“Our lead antibacterial asset is undergoing first-in-human phase-I clinical trials”

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”

How has the company utilized the $18 million funding raised in Series B last year? Do you plan to go for more funding rounds from VCs in the near future?

Given the complexity of late-stage clinical development, the funding has supported development of BWC0977 into an intravenous/oral product and progress into Phase 1 studies, expansion of IO portfolio to interrogate multiple targets in modulating the tumour microenvironment.  We have built the PICASO platform – a state-of-the-art translational laboratory inside a cancer hospital to evaluate effectiveness of our IO molecules to prevent proliferation/reduce primary human tumour volumes.  Given our ambitious growth trajectory, we plan to raise more funds in the coming years to support the planned activities towards product registration.

Where do you see the company in the next five years? 

 In the next 5 years, we expect one AMR asset to have completed the pivotal registration trials and be in market and two IO assets to have completed Phase 1b trials and ready for out-licensing. We also expect that one or more countries would’ve chosen our AMR asset as a biodefense solution to be prepared against potential bioterror warfare.

Key trends in biological therapeutics globally? Are the Indian companies innovating enough for the future and why?

The current global innovation wave in basic biology and healthcare is built around advances in omics, molecular technologies and its interplay with bioengineering, high-end computing, machine learning and artificial intelligence. These impactful innovations are enhancing the speed of discovery, scalability and productivity in R&D.  A wave of next-generation cell and gene therapies are transformative in offering potential cure for certain hard-to-treat diseases.  Given our IT prowess and huge manufacturing capacity, Indian companies are innovating in many of these areas to build affordable technologies that can be readily scaled-up and deployed across LMICs. Additionally, efforts are being directed in developing point-of-care diagnostics to guide initiation of appropriate therapies.

Your take on the current start-up ecosystem in India? Remarkable differences in the last one decade? Challenges that need to be addressed?

 The biotech startup ecosystem has shown tremendous growth over the last decade with generous funding from Government of India and private investors for early discovery research in Biotech, Medtech, Agritech, cell/gene therapies and diagnostics. The biggest challenges for start-ups is the huge financial support for late-stage clinical development, infrastructure and cultural appetite for risk that is required to build a portfolio of globally competitive products.  With very limited late-stage funding to build this pipeline and the inherent long duration for biotech products, the attractiveness for out-licensing to big pharma or delivering innovative, affordable life-saving therapies remains bleak.

How do you view the government’s PLI scheme to promote manufacturing in India? Any recommendations in the biotech context?

 This is a welcome move to support large-scale manufacturing of pharmaceuticals drugs and APIs to mitigate over-reliance on overseas suppliers and to keep the Indian generic manufacturers competitive in the global marketplace.  However, there is a lack of clarity on how the PLI scheme will spur and sustain the development of cutting-edge, innovative biotech products to treat/manage a variety of human diseases for global markets.

Outlook for India’s growing biotech market in India and key growth drivers?

 India’s global leadership role in making affordable diagnostics and life-saving vaccines during the pandemic should serve as an eye-opener and trigger to build a culture of innovation to become a global powerhouse of innovative, affordable healthcare products rather than continuing to be a generic player.  With India as G-20 Chair, the timing is perfect to build critical global networks and enable business-friendly initiatives to promote a culture of innovation in biotech and healthcare which could bring about meaningful change across economies and societies.

**This interview was first published in the February 2023 edition of the BioVoice eMagazine.