What Immunity Pharma does

Immunity Pharma Ltd. is a privately-held, clinical-stage neurology-focused biopharmaceutical company headquartered in Mevasseret Zion, Israel. The company develops biologically active peptides that stimulate therapeutic cell-signaling processes for the treatment of neurodegenerative diseases, with an initial focus on amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease). The lead drug candidate, IPL344, is a proprietary peptide discovered at the Weizmann Institute of Science (Prof. Irun Cohen's laboratory) that activates the Akt signaling pathway — a pathway down-regulated in neurodegenerative diseases — independently of cell membrane receptors. By restoring Akt activity, IPL344 is designed to induce pro-survival intracellular processes including reduced apoptosis, reduced oxidative stress, reduced misfolded protein accumulation, reduced inflammation, and improved glucose metabolism.

The company operates a focused, single-asset pipeline strategy centered on IPL344, administered as a once-daily intravenous injection with home administration capability. Clinical development to date includes a Phase 1/2a open-label trial (9 ALS participants with progression rate >0.55 points/month on ALSFRS-R) conducted at the Hadassah Medical Center in Jerusalem, with results published in the peer-reviewed journal Muscle and Nerve in March/April 2025. Reported outcomes include 48-64% slower ALSFRS-R disease progression (p=0.028-0.034), 27% reduction in plasma neurofilament light (NfL) levels, a +0.47 kg/month weight gain versus -0.39 kg/month in placebo, 44% slower SVC decline, and median survival of 43.4 months vs. 19.1 months in historical controls. The company has secured Orphan Drug Designation from both the FDA (7-year US exclusivity) and EMA (10-year EU exclusivity) and is preparing for a larger placebo-controlled pivotal Phase 3 trial with planned multicenter sites in the US and Europe.

The business model is pre-revenue clinical-stage drug development, with future revenue expected to be generated through commercialization of IPL344 and related peptide therapies. Pricing details are not publicly disclosed. The company's market presence is currently restricted to a Middle East footprint, with planned expansion into US and European clinical trial sites for the Phase 3 program. Management is founder-led (CEO Eran Ovadia, co-founder/VP R&D Dr. Ilana Cohen) with investor oversight from Chairman Ron Pfeifer. Strategic communication is conducted primarily through peer-reviewed publications, scientific conference presentations (Northeast ALS Consortium, International ALS/MND Symposium), and press releases in ALS-focused media.

Name

Immunity Pharma

Legal name

Immunity Pharma Ltd.

Website

https://immunitypharma.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

1–10 employees

Short description

Immunity Pharma is a privately-held, clinical-stage Israeli biopharmaceutical company developing IPL344, a proprietary peptide that activates the Akt signaling pathway to treat neurodegenerative diseases, with an initial focus on ALS. The company is preparing for a pivotal Phase 3 trial following positive Phase 2a results.

Ownership category

akta.pro rank

Product category

Neurodegenerative Disease Therapeutics

NAICS

Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Immunology & Inflammation Pharmaceuticals (HLAIAAAD)

akta.pro secondary industry

Monoclonal Antibody Therapeutics (mAbs) (HLAAAAAA)

Keywords

• Biopharmaceutical therapies
• Neurodegenerative disease treatments
• Akt pathway activators
• ALS drug development
• Peptide therapeutics

Headquarters

HQ city

Jerusalem

HQ country

Israel

HQ region

Middle East

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Drug Development and Commercialization: Pre-revenue clinical-stage biopharma company. Revenue will be generated through commercialization of novel therapeutic drugs, initially focused on IPL344 for ALS treatment. Orphan drug designation from FDA and EMA provides regulatory exclusivity (7 years in US, 10 years in Europe).

Go-to-market motion2 records

Distribution channels1 record

Marketing channels3 records

Core offering

Immunity Pharma is a clinical-stage biopharmaceutical company developing IPL344, a biologically active peptide administered as a once-daily intravenous injection that activates the Akt cell-signaling pathway to treat amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases. The company is preparing for a pivotal Phase 3 trial following positive Phase 2a results showing 48-64% slower disease progression, with FDA and EMA Orphan Drug Designations already granted.

Product overview

Immunity Pharma is a clinical-stage neurology-focused biopharmaceutical company developing a single lead drug candidate, IPL344. IPL344 is a biologically active peptide that activates the Akt pathway and is being developed as an intravenous injection for the treatment of ALS, with potential applications in other neurodegenerative diseases such as Parkinson's disease. The company operates with a focused pipeline strategy centered on this one core product.

Differentiator

Problem solved

Functional benefit

Brands

• IPL344: Lead drug candidate - a biologically active peptide that stimulates therapeutic cell-signaling processes including activation of the Akt pathway for the treatment of ALS.

Products and services

• IPL344

Quantifiable outcome

• 48-64% slower ALSFRS-R disease progression (p=0.028-0.034)
• +4 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

One partnership is on record.

• Hadassah Medical CentercoreStrategic or Co-development PartnerClinical trial partnership for Phase 1/2a study of IPL344 in ALS patients. The trial was conducted at the ALS unit of Hadassah Medical Center in Jerusalem under principal investigator Dr. Marc Gotkine. The center provides clinical research infrastructure and patient access for the ongoing clinical development program.

Scale indicators3 records

Recent moves5 records

Expansion highlights4 records

Emerging players

• Ionis Pharmaceuticals: Ionis is the antisense oligonucleotide platform company whose SOD1-ALS drug (tofersen, partnered with Biogen) gained FDA accelerated approval in 2023. Comparable as a developer of novel-mechanism therapeutics for neurodegenerative diseases, demonstrating how targeted molecular approaches compete in the ALS market with new modalities.
• Voyager Therapeutics: Voyager Therapeutics is a clinical-stage gene therapy company developing AAV-delivered therapeutics for neurological diseases including ALS (VY-SOD101 for SOD1 ALS). Comparable because it represents an emerging modality (gene therapy) that could leapfrog small-molecule and peptide approaches in ALS and competes for the same strategic investor and partnership interest as Immunity Pharma.

Direct peers

• AB Science: AB Science is developing masitinib, a tyrosine kinase inhibitor that has been evaluated in multiple Phase 3 trials for ALS. It is a relevant clinical-stage peer running registrational studies in ALS with their own novel mechanism, illustrating the typical European mid-cap biotech competing in the same indication space as Immunity Pharma.
• MediciNova: MediciNova has run an MN-166 (ibudilast) ALS program reaching Phase 2/3. It is a comparable small-cap clinical-stage biopharma whose platform repurposing approaches target neuroinflammation in ALS, intersecting with Immunity Pharma's neuroinflammation biology and disease-modifying positioning.
• Amylyx Pharmaceuticals: Amylyx developed AMX0035 (Relyvrio), the most recent novel ALS therapeutic (approved 2022, voluntarily withdrawn after Phase 3 PHOENIX failure). It is a direct peer because it operated at a similar clinical-stage profile with Phase 2 efficacy in ALSFRS-R and survival, and its experience illustrates both the regulatory pathway and the Phase 3 risk profile for an ALS-focused biotech with a single lead asset.
• Cytokinetics: Cytokinetics is a clinical-stage biopharma focused on ALS (reldesemtiv failed Phase 3; tirasemtiv failed Phase 3) and other neuromuscular diseases. Closely comparable as a peer ALS drug developer running registrational trials with a novel mechanism and demonstrates the typical small-cap, single-platform profile of an ALS-focused clinical biotech.

Broad incumbents

• Biogen: Biogen is the dominant neurology-focused biopharma with multiple ALS assets (Qalsody/tofersen for SOD1 ALS, Spinraza for SMA). It is the most relevant comparator because it directly competes in the ALS space with approved disease-modifying therapies and has set the regulatory and commercial benchmark that any new ALS entrant like Immunity Pharma's IPL344 must beat or partner against.
• Denali Therapeutics: Denali Therapeutics is a clinical-stage biotech developing therapeutics for neurodegenerative diseases (Parkinson's, Alzheimer's, ALS) including programs targeting LRRK2 and other pathways. Comparable because its pipeline is built on novel biological mechanisms for neurodegeneration, and its scale and partner relationships (Biogen) make it a relevant broader incumbent in the neurodegeneration pipeline space.
• Mitsubishi Tanabe Pharma America: Mitsubishi Tanabe commercializes Radicava (edaravone), the second FDA-approved ALS disease-modifying therapy. Comparable because it operates in the same disease and regulatory exclusivity (orphan protection), and is the standard-of-care reference comparator Immunity Pharma's Phase 3 must demonstrate added benefit against.

Regional players

• Ferrer (via MedDay Pharmaceuticals assets): European clinical-stage biotech players such as Ferrer that have pursued novel CNS mechanisms in neurodegenerative indications are relevant regional comparables. They operate in similar regulatory pathways (EMA orphan drug designations) and demonstrate the typical European mid-cap neurology biotech profile that competes for the same partnership and capital pool as Immunity Pharma.

Market position

Strengths5 records

Weaknesses4 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/immunity-pharma

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Immunity Pharma