By Ben AdamsOnxeo CEO Judith Greciet
Onxeo (EPA:ONXEO) has acquired DNA Therapeutics for €1.7 million ($1.85 million) and set out on a search for a new partner to help fund late-stage studies for its delayed drug Validive.
The Franco-Danish biotech has acquired the privately-held, clinical-stage biopharmaceutical French company DNA Therapeutics for its signal-interfering DNA repair technology in what it hopes will be a new and effective way of treating certain cancers.
Onxeo, a product of the merging of BioAlliance Pharma and Topotarget in 2014, is paying €1.7 million in common shares--with an additional €1 million milestone payment in shares upon starting a Phase II trial in a selected indication of its lead candidate--as well as royalty payments on future commercial sales. This could reach up to €25 million per indication to be developed and approved in the future, the firm said.
What's it getting for its money? Well, it gains access to its as yet unnamed lead candidate, formerly known as Dbait or DT01, a potentially first-in-class clinical signal-interfering DNA (siDNA) molecule with the potential to treat several types of genetically unstable or resistant types of cancers while sparing healthy cells.
It's currently in early to mid-stage testing, with a recent first-in-human Phase I/IIa trial in patients with late-stage melanoma showing a good local, systemic and immune tolerance and safety when administered intra-tumorally and subcutaneously around the tumors.
In current cancer treatment, the effectiveness of radiotherapy and chemotherapy are often limited by the action of DNA repair processes on the damages caused by these therapies.
The new aspect of siDNA is to use a short fragment of DNA, a mimetic of DNA damage, to interfere with the sensing and signaling of DNA damages in the nucleus, and ultimately, inhibit their repair during the treatment period. Thus the theory goes that siDNA increases the effectiveness of radiotherapy and chemotherapy without adding any cytotoxic effect.
Onxeo now plans to start its development of the drug and assess the safety and tolerance of the product both on its own and in combination with other DNA-damaging agents in various solid tumors. Trials will start after Onxeo has had a chance to finesse the manufacturing process for the drug--something the company says it will start as soon as the deal closes later this year.
Judith Greciet, CEO of Onxeo, told FierceBiotech: "The deal to buy DNA Therapeutics fits in broadly with our strategy to grow by acquiring external R&D businesses, but why have we gone specifically with DNA Therapeutics? Well, we are very excited by its siDNA technology, which itself is a spin-off from three major academic units in France [the National Centre for Scientific Research, the French National Museum of Natural History and the Institut Curie], because it is one of the most promising new approaches in the future of cancer treatment, and we want to be one of the first adopters of this.
"The compound and the technology are very interesting because it is not targeting just a small sub-set of genetic mutations but is more universal in scope by potentially treating a large number of tumors."
Outside of melanoma, Greciet said the firm is also seeking to target the hard-to-treat tumors from triple-negative breast cancer and platinum-resistant ovarian cancer, with more likely to come in the future.
She said that this is hard, cutting-edge science and very attractive to the company--and potentially a breakthrough product that could put Onxeo on the map when it comes to oncology R&D.
Meanwhile, the firm has also announced that it needs help to run new trials for its severe oral mucositis drug Validive.
The drug endured a setback in 2015 after the FDA told Onxeo it needs extra Phase III clinical trials to be completed before it can be registered for marketing approval. This will add significant costs to the entire program, and Onxeo does not have the cash reserves to take on the extra work alone.
Therefore, the company said it is in the "best interest of its shareholders" to get an external partner to help spread the costs.
Greciet said she was "flexible" when it came to who the partner could be--whether that means it was a VC or a pharma partner. She said that the firm didn't specifically need a pharma company to help on the R&D side of things as they have that hand; it is more about having the capital to undertake the extra trials.
She wouldn't divulge who the company has been speaking to, but said they had undertaken some "interesting conversations with certain groups, but until a deal is signed you can't rely on anything, so we're still seeking a partner.
"But because we're looking really for just funding, a VC or an investor that can fuel the investment side of things would be sufficient. But if a pharma company was interested, we'd be happy to talk to them as well."
Greciet didn't give a timeline as to when a new partner could be in place. "It all depends what we can find out on the ground," she explained, but added that they were still confident the drug will hit the market if it gains the additional funding.
The firm also posted its full year results this afternoon, showing steady growth for its newly approved lymphoma drug Beleodaq, which is sold by its partner Spectrum Pharmaceuticals, with recurring revenues increased 68% over 2014 to €2.7 million.
Onxeo's plan to raise cash for R&D causes stock to drop
Onxeo moves to PhIII after oral mucositis drug beats placebo in midstage trial