On September 16, 2022 ADC Therapeutics SA (NYSE: ADCT) and Swedish Orphan Biovitrum AB (Sobi) reported the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the marketing authorization of ZYNLONTA (loncastuximab tesirine) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Press release, ADC Therapeutics, SEP 16, 2022, View Source [SID1234619608]). The positive opinion from the CHMP is now referred to the European Commission for an approval decision.

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Earlier this year, ADC Therapeutics announced an exclusive license agreement with Sobi to develop and commercialize ZYNLONTA for all hematologic and solid tumor indications in Europe and select international territories.

The opinion is based on data from LOTIS-2, a large (n=145) Phase 2 multinational, single-arm clinical trial of ZYNLONTA for the treatment of adult patients with relapsed or refractory DLBCL following two or more prior lines of systemic therapy. In April 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval of ZYNLONTA as the first CD19-targeted antibody drug conjugate (ADC) as a single-agent treatment for adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy. In September 2021, the European Commission granted Orphan Drug Designation to ZYNLONTA for the treatment of DLBCL.

ADC Therapeutics has an exclusive license agreement with Mitsubishi Tanabe Pharma Corporation (MTPC) for the development and commercialization of ZYNLONTA for all hematologic and solid tumor indications in Japan. In addition, Overland ADCT BioPharma, a joint venture formed by Overland Pharmaceuticals and ADC Therapeutics, is working to develop and commercialize ZYNLONTA in greater China and Singapore. Overland ADCT BioPharma is now conducting a registrational pivotal Phase 2 clinical trial of ZYNLONTA in relapsed or refractory DLBCL in China.

About ZYNLONTA (loncastuximab tesirine-lpyl)

ZYNLONTA is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.

The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.

On September 16, 2022 Servier reported that it has launched an initiative with California Life Sciences Association (CLSA) to support an early-stage life sciences company developing innovative approaches in the therapeutic areas developed by the Group: oncology; auto-immune diseases ; genetically driven neurodegenerative and movement disorders (Press release, Servier, SEP 16, 2022, View Source [SID1234619606])

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"This collaboration offers a great opportunity for California-based innovators and disruptors in earlier stages to get on the radar of a potential licensing or exit partner by applying to this call," said Sibylle Hauser, executive director of Innovation Services at CLS.

"Our partnerships’ philosophy is about accessing innovative new therapeutic solutions to meet patient needs," said Christophe Thurieau, executive director of Servier Research. "Starting a collaboration with California Life Sciences, a leading life science organization in the US, is definitely inspiring. Networked innovation without barriers is crucial for serving patients’ unmet needs even more effectively and rapidly. Agile methods to accelerate R&D programs are based on synergies and teamwork."

Among the 23 applications, Servier has awarded the Servier FAST Discovery Award to F5 Therapeutics. This start up sets up a technological platform to develop First-in-Class small molecules for the treatment of diseases with high unmet medical need notably in oncology and immunology.

Beyond supporting innovation, this initiative is also the opportunity for Servier, to reinforce its interaction with innovative players in the US and more specifically on the West coast and to set up long term relationships with F5 Therapeutics to boost innovation for the benefit of patients.

*Servier favors open collaboration to accelerate the development of therapeutic solutions for the benefit of patients. Convinced that work and ongoing dialogue between healthcare players is the best framework for rapid innovation focused on patients’ needs, Servier continues to expand and diversify its network of R&D partners.

On September 16, 2022 EXACT Therapeutics AS ("EXACT-Tx", Euronext Growth: EXTX), a clinical stage precision health company utilising Acoustic Cluster Therapy (ACT) across multiple therapeutic areas, reported the appointment of Dr Amir Snapir as Chief Medical Officer (CMO), effective 21 September 2022 (Press release, Exact Therapeutics, SEP 16, 2022, View Source [SID1234619605]).

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"We are delighted to welcome Amir to EXACT-Tx as CMO. His extensive experience in clinical development and thorough understanding of the regulatory and clinical framework for drug-device combinations will be pivotal for our further development of ACT.", said Dr Per Walday, CEO of EXACT-Tx. "We continue to build a strong organisation with clinical and regulatory expertise for excellence in development strategy and execution. We are very happy to have Amir in this critical leadership role for the future development of ACT".

Dr Snapir has a PhD from the University of Turku, Finland and an MD from the University of Tel Aviv, Israel. He has extensive experience in global clinical development of novel therapeutics, from early clinical translation to marketing authorisation, combined with extensive international regulatory experience. Dr Snapir also has years of experience in business collaborations, alliances and product co-developments. Dr Snapir comes from the position as CMO of PCI Biotech where he was responsible for the clinical development of drug-device combination product candidates. From 2007 to 2020 he held various positions at Orion Pharma, Espoo, Finland, spanning from leader of clinical pharmacogenomics to clinical development leader in Oncology. Dr Snapir is the author of numerous scientific publications.

On September 16, 2022 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its bacterial Mimicry drug discovery platform, reported that an oral presentation of its Phase 1/2 clinical trial of EO2401 in patients with first progression/recurrence of glioblastoma (ROSALIE trial), will be made at the European Association of Neuro-Oncology (EANO) Meeting 2022 (Vienna, Austria) in the Award Winning Abstracts session on Saturday, September 17 at 16:00 CEST (full details below) by Professor Ahmed Idbaih, Sorbonne University, AP-HP La Pitié-Salpêtrière & Paris Brain Institute (Paris, France) and a clinical investigator in the ROSALIE trial (Press release, Enterome, SEP 16, 2022, View Source [SID1234619604]).

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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, 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.

Professor Ahmed Idbaih said, "Immunotherapies have dramatically improved the prognosis of multiple cancers. At EANO we will be presenting our promising results with a new highly innovative immunotherapy, the OncoMimics-based therapeutic cancer vaccine EO2401 in combination with nivolumab and/or bevacizumab in patients with glioblastoma. We are delighted to have this opportunity to share our findings with the neuro-oncology community at this prestigious meeting."

Highlights from the EO2401/ ROSALIE Phase 1/2 trial:

Data published to date confirm that EO2401 in combination with nivolumab +/- bevacizumab is well tolerated with a safety profile consistent with the safety profiles of nivolumab and bevacizumab.
EO2401 in combination with nivolumab generated strong systemic immune responses through activation of specific effector memory CD8+ T cells, correlating with efficacy.
Addition of bevacizumab to EO2401 and nivolumab supported longer treatment durations, and an increase of objective response rate (ORR – 55% vs. 10%), disease control rate (DCR – 82% vs. 34%), and progression-free survival (PFS – 5.5 months vs 1.8 months), with 3 of the first 11 patients showing complete remission.
Details on Enterome’s oral presentation at EANO (ROSALIE study)

The abstract has been published in the Official Journal of the Society for Neuro-Oncology and can be viewed here.

About ROSALIE

ROSALIE (EOGBM1-18, NCT04116658) is a multicenter, open-label, Phase 1/2 trial investigating EO2401 in combination with nivolumab, and in combination with nivolumab/bevacizumab in patients with glioblastoma at first progression/recurrence after surgery and adjuvant radiotherapy/temozolomide. The trial is assessing safety, tolerability, immunogenicity and preliminary efficacy in approximately 80 patients at centers in the US and Europe.

On September 15, 2022 Athebio AG, an innovation leader in the discovery and design of designed ankyrin repeat proteins (DARPins), reported that it has entered into a collaboration agreement with 3T Biosciences ("3T"), an immunotherapy company focused on discovering and developing next-generation therapies with curative potential based on its immune-response guided target discovery approach (Press release, AtheBio, SEP 15, 2022, View Source [SID1234638729]).

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Under the agreement, Athebio will provide 3T with Athebody DARPins selected from its proprietary library against undisclosed peptide antigens presented on the cell surface by major histocompatibility complex (MHC) proteins. 3T may option the selected Athebody DARPins for further development.

"We are looking forward to working with the highly talented team at 3T Biosciences. We believe that Athebody DARPins have ideal properties to optimally recognize pMHC targets with very high specificity, which is crucial to be successful in this space," said Patrik Forrer, CEO and Chairman at Athebio, and one of the inventors of the DARPin technology.

"Combined with other key characteristics like their superior manufacturability and their ease of constructing multi-specific binders, Athebody DARPins will prove a great asset for various molecular formats, including the field of T-cell engagement. We are looking forward to exploring this huge potential together with 3T Biosciences."