US biotech start-up set to have huge impact on breast cancer treatment landscape

Backed by more than 20 years of research and development expertise, Concarlo Holdings is developing diagnostics and therapeutics that could have huge impact for metastatic breast cancer patients. Lu Rahman finds out more.

Stacy Blain, Co-Founder, Concarlo Holdings, wants to change the conversation around breast cancer. This biotechnology start-up whose technologies aim to diagnose and treat metastatic breast cancer, is says Blain, “a woman-led venture, addressing women’s issues.” Blain has been considering this issue for over 20 years.

Blain, a Princeton and Columbia University-trained cellular and molecular biologist, heads up this business which also includes Co-Founder and Chief Operating Office, LisaMarie Casey, who has 30 years’ experience in strategic planning and business management as well as being the Co-Founder of the Golden Seeds Angel Group.

ER/PR+ (endocrine responsive) HER2- tumours occur in around 198,000 US breast cancer patients each year, of which approximately 60,000 will develop recurrent disease. 37,000 patients are treated for metastatic disease annually, and most develop resistance to current drug options. For these patients, despite advances in available drugs, the best existing solutions do not provide durable arrest of the tumours. The patient becomes resistant to the drug and overall survival rates are unchanged.Recognising that the issue is wider than this – that for many women there is the constant worry of developing breast cancer, or the stress of knowing family and friends that are undergoing treatment for what is still a terminal illness – Blain and Concarlo Holdings are developing diagnostics and therapeutics based on a novel target.

Earlier this year Concarlo Holdings’ licensor, was issued a US patent, marking the latest step in the company’s journey to commercialise revolutionary medicines for metastatic breast cancer. The patent, for which Concarlo is the exclusive licensee, covers IpY, a novel therapeutic peptide that addresses drug-resistant breast cancer by targeting a unique cellular pathway — p27Kip1. Concarlo has also filed a new provisional patent application for modified versions of the therapeutic peptide that are believed to exhibit enhanced bioavailability.

“The issuance of this patent is a huge step, validating our focused efforts and activities to-date,” comments Casey. “The new US patent and the pending provisional application perfectly position us to continue our innovative work with a technology that has the ability to overcome a significant challenge in breast cancer care — that of CDK4i resistance. We look forward to exploring opportunities for further partnerships and collaborations as we realise the commercialisation of IpY.”

The IpY technology is the first to address the high incidence of drug-refractory disease that develops with currently available CDK4 inhibitor (CDK4i) treatments. Such a solution has the potential to drastically increase overall survival of breast cancer patients, says Concarlo Holdings.

The recent introduction of CDK4i drugs, a class of medicines that directly targets the CDK4/6 pathway implicated in many malignancies, has had a significant impact on the way in which the disease is managed. However, such therapeutics are associated with patients transitioning to a treatment-resistant form of the condition, despite initial extended periods of remission. Backed by more than 20 years of research and development expertise, Concarlo has developed IpY and a companion diagnostic, ApY, to effectively overcome the issue of CDK4i resistance and roll out a more targeted treatment approach for optimised patient outcomes.

“Despite the clinical efficacy of CDK4 inhibitors, we’re seeing that primary or secondary resistance to therapy is presenting a significant challenge to overall survival,” comments Dr Dominique Bridon, Head of Therapeutics  at Concarlo.

“With the IpY technology and its unique mechanism of action, we’re effectively targeting CDK4 while simultaneously inhibiting another target — CDK2 — which has been found to be a key molecular player in the development of drug resistance. In doing so, we are the first company to successfully address the CDK4i resistance issue to provide long-term durable tumour arrest. Combined with its highly specific targeting and low toxicity profile, the positive impact of this drug on the breast cancer treatment landscape is hard to understate.”

In studies using mouse models Blain outlines that mice treated with the standard therapy Palbociclib  – which extends the life of a woman diagnosed with metastatic breast cancer by two to three years – all died by 20 days. However, when these mice were given Concarlo Holdings’ drug or a combination of the FDA-approved drug and Concarlo’s, the mice were able to stay alive for between 50 and 100 days respectively.

Concarlo Holding’s therapy is still pre-clinical but is hoping to be in Phase 1 clinical trials in the next two years, after which the company will be looking to partner with pharma for commercialisation.

“While we are focusing on this important women’s issue, our addressable market is much larger,” says Blain. “p27 drives drug resistance and cancer progression in numerous tumour types including lung, ovarian, pancreatic and head and neck.” With this in mind, the company will be looking to move into all those markets.

“The challenges to developing oncology products are those that plague all biotech: cancer is hard and frequently what looks good in the lab or in animals, doesn’t play out in humans. But, we feel that we are the mechanistic experts on this pathway and are bringing that knowledge to the problem, and derisking by attacking it in different ways.

“Bio companies are kind of the reverse. Practically every one sounds like a great idea (curing cancer, alleviating pain, treating neurodegenerative disease), and many turn out to be worth nothing. Investments that work out, however, may take a while, but eventually deliver in a big way, Blain concludes.

Volume 21, Issue 4 – Fall 2020

Stacy Blain, Co-Founder, Concarlo Holdings



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