Glenmark, a leading generics company, is undergoing a significant transformation to a producer of proprietary compounds and has a growing pipeline of novel drug candidates in oncology, dermatology and respiratory.
Drug Discovery & Development spoke with Glenmark’s president and chief medical officer, Fred Grossman, DO, FAPA, who presented at the 2017 BIO International Convention in San Diego last month about the company’s growth and its future.
DD&D: What did you share with the audience at BIO regarding Glenmark’s pipeline?
Grossman: What I presented was the innovative portfolio that has come out of the biologics unit in Switzerland, which has been in existence since 2006. They’ve created a platform technology called BEAT technology (Bispecific Engagement by Antibodies Based on the T Cell Receptor), which has produced several bispecific and monoclonal antibodies that currently make up our biologics pipeline.
We’ve gotten to a size where we can develop our compounds internally versus in the past where compounds would be created and be licensed out. Now that we have grown and have brought in expertise—many of whom have come from large pharma—we have full capacity in clinical development in our key strategic therapeutic areas, which include respiratory, dermatology and oncology. We have full capacity in clinical operations, regulatory staff, and the usual so we can bring forward our pipeline by ourselves, but our molecules really lend themselves to strategic partnerships. We are in discussions now and will continue to be.
DD&D: What can you tell us about Glenmark’s novel drug candidates?
Grossman: We have five biologics encompassing oncology and dermatology, and we have four respiratory agents as well. Our furthest along is a biologic in dermatology, GBR 830, which is an OX40 antagonist that has completed Phase 2A trials. That data will lead off this summer targeting atopic dermatitis. This is a very exciting molecule for us because its mechanism lends itself well not only to its effect on activated T cells but also on memory T cells, so this has the potential to have significant durability of response if it’s effective in atopic dermatitis. It also lends itself well to other inflammatory diseases.
In our oncology portfolio, of the four biologics, three of them are bispecific antibodies that take advantage of our internal platform and they encompass areas of significant unmet medical needs in breast cancer, gastrointestinal cancers, multiple myeloma and colorectoral cancer. We have one that’s in the clinic now, GBR 1302, that’s a HER2xCD3 bispecific antibody. The HER2 binds to the HER2 receptor expressed on the tumor and the CD3 redirects cells to destroy the tumor. We have very good preclinical full line data pointing us toward breast cancer that has been unresponsive to current first and second-line agents.
Our second molecule is also a bispecific monoclonal antibody. GBR 1342, which is a CD38xCD3 targeting multiple myeloma, and that should be in the clinic this summer. It has very good preclinical data compared to currently approved therapy for multiple myeloma. We’re enthusiastic about this agent because it lends itself well to solid tumor.
We also have GBR 1372, which is an EGFRxCD3. What’s interesting about this molecule is the potential to bypass KRAS mutations in people that have colon cancers. In people that have a mutation there is no treatment and this mechanism lends itself well to those patients.
Finally, in our oncology portfolio, we have a checkpoint inhibitor, GBR 8383, which is an OX40R agonist. It will be targeting multiple cancers as well as in combinations, not only with our own agents but with others, and that’s why we are interested in strategic partnerships with large companies.
We also just announced that we acquired drugs from a Boston-based company called APC Therapeutics. It’s a small company with assets that help to stimulate the inflammatory response in T cells.
DD&D: What’s new in Glenmark’s respiratory portfolio?
Grossman: The other part of our portfolio is the respiratory side. It includes agents for allergic rhinitis, as well as COPD and nebulized treatments, and in fact, one of them is a biosimilar. We’ve had very good discussions with the FDA and if we’re successful we may be among the first approved biosimilar for asthma and chronic idiopathic urticarial (CIU).
This respiratory portfolio is emerging and we will have new drug applications and biologic license applications filed starting in 2019. (We plan to file a respiratory drug for allergic rhinitis, a combined steroid and antihistamine, in 2019.) We’ll have nine in the next 10 years. If we’re successful, that’s almost one per year—and it all starts with respiratory.
DD&D: What’s next for Glenmark in this transition?
Grossman: The current model that we have is that we have a very successful generics business. We’ve moved up to complex generics and that’s helping to mitigate the challenges in generics and will be funding this very potent portfolio moving forward.
This company has a very, very good track record all around, both in compliance and in the ability to move drugs forward. We have a global footprint that we are taking advantage of.
We’ve doubled our size and hired upwards of 80 people in the U.S. We’ve drawn very experienced developers, functional leaders, and personnel from large pharma who want to be part of this rather significant transition.
There’s a long history to Glenmark—40 years. Glenn Saldanha took over in 2001 and grew it from a 36 million dollar company to a 1.4 billion dollar one. It’s been very successful in areas of dermatology, as well as injectables, respiratory and that’s why we’re taking advantage of this inherent expertise in innovation which has led us to focus on the three areas of respiratory, dermatology and oncology.
All-in-all, this is a company with a pretty unique business plan because we have homegrown internal platform of agents which are fully funded from our own business while looking for strategic partnerships moving forward. We are pretty well positioned for the future.
Filed Under: Drug Discovery