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Aptevo Therapeutics looking to busy year ahead after transformative 2019 as it advances ADAPTIR pipeline

Aptevo's lead candidate APVO436, a designated orphan drug, is being investigated to tackle acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)

Medexus Pharmaceuticals Inc -
The firm's ADAPTIR platform can generate highly differentiated bispecific antibodies to treat different types of cancer

Aptevo Therapeutics Inc (NASDAQ:APVO) said last year was 'transformative' as the company executed on its plans to divest its non-core IXINITY hemophilia B treatment to become a 'pure play' biotech to focus on its novel ADAPTIR platform.

The ADAPTIR platform can generate highly differentiated bispecific antibodies to treat different types of cancer.

READ: Medexus expands US product portfolio by acquiring hematology asset IXINITY

Aptevo's lead candidate APVO436, a designated orphan drug, is being investigated to tackle acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS.)

Last month, the firm completed the sale of worldwide rights to IXINITY to Medexus Pharmaceuticals Inc (CVE:KMDP) (OCTMKTS:PDDPF) for estimated total proceeds of more than $100 million.

That included an upfront payment to Aptevo of $30 million, along with potential milestone payments totaling up to $11 million; and the opportunity to receive deferred payments on future US and Canadian net sales of IXINITY estimated to be worth in excess of $60 million.

The transaction provided non-dilutive funding for Aptevo, strengthened the balance sheet, and streamlined the focus on the ADAPTIR antibody platform, Marvin L. White, Aptevo's chief executive, told investors.

"Our progress in 2020 will mark a pivotal stage in the development program for APVO436 as we continue enrollment in dose cohorts 6 through 8 during the year in our ongoing Phase 1/1b clinical study," he said.

"Pharmacokinetic modeling suggests that this is the dose range in which clinical activity could become apparent.

"Preliminary data from a patient in cohort 4 showed a 'marrow complete response' suggesting evidence of early clinical activity of APVO436, so we are very encouraged and excited to monitor and report accumulating data from this study throughout the year."

Ground-breaking trial

Notably, APVO436 has also been selected by the Leukemia & Lymphoma Society (LLS) for inclusion in a groundbreaking clinical trial, which will evaluate the candidate in a front-line AML treatment setting, bringing increased exposure and recognition among leading national cancer research centers, said Aptevo.

Also last year, the firm selected a new preclinical ADAPTIR candidate - APVO603 - a potentially first-in-class bispecific antibody designed to amplify the adaptive immune response to cancer. What's more, later in 2020, the firm plans to announce a new ADAPTIR pipeline candidate.

Last year, with partner Alligator Bioscience, Aptevo completed CTA/IND-enabling studies for ALG.APV-527 intended for tumor-directed treatment of solid cancers and the firm says it is focused on partnering this asset for future clinical development.

Aptevo posted a net loss for the year to December 31 of $40.5 million, down from a loss of $53.6 million in 2018, on revenue of $32.4 million, up from $23 million in 2018.

Shares eased around 3.6% in New York on Wednesday to stand at $0.28 each.

Contact the author at [email protected]

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