On December 4, 2024 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported the results from a prospective, open-label, single-arm, multi-center phase Ib/II clinical study (AK104-IIT-018) of cadonilimab (PD-1/CTLA-4 bispecific antibody) in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who had progressed after prior PD-(L)1 inhibitor treatment, were presented at the 2024 Asian Conference on Lung Cancer (ACLC) (Press release, Akeso Biopharma, DEC 4, 2024, View Source [SID1234648812]).

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Professor Han Baohui from Shanghai Chest Hospital presented the initial positive results of the cadonilimab combination therapy for immune-resistant NSCLC at the conference. The treatment demonstrated a 6-month progression-free survival (PFS) rate of 56.9%, a median PFS of 6.5 months, a disease control rate (DCR) of 94.0%, and a median duration of response (DoR) of 5.0 months. Nearly all patients showed long-lasting tumor control, highlighting cadonilimab as a promising and effective second-line treatment for advanced immune-resistant NSCLC.

The AK104-IIT-018 study is a prospective, open-label, single-arm, multicenter Phase Ib/II clinical trial (NCT05816499) conducted across four centers in China. The study was initated in February 2023, and this report presented the preliminary data analysis. The study enrolled patients with unresectable, incurable locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC), who tested negative for driver mutations and had previously received PD-1/L1 inhibitors along with platinum-based doublet chemotherapy (either in combination or sequentially, regardless of sequence), with disease progression. Patients were treated with a combination regimen of cadonilimab (10 mg/kg every 3 weeks), anlotinib, and docetaxel (60 mg/m²). The primary endpoint of the study is the 6-month progression-free survival (PFS) rate.

As of May 31, 2024, 46 patients had been enrolled in the study. Among these, 41.3% had non-squamous NSCLC and 58.7% had squamous NSCLC. Regarding PD-L1 expression, 10.9% of patients had levels <1%, 28.3% between 1-49%, and 15.2% had PD-L1 expression≥50%. Reflective of the real-world NSCLC patient population, 10.9% of patients had brain metastasis, 6.5% of the patients had liver metastasis, and 23.9% of the patients had bone metastasis.

Progression-Free Survival (PFS):

As of May 31, 2024, the maturity of PFS was 30.4%, with a 6-month PFS rate of 56.9% (compared to 30% for docetaxel monotherapy). The median PFS was 6.5 months (versus 4 months for docetaxel monotherapy).

Tumor Response:

Out of 33 patients, 10 achieved partial response (PR), and 21 had stable disease (SD). The overall objective response rate (ORR) was 30.3%, which is significantly higher than the 14% ORR observed in previous studies of docetaxel alone. Among the 10 patients with partial response, the median duration of response (DoR) was 5.0 months.

Disease Control Rate (DCR):

The DCR reached 94.0%, with nearly all patients experiencing effective tumor control.

Safety:

The combination of cadonilimab, anlotinib, and docetaxel for treating advanced, driver gene-negative, immune-resistant NSCLC was well-tolerated. The adverse events were manageable and controllable, and the safety profile was favorable.

For patients with advanced, driver gene-negative NSCLC who progress after first-line immunotherapy combined with chemotherapy, treatment options are limited. The standard treatment recommended by the NCCN guidelines is single-agent chemotherapy, but its efficacy is limited, with an objective response rate (ORR) of 14%–17%, a 6-month progression-free survival (PFS) rate of approximately 30%, PFS of 4.0–5.4 months, and overall survival (OS) of 10.5–12 months. The cadonilimab regimen holds potential as a new treatment option for immune-resistant NSCLC. Cadonilimab is a bispecific antibody that targets both PD-1 and CTLA-4, and is independently developed by Akeso. It is a humanized immunoglobulin G1 (IgG1) bispecific antibody (BsAb). Cadonilimab promotes "immune normalization" in the tumor microenvironment through multiple mechanisms. Its unique tetravalent symmetric structure design and Fc modifications enable enhanced accumulation in tumor tissues. As a result of this study, cadonilimab demonstrated the potential to improve the efficacy of tumor immunotherapy while reducing adverse reactions.

Akeso has conducted several clinical trials to evaluate cadonilimab in the treatment of immune-resistant or poorly responsive tumors. These include the registrational phase III trial (AK109-301) of cadonilimab combined with its VEGFR-2 monoclonal antibody for advanced gastric cancer progressing after PD-1/L1 inhibitors plus chemotherapy, and the phase III trial (AK104-307) comparing cadonilimab plus chemotherapy to tislelizumab plus chemotherapy as first-line treatment for PD-L1-negative NSCLC.

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."

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 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 Rgenta Therapeutics, a clinical-stage biotechnology company pioneering the development of a new class of oral small molecules targeting RNA for oncology and neurological disorders, reported that it has entered into a multi-year, multi-target strategic research alliance with GSK (Press release, Rgenta Therapeutics, DEC 4, 2024, View Source [SID1234648808]). The alliance aims to advance the discovery and development of novel RNA-targeted small molecule splice modulators for multiple disease areas including oncology.

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"We are excited about Rgenta’s differentiated approach to discover and develop oral small molecule splice modulators for high-value targets," said Christopher Austin, M.D., SVP Research Technologies at GSK. "We are dedicated to partnering with leading companies to complement our existing expertise in RNA-targeting medicines and look forward to advancing this promising modality to more patients with difficult-to-treat diseases."

"We are thrilled to have GSK, a leading biopharma company, as our partner. This alliance further validates the potential of Rgenta’s small molecule RNA-targeting drug discovery platform," said Simon Xi, Ph.D., co-founder and chief executive officer of Rgenta. "Together we have the potential to accelerate the development of a new class of medicines that can provide new therapeutic options for patients."

Under the terms of the agreement, Rgenta will receive up to $46 million in a cash upfront and pre-option milestone payments. Rgenta has the potential to receive up to nearly $500 million per target in option exercise, research, development, regulatory, and commercial milestone payments plus tiered royalties and a future equity investment. GSK also has an option to expand the alliance to include additional targets. Under the alliance, Rgenta will use its proprietary discovery platform to develop novel oral RNA-targeting small molecule splice modulators against multiple targets nominated by GSK for development. Following GSK’s exercise of its options, GSK will be responsible for further development and commercialization of any drug candidates that arise from the alliance.

Travis Wager, Ph.D. co-founder, president and chief scientific officer of Rgenta added, "We are excited to partner with GSK, whose science-driven philosophy and successful track record of harnessing scientific innovation to benefit patients aligns perfectly with our mission. This alliance additionally validates our discovery platform which has already led to our first clinical stage asset, RGT-61159, an orally available small molecule designed to specifically modulate splicing of the transcription factor MYB."