Kareus partners with Quintiles to get conjugate NCEs into clinic
This article was originally published in Scrip
Kareus Therapeutics, a Switzerland-based biotech company,has entered a strategic alliance with the CRO firm Quintiles to advance two of its preclinical programmes through to clinical trials.
Under the alliance, Quintiles will make an investment in Kareus in the seven figure dollar range, consisting of "one third investment, two thirds risk-sharing clinical services", Kareus' head of business and corporate development, Dr Patrick Doyle, told Scrip.
Quintiles will own a minority stake in Kareus, with the majority shareholders being the company's management, added Dr Doyle.
Kareus' discovery platform and development programmes were invented by Kareus' founding scientists. One of these, Dr Uday Saxena, was formerly CSO of Dr Reddy's prior to the closure of its Discovery unit in Atlanta. Kareus' founder and chairman is Dr K Anji Reddy, who has invested his own money into Kareus, "but there is no relationship apart from that to Dr Reddy's Laboratories," confirmed Dr Doyle.
Following the investment by Quintiles, Kareus plans to submit an investigational new drug (IND) application for KU-046, a first-in-class NCE for the treatment of Alzheimer's disease, "at the latest in the first quarter of next year", said Dr Doyle. Kareus has also identified a lead series of molecules demonstrating long-lasting insulin sensitisation for the treatment of type 2 diabetes and will select a clinical candidate for development later this year. The company intends to seek additional financing after it has filed the INDs for both programmes.
Quintiles will conduct Phase I "proof-of-relevance" clinical trials for both KU-046 and the chosen diabetes candidate. Dr Doyle defines proof-of-relevance as a "beefed up Phase Ib or IIa" that would provide enough information for "either us or a major pharma to take a leap of faith into extensive full [more than] 200-patient Phase II", explained Dr Doyle.
Tom Perkins, senior vice president of corporate development for Quintiles, said: "This agreement is an example of how leading biotechnology companies are building partnerships that extend beyond the traditional licensing model to manage risk, increase productivity, and increase value to stakeholders." Quintiles' new Phase I research unit in Hyderabad, India, will be involved in the trials.
KU-046 was discovered using the company's KARLECT chemistry platform technology.
"KARLECT links molecules via chemical conjugation," explained Dr Doyle. "This results in agents that are regarded as new chemical entities (NCEs) with differentiated properties compared to the individual components i.e. improved pharmacokinetics, side effect profile and efficacy."
KU-046 targets pathways upstream from the increased Abeta peptide production found in Alzheimer's disease and has demonstrated cognitive improvements in a number of preclinical models. "We have combined a GRAS molecule with an on-market product (not indicated for Alzheimer's disease) using our KARLECT combination technology. The individual components were screened against a neuronal energy target and an oxidative stress target," continued Dr Doyle. "Our diabetes approach is targeting a specific enzyme via novel small molecule, non-PPAR (peroxisome proliferator-activated receptors), insulin sensitisation."
The arrangement with Quintiles covers the first two molecules in Kareus' portfolio but it can be expanded to include "several more", noted Dr Doyle.
There were a number of reasons that Kareus decided to take this route to drug development. "We held some discussions with pharma," said Dr Doyle, but "we realised our programmes were too early to get the type of deal we were looking for". Also, "Venture capital was too expensive in terms of expectations from a VC and the type of support we were looking for. We have been primarily looking for close collaboration in clinical development expertise rather than cash."
The upsides to signing with Quintiles were "endorsement from a global world class organisation, access to excellent clinical trial ability and expertise and funding," according to Dr Doyle. However, there were downsides to negotiate. ""How much stock were we willing to sell? How to ensure doing a deal with a partner that got us through clinical activity without giving away rights to the molecules?"
Kareus has managed to retain full rights to the molecules the two companies are developing.
To persuade Quintiles that Kareus was up to the investment it was making, Kareus had to show that it was a "capable IND machine with experienced management with a track record", said Dr Doyle. Also, that its "therapy area approaches made sense, and that we had optimised our leads well into the preclinical phase, [and] that our business plan made sense over the next five years".