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Calando Pharmaceuticals, Tacere Therapeutics, Oncolys BioPharma, PhaseRx

Calando Files IND for RNAi Cancer Therapy
Calando Pharmaceuticals said this week that it has filed an investigational new drug application with US regulators to begin testing its RNAi-based cancer therapy CALAA-01 in a phase I trial.
According to Calando, the drug is a non-modified siRNA targeting the M2 subunit of ribonucleotide reductase and delivered using a proprietary nanoparticle delivery system. About a year ago, Calando published data in the Proceedings of the National Academy of Sciences showing that CALAA-01 could be systemically administered to non-human primates with no adverse effects (see RNAi News, 3/22/2007).
At the time, Calando’s then-CEO John Petrovich told RNAi News that the company expected to move the drug into phase I testing some time in 2007.
The company missed that milestone, but now appears poised to begin the trial before the end of 2008.
Calando said that the proposed phase I study is an open-label, dose-escalation trial in patients with non-resectable or metastatic solid tumors. The study’s primary endpoints are safety and tolerability, but the trial is also designed to evaluate pharmacokinetics and tumor response, and help the company determine dosing for future trials.
The study will be conducted at the UCLA Jonsson Cancer Center and the South Texas Accelerated Research Therapeutics clinic, Calando said.

Tacere, Oncolys Formalize Deal for HCV Drug’s Asian Rights
Tacere Therapeutics and Oncolys BioPharma said this week that they have signed a license agreement to develop and market Tacere’s expressed RNAi treatment for hepatitis C in Asia.
The deal builds on an earlier agreement between the companies that included Oncolys taking an undisclosed equity stake in Tacere in exchange for an option to the Asian rights to the drug, called TT-033 (see RNAi News, 6/21/2007).
It also follows an agreement under which Pfizer acquired the worldwide rights, except Asia, to the drug (see RNAi News, 1/10/2008).
Under the terms of the newest deal, Tacere and Oncolys will form a joint steering committee that will work with the Tacere and Pfizer steering committee to oversee preclinical research and development efforts for TT-033, which Oncolys has named OBP-701.
Tacere will receive an undisclosed upfront payment from Oncolys, and stands to receive development milestones of up to $60 million, as well as royalties on net sales.
”If Oncolys sublicenses its rights under the strategic alliance to any major pharmaceutical company, the milestone payments and sales royalties Oncolys receives will be shared with Tacere at predetermined rates based upon the stage of development at which the milestones occur,” Tacere noted.
Additional terms were not disclosed.

Seattle RNAi Startup Receives Commitments for $19M
A new RNAi drug startup called PhaseRx has received $4 million in venture capital, with commitments for $15 million more, company founder Robert Overell confirmed last week.
According to Overell, the funding will help the Seattle-based company build a staff and continue developing its core delivery technology, which was developed by University of Washington researchers Patrick Stayton and Allan Hoffman.
Already, the company has signed on former Nastech Pharmaceutical CSO Paul Johnson, who will serve in the same position at PhaseRx.
Overell declined to provide details of the delivery technology or comment on PhaseRx’s pipeline.

The Scan

Taking Stock of the Stockpile

The US and European countries are evaluating their smallpox vaccine stockpiles as the number of monkeypox cases increases, the Washington Post reports.

Vitamin D From Tomatoes

According to Reuters, researchers in the UK have gene-edited tomatoes so their fruit contains vitamin D.

Cause Not Yet Spotted

NPR reports that a new study was unable to find a cause for persistent long COVID symptoms.

PNAS Papers on Central African Hunter-Gatherers, Myopia Development, Ancient Microtia Allele

In PNAS this week: population patterns among Central African hunter gatherers, effect of myopia-linked gene variant, and more.