APVO210 / Aptevo Therap - LARVOL DELTA

Study to Evaluate APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis (clinicaltrials.gov) - P1; N=85; Terminated; Sponsor: Aptevo Therapeutics; N=144 ➔ 85; Trial completion date: Sep 2020 ➔ Jun 2020; Active, not recruiting ➔ Terminated; Trial primary completion date: Sep 2020 ➔ Jun 2020; Business decision

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Psoriasis • Psoriatic Arthritis • Ulcerative Colitis

[Effect of Human Serum Albumin on Endotoxin Scattering Photometry]. (PubMed) - Kansenshogaku Zasshi - "HSA or plasma protein seemed to affect the result, especially in the ESP630 method, and a non-specific reaction was found to occur in the ESP methods."

Journal • Biosimilar

Study to Evaluate APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis (clinicaltrials.gov) - P1; N=144; Active, not recruiting; Sponsor: Aptevo Therapeutics; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

Aptevo Therapeutics Reports Second Quarter 2019 Financial Results (GlobeNewswire, Aptevo Therapeutics Inc.) - Reports Positive Preliminary Top-Line Safety Data for APVO210. Advances APVO210 into Phase 1 Multiple Ascending Dose (MAD) Study. Commences Dosing in Cohort 4 of APVO436 Phase 1 AML/MDS Clinical Trial . Achieves 32% Increase in First Half 2019 Year-Over-Year IXINITY® Net Revenue;. Launches New 3,000 IU IXINITY Assay for Enhanced IXINITY User Experience & Convenience. “With both our APVO210 and APVO436 programs making important progress in the clinic this year, we anticipate robust news flow over the next several quarters.

Clinical data • Launch

Aptevo Therapeutics Reports IXINITY® and Pipeline Progress (GlobeNewswire, Aptevo Therapeutics Inc.) - "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....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 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."

Clinical data • FDA event • Launch • Regulatory • Sales • Trial status

New treatment for autoimmune inflammatory diseases begins phase 1 trial in Australia (Lupus) - "Dosing has begun in a new Phase 1 clinical trial of a bispecific antibody called APVO210 which is being developed to treat autoimmune and inflammatory diseases such as lupus. Preclinical data suggests the agent has shown to generate T cells that could play a key role in the suppression of inflammatory processes in the body."

Trial status

Aptevo Therapeutics Begins Phase 1 Clinical Trial of APVO210 a Novel Bispecific Antibody for the Treatment of Autoimmune and Inflammatory Diseases (GlobeNewswire, Aptevo Therapeutics Inc.) - "Aptevo Therapeutics Inc...announced today that it has commenced dosing in a Phase 1 clinical trial of APVO210, a novel bispecific antibody candidate built on Aptevo’s ADAPTIR™ therapeutic protein platform which is being developed to treat autoimmune and inflammatory diseases. There is a growing body of data to support APVO210 as a novel, first-in-class targeted cytokine immunotherapy."

New P1 trial

Study to Evaluate APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis (clinicaltrials.gov) - P1; N=144; Recruiting; Sponsor: Aptevo Therapeutics; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open