On May 6, 2021 Isofol Medical AB (publ) ("Isofol"), (Nasdaq First North Premier Growth Market: ISOFOL) reported that reached its primary recruitment objective with the recruitment of 440 patients in the global phase III AGENT study (Press release, Isofol Medical, MAY 6, 2021, View Source [SID1234579262]). Today the company announces that it has completed the recruitment of Japanese patients in accordance with the regulatory requirements by the PMDA (the Japanese Medicines Agency) to reach market approval in Japan. As previously communicated, Isofol expects the top line results for the AGENT study to be available during H1 2022.

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Following today’s announcement of the completion of recruitment of Japanese patients, the full patient population, including the entire Japanese cohort, will be included in PMDA’s assessment for a potential market approval in Japan. For a market approval in Japan, the PMDA set a specific requirement for the number of participating Japanese patients of a total of 56 Japanese patients (of which 14 Japanese patients were already included in the primary recruitment of 440 patients) in the AGENT study. The rationale for the specific requirement from PMDA is e.g. that the metabolism of Japanese patients tends to differ from patients in other countries, which is why the effect and potential side effects must be investigated separately.

For the rest of the world, the original 440 patients will be analyzed for efficacy, but the full patient population will be analyzed for safety purposes.

"I am satisfied that we now have completed the recruitment of the Japanese patients, an important step on the way to receive market approval in Japan, the second largest oncology market worldwide. We are now looking forward to continue working with Solasia on the development and registration of arfolitixorin to bring a new treatment option to patients living with mCRC in Japan", said Ulf Jungnelius, M.D, CEO of Isofol.

Solasia Pharma ("Solasia") will fund and supervise clinical development activities in Japan and will be responsible for registrational filing, and following potential regulatory approvals, Solasia will, as the Market Authorization holder, be responsible for the commercialization of arfolitixorin in Japan. Isofol remain the global sponsor of the AGENT study.

"We are very pleased to have completed the recruitment of the target number of patients in Japan in the AGENT study and contributed to the global development of arfolitixorin. I would like to thank all the patients and investigators participating in the study, the CRO in charge of conducting the study, and Isofol, our partner and the sponsor of the AGENT study, for supporting us achieve this important goal. Patient recruitment was completed earlier than expected, and Solasia, together with Isofol, will further proceed development of arfolitixorin for market approval in Japan with the aim of becoming a new treatment option for mCRC patients", said Yoshihiro Arai, President & CEO of Solasia.

Arfolitixorin is evaluated in the AGENT study for the treatment of patients with first-line metastatic colorectal cancer (mCRC). The study is currently being conducted in the U.S., Canada, Europe, Australia and Japan in more than 90 clinics.

The information was submitted for publication, through the agency of the contact person set out above, at 08:30 CET on May 6, 2021.

About the AGENT study
The Phase III AGENT study is a randomized, controlled, multi-centre study assessing the efficacy and safety of arfolitixorin, [6R]-5,10-methylene-THF acid (MTHF), compared to leucovorin, both used in combination with 5- FU, oxaliplatin, and bevacizumab, in first-line metastatic colorectal cancer patients. Patients are randomized in a 1:1 ratio and the primary endpoint is overall response rate (ORR). The key secondary endpoints are progression free survival (PFS) and duration of response (DOR). Other secondary endpoints include overall survival (OS), number of curative metastasis resections, safety, and patient reported outcomes such as quality of life (QoL). Exploratory endpoints include pharmacokinetic (PK) measurements and level of gene expression of folate relevant genes in tumour cells. The study is designed to show superiority for arfolitixorin over leucovorin. The study is ongoing at approximately 90 sites in the U.S., Canada, Europe, Australia and Japan. In December 2020, the last of the AGENT study’s 440 patients was recruited, which is the basis in the statistical analysis plan. Recruitment has since continued in Japan to reach 56 Japanese patients. Isofol is now focusing on completing the ongoing AGENT study where the patients receive first-line standard treatment for metastatic colorectal cancer (mCRC). The company expects that the results of the AGENT study will be available during H1 2022.Further information about the study, including patient eligibility requirements, is available at www.clinicaltrials.gov id: NCT03750786.

About arfolitixorin
Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On May 6, 2021 Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, reported its first quarter 2021 results (Press release, Targovax, MAY 6, 2021, View Source [SID1234579261]).

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An online presentation by Targovax’s management to investors, analysts and the press will take place at 10:00 CET today (details below).

FIRST QUARTER HIGHLIGHTS
REASEARCH & DEVELOPMENT
Reported continued survival benefit in Targovax’s ONCOS-102 trial in mesothelioma at the 21-month follow-up
Median Overall Survival (mOS) has still not been met for randomized first-line patients receiving ONCOS-102 plus chemotherapy
mOS will be at least 20.5 months for randomized first-line patients receiving ONCOS-102 plus chemotherapy, compared to mOS of 13.5 months in the chemotherapy-only control group
Received Fast-Track designation from the US FDA for ONCOS-102 in malignant pleural mesothelioma. This opens the potential for expedited development path and review
Entered a research collaboration with Papyrus Therapeutics to develop novel ONCOS viruses with receptor tyrosine kinase (RTK) inhibitor functionality
CORPORATE
Announced Dr Sonia Quaratino as a new member of the Board of Directors
Obtained US Patent for ONCOS-102 in combination with checkpoint inhibitors
Maintained TG + chemo patent as granted after opposition in European Patent Office
FINANCIALS

The interim financial information has not been subject to audit

Øystein Soug, CEO commented: "Targovax is at the beginning of a new and exciting development phase. Based on impressive ONCOS-102 clinical data, our main priority going forward is to start a next trial in PD1 refractory melanoma. At the same time, it is also important that we do it right and discuss our strategy with the FDA, since the aim of this trial is to support an accelerated approval. Moreover, based on the strength and breadth of the clinical and immune data, we believe our technology warrants a broader application. Hence, we envision several expansion possibilities beyond melanoma in other indications, with other novel combinations, and for our next generation pipeline products."

Presentation
We invite to a live webcast today at 10.00 CET. You can join the webcast here. It will be possible to ask questions during the presentation.

On May 6, 2021 Sanofi reported that it has entered into a three-year research collaboration with Stanford University School of Medicine. Together, the two organizations and their scientists will work to advance the understanding of immunology and inflammation through open scientific exchange (Press release, Sanofi, MAY 6, 2021, View Source [SID1234579260]). Additionally, Sanofi will provide funding and scientific inputs into projects of mutual interest, crossing multiple therapeutic areas including autoimmune diseases and inflammatory conditions.

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"We look forward to working with some of the most innovative scientists in the human immunology community. Together we will explore groundbreaking concepts and obtain deeper insights into underlying inflammatory disease mechanisms," said Frank Nestle, Global Head of Research and Chief Scientific Officer, Sanofi. "Sanofi’s collaboration with Stanford University aims to transform how autoimmune disorders and inflammatory conditions are understood and treated. It will help accelerate our ambitious immunoscience programs as we advance a rich pipeline of first- and best-in-class medicines across key therapeutic areas to address unmet patient needs."

Sanofi and Stanford Medicine will create a Joint Steering Committee to fund up to three programs a year. Sanofi will host an annual research forum for researchers from both organizations to further exchange ideas, share knowledge and perspectives on relevant scientific matters, and discuss collaborative research projects.

"Stanford Medicine is dedicated to advancing knowledge and discovery with the goal of improving our ability to predict, prevent and cure disease with the most precise approaches," said Lloyd Minor, MD, Dean of the Stanford School of Medicine. "The opportunity for long-term collaboration with our colleagues at Sanofi will allow us to explore together new frontiers in autoimmune diseases and inflammatory conditions."

The collaboration will begin with three "deep-dive" research projects:

Exploring cytokine crosstalk in type 2 inflammation, specifically examining the impact of Sanofi’s investigational molecules on excessive type 2 inflammation.
Decoding molecular drivers of effector and suppressor T cells in autoimmunity, to better understand the specific antigens that may cause type 1 diabetes.
Defining the mechanisms of immune-related adverse events with immune checkpoint inhibitor therapy – with a focus on pneumonitis and inflammatory arthritis – to explore the role of genomics and pathogenic cell identification.

EDITOR’S NOTE: This new initiative is the latest chapter in Sanofi’s long history of collaboration that includes the Sanofi Innovation Awards (iAwards), a multi-institutional academic partnership program designed to accelerate and innovative, early-stage, disease-relevant research towards the clinic. The iAwards represent one of the largest academic–industry collaborations run by a biopharma company, and have generated early research that has led to important scientific advancements in the field, including contributions to Sanofi’s own pipeline.

On May 6, 2021 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that the U.S. Patent and Trademark Office (USPTO) has granted the patent application for Clarity’s SAR-bisPSMA compound and its variants (Press release, Clarity Pharmaceuticals, MAY 6, 2021, View Source [SID1234579259]). The grant of the patent application bolsters Clarity’s strong Intellectual Property (IP) position on the Prostate Specific Membrane Antigen (PSMA) targeting agent for imaging and treatment of prostate cancer.

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SAR-bisPSMA is the result of Clarity’s optimisation of the well characterised PSMA targeting peptide, which has been in many thousands of patients to date, by combining two PSMA targeting peptides with Clarity’s proprietary SAR Technology and the theranostic isotopes of copper, copper-64 for imaging and copper-67 for therapy. The copper pairing enables diagnosis, staging and subsequent treatment of prostate cancers that express PSMA. The optimisation of the targeting peptide has resulted in superior targeting of, and retention in, tumours compared to a singular PSMA targeting peptide in preclinical models (Zia et al., 2019)1. The product was developed through the long-standing collaboration between Clarity and Professor Paul Donnelly at the University of Melbourne.

Clarity’s Executive Chairman, Dr Alan Taylor, commented: "The grant of the SAR-bisPSMA patent application is an example of the effectiveness of Clarity’s broad patent strategy around its SAR Technology, which allows the filing of additional patents with a wide range of new disease targeting agents."

The news from the USPTO come shortly after Clarity has completed the assignment of its key patent portfolio from the University of Melbourne, providing Clarity with the full rights and ownership of the patents.

"The grant of the SAR-bisPSMA patent application also comes soon after Clarity received a response from the U.S. Food and Drug Administration on its an Investigational New Drug (IND) application for a theranostic trial of 64Cu/67Cu SAR-bisPSMA in the U.S. (NCT04868604)2 that the study may proceed. With our diagnostic trial of 64Cu SAR-bisPSMA in previously diagnosed but yet untreated patients prior to surgical removal of the prostate in the start-up phase (NCT04839367)3, we are now ready to embark on two clinical trials of SAR-bisPSMA in the next few months," said Dr Taylor.

Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of death worldwide4. The American Cancer Society estimates in 2021 there will be 248,530 new cases of prostate cancer in the U.S. and around 34,130 deaths from the disease5. For metastatic prostate cancer, the 5-year relative survival rate is 30%, indicating a high unmet need for early detection and better treatment options for mCRPC. Annually, there are around ~34,000 men in the U.S. who are diagnosed with mCRCP5, ~90% of whom have tumours which express PSMA6.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "The theranostic SAR-bisPSMA product has blockbuster market potential for prostate cancer. The product has ideal characteristics for a radiopharmaceutical and numerous advantages associated with the optimisation of the targeting peptide and using the copper pairing, including increased targeting and retention of the product in tumours, centralised manufacture, reaching more treatment sites and patients around the world, as well as diagnostic, dosimetry and therapeutic benefits. We are excited to progress the development of this proprietary asset into the clinic for the treatment of men with prostate cancer as part of our ultimate goal of improving treatment outcomes for kids and adults with cancer. We are pleased to have received the patent grant to reinforce Clarity’s IP position around our PSMA compounds, giving us confidence in the commercialisation process moving forward."

On May 5, 2021 Oncopeptides, a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, reported that the Company has completed patient enrollment in the phase 2 PORT study (Press release, Oncopeptides, MAY 5, 2021, View Source [SID1234646796]). The PORT study is an open-label, randomized, cross-over study which compares safety, tolerability and efficacy of peripheral or central intravenous administration of melflufen (INN melphalan flufenamide) in combination with dexamethasone in relapsed refractory multiple myeloma. Oncopeptides expects topline data in Q3 2021.
"I am very pleased that we have enrolled the final patient in the PORT study," said Klaas Bakker, MD, PhD and Chief Medical Officer at Oncopeptides. "The data could potentially provide a pathway for us to work with the U.S. Food and Drug Administration to include an additional mode of administration for PEPAXTO."

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"The continued development of melphalan flufenamide could potentially bring forward an additional therapeutic option to physicians and patients," said Joshua Richter, MD, Assistant Professor of Medicine, Hematology and Medical Oncology at The Tisch Cancer Institute at Mount Sinai and Site Director of Multiple Myeloma at the Blavatnik Family – Chelsea Medical Center at Mount Sinai, New York.