On September 16, 2022 Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, reported that the company has withdrawn the Marketing Authorization Application (MAA) for the company’s Herceptin Biosimilar, HD201(Tuznue), submitted to the European Medicines Agency (EMA) (Press release, Prestige BioPharma, SEP 16, 2022, View Source [SID1234619613]). The company will reapply to EMA for the MAA with supplementation of data and analysis.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On May 23, the company requested re-examination on the MAA for the HD201, after receiving a negative opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) on May 19. Despite the evidence of the analytical comparability and biological similarity proven through clinical trials of HD201, CHMP delivered a negative opinion due to disparity in the range of acceptance for the criteria of analytical comparability between the clinical testing batch and commercial production batch of HD201.

During re-examination, it was reported that the newly assigned main rapporteur suggested a positive opinion. Nonetheless, it couldn’t overturn CHMP’s range of acceptance for the criteria of analytical comparability. Based on long-term marketing strategy, the company decided to voluntarily withdraw its application and plans to reapply after supplementing data through additional tests and analysis to meet CHMP’s criteria of analytical comparability.

Prestige Biopharma’s HD201 is a proposed biosimilar to Roche’s Herceptin (trastuzumab) and can be prescribed for the treatment of HER2 positive breast and metastatic gastric cancer. Trastuzumab targets human epidermal growth factor 2 (HER2). In some types of cancer cells, HER2 is overexpressed and stimulates the growth of the cancer cells. Trastuzumab works by selectively binding to HER2, thereby stopping the growth of these cancer cells.

Currently, the MAA for HD201 is under review by Health Canada and Korea Ministry of Food and Drug Safety and will be submitted to the US Food and Drug Administration (FDA) by the end of this year. At the same time, Prestige Biopharma plans to focus on the reapplication process of the MAA to EMA for HD201 and prepare for the global market entry based on partnerships with global biopharmaceuticals.
The internal and external expert advisory panel of Prestige Biopharma stated: "The company’s confidence is based on the excellent pharmaceutical quality of HD201 proven through clinical studies and multiple analysis. Through the re-examination, we received positive opinion by the main rapporteur, which is encouraging. We will do our best to obtain approval for HD201 in US and Europe without any doubt and provide patients with better access to treatments."

On September 16, 2022 NH TherAguix ("NHT"), reported the arrival of Dr. Olivier de Beaumont as Chief Medical Officer from September 2022. – Sept. 09, 2022 (Press release, NH TherAguix, SEP 16, 2022, View Source [SID1234619612]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.