Beginning last June, Kiromic took action to prioritize Deltacel™. We announced and are executing the Deltacel™-aligned development strategy, which includes streamlined operations and aligned key resources to advance Deltacel™ while maintaining our other product candidates, Procel™ and Isocel™. We are not currently deploying resources against either Procel™ or Isocel™. This prioritization also mitigates supply-chain challenges associated with a manufacturing approach involving cell engineering.
Less than four months after announcing this pipeline prioritization and with written feedback from an FDA Type B Pre-IND meeting in hand, we streamlined our operations and made the difficult yet necessary decision to eliminate nearly 30% of our workforce. We successfully managed through subsequent changes to our executive team and Board of Directors. These actions were part of our aligned prioritization strategy and were made following a thorough evaluation to maximize operational efficiencies.
The Company believes these critical actions and overall strategy align with the financing options it is actively pursuing.
Promising Preclinical Study Results
Two recently completed preclinical studies demonstrated the safety and efficacy of Deltacel™ in mice. We are highly encouraged by these early findings and have concluded that these results are sufficient for a robust IND submission package.
The first preclinical study was a toxicity evaluation of Deltacel™ administered alone and confirmed that Deltacel™ exhibited no toxicity. This study was conducted by Charles River Laboratories, a large CRO (contract research organization).
The second preclinical study was a pharmacology and toxicity evaluation of Deltacel™ administered in combination with a standard antitumor modality, the same that we propose for the first-in-human trial. This study, conducted by the research team led by James W. Welsh, M.D., of The University of Texas MD Anderson Cancer Center, found that Deltacel™ in combination with a standard antitumor modality was more efficacious, without adding any toxicity, compared to Deltacel™ given as a monotherapy.
The histopathology evaluation of this second study is underway, and the final report, to be authored and certified by a qualified pathologist, will be completed in the second half of February. Kiromic plans to issue a press release announcing the final results upon completion. This will conclude the pharmacological evaluation of Deltacel™.
Presuming the acceptance of the Deltacel™ IND application by the FDA, Kiromic plans to initiate the clinical trial in the first half of this year. In addition to the preclinical work we are concluding, we have also taken significant steps to ensure a smooth transition into the clinic by preparing our clinical trial partners.
We recently engaged Stiris Research to manage this clinical trial. Stiris will provide cell therapy specific CRO services, and it is best equipped to manage the clinical trial logistics for an allogeneic cell therapy product like Deltacel™. We have also enlisted Labcorp to handle all testing necessary to support our exploratory endpoints.
Financing Update
We are proud to have secured funding that has led us to the point of an IND submission. We are now working to secure additional capital that enables Deltacel™ to enter the clinic in line with our previously communicated timelines. However, stockholder approval of the proposals at our special meeting on March 7th is critical to continuing this work. We are thankful to have such a strong and supportive investor base including, in particular, a few key investors who strongly embrace the work with our oncology candidates and the potential benefit they may bring patients.