Biopharma and life sciences companies from across the globe provide updates on their pipelines and business operations.
Singapore-based AUM Biosciences raised $27 million in a Series A financing round. The company said the funds will be able to fuel its vision to develop a pipeline focused on developing medicines for targets that are currently considered undruggable.
AUM Biosciences has several assets in its pipeline, including AUM001, a selective, synergistic MNK inhibitor that addresses multiple key pathways, including RAS-MAPK, PI3K and MYC. AUM001 is being developed in combination cancer therapies to minimize resistance risk, overcome resistance and improve responses in cancer patients. Also, AUM has AUM601, a promising therapy for TRK fusions and solvent front mutations and AUM302, a first-in-class small molecule that co-targets PIM, PI3K and Mtor, which is believed to address significant unmet need in resistance emergence.
The Series A financing round was led by private equity funds including Singapore-based Everlife and health sciences investment firm SPRIM Global investments.
Earlier this year, AUM had entered into a strategic collaboration agreement with Handok Inc. and CMG Pharmaceutical Co. Ltd. Additionally, AUM Biosciences and Newsoara Biopharma also announced a five-year transformational strategic partnership in 2020 to co-develop and co-discover next-generation cancer therapeutics.
Elsewhere around the globe:
OSE Immunotherapeutics SA – France-based OSE secured a patent from the European Patent Office related to Tedopi, a neoepitope therapeutic vaccine, protecting a method for manufacturing a ready-to-use peptide emulsion for its use in the treatment of cancers in HLA-A2 positive patients. This patent will provide protection until 2038. Tedopi has shown positive final results from the Atalante 1 Phase III study in non-small cell lung patients after secondary resistance to immune checkpoint inhibitors. In parallel, additional Phase II clinical trials are ongoing to continue developing Tedopi in metastatic NSCLC after failure to first-line chemo-immune checkpoint Inhibitors and in other cancer indications in combination with ICIs or with chemotherapy.
CatalYm – Germany-based CatalYm announced an update to the dose-escalation part of its GDFather study assessing its lead product candidate, CTL-002, as a monotherapy and in combination with an immune checkpoint inhibitor, nivolumab. CTL-002 is a neutralizing antibody that specifically targets growth and differentiation factor 15.& Patients treated with CTL-002 and nivolumab at the first four of five dose levels to be evaluated showed an excellent tolerability profile and no dose limiting toxicities, the company said. Preliminary sequential tumor biopsy analyses for dose level 1-3 showed signs for a tumor-selective influx of T cell under CTL-002 treatment.
RhoVac AB – Oncology-focused RhoVac, based in Sweden, has retained the services of Stifel Nicolaus Europe Limited, a global investment bank, as its exclusive financial adviser. The company said the bank will provide advice related to a potential transaction or partnership deal that could be associated with the company’s lead drug candidate, RV001. A potential deal hinges on the outcome of the company’s Phase IIb study in prostate cancer, which is expected to read out next year. Stifel has a vast experience of both M&A and license deals.
OPTIMA – Optimal Treatment for Patients with Solid Tumours in Europe Through Artificial intelligence), a public-private partnership that seeks to use artificial intelligence to improve patient care in breast, lung and prostate cancers, was formed this week with multiple global partners. A joint undertaking of the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA), OPTIMA’s goal is to design, develop and deliver the first interoperable, GDPR-compliant real-world oncology data and evidence generation platform in Europe, to potentially advance treatment for patients with solid tumors in the three cancers.
Dotmatics – U.K.-based Dotmatics forged a partnership with Main-based RockStep Solutions, a software development company. The collaboration combines the simple, unified, real-time access to all research data afforded by the Dotmatics Platform with RockStep’s in vivo study management software, dubbed Climb. The partnership is expected to enable a fully integrated workflow that will save researchers’ time and improve ease of operation as a further step towards the Lab of The Future.
Hansoh Pharmaceuticals Group – China’s Hansoh and Korea-based OliX Pharmaceuticals announced a licensing and collaboration agreement to discover, develop and commercialize siRNA therapeutics in key targeted indications in Greater China, which includes mainland China, Taiwan, Hong Kong and Macau. As part of the collaboration agreement, the companies will leverage OliX Pharmaceuticals’ GalNAc-asiRNA platform to address various liver-based targets that are implicated in cardiovascular, metabolic, and other indications, utilizing Hansoh’s strong R&D, manufacturing and commercialization capabilities in Greater China.
InflaRx NV – Based in Germany, InflaRx NV completed enrollment of its Phase III vilobelimab study in severe COVID-19 patients. The randomized, double-blind and placebo-controlled Phase III part of a Phase II/III study enrolled 369 mechanically ventilated patients with COVID-19 across sites. Patients were randomized 1:1 to receive either vilobelimab or placebo. All patients received standard of care. The primary endpoint is 28-day all-cause mortality; key secondary endpoints include assessment of organ support and disease improvement. Treatment is still ongoing and topline results are expected to be available in the first quarter of 2022.
Salipro Biotech AB – Sweden-based Salipro entered into a collaboration and licensing agreement with AbCellera for access to its proprietary Salipro Platform, which stabilizes challenging G protein coupled receptor (GPCR), ion channel, and transporter antigens. Under the terms of the agreement, Salipro Biotech will receive an upfront payment, research payments and is eligible for downstream milestone payments for a defined number of targets.
Kadimastem – Based in Israel, Kadimastem met with the U.S. Food and Drug Administration regarding IsletRx, the company’s cell therapy product in development for the treatment of diabetes. Kadimastem received a response document from the FDA noting that the company’s clinical development plan for IsletRx was being positively considered. It also included constructive comments and guidelines applicable for the next step pre-IND submission.
BioNova Pharmaceuticals – Shanghai-based BioNova and Sutro Biopharma, Inc. announced an option agreement for BioNova to develop and commercialize STRO-001, a CD74-targeting Antibody-Drug Conjugate (ADC), for patients with hematologic cancers, in Greater China, including mainland China, Hong Kong, Macau and Taiwan. BioNova has the option to obtain exclusive rights to develop and commercialize STRO-001 in Greater China. BioNova will pursue the clinical development, regulatory approval, and commercialization of STRO-001 in multiple indications, including non-Hodgkin’s lymphoma, multiple myeloma, and leukemia in the licensed territory.
Relief Therapeutics – Switzerland’s RELIEF Therapeutics and its U.S. partner NRx Pharmaceuticals, Inc. submitted a revised Investigational New Drug module on the manufacturing of Zyesami (aviptadil) to the U.S. Food and Drug Administration. The revision contained documentation that confirmed Nephron Pharmaceuticals, Inc. is prepared to supply Zyesami on a commercial scale.
Smart Immune SAS – France’s Smart Immune announced the institutional review board (IRB) of the Memorial Sloan Kettering Cancer Center (MSK) has approved the start of the company’s Phase I/II clinical trial. MSK will start enrolling patients in November. Study subjects chosen are AML/ALL patients who are eligible for allogeneic hematopoietic stem cell transplant (HSCT) and will receive their routine stem-cell transplant of CD34+ cells at first, and then Smart-101 at approximately day 7 after initial transplant. In all cases, Smart-101 ProTcells will be cultured from the same donor from whom the patient has received the initial CD34+ HSCT. This trial will rely upon a prospectively generated control database of AML/ALL patients who undergo routine HSCT’s at MSK.
Cellumed Co. – Korea’s Cellumed and Germany’s ARTES Biotechnology GmbH entered into a licensing agreement aimed at the generation of microbial production cell lines, processes and documentation for the cGMP manufacturing of two enzymes required in the manufacturing process of mRNA vaccines. Under this agreement, ARTES shall be responsible for the development of high yield microbial cell lines expressing two recombinant enzymes.
Oryzon Genomics, SA – Spain’s Oryzon presented final data from its Phase II SATEEN study of vafidemstat in multiple sclerosis. Vafidemstat is being investigated as a treatment to reduce the inflammatory response in MS. The small scale study was not powered to gain conclusive efficacy, however, the company said selected patients treated with vafidemstat showed improvement in one or more clinical readouts. In addition, promising pharmacodynamic anti-inflammatory activity was reported in most of the vafidemstat-treated patients compared to placebo.
