Articles from Tubulis

Tubulis today announced positive early clinical data from its NAPISTAR1-01 Phase I/IIa study (NCT06303505) in a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin, Germany. Principal Investigator, Dr. Antonio González-Martín, Director Medical Oncology Department and Cancer Center Director at Clínica Universidad de Navarra, presented the results of Tubulis’ lead antibody-drug conjugate (ADC), TUB-040, in platinum-resistant high-grade serous ovarian cancer (PROC-HGSOC), with a focus on dose levels 1.67 – 3.3 mg/kg. This is the first clinical data to validate Tubulis’ proprietary Tubutecan technology, establishing clear proof of concept for the company’s most advanced ADC targeting NaPi2b.

Tubulis today announced the successful closing of a €308 million (USD 361 million) financing. The round was led by Venrock Healthcare Capital Partners with participation from additional new investors Wellington Management and Ascenta Capital. Existing investors who supported the Series C include Nextech Invest, EQT Life Sciences, Frazier Life Sciences, Andera Partners, Deep Track Capital, Bayern Kapital, Fund+, High-Tech Gründerfonds (HTGF), OCCIDENT, and Seventure Partners.

Tubulis today announced that its late-breaking abstract covering first clinical data from its ongoing Phase I/IIa NAPISTAR 1-01 trial (NCT06303505) has been accepted for oral presentation at the upcoming European Society of Medical Oncology (ESMO) Congress, being held October 17-21, 2025, in Berlin. The presentation by the principal investigator of the study, Dr. Antonio Gonzalez-Martin, will provide interim data from the dose escalation part of the ovarian cancer cohort in the first-in-human study with TUB-040. Tubulis’ lead antibody-drug conjugate (ADC), TUB-040 is a next-generation NaPi2b-targeting ADC developed using Tubulis’ proprietary Tubutecan linker-payload platform. It combines the company’s P5 conjugation system with an exatecan payload enabling the development of stable, highly targeted ADCs, optimized for the on-target delivery of the topoisomerase-1 inhibitor while minimizing systemic toxicity. In a range of preclinical models, including ovarian cancer, TUB-040 demonstrated superior biophysical properties as well as effective and durable responses.

Tubulis today announced the appointment of Halley Gilbert, JD, as Chief Legal Officer and Chief Operating Officer (CLO/COO). Bringing over 20 years of transaction and operations experience in the biopharmaceutical industry, Ms. Gilbert will further expand Tubulis’ leadership capabilities at a pivotal stage of clinical and corporate development. In this newly created role, she will leverage her combined expertise as an attorney and seasoned biotech executive to shape Tubulis’ strategy and support the continued growth of the company’s U.S. presence. Ms. Gilbert will be responsible for legal and administrative functions and play a key role in executing strategic transactions for the company.

Tubulis today announced the appointment of Matthew Norkunas, MD, MBA, as Chief Financial Officer (CFO) and President of Tubulis Inc., further strengthening its management team at a pivotal stage of growth. Dr. Norkunas’ proven track record of achieving financial and corporate goals for rapidly evolving biotechs will be instrumental in advancing Tubulis’ strategic objectives. His unique background as a physician-turned-business executive will support the company’s position as a leader and innovator in ADC drug development. Based in Tubulis’ U.S. Cambridge office, Dr. Norkunas’ appointment also expands the company’s U.S. presence.

Tubulis announced today that its second drug candidate, TUB-030, has entered clinical evaluation with successful dosing of the first patient in the 5-STAR 1-01 Phase I/IIa trial (NCT06657222). The study is evaluating TUB-030, Tubulis’ next-generation antibody-drug conjugate (ADC), in patients with advanced solid tumors. The ADC targets 5T4, an oncofetal antigen expressed in a broad range of solid tumors. The program was developed using Tubulis’ proprietary Tubutecan linker-payload platform, which enables superior biophysical properties for precise and sustained on-tumor payload delivery.

Tubulis today announced that its CEO and Co-founder Dominik Schumacher will present a company overview and update at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco. The presentation will take place on Tuesday, January 14, 2025, at 9:00 am PST in the Golden Gate Room (32. Floor) at The Westin St. Francis.

Tubulis announced today that Fierce Biotech has named the company as one of 2024’s “Fierce 15” biotechnology companies. The annual special report features the most innovative and promising biotechnology companies in the industry.

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.

Tubulis announced today that the first patient has been treated in its first Phase I/IIa trial (NAPISTAR 1-01, NCT06303505). The study is evaluating Tubulis’ next-generation antibody-drug conjugate (ADC) TUB-040 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. TUB-040 targets NaPi2b, a highly overexpressed antigen in ovarian cancer and lung adenocarcinoma. The candidate is the first to enter the clinic from the company’s growing pipeline and represents one of Tubulis’ two lead candidates developed using its proprietary suite of platform technologies, which enable the creation of uniquely matched ADCs with superior biophysical properties.

Tubulis today presented comprehensive preclinical data on its two lead antibody-drug conjugate (ADC) candidates TUB-030 and TUB-040 at this year’s Annual Meeting of the American Association for Cancer Research (AACR) in San Diego. The poster presentations contained preclinical data, highlighting the ability of the two next-generation Tubutecan ADCs to create effective and durable responses even in low target-expressing tumor mouse models. Tubulis is leveraging a proprietary suite of platform technologies to build a pipeline of uniquely matched ADC candidates that combine the right targeting molecule, conjugation chemistry and payload to deliver the true therapeutic value of the ADC approach. The company’s lead candidates, both targeting solid tumor indications, are in late-stage preclinical testing, with TUB-040 ready for clinical evaluation.

Tubulis today announced the successful completion of an upsized and oversubscribed €128 million ($138.8 million) Series B2 financing. The round was co-led by EQT Life Sciences and Nextech Invest Ltd, on behalf of one or more funds managed by it, with participation from new US-based funds, Frazier Life Sciences and Deep Track Capital as well as all existing investors, including Andera Partners, BioMedPartners, Fund+, Bayern Kapital (with ScaleUp-Fonds Bayern), Evotec, coparion, Seventure Partners, OCCIDENT and High-Tech Gründerfonds (HTGF). Tubulis is developing a pipeline of uniquely matched antibody drug conjugates (ADCs) with an indication-tailored targeting molecule and payload combination to develop novel ADCs with superior properties.

Tubulis today announced that two abstracts with comprehensive preclinical data on their next-generation antibody-drug conjugate (ADC) candidates TUB-030 and TUB-040, have been accepted for poster presentations at the Annual Meeting of the American Association for Cancer Research (AACR), taking place April 5-10, 2024 in San Diego.

Tubulis and Bristol Myers Squibb (NYSE: BMY) today announced that they have entered into a strategic license agreement to develop differentiated antibody-drug conjugates (ADCs).

Tubulis today announced the appointment of Björn Hock, PhD, as Chief Development Officer (CDO) to further strengthen its leadership team with a seasoned drug development expert. Dr. Hock previously served on the company’s scientific advisory board and has more than 20 years of experience in the field of antibody-based therapeutics, including antibody-drug-conjugates (ADCs). At Tubulis, he will be responsible for defining preclinical development strategies for the company’s current drug candidates in oncology to rapidly achieve IND-readiness. In addition, he will work closely with the leadership team to design and execute relevant biomarker studies and investigate novel antibody-drug-combinations to further broaden the company’s pipeline of uniquely matched ADCs for a range of indications.

Tubulis today announced the successful completion of a €60 million (USD $63 million) Series B financing led by Andera Partners with participation from new investors Evotec and Fund+. All existing investors also participated in the round, including Bayern Kapital (with Wachstumsfonds Bayern 2), BioMedPartners, coparion, High-Tech Gründerfonds (HTGF), OCCIDENT and Seventure Partners. The new capital will be used to advance Tubulis’ proprietary pipeline of uniquely assembled antibody drug conjugates (ADCs), towards clinical evaluation as well as introduce programs addressing a range of solid tumor indications. The proceeds will enable the company to deliver the true therapeutic potential of ADCs through further innovation of novel payload classes and identification of new cancer targets.

Tubulis today announced the formation of a Scientific Advisory Board (SAB) with the appointment of international industry experts in the development of antibody drug conjugates (ADCs) and in-depth knowledge in the therapeutic areas of oncology and hematology. The SAB will provide scientific guidance and advice, working in close collaboration with the Tubulis management team, as the company advances its pipeline of disease-specific protein-drug conjugates towards clinical evaluation.

Tubulis today announced the appointment of Dr. Christian Grøndahl, as the inaugural Chairman of the company’s Supervisory Board. As an experienced biotech executive and company founder, Dr. Grøndahl has an established track record in advancing early-stage biotech innovations and distinguished technology platforms into valuable products and medicines. His leadership will be fundamental to shaping Tubulis as it designs and moves its novel antibody-drug conjugates (ADCs) toward clinical evaluation to improve cancer treatments and further establishes itself as an up-and-coming leader in the oncology and ADC drug development field.

Tubulis today announced the appointment of Günter Fingerle-Rowson, MD, PhD, as Chief Medical Officer to complement the leadership team and to further build the company’s clinical expertise. Dr. Fingerle-Rowson is an experienced hematologist and medical oncologist who brings to Tubulis more than two decades of academic, biotechnology and pharmaceutical industry experience. Moreover, he has a proven track record of advancing product candidates from early clinical phase through regulatory approval and into clinical practice. In this newly established role, he will use his extensive knowledge in the development of cancer therapeutics to oversee Tubulis’ clinical activities and advance the company’s Antibody Drug Conjugates (ADCs) towards clinical evaluation.