Avalo Reports Positive Phase 1b Results for AVTX-002 in Moderate to Severe Crohn’s Disease Patients and Presents Additional Program Updates at 2022 Investor Event

• Immunology portfolio highlighted by success of a second positive study with AVTX-002 further validates the LIGHT mechanism of action in inflammatory diseases
• Efficacy signal demonstrated in heavily pre-treated subjects support further evaluation in inflammatory bowel disease patients’ refractory to three or more treatments, including anti-TNF alpha and other biologics
• Expands AVTX-002 target indications to include moderate to severe Non-eosinophilic Asthma patients with a Phase 2 randomized, placebo-controlled trial; top-line data anticipated in the second half of 2022
• AVTX-007 data in multiple myeloma indicated the therapy is generally safe and well tolerated; no efficacy signal was seen at the high dose and the decision was made to discontinue the program
• Prioritizing focus of AVTX-007 development in Adult Onset Still’s Disease; top-line data for Phase 1b trial anticipated by mid-year 2022
• Rare disease development programs progressing; pivotal study for AVTX-803 for Leukocyte Adhesion Deficiency II remains on track to dose its first patient in the first quarter of 2022; top-line Phase 1b data for AVTX-006 for complex lymphatic malformations in mid-year 2022

Excerpt from the Press Release:

WAYNE, Pa. and ROCKVILLE, Md., Jan. 06, 2022 (GLOBE NEWSWIRE) — Avalo Therapeutics, Inc. (Nasdaq: AVTX), a leading clinical-stage precision medicine company that discovers, develops, and commercializes targeted therapeutics for patients with significant unmet clinical need in immunology and rare genetic diseases, today provides a comprehensive update on the Company’s growth opportunities and mid-stage development portfolio.

“Avalo is poised for a pivotal year in 2022,” said Mike Cola, Chief Executive Officer of Avalo Therapeutics. “With multiple product candidates in clinical development, our focus is now on advancing and unlocking the value of these innovative therapies. We are particularly encouraged by our second positive trial with AVTX-002 and are excited by the broad potential in inflammatory diseases. As we progress our therapies towards pivotal trials and potential approvals, we believe there will be a number of business development opportunities creating optionality for the Company.”

Program Updates and Key Highlights

AVTX-002 Phase 1b Crohn’s Disease (CD) Clinical Trial Results:

• The Phase 1b, open-label, dose-escalation, signal-finding, multi-center study evaluated the safety, tolerability, pharmacokinetics, and short-term efficacy of AVTX-002 in adults with moderate to severe, active CD who have previously failed anti-tumor necrosis factor alpha (anti-TNFα) treatment. The study evaluated two different doses of AVTX-002 (1.0 mg/kg and 3.0 mg/kg) in which all subjects received a total of four doses of AVTX-002 by subcutaneous (SQ) injection at 14-day intervals and underwent colonoscopies at baseline and again at eight weeks.
  
• Clinically meaningful mucosal healing, determined by colonoscopy and adjudicated by a central reader, was observed in fifty percent (4/8) of subjects with one subject achieving remission (SES-CD = 0). Additionally, patients responded rapidly to treatment within eight weeks and free LIGHT levels decreased in all subjects.
  
• Seventy-five percent (3/4) of patients that demonstrated mucosal healing by colonoscopy reported they had returned to doing poorly two to three months after cessation of study drug, suggesting a drug-related effect; follow-up is ongoing for the remaining responder. Data continued to show that treatment with AVTX-002 was safe and well tolerated with no drug-related serious adverse events observed.
  
• Avalo continues to evaluate the biomarker data from this study.

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