Author : adminDate : 2020-05-07 15:31

Apealea completes Pre-NDA meeting

On April 30th, Oasmia pharmaceutical AB (Oasmia) held FDA's ovarian cancer pre-NDA meeting for Apealea, which Elevar Therapeutics (Elevar) secured global rights in March. The meeting was held over the phone due to COVID-19 and based on the discussions with the FDA, we will faithfully make preparations for the NDA. 

Based on marketing authorization in Europe, Apealea plans to expand its sales area, with discussions for launch in individual European countries, the Middle East and North Africa (MENA), China, and Latin America. 

NDA of Rivoceranib

Apart from our efforts, the NDA is somewhat delayed due to COVID-19, but there will be no change in the framework. 

In addition, the American Association for Cancer Research (AACR) recently announced the results of Rivoceranib for Small-Cell Lung Cancer. 

Immunomic Therapeutics (ITI) ends Investment and Acquisition Procedures 

HLB ($ 40 million ) and HLB consortium ($ 21.3 million, including Next Science) invested a total of $ 61.3 million.

Related Link: https://www.immunomix.com/immunomic-therapeutics-announces-close-of-61-3m-financing/

As a result, the company secured a 47.6% stake (based on common stocks) and plans to expand the stake further under the acquisition contract. In addition, five executives from HLB will join the board.

ITI's Development Status of COVID-19 Vaccine

ITI's vaccine candidate, ITI-SARS, has now entered animal testing. In addition, it has recently started a collaboration with Epivax and Pharmajet, and ITI will lead to the development of vaccines. ITI has applied for funding to the Biomedical Advanced Research and Development Authority (BARDA) and is currently awaiting results, and plans to start a phase 1 trial in the second half after the animal experiment. ITI's vaccine targets multiple antigens and multiple epitopes. especially, since it is involved in the functionally essential epitopes of the virus and as the UNITE technology itself is flexible, the vaccine is expected to be effective against various mutated viruses.