On February 8, 2022 Catalyst Clinical Research, a leading provider of clinical research services, and Ledger Run, a leading innovator in clinical operations technology, reported that it will partner to create streamlined clinical trial business processes to enhance and accelerate global studies (Press release, Catalyst Clinical Research, FEB 8, 2022, View Source [SID1234607815]).

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Ledger Run will expand its partnership with Catalyst Oncology, Catalyst Clinical Research’s full-service, niche oncology CRO solution. Catalyst Oncology has implemented a proprietary Ledger Run platform known as ClinRunTM to improve site budget and payment capabilities. The expanded partnership will allow Catalyst to take advantage of the fully integrated capabilities of ClinRun by adding contracting and forecasting solutions.

"Ledger Run is a great strategic partner for Catalyst because the company provides a unique combination of innovative technology solutions and professional services," said Nick Dyer, CEO at Catalyst. "Their ClinRun integrated platform and first-class support have helped us overcome the operational challenges of complex oncology studies and deliver real value to our customers and investigative sites."

Focusing on next-generation cancer therapies, Catalyst Oncology provides skilled management of immuno-oncology and targeted therapies as well as expert oversight of complex studies to deliver customized clinical research solutions exclusively for the biotech market. Ledger Run’s ClinRun platform helps with budgeting, contracting, making payments, and forecasting. The software suite also automates manual tasks, reduces errors, and speeds cycle times while promoting engagement with investigator sites.

"Catalyst is doing remarkable work in oncology," said Gary Lubin, Chief Executive Officer at Ledger Run. "They are managing very complicated trials, often with challenging protocol designs.

"We are thrilled that Catalyst has selected us to help manage their critical clinical business operations and embraced our responsibility as a trusted business partner," Lubin added. "We are confident that our smart technologies and services will create value for their customers."

On February 8, 2022 Patrys reported that new data from a preclinical study that demonstrated potential for using our deoxymab antibodies as targeting agents in ADCs (Press release, Patrys, FEB 8, 2022, View Source [SID1234607814]). This was a promising development, and one which opens up a range of possibilities for our platform in precision medicine.

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ADCs harness the targeting attributes of antibodies to deliver drugs specifically to the sites of disease.

Our preclinical study has shown the affinity our deoxymabs have for DNA is sufficient for them to target the delivery of cancer drugs to tumours, where they can inhibit tumour growth and improve survival.

On February 8, 2022 Chimeric Therapeutics (ASX:CHM, "Chimeric"), a clinical-stage cell therapy company and the ASX leader in cell therapy, reported that encouraging initial data for the 2nd dose cohort of the CLTX CAR T phase 1 dose escalation study for patients with recurrent/progressive glioblastoma at the City of Hope, one of the largest cancer research and treatment organizations in the United States (Press release, Chimeric Therapeutics, FEB 8, 2022, View Source [SID1234607813]).

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In the 2nd dose cohort, dual routes of intratumoral and intraventricular CLTX CAR T cell administration were introduced at a total dose of 88 X 106 CLTX CAR T cells. City of Hope developed and manufactured the therapy.

Positive initial safety was seen as patients generally well tolerated the dual routes (intratumoral and intraventricular) of CLTX CAR T cell administration introduced in this dose cohort. As previously announced, all patients advanced past the 28-day follow-up without experiencing dose limiting toxicities. Additionally, an encouraging activity signal was demonstrated with 2/3 evaluable patients treated achieving local stability of disease.

Additional insights into this cohort are anticipated to be presented at a scientific congress as the trial progresses.

The study is now enrolling patients in the 3rd dose cohort, which will administer CLTX CAR T cells to patients through the dual routes of administration at an increased total dose of 220 X 106 CLTX CAR T cells.

"This preliminary data is encouraging as it demonstrates safety with dual routes of administration. We now look forward to advancing the trial to higher dose levels which may provide more therapeutic benefit to patients," said Behnam Badie, M.D., Professor and Chief, Division of Neurosurgery; Director, Brain Tumor Program, Department of Surgery, City of Hope.

Authorised on behalf of the Chimeric Therapeutics board of directors by Chairman Paul Hopper.

ABOUT CHLOROTOXIN CAR T
Chlorotoxin CAR T (CLTX CAR T) cell therapy is a first and best in class CAR T cell therapy that has the potential to address the high unmet medical need of patients with recurrent/ progressive glioblastoma. Research to develop the intellectual property covering this CAR T cell therapy took place at City of Hope.

CLTX CAR T cell therapy uniquely utilizes chlorotoxin (CLTX), a peptide derived from scorpion toxin, as the tumour-targeting component of the chimeric antigen receptor (CAR). CLTX and CLTX CAR T cells have been shown in preclinical models to bind more broadly and specifically to GBM cells than other targeting domains like EGFR, HER-2 or IL-13.

In preclinical models, CLTX CAR T cells also demonstrated potent antitumor activity against glioblastoma while not exhibiting any off-tumor recognition of normal human cells and tissues, indicating a potentially optimal safety and efficacy profile.

On February 7, 2022 Nordic Pharma reported that they have entered into an agreement with SANOFI to fully acquire the rights to ALTIM (cortivazol), a legacy product in France (Press release, Nordic Pharma, FEB 7, 2022, View Source [SID1234607876]).

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ALTIM contains a 3.75mg/1.5ml cortivazol suspension for injection, presented in a pre-filled syringe, and is approved in France in Rheumatology indications, where a local corticosteroid treatment is required.
See prescribing information: Résumé des caractéristiques du produit – ALTIM 3,75 mg/1,5 ml, suspension injectable en seringue pré-remplie – Base de données publique des médicaments (medicaments.gouv.fr)

This acquisition supports Nordic Pharma’s strategy to grow its proprietary portfolio and to become a key player in Rheumatology in France and beyond.

ALTIM was commercialized in France since the 70’s and subsequently withdrawn from the French market by Sanofi in 2018 due to manufacturing issues. It is the intention of Nordic Pharma to re-engineer the process and the manufacturing for both the active substance and the finished product to allow the product to be re-launched onto the French market at the earliest possibility as the product is still requested by clinicians.

Jean-Michel Quinot, CEO of Nordic Pharma stated:" We are very pleased to have reached an agreement with Sanofi allowing us to re-introduce ALTIM into the French market. Nordic Pharma is dedicated to providing Patients and Physicians with innovative medications addressing significant unmet medical needs. We are very eager to further expand our successful collaboration with Sanofi."

Veronique Rebours-Mory, CSO of Nordic Pharma stated: "Physicians are still demanding this unique treatment option for Rheumatology patients, and despite the challenge and investment needed, we are committed to solving the manufacturing issues that led to the discontinuation of the product."

On February 7, 2022 Biogen Inc. (Nasdaq: BIIB) and Xbrane Biopharma AB (STO: XBRANE) reported that they have entered into a commercialization and license agreement to develop, manufacture, and commercialize Xcimzane, a preclinical monoclonal antibody that is a proposed biosimilar referencing CIMZIA (certolizumab pegol)1 (Press release, Biogen, FEB 7, 2022, View Source [SID1234607852]).

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CIMZIA’s primary indication is for rheumatoid arthritis in adults as well as axial spondylarthrosis, psoriasis and Crohn’s disease. In 2020 global sales of CIMZIA were 1.8 billion Euro2. Under the terms of the agreement, Biogen will gain exclusive global regulatory, manufacturing, and commercial rights to Xcimzane and will be the Marketing Authorization Holder.

"We aim to bring more biosimilars products to more patients and more geographies and we are excited to bring this additional asset to our Biosimilars pipeline," said Ian Henshaw, Head of Global Biosimilars at Biogen. "This preclinical biosimilar candidate has the potential to add another option for patients living with Rheumatoid Arthritis and other indications."

"Given their vast development and commercialization experience, we are convinced that Biogen is the best possible partner we could have for Xcimzane," said Martin Åmark, CEO of Xbrane Biopharma AB. "Today’s announcement confirms Xbrane’s ambition to become a global biosimilar developer."

Under the terms of the agreement, Biogen will make an upfront payment of $8 million to Xbrane. Should certain development and commercial milestones be achieved, Xbrane will be eligible to receive up to $80 million in potential milestone payments. Xbrane is also eligible to receive tiered royalties. Xbrane will be responsible for the completion of pre-clinical development of Xcimzane and Biogen will be responsible for all remaining development activities and costs required to achieve Marketing Authorization in all territories, including those for clinical development.

About Biosimilars
Biosimilars are biologic products that have been demonstrated to be similar in efficacy, safety and immunogenicity to the originator’s approved reference product, with the advantage that they can offer significant cost savings. Biosimilars may lower healthcare system costs broadly, creating headroom for innovation and could enable governments to potentially redirect savings to priorities such as increasing access to transformative therapies.