Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
Cytovation AS, a clinical-stage oncology company based in Norway, raised $20 million in a Series A financing round. Funds will be used to advance the development of its immunotherapy candidate CyPep-1 in combination with Keytruda as a potential treatment of solid tumors.
Lars Prestegarden, chief executive officer of Cytovation, said the company is making significant progress with CyPep-1 in the Phase I/II clinical trial. Following what Prestegarden called “promising data,” he said the company has begun dosing of CyPep-1 in combination with Keytruda in patients with a range of solid tumors.
CyPep-1 is designed to eliminate cancer cells through the formation of pores in the plasma membrane, which causes the release of cancer specific antigens to the immune system. That promoted an inflammatory microenvironment and induces a tumor-specific immune response by in situ vaccination, the company said. Preclinical data suggest this mode of action is highly synergistic in combination with checkpoint inhibitors.
“These new proceeds will enable us to further advance and expand our clinical development plans in cancer, and we look forward to reporting further data from this clinical program in 2022. Additionally, we will now have the financial flexibility to investigate opportunities to expand our CyPep-1 development pipeline,” Prestegarden said in a statement.
The Series A round was led by Sandwater, a Norwegian venture capital firm that invests in groundbreaking companies, and Canica, a large, privately owned investment company operating out of Norway and Switzerland.
Elsewhere around the globe:
Juva Life – Canada-based Juva Life, a cannabis-focused company, has advanced JUVA-041 into pre-clinical development. JUVA-041 is a small molecule isolated from cannabis that inhibits key cytokines proven to be of clinical relevance in inflammation.
MediWound – Israel-based MediWound Ltd. announced positive topline results from its Phase II study of EscharEx for the debridement of venous leg ulcers (VLUs). The company said the clinical trial met its primary endpoint. Patients treated with EscharEx have a statistically significant higher incidence of complete debridement compared to the gel vehicle, the company said. In addition to the positive results, the Independent Data Monitoring Committee found that safety concerns were identified in the study population. EscharEx was well-tolerated and patient baseline characteristics were comparable across all study arms.
BenchSci –Also based in Canada, BenchSci announced it raised $50 million in a Series C financing round. The latest fundraising effort brings the company’s finances to a total of approximately $97 million. BenchSci said the funds provide the company with the capabilities to expedite the expansion of its transformative AI-powered software platform that accelerates research in 16 top-20 pharmaceutical companies, The Series C financing was led by Inovia Capital and TCV, with participation from existing investors.
MaaT Pharma – France’s MaaT Pharma announced positive interim engraftment data from the first four cohorts of the CIMON trial with MaaT033, the company’s high-richness, high-diversity, Microbiome Ecosystem Therapy for oral administration. In this dose-ranging study, data from four out of five intended cohorts showed satisfactory safety and good microbiome engraftment. Based on this positive data, Maat Pharma intends to halt the CIMON trial in order to enable faster than planned completion and evaluation of the full data. The company hopes to advance MaaT033 into a planned Phase II/III trial in the second half of 2022. Complete results from the Phase Ib CIMON trial are expected in the first half of 2022.
ITM – Germany’s ITM Isotope Technologies Munich has treated its first patient in the second pivotal Phase III COMPOSE clinical trial evaluating lead radiopharmaceutical candidate, ITM-11 as a potential treatment for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM-11 is a Targeted Radionuclide Therapeutic consisting of the high-quality radioisotope no-carrier-added lutetium-177 fused with a somatostatin analogue to specifically target somatostatin receptor-positive (SSTR+) GEP-NETs. The radiopharmaceutical is also being investigated in ITM’s ongoing pivotal Phase III COMPETE trial in patients with grade 1 and 2 GEP-NETs. GEP-NETs are rare types of tumors that can occur in the pancreas or in other parts of the gastrointestinal tract. Due to their frequent asymptomatic and progressive nature, GEP‑NETs often present late with advanced disease requiring innovative therapeutic measures.
Exabel – London-based Exabel forged a partnership with MedMine, a hospital supplies procurement company, to create the MedMine Insights Platform. This will provide portfolio managers and hedge funds additional insights based on MedMine’s medical products purchase data.
Neurophth Therapeutics – China’s Neurophth announced the European Medicines Agency Committee for Orphan Medicinal Products granted the Orphan Drug designation to the Company’s lead gene therapy drug candidate, NR082 (rAAV2-ND4). NR082 is being developed for the treatment of Leber’s hereditary optic neuropathy (LHON) associated with mtND4 mutation. NR082 is a novel recombinant adeno-associated viral vector, serotype 2, which contains a mitochondria codon-optimized NADH-dehydrogenase subunit 4 (ND4) gene under the control of the cytomegalovirus promoter and enhancer.
Daewoong Pharmaceutical – Based in South Korea, Daewoong confirmed Phase III results from a combination study of an Enavogliflozin monotherapy and a combination therapy with Metformin. Daewoong’s Enavogliflozin is an SGLT-2 inhibitor. The recent topline report makes it highly anticipated for the successful outcome of the Phase III clinical trial of which the final report will be released in the second half of this year, the company said.
OSE Immunotherapeutics SA – French company OSE Immunotherapeutics announced that the Japanese Patent Office has issued the notice of allowance for a new patent covering Tedopi, a combination of neoepitopes, for use after failure with PD-1 or PD-L1 immune checkpoint inhibitor treatment in HLA-A2 positive cancer patients.
Evaxion Biotech – Denmark-based Evaxion announced the publication of a paper on personalized therapy with EVX-01 in patients with metastatic melanoma in the open access journal OncoImmunology. The paper, entitled, “Personalized therapy with peptide-based neoantigen vaccine (EVX-01) including a novel adjuvant, CAF09b, in patients with metastatic melanoma”, outlines results from a continuing Phase I/IIa trial of EVX-01, a novel personalized cancer immunotherapy based on Evaxion’s proprietary PIONEER AI technology. Data from five patients who were dosed in the study is showing that EVX-01 is safe. Also, study data is showing that EVX-01 is capable of eliciting T-cell responses in a clinical setting where the patients received concurrent standard immune therapy. Results demonstrated an antitumor effect in combination with anti-PD-1 treatment.
Core One Labs – Vancouver-based Core One forged an agreement with the University of Barcelona. Through the agreement, Maria Carmen Escolano, a full professor at the University’s Unit of Medicinal Chemistry in the Faculty of Pharmacy and Food Sciences, and her team will provide technical guidance for the in vitro development of Akome’s psychedelic based bioactive compounds targeting Major Depressive Order, Stroke, Parkinson’s disease and Alzheimer’s disease.
