Fosgemcitabine palabenamide

France’s TreeFrog Therapeutics, a privately-held biotech startup, closed a $75 million (€64M) Series B financing round, named a new chief executive officer and established an office in Boston to gain a U.S. toehold. TreeFrog is developing stem cell-derived cell therapies developed with the company’s C-Stem platform. Data published in multiple journals indicated C-Stem is the only technology capable of maintaining genomic integrity through large-scale human-induced pluripotent stem cells (hiPSC) expansion. Based on best-in-class preclinical results in Parkinson's disease, TreeFrog Therapeutics is preparing for a first-in-human trial in 2024, and intends to expand its pipeline of cell therapies through in-house programs and partnerships. With the infusion of funds, TreeFrog brought in Frederic Desdouits as its new CEO. Desdouits had been serving as an independent director of the board. He previously served as CEO of PCAS and managing director at Seqens CDMO. Before that, Desdouits was executive vice president, Corporate Licensing, Acquisition and Market Intelligence, and director of U.S. Pharmaceuticals, Pierre Fabre Group. The Series B round was led by Bpifrance Large Venture, which is part of the French Public Investment Bank. Leonard Green & Partners, Bristol Myers Squibb and Xange also joined in the round. It was also announced that Kevin Alessandri, co-founder of the company, will relocate in early 2022 to Boston to lead the newly created U.S. subsidiary, TreeFrog Therapeutics Inc. Relief Therapeutics – Switzerland-based RELIEF Therapeutics received updated guidance regarding potential conditional marketing authorization from the U.K.’s Medicines and Healthcare products Regulatory Agency regarding the development of its lead investigational drug, RLF-100 (aviptadil), for the treatment of respiratory deficiency due to severe COVID-19. Based on the meeting, the company believes such an authorization through a rolling review or expedited process will be appropriate. A rolling review allows the MHRA to start review of various sections of a submission as they are completed by Relief and provided to the MHRA. HutchMed – China’s HutchMed announced the Center for Drug Evaluation, a part of China’s National Medical Products Administration, granted Breakthrough Therapy Designation to amdizalisib (HMPL-689), a highly selective and potent PI3Kδ inhibitor, for the treatment of relapsed or refractory follicular lymphoma (FL), a subtype of non-Hodgkin’s lymphoma (NHL). To date, amdizalisib has been shown to be well tolerated, exhibiting dose-proportional pharmacokinetics, a manageable toxicity profile, and single-agent clinical activity in relapsed/refractory B-cell lymphoma patients. Amdizalisib is also being evaluated in an ongoing Phase I/Ib study in the U.S. and Europe in patients with relapsed or refractory NHL. CytoLynx Therapeutics – The new China-based subsidiary of Cytovia Therapeutics closed a $45 million investment round that will finance the IND-enabling and clinical development of the company’s pipeline. The company is developing allogeneic “off-the-shelf” gene-edited iNK and CAR (Chimeric Antigen Receptor)-iNK cells derived from induced pluripotent stem cells (iPSCs) and NK cell engager multifunctional antibodies. The financing was supported by TF Capital along with YF Capital, BioTrack Capital, Ruihua Capital, and TG Sino-Dragon Fund. AGC Biologics – Germany-based AGC Biologics is expanding its Heidelberg facility in order to increase manufacturing capacities for plasmid-DNA (pDNA) and messenger RNA (mRNA) projects. With this expansion, AGC Biologics is boosting its current 100L and 1,000L manufacturing capacities for a variety of different biologics projects by adding an additional GMP manufacturing line. The expansion includes a new GMP cleanroom for mRNA development and manufacturing, a new process development lab for microbial protein and cell and gene therapy (C>) projects, and additional warehouse capacity. The expanded capabilities will also allow AGC Biologics to meet the increasing demands of the rapidly growing C> market. The facility's new capabilities will be fully operational in 2023. Telix Pharmaceuticals – Australia-based Telix announced the U.S. Food and Drug Administration accepted an Investigational New Drug Application for its investigational kidney cancer therapy, TLX250 (177Lu-DOTA-girentuximab). The drug will be assessed in the Phase II STARLITE 2 study in patients with advanced clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer. TLX250 targets carbonic anhydrase IX (CA9), a protein that is highly expressed in patients that are likely to demonstrate a more limited response to cancer immunotherapy. Zai Lab Limited – China’s Zai Lab announced that the Center for Drug Evaluation of the National Medical Products Administration granted Breakthrough Therapy Designation for bemarituzumab, for first-line treatment for patients with FGFR2b overexpressing and human epidermal growth factor receptor (HER2)-negative metastatic and locally advanced gastric and GEJ cancers in combination with modified FOLFOX6 (fluoropyrimidine, leucovorin, and oxaliplatin). Abivax– France-based Abivax SA provided additional analysis of data regarding its lead compound ABX464 in ulcerative colitis. According to the latest additional analysis, the results after 16 weeks of once-daily oral treatment with ABX464 confirm and further extend the data with respect to the efficacy and the good safety pro observed after 8-weeks of induction treatment. That data was initially announced in May. The baseline disease characteristics were well balanced across all ABX464 dose groups and the placebo group. Enrolled patients suffered from longstanding UC with an overall median duration of 5.45 years. At inclusion, 71.4% of the patients showed a severe disease profile, with a baseline modified Mayo Score of 7 to 9 points. About 50% of the patients in each ABX464 treatment group and placebo were previously refractory to biologic treatments and/or JAK inhibitors. The majority of the patients was treated with concomitant UC medication at a stable dose. ObsEva SA – Switzerland’s ObsEva announced it submitted a New Drug Application to the FDA for linzagolix for the treatment of uterine fibroids. Linzagolix is an oral GnRH receptor antagonist with potential best-in-class efficacy, favorable tolerability profile, and unique and flexible dosing options. If approved, linzagolix will be the only GnRH antagonist in uterine fibroids with a low dose non-add-back therapy (ABT) option. Data is based on the Phase III PRIMROSE 1 and PRIMROSE 2 studies. In both clinical studies, all doses showed statistically significant and clinically relevant reductions in HMB compared to placebo. Biophytis SA – France-based Biophytis AS announced the Data Monitoring Committee cleared its Phase II/III COVA study in COVID-19 to continue. The COVA study primary endpoint is the proportion of participants with “negative events” of either the following: all cause mortality; respiratory failure defined as requiring mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO). Sensorion – Also based in France, Sensorion forged a collaboration with Sonova to introduce genetic analysis to the routine diagnosis of progressive hearing loss in adults. The key element of the collaboration is a natural history study including genotyping thousands of patients suffering from early onset of severe age-related hearing loss with the aim of confirming hundreds of patients for specific mutations. NuCana – Scotland-based NuCana plc completed enrollment in its Phase III NuTide:121 study. The study, is comparing Acelarin combined with cisplatin to the global standard of care, gemcitabine plus cisplatin, as a first-line treatment for patients with advanced biliary tract cancer, has enrolled 418 patients with measurable disease. The first interim analysis will be conducted after the 418th patient has completed 28 weeks of follow-up, which is expected to occur in the first half of 2022. Gedea Biotech – Sweden’s Gedea has enrolled more than 50% of patients in the NEFERTITI clinical study of its lead product, pHyph, a vaginal tablet for topical treatment of bacterial vaginosis (BV). Bacterial vaginosis is the most common vaginal infection and affects around 10-30% of women of reproductive age.