In an exclusive interaction, Dr Vasan Sambandamurthy, Senior Vice President, Bugworks Research India shares his views on the current biotech and startup scenario, his company’s journey so far, R&D initiatives, future outlook and much more.
Take us through the company’s journey so far including the key milestones achieved in the last 9 years?
Bugworks has transformed into a clinical-stage biopharma company at the forefront of discovering novel antibiotics and immuno-oncology (IO) drugs to address major health challenges afflicting humanity – antimicrobial resistance (AMR) and cancer. Few of our key milestones include building a proprietary ELUDE platform – a novel modelling tool to overcome efflux mediated drug-resistance in Gram-negative bacteria; and developing strong patent portfolio of 45 global patent applications filed for AMR and IO. Till date, 17 patents have been granted across India, US, EU, SA, China and Japan.
We have also been funded by global investors from Japan, South Africa, India, EU, US Government. Over the time, we have successfully built a world-class network (>50 academic/industrial partners) to leverage funding, innovation and product development. We have also advanced a novel antibacterial drug candidate into first-in-human study in healthy volunteers besides setting up PICASO platform, a laboratory within a cancer hospital to evaluate translational research to support the IO program.
Key R&D initiatives being spearheaded by Bugworks currently and the timeline for expected outcomes?
Our lead antibacterial asset, BWC0977, is undergoing first-in-human phase I clinical trials in Australia with anticipated completion by early 2024. We plan to embark on pivotal global trials in patients with complicated intra-abdominal infections in 2025 with the study outcome enabling product registration across global markets.
Our lead IO assets are in an advanced preclinical stage of development with potential first-in-human trials in the next 12-15 months. Outcome from these trials will guide further clinical development across a variety of cancers.
“With India as G-20 Chair, the timing is perfect to build critical global networks and enable business-friendly initiatives”
Your anti-bacterial (GYROX) and immuno-oncology (DARE) products under development by the company to tackle AMR and cancer respectively?
Under GYROX antibacterial agents category, we are developing a novel class of dual-acting topoisomerase inhibitors as broad-spectrum agents to treat a variety of bacterial infections caused by both Gram-positive and Gram-negative pathogens.
Under DARE immune-oncology assets category, we are developing novel class of adenosine receptor antagonists as immunotherapies for the treatment of solid tumors (head-neck, colorectal, gastric, non-small cell lung, renal-cell carcinoma and hard-to-treat breast cancers).
Stage of development of these products and by when are they expected to get commercialized?
The pivotal registration enabling trials for BWC0977 is likely to be completed by 2027. The entire data package from these studies will enable the filing for marketing authorisation across major global markets in 2028/2029.
Our lead IO asset is likely to enter first-in-human trials within the next 12-15 months. The outcome from this Phase 1b trial will further guide the clinical development across a variety of cancers either as monotherapy or in combination with frontline therapies. Given the highly competitive nature of IO space, we envisage exploring potential partnering and out-licensing opportunities to progress the asset towards completion of pivotal clinical trials and eventual product registration.
Market size for your products in India and globally? Revenue expectations in the future?
Based on the huge unmet market need for a novel broad-spectrum antibiotic that can treat a variety of drug-resistant bacterial infections, we believe BWC0977 has the potential for $1billion/year peak sales across indications spanning critical care, public health and biothreat space (it will take 5years post-launch of drug to hit peak sales of $1B). We believe our best-in-class adenosine antagonists have the potential to capture a market size of $3-5billion/year across a variety of hard-to-treat cancers.
“In the next 5 years, we expect one AMR asset to have completed the pivotal registration trials and be in market”