Allarity Therapeutics A/S, of Horsholm, Denmark, provided an update on dovitinib, a pan-tyrosine kinase inhibitor, regarding the timing of the first NDA in renal cell carcinoma. The company’s preparation of the application itself is progressing as scheduled, but the third-party contract manufacturer of the registration batch of the drug is experiencing delays, in part as a result of the ongoing coronavirus pandemic. A registration batch is a mandatory component of the NDA filing. Due to the delay, Allarity is now expecting to file the NDA in 2021.
Bayer AG, of Leverkusen, Germany, said the U.K.’s National Institute for Health and Care Excellence recommended Nubeqa (darolutamide) with androgen deprivation therapy as an option for treating hormone-relapsed prostate cancer in adults at high-risk of developing metastatic disease. Darolutamide, an oral, nonsteroidal androgen receptor inhibitor, in combination with androgen deprivation therapy, is the first treatment the institute has recommended in this indication.
Curevac NV, of Tubingen, Germany, disclosed data from preclinical studies of its investigational COVID-19 vaccine candidate, CVnCoV, in mice and hamsters. The vaccine candidate elicited balanced humoral and cellular immune responses, featuring high antibody titers and very good T-cell activation. It also induced favorable Th1 cytokine levels.
Entos Pharmaceuticals Inc., of Edmonton, Alberta, said it is receiving advisory services and funding of up to CA$5 million (US$3.8 million) from the National Research Council of Canada Industrial Research Assistance Program to support development of domestic COVID-19 vaccine candidates. Entos is developing a Fusogenix DNA vaccine called Covigenix that in preclinical studies has induced a strong neutralizing antibody response plus a potent and balanced T-cell response against SARS-CoV-2. The Canadian government support will help progress the vaccine research to phase I testing.
Gilead Sciences Inc., of Foster City, Calif., completed its acquisition of Immunomedics Inc., of Morris Plains, N.J., for $21 billion.
Innate Pharma SA, of Marseille, France, said the start of the phase III trial testing monalizumab in combination with cetuximab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck triggered a $50 million milestone payment from Astrazeneca plc, of Cambridge, U.K.
New data from Innocan Pharma Corp., of Herzliya, Israel, and Calgary, Alberta, demonstrated that exosomes have the ability to enhance alveolar fluid clearance and promote epithelial and endothelial recovery through secretion of protective factors. The company also said its data show that the non-psychoactive reagent in cannabis (CBD) can significantly reduce lung damage induced by cytokine storms caused by COVID-19. Innocan is developing CDB-loaded exosomes to treat COIVD-19.
KBP Biosciences Holdings Ltd., of Princeton, N.J., said a preclinical study investigating the effect of KBP-5074, a nonsteroidal, highly selective mineralocorticoid receptor antagonist being developed for patients with hypertension and advanced chronic kidney disease (CKD), on aldosterone-mediated renal injury in the uninephrectomized SD rat CKD model showed a significant effect on urinary albumin creatinine ratio reduction, with less risk for hyperkalemia, resulting in a wider therapeutic window when compared to eplerenone. The study also showed increased urinary sodium secretion induced by KBP-5074 compared to eplerenone, which correlates with one of the expected mechanisms of action for blood pressure reduction in humans.
Medicago Inc., of Quebec City, said it reached an agreement to supply the Canadian government with up to 76 million doses of its COVID-19 vaccine, subject to Health Canada approval. Medicago will also receive CA$173 million (US$131.6 million) in funding support from the government of Canada for its vaccine research and development, and for the construction of its Quebec City manufacturing facility. Medicago announced successful production of coronavirus virus-like particle in March. It initiated preclinical trials with financial support from the government of Quebec and began phase I testing in July. Phase II trials are expected to start in early November, with phase III to begin shortly after, in December.
Nicox SA, of Paris, said it selected a new development candidate, NCX-1728, from its research program focused on nitric oxide (NO)-mediated intraocular pressure (IOP)-lowering agents. An analogue of the molecule demonstrated positive results in ocular hypertensive nonhuman primates compared to travoprost 0.1%, a prostaglandin analogue, the company added. Prostaglandin analogues are the standard of care for IPO-lowering therapies. Nicox owns exclusive worldwide rights to NCX-1728, a class of compounds where NO-mediated effects are enhanced by concomitant action of PDE5 inhibition within the same molecule. Further optimization of the ophthalmic formulations of NCX-1728 will continue prior to initiating formal pre-IND tests required for the filing of an IND application, the company added.
Orphazyme A/S, of Copenhagen, Denmark, is accelerating its commercial and other pre-launch activities for its Niemann-Pick disease type C drug, arimoclomol, which is currently under FDA priority review with a PDUFA date of March 17, 2021. As a result, the company expects a 2020 operating loss of DKK625 million to DKK650 million (US$96 million to US$104 million), increased from previous guidance of DKK500 million to DKK550 million. Orphazyme plans to end the year with more than DKK400 million in cash.
Precision Nanosystems Inc. (PNI), of Vancouver, British Columbia, said it received a commitment of up to CA$18.2 million (US$13.8 million) in support from the Canadian government under the Innovation, Science and Economic Development's Strategic Innovation Fund to develop a COVID-19 vaccine. PNI will use the investment to advance a COVID-19 mRNA vaccine candidate to clinical trials.
Sensyne Health plc, of Oxford, U.K., signed a research collaboration with New York-based Bristol Myers Squibb Co. to use Sensyne's machine learning platform to study disease progression and stratification of patients with various diseases within the broader group of myeloproliferative neoplasms. Financial terms of the deal weren't disclosed.