Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
Germany-based Affimed’s ongoing Phase I study of its lead candidate for hematological cancers is showing significant promise.
The latest data from an ongoing Phase I study of AFM13 shows a 100% objective response rate at the highest dose, with a 42% complete response rate in 12 patients, the company said. So far, the data shows seven complete responses, nine partial responses and two patients with disease progression. AFM13 is one of the company’s innate cell engager programs that link NK cells or macrophages with tumor cells, which is designed to facilitate the killing of cancer cells. As of Oct. 31, a total of 18 patients with CD30-positive relapsed or refractory Hodgkin and non-Hodgkin lymphomas were treated with the novel combination of cbNK cells pre-complexed with AFM13.
As part of the dose-escalation phase, three doses have been investigated. The tolerability profile so far has been highly positive with no serious adverse events such as cytokine release syndrome, neurotoxicity syndrome, or graft-versus-host disease observed, the company said.
Andreas Harstrick, chief medical officer at Affimed, said the patients in the study have all been heavily pre-treated with a median of 6 lines of prior therapy and had progressive disease after their previous line of therapy.
“We are encouraged by the response rates that we continue to observe in these difficult to treat patients. Combining our ICE molecules with NK cells is an integral part of our strategy to bring innovative therapies to patients in need. We believe these preliminary data provide further validation of this approach,” Harstrick said in a statement.
Elsewhere around the globe:
Xeltis – Netherlands-based Xeltis lands €15 million European financing from the European Investment Bank (EIB). Xeltis intends to use the funding to accelerate the clinical programs of three restorative devices that can substantially impact cardiovascular medicine. According to the company, Xeltis’ devices are vascular grafts and heart valves that are designed to “turn into living valves and vessels by harnessing the body’s natural healing process and by facilitating tissue formation once implanted.” Xeltis’ endogenous tissue restoration (ETR) uses the patient’s natural healing system to restore heart valves and blood vessels with the patient’s own tissue, the company noted.
Obseva SA – Switzerland-based Obseva announced the U.S. Food and Drug Administration accepted its New Drug Application for linzagolix as a management therapy for heavy menstrual bleeding associated with uterine fibroids in premenopausal women. Linzagolix has a differentiated profile and if approved, would be the first and only GnRH receptor antagonist with flexible dosing options for uterine fibroids, the company said. The NDA is based on data from the two Phase III PRIMROSE trials, including a low dose option to address the needs of women who cannot or do not want to take hormones. The FDA set a target action date of Sept. 13, 2022.
Transgene – France-based Transgene and Japan’s NEC Corporation announced positive preliminary immunogenicity and clinical data for TG4050, a jointly-developed individualized neoantigen cancer vaccine. TG4050 is the first candidate based on Transgene’s myvac platform. The companies are harnessing the power of NEC’s AI capabilities to evaluate TG4050 in two ongoing multicenter Phase I trials in patients with ovarian cancer and head and neck cancer.
Cardiologs – Also based in France, Cardiologs received 510(k) clearance from the FDA to use its AI-powered cardiac diagnostics platform for pediatric cardiology. In its announcement, the company said the clearance was based on an analysis of the company’s improved deep learning algorithm, which first received FDA clearance in 2017. Results from the new model showed the updated algorithm “improved average sensitivity over all major arrhythmias by 14% while reducing the number of false positives by 48%.” Additionally, arrhythmias detection performance was similar across all age groups, including newborns and adolescents, regardless of the EKG recording device, Cardiologs said.
MEDIAN Technologies – Another French company, Median Technologies announced new capabilities of its lung cancer screening CADx that can characterize malignant from benign nodules. New results specifically focus on the characterization of stage 1 lung cancer nodules, using Median’s proprietary iBiopsy deep learning algorithm on low-dose chest computed tomography (LDCT), the company said.
Qurient Co. – Korea-based Qurient forged a collaboration with Merck to pair Q702 a triple inhibitor of Axl/Mer/CSF1R, with Keytruda. Qurient will conduct a phase Ib/II study to assess the combination for the treatment of selected advanced solid tumors, including esophageal, gastric, hepatocellular and cervical cancers. Terms of the collaboration were not disclosed.
