Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
Spain’s ORYZON Genomics is taking its experimental acute myeloid leukemia (AML) treatment to the clinic. The company received clearance from the U.S. Food and Drug Administration to initiate a Phase Ib study of iadademstat in patients with relapsed/ refractory AML who harbor an FMS-like tyrosine kinase mutation (FLT3mut+).
The Phase Ib FRIDA study will assess iadademstat plus gilteritinib in those patients. The study’s primary endpoints will assess the safety and tolerability of the combination treatment and aim to establish a recommended dosing for a Phase II study. Secondary objectives of the study include duration of response and the assessment of Measurable Residual Disease. The FRIDA trial will enroll up to 45 patients.
Ladademstat is a small oral molecule that acts as a highly selective inhibitor of the epigenetic enzyme LSD1. It is also believed to have a powerful differentiating effect in hematologic cancers.
“Epigenetics is emerging as one of the underlying roots of leukemia and other cancers. LSD1 is a key target in this space. Ladademstat, a uniquely potent and selective LSD1 inhibitor, has already shown a safe profile and high and prolonged responses in AML patients in combination with azacitidine,” Ana Limon, senior vice president of clinical development and global medical affairs at Oryzon said in a statement. “Ladademstat’s excellent pharmacologic properties and synergy with Flt3 inhibitors make this study a very solid proposition for the treatment of this relapsed/refractory patient population. At Oryzon, we are thrilled to pioneer this momentum in creating next-generation medicines.”
Elsewhere around the globe:
Sigrid Therapeutics: Sweden’s Sigrid Therapeutics announced the publication of a scientific study in the peer-reviewed European Journal of Pharmaceutics and Biopharmaceutics that suggests that interactions between micron-sized mesoporous silica particles, lipid digestion and absorption pathways are a likely mechanism for reducing calorific uptake. The results are compatible with previous findings that the mode of action for MSPs acting as “molecular sieves” block food enzyme activity, the company said. Several previous studies, both in animals and in man, have shown promising results in applying mesoporous silica particles (MSPs) to prevent type 2-diabetes and treat obesity.
Atrogi: Also based in Sweden, early-stage company Atrogi received approval from the German authorities BfArM to initiate a Phase I study with their small molecule drug candidate ATR-258 in healthy volunteers and type 2 diabetics. The trial is expected to be completed by the end of 2022. Atrogi believes ATR-258 has the potential to produce a frontline treatment for type 2 diabetes that produces minimal side effects.
University of Waterloo: The Ontario-based university is studying a new magnetic resonance imaging (MRI) form that can make cancerous tissue glow in medical images. The MRI is thought to help doctors more accurately detect and track the progression of cancer over time. The innovation creates images in which cancerous tissue appears to light up compared to healthy tissue, making it easier to see. Irregular packing of cells leads to differences in how water molecules move in cancerous tissue compared to healthy tissue. The new technology, called synthetic correlated diffusion imaging, highlights these differences by capturing, synthesizing and mixing MRI signals at different gradient pulse strengths and timings.
AEterna Zentaris: Also based in Ontario, Aeterna Zentaris provided an update on its ongoing Phase III study assessing macimorelin for the diagnosis of childhood-onset growth hormone deficiency (CGHD). The DETECT-trial is a multicenter, open-label trial to investigate the efficacy and safety of a single oral dose of 1.0 mg/kg macimorelin acetate as a growth hormone stimulation test in pediatric patients with suspected growth hormone deficiency.
Saniona: Denmark-based Saniona announced an ongoing ion channel research collaboration with Boehringer Ingelheim has advanced to the next stage. The two companies first entered into a collaboration in 2020. The partnership is focused on a novel, undisclosed CNS ion channel target for schizophrenia. Saniona receives ongoing research funding and may receive up to €76.5 million in milestone payments as well as royalties on worldwide net sales.
CanSino Biologics: China-based CanSino announced its Recombinant Novel Coronavirus Vaccine was approved by the Ministry of Health Malaysia and the Indonesian National Agency of Drug and Food Control as a heterologous booster. In addition to Malaysia and Indonesia, Convidecia has been approved for use as a heterologous booster in China and Argentina for national vaccination programs in February 2022 and November 2021. It is also the first and only adenovirus-vectored vaccine to be included in the heterologous vaccination program in China.
Nucleai: AI-powered spatial biology company Nucleai, based in Israel, closed a $33 million Series B financing round. Nucleai will use the funds to develop its platform and expand its commercial footprint across biopharmaceutical companies and contract research organizations, who are applying its technology throughout translational research, clinical trials, and novel applications for drug discovery. The financing was led by Section 32 and Sanofi Ventures. This Series B financing brings Nucleai’s overall funding to close to $50 million since the company was founded four years ago.
ITM: Germany’s ITM Isotope Technologies Munich closed a €33 million equity investment fund from the Indigenous Critical Infrastructure Fund Canada (ICIF) and a private equity fund managed by Portland Investment Counsel Inc. The proceeds will primarily be used for the finalization of the late-stage development of the company’s lead candidate, ITM-11, a targeted radiopharmaceutical currently being evaluated in two Phase III clinical trials for the treatment of gastroenteropancreatic neuroendocrine tumors, a high-need cancer indication. In addition, the funding will be used to accelerate the strategic development of additional radiopharmaceutical candidates in ITM’s broad proprietary pipeline and the expansion of ITM’s radioisotope supply capabilities.
Closed Loop Medicine: U.K.-based Closed Loop announced that the last patient has completed participation in a clinical trial investigating the company’s integrated precision care solution for hypertension patients.
Telix Pharmaceuticals: Based in Australia, Telix Pharmaceuticals is building a radiopharmaceutical production facility in Brussels, Belgium. The state-of-the-art facility will serve as the primary European manufacturing site for the company’s products. It will also be an integral hub for Telix’s R&D activities, specifically in relation to the scale-up of radioisotope production.
Hikma Pharmaceuticals: London-based Hikma Pharmaceuticals announced its venture capital arm, Hikma Ventures led a $15 million financing round for Activ Surgical, a company that aims to revolutionize access to surgical care.
