Avecia to Expand Oligo Manufacturing Facility, Status of eXegenics Deal Unclear
Avecia OligoMedicines, a unit of Avecia Biotechnology, said this week that it is expanding its Milford, Mass.-based manufacturing facility in order to enhance its siRNA manufacturing capabilities.
The facility upgrade, which is expected to be completed in September, will enable large-scale manufacturing of siRNAs in batches of 75 millimoles to 100 millimoles, Avecia said.
The company also said that it has installed new duplexation/annealing vessels that allow for controlled siRNA duplexation in batch sizes up to 150 millimoles.
As reported by RNAi News last month, Avecia’s previously announced deal to manufacture an siRNA-based clinical drug candidate for Acuity Pharmaceuticals (now eXegenics) is expected to end prematurely (see RNAi News, 4/5/2007).
In a filing with the US Securities and Exchange Commission, eXegenics said that the deal — which called for Avecia to manufacture the drug through commercial launch — is to be terminated because of Avecia’s “failure to produce product.”
Charles Shields, vice president of business development for Avecia, declined to comment on the status of his company’s deal with eXegenics or whether the expansion of the manufacturing facility would impact the arrangement.
Calando Says Phase I Trial of RNAi Cancer Drug on Track for 2007
Calando Pharmaceuticals said last week that it expects to begin a phase I trial of its lead RNAi-based cancer drug CALAA-01 this year in collaboration with the City of Hope and the University of California, Los Angeles, Jonsson Cancer Center.
Calando said it has begun toxicity studies in rats and monkeys and is scaling up to manufacture cGMP-grade clinical materials for the clinical trial.
Calando said it will be responsible for filing an investigational new drug application with the US for the drug with US regulators. “Upon regulatory approval, Calando, COH, and UCLA plan to conduct an open-label, dose-escalation phase I clinical trial in patients with unresectable or metastatic solid tumors,” the company said.
“Based upon the evaluation of the results from this study, Calando plans to conduct separate, disease-specific phase II trials,” it added.
Earlier this year, Calando published data showing CALAA-01 can be systemically administered to non-human primates with no adverse effects using a proprietary nanoparticle delivery technology (see RNAi News, 3/22/2007).
eXegenics Provides Details on President’s Severance Package
eXegenics last week provided details about the severance package provided to outgoing President Dale Pfost, who recently resigned to pursue “other professional interests” (see RNAi News, 5/10/2007).
According to an eXegenics filing with the US Securities and Exchange Commission, Pfost will remain with the company until the end of the month. After leaving the firm, he will receive a severance payment of $325,000, which is equal to one year’s salary, as well as relocation expenses up to $65,000.
All of Pfost’s outstanding equity awards, which would vest by May 31, 2008, will be automatically vested. Pfost will be able to exercise all vested options until May 31, 2008.
CytRx Posts Lower Q1 Loss on Revenue Increase, Breaks out RNAi Unit’s Planned Burn
CytRx last week reported its financial results for the first quarter, posting slightly lower losses on higher revenues.
The company’s net loss dipped to $4.5 million, or $0.06 per share, from $4.7 million, or $0.07 per share, a year earlier.
Revenues in the quarter jumped to $1.6 million from $61,000 in the year-ago quarter, reflecting service revenue from a deal under which a non-profit institution agreed to pay CytRx $24 million in exchange for royalties for an investigational small-molecule treatment for amyotrophic lateral sclerosis.
CytRx’s research and development spending climbed to $4 million in the first quarter from $2.3 million in the same period a year earlier, in part reflecting costs associated with its majority-owned RNAi drugs subsidiary RXi Pharmaceuticals (see RNAi News, 1/11/2007).
As of March 31, CytRx had cash and cash equivalents totaling $36.4 million.
In a filing with the US Securities and Exchange Commission, CytRx provided some details on RXi’s expected operations during 2007, stating that the subsidiary is expected to spend $6.2 million in 2007. This number includes $400,000 in payments to the University of Massachusetts Medical School pursuant to licensing agreements, $3.2 million in R&D costs, and $2.6 million in general and administrative expenses.