Tubulis Receives FDA Fast Track Designation for Antibody-Drug Conjugate Candidate TUB-040 in Platinum-resistant Ovarian Cancer
June 27 2024 - 8:30AM
Business Wire
- TUB-040 is a next-generation NaPi2b-targeting Exatecan ADC
based on the company’s proprietary P5 technology, currently being
evaluated in a multicenter Phase I/IIa study NAPISTAR 1-01
- Designation for TUB-040 in platinum-resistant ovarian cancer is
based on preclinical data in a range of models, demonstrating
superior biophysical properties with effective and durable
responses
- Fast Track status allows for increased interaction with the
U.S. Food and Drug Administration ("FDA") to support the
development of TUB-040 to expedite regulatory review
- Ovarian cancer (OC) is the leading cause of death among women
diagnosed with gynecological cancers1, with
platinum-resistant OC being associated with especially poor disease
outcomes
Tubulis announced today that the U.S. Food and Drug
Administration (“FDA”) has granted Fast Track designation to its
lead antibody-drug conjugate (ADC) TUB-040 for the treatment of
patients with platinum-resistant ovarian cancer. TUB-040 is a
next-generation NaPi2b-targeting Exatecan ADC based on Tubulis’
proprietary P5 technology with superior biophysical properties that
demonstrated effective and durable responses in a range of
preclinical models, including ovarian cancer. The candidate is
currently being evaluated in a multicenter Phase I/IIa study
(NAPISTAR 1-01, NCT06303505) 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.
“Almost all patients with ovarian cancer who are not cured by
initial therapy will develop resistance to platinum-based therapy
over time. Once platinum-resistant, therapeutic options for these
patients are poor with highly unsatisfactory outcomes. The FDA´s
Fast Track designation of TUB-040 is an important step in the
development of TUB-040 to provide these women with urgently needed
new therapeutic options,“ said Günter Fingerle-Rowson, MD, PhD,
Chief Medical Officer of Tubulis. “The FDA decision brings us one
step closer to our goal of delivering the true value of ADCs to
patients in need, and we are grateful for the agency’s support on
this path to develop TUB-040 fast and efficiently.
The Fast Track status granted by the FDA is designed to
facilitate the development and expedite the review of new therapies
that are intended to treat serious conditions and have the
potential to address an unmet medical need. Programs granted Fast
Track designation are subject to more frequent interactions with
the FDA during clinical development and may be eligible for
accelerated approval and/or priority review if certain criteria are
met.
TUB-040 is currently being evaluated in a multicenter,
first-in-human, dose-escalation and optimization Phase I/IIa study.
The trial is designed to evaluate the safety, tolerability,
pharmacokinetics, and efficacy of TUB-040 as monotherapy and is
being conducted in the US, UK, Spain, Belgium and Germany. Phase Ia
includes dose escalation and will determine the safety and the
maximum tolerated dose or identified dose for optimization, while
Phase IIa will focus on dose optimization, safety, and preliminary
efficacy of TUB-040.
About Platinum-resistant Ovarian Cancer
Ovarian cancer (OC) is the leading cause of death among women
diagnosed with gynecological cancers. While early-stage disease has
a high survival rate, OC is often diagnosed at later stages due to
its non-specific clinical symptoms and lack of preventive screening
methods.2 The current standard of care is platinum-based therapy,
but approximately 20% of patients are platinum-resistant during
each treatment line.3,4 Platinum-resistant OC is defined as disease
recurrence during or within 6 months after completing the
platinum-based chemotherapy. Platinum-resistant OC is associated
with poor disease outcomes and low response rates to subsequent
chemotherapy treatment. The median survival for these patients is
12-16 months, highlighting the high unmet medical need of this
patient population. 5,6
About TUB-040 and the P5 Technology
Tubulis’ lead antibody-drug conjugate (ADC) 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 DAR of 8. P5 conjugation
is a novel chemistry for cysteine-selective conjugation that
enables ADC generation with unprecedented linker stability and
biophysical properties. It originated from the fundamental work of
Prof. Christian Hackenberger at the Leibniz-Forschungsinstitut für
Molekulare Pharmakologie im Forschungsverbund Berlin e.V. (FMP),
which unlocked the use of phosphorus chemistry for superior
bioconjugation. Preclinical pharmacokinetic analysis also
demonstrated that TUB-040 efficiently delivers its payload to the
tumor while reducing off-site toxicities. The candidate 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.
About Tubulis
Tubulis’ suite of proprietary platform technologies generates
uniquely matched antibody-drug conjugates with superior biophysical
properties for treating solid tumors. By demonstrating durable
on-tumor delivery of the payload and long-lasting anti-tumor
activity, we have reached the clinic with our first program,
TUB-040, in ovarian and non-small cell lung cancer. The second
candidate from our growing pipeline, TUB-030, is set to follow in
the near-term. We will solidify our leadership position by
continuing to innovate on all aspects of ADC design to expand their
therapeutic potential for our pipeline, our partners and for
patients. Visit www.tubulis.com or follow us on LinkedIn.
1 https://pubmed.ncbi.nlm.nih.gov/33620837/; accessed June 26,
2024 2 https://pubmed.ncbi.nlm.nih.gov/33620837/; accessed June 26,
2024 3 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11118117/;
accessed June 26, 2024 4
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8971787/; accessed
June 26, 2024 5
https://www.sciencedirect.com/science/article/abs/pii/S0090825814002029#:~:text=Patients%20with%20primary%20'platinum%20refractory,than%20the%20more%20common%20HGSC.;
accessed June 26, 2024 6
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9358431/#:~:text=Platinum%20resistant%20ovarian%20cancer%20is,et%20al.%2C%202021);
accessed June 26, 2024
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For Tubulis Dominik Schumacher, CEO & Co-Founder
Phone: +49 175 800 5594 Email: contact@tubulis.com
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Stephanie May, PhD Phone: +49 (0) 171 185 56 82 Email:
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