On October 16, 2024 Akeso Biopharma (9926.HK) (" Akeso", the "Company" ) reported positive results in progression-free survival (PFS) and overall survival (OS) from its Phase 3 clinical study (COMPASSION-16/AK104-303). This study evaluated the efficacy of its independently developed PD-1/CTLA-4 bispecific antibody, 开坦尼 (cadonilimab), in combination with or without platinum-based chemotherapy and bevacizumab, compared to placebo with platinum-based chemotherapy and bevacizumab for first-line treatment of persistent, recurrent, or metastatic cervical cancer (Press release, Akeso Biopharma, OCT 16, 2024, View Source [SID1234647236]). These findings were presented as a Late-Breaking Abstract (LBA) in an oral session at the 2024 annual global meeting of the International Gynecologic Cancer Society (IGCS 2024).

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The principal investigator of the study, Professor Wu Xiaohua from the Fudan University-affiliated Cancer Hospital, presented the results in an oral report, sharing these remarkable outcomes with global experts in gynecological oncology. Concurrently, the findings of the COMPASSION-16 study have been published in the medical journal The Lancet. This also highlights the study’s pivotal role in advancing the frontiers of international clinical cancer research and its potential role in cervical treatment options.

The COMPASSION-16 study shows that the cadonilimab regimen, with or without bevacizumab, demonstrates promising efficacy in treating persistent, recurrent, or metastatic cervical cancer, addressing a critical unmet need for patients without access to bevacizumab. Additionally, cadonilimab offers significant benefits for all patients, regardless of PD-L1 expression status. This study highlights the clinical value and commercialization potential of cadonilimab to advance standard treatment for advanced cervical cancer.

The primary endpoints of the COMPASSION-16 study were progression-free survival (PFS) and overall survival (OS) assessed by independent central imaging review (BICR) based on RECIST v1.1 criteria. A total of 445 patients were enrolled in the COMPASSION-16 study, with 27.9% of patients in the cadonilimab combined with chemotherapy ± bevacizumab treatment group having a CPS < 1, compared to 24.2% in the control group.

The study results indicate that the cadonilimab regimen significantly prolonged survival in the overall population, substantially decreasing the risk of disease progression and the risk of death.

In the intention-to-treat (ITT) population, the median overall survival (OS) for the cadonilimab regimen has not yet been reached, while the control group exhibited a median OS of 22.8 months (the hazard ratio [HR] 0.64, P=0.0011). The 12-month OS rates were 83.1% for the cadonilimab group compared to 73.7% for the control group, and the 24-month OS rates were 62.6% and 48.4%, respectively.
In the ITT population, the median progression-free survival (PFS) for the cadonilimab regimen was 12.7 months, compared to 8.1 months in the control group (HR 0.62, P<0.0001). The 12-month PFS rates were 51.1% and 35% , respectively. As the follow-up time extended (as of April 30, 2024), the benefits of the cadonilimab regimen became increasingly evident, with updated median PFS rates of 13.3 months and 8.2 months (HR 0.62).
Regardless of whether it is combined with bevacizumab, the cadonilimab regimen shows a significant improvement in overall survival (OS).

In the absence of bevacizumab, the cadonilimab regimen is associated with a 50% reduction in the risk of death compared to the control group (OS HR 0.5), thereby effectively addressing the clinical need for patients who are ineligible for bevacizumab.
Regardless of PD-L1 expression levels, cadonilimab regimen significantly reduces the risk across the entire patient population.

In the CPS < 1 cohort, the cadonilimab regimen was associated with a 23% reduction in the risk of death (OS HR 0.77). In the CPS ≥ 1 cohort, there was a 31% reduction in the risk of death.(OS HR 0.69). Notably, in the CPS ≥ 10 cohort, the regimen led to a 32% reduction in the risk of death (OS HR 0.68).
The cadonilimab regimen exhibits a high and sustained antitumor response.

The objective response rate (ORR) for the cadonilimab group was 82.9%, compared to 68.6% in the control group. The complete response (CR) rates were 35.6% and 22.9%, respectively. The median duration of response (DOR) was 13.2 months in the cadonilimab group, compared to 8.2 months in the control group.
The combination of cadonilimab with chemotherapy ± bevacizumab has a manageable safety profile, with no new safety signals identified.

On October 16, 2024 Pillar Biosciences, Inc., the leader in Decision Medicine, reported an expansion of their existing partnership with Illumina, through which a broader portfolio of Pillar’s oncoReveal NGS panels will now be offered directly by Illumina (Press release, Pillar Biosciences, OCT 16, 2024, View Source [SID1234647235]). Several of Pillar’s oncology panels will be available as part of the validated libraries on the MiSeq i100 Series sequencing platform, which launched last week.

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The additional research-use-only (RUO) oncology NGS panels manufactured by Pillar Biosciences and available directly through Illumina will include:

Liquid Biopsy Tumor Profiling:

oncoReveal Core LBx
oncoReveal Essential LBx
oncoReveal Fusion LBx
Solid Tumor Profiling:

oncoReveal Multicancer RNA Fusion (18-Driver gene RNA panel)
oncoReveal Solid Tumor v2 (48-gene DNA panel)
These panels are enabled on the MiSeq and NextSeq 550 Systems. Pillar Biosciences panels that are enabled on the newly launched Illumina MiSeq i100 Series include:

oncoReveal Essential MPN
oncoReveal Myeloid
oncoReveal Multi-Cancer with CNV and Fusion Panel
oncoReveal BRCA1 & BRCA2 plus CNV Panel
"As part of Illumina’s commitment to address our customers’ total workflow, we are pleased to bring more oncology assays from Pillar Biosciences into our product lineup, including the new MiSeq i100 Series," said Angela Ryan, Vice President, Product Management at Illumina.

"We are excited about the commercial progress generated through our collaboration with Illumina over the past 18 months. By expanding their oncology offering with rapid, high-quality targeted genomic content we can ensure more customers have a full suite of NGS solutions to fulfill their genomic profiling needs," said Dan Harma, Chief Commercial Officer at Pillar Biosciences. "Pillar and Illumina’s NGS solutions are complementary and have very specific technical benefits. These can be utilized together efficiently. We look forward to working together to better enable our customers and further driving localized NGS services."

On October 16, 2024 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, reported that it will present at the 16th Annual Protein & Antibody Engineering Summit (PEGS) to be held from November 5-7, 2024 in Barcelona as well as at the Cell 2024 conference by Oxford Global from November 6-8, 2024 in London (Press release, MediGene, OCT 16, 2024, View Source [SID1234647234]). In addition, two posters will be presented at the 39th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) from November 6-10, 2024, in Houston, TX, USA.

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Oral presentation

PEGS 2024
View Source
Location: Montjuic Palau de Congressos- Fira Barcelona, Spain
Date and time: Thursday, November 7, 2024, 8:25 am local time
Presenter: Kanuj Mishra, PhD, Team Lead & Lab Head, Innovation
Session: Next-Generation Immunotherapies
Title: Seamless Integration of a Universal Epitope into Recombinant TCRs for Tagging and Tracking of TCR-T Cells Expressing 3S TCRs

The presentation will highlight the Company’s latest technology, UniTope & TraCR, an innovative combination of universal TCR tagging and tracking. This advanced system is engineered to greatly improve the precision and efficiency of T cell receptor identification and monitoring, providing benefits for immunotherapy research and clinical applications.

Cell 2024 by Oxford Global
View Source

Panel Discussion
Location: Novotel London West, London, UK
Date/time: Wednesday, November 6, 2024, 3 p.m. local time
Presenter: Kirsty Crame, MD, Vice President, Clinical Strategy and Development
Session: Exploring Autologous Vs. Allogenic Therapies

Keynote Address
Location: Novotel London West, London, UK
Date/time: Thursday, November 7, 2024, 9.30 a.m. local time
Presenter: Kirsty Crame, MD, Vice President, Clinical Strategy and Development
Session: CGT Development
Title: Making The Ordinary Extraordinary: MDG1015 A Clinic Ready 3rd Generation TCR-T Therapy

Oral presentation
Location: Novotel London West, London, UK
Date/time: Friday, November 8, 2024, 2.20 p.m. local time
Presenter: Prof. Dolores Schendel, CSO
Session: iPSCs and stem cell therapy development
Title: TCR-T Platform for Solid Tumors

SITC 2024
View Source
Location: George R. Brown Convention Center in Houston, TX
Date and time: November 6-10, 2024 in Houston, TX

Details on the poster presentation are as follows:
Abstract and Title: " UniTope & TraCR – A universal tagging and tracking system for TCR-T cells directly integrated in recombinant TCR."
Authors: Kanuj Mishra, Justyna Ogonek, Dolores Schendel, Barbara Loesch
Abstract number: 20
Date/time: Saturday, November 9, 2024, George R. Brown Convention Center – Level 1 -Exhibit Halls AB, poster reception from 7:10-8.30 p.m.
Presenter: Barbara Loesch, PhD, Head of Technology and Innovation Department
Session: Biomarkers, Immune Monitoring and Novel Technologies

Abstract and Title: "The IFN-γ Biosensor – A universal tool for IFN-γ detection in cellular co-culture assays."
Authors: Barbara Loesch, Kanuj Mishra, Justyna Ogonek, Dolores Schendel
Abstract number: 21
Date/time: Friday, November 8, 2024, George R. Brown Convention Center – Level 1 -Exhibit Halls AB, poster reception from 5:30-7 p.m.
Presenter: Barbara Loesch, PhD, Head of Technology and Innovation Department
Session: Biomarkers, Immune Monitoring and Novel Technologies

On October 16, 2024 Theriva Biologics (NYSE American: TOVX), ("Theriva" or the "Company"), a clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, reported that the European Commission has adopted the European Medicines Agency (EMA) recommendation to grant orphan medicinal product designation to lead clinical candidate VCN-01, Theriva’s systemic, selective, stroma-degrading oncolytic adenovirus, for the treatment of retinoblastoma (Press release, Theriva Biologics, OCT 16, 2024, View Source [SID1234647233]). The United States Food and Drug Administration (FDA) has previously granted orphan drug designation and rare pediatric disease designation to VCN-01 for the treatment of retinoblastoma.

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"We are very pleased with the European Commission’s grant of orphan medicinal product designation to VCN-01, emphasizing the urgent need for new treatment options for retinoblastoma," said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. "We have previously reported encouraging results from an investigator sponsored Phase 1 trial evaluating the safety and activity of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma, and we are working closely with leading physicians and regulatory agencies worldwide to refine our clinical strategy for VCN-01 as an adjunct to chemotherapy in children with this challenging disease."

The EMA recommends orphan designation for products intended to treat, prevent or diagnose a disease that is life-threatening or chronically debilitating and either the prevalence of the condition in the European Union (EU) does not exceed 5 in 10,000 or it is unlikely that marketing of the product would generate sufficient returns to justify the investment needed for its development. Additionally, there should be no authorizable method of diagnosis, prevention or treatment of the condition, or, if such a method exists, the medicine must be of significant benefit to those affected by the condition. Orphan designation is designed to provide drug developers with various benefits to support the development of novel therapies, including 10-years of market exclusivity once they receive marketing authorization in the EU, protocol assistance, administrative and procedural assistance, and reduced fees for regulatory activities.

About Retinoblastoma

Retinoblastoma is a tumor that originates in the retina and is the most common type of eye cancer in children. It occurs in approximately 1/14,000 – 1/18,000 live newborns and accounts for 15% of the tumors in the pediatric population < 1 year old. The average age of pediatric patients at diagnosis is 2, and it rarely occurs in children older than 6. In Europe, retinoblastoma has an estimated incidence rate of 1 per 13,844 live births (14.1 per million children under the age of 5) with approximately 300 children diagnosed per year (Stacey et al. 2021). Preserving life and preventing the loss of an eye, blindness and other serious effects of treatment that reduce the patient’s life span or the quality of life, remains a challenge. In addition, children with retinoblastoma have been more likely to lose their eye and die of metastatic disease in low-resource countries.

About VCN-01

VCN-01 is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to over 140 patients to date in clinical trials of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at Clinicaltrials.gov.

On October 16, 2024 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported that the Company will be providing a corporate update at the upcoming investor conferences on the dates below (Press release, Soligenix, OCT 16, 2024, View Source [SID1234647231]).

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2024 Maxim Healthcare Virtual Summit, held October 17, 2024. For more information, please refer to the conference website https://m-vest.com/events/healthcare-10152024.

ThinkEquity Conference, held October 30, 2024. For more information, please refer to the conference website View Source

Spartan Capital Investor Conference 2024, held November 4, 2024. For more information, please refer to the conference website View Source
Key members of Soligenix management will hold one-on-one meetings throughout the conferences. If you are unable to attend the conferences and would like to schedule a meeting with management, please contact [email protected].