BioSpace Global Roundup, Aug. 13
Evotec SE – Germany’s Evotec SE and Secarna Pharmaceuticals GmbH & Co. KG announced a strategic partnership in the field of antisense oligonucleotide (“ASO”)-based therapeutics. Antisense therapy is an innovative, clinically and commercially validated, highly-targeted pharmacological approach which interferes with gene expression in the cells of interest to specifically inhibit the production of proteins which promote development and progression of diseases. Evotec and Secarna have laid the foundation for a long-term platform collaboration spanning across a number of targets and indications. The first program has been identified and the companies are now progressing towards the establishment of a pipeline of co-owned antisense oligonucleotide therapies. This partnership creates a unique opportunity for biotech and pharmaceutical companies to enter the rapidly growing field of antisense therapeutics by partnering with Evotec and Secarna and to gain access to the companies’ co-owned pipeline through a variety of individual deal structures.
Pharming Group N.V. – Netherlands-based Pharming Group enrolled its first patient in a randomized clinical study assessing Ruconest (recombinant human C1 inhibitor) as a potential treatment for COVID-19 patients who have been hospitalized with related severe pneumonia. In April 2020, Pharming reported encouraging results from a compassionate use program at the University Hospital Basel, Switzerland, in which four male patients and one female patient (between 53-82 years of age) with COVID-19, suffering from related severe pneumonia, who did not improve despite standard treatment, including hydroxychloroquine and lopinavir/ritonavir, had been administered Ruconest. Following treatment, fever resolved in four of the five patients within 48 hours, and laboratory markers of inflammation decreased significantly. Soon thereafter, four of the five patients were discharged from the hospital as fully recovered. One patient had increased oxygen requirement and was eventually transferred to the ICU for intubation but has also since made a full recovery.
RhoVac – Based in Sweden, RhoVac announced the first patient involved in its Phase IIb prostate cancer study BRaVac, has been dosed at a location in the United States. BraVac is a randomized, placebo-controlled and double-blind study, with the primary objective of evaluating if treatment with the drug candidate RV001 can prevent or limit the development of advanced prostate cancer after curative-intent treatment. The study has already begun in Denmark, Finland, Germany and Belgium. The company anticipates recruitment to soon begin in Sweden and the U.K. RhoVac expects the Phase IIb recruitment to be complete by end 2020, and the trial to conclude end 2021.
Mallinckrodt – The U.S. Food and Drug Administration accepted the Biologics License Application for U.K.-based Mallinckrodt’s StrataGraft, an investigational regenerative skin tissue therapy in development for the treatment of adult patients with deep partial-thickness thermal burns. The FDA granted the application priority review and assigned a Prescription Drug User Fee Act (PDUFA) target date of Feb. 2, 2021. Autograft, the current standard of care for deep partial-thickness thermal burns, involves the surgical harvesting of healthy skin from an uninjured site on the patient and transplanting the skin graft to the injury, leaving the patient with more wounded areas requiring care. The StrataGraft skin tissue BLA is based on data from the pivotal Phase III STRATA2016 clinical trial, previously published as an abstract in the Journal of Burn Care & Research and presented via a prerecorded video at the virtual American Burn Association 52nd Annual Meeting, with support from the STRATA2011 clinical trial, previously published in Burns. The Phase III trial of StrataGraft skin tissue met both primary endpoints in adults with deep partial-thickness thermal burns.
Molecular Partners – Switzerland became the first country to secure access to Zurich-based Molecular Partners’ novel drug candidate for the treatment of COVID-19 – pledging millions in return for up to 3.2 million doses of the company’s unique DARPin antiviral drug in development. DARPins tackle COVID-19 differently by engaging up to three parts of the SARS-CoV-2 virus simultaneously. The deal with Molecular Partners came days after the Swiss government signed a deal with Moderna Therapeutics for its experimental mRNA COVID-19 vaccine.
Atriva Therapeutics – Germany-based Atriva Therapeutics GmbH closed a $10.2 million loan. The proceeds of the transaction will enable Atriva to start a multinational, double-blind, randomized clinical Phase II study in patients with moderate to severe COVID-19 infections. It will also be used to prepare a Phase II trial in influenza and to continue building a therapy platform to treat respiratory diseases induced by RNA viruses, such as Hantavirus. ATR-002 has been developed specifically to treat respiratory viral infections by inhibiting MEK, a host cell factor required for the replication of various RNA viruses, including influenza virus and SARS-CoV-2.
Lytix Biopharma – Norway’s Lytix Biopharma AS entered into a licensing agreement with Verrica Pharmaceuticals Inc. to develop and commercialize LTX-315 for dermatologic oncology indications. LTX-315 is a first-in-class oncolytic peptide that is injected directly into a tumor to induce immunogenic cell death. The compound has demonstrated positive tumor-specific immune cell responses in multi-indication Phase I/II oncology trials. The company intends to focus initially on basal cell and squamous cell carcinomas as the lead indications for the development of LTX-315.
Byondis BV – Formerly known as Synthon Biopharmaceuticals, Netherlands-based Byondis announced that the first cancer patients have started treatment with its investigational antibody-drug conjugate (ADC) SYD1875. The study will evaluate the safety, pharmacokinetics and preliminary efficacy of SYD1875 in patients with 5T4-expressing, locally advanced or metastatic solid tumors. SYD1875 is the second Byondis ADC to progress to clinical studies. The company’s anti-HER2 ADC [vic-]trastuzumab duocarmazine (SYD985) is its most advanced ADC, targeting a range of HER2-expressing cancers such as metastatic breast cancer and endometrial (uterine) cancer.