On June 6, 2022 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its bacterial Mimicry drug discovery platform, reported proof-of-concept immune response data and first clinical data from its Phase 1/2 clinical trial of EO2401 in combination with an immune checkpoint inhibitor (nivolumab, Opdivo) in patients with non-resectable adrenocortical carcinomas (ACC), treated with at least one line (but not more than two prior lines of systemic therapy), or without prior systemic therapy for advanced/metastatic disease (SPENCER trial, EOADR1-19, NCT04116658) (Press release, Enterome, JUN 6, 2022, View Source [SID1234615606]). The data1 were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, on June 4, 2022 in Chicago and virtually.

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EO2401 is Enterome’s first-in-class off-the-shelf OncoMimics cancer immunotherapy. It combines three OncoMimics peptides that closely mimic IL13Ra2, BIRC5 and FOXM1, all of which are known driver antigens present on aggressive solid tumors. In addition, EO2401 contains a CD4 helper peptide UCP2. Enterome selected these OncoMimics peptides using its Mimicry platform, which applies best-in-class biocomputational tools and bioassays to identify novel therapeutics from its proprietary database of 20+ million bioactive gut microbiome peptides and proteins.

Key highlights from the EO2401 poster presentation covering the Phase 1/2 SPENCER trial were:

Proof-of-concept immune response data

Immune monitoring of Cohort 2a demonstrates the ability of microbiome-derived peptides to induce a strong Tc1- skewed CD8+ T cell response with strong cross-reactivity against human selected tumor associated antigens.

The level of the specific CD8+ T cell immune responses against the microbiome-derived peptides comprising EO2401 were also found to correlate with clinical outcome (objective responses and progression-free survival).

Promising clinical outcome in sub-group of patients

The combination of EO2401 plus nivolumab was evaluated:

in patients with previously treated ACC (Cohort 2a, n=26) and
in patients who received no prior systemic therapy for advanced/metastatic disease (Cohort 2b, n=7)
Cohort 2a – group of patients showing benefit in objective tumor responses and time to progression

Analysis of Cohort 2a identified patients with clearly different efficacy outcomes, with one group showing benefit in objective tumor responses and time to progression, and another group with short progression-free survival (PFS) and short survival.

To refine the population for expansion in a randomized Phase 2 trial, different laboratory and clinical parameters were investigated as possible selection criteria.

No correlation was found between clinical outcome and tumor mutational burden, MSI-status, PD-L1 expression, serum cytokines/chemokines, or hormonal levels. However, the study found that patients in Cohort 2a who fulfilled the criteria of having received prior mitotane treatment, ECOG ≤ 1, ACC primary diagnosis > 9 months, max lesion size ≤ 125 mm, ≤ 3 organs involved, reduced lymphocytes ≤ grade 1 (n=14), demonstrated a clinical benefit vs patients not fulfilling these criteria (n=12), as follows:

Objective response rates (ORR) – 28.6% (95% CI 8.4; 58.1) vs 0% (95% CI 0.0; 26.5)
Disease control rates (DCR) – 64.3% (95% CI 35.1; 87.8) vs 3% (95% CI 0.2; 38.5)
Median progression-fee survival (PFS) – 3.9 months (95% CI 1.9; 9.2) vs 6 months (95% CI 0.5; 1.9)
Median survival – 13.0 months (95% CI 11.3; not evaluated) vs 1 months (95% CI 1.5; 7.4)

Cohort 2b – further follow up to be conducted

The clinical responses to EO2401 plus nivolumab observed in patients in Cohort 2b showed no benefit over the results from all patients in Cohort 2a, and further follow-up will be conducted.

Safety

The combination of EO2401, administered sub-cutaneously with the adjuvant Montanide ISA 51 VG, with nivolumab was well tolerated. The safety profile was consistent with the profile of nivolumab monotherapy, except the addition of local administration site reactions (occurring in 21% of patients).

Dr. Eric Baudin, Associate Professor and Head of the Endocrine Oncology Unit at the Institut Gustave Roussy (Villejuif, France) commented, "There has been no significant innovation in the treatment of advanced adrenal tumors and patients with this rare group of diseases are desperately in need of new effective therapies especially at relapse after first-line therapy. If confirmed, EO2401 in combination with nivolumab, represents the most promising therapy of the last three decades in this ultra rare cancer. I am pleased to be participating in this trial and to move forward into a randomized Phase 2 trial in this underserved patient population."

Dr. Jan Fagerberg, Chief Medical Officer of Enterome said, "The data presented at ASCO (Free ASCO Whitepaper) for EO2401 in combination with nivolumab are very encouraging, with strong immune responses correlating to clinical outcome in patients having been previously treated for adrenocortical carcinoma. We are also pleased to have been able to define a set of clinical selection criteria that will enable us to refine a patient population for expansion in a Phase 2 randomized trial. We are on track to start this new trial in the coming months and look forward to the results in due course."

EO2401 in recurrent glioblastoma

At ASCO (Free ASCO Whitepaper), and separately announced today, Enterome presented the first clinical data from its Phase 1/2 clinical trials of EO2401 in combination with nivolumab +/- bevacizumab for the treatment of patients with recurrent glioblastoma (the ROSALIE trial, EOGMB1-18). View press release here.

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About SPENCER

The SPENCER trial (EOADR1-19, NCT04187404) is a multicenter, open-label, Phase 1/2 study assessing the safety, tolerability, immunogenicity and preliminary efficacy of EO2401 in combination with the immune checkpoint inhibitor nivolumab in patients with adrenal tumors (adrenocortical carcinoma [ACC] and metastatic pheochromocytoma/paraganglioma [MPP]). The trial is expected to enrol at least 100 patients at clinical sites in Europe and the US.

On June 6, 2022 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company noted that its Founded Entity, Akili Interactive Labs, Inc. ("Akili"), a leading digital medicine company pioneering the development of cognitive treatments through game-changing technologies, reported that industry veteran Matt Franklin will join the company in the newly created role of President and Chief Operating Officer, effective June 21, 2022 (Press release, PureTech Health, JUN 6, 2022, View Source [SID1234615605]).

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As President and COO, Franklin will join Eddie Martucci, Akili’s Chief Executive Officer, and the company’s executive leadership team to scale the organization and bring Akili’s diverse pipeline of cognitive treatments to market, with an initial focus on the commercial launch of EndeavorRx. He will lead the day-to-day operations of the company, and oversee Commercial, Product, Engineering, Medical and People Operations.

Franklin brings more than two decades of experience across business, commercial and strategic marketing in the diagnostics, life sciences and technology industries leading and evolving innovation. Most recently, Franklin served as General Manager of the Precision Oncology business unit at Exact Sciences. Previously, Franklin was the Chief Commercial Officer at Thrive Earlier Detection Corp, where he led the go-to-market strategy development for their ground-breaking multi-cancer early detection assay. In addition, Franklin served as the Chief Business Officer for ArcherDX, a growth-stage molecular diagnostics company, where he was responsible for establishing and scaling the global sales, customer support, marketing, market access, business development and corporate development teams. Prior to ArcherDX, Franklin served as the Senior Vice President of Global Marketing and Clinical Product Strategy at Foundation Medicine where he led the global launch of three products in three years, including the company’s first liquid biopsy offering and the first FDA-approved, CMS-covered, comprehensive genomic profiling companion diagnostic test. Franklin held progressive leadership roles overseeing novel interventional medical devices at Boston Scientific, culminating in his running global strategic planning, product development and marketing for the company’s cardiovascular division.

On June 6, 2022 JSR Corporation (Head Office: Minato-ku, Tokyo, Representative Director and CEO: Eric Johnson, JSR Corporation) reported that it has entered into a facility usage agreement with AuB Co., Ltd. (AuB), a company engaged in the study of intestinal microbiota in athletes, for the Collaborative Lab, a collaborative research facility with startups, which is located in a new research laboratory "JSR Bioscience and Informatics R & D center (JSR BiRD)" in Kawasaki City, Kanagawa Prefecture, which opened last July (Press release, JSR, JUN 6, 2022, View Source [SID1234615601]).

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AuB, founded in Oct 2015, is a company that conducts food-tech business based on research into the intestinal bacteria of athletes. Representative director Keita Suzuki is a former top athlete who was a professional player for the Urawa Red Diamonds, a J.League soccer team, and also played for Japan’s national team. Since its foundation, the company has analyzed the intestinal environment of more than 750 athletes (1,700 samples), developed proprietary materials based on this knowledge, and developed a business to sell them externally. In the future, the company is also considering entering the pharmaceutical field.

JSR is developing its life science business as a core business, focusing on diagnostic reagent materials, bioprocess materials, and drug discovery support businesses. At the same time, JSR is engaged in research on the microbiome, etc. as next-generation technology research, and is pursuing the realization of innovation that leads to new products and services required for a healthy and long-lasting society. Through joint research with AuB in collaboration labs, we aim to further accelerate next generation research and commercialize it.

On June 6, 2022 EpiAxis Therapeutics reported as we return to face-to-face biotech conferences after more than two years of virtual attendance (Press release, EpiAxis Therapeutics, JUN 6, 2022, View Source;utm_medium=rss&utm_campaign=epiaxis-executives-attend-us-biotech-conferences [SID1234615600]).

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Chairman Dr David Fuller is currently representing EpiAxis at the ASCO (Free ASCO Whitepaper) 2022 Annual Meeting in Chicago; while CEO Dr Jeremy Chrisp will attend the BIO International Convention from June 13-16, 2022 at San Diego Convention Center.

The American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the world’s premier oncology gathering, opened in Chicago on June 3 for the first time since 2019, bringing the largest crowd of cancer care leaders together since the start of the pandemic. The 2022 ASCO (Free ASCO Whitepaper) Annual Meeting Program is offering presentations on the latest research in cancer care and extensive networking opportunities. This year’s program will feature over 200 sessions complementing the meeting’s theme: Advancing Equitable Cancer Care Through Innovation.

ASCO organisers said last week more than 36,000 people had registered for the conference and 80% were planning to attend the meeting in person.

"It is great to see ASCO (Free ASCO Whitepaper) return to Chicago and have the opportunity to interact with with industry colleagues again after the COVID-19 pandemic," Dr Fuller said. "Each year, the ASCO (Free ASCO Whitepaper) conference brings together oncologists from all around the globe and is attended by medical, educational and industrial stakeholders involved in the field of oncology worldwide. It’s an invaluable opportunity to share EpiAxis’ epigenetic advances with a highly engaged audience."

Dr Jeremy Chrisp is looking forward to attending the 2022 BIO International Convention later this month. The convention will feature more than 100 interactive sessions across four days, covering a variety of therapeutic areas, business development, digital health, patient advocacy and next generation biotherapeutics.

"We are seeking new investors to advance our pioneering epigenetic program into the clinic and the Bio International Convention will be an excellent opportunity to update the industry on our progress in the epigenetic space," Dr Chrisp said.

"We are looking to continue our discussions with potential pharma partners who are receptive to our novel first-in-class oncology therapeutics. Epigenetics is an emerging and active therapeutic area and offers the prospect of a less toxic cancer treatment by re-programming both cancer and immune cells for superior outcomes.

"Importantly, we believe through face-to-face discussion, the underlying value in our programs can best be communicated. EpiAxis is now moving into the next phase of development and is seeking to raise US $12million (tranched) to take us from lead candidate selection through IND filing and an initial Phase 1/2 dose escalation expansion study."

On June 6, 2022 OREGA Biotech, the biotech company committed to the discovery of novel immuno-oncology targets for cancer immunotherapy, provides an update on its CD39 program: Innate Pharma reported that IPH5201, the CD39 blocking monoclonal antibody developed in collaboration with AstraZeneca, will advance into a Phase 2 clinical trial in lung cancer(Press release, OREGA BIOTECH, JUN 6, 2022, View Source [SID1234615566]).

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About IPH5201 antibody

IPH5201 is a humanized CD39 blocking antibody. OREGA Biotech commenced the CD39 program at its inception in 2010, then entered into an exclusive and worldwide License Agreement with Innate Pharma in 2016. The lead antibody has been further partnered with AstraZeneca in 2018. AstraZeneca conducted a multicenter, open-label, dose-escalation Phase 1 trial in advanced solid tumors (NCT04261075) with IPH5201 alone or in combination with durvalumab (anti PD-L1 antibody).

Jeremy Bastid, Chief Executive Officer of OREGA Biotech, commented "We are very pleased that IPH5201 antibody is now progressing into a Phase 2 trial; this represents a major achievement for our company. Our academic cofounders are also very proud of having been involved in the discovery of the immunoregulatory role of the adenosine pathway in cancer, the components of which are now being targeted in multiple clinical trials".