Califia’s Drug, CAP-0121

Is the Solution

The Challenge

Solid-tumor cancers are the highest area of unmet need representing 90% of all adult cancers.

Current treatments are ineffective against our lead targets: drug resistant ovarian, liver, sarcoma, and prostate cancers.

Our Solution

We have a promising treatment for cancer that no one else has. We are raising $10 million to get us through phase I clinical trials and advance an opportunity to treat annually over 500,000 patients with advanced drug-resistant cancers.

CAP-0121 is the solution

We have been working on this problem for over 35 years, we have synthesized hundreds of drug analogs, and treated more than 1,200 patients, and now we have the key to the solution.

Human trials for the 1st gen drug (irofulven) in 1,200 patients demonstrated:

  • Strong responses (e.g., ~20% response in heavily pretreated ovarian or liver cancer)

  • Relatively low toxicity (except prolonged low platelet counts)  

  • NO stomatitis, hand-foot syndrome, peripheral neuropathy, liver damage, or renal damage common with other cancer drugs

However, the prolonged periods of low platelets hindered treatment

Human irofulven trials showed some striking results

  • 18-year-old sarcoma  patient who failed multiple chemotherapeutic regimens and radiation therapy. Tumor outlined in red.

  • Left: tumor compressed heart and lungs. Hard to walk or breathe

  • Right: marked reduction in tumor size after three rounds of irofulven. No surgery involved during therapy.

What we have learned and what we have changed

  • We screened 450 analogs of irofulven. Of these, CAP-0121 shows the best efficacy and lowest toxicity in rodents and in canine studies, and rapid recovery of platelets

  • Such precision medicine screening was not possible with the prior drug (irofulven)

    • Illudins work by damaging DNA (a unique damage, compared to other drugs)

    • This damage is normally repaired by the TCR DNA-repair pathway

    • About 20% of cancers downregulate TCR repair (“TCR deficient” cancers)

      • These cancers can’t repair damage by illudins

      • These cancers are thus 30 to 100x more sensitive to illudins like CAP-0121

      • We believe this is why only 16% of irofulven patients showed a response and we will now select these patients for treatment