A real cancer story

As founder and CEO I have been in this business several decades and oh boy, do we so often miss the story when it comes to developing cancer treatments.

Here is a real story:

David is diagnosed with late-stage (IV) colon cancer. He bounces from clinic to clinic and doctor to doctor for over a year. In total he is prescribed six regimens of treatment. His body is slammed by three chemotherapy combinations, two target therapies and an immunotherapy drug. Nothing works and his tumor grows to a size that makes it noticeable even to passersby.

The side effects of all those chemicals rob David of his manhood, his ability to walk, his confidence to hold a cup of tea without shaking so much it falls on the floor. He even has to wear diapers at age 50 and is moved around in a wheelchair by his siblings. This is horrible to read, and also, it is the reality of many cancer drug side effects. This is reality for half of all people with late stage cancers because half of all cancers become resistant to the drug used to treat it.

The pharma industry, of which I have been a part for over thirty years, knows this. This is the toughest challenge, so, a blind eye is often turned in favor of easier targets. Shareholders often won’t allow a company to even attempt addressing this problem. Investors naturally shy away.

After his six core-treatments, David is ready to give up. Then, his daughter announces she’s is getting married. David guesses he only has weeks to live. All he wants is to live long enough to see his daughter married. His doctor said there was one more chance. He ‘recruited’ David to the Neovia cancer drug trial for our lead compound NEV-801. We are the only company in the world addressing this problem, the most difficult aspect of cancer.

David agreed to go on our study only because the doctor said she had seen the side-effect data in other patients under her care and it would not cause him any more quality of life problems.

It didn’t.

Not only did David get to see his daughter married, but nine months later he got to hold is grandson. He had no side effects.

This is why Neovia Oncolgy exists. The reason it was started at all was because of my mother.

When I was 7 years old, my mother was diagnosed with aggressive advanced breast cancer. I chronicled her inspiring fight against the prognosis of having only six months left to live in a book called, Three Simple Steps. My mother refused to succumb until her three children were grown and safe. She was a woman of her word. I was inspired by her fight and also dismayed by what the side effects of the cancer treatment did to her. It robbed her of womanhood and grace. Helplessly watching her suffer left a scar on me, one I have wanted to erase ever since.

Fast forward to 2005, I met a brilliant doctor at a cancer hospital in San Francisco. He had the idea that instead of bombarding patients with a barrage of cancer drugs causing multiple toxicities he could invent combination small molecules structurally redesigned to simultaneously hit multiple cancer cell pathways and at the same time stabilize the combination to reduce side effects. It seemed too good to believe, but we set about testing his inventions in our labs.

Over a seven year period we tested 5000 combinations and 3000 linkers from which we selected a portfolio of combinations to patent. From there we selected a lead compound code-named NEV-801 and began toxicity testing. The results were so promising that many auditors felt sure we must have missed some steps. We had a face to face discussion with the FDA and based on the data within two weeks they gave permission for Neovia to begin phase I testing in humans.

Since then we have completed phase I(a) dose escalation study with the starting dose of 20mg/m2. At the completion of phase I(a) in more than 30 patients with late stage, drug-resistant solid tumors the treatment dose has risen to 600mg/m2. Not a single serious adverse event was attributable to NEV-801

We observed 22% partial response (>30% reduction in tumor size) and >60% stable disease (No further tumor growth) in patients taking doses above 420mg/m2. NEV-801 has a potentially wide therapeutic window offering the possibility to one day become the ideal combination treatment with other therapies for people like David. There is still a long way to go and a lot of work to be done to prove that.

To date, Raymond Su and I have funded the company personally because no investor or potential pharma partner shared our vision. We feel we have a proof of concept now and our next vision is to continue studies, to find the best dosage regimen, and to eventually make this drug available and affordable for everyone, everywhere who doctors believe can benefit from the combinations while maintaining the a cancer patient’s quality of life. To do that Neovia Oncology needs additional funding and resources.