Altamira Therapeutics (NASDAQ:CYTO) provided a business update as it repositions around RNA therapeutics and continues to progress towards upcoming key catalysts with its non-RNA legacy programs.
“We are progressing preclinical development of AM-401 for treatment of KRAS-driven cancer as the first indication for our OligoPhore delivery platform with siRNAs,” Thomas Meyer, Altamira’s founder, chairman and CEO, said in a statement.
“In our legacy business, we are laying the foundations for long-term growth with our drug-free Bentrio nasal spray through partnering with international distributors, as well as advancing our AM-125 nasal spray for vertigo treatment towards important milestones this year,” he added.
Mr. Meyer said the company remains on track to release top-line results during the second half this year from Part B of the Phase 2 TRAVERS clinical trial with AM-125, and the house dust mite challenge study with Bentrio.
“As we are moving towards important clinical and regulatory milestones with our legacy programs, we have been preparing for the second step of our transformation, the planned divestiture or spin-off of our legacy business targeted for the second half of 2022,” Mr. Meyer added.
“With that step, Altamira will become an RNA therapeutics-focused company with disruptive prospects, while unlocking the intrinsic value of our legacy business,” Mr. Meyer said.
Altamira has selected KRAS-driven cancers, which may affect the pancreas, lungs or colorectum, among others, as the first indication for drug development. Under project code AM-401, the company is aiming for an FDA IND in 2023 to initiate a clinical proof-of-concept study in humans.
Mr. Meyer said that since the acquisition of Trasir, Altamira has expanded its RNA activities and resources.
Within its legacy business, he said Altamira has made good progress with Bentrio, its novel drug-free nasal spray for protection against airborne viruses and allergens that is now being commercialized in Germany and other European countries under the CE mark as an over the counter product.
For accessing the U.S. market, the company filed with the FDA in October 2021 a 510(k) application for premarket clearance of Bentrio in the allergy indication. The review of the submission is still ongoing.
In addition, Mr. Meyer said Altamira is currently preparing the submission of an IND to the FDA for the next steps in the clinical development of AM-125. The product is an intranasal formulation of betahistine, which has been widely used for decades in tablet form as a vestibular stimulant and standard of care in vertigo treatment and management around the world, with the US being a notable exception.