Full Press Release Details
IBA101: The Strategic Answer to the PD-1/L1 Patent Cliff
Liminatus Pharma, Inc. (the "Company")
believes that the immuno-oncology landscape is approaching a critical inflection point. Since their first approval in 2014, PD-1/PD-L1
inhibitors such as Keytruda (Merck) and Opdivo (Bristol Myers Squibb) have rapidly become standard-of-care therapies across numerous cancer
indications. However, with key patents set to expire by 2028-2030, this therapeutic class is now facing the classic life-cycle
challenge of every blockbuster: the looming entry of biosimilars.
As the table below summarizes, multiple PD-1/L1
inhibitors will lose exclusivity in the coming years:
| Drug | Company | U.S. Patent Expiry (Est.) |
| Keytruda (pembrolizumab) | Merck & Co. | 2028 (core patent), up to 2036 (formulations) |
| Opdivo (nivolumab) | BMS | 2028 |
| Tecentriq (atezolizumab) | Roche | 2029 |
| Imfinzi (durvalumab) | AstraZeneca | 2030 |
| Libtayo (cemiplimab) | Regeneron/Sanofi | 2030 |
Biosimilar competition will inevitably lead to
pricing pressure and revenue decline. In response, leading pharmaceutical companies are actively pursuing strategies to extend commercial
exclusivity, such as:
| Developing subcutaneous (s.c.) formulations | ||
| Launching new indications through combination therapies with novel immune-oncology agents |
However, while many combinations have been explored-including
IDO1, CSF-1R, and even LAG-3 blockers-none have yet delivered breakthrough efficacy or commercial viability that reinvigorates the
IBA101: Synergy Through Innate Immune Activation
Liminatus Pharma's IBA101 presents a unique
strategic opportunity in this evolving landscape. As a next-generation CD47 monoclonal antibody, IBA101 has been engineered to avoid binding
to red blood cells and platelets, thereby eliminating the severe cytopenia issues that derailed earlier CD47 programs such as Hu5F9 and
More importantly, IBA101 activates innate immune
responses, particularly macrophage-mediated phagocytosis. This innate activation primes and amplifies adaptive immunity, making it a rational
and potent partner for PD-1/PD-L1 inhibitors, which act downstream by releasing T cells from checkpoint inhibition.
Preclinical data suggest that the IBA101 + anti-PD-1
combination produces a synergistic anti-tumor response, with a favorable safety profile. If this synergy is confirmed in clinical trials,
it offers an elegant path for pharma companies to extend the life cycle of their PD-1/PD-L1 franchises: by launching a new combination
indication covered under a fresh IP portfolio, the loss of exclusivity on the original monotherapy may be offset.
A Rare Asset in a Crowded Race
The Company believes that the CD47 space remains
one of the most promising but technically difficult targets in immuno-oncology. While several Chinese companies have advanced programs,
the Company believes that Liminatus is the only U.S.-based company developing a CD47 blocker with a validated safety profile. This distinction
is critical. In an increasingly fragmented global market, the Company believes that access to U.S.-origin, low-toxicity CD47 agents will
be strategically valuable for multinational pharma companies seeking to pair their PD-1/PD-L1 drugs with patent-protected synergistic