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March 15, 2022

Pipeline Moves: Harpoon secures Fast-Track for multiple myeloma asset, shot at further study rise

Clinical Trials Arena also reviews other Phase I assets by Lumen Bioscience, Pfizer, and Lung Therapeutics.

By Urtė Fultinavičiūtė

In this week’s edition of Pipeline Moves, we dive into four Phase I assets. First up is Harpoon Therapeutics which received a Fast-Track designation for its blood cancer asset. Lumen Bioscience, Pfizer, and Lung Therapeutics updated their respective Phase I trials as completed, leading to their Phase Transition Success Rates (PTSR) to increase. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.

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Harpoon achieves fast-track designation

Harpoon’s HPN-217 saw a high increase in its PTSR after the company announced the FDA granted Fast-Track designation for treatment of patients with relapsed, refractory multiple myeloma (RRMM) who have already received multiple lines of therapy.

The PTSR increased by 22 points to 37% for RRMM. Harpoon Therapeutics announced the designation on 2 March and GlobalData’s PTSR change took effect on 4 March.

HPN-217’s safety, tolerability and pharmacokinetics (PK) is being tested in 114 RRMM patients who have been nonresponsive to at least three prior lines of therapy, in a Phase I/II clinical trial (NCT04184050). HPN-217 is codeveloped by AbbVie and is a trispecific recombinant protein construct, designed to direct cancer-killing immune T-cells specifically toward myeloma cells.

Lumen completes Phase I infectious disease trial

Lumen’s LMNCdiff-01 (LMN-201) saw a rise in its PTSR after Phase I completion. The PTSR increased by seven points to 67% in Clostridioides difficile infections (C. difficile-associated disease). GlobalData appraised the asset on 4 March after a ClinicalTrials.gov update on 3 March.

The open-label study (NCT04893239) assessed the delivery of LMN-201 components via enteric capsules in the gut of 12 subjects with ostomies. The primary endpoint measured the asset’s absence or presence in the ostomy fluid by visual observation up to 12 hours after the administration.

Pfizer updates Phase I SLE, RA trial

Pfizer’s PF-06835375 posted an increase in its PTSR after the completion of a Phase I trial in patients with seropositive systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). The PTSR increased by six points, reaching 51%. The study was completed on 1 March and GlobalData reported it on 4 March.

The Phase I study (NCT03334851) evaluated the safety, tolerability and PK of PF-06835375 immunotherapy in 75 subjects with seropositive SLE or RA. The drug is a chemokine receptor type 5 antagonist which is administered either intravenously or subcutaneously.

SLE is a chronic, autoimmune condition that causes inflammation in connective tissues throughout the body and may result to kidney disease. RA is also a long-term autoimmune and inflammatory condition leading to pain and stiffness in the joints.

Lung Therapeutics makes progress in IPF

Lung Therapeutics’ LTI-03 saw a rise it its PTSR after Phase Ia completion in healthy volunteers. The PTSR increased by six points to 56% in idiopathic pulmonary fibrosis (IPF). The asset was appraised by GlobalData on 8 March after a ClinicalTrials.gov update on 7 March.

The double-blind study (NCT04233814) enrolled 71 subjects, investigating the safety, tolerability, and PK profile of inhaled LTI-03. The trial first tested single-ascending doses (SAD) of the asset, followed by multiple-ascending dose (MAD) cohorts.

Additional writing by Clinical Trials Arena healthcare researcher Irena Maragkou

Need to Know:

GlobalData’s proprietary model uses a combination of machine learning and an algorithm to calculate an individual drug’s PTSR and LoA. While LoA provides the probability of a drug ultimately receiving market authorization, PTSR indicates the probability of a drug’s advancement to the next stage of clinical development. The model uses data points from the individual drugs, clinical trials, regulatory milestones, company, and financial databases.

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