Enabling durable treatment options in oncology

We are building a pipeline of uniquely-assembled, highly stable ADCs by leveraging proprietary conjugation, linker and payload technologies that enable us to utilize previously inaccessible targeting molecules and novel payloads. Our candidates have first-in-class potential targeting the deadliest cancers globally. Our goal is to consolidate the knowledge gained over the last 20 years and translating it into meaningful therapeutic benefits to broaden the treatment horizon of ADCs.

Proprietary programs

Program

Discovery

Preclinical

Phase I

TUB-040targeting Napi2b

Discovery

Preclinical

Phase I

ovarian, NSCLC

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TUB-040

Tubulis’ lead antibody-drug conjugate (ADC) candidate TUB-040 is directed
against NaPi2b, an antigen highly overexpressed in ovarian cancer and lung
adenocarcinoma.

It consists of an IgG1 antibody targeting NaPi2b connected to
the topoisomerase I inhibitor Exatecan through a cleavable linker system based
on the company’s proprietary P5 conjugation technology with a homogeneous
drug-to-antibody-ratio (DAR) of 8. P5 conjugation is a novel chemistry for
cysteine-selective conjugation that enables ADC generation with unprecedented
linker stability and superior biophysical properties.

Preclinical pharmacokinetic analysis showed that TUB-040 efficiently delivers its payload to the tumor while reducing off-site toxicities. The candidate demonstrated effective and durable responses as well as an excellent safety profile in a range of preclinical solid tumor models. TUB-040 is currently being investigated in a multicenter Phase I/IIa study (NAPISTAR 1-01, NCT06303505) that aims to evaluate the safety, tolerability, pharmacokinetics and efficacy of TUB-040 as a monotherapy in patients with platinum-resistant high-grade ovarian cancer (PROC) or relapsed/refractory adenocarcinoma non-small cell lung cancer (NSCLC), who
have exhausted other available treatment options. In June 2024, the U.S. Food
and Drug Administration (“FDA”) granted Fast Track designation to TUB-040 for
the treatment of patients with platinum-resistant ovarian cancer.

Status

Phase 1

Indications

Ovarian cancer
Non-small cell lung cancer

Technology

Tubutecan

Conjugation: P5
Payload: Exatecan

technology video

TUB-030targeting 5T4

Discovery

Preclinical

Phase I

multiple solid cancers

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TUB-030

Tubulis’ antibody-drug conjugate (ADC) candidate TUB-030 is directed against 5T4, a cancer-associated antigen expressed in a wide range of solid tumor indications. It consists of an IgG1 antibody targeting 5T4 connected to the topoisomerase I inhibitor Exatecan through a cleavable linker system based on the company’s proprietary P5 conjugation technology with a homogeneous drug-to-antibody-ratio (DAR) of 8. P5 conjugation is a novel chemistry for cysteine-selective conjugation that enables ADC generation with unprecedented linker stability and superior biophysical properties.

Preclinical pharmacokinetic analysis showed that TUB-030 efficiently delivers its payload to the tumor while reducing off-site toxicities. The candidate demonstrated effective and durable responses, even at lower target expression levels, as well as an excellent safety profile in a range of preclinical solid tumor models. TUB-030 is currently being investigated in a multicenter Phase I/IIa study (5-STAR 1-01, NCT06657222) that aims to evaluate the safety, tolerability, pharmacokinetics and efficacy of TUB-030 as a monotherapy in patients with advanced solid tumors.

Status

Phase 1

Indications

Pan-cancer target with the potential to address 13 out of 15 of the most fatal solid cancer types

Technology

Tubutecan

Conjugation: P5
Payload: Exatecan

technology video

TUB-050target undisclosed

Discovery

Preclinical

Phase I

solid cancers

TUB-050

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TUB-060target undisclosed

Discovery

Preclinical

Phase I

solid cancers

TUB-060

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Pharma partnered programs

Program

Discovery

Preclinical

Phase I

BMSmultitarget collaboration

Discovery

Preclinical

Phase I

BMS

Detailed Content Here

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Gileadsingle target collaboration

Discovery

Preclinical

Phase I

Gilead

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Expanded Access Policy

Expanded access, also known as “Compassionate Use”, offers a potential pathway for patients with immediately life-threatening conditions or serious diseases to access investigational drugs for treatment when comparable or satisfactory alternative therapies are not available.

Tubulis products are investigational drugs that have not yet received marketing approval or clearance from the FDA, EMA, or any other regulatory agency. The effectiveness of investigational products in treating the condition is uncertain, and their use may lead to unexpected serious side effects. Currently, Tubulis does not have an expanded access program available for our investigational products beyond clinical trials. Our primary focus is on enrolling and conducting the necessary clinical trials to bring innovative, safe, and effective products to patients as swiftly as possible.

Participation in one of our clinical trials is presently the sole means to access Tubulis’ investigational products. We encourage patients and healthcare providers interested in our investigational products to explore details about our ongoing studies on clinicaltrials.gov and our website.

For further information, please contact us at contact@tubulis.com.