Tubulis GmbH

A London-based biotechnology company is capitalizing on investor interest in antibody-drug conjugates for cancer, announcing Sunday the completion of a Series A round that raised $114 million.Myricx Bio, which launched in 2019, claims its approach to antibody-drug conjugates, or ADCs, could offer advantages over existing treatments by using a new kind of payload to attack tumors.ADCs have emerged as a research hot spot in recent years. Theyre built from a monoclonal antibody, a precise dose of a toxin and a chemical linker pairing the two. More than a dozen ADCs are approved by U.S. regulators as cancer treatments, and over 100 programs are in clinical development, according to estimates. While early iterations of the drugs were effective in destroying tumor cells, developers next step has been dialing in the drugs precision and safety.All ADCs come through looking compelling in terms of potency in preclinical models, the challenges are often how they're differentiated, said Robin Carr, Myricxs CEO.Myricx is building its ADCs around N-myristoyltransferase inhibitors, compounds that block an enzyme thats important to cancer cell survival. Last year, the company licensed antibodies from two Chinese companies, Biocytogen and WuXi Biologics.Carr said that, in preclinical models, drugs using NMTi payloads were more effective than other types of ADCs. Furthermore, they showed activity in cancer models designed to be resistant to ADCs based around a toxin called topoisomerase inhibitors, like AstraZeneca and Daiichi Sanykos Enhertu as well as Gileads Trodelvy.The biotech was co-founded by a group of British researchers that included Exscientias chief research officer Andy Bell, former GSK executive Roberto Solari and former Myricx chief scientific officer Ed Tate. Launched with 4.5 million in seed financing, Myricx initially licensed its technology from Imperial College London, where Tate and Solari were professors. Carr came to Myricx from GSK, where he was an executive overseeing the companys small molecule and platform research.Initially, Myricx planned to develop NMTi inhibitors as standalone small molecule drugs for cancer. But, while having conversations with investors, the company pivoted to consider NMTi inhibitors as an ADC payload.Myricxs early backers included Sofinnova Partners and Brandon Capital Partners. Investors Novo Holdings and Abingworth co-led its Series A, with participation from British Patient Capital, Cancer Research Horizons, Eli Lilly, Brandon Capital and Sofinnova. The $114 million will go toward funding two proof-of-concept studies, as well as adding about 15 employees, Carr said.Not many U.K. and European institutes spinouts get out there with a Series A, so were super pleased, Carr said.Since January 2022, investors have put more than $2.7 billion into ADC companies, according to investment firm Piper Sandler. Notable private raises include TORL BioTherapeutics' $158 million Series B financing last year and Tubulis' $139 million Series B2 in March.ADC companies are on pharmaceutical companies radar, too: AbbVie spent $10 billion last year to acquire ImmunoGen, while more recently GenMab bought ProfoundBio for $1.8 billion. '

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 MUNICH--(BUSINESS WIRE)-- 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 or follow us on LinkedIn. 1 ; accessed June 26, 2024 2 ; accessed June 26, 2024 3 ; accessed June 26, 2024 4 ; accessed June 26, 2024 5 'platinum%20refractory,than%20the%20more%20common%20HGSC.; accessed June 26, 2024 6 ); accessed June 26, 2024

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 The clinical trial will enroll up to 140 patients with platinum-resistant high-grade ovarian cancer or relapsed/refractory adenocarcinoma non-small cell lung cancer in the US, the UK and Europe MUNICH--(BUSINESS WIRE)-- 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. The multicenter, first-in-human, dose escalation and optimization Phase I/IIa study aims to investigate the safety, tolerability, pharmacokinetics, and efficacy of TUB-040 as a monotherapy. The trial will be conducted in the US as well as the UK, Spain, Belgium, and Germany. Phase Ia comprises the dose escalation and will determine safety and the maximum tolerated dose or the identified dose for optimization, whereas Phase IIa will focus on dose optimization, safety, and preliminary efficacy of TUB-040. The first patient has been dosed in the US following IND approval by the FDA. “ADCs are beginning to show their potential as a core treatment modality replacing conventional chemotherapy for several solid tumor indications. Based on our preclinical data we are convinced that TUB-040 can represent a new option for the effective treatment of NSCLC and ovarian cancer patients,” said Günter Fingerle-Rowson, MD, PhD, Chief Medical Officer at Tubulis. “The novel P5 technology we use in TUB-040 improves upon current limitations due to off-target toxicity and restricted durability, the main challenges of current ADC treatments. By achieving reduced non-target toxicity together with a more specific, more powerful, and continued on-tumor delivery of the payload, we aim to improve long-term anti-tumor responses and, ultimately, clinical outcomes for patients.” “Initiating our first clinical trial represents an important milestone for the entire Tubulis team and underscores our vision to innovate on all fronts of the ADC design for patient benefit,” said Dominik Schumacher, PhD, Chief Executive Officer and Co-founder of Tubulis. “Our objective is to achieve clinical proof-of-concept for our lead candidate, TUB-040, and validate our differentiated platform approach to ADC development.” TUB-040 consists of a humanized, target-specific, Fc-silenced IgG1 antibody equipped with Tubulis’ proprietary Tubutecan linker-payload technology, which is based on P5 conjugation chemistry and the topoisomerase-1 inhibitor Exatecan. Tubulis recently presented a comprehensive preclinical data set at AACR, demonstrating the superior stability and minimal loss of linker-payload conjugation for their lead candidate. In a range of preclinical models, Tubulis was also able to show high and long-lasting anti-tumor responses, even at lower expression levels of NaPi2b, with an excellent safety and tolerability profile. 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 or follow us on LinkedIn. View source version on businesswire.com: Contacts For Tubulis Dominik Schumacher, CEO & Co-Founder Phone: +49 175 800 5594 Email: contact@tubulis.com Media Requests for Tubulis Trophic Communications Stephanie May, PhD Phone: +49 (0) 171 185 56 82 Email: tubulis@trophic.eu Source: Tubulis View this news release online at: