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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

On March 5, 2024 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "Company") reported that it has received a Notice of Allowance from the Japanese Patent Office for a Patent ("Patent") for inducing an antibody immune response from a low dose volume delivery of a B-cell epitope formulated with DPX (Press release, BioVaxys Technology, MAR 5, 2024, View Source [SID1234640829]). This Patent was part of the extensive Intellectual Property portfolio recently acquired by BioVaxys from the former IMV, Inc. This Patent has already been issued in the US, and is currently pending in the EU.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

DPX is a proprietary lipid-based delivery platform with no aqueous component that can be formulated with a range of packaged antigens, proteins, peptides, mRNA, or small molecules. Its unique "no release" mechanism of action allows antigen presenting cells (APCs) to be attracted to the injection site, facilitating a robust and sustained immune response.

The smallest dose of a currently approved vaccine is 0.1ml for Sanofi-Pasteur’s Fluzone Intradermal Quadrivalent vaccine. Low dose volume delivery of DPX formulated B-cell epitope is designed to be delivered in single dose as low as 50µL to 90 µL.

An epitope is the part of an antigen that the host’s immune system recognizes, eliciting the immune response to an invading pathogen. It specifically binds to the corresponding antigen receptor on the immune cell (such as a B-cell). Whereas T-cells protect people from getting infected by destroying cancerous and infected cells, B-cells produce antibodies to fight infection.

BioVaxys President and Chief Operating Officer Kenneth Kovan says "Expanding patent protection into major biopharma markets such as Japan further increases the value of the DPX platform for our Company. Having an ability to create low dose DPX+B cell epitope formulations is an attractive approach for packaging antigens for cancer immunotherapeutics and therapeutic vaccines such as for influenza, Zika virus, RSV, HSV, and many other viral or bacterial pathogens.

BioVaxys also is pleased to announce it filed an international patent application through the Patent Cooperation Treaty ("PCT") from two pending patent applications in the US related to methods of formulating DPX compositions that comprise both a lipid-based adjuvant (i.e. PAM) and a polyI:C polynucleotide adjuvant.

The PCT is a patent treaty with more than 150 member countries, makes it possible to seek patent protection for an invention simultaneously in a large number of countries by filing a single "international" patent application instead of filing several separate national or regional patent applications.

On March 5, 2024 Shasqi, Inc. ("Shasqi") a biotech company whose mission is to make cancer drugs more effective with click chemistry, reported that Founder & Chief Executive Officer José M. Mejía Oneto, MD, PhD, will present at the 14th Annual World ADC Conference in London, United Kingdom on Tuesday March 12th at 11:00am GMT (Press release, Shasqi, MAR 5, 2024, View Source [SID1234640828]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The session titled "CAPAC: A Modular Platform for Tumor-Targeted Drug Activation Using Click Chemistry In Vivo" will be part of the "Supercharging ADC Efficacy & Conquering Toxicity Through Transformative Emerging Conjugation Technologies" track as part of the 2nd Generation Conjugates Day.

"We are honored to be an invited speaker at the 2nd Next-Generation Conjugation Day during World ADC Europe—an event synonymous with innovation." said Dr. Mejía Oneto. "We’re excited to share more about our technology and present new data demonstrating how our unique approach has the potential to meaningfully increase the therapeutic index of cancer drugs."

As part of the session, Shasqi will share background on its novel Click Activated Protodrugs Against Cancer (CAPAC) platform, which leverages click chemistry for tumor-targeted drug activation. Shasqi will also share clinical proof-of-concept data and unveil preclinical data from the pipeline, showcasing the ability to use antibody fragments to activate high potency payloads at the tumor.

Shasqi has developed a novel approach to activating drugs at the tumor. First, an antigen targeting activator is infused, which binds to the tumor. Then, an inert version of a cancer therapeutic, called a protodrug, is infused. The protodrug finds the activator at the tumor and the active drug is released via a click chemistry reaction. Separation of payload from tumor targeting confers several advantages over antibody-drug conjugates (ADCs) including selective activation at the tumor and the ability to optimize the ratio of each component throughout development, including in the clinic. Together, this allows the therapeutic index of cancer drugs to be maximized.

On March 5, 2024 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported three poster presentations at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper), taking place April 5-10, 2024, in San Diego, CA (Press release, Sapience Therapeutics, MAR 5, 2024, View Source [SID1234640827]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Sapience will present non-clinical immunotherapy results at AACR (Free AACR Whitepaper) from both of its clinical programs, ST316, a first-in-class antagonist of β-catenin, and ST101, a first-in-class antagonist of C/EBPβ. Sapience will also present first disclosure of pre-clinical data describing its first-in-class AP-1 complex antagonist targeting the interaction of cJun with Fra1.

Poster Presentation Details:

Title: "ST316, a clinical peptide antagonist of beta-catenin, induces anti-tumor immune responses by multiple mechanisms of action"
Session Title: Inflammation in Tumor Initiation and Progression
Location: Poster Section 4
Abstract Number: 5332
Date and Time: Tuesday, April 9, 2024, 1:30 PM to 5:00 PM

Title: "ST101, a clinical CEBPβ antagonist peptide, promotes an immune-active tumor microenvironment by multiple cellular mechanisms"
Session Title: The Tumor Microenvironment as a Drug Target
Location: Poster Section 13
Abstract Number: 2909
Date and Time: Monday, April 8, 2024, 1:30 PM to 5:00 PM

Title: "JunAP, a peptide antagonist against the activator protein 1 transcription factor complex, demonstrates cancer cell cytotoxicity and reduced invasion in vitro and tumor regression in vivo in TNBC models"
Session Title: Oncogenic Transcription Factors
Location: Poster Section 18
Abstract Number: 3051
Date and Time: Monday, April 8, 2024, 1:30 PM to 5:00 PM

More information can be found on the 2024 AACR (Free AACR Whitepaper) website.

About ST316

ST316 is a first-in-class peptide antagonist of the interaction between β-catenin and its co-activator, BCL9, a complex that drives oncogene expression in multiple cancers where aberrant Wnt/β-catenin pathway signaling is observed. ST316-101 (NCT05848739) is a first-in-human, open-label, Phase 1-2 dose-escalation and expansion study designed to determine the safety, tolerability, PK, PD and early efficacy of ST316. The Phase 1 dose-escalation portion of the Phase 1-2 study is enrolling and dosing patients with select advanced solid tumors that are known to harbor abnormalities of the Wnt/β-catenin signaling pathway. The Company expects to complete the Phase 1 portion of the study in the first half of 2024. Following completion of the study’s Phase 1 portion, the recommended dose will advance to the Phase 2 dose expansion portion of the study in colorectal cancer patients.

About ST101

ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with recurrent GBM (rGBM) (NCT04478279). In an ongoing window-of-opportunity sub-study, ST101 is being evaluated as a monotherapy in rGBM and in combination with radiation and temozolomide in newly diagnosed GBM, with patients receiving ST101 before and after surgical resection. ST101 has been granted Fast Track designation for rGBM from the U.S. FDA and orphan designations for glioma from the U.S. FDA and the European Commission.