BY SUMI KHAN
Dhaka, July 6 (IANS) Claiming success in preliminary animal modeling trial of Covid-19 vaccine, Globe Biotech Limited has claimed to be the first company from Bangladesh to have a Covid-19 vaccine under development. It says it is aiming for a December 2020 availability of the vaccine in the market.
They received the result after conducting the preliminary trial on five rabbits from June 10 to June 28, says Dr Asif Mahmud, Assistant Manager and incharge of Research and Development, Globe Biotech Limited, in an exclusive interview to IANS.
Earlier, he led the team to claim success in preliminary trial for the vaccine in national capital Dhaka on Thursday afternoon.
Excerpts from the interview of scientist Dr Asif Mahmud
Q: Globe Biotech is a research company in Bangladesh. Is it a branch of any MNC in the world?
A: No, in fact, Globe Biotech Limited is a Biological Drug Discovery Company in operation in Bangladesh since 2015. The project was started by our CEO Kankon Nag and COO Dr Nazneen Sultana. We have prepared 18 bio similar. We are also working on our own Nobel drug. After completing the animal trials of 6 bio similar, we have applied for Ethical Approval through our PRO at the Bangladesh Medical Research Council (BMRC) in Dhaka. We have that ability and experience to invent a vaccine against this pandemic. Under the supervision of our CEO and COO, after a Covid-19 patient was reported in Bangladesh on March 8, we shifted our focus to SARS-Cov2 and started 3 new projects. Number one — we will do kit development; number two — we will do vaccine development for the country; and in the last — the biological molecule development.
Q: Is the research by Globe Biotech independent? Or is your research done under the supervision of any other country?
A: Globe Biotech is researching independently. Under the supervision of our CEO and COO, both of whom supervised the team from Canada. They are experienced in this matter. Dr Kankon was directly involved in the HIV vaccine project. He is using that experience here. We are conducting research under their direct supervision. A 12-member scientific group started research on March 18 under the leadership of both.
We have taken some 76 genome sequences under consideration, wherein we found that a sequence (numbered 614) has a mutation point that they have used for amino acid bonding.
Q: Which method did you follow for the research you are undertaking? And how do you make sure it will work to protect people from Covid-19?
A: We went for the SPR method for the tests. Surface plasmon resonance (SPR) is a phenomenon where electrons in the metal surface layer are excited by photons of incident light with a certain angle of incidence, and then propagated parallel to the metal surface. It is an optical technique utilised for detecting molecular interactions. Actually, we have set a vaccine target. We have analysed the sequences from all the databases we have worldwide, including the sequences in Bangladesh. We set the target by our analysis. We have modified that target according to our needs. We have set multiple targets.
We have placed multiple delivery systems in consideration.
By applying the delivery system we have done an animal trial on rabbits.
By this we have got a very good antibody titer. And those antibodies have shown strong binding affinity with our antigen. We have additional candidates, some of which we have presented to the press. But the company is yet to apply for a patent or any publication; and before the patent is ensured it would not disclose the data received from the trial. We have said that we need to convert the data from the preliminary animal trial into a regulated animal trial. That we will do within the next 6 to 8 weeks. Then we will apply for Ethical Approval.
Q: This 6 to 8 weeks period, to get proof of animal trial? Or, for trial on humans?
A: No, we have already got proof of antibody generation in the preliminary animal trial. Now, it needs to be converted to a regulated animal trial. Because, for human trial, we have to submit it to the regulatory body for Ethical Approval. Regulated trials will require some further characterisation. Then, we will apply for human trials.
Q: Did you inform about your research to the drug administration of the country?
A: Not yet. There is no role of the regulatory body now. When we do a regulated animal trial, of course, we go to the regulatory body.
Q: What are your expectations? When will the vaccine be released?
A: We have already formulated the regulated animal trial guidelines and the tests would be concluded within four to six weeks. Thereafter, the company will seek Ethical Approval from the Bangladesh Medical Research Council (BMRC) in early September, when the data from the Regulated Animal Trial reaches us within 6 to 7 weeks.
And then, we will apply for market authorisation to the regulatory authority in December within three months after completing the phases 1, 2 and 3. If everything goes smoothly, we expect to be able to bring our vaccine to the market by December.
Q: If you get government support, do you think success for you can be faster or smoother?
A: Obviously! This will be the first discovery of this vaccine in Bangladesh. The first task always comes with more obstacles and hindrances. We will remove the obstacles with the support of the government and will bring the vaccine to the market in due course.
(Sumi Khan can be contacted at firstname.lastname@example.org)