Aptose Bioscience is the only company with a small molecule in development without those toxicities for AML patients with its products.
While the best standard of care is being implemented for most types of cancer, that doesn’t mean treatments don’t come without toxicities—such as bone marrow suppression, drug-resistance, and intolerance issues from ibrutinib for acute myeloid leukemia (AML).
Among the many companies developing small molecule cancer drugs, Aptose Biosciences (NASDAQ:APTO; TSX:APS) is the only one with a MYC inhibitor in APTO-253 for AML that does not cause bone marrow suppression and a pan-FLT3/pan-BTK kinase inhibitor in CG-806 for AML and B-cell cancers that avoids the intolerance and drug-resistance issues of ibrutinib.
While at the the Bloom Burton & Co Healthcare Investor Conference, which was held in Toronto from May 2-3, the Investing News Network (INN) had the chance to catch up with the company’s president and CEO, William Rice and vice-president and Chief Financial Officer, Greg Chow, to discuss the company’s upcoming pipeline updates and its first quarter financial results.
To provide some background, back in 2015, the US Food and Drug Administration (FDA) put APTO-253 Phase 1b trial on clinical hold after Aptose voluntarily suspended the dosing. Rice explained this was due to manufacturing issues which has now been solved and the company expects to announce this quarter the hold has been lifted.
“We hope that molecule will return to the clinical in the coming months,” Rice added. “The candidate APTO-253 is a molecule that inhibits the expression of c-Myc oncogene for the treatment of patients with AML.”
The c-Myc oncogene is overexpressed in hematologic cancers, such as AML, and is a transcription factor which regulates cell growth, proliferation, differentiation and apoptosis. The overexpression of the factor amplifies new sets of genes, promoting oncogenesis—which is the formation of normal cells to cancer cells.
In the case of the AML indication for the drug, APTO-253 downregulates expression of this oncogene and depletes its oncoprotein, leading to apoptotic cell death in AML cells. The hope for the future clinical trials is to prove the drug can be a safe and effective c-Myc inhibitor for AML patients, combining with other agents and doesn’t impact the normal bone marrow.
CG-806 is the companiy’s second candidate in pre-clinical development for AML and B cell cancers, including CLL, MCL, and DLBCL. Rice said the company intends to file the investigational new drug (IND) application later this year and get it into the clinic. CG-806 is a first in class Pan-FLT3 and Pan-BTK inhibitor, the first is a major target for patients with AML because it becomes mutated.
The drug inhibits every form of FLT3, “it truly has the broadest and superior profile in terms of killing the AML cells than any other FLT3 inhibitors out there,” Rice told INN.
In terms of its financial results, Aptose released its Q1 results on May 10, which showed research and development expenses nearly doubled from the first quarter in 2017, which is based on the company increasing its CG-806 development program and expenditures on the APTO-253 program.
“There’s a lot more confidence in the programs that we’re developing, investor confidence and our ability to be able to raise capital and fund the programs,” Chow told INN prior to the results being released. “Our financial condition is much better than we were this time last year.”
Chow said some highlights of the report include an “effective,” $100 million shelf filing, a $30 million at-the-market facility, and a committed equity facility with Aspire Capital which has now raised $15.5 million from the common shares purchase agreement—which began in 2017.
While the company does expect a greater spending rate in terms of research and development in the coming years as clinical operations activities increase—with returning to the clinic—both Chow and Rice added this will be a positive for the company.
Aside from its APTO-253 and CG-806 candidates, Aptose is also working on APL-581 in discovery also for hematologic malignancies.
Since the company released its first quarter financial results, the company’s share price saw a 2.45 percent increase to reach $3.35, as of market close Monday (May 14).
On May 11, H.C. Wainwright analyst Joseph Pantginis reiterated a “buy” target for the company with a $6.00 price target. In April, Roth Capital analyst Jotin Marango also reiterated a “buy” rating with the same price target.
Investors can expect to see a “step up in values,” which may be triggered by APTO-253 returning to the clinic and clinical data towards the end of this year and into 2019, Rice said. For CG-806 following IND allowance late this year, the company expects to move into the clinic for AML and B cell malignancies throughout 2019, adding to the step up in value for the company.
Other molecules in development with a FLT3 inhibitor or BTK inhibitor may also result in a big increase in evaluations for shareholders, based on other companies, Rice added he hopes to see the same for Aptose likely in 2019.
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Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.
Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.