Mental health conditions continue to defy available treatment options, but Aditum Bio is hoping to rise to the challenge with a new biotech that will take another look at Taisho Pharmaceutical's failed major depressive disorder candidate TS-121.
Aditum Bio, an investment firm co-founded by former Novartis CEO Joe Jimenez, launched Ancora Bio, the firm's fifth biotech, on Wednesday with the in-licensing of Taisho's molecule.
Ancora is making an undisclosed upfront payment to Taisho for the exclusive worldwide rights to the molecule, renamed ANC-501, for development, manufacturing and commercialization. Tokyo-based Taisho will provide funding to Ancora, according to a statement.
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ANC-501 is a selective vasopressin 1b receptor (V1b) antagonist. Taisho previously tested the safety and efficacy of the molecule in a phase 2 study of patients with major depressive disorder who didn't meaningfully benefit from existing antidepressant therapy. The treatment was unsuccessful at improving patients' depressive episodes, according to results published in the September 2020 issue of the Journal of Psychiatric Research.
Despite the failure, Ancora Bio saw a sliver of hope in that the drug appeared to have a meaningful benefit in a certain group of patients with HPA axis dysfunction, which means they typically resist other treatments.
"We think that that’s a promising signal to explore further," said Ilan Zipkin, Aditum's vice president of business development and licensing, in an interview with Fierce Biotech.
The drug candidate could work together with more traditional therapies called selective serotonin reuptake inhibitors (SSRIs), such as Zoloft, Prozac and others, to provide "extra support," Zipkin said. SSRIs are commonly used in treating depression, anxiety and other psychological conditions.
"It’s not going to be the answer for every patient with depression, but for those with HPA axis dysfunction, being able to treat that independently of their SSRI, we believe gives the SSRI a much better chance of being effective," Zipkin said.
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A phase 2 or phase 2b trial of ANC-501 in patients with depression will kickoff "as soon as possible," Zipkin said.
Ancora is one of many biotechs attempting to treat a disorder that for years was stigmatized, but has come to the forefront in recent years. The COVID-19 pandemic has nearly quadrupled the number of Americans reporting anxiety or depression symptoms and the impact of the past year will linger for years as the mental health challenge defies many treatments.
Biogen and Sage Therapeutics said earlier this month that their jointly developed depression drug improved depression symptoms in adults with major depressive disorder, but the therapy, called zuranolone, could wear off too quickly.
Eliem Therapeutics raised $60 million in a series B last month to fund a phase 2a study for patients with major depressive disorder and those with hormone-related depressive disorders.
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Ancora Bio should have the runway to get to proof of concept clinical data. Aditum typically is the sole institutional investor in its portfolio companies until the firm is able to generate "some new proof of concept clinical data," which takes about $25 million to $30 million, on average to achieve, Zipkin said.
The investment firm has also launched Teres Bio, which focuses on atopic dermatitis and plaque psoriasis treatments; Anteris Bio, which has licensed a renal disease treatment from vTv Therapeutics; and Tempero Bio, another licensee that picked up a drug for anxiety and substance use disorders from Sosei Heptares.
The firm is also led by co-founder Mark Fishman, M.D., who was a long-time president of the Novartis Institutes for BioMedical Research. Aditum management provides regulatory affairs, legal, clinical operations and other operational support across its portfolio companies to reduce overhead costs, Zipkin said.