Gennova Biopharmaceuticals Ltd | Emcure Pharmaceuticals

Realizing the importance and potential of biologics and new technology, Emcure incorporated its biotechnology arm, Gennova Biopharmaceuticals in 2002

Gennova is dedicated to the development and production of bio-therapeutics to address life-threatening diseases across various areas. Gennova has multiple collaborations with research institutes and organizations across the globe which have helped build its expertise.

Vaccines Research & Development

Over the past few years, Gennova has been working on developing an mRNA platform for developing bio-therapeutics and vaccines. It currently has four vaccines in its pipeline including India’s first indigenously developed mRNA vaccine, HGC019 which is in Phase I clinical trials. Gennova is also leveraging this technology to develop vaccines for Zika, Rabies and Zoster which are in the pre- clinical stage.

Novel vaccine development can take anywhere between 10 – 15 years. Considering the immediate need for a vaccine against COVID 19, the developmental time for the vaccine is critical. mRNA vaccines are thus, the ideal choice given their rapid developmental timeline
mRNA vaccines are considered safe as the mRNA is non-infectious, non-integrating in nature and degraded by normal cellular mechanisms. They are highly efficacious because of their inherent capability of being translatable into the protein structure inside the cell cytoplasm
Additionally, mRNA vaccines are fully synthetic and do not require a host for growth, example eggs or bacteria.Therefore, they have a shorter manufacturing lead time

The novel mRNA vaccine candidate, HGC019, has all the necessary information to guide the host cells to make the antigen – spike protein of the virus, reported to interact with host cells receptor, and supported by ‘lipid inorganic nanoparticle (LION™)’ as a delivery vehicle
When the vaccine is injected into the body the synthetic mRNA is taken to muscle cells where it instructs the cells to make numerous copies of the mRNA and antigen
The coronavirus also uses its RNA genome guided approach to multiply and express viral proteins within the human body cells. Hence, Gennova’s approach which is similar to this action, gives it an advantage over other vaccine candidates to present the identically folded form of spike protein of coronavirus as it is reported during its infection cycle
Other immune cells then act on the spike proteins and in the process learn to identify the coronavirus and protect the body if the person were ever to be actually infected
The mRNA is associated with the ‘lipid inorganic nanoparticle (LION™) and acts as mRNA vaccine delivery system’ which stabilizes the mRNA and acts as adjuvant till delivery into patients

HGCO19 uses the self-amplifying mRNA platform which gives it the advantage of a low dosing regimen
HGCO19 is stable at 2-8°C

Gennova has concentrated its research and development efforts to create specifically designed mammalian production cell lines that can survive more than 90 days in a perfusion-based bioreactor system. This innovative approach has allowed Gennova to not only commercialize these life-saving bio-therapeutics at an affordable price but also achieve high-quality & uniformity across batches which is a key challenge in biologic production. Gennova is also leveraging AI tools to improve manufacturing processes, quality and yields of products. It also intends to employ Machine Learning Algorithms to develop next-gen, data driven automated bio-manufacturing processes to minimize manufacturing deviations and meet regulatory compliance and improve cost efficiencies.

Continuous Bio-manufacturing:

Product	Benefit
Tenecteplase for AMI	Tenecteplase, a third gen- thrombolytic, is a fibrin specific tissue plasminogen activator which is a much faster clot buster than the previous gen- alteplase It has greater fibrin specificity (by 14 folds) allowing for faster and more complete clot lysis with decreased bleeding complications It has a longer half- life which permits a single bolus dose Tenecteplase, a third gen- thrombolytic, is a fibrin specific tissue plasminogen activator which is a much faster clot buster than the previous gen- alteplase It has an increased resistance to degradation by plasminogen activator inhibitor- 1 It has an improved production yield of Elaxim by more than 100% within the same facility
Tenecteplase for AIS	Gennova holds a global patent for Tenectase for this indication Gennova introduced the first ever third-generation thrombolytic, tenecteplase approved for the indication of Acute Ischemic Stroke (AIS) This offers much better efficacy than current first line treatments

Gennova’s innovation around high cell density fermentation, genetic manipulations for its microbial products and a cost-effective pegylation technology puts it in a unique position to address the problems of quality, affordability and availability of the portfolio of products.
The key innovations include:

Product	Benefit
Pegaspargase: Hamsyl Commercial	First Indian company to launch pegaspargase pegylated form of ‘native asparaginase’ and it deals with the hypersensitivity issue of ‘native asparaginase’ hence, is used as the first-line treatment for ALL Because of its longer half, requirement of fewer dose and sustained therapeutic activity through the course, it is preferred over asparaginase
Recombinant Asparaginase: Pipeline	Gennova has developed Recombinant Asparaginase as a novel way of ensuring quality to cater to stringent regulatory rules and ensuring affordability It has also developed Recombinant Pegaspargase which assures quality, stable storage and is more safe, effective and economical for treatment of ALL

Research