On June 20, 2021 MaaT Pharma, a French clinical-stage biotech company specialized in the development of microbiome-based therapies aiming to restore the microbiome/immune system symbiosis in oncology patients, reported that its MEPA (Microbiome Engineering Platform) program was awarded a EURO 1.9 million grant from the Plan France Relance (Press release, MaaT Pharma, JUL 20, 2021, View Source [SID1234584975]). Initiated during the Summer of 2020, Plan France Relance was established to make strategic investments in critical sectors of French industry, including Health.

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"We are very honored and proud to be laureates of the France Relance initiative. The French Government’s commitment to invest in strategic industries is an opportunity for MaaT Pharma, as a key player in the microbiome industry, to further pursue our development plans and to actively contribute to the biomanufacturing of innovative drugs in France. This is a team success, and this financing supports the efforts of women and men at MaaT Pharma who work tirelessly to deliver groundbreaking innovations in microbiome therapeutics," said Hervé Affagard, Founder and CEO at MaaT Pharma. "The France Relance program will support the development of our unique and innovative industrial processes that leverage all the functional diversity of the microbiome to deliver better outcomes in cancer treatment."

MEPA, supporting a new generation of microbiome therapies

MaaT Pharma has developed two approaches for its oncology-focused therapies. The first relies on healthy donor donations ("native" products) and aims to restore the gut microbiota of patients with liquid tumors (notably leukemia). The second is focused on the development of "synthetic" microbiome therapies, which are co-fermented and are designed to colonize the patient’s gut with a functional microbiome to improve response to treatment in patients with solid tumors.

MaaT Pharma’s unique pharmaceutical drug development platform relies on advanced artificial intelligence data analysis tools and on a proprietary technology for the co-fermentation of microbial ecosystems to support the design, development, and large-scale manufacturing of novel Microbiome Ecosystem Therapies (MET).

The grant funding will support a key step in developing this platform, namely the industrialization and standardization of co-fermentation processes according to cGMP manufacturing standards, as well as the manufacturing of clinical batches. Ultimately, MaaT Pharma’s manufacturing platform may be used to deliver a large range of microbiome ecosystem therapies in various indications.

Accelerating the development of products in immuno-oncology

The MEPA program is a new step in Maat Pharma’s development as it supports the expansion of its indications to include solid tumors and the acceleration of its immuno-oncology program.

Recent studies have shown that the gut microbiome composition may improve the therapeutic effect of immune checkpoint inhibitors (ICI). In particular, a patient’s gut microbiome richness1 and diversity2 are predictors of their response to ICI3. Two pilot clinical studies also suggest that gut microbiota transfer from ICI-responding donors to non-responders can restore the response in the latter4.

With its therapies, MaaT Pharma aims to synthetically replicate a responder microbiota, combining high richness and diversity with selected functional networks in each indication of interest to improve the response to immune checkpoint inhibitors.

1 Total number of bacteria present in the gut
2 Total number of different strains present in the gut
3 Gopalakrishnan, V. et al, Science, 2018; Routy et al, Science 2018
4 Davar D. et al, Science 2021 ; Baruch E.N. et al, Science, 2021

On July 20, 2021 ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company, reported that a consortium between the Erasmus MC and ISA has been awarded a Private-Public Partnerships (PPP) Allowance made available by Health~Holland, Top Sector Life Sciences & Health, to conduct a first-in-human, phase 1 study of ISA104 to treat hepatitis B in chronically infected patients, in collaboration with Erasmus MC in The Netherlands (Press release, ISA Pharmaceuticals, JUL 20, 2021, View Source [SID1234584992]).

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The clinical study, to be conducted in close collaboration with the Gastroenterology & Hepatology department of the Erasmus MC, is entitled the ‘HEB-PEP study’. The project starts in August 2021 and the clinical phase is expected to begin in 2022. It will provide an insight into which dose of ISA104 is safe, tolerable and potentially effective in chronic HBV patients.

ISA104 is an immunotherapy based on ISA’s Synthetic Long Peptide (SLP) technology designed to direct a strong and specific immune response against the hepatitis B virus (HBV), with the aim to cure chronically infected patients. It will be ISA’s next program to go into clinical development, with its lead program ISA101b in late-stage clinical trials for human papillomavirus type 16 (HPV16) induced cancers.

ISA Pharmaceuticals has previously demonstrated that SLP immunotherapy for HPV16 can eradicate HPV16-induced pre-cancerous lesions1,2,3. ISA, in collaboration with Erasmus MC, has developed a set of antigenic long peptides to create an SLP vaccine, ISA104, aimed to boost the patient’s immune response to clear cHBV.

Leon Hooftman, Chief Medical Officer of ISA Pharmaceuticals commented: "We are excited to announce this TKI project which will enable us to bring a next product to the clinic from ISA’s pipeline. It is a new highlight of our long-standing collaboration with Erasmus MC. This project will test the safety and immune-stimulatory capacity of ISA104, by taking an important next step to potentially curing patients with chronic Hepatitis B, a tremendous global health burden."

Chronic HBV infection affects an estimated 257 million patients worldwide and 20–30% of adults who are chronically infected will develop cirrhosis and/or liver cancer4. Currently, no effective curative treatments exist. Therapeutic vaccines harbour great potential to cure chronic HBV aiming to achieve viral control and clearance. SLP immunotherapies act through induction of potent and durable anti-viral adaptive immune responses.

On July 20, 2021 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that its 64Cu SAR-bisPSMA clinical trial in patients with confirmed prostate cancer is open for recruitment at two sites, GenesisCare CTA Medical Clinic, Perth and Nepean Hospital, Sydney (Press release, Clarity Pharmaceuticals, JUL 20, 2021, View Source [SID1234584961]).

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Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are very excited to open this trial for patients with newly diagnosed prostate cancer using our optimised PSMA agent, 64Cu SAR-bisPSMA, that has the novel combination of two targeting agents attached to our SAR Technology. The preclinical data to date is compelling, with both higher tumour uptake and greater tumour retention compared to the single targeted products utilised by other radiopharmaceutical products on the market, and we look forward to recruiting our first patient for this trial shortly."

The PROPELLER trial is a Phase I Positron Emission Tomography (PET) imaging trial of participants with confirmed prostate cancer using 64Cu SAR-bisPSMA. It is a 30-patient clinical trial conducted across three sites in Australia (NCT04839367)1. PROPELLER is a multi-centre, blinded review, dose ranging, non-randomised study of 64Cu-SAR-bisPSMA administered to patients with confirmed prostate cancer prior to radical prostatectomy. The primary endpoints of the trial are safety, tolerability and efficacy in the detection of primary prostate cancer compared to histopathology.

Dr Taylor said: "Prostate cancer is one of the largest indications in oncology, and due to the logistical, manufacturing and imaging issues related to other radiopharmaceuticals, represents a lucrative opportunity for us to enter this space with our Targeted Copper Theranostics (TCT) platform. Clarity’s centralised manufacture and broad distribution model coupled with the flexibility of imaging at later time points, gives us confidence to believe that we can provide a large patient population with early, accurate and precise detection of prostate cancer and improve patient outcomes. We look forward to further progressing the development of our SAR-bisPSMA product and exploring the benefits of our TCT platform for patients with prostate cancer, including in our upcoming US based 64Cu/67Cu bis-PSMA theranostic trial (SECuRE trial (NCT04868604)2 which is due to commence shortly. The progress of these two trials will get us one step closer to our ultimate goal of developing better treatments for children and adults with cancer."

On July 20, 2021 Micronoma, the first cancer detection company to harness tumor-associated circulating microbial biomarkers to diagnose cancer at an early stage via microbiome-driven liquid biopsy technology, reported a collaboration with the University of New South Wales (UNSW), Sydney for a $4 million grant from the Australian Government to fund research into hepatocellular carcinoma (HCC), the most common type of primary liver cancer (Press release, Micronoma, JUL 20, 2021, View Source [SID1234584976]).

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The collaboration, led by Associate Professor Amany Zekry and Professor Emad El-Omar from UNSW Medicine & Health will enable the development of microbial-based biomarkers powered by artificial intelligence for early detection of liver cancer. Micronoma’s Chief Scientific Officer, Eddie Adams, joins these world-class, multi-disciplinary experts at UNSW in the fields of liver disease, liver cancer, microbiome, metabolomics, and artificial intelligence as a co-principal investigator on the grant.

This research will use machine learning to examine thousands of microbiome plasma features to discover, validate, and translate microbial-derived biomarkers for the early detection of HCC, thus improving the chances of survival of HCC patients and making effective risk disease stratification possible.

"This collaboration with UNSW combines a rare and exciting set of expertise in liver cancer and gut microbiome with our proprietary method of analyzing circulating microbiome signatures. Importantly, being awarded this grant by the Australian Government serves as a strong external validation of our technique and will serve to showcase Micronoma’s unique approach to diagnostics," Micronoma CEO Sandrine Miller-Montgomery said. "There has been growing interest in the compelling link between circulating microbiome signatures and early detection since our publication in Nature. Developing a method to enable the identification of robust microbial plasma biomarker signatures of HCC is in our product pipeline and this collaboration enables us to fast-track product development."

"Our ongoing collaboration with Micronoma strengthens the innovative potential of this research. Micronoma is currently the only cancer diagnostic company in the world that uses microbial DNA signatures in the blood (mb-DNA) to detect early-stage cancer," said Professor Zekry. "Their minimally invasive microbiome-driven liquid biopsy approach is focused on detecting early-stage lung cancer and will provide valuable expertise in establishing an HCC-related microbiome platform."

The diagnostic implications of microbiome markers in liquid and tissue biopsies are extensive, and Micronoma is prepared to lead the way on helping prevent unnecessary suffering caused by later-stage cancer diagnosis, as well as potentially enabling personalized and less invasive treatments at the earliest stages of cancer.

On July 20, 2021 Flatiron Health real-world data (RWD) reported the U.S. Food and Drug Administration (FDA)’s recent approval of a new dosing regimen for ERBITUX (Eli Lilly and Company’s cetuximab) that can have a direct positive impact on the lives of patients with metastatic colorectal cancer (CRC) or squamous cell carcinoma of the head and neck (SCCHN) (Press release, Flatiron Health, JUL 20, 2021, View Source [SID1234584993]).

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The FDA approved a supplemental biologics license application (sBLA) for ERBITUX which provides a new, biweekly dosing regimen for the medicine’s indicated use in patients with K-Ras wild-type, EGFR-expressing metastatic CRC or SCCHN, when used as a single agent or in combination with chemotherapy.

This alternate dosing regimen to the previously approved weekly dosing regimen allows ERBITUX infusions to be scheduled alongside other biweekly treatments, significantly reducing the frequency of patient visits to an infusion center.

"Time is a precious commodity for patients with advanced cancer – every moment that is not spent traveling to and from or in the clinic are moments spent living life," said Michael Vasconcelles, MD, Chief Medical Officer at Flatiron Health. "We are proud that Flatiron RWD brings the evidence we gather from patients’ real-life experiences to bear directly on improvements to their care."

"This dosing change approval allows physicians to provide our patients with the same efficacious treatments in less frequent clinic visits," says Lee Schwartzberg, MD, Chief Medical Officer at OneOncology, a longtime Flatiron community oncology partner. "It is encouraging to see the innovative use of real-world data and regulatory pathways that made this label change a reality."

The approval decision marked a foundational proofpoint for the successful use of RWD to fill evidence gaps in the post-approval setting for regulatory decision-making. Efficacy results from overall survival analyses using Flatiron RWD in patients with metastatic CRC, who received either the weekly or biweekly ERBITUX dosing regimens, supported the results of the population pharmacokinetic modeling analyses in the sBLA. The application was also supported by pooled analyses of overall response rates, progression-free survival, and overall survival (OS) from published literature in patients with CRC and SCCHN.

"We are proud that our long-standing partnership with Flatiron Health is helping to advance the adoption of real-world evidence to support regulatory decision-making," said Christian Nguyen, Pharm.D., vice president of global patient outcomes and real-world evidence, Lilly Oncology. "Being able to fill key evidence gaps through the rigorous analysis of high-quality real-world data will help us all to more quickly bring potential new treatment options for approved medicines to patients."