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Mar 12, 2025, 12:04

Tanja Obradovic about the Growing Importance of Strategic Program and Pipeline Management in Pharma

Tanja Obradovic, Vice President of Oncology Scientific Affairs at ICON PLCh, shared a post on LinkedIn:

“Strategic program and pipeline management and decision making in Pharmaceutical industry has received increased attention during last year for several reasons.

Most notable ones are general economic conditions resulting in a need for managing costs across large, mid-size and particularly biotech Pharma, introduction and implementation of Inflation Reduction Act (IRA) that puts pressure on shorter and more efficient development prior to launch, rise of increased competition from novel drug modalities with increased number of targeted biomarkers such as Antibody Drug Conjugates (ADCs).

Pressure for development and implementation of scientifically sound, rational and efficient strategic management is especially high in Oncology considering high cost of development and still low success rate for early clinical assets.

So, how is Pharma moving toward this trend? One example is very recent. Merck announced last December termination of anti-TIGIT antibody vibostolimab and anti-LAG-3 antibody favezelimab but that happened only after initiating/conducting 5 Phase III and 13 Phase II trials for vibostolimab and 4 Phase III and 13 Phase II trials for favezelimab.

In a much faster move to evaluate potential of the drug candidate Merck just de-reprioritized of MK-4830, an anti-ILT4 antibody that so far has been tested up to Phase II in various cancers with finishing in the neoadjuvant ovarian cancer (NCT05446870) while active but not recruiting in NSCLC, CRC, esophageal, RCC and ES-SCLC.

Umbrella study (MK-3475-U01/KEYMAKER-U01) in NSCLC is still enrolling with unclear opening of the arm with MK-4830 but umbrella study in second line esophageal squamous cell carcinoma (ESCC) although enrolling in general specifically stoped arm of the Pembrolizumab in combination with MK-4830 and Lenvatinib.

Immunoglobulin-like transcript 4 (ILT4) is an immunosuppressive molecule expressed in both myeloid innate and malignant tumor cells that due to its role in induction of tumor cells-mediated senescence in naïve/effector T-cells was hypothesized to play a role in PD(L)1 resistance. Thus, hypothesis for the potential of ILT4 inhibitor to help overcome resistance to PD(L)1 inhibitors.

However, this hypothesis so far is not holding in the clinical space considering relatively low early clinical efficacy data of competitor compounds NGM707, BND-22 and OR502. For BND-22, similar to Merck, Sanofi just announced de-prioritization and returning the rights of BND-22 to partner Biond Biologics Ltd.

Additional compounds targeting ILT4 are in the clinical development within Phase I or Phase I/II space so interesting to see how other companies approach this target after decisions made by Merck and Sanofi.”