Cerecor Rebrands to Avalo Therapeutics

The rebranding to Avalo reflects the company’s aims to focus on three core indications, on immunology, immuno-oncology, and rare genetic diseases.

Eighteen months after completing its merger with Aevi Genomic Medicine, Cerecor is rebranding to Avalo Therapeutics. The merger with Aevi provided Cerecor with what Chief Executive Officer Mike Cola described to BioBuzz as a “clean break” from the company’s past history with diseases of the central nervous system. Now, the company will maintain its focus on developing precision medications for its core areas of focus. In addition to the break with the therapeutic focus, the merger also provided the company with a new leadership team that includes Cola, who served as CEO of Aevi since 2013, as well as Chief Scientific Officer Garry Neil, who was also on the Aevi leadership team.   

Cola said that the timing for the rebranding announcement comes at a defining moment for the company after the completion of the merger. He said the company has forward momentum and its clinical and developmental programs are “now up to speed.” In fact, Avalo has multiple clinical programs that are expected to read out by the end of this year, including CERC-002 (now AVTX-002), a promising first-in-class monoclonal antibody being assessed for ulcerative colitis and Crohn’s disease. In July, the company announced positive initial results from a Phase Ib proof-of-concept study evaluating CERC-002 in adults with moderate to severe Crohn’s disease. The company reported rapid response from patients within eight weeks of treatment and also noted there was a mean reduction in LIGHT (tumor necrosis factor superfamily member 14, TNFSF14) levels of approximately 80% as compared to baseline. Following the preliminary announcement, the company said the dose exploration trial will continue without changes to protocol.

AVTX-002 a first-in-class fully human monoclonal antibody targeting, LIGHT is also being assessed as a potential treatment for cytokine storm-induced COVID-19 acute respiratory distress syndrome (ARDS). Earlier this year, the company was granted Fast Track Designation from the U.S. Food and Drug Administration for the COVID program. It’s thought that LIGHT can play a role in treating inflammatory issues related to COVID-10. LIGHT stimulates T-Cell and B-Cell response as well as induces the release of other cytokines such as IL-1, IL-6, IL-8, IL-10, TNF, and GM-CSF, according to company data.

In addition to AVTX-002, the company is also developing AVTX-007, an anti-interleukin-18 monoclonal antibody (mAb) targeting immuno-oncology and immune-inflammatory diseases including multiple myeloma and Still’s disease. Also, the company is developing AVTX-006, a dual mTORc1/c2 inhibitor targeting lymphatic malformations. The asset has Orphan Drug and Rare Pediatric Disease designations from the FDA and is eligible for a Priority Review Voucher if approved.

Rounding out its clinical assets is the ATVX 800 program. That particular program includes three different assets, AVTX-801, AVTX-802, and AVTX-803, which deliver doses of monosaccharide therapies for congenital disorders of glycosylation. Like AVTX-006, each product candidate has Orphan Drug, Fast Track, and Rare Pediatric Disease Designations and is eligible for a Priority Review Voucher

Following the merger, Cerecor’s team has been focused on its proof-of-concept data across the entire portfolio, Cola said.

Weeks prior to the rebranding, Avalo announced positive second-quarter financial data for 2021, which included a recent expansion of its pipeline and favorable results in the Crohn’s disease program for CERC-002. Instead of announcing the rebranding during the quarterly report, Cola said they opted to wait until for a break in the news flow to promote the new brand while re-emphasizing the company’s “universal compassion for people.”

Looking at the company’s pipeline of six clinical-stage assets, Cola predicted the newly-branded Avalo will be a fully innovative pharmaceutical company within the next five years.

“Our goal is to serve patients by bringing high-value medicines to them,” Cola said. “We’re very patient-centric and are focused on finding patient needs… focused on being first-in-class in those areas.”

The company’s ticker symbol on the Nasdaq Stock Exchange will change to “$AVTX.” The company is also launching a new website address, www.avalotherapeutics.com.