On March 5, 2024 Tubulis reported 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) (Free AACR Whitepaper), taking place April 5-10, 2024 in San Diego (Press release, Tubulis, MAR 5, 2024, View Source [SID1234640834]).

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Tubulis is building a pipeline of uniquely matched ADCs, tailored to respective disease biology by leveraging the company’s proprietary suite of platform technologies to combine the right targeting molecule, conjugation chemistry and payload. TUB-030 is directed against the tumor-associated antigen 5T4 which addresses a wide range of solid tumor indications. TUB-040 targets Napi2b, a well-characterized target in ovarian and lung cancer. Both ADC candidates are optimized for long-lasting, durable tumor engagement and minimal off-target toxicity.

"Our novel technologies allow us to push the boundaries of ADC design to fully leverage the biology of well-understood therapeutic targets as well as unlock less-validated ones to create treatments that deliver meaningful patient benefit. The results we will present at the AACR (Free AACR Whitepaper) Annual Meeting will highlight the preclinical differentiation of our two lead candidates, TUB-030 and TUB-040. We believe that these two ADC candidates hold great potential to effectively enable durable responses and prolong overall survival in patients with a broad range of solid tumors while maintaining a significant safety and tolerability profile," said Jonas Helma-Smets, Chief Scientific Officer of Tubulis. "We look forward to further investigating the impact these two candidates can make in the clinic."

Details of the poster presentations:

TUB-030 Poster Information

Title: Enabling 5T4 for targeted cancer therapy: TUB-030, a novel ADC built with ethynylphosphonamidate conjugation chemistry, shows long-lasting anti-tumor activity via Topoisomerase-I inhibition with an optimized therapeutic index
Presenter: Jonas Helma-Smets, CSO of Tubulis
Session Category and Title: Immunology – Antibody-Drug Conjugates
Session Date and Time: Monday, Apr 8, 2024, 1:30 PM – 5:00 PM PT
Location: Poster Section 2
Abstract Number: 2623

The poster will highlight the pre-clinical proof-of-concept data for TUB-030, an ADC that targets the oncofetal 5T4 antigen. 5T4 is a tumor-associated protein that is overexpressed in various types of cancers, including bladder, lung, breast, stomach, esophagus, head and neck, colon, and ovarian cancer. Tubulis’ ADC candidate differs from previous ADCs targeting 5T4 by implementing several layers of differentiation in terms of antibody, payload and conjugation technology. It combines the company’s proprietary P5 conjugation technology with its Tubutecan topoisomerase-I payload platform, resulting in a homogenous DAR (drug-antibody-ratio) of 8. TUB-030 has shown strong cytotoxicity towards cancer cells from different tumor indications with a broad range of 5T4 expression levels. Pharmacokinetic analysis further demonstrated the highly stable profile of TUB-030, enabling the efficient delivery of the payload to the tumor.

TUB-040 Poster Information

Title: TUB-040, a novel Napi2b-targeting ADC built with ethynylphosphonamidate conjugation chemistry, demonstrates high and long-lasting anti-tumor efficacy via Topoisomerase-I inhibition and excellent tolerability predictive of a wide therapeutic window in humans
Presenter: Jonas Helma-Smets, CSO of Tubulis
Session Category and Title: Immunology – Antibody-Drug Conjugates
Session Date and Time: Monday, Apr 8, 2024, 1:30 PM – 5:00 PM PT
Location: Poster Section 2
Published Abstract Number: 2622

The poster will provide a detailed overview of the preclinical proof-of-concept for TUB-040. The ADC candidate is directed against Napi2b, an antigen highly overexpressed in ovarian cancer and lung adenocarcinoma. Its IgG1 antibody targeting Napi2b is connected to its payload, the Topoisomerase I inhibitor Exatecan through a cleavable linker system. The company’s P5 conjugation technology was used to build TUB-040 with a homogenous DAR of 8. TUB-040 induces DNA damage and cell death, without causing unspecific uptake and cytotoxicity in healthy, target-negative cells. Moreover, Pharmacokinetic analysis showed that TUB-040 is highly stable, thus efficiently delivering its payload to the tumor while reducing offsite toxicities.

The full abstracts will be published on March 22, 2024, in an online-only proceedings supplement to the AACR (Free AACR Whitepaper) journal, Cancer Research. The company will issue a press release detailing the full preclinical data following the presentation at AACR (Free AACR Whitepaper).

On March 5, 2024 EpimAb Biotherapeutics, a global clinical stage biotechnology company specializing in the development of bispecific antibodies, reported the acceptance of a late-breaking abstract featuring our novel T-cell engager (TCE) EMB-07 as a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in San Diego, California between April 5-10, 2024 (Press release, EpimAb Biotherapeutics, MAR 5, 2024, View Source [SID1234640833]).

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This presentation will highlight the preclinical results for EMB-07, a novel ROR1 targeting TCE designed with an optimized efficacy, safety and pharmacokinetic profile. Furthermore, the presentation will discuss the TCE’s differentiated in vitro potency relative to benchmark molecules constructed using different modalities. The presentation details are as follows:

Title: Generation of a novel ROR1 x CD3 bispecific T-cell engager for better tumor killing and minimal cytokine release
Session Date: April 8, 2024
Session Time: 9:00AM – 12:30PM local time
Presentation number: LB126 (poster section 52, number 14)

"With EMB-07 EpimAb is applying a unique and proprietary approach to target ROR1, a protein expressed on the surface of a multitude of solid and liquid tumor cells," Dr. Chengbin Wu, Founder and CEO of EpimAb commented. "We are very excited to share the preliminary preclinical findings for this bispecific at the AACR (Free AACR Whitepaper) Annual Meeting, and look forward to further unlocking the potential of our T-cell engager and bispecific antibody platforms to target diseases with unmet need and help patients around the world."

About EMB-07
EMB-07 is a novel ROR1×CD3 T-cell engaging bispecific antibody developed based on EpimAb’s proprietary bispecific antibody platforms. This molecule was carefully designed for an optimized efficacy and safety profile, as demonstrated by only modest levels of cytokine release in preclinical studies. EMB-07 is currently being evaluated in a Phase I trial in solid tumors and lymphomas (NCT05607498; CTR20230350).

On March 5, 2024 Dragonfly Therapeutics, Inc., a clinical stage biotechnology company developing novel immunotherapies, reported receipt of a milestone payment following dosing of the first patient in a clinical trial conducted by AbbVie (NYSE: ABBV) to evaluate ABBV-303, a solid tumor targeting TriNKET (Press release, Dragonfly Therapeutics, MAR 5, 2024, View Source [SID1234640832]).

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ABBV-303, an investigational drug being developed for the treatment of solid tumors, is the eighth drug using Dragonfly’s platform technology to enter the clinic, and the first AbbVie-licensed TriNKET drug candidate to enter into the clinic. The Phase 1 clinical trial, conducted by AbbVie, is evaluating ABBV-303 alone and in combination with AbbVie’s budigalimab (ABBV-181), in solid tumors.

"We are delighted that AbbVie has advanced ABBV-303 into the clinic," said Bill Haney, CEO and Dragonfly co-founder. "AbbVie is a global leader in advancing novel treatments for some of the most complex diseases and a terrific partner. We look forward to continued success and rapid progress with the AbbVie team to advance potential new treatment options for patients."

Additional information about the M24-122 Phase 1 trial, can be found at: View Source (ClinicalTrials.gov Identifier: NCT06158958).

On March 5, 2024 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company specializing in the development and commercialization of innovative therapeutic and pharmaceutical products, and BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, reported preliminary encouraging efficacy data for BI-1206 in combination with rituximab in patients with relapsed/refractory (R/R) indolent Non-Hodgkin’s Lymphoma (iNHL) in the ongoing development program in China (Press release, CASI Pharmaceuticals, MAR 5, 2024, View Source [SID1234640831]).

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BI-1206 is a first-in-class fully human monoclonal antibody (mAb) that targets FcγRIIB. It is being evaluated in combination with rituximab in patients with R/R iNHL. The Phase 1 study is designed to assess the safety, tolerability, pharmacology, and clinical activity of BI-1206, administered though intravenous (IV) infusion.

The Phase 1 dose-escalation study showed impressive signs of clinical efficacy, with 4 partial responses (PR) and 1 complete response (CR) out of 8 evaluable patients. The results are consistent with the clinical data that have been previously reported by BioInvent. Among the responders in the study being conducted in China, one patient with relapsed Marginal Zone Lymphoma (MZL) patient who achieved CR has maintained a durable complete remission for 20+ weeks. The preliminary results demonstrated a manageable safety profile across all patients.

Dr. Wei-Wu He, CEO of CASI, said "These initial BI-1206 data showed promising response for patients with difficult-to-treat disease. The data are especially notable as they demonstrated strong and durable responses at lower dose levels. We believe these results represent important steps toward validating BI-1206 as a potential treatment as well as de-risk our plan for future development."

Dr. He continued, "Further developing BI-1206 to help treat more patients with iNHL is an important goal we share with our partner BioInvent. The interim results further strengthen our confidence in progressing BI-1206 into the next stage of clinical development as a potential treatment option for patients with R/R iNHL."

Dr. Martin Welschof, CEO of BioInvent commented, "We are encouraged by the promising new interim Phase 1 data reported today by our partner, CASI. BI-1206 is being developed to re-establish the clinical efficacy of cancer therapies such as rituximab by addressing fundamental resistance mechanisms to cancer treatments. The clinical efficacy results reported today, including a long-lasting complete response, reinforce previously reported data. We continue to be enthusiastic about the development of BI-1206 in NHL and look forward to reporting data from additional studies in the first half of 2024."

About BI-1206 (Anti-FcyRIIB antibody)

The National Medical Products Administration (NMPA) granted the BI-1206 Clinical Trial Application (CTA) approval in December 2021. Ethics committee approval from a leading investigational site was granted in January 2022. BI-1206 is currently being evaluated in the US, the EU, Brazil and China in three Phase 1/2 trials. Two studies are evaluating BI-1206 in combination with rituximab for the treatment of indolent non-Hodgkin lymphoma (NHL), which includes patients with follicular lymphoma (FL), mantle cell lymphoma (MCL), and MZL who have relapsed or are refractory to rituximab. The third Phase 1/2 trial is investigating BI-1206 in combination with the anti-PD1 therapy KEYTRUDA (pembrolizumab) in solid tumors. The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for BI-1206 for the treatment of follicular lymphoma, the most common form of slow-growing non-Hodgkin lymphoma. BioInvent has licensed the rights for BI-1206 to CASI for China, Hong Kong, Macau, and Taiwan.

On March 5, 2024 Sonata Therapeutics, a biotechnology company developing a new class of therapeutics called Network Medicines, and the Champalimaud Foundation, a world leader in biomedical research and academic medicine, reported a research collaboration for the development of Sonata’s novel Network Medicine, SNT-3012 (Press release, Sonata Therapeutics, MAR 5, 2024, View Source [SID1234640830]). The partnership will drive the continued research and development of SNT-3012 for the treatment of pancreatic and colorectal cancers.

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The collaboration combines Sonata’s foundational understanding of Network Medicines with the Champalimaud Foundation’s patient-derived samples as well as scientific and clinical excellence to conduct proof-of-concept studies that will play a role in the clinical translation of SNT-3012.

"Network Medicines hold the promise to drive resolution of intractable diseases by coordinating all key cells in a disease network toward cure," said Francesco Marincola, M.D., Chief Scientific Officer of Sonata Therapeutics. "To date, SNT-3012 has demonstrated a strong network effect preclinically, and we are excited to further this research in collaboration with the Champalimaud Foundation, with their cutting-edge research capabilities and clinical center of excellence. Together, we aim to make a meaningful difference in the lives of those suffering from pancreatic and colorectal cancers."

The Immunotherapy team at the Champalimaud Foundation added, "This partnership exemplifies our commitment to fuse research and clinical development into one common pathway in order to bring scientific discoveries from the lab to the clinic. Given the potential of Network Medicines to transform the standard of care for pancreatic and colorectal cancer, we look forward to collaborating with Sonata as we work together to create new treatment options for patients with unmet clinical needs and to improve the health and well-being of humankind."

Network Medicines are a new category of therapeutics that are purposefully designed to reprogram diseased cells to release a precise combination of therapeutic signals, coordinating all key cell types in the network to drive disease resolution. SNT-3012 is Sonata’s preclinical Network Medicine being developed for the treatment of pancreatic and colorectal cancers, diseases known for their complexity and limited treatment options. Treatment with SNT-3012 has demonstrated significant tumor regression, in both warm and cold syngeneic tumor models, by coordinating all key cell types in the cancer network to drive immune-mediated tumor rejection.