Beijing-based CANbridge Life Sciences has sent the Taiwan FDA an Investigational New Drug (IND) application for candidate CAN-008 aimed at brain cancer immunotherapy that was in-licensed for China rights from Germany's Apogenix.
CANbridge Chairman and CEO James Xue
The Taiwan trials will see CAN-008 administered with temozolomide (Temodar) along with radiation therapy for 55 patients in the open-label, dose-escalation Phase I on safety, tolerability pharmacokinetics and preliminary efficacy, according to a press release.
The WuXi Biologics unit of Shanghai-based WuXi AppTec will manufacture the candidate in China, aiming to use the speedier IND process in Taiwan as a possible springboard into Mainland China, though the pathway relies on China FDA granting a fast-track review.
"We are delighted to join forces with WuXi, which will manufacture CAN-008 for the Chinese market, where we plan to begin the pre-clinical work immediately, preparatory to an IND submission," James Xue, CANbridge Chairman and CEO, said in a statement. CANbridge will rely on WuXi for CD-95 fusion protein.
In a phone interview with FiercePharmaAsia, Xue said that patient enrollment should be finished by the end of the year and results for the Phase I leg out by the second quarter of 2017. He said the trial was being conducted under a 4 + 4 arrangement between Taiwan and China that recognizes clinical trial data from 4 hospitals in each country.
In that regard, CANbridge hopes to take successful Phase I data to the China FDA for an IND application and if the data is exceptional - aim for a straight shot into Phase II without having to repeat the Phase I in China.
With a bit more than $15 million raised up to Series A, Xue expects Series B cash this year at around twice that amount to carry on work through 2018, adding that he sees the biotech space in China moving to a "self-select" mode in funding in the coming years as excellent talent and candidates are in place now.
The multi-center, double-blind, randomized, placebo-controlled Phase II leg of the trial eyes efficacy and safety with a start date seen in August of this year.
Apogenix's own efforts in a Phase II trial in Europe saw increased median survival to 16.1 months from 6.5 months and meeting efficacy endpoints and no serious adverse effects.
In March, CANbridge inked a deal worth a potential $134 million deal with Nasdaq-listed Aveo Oncology ($AVEO) for a clinical-stage ErbB3 (HER3) antibody candidate AV203.
CANbridge received $10 million in venture capital financing in October of last year, led by Qiming Venture Partners and TF Capital, the venture arm of Chinese CRO Tigermed, which built on angel investor funding of the same amount received in 2014.
- here's the release