Reports 73% Increase in IXINITY Year-Over-Year Quarterly Net Revenue in Q1 2019
Anticipates Launching New IXINITY 3,000 IU Assay Mid-2019
Advances Dosing in Additional Cohorts in APVO436 and APVO210 Clinical Programs
On Schedule to File a CTA for ALG.APV-527 in Q4 2019
SEATTLE, April 15, 2019 (GLOBE NEWSWIRE) — Aptevo Therapeutics Inc. (Nasdaq: APVO), a biotechnology company focused on developing novel oncology, autoimmune and hematology therapeutics, today announced continued progress in the Company’s commercial and clinical development programs, reporting first quarter 2019 IXINITY net revenue of $7.0 million, which represents a 73% increase from the first quarter of 2018. Additionally, Aptevo announced today that it has received approval from the U.S. Food and Drug Administration (FDA) for a Prior Approval Supplement (PAS) describing plans for the manufacture of a new 3,000 IU assay and remains on track to begin supplying the market with 3,000 IU IXINITY vials in mid-2019.
“We outlined key priorities for Aptevo at the beginning of 2019 focused on advancing three novel bispecific candidates in the clinic over the next 18 months and driving continued growth of IXINITY. I’m very pleased with our progress so far this year as we prepare to roll-out new IXINITY growth initiatives and continue to advance two clinical programs towards preliminary data read-outs later in the year, with a third program, ALG.APV-527, on track for a clinical trial authorization (CTA) submission in the fourth quarter of 2019. Importantly, we also continue to project that our cash burn rate in 2019 will be in the range of $36-40 million, a 33% reduction compared to our projected burn rate in 2018 of between $55-60 million. For several reasons, we believe 2019 has the potential to be a transformative year for Aptevo as the first clinical data begins to emerge for our next-generation ADAPTIR™ programs, which have shown promising differentiation in preclinical studies. I look forward to keeping our shareholders updated on our progress as we reach key milestones in both our ADAPTIR and IXINITY programs this year,” said Marvin L. White, President and Chief Executive Officer.
“Patient conversions onto IXINITY therapy have continued as awareness of IXINITY and Aptevo builds within the Hemophilia B community,” said Mike Adelman, Senior Vice President, Commercial Operations. “Net revenue for IXINITY more than doubled in 2018 and continues to grow in 2019. Last year we outlined several growth initiatives that we believe will help to further drive momentum in our IXINITY commercial operation. The first of these initiatives – launch of a larger 3,000 IU assay, is scheduled for deployment in mid-2019, following recent FDA approval of our plans for the manufacture of this assay.”
“Aptevo is proud to have a strong reputation within the Hemophilia B community for being responsive to the needs of the community. This new, larger vial size gives us more diversity in our assay presentations and enhances the user experience for IXINITY – particularly for patients with more severe factor IX deficiency as it reduces the time necessary to reconstitute product for infusion. The larger vial size also requires less space for storage and is more compact for travel, offering enhanced convenience for patients,” said Mr. Adelman.
In addition to the launch of a larger assay for IXINITY, Aptevo is also advancing plans to commence a confirmatory Phase 4 study of IXINITY in the third quarter of 2019 with the objective of seeking a label expansion in the United States for IXINITY in a pediatric setting. IXINITY is currently approved for use in individuals 12 years of age or older. Data from a pooled analysis evaluating patients under the age of 12 with Hemophilia B treated with IXINITY show that IXINITY appeared to be safe and well tolerated in this subject population and was comparable to the results from the overall patient population studied in the pivotal clinical trial of IXINITY. Aptevo is also pursuing opportunities to license or partner distribution and marketing rights for IXINITY in select ex-U.S. markets.
“We are excited to undertake these new growth initiatives for IXINITY, which could build upon our current momentum and expand the use of IXINITY in both U.S. and ex-U.S. markets,” continued Mr. Adelman. IXINITY is currently marketed exclusively in the United States by Aptevo.
ADAPTIR Pipeline Update
As previously announced, Aptevo has also recently commenced Phase 1 clinical development of two novel bispecific antibody candidates, APVO436 and APVO210, being investigated for the treatment of acute myeloid leukemia (AML) and autoimmune disorders, respectively. Each candidate was built using the company’s ADAPTIR protein therapeutic platform and features a unique mechanism of action for activating the immune system to fight cancer or suppressing the immune system and inflammatory processes for the treatment of autoimmune diseases.
“Enrollment in both the APVO436 and APVO210 clinical programs is proceeding on target,” said Dr. Scott Stromatt, Chief Medical Officer for Aptevo. “Dosing in Cohort 2 has been completed in the APVO210 study, while dosing in Cohort 2 is ongoing for APVO436. No dose-limiting toxicities have been observed in either study to date.”
“We anticipate reporting a preliminary read-out on ADA for APVO436 in the third quarter and also reporting preliminary Phase 1 safety data for APVO436 in the fourth quarter. Similarly, for APVO210, we anticipate reporting initial results of the single dose cohorts in the third quarter and reporting preliminary Phase 1 safety data in the fourth quarter. If preclinical observations can be confirmed in clinical studies, we believe that both APVO436 and APVO210 offer unique attributes that could position them as potential best-in-class or first-in-class molecules in their therapeutic categories,” continued Dr. Stromatt.
The APVO436 Phase 1/1b clinical trial is being conducted in two parts. The first part will enroll up to 60 patients and is an open-label, dose-escalation study evaluating the safety and pharmacokinetic profile of APVO436 to determine a recommended dose for part 2. The second part of the study is a Phase 1b open-label expansion study to assess the clinical activity and safety profile of APVO436 at the recommended dose in a larger group of patients.
The APVO210 Phase 1 clinical trial is a randomized, double-blind, placebo-controlled, single and multiple ascending dose study of APVO210, designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of APVO210 in healthy subjects. The study will be conducted in 2 stages; the first stage will assess single ascending doses (SAD) of APVO210, followed by an evaluation of multiple ascending doses (MAD) of APVO210 administered by intravenous (IV) infusion either weekly or biweekly over 4 weeks. The study is expected to enroll a maximum of 64 subjects in the initial SAD dose cohort and up to 40 subjects in the MAD dose cohort.
ALG.APV-527 is a bispecific ADAPTIR candidate that targets 4-1BB, a co-stimulatory receptor expressed on activated T cells, and 5T4, a solid tumor antigen. The candidate continues to advance through preclinical development to support CTA filing in Q4 2019 and enable first-in-human dosing of ALG.APV-527 in multiple solid tumors in early 2020. This program, in co-development with Alligator Bioscience, has shown increased tumor targeting in preclinical studies, while stimulating T cells through 4-1BB when drug engages 5T4 on tumors. This candidate has the potential to increase potency while limiting liver toxicities observed with monospecific 4-1BB targeting therapeutics.
Indications and Important Risk Information for IXINITY
IXINITY [Coagulation Factor IX (Recombinant)] Lyophilized Powder for Solution for Intravenous Injection is a coagulation factor IX (recombinant) indicated in adults and children ≥ 12 years of age with Hemophilia B for control and prevention of bleeding episodes, and for perioperative management. IXINITY is not indicated for induction of immune tolerance in patients with Hemophilia B. IXINITY is contraindicated in patients who have known hypersensitivity to IXINITY or its excipients, including hamster protein.
Hypersensitivity reactions, including anaphylaxis, may occur following IXINITY administration. Discontinue use of IXINITY if hypersensitivity symptoms occur, and initiate appropriate treatment. Regularly evaluate patients for the development of factor IX inhibitors by appropriate clinical observations and laboratory tests. If expected factor IX activity plasma levels are not attained, or, if bleeding is not controlled as expected with a certain dose, perform an assay that measures factor IX inhibitor concentration. An association between the occurrence of a factor IX inhibitor and allergic reactions has been reported. Individuals with factor IX inhibitors may be at increased risk of severe hypersensitivity reactions or anaphylaxis if re-challenged.
Nephrotic syndrome may occur with IXINITY. Nephrotic syndrome has been reported following attempted immune tolerance induction in Hemophilia B patients with factor IX inhibitors and a history of allergic reactions. Thromboembolism may occur when using IXINITY (e.g., pulmonary embolism, venous thrombosis, and arterial thrombosis). Patients may develop hypersensitivity to hamster (CHO) protein as IXINITY contains trace amounts. The most common adverse drug reaction observed in >2% of patients in clinical trials was headache.
Please see full Prescribing Information at www.IXINITY.com.
About Aptevo Therapeutics Inc.
Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on developing novel oncology, autoimmune and hematology therapeutics to meaningfully improve patients’ lives. Aptevo has a commercial product, IXINITY® coagulation factor IX (recombinant), approved and marketed in the United States for the treatment of Hemophilia B, and a versatile core technology – the ADAPTIR™ modular protein technology platform capable of generating highly-differentiated bispecific antibodies with unique mechanisms of action to treat cancer and autoimmune diseases. Aptevo has a broad pipeline of novel investigational-stage bispecific antibody candidates focused in immuno-oncology and autoimmune disease and inflammation. For more information, please visit www.aptevotherapeutics.com.
Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including, without limitation, statements regarding potential milestone payments, Aptevo’s outlook, financial performance or financial condition, Aptevo’s technology and related pipeline, collaboration and partnership opportunities, commercial portfolio, milestones, and any other statements containing the words “believes,” “expects,” “anticipates,” “intends,” “plans,” “forecasts,” “estimates,” “will” and similar expressions are forward-looking statements. These forward-looking statements are based on Aptevo’s current intentions, beliefs and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo’s expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not undertake to update any forward-looking statement to reflect new information, events or circumstances.
There are a number of important factors that could cause Aptevo’s actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo’s business or prospects; adverse developments in research and development; adverse developments in the U.S. or global capital markets, credit markets or economies generally; and changes in regulatory, social and political conditions. Additional risks and factors that may affect results are set forth in Aptevo’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, as filed on March 18, 2019 and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo’s expectations in any forward-looking statement.
Senior Director, Investor Relations and Corporate Communications