AbbVie Gains Landos Biopharma and Full FDA Approval for ADC Product

Editor's note: this story was originally published on BioPharmInternational.com.

AbbVie has entered into a definitive agreement to acquire Landos Biopharma, a clinical-stage biopharmaceutical company focusing on autoimmune diseases, following an earlier approval of ELAHERE (mirvetuximab soravtansine-gynx), a new antibody-drug conjugate (ADC) for treating ovarian cancer, by FDA, the company announced on March 25, 2024.

Under the Landos agreement, AbbVie will acquire Landos for $20.42 per share, an aggregate value of approximately $137.5 million, in cash upon closing. The deal also includes one non-tradable contingent value right per share at a value of up to $11.14 per share (approximately an additional $75 million in aggregate), dependent on achieving a clinical development milestone. The transaction is expected to close in the second quarter of 2024

The Landos acquisition includes a lead asset, NX-13, an oral nucleotide oligomerization domain-like receptor family member X1 (NLRX1) agonist with a bimodal mechanism of action (MOA) that is anti-inflammatory and that facilitates epithelial repair. NX-13 is in a Phase II clinical trial (NEXUS ) in the United States and Europe for treating ulcerative colitis (UC). According to AbbVie in a company press release, “NLRX1 regulates immunometabolism and inflammation, and its activation impacts multiple mechanisms of inflammatory bowel disease (IBD) pathogenesis.”

"This announcement is a testament to Landos' talented team and their commitment to our mission of creating oral treatments that can address a therapeutic gap," said Gregory Oakes, president and chief executive officer, Landos, in the press release. "NX-13 and its bimodal MOA have the potential to provide a novel approach to the treatment of ulcerative colitis and Crohn's disease. With AbbVie's therapeutic area leadership and expertise in global development, they are the right company to further advance NX-13."

Advancing the ADC field

The March 22, 2024 full approval granted by FDA for ELAHERE, meanwhile, advances the field of ADC therapeutics. ELAHERE is now indicated for treating adult patients with folate receptor-alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. The indication is specifically for those patients who have received one to three prior systemic treatment regimens.

ELAHERE, which came to AbbVie with its acquisition of ImmunoGen in February 2024 (1), was first granted accelerated approval by FDA in November 2022 (2). Full approval was based on a confirmatory Phase III trial (MIRASOL), whose data showed that treatment with ELAHERE resulted in an overall survival benefit and a reduced risk of cancer progression by 35%, according to a company press release.

"The full FDA approval of ELAHERE for eligible patients with ovarian cancer represents the culmination of years of work by the ImmunoGen team. ELAHERE is the first and only antibody-drug conjugate (ADC) approved in the US for this difficult-to-treat malignancy," said Roopal Thakkar, senior vice-president, chief medical officer, global therapeutics, AbbVie, in the press release

"As the first treatment to show a statistically significant overall survival benefit in patients with platinum-resistant ovarian cancer, ELAHERE provides an effective new option for patients with folate receptor alpha positive tumors. These patients previously had very limited options and ELAHERE changes that," said Kathleen Moore, deputy director and associate director of clinical research at the Stephenson Cancer Center of The University of Oklahoma and MIRASOL principal investigator.

A marketing authorization application for the ADC in Europe has been accepted by the European Medicines Agency, and regulatory submissions are also under review in multiple other countries.

References

1. AbbVie. AbbVie Completes Acquisition of ImmunoGen. Press Release, Feb. 12, 2024.
2. FDA. FDA Grants Accelerated Approval to Mirvetuximab Soravtansine-Gynx for FRα Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer. Press Release, Nov. 14, 2022.

Source: AbbVie for Landos acquisition and FDA approval