy (MET) platform to the ambulatory setting, after positive data achieved in aGvHD with MaaT013, an enema product for acute, hospital use. This is the first step towards treating larger patient populations that may benefit from orally-administered microbiome therapies, including patients receiving allo-HSCT, but also patients with solid tumors."

said Hervé Affagard, CEO and co-founder of MaaT Pharma.

MaaT033 is intended to improve survival outcomes in hemato-oncology patients receiving allo-HSCT by protecting and restoring their gut microbiome. In these patients, intensive chemotherapy and antibiotic treatments that are administered to prepare for the allo-HSCT procedure result in a severely damaged gut microbiome. Importantly, higher gut microbiome diversity at the time of allo-HSCT has been correlated to higher survival and lower risks of complications, including incidence of graft-vs-host-disease and multi-resistant infections[2].

"With a very satisfactory safety profile and very promising engraftment data in the first four cohorts of this trial, we believe we have the appropriate amount of data in hand to confidently move forward with MaaT033’s clinical development, without testing the highest planned dose of nine capsules a day. We look forward to further exploring the data from CIMON and preparing for a Phase 2/3 trial start."

added John Weinberg, MD, Chief Medical Officer at MaaT Pharma.

The CIMON Phase 1b trial (NCT04150393) is an open-label, dose-ranging study and has enrolled to date a total of 21 patients in four cohorts (up to three capsules a day for 14 days) across six sites in France. CIMON is designed to investigate the maximum tolerated dose of MaaT033, over 7 or 14 days of therapy, that supports optimal gut microbiome colonization in patients with acute myeloid leukemia or high-risk myelodysplastic syndrome who have undergone intensive chemotherapy. Overall, four Data and Safety Monitoring Board meetings have been conducted evaluating the safety of the trial. All concluded in support of the continuation of the study with the latest taking place in December 2021. Complete results from the trial will be submitted for a presentation at an upcoming key major conference in hemato-oncology as well as for peer-reviewed publication.

[1] OTU or Operational Taxonomic Unit is used to classify bacteria at the genus level, based on sequence similarity of the 16S marker gene. An OTU consists of a group of bacteria whose 16S marker gene shows a sequence identity of 97 percent and above.
[2] Peled, J.U. & al N Engl J Med 2020;382:822-34
About MaaT033

MaaT033 is an oral, full-ecosystem, off-the-shelf, standardized, pooled-donor, high-richness Microbiome Ecosystem Therapy. It is manufactured at MaaT Pharma’s centralized European cGMP production facility. MaaT033 is designed to restore the gut ecosystem to full functionality to improve clinical outcomes as well as to control adverse events related to conventional treatments for liquid tumors. The capsule formulation facilitates administration while maintaining the high and consistent richness and diversity of microbial species, including anti-inflammatory ButycoreTM species, which characterize MaaT Pharma’s Microbiome Ecosystem Therapies.

On January 24, 2022 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that its Board of Directors has authorized the Company’s management to implement a stock repurchase program for up to $10 million of the Company’s common stock at any time (Press release, Greenwich LifeSciences, JAN 24, 2022, View Source [SID1234606707]).

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The term of the board authorization of the repurchase program is until March 31, 2023. The repurchase program may be suspended or discontinued at any time and will be funded using the company’s working capital.

CEO Snehal Patel commented, "The implementation of this board-approved share repurchase program provides us with another tool to deliver shareholder value. We have the ability to make opportunistic share repurchases while continuing our clinical development plans for GP2."

In addition, the Board of Directors has also extended the lock-up of the shares owned by the Company’s directors, officers, and existing pre-IPO investors to March 24, 2023 (30 months from date of the Company’s IPO) from March 24, 2022 (18 months from date of the Company’s IPO). During this period, current officers, directors and certain shareholders will not be able to sell their shares of the Company’s common stock unless otherwise modified by the Board of Directors.

About FLAMINGO-01 and GLSI-100

The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently being registered on clinicaltrials.gov and the link and trial identifier will be published shortly. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On January 24, 2022 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), the German-American cancer molecular diagnostics company, reported that the Supervisory Board retained Greg Hamilton as Chief Executive Officer through December 31, 2025 (Press release, Epigenomics, JAN 24, 2022, View Source [SID1234606706]). Mr. Hamilton has been CEO of Epigenomics AG since mid-2016 and will continue to lead the company through the development, FDA approval and commercialization of the company’s Epi proColon "Next-Gen" Colorectal Cancer (CRC) screening test.

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Mr. Hamilton, (51), has been instrumental in working with Centers for Medicare and Medicaid Services (CMS) to establish clear reimbursement requirements for future blood-based CRC tests. Based upon the efforts of Epigenomics, CMS has issued a National Coverage Determination (NCD) for blood-based CRC screening that gives Epigenomics a clear path to develop a commercially successful next generation product. Prior to joining Epigenomics, Mr. Hamilton was Chief Executive Officer & Director of AltheaDx Inc., Chief Operating Officer and Chief Financial Officer of Enigma Diagnostics Inc., Vice President of Operations and Finance at Third Wave Technologies Inc. and Vice President of Operations at Hologic Inc. He has been responsible for multiple FDA-approved products including a Human Papillomavirus (HPV) High Risk Screening assay and the first ever cleared HPV genotyping assay. Mr. Hamilton received his MBA from the University of Chicago and his Bachelor of Science in Finance from Purdue University.

"Securing Greg’s leadership through the development, clinical trial, FDA approval and commercialization of Epi proColon’s "Next-Gen" CRC test, which has already advanced substantially since mid of last year, was a priority for the Supervisory Board," said Heino von Prondzynski, Chairman of the Supervisory Board. "His experience and strategic vision make him ideally suited to grow the company into a cancer diagnostics leader."

"I’m thrilled and honored to continue to lead Epigenomics toward our goal of becoming a leader in blood-based CRC screening," said Mr. Hamilton. "Epigenomics has always been a pioneer in liquid biopsy and now we get the chance to use all of our experience to deliver a product that will immediately receive reimbursement upon FDA approval."

On January 24, 2022 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a late clinical-stage biopharmaceutical Company focused on oncology, reported that the Company has completed enrollment of the Phase 1/2a study of its innovative intratumoral cancer vaccine candidate, AGI-134, designed to evaluate the safety and biological activity of AGI-134 in patients with unresectable metastatic solid tumors (Press release, BioLineRx, JAN 24, 2022, View Source [SID1234606705]). Results of AGI-134’s safety and proof of mechanism are anticipated in the first half of 2022.

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"The completion of enrollment of the AGI-134 first-in-man study is a very significant milestone for our Company, especially taking into account the difficulties caused by the COVID-19 pandemic on patient recruitment," stated Philip Serlin, Chief Executive Officer of BioLineRx. "AGI-134, our second clinical-stage oncology asset, has a unique mode of action, applicable to all injectable tumor types. In preclinical models, AGI-134 led to regression of primary tumors, prevented growth of secondary tumors via an abscopal effect, and triggered a vaccine effect that we believe may prevent the development of metastases. This clinical study aims to confirm the proposed mechanism of action and safety profile of AGI-134 in humans, based on which we also plan to explore potential combinations as part of its future clinical development program."

The Phase 1/2a study is a multicenter, open-label study, which recruited a total of 38 patients in the UK, Spain and Israel, and is comprised of two parts. Part 1 was completed, and was an accelerated dose-escalation study in five patients, to determine the maximum tolerated dose and the recommended dose for part 2 of the study. Part 2 is a dose expansion study at the recommended dose in 33 patients, designed to evaluate the safety and tolerability of AGI-134, and to validate AGI-134’s mechanism of action using a wide array of biomarkers. For more information on this Phase 1/2a study, see NCT03593226.

On December 15, BioLineRx announced the formation of an Immuno-Oncology Scientific Advisory Board (SAB) to provide insight and guidance on the Company’s immuno-oncology activities. The SAB, which has provided valuable guidance to the AGI-134 development program, is comprised of recognized key opinion leaders in the fields of cancer immunology, intra-tumoral cancer treatments and clinical development.

About AGI-134
AGI-134 is a synthetic alpha-Gal glycolipid in development for solid tumors that is highly differentiated from other cancer immunotherapies. AGI-134 is designed to label cancer cells with alpha-Gal via intra-tumoral administration, thereby targeting the body’s pre-existing, highly abundant anti-alpha-Gal (anti-Gal) antibodies and redirecting them to treated tumors. Binding of anti-Gal antibodies to the treated tumors results in activation of the complement cascade, which destroys the tumor cells and creates a pro-inflammatory tumor microenvironment that also induces a systemic, specific anti-tumor (vaccine) response to the patient’s own tumor neo-antigens.

AGI-134 has been evaluated in numerous pre-clinical studies. In a mouse melanoma model, treatment with AGI-134 led to regression of established primary tumors and suppression of secondary tumor (metastases) development. Synergy has also been demonstrated in additional pre-clinical studies when combined with an anti-PD-1 immune checkpoint inhibitor, offering the potential to broaden the utility of such immunotherapies, and improve the rate and duration of responses in multiple cancer types. AGI-134 was obtained by BioLineRx through the acquisition of Agalimmune Ltd.

On January 24, 2022 Oasmia Pharmaceutical AB (Oasmia), an oncology-focused specialty pharmaceutical company, reported progress on the in-house development of XR-18, the next generation of its proprietary drug delivery technology (Press release, Oasmia, JAN 24, 2022, View Source [SID1234606704]).

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The Company has identified and synthesized a promising novel candidate for use in the
XR-18 drug delivery platform, which it believes could offer enhanced capabilities compared with its existing XR-17 technology. The XR-17 drug delivery platform is designed to increase the solubility of intravenously delivered compounds and has been used successfully in Oasmia’s ovarian cancer therapy Apealea.

The next-generation formulation applied in XR-18 is already being tested in combination with a widely used oncology compound, and steps for securing Intellectual Property are being taken.

Reinhard Koenig, MD, Chief Science Officer, Oasmia, commented: "Oasmia’s growth strategy is centered on the in-licensing and acquisition of innovative oncology therapies alongside the in-house development of promising new treatments. With the in-licensing of Cantrixil for ovarian cancer in 2021 and encouraging progress in the development of XR-18, we are keeping our promise to both investors and patients. We believe XR-18 has the potential to offer enhanced delivery of current and future investigational drug candidates, and we look forward to updating the market on our progress."