Actis Biologics has raised $50 million to fund research for the development of colorectal cancer. While around $5 million was raised via grants and soft loan from the Department of Science and Technology, the remaining $45 million has been in the form of investment and loan by the ABI of the US.
The Mumbai-based company which has operations in the US and Malaysia is also planning to raise another $30 million for funding organic and inorganic growth efforts.
As a part of its global trial for the drug for the colorectal cancer drug ‘Angiozyme’, the company has entered the phase III clinical trials in the country.
It is now looking for strategic tie-ups with domestic pharma companies and multinational companies for phase III studies. While dosing study is only 24 weeks, it expects another 18 months to go by, before the product enters the market.
Over $250 million has gone into the development of this molecule. It will cost another $65 million to develop this molecule of which $50 million has already been raised. Part of the $30 million will be used for further development of this molecule i.e. for the completion of phase III in India.
“We are just starting the process of exploring potential strategic tie-ups and hence its too early to talk about it now”, Sanjeev Saxena, Chairman & Chief Executive Officer, Actis Biologics told Pharmabiz in an email interaction. Efforts to raise additional funds from govt. and non govt sources are continuing, he added.
The advanced production plant and research centre at Marol Naka, Mumbai, spans 18,000 sq ft to develop various pharmaceutical products.
Plans are underway to set up a larger pilot plant and manufacturing centre on 11 acres at Khopoli, Maharashtra. These facilities have one of the best current Good Laboratory Practices (cGLP) laboratories for recombinant, mammalian and bacterial yeast cultures.
The facility has level 2t, gene therapy laboratories with incineration at exhaust points to control any virus spillage and positive pressure corridors. Besides, all laboratories are in a clean zone environment and accessible only with the help of electronic keys and electronic air-lock system.
Currently, the company has no manufacturing plants but has five acres of land in Khapoli (close to Mumbai), where it plans to set up the plant for manufacture of Angiozyme. The initial plant size will be 20,000 sq ft of cGMP area and will be doubled the following year. It is expected to reach about 150,000 sqft of cGMP area in three years of launch to to keep up with expected demand. Additional land will be acquired as and when the technologies mature.
Further, Actis has entered into Malaysia after it had teamed up with a local company to fund the development of Biocity, a project on 270 acres. The Biocity by the government of Malaysia would be patterned on the biotech centres around the world, like South San Francisco, the hub of biotechnology, San Diego, Seattle, Boston etc. It will not only have the biotech outfits but also, houses for employees,a commercial complex and a healthcare centre etc.
The company has three subsidiaries: Kohinoor Biotech which focuses on a Ribozyme tech platform, Aum Life Sciences, engaged in the development of various recombinant proteins and MAbS , Mercury Biotech which develops gene therapy- based products and Deep Biotech, engaged in immune-therapies. According to Saxena, the technologies are still being developed by Actis and will be provided to these companies at an appropriate time.
Actis is a Department of Scientific Industrial Research recognized R&D centre which is carrying out research of recombinant proteins, gene therapy and antisense drugs.
Products in the pipeline comprises VFF2 which is a promising technology for production of various off patent biotech products at less than one-tenth of the cost of the original brand. The ICICI‘s Technology Development Fund provided by the World Bank to India for for promising projects is managed by ICICI Bank. Out of the total $2 million cost of the project, $ 1million was provided as a conditional grant. This technology has now been developed and is entering the commercialization phase.
The second promising technology under development is MSP36 which was reviewed by a scientific group of the government of India. The project was funded as a soft loan by the Department of Biotechnology (DBT) to the tune of $ 2 million, out of the total $3 million cost of the project. Thee third is Angiozyme for colorectal cancer in Phase III.
The fourth is LIV1 which has 20 patents, reviewed by the US FDA and given an Orphan drug status. The technology focuses on making existing drugs more effective and less toxic by creating a more targeted delivery mechanism. The first application developed is for liver cancer and works by having existing chemotherapy agents be targeted to a particular receptor on the liver cells and hence allows the full intake into the cell and then destroy the cell. These receptors are found only on liver and kidney cancer cells. This technology can be further tailored to target other cells for other diseases.