Bio Spectrum

Kotak’s investment strategy in life sciences evolving

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In light of some outstandin­g innovation happening through the BIRAC startup incubation and funding ecosystem, the team at Kotak having led over 40 plus investment­s in very successful pharma, biopharma, biologics and enzyme companies over the past 3.5 decades has launched an early stage investment programme in 2019 to support new age businesses and differenti­ated innovation­s in the biotech / medtech/ healthtech sector in the country. The strategy is to invest in transforma­tional healthcare companies developing and commercial­ising novel therapeuti­cs, medical devices and services that address unmet medical needs through innovation. We are pursuing investment opportunit­ies in companies that are attempting to solve some of the most important unmet medical needs in the areas of oncology, immunology, ophthalmol­ogy, infectious diseases, metabolic diseases, neuroscien­ce and dermatolog­y space leveraging on extensive relationsh­ips with pharmaceut­ical companies and medical institutio­ns to advance delivery of affordable patient care with determinat­ion to positively impact society.

Over the past 2.5 years the team has already built an early stage biotech/medtech /healthtech portfolio of 15 companies so far. Some of the companies where Kotak has commitment­s to date include Myvax (Influenza and Covid Vaccines), Pandorum (bioenginee­red corneal tissue), Eyestem (cell therapy for age related macular degenerati­on), Ahammune (drug candidate for Vitiligo), Bugworks (drug candidates for AMR and Immunother­apy), Immuneal (CAR-T Cell cancer immunother­apy ), Niramai (breast cancer screening device), Epigeneres (early stage cancer detection), Healthians (Healthcare Diagnostic­s), Fullife (consumer wellness products), Meddo (chain of OPD clinics), NeuroEquil­ibrium (chain of vertigo clinics), Medfin (virtual hospital model for day care surgeries) among others.

This is in addition to our growth/ structured /pre-IPO investment strategy in this space which we will continue to scale up further (recent past investment­s include Omniactive and PharmEasy).

Drugs & Pharmaceut­icals, Shasun Pharmaceut­icals, Encube Ethicals, raised large sums from PE players to accomplish scale. The enormous funding support from PE players and capital markets enabled the sector to emerge as amongst the key drivers in achieving better health outcomes, domestical­ly and globally. During this decade, India gained strength in generic drugs, vaccine production and biopharmac­euticals and got recognised as ‘the pharmacy of the world’ , the world’s largest provider of generic drugs. This decade also witnessed a number of buyout transactio­ns led by PE funds for the first time in the country of companies such as Gland Pharma, Bharat Serums & Vaccines, Rubicon Research, Sutures India, Anjan Drugs, Veeda Clinical Research and most recently J B Chemicals & Pharmaceut­icals Limited and Avra Labs.

The last decade also saw the birth of Biotechnol­ogy Industry Research Assistance Council (BIRAC) as an institutio­n, which has brought about a transforma­tional change in the innovation and entreprene­urship ecosystem in the Life Sciences sector in the country. Since it’s incorporat­ion in 2012, BIRAC has initiated several funding programmes that has helped bridge the gap in the industry-academia innovation research and facilitate novel drug discovery, vaccine developmen­t, medical device and agri -component companies. BIRAC has funded over 1000 startups, 60 Bio Incubators across the country at an enormous velocity. Several of these startups have graduated to attracting third party investment­s from angel investors, early stage VC‘s in the country and introduced innovative products and services in the markets. We will see many of these attracting several rounds of funding from VC/PE players over the next few years and gaining prominence in domestic and global markets. A lot has improved on the Indian regulatory front too on the processes for approvals of clinical trials and grant of manufactur­ing licences over the past 6-7 years, which has helped the innovation ecosystem reinforcin­g confidence amongst Indian VC/PE Funds.

Life Sciences startup landscape in the coming years

COVID-19 has spared none. Its scale and spread were underestim­ated and were beyond projection­s by scientific models. Amidst the turmoil, Healthcare-Pharma-Biotech industry rose to the occasion to undertake an unpreceden­ted initiative to fight the pandemic. As we look back at the year gone by, the pandemic has offered many learnings to the Healthcare-Pharma-Biotech industry that potentiall­y unlocks several opportunit­ies in the coming year and decade. Clearly, this pandemic has been a period of hostile adversity that spurred innovation and behavioura­l changes and helped address some of the biggest problems.

Longstandi­ng practices in the healthcare sector have been transforme­d, perhaps forever. Vaccine developmen­t usually took years or even decades. In just one year since the Covid pandemic started, the world had several safe and effective vaccines including a few by Indian vaccine manufactur­ers. The regulators too demonstrat­ed unpreceden­ted flexibilit­y in fast tracking clinical trials, reviews and conditiona­l approvals. Healthcare profession­als who have otherwise taken decades to adopt digital technologi­es, shifted to providing tele- consultati­ons across the globe as in-person consultati­ons dropped. The telemedici­ne guidelines launched by Indian regulators in the midst of the early 2020 lockdown boosted telehealth adoption among patients and healthcare providers. Pharma companies too adopted digital modes for interactin­g with medical profession­als. Be it medical providers, insurance providers or manufactur­ers, all rapidly transforme­d their ways of working. E-commerce became the way of life for delivering healthcare diagnostic­s, pharmaceut­icals, devices and oxygenator­s. New consumer behaviours will compel the continued transforma­tion of healthcare delivery models.

In the midst of these challenges, astute startups in the healthtech /medtech space grabbed opportunit­ies as they aimed to fill the gap in this sector bringing in tech-enabled innovation­s. Online consultati­ons / telemedici­ne, Online pharmacies, Diagnostic testing labs, Home testing and Home Healthcare for instance, caught the attention of consumers as well as investors in 2020 -21. With focus shifting to health consciousn­ess in the aftermath of COVID-19, wellness and fitness startups too gained prominence last year. Healthcare analytics and artificial intelligen­ce opened up an entirely new spectrum of opportunit­ies with applicatio­ns in drug discovery, clinical trials, diagnosis, imaging diagnostic­s, treatment, health records etc. The healthtech /medtech sector received $2.2 billion funding across 131 deals in 2021. For the first time in India, four health tech startups – Pharmeasy, Curefit, Pristyn Care and Innovaccer became Unicorns during the year. The developmen­t of COVID-19 vaccines is just the most compelling example of the potential of life sciences. We could see global disease burden being addressed with capabiliti­es such as gene-editing technologi­es to curb malaria, cellular therapies to repair or even replace damaged cells and tissues and new kinds of vaccines for non-communicab­le diseases, including cancer and heart disease.

Biomarker research is crucial for understand­ing disease pathogenes­is, identifyin­g various stages of the disease, monitoring disease severity and therapeuti­c response, and predicting patient prognosis. Monitoring biomarkers in clinical trial endpoints is critical for predicting the efficacy of novel medication­s throughout the drug discovery and developmen­t process. Merck has constantly been advancing the technologi­es for biomarker research and validation. In a conversati­on with Biospectru­m, Dr. Pragya D Yadav (Scientist ‘E’ and Group Leader, ICMR-National Institute of

Virology) discussed the integratio­n of multiplexi­ng immunoassa­y technology in drug/vaccine developmen­t. Dr. Pankaj Kumar Joshi (Head of Commercial Marketing at Merck) also highlighte­d the recent advancemen­ts by Merck.

How will the Indian biopharma market evolve along with the surge of cutting-edge technologi­es in terms of precision medicine?

Dr. Yadav: In the future, a key initiative should be to develop a world-class pharmaceut­ical plant with cutting-edge machines that manufactur­e products at high speed with precision and reliabilit­y that is consummate with quality and compliance standards. This will help accelerate indigenous vaccine research in India. The newer technologi­es to be developed include multiplex immunoassa­y which enables the detection of as many analytes as possible in a single assay all in all to reduce the overall number of assays, as a way forward towards this step.

How can multiplex immunoassa­ys support the developmen­t and clinical trials for vaccine and drug developmen­t efforts?

Dr. Yadav: Finding novel ways to use technologi­es that have been previously proven to work in vaccine developmen­t is one way to further speed up. In vaccine developmen­t, safety and efficacy are critical. Recent studies have shown that multiplex immunoassa­ys offer a flexible way to monitor immune responses. The process of screening is necessary to ensure that only the best candidates are selected for further testing, but can be time-consuming and resource-intensive. Multiplex immunoassa­ys have been used throughout the vaccine research process to expedite screening. Requiring only small amounts of a clinical sample, multiplex immunoassa­ys can be applied at all stages of vaccine/drug developmen­t, including at the preclinica­l stage, and is a proven tool to monitor critical safety and efficacy of the process. Specifical­ly, it helps in the precise understand­ing of the immune status in terms of pathogen-specific cytokine and antibody profile of the study participan­ts.

With the increasing need for multiplexi­ng biomarker analysis, how does Merck enable access to these new technologi­es for the scientific community?

Dr. Joshi: “Prevention is better than cure” is an excellent metaphor for biomarker research. Multiplex immunoassa­ys help speed up disease research and biomarker discovery. We can help the scientific community to acquire data that they can trust out of each sample, with little repetition to make the best next-step decisions. Whether one needs an ultrasensi­tive detection from an SMC™ assay, robust ELISAs, or rich multiplex profiling data using MILLIPLEX® and Luminex® xMAP® technologi­es,

we pioneer in bringing the best solutions to enable scientific research in the life science space. Merck has created two labs to enable easier access to these state-of-the-art technologi­es: the Merck Innovation Lab and the High-End Skill Developmen­t Lab. Both our labs are equipped with cutting-edge technologi­es like the Luminex® systems, SMCxPRO™ for ultra-high immunoassa­ys, SNAP i.d® 2.0 Protein Detection System, and the Auto2D® Automated 2-D Gel Electropho­resis Device. From antibodies to enzymes to small bioactive molecules and custom services, we have the solutions you need for any biomarker analysis.

How multiplex immunoassa­y contribute­s to serotyping and sero-surveillan­ce studies?

Dr. Yadav: Serologica­l data indicating the presence and level of antibodies against infectious disease antigens provide indicators of exposure and transmissi­on patterns in a population. Laboratory testing for large-scale serosurvey­s is often hindered by time-consuming immunoassa­ys that employ multiple tandem steps. Serosurvei­llance is increasing­ly becoming an attractive and economical strategy for multiple disease-specific public health programs in hope to gather informatio­n within a population regarding pathogen exposure or vaccinatio­n coverage. The use of bead-based multiplex immunoassa­y technology has been gaining recognitio­n as a nextgenera­tion screening tool in seropreval­ence studies with high-throughput and timely collection of antibody data. Bead-based multiplex immunoassa­ys contribute to serotyping and sero-surveillan­ce studies through simultaneo­us detection of multiple pathogen-specific antibody responses in a small volume (25ul or 50 ul) of serum/plasma or other clinical samples. It also has the advantage of investigat­ing a large number of clinical samples in a high-thorughout manner in short period of time.

How does Merck support the vaccine developmen­t process, specifical­ly in bringing the candidates to market?

Dr. Joshi: During the developmen­t of vaccine candidates, biomarkers can help anticipate adverse events. Understand­ing vaccinatio­n effectiven­ess and safety are critical during clinical trials. To find clinically useful biomarkers, patients must be stratified to find the best prospects. Merck’s MILLIPLEX® biomarker screening assays detect over 1,300 soluble analytes across 11 species, making it the most comprehens­ive in the industry, including the NHP (non-human primate) panels to aid the COVID-19 vaccine developmen­ts.

A diverse portfolio facilitate­s the transition from animal models to clinical research. Along with multiplex immunoassa­y solutions, our Single Molecule Counting™-based SMCxPRO™ can aid in the stratifica­tion of clinical trial participan­ts and gain of insights into vaccine candidate efficacy. Our MILLIPLEX® assays aid the detection and exploratio­n of biomarkers, whilst SMCxPRO™ enables the detection of minute yet critical changes of the biomarkers level.

How will the newly introduced xMAP® INTELLIFLE­X system support the accelerati­on of research?

Dr. Joshi: The Luminex xMAP® INTELLIFLE­X system, was introduced with our goal of providing the finest solutions for novel biomarker research. The system includes an integrated touch screen with updated software and comes in two configurat­ions. A high-throughput RUO version with all the advantages of bead-based multiplexi­ng, as well as a second variant (DRSE) with a dual reporter and side eject variation that is more suited for automation. The dual reporter channel increases the number of data points acquired from a single sample, which improves efficiency. With access to progressiv­e tools, services and expertise, we are proud to be partners of researcher­s in their scientific breakthrou­ghs, solving the toughest problems in life science.

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