In an exclusive interview with The Fly, Aptevo Therapeutics’ (APVO) CFO Jeff Lamothe talked about the company, its pipeline, ongoing clinical trials, pandemic-related impacts, and much more.
APVO436 PHASE 2 EXPECTED LATER THIS YEAR: Aptevo Therapeutics is a biotech company focused on bringing novel immuno-oncology therapeutics to market. Its ADAPTIR and ADAPTIR-FLEX platform technologies are designed to engineer products that have potential to meaningfully improve and extend the lives of patients.
The company is developing several drug candidates. Among those is APVO436 with two potential indications: acute myeloid leukemia or AML/Myelodysplastic syndromes or MDS and AML front-line setting. For the former, the company announced last month data from its Phase 1b trial. Meanwhile, in the latter indication, APVO436 was selected for inclusion in groundbreaking BEAT AML Master Clinical Trial spearheaded by LLS.
“The drug APVO436 is the most advanced candidate in our pipeline. It’s a clinical stage drug targeting AML and MDS. That’s a drug that will be taken into Phase 2 later this year. But following quickly on its heels is another drug called ALG.APV-527, which is a solid tumor drug whereas APVO436 is a drug cancer drug. We have candidates that can cover the hematology front of the cancer and now we’re bringing along solid tumor candidates as well. The 527 is heading into Phase 1 now; we’re actively recruiting patients and expecting to dose the first patient really soon,” CFO Jeff Lamothe told The Fly.
“The data on 436 that we put-up late last year are very exciting. It’s pretty rare to have clinical data in a subset population where 100% of the patients saw clinical benefit, each patient in varying degrees. Some patients achieved complete remission, others partial remission. I think 100% clinical benefit rate is almost unheard of. We’re really excited about it.”
MOVING ALL DRUGS FORWARD: The drug candidate APVO436 is not the only one in current development by Aptevo. “We’re actively moving all of our drugs forward. We’re putting our higher emphasis on our clinical stage drugs. We have two of those now: 436 which is going into Phase 2, and then 527 which is starting Phase 1 now. The next drug after that in the pipeline is called APVO603 and it’s another solid tumor drug, a dual antagonist. That drug is in IND enabling studies. After that is APVO442, which is earlier in the pre-clinical pipeline. We’re conducting pre-clinical work but we’re not yet at the stage of doing IND enabling studies. And before that is the drug we announced recently, APVO711,” the executive explains.
Earlier this month, the company filed a provisional patent with the U.S. Patent and Trademark Office pertaining to an anti-PD-L1 x anti-CD40 compound, APVO711, with the potential to fight a range of solid malignancies such as head and neck squamous cell carcinoma, melanoma, and carcinomas of the lung, gastrointestinal tract and colon. Aptevo plans to initiate pre-clinical studies this year.
MULTIPLE DATA READOUTS: Looking out over this new year, the company expects to potentially have multiple data readouts. “We’re excited to be at that stage where we have multiple candidates in the clinic, which gives us the opportunity to have multiple data readouts in any given period of time. We have the initiation of Phase 2 to look forward in the second half of this year for our AML drug. And with the 527 that is starting dosing now, we anticipate having a preliminary data readout in the second half of the year,” Lamothe says.
COVID-RELATED IMPACT: Discussing COVID-related impacts with The Fly, CFO Jeff Lamothe says the company is “back on track.” But like “anyone in the industry, Aptevo saw share of COVID impacts in the earlier days.” “We had to adjust our way of working…. We’re really proud of how our team conducted themselves through all of this and how we were able to continue to advance all of our programs – clinically and preclinically—without really missing a beat. The other impact we felt was, as related to our clinical trials, in the early days of the pandemic we had clinical sites that were having to redirect their efforts away from cancer trials to address the pandemic. We also saw situations where patients chose not to initiate their participation because of concerns they were going to contract COVID if in a medical facility. These issues seem now to be in the rearview mirror as we get into a new normal. I think that as an industry, we got a healthy rhythm around it,” the executive told The Fly.
‘A LOT OF VALUE OFFER’: Aptevo’s CFO believes the company has “accomplished a lot and has a lot of value offer.” “We are now a company with proof of concept through our clinical trial and our platform technologies. That speaks not only to the drug we are running in AML but also to other drugs that will follow on its heels. Each drug is not a standalone drug; it’s part of a platform story that has been validated in the clinic. While we’re focusing now in AML for 436, we also had pretty exciting clinical data in MDS with 436 that create the opportunity to move in that direction as well,” Lamothe adds.
"Meet the Company" is The Fly’s recurring series of exclusive short interviews with Executive Officers to offer a deeper look inside the company.
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