On December 4, 2024 Physician-scientists from Rutgers Cancer Institute and RWJBarnabas Health reported that it will showcase a diverse range of hematology/oncology data from their clinical research program at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held in San Diego, California (and online) from December 7-10, 2024 (Press release, Rutgers Cancer Institute of New Jersey, DEC 4, 2024, View Source [SID1234648809]). A total of 66 abstracts have been accepted (including 21 oral presentations, 39 poster presentations, 1 special-interest session, 1 oral symposium, 2 satellite symposia and 2 scientific workshops), comprising of clinical data and analyses that advance the understanding, treatment, and prognosis of blood cancers and disorders such as sickle cell disease, lymphoma, leukemia, and myeloma. Rutgers Cancer Institute, together with RWJBarnabas Health, is New Jersey’s only National Cancer Institute-designated Comprehensive Cancer Center.

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Rutgers Cancer Institute and RWJBarnabas Health (PRNewsfoto/Rutgers Cancer Institute and RWJBarnabas Health)
Rutgers Cancer Institute and RWJBarnabas Health (PRNewsfoto/Rutgers Cancer Institute and RWJBarnabas Health)
"At the heart of our research efforts is a commitment to improving patients’ lives and serving our community. This promise is shared by our nationally recognized team of cancer specialists, who work tirelessly to translate groundbreaking discoveries into the best options for our patients," said Matthew Matasar, MD, Chief, Division of Blood Disorders, Rutgers Cancer Institute, and Professor of Medicine, Rutgers Robert Wood Johnson Medical School. "The impressive contributions of our faculty, showcased at this year’s ASH (Free ASH Whitepaper) Annual Meeting, underscore the clinical excellence, innovation, and discovery that define Rutgers Cancer Institute and RWJBarnabas Health. We’re proud to lead cutting-edge research that has the potential to improve the lives of every patient and family we serve. We remain singularly focused on my, and our, goal to end blood cancers and disorders entirely."

Highlights of the high-impact science from Rutgers Cancer Institute at ASH (Free ASH Whitepaper) 2024:

Data from a study that leverages big data to improve prognostication in advanced stage classic Hodgkin Lymphoma (cHL). This study, which analyzed 1,240 patients, used multistate modeling (MSM) and individual patient data from the HoLISTIC Consortium to refine prognostication across the cHL disease course, through specifically assessing the relationships between Advanced Stage Hodgkin Lymphoma International Prognostication Index (A-HIPI), interim PET (iPET) and end of treatment (EOT) response, and whether the A-HIPI and iPET provide independent prognostic information.

Researchers examined the bispecific antibody linvoseltamab in patients with relapsed/refractory multiple myeloma (RRMM), assessing longer follow-up and a select high-risk subgroup analysis of the Linker-MM1 study. Additional analyses were conducted to evaluate the effectiveness of linvoseltamab, focusing on how long patients responded to treatment (duration of response), how long they remained free from disease progression (progression-free survival), and their overall survival. These results, based on a safety follow-up period of over 14 months, were specifically looked at in high-risk patient groups.

A primary analysis from the ELM-1 expansion cohort, evaluated the efficacy and safety of the bispecific antibody odronextamab monotherapy in patients with diffuse large b-cell lymphoma (DLBCL) who had disease progression after CAR T-cell therapy. The primary endpoint was objective response rate, as assessed by independent central review according to the Lugano classification. The key secondary endpoints included duration of response, progression-free survival, and overall survival. Exploratory endpoints included immune biomarker assessment.
A study leveraging real-world evidence compared the overall survival associated with different treatment sequences in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in the United States. The study used an electronic health record database from Flatiron Health to identify adult patients with CLL or SLL who started treatment in 2016 or later and had received at least two lines of therapy.
An evaluation of CAR-HEMATOTOX scoring as a predictor of infection risk following treatment with odronextamab in relapsed/refractory (R/R) diffuse large b-cell lymphoma (DLBCL) and in follicular lymphoma (FL). These retrospective analysis of the ELM-1 and ELM-2 studies evaluated infections in 219 patients receiving odronextamab monotherapy for R/R DLBCL and FL, respectively.

On December 4, 2024 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported new data from its mRNA-based neoantigen vaccine platform for individualized cancer immunotherapy, presented at the Personalized Cancer Vaccines Summit in Boston (Press release, Nykode Therapeutics, DEC 4, 2024, View Source [SID1234648789]). The findings highlight the platform’s ability to elicit robust and durable immune responses.

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Nykode has previously demonstrated that the neoantigen vaccine induces strong, CD8-biased T cell responses, targeting the majority of the encoded neoantigens. The novel pre-clinical data examines the kinetics of individual neoantigens, showing distinct dose-response patterns. The findings underscore the importance of an optimal vaccination schedule, highlighting differentiated responses to early versus late boost vaccinations.

The vaccine’s ability to provide complete tumor protection with prophylactic administration has been demonstrated. Now, new data reveal that this tumor protection is durable: a single vaccination provided partial long-term protection, while two vaccinations achieved complete and sustained protection at day 90.

"These data reinforce the robust and durable immune responses our neoantigen vaccine generates also in a mRNA format, further validating its potential as a personalized cancer immunotherapy platform," said Agnete Fredriksen, Chief Scientific Officer and Co-founder of Nykode Therapeutics.

Details for the Nykode Therapeutics’ presentation are as follows:

Title: Nykode’s Individualized Cancer Vaccine Approach Across DNA and mRNA

Time & Date: 1:30pm ET, December 4, 2024

The presentation is available on the Nykode website at View Source

About VB10.NEO

VB10.NEO is a proprietary individualized neoantigen vaccine in development for the treatment of locally advanced or metastatic solid tumors. The vaccine is designed to be produced on-demand according to the neoantigen profile of an individual patient. Neoantigens are proteins generated by tumor-specific mutations not present in normal tissues and are thus an attractive target for cancer immunotherapy as they may be recognized as foreign by the immune system. VB10.NEO has been evaluated in multiple indications in two clinical trials. It has been shown to be generally well tolerated and with an ability to generate uniquely broad patient- and tumor-specific long-lasting immune responses.

On December 4, 2024 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported an update on the progression of the ACHIEVE UK Trial (Press release, TC Biopharm, DEC 4, 2024, View Source [SID1234648810]).

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As of this week, over half of the Cohort A patients in Stage One of the ACHIEVE study have received TCB008. These patients have an unmet clinical need, as they have been unable to attain remission with the existing Standard of Care, other treatments, or tolerate further chemotherapy. Data evaluated at this milestone demonstrate positive safety signals for the 5mL dose of TCB008, as no Serious Adverse Events have been attributed to the TCB008 drug product. The Company intends to use this data to justify further increases in the TCB008 dose, from 230 million Gamma Delta T-Cells up to 819 million Gamma Delta T-Cells, to identify the optimal dose for Cohort A patients.

Cohort B patients with residual disease after initially achieving remission with existing available treatment continue to be actively recruited into the ACHIEVE study at the current TCB008 dose of 230 million Gamma Delta T-Cells. These patients will be recruited at 1 of the 4 active clinical trial sites. Each site, including Guy’s and St. Thomas, is led by a Principal Investigator, who are experienced hematologists who oversee the use of TCB008 as an experimental acute myeloid leukemia treatment. Two more sites will be onboarded in the first half of 2025 for 6 recruiting sites in the United Kingdom.

"Medicinal products cannot be effective if they are not safe, and it’s clear from these initial data that TCB008 is safe for our patients," said Alison Bracchi, Executive Vice President of Clinical Operations. "Our priority now, for Cohort A, is to find the optimal biologically effective dose for patients that have exhausted all other treatments to drive a long term response. We look forward to completing the recruitment of Cohort B patients, and are planning to evaluate these data in the first half of 2025."

The increased TCB008 dose will be implemented concurrently to the scaled-up manufacturing process, developed by Dr. Lauren Bor’s team, in 2025.

"The operational teams at TC BioPharm are incredibly resourceful," said Callum Fiske, Head of Operations. "Cross-functional collaboration is ongoing to deliver improvements to the manufacturing process as soon as possible, enabling increased yields that will expedite TCB008 delivery from cleanroom to clinic, and drive economic efficiencies to the commercial cost, in 2025."

On December 4, 2024 Sonnet BioTherapeutics Holdings, Inc. (the "Company" or "Sonnet") (NASDAQ: SONN), a clinical-stage company developing innovative targeted immunotherapeutic drugs, reported the publication of extensive discovery, development and preclinical data on SON-1010 demonstrating its mechanism of action in Frontiers in Immunology (Press release, Sonnet BioTherapeutics, DEC 4, 2024, View Source [SID1234648794]). SON-1010, Sonnet’s lead proprietary drug candidate, combines the Company’s fully human albumin-binding (FHAB) construct with a native single-chain IL-12 sequence to simplify delivery of the cytokine systemically. The paper entitled "SON-1010: An Albumin-binding IL-12 Fusion Protein with Improved Cytokine Half-life Targets Tumors and Enhances Therapeutic Efficacy," details the identification of single-chain variable fragments (scFv) from a human phage display library that bound human, mouse, and cynomolgus macaque serum albumin, both at physiologic and acidic conditions. The composition of matter patent claims on the FHAB domain and SON-1010 fusion protein have been issued in a number of major markets, including but not limited to the U.S., China, Japan, Russia and New Zealand, and expire between 2038 and 2039. Additionally, the Company announced the release of a "What This Means" segment to discuss the publication which is now available here.

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The extensive discovery program included putting the scFv domains through a series of steps to identify strongly binding molecules that bind tightly over a 5.8 to 7.2 pH range and do not interfere with the normal physiology of albumin to bind the neonatal Fc receptor (FcRn). This resulted in having prolonged half-life in serum and binding to SPARC/GP60, which allows albumin to target the tumor microenvironment (TME). A final molecule was selected and a single mutation was introduced that minimizes the potential for immunogenicity. This FHAB domain was characterized, and manufacturing processes were developed to prepare Sonnet’s first drug candidate for the clinic. Once identified, the murine form of mIL12-FHAB was shown to be much more efficient at blocking tumor growth compared to murine IL-12, while stimulating significant and prolonged IFNγ production with minimal toxicity. Biodistribution studies in mice confirmed tumor delivery and toxicological studies in non-human primates allowed the initiation of the clinical trials.

"We are pleased to share these findings, which is the first time we have fully described the extensive research that was required to discover and develop our signature FHAB platform," said Pankaj Mohan, Ph.D., Founder and CEO of Sonnet. "This work lays the foundation for all of the products on our platform that are designed to safely extend the half-life of cytokines and deliver them to the tumor, where they can convert the immunological response from ‘cold’ to ‘hot’ and potentially realize the promise of immunotherapy."

"IL-12 and related compounds have been extensively studied in cancer and immunotherapy indications. However, recombinant interleukins have had limited clinical success owing to their short circulating half-life, inefficient TME targeting, and requirement for frequent dosing, often leading to substantial systemic toxicities," added John Cini, Ph.D. Co-Founder and CSO of Sonnet. "We believe we have addressed these issues with our discovered platform, having utilized a molecule that can be applied in any solid tumor type that concentrates albumin, such as sarcoma, gynecologic, and gastrointestinal cancers. We intend to explore new compounds as well, as funds become available."

The Company is currently conducting a Phase 1 clinical trial of SON-1010 (IL12-FHAB) as a monotherapy in adult patients with advanced solid tumors (SB101; NCT05352750). The Company expects to report safety data from this study in Q4 2024. SON-1010 is being evaluated in an ongoing Phase 1/2a study through a Master Clinical Trial and Supply Agreement, along with ancillary Quality and Safety Agreements, with Roche in combination with atezolizumab (Tecentriq) for the treatment of Platinum-Resistant Ovarian Cancer (PROC).

On December 4, 2024 Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") reported that it has successfully completed an underwritten public offering of 18,000,000 shares of its common stock to the public at a price of NT$76 per share (Press release, Foresee Pharmaceuticals, DEC 4, 2024, View Source [SID1234648811]). The aggregate gross proceeds to Foresee from the offering were NT$1,368 million (or US$42.1 million at FX=32.5).

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The proceeds of the public offering will be used for general corporate purposes, including FP-014 (triptorelin), a ready-to-use long-acting injectable, administered either every three months or six months, in two Phase 3 clinical trials for advanced prostate cancer, respectively; FP-020 (linvemastat), an MMP-12 inhibitor, in two Phase 2 studies for both asthma and inflammatory bowel disease (IBD), and FP-045 (mirivadelgat), an ALDH2 activator, in a Phase 2 clinical trial for pulmonary hypertension associated with interstitial lung disease (PH-ILD).

"We are pleased to announce the successful completion of the public offering. I would like to express my gratitude once again for shareholders’ full support and trust in us." said Dr. Ben Chien, Founder and Chairman of Foresee. "This funding will enable us to accelerate our R&D progress and create more value for our shareholders."