On September 20, 2023 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported that its partner Asieris Pharmaceuticals (SSE: 688176) has communicated that the multinational Cevira Phase III clinical trial has been completed and successfully met its primary endpoint (Press release, Asieris Pharmaceuticals, SEP 20, 2023, View Source [SID1234635295]). Cevira (APL-1702) is a photodynamic drug-device combination product in development for the non-surgical treatment of high-grade squamous intraepithelial lesions (HSIL), licensed to Asieris by Photocure.

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The results of the study will be submitted to the Chinese National Medical Products Administration (NMPA) as part of a new drug application (NDA) in the coming months.

This study is a prospective, randomized, double-blind, placebo-controlled international multicenter Phase III clinical trial designed to evaluate the efficacy and safety of APL-1702 for the treatment of cervical HSIL. It is led by Academy Member Dr. Jinghe Lang from Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, and has enrolled 402 participants. The trial met its primary endpoint, together with a robust safety profile. Comprehensive data from this study will be presented at forthcoming academic conferences and published in scientific journals.

Dr. Linda Wu, Chief Development Officer of Asieris Pharmaceuticals, said "This milestone marks a significant leap forward in the management of HSIL, with the potential to transform care in this domain. Moreover, tackling precancerous cervical conditions is pivotal for early prevention of cervical cancer and is an integral part of the three-tier cancer prevention system. Asieris Pharmaceuticals is committed to playing an active role in advancing China’s Action Plan to Eliminate Cervical Cancer (2023-2030) and contributing to Healthy China 2030, aligning our efforts with the WHO’s global strategy to accelerate the elimination of cervical cancer."

"It is exciting to see that the Phase III clinical trial for Cevira has met its primary endpoint. There are many patients globally who can benefit from a non-surgical approach to treating high-grade squamous intraepithelial lesions (HSIL). Given the high unmet need and the importance of novel therapies to improve HSIL clinical outcomes, Photocure will continue to support Asieris, as our partner advances to the next stages of product development and regulatory approval," said Anders Neijber, Photocure’s Chief Medical Officer.

According to the Global Cancer Statistics 2020, there were 604,127 new cases of cervical cancer in women, with 341,831 deaths worldwide, ranking it as the fourth most prevalent malignancy among females.1 In China, cervical cancer ranks as the second most common malignancy among women.

The primary cause of cervical cancer is persistent HPV infection, leading to precancerous cervical lesions. Alarmingly, approximately 20 percent of individuals with HSIL may progress to invasive cervical cancer within a span of 10 years.2 According to Frost & Sullivan, the number of HSIL patients is projected to reach 16.6 million globally and 2.2 million in China by 2030.

Read Asieris’ full media release here: View Source

On September 20, 2023 Galvanize Therapeutics, Inc. reported the treatment of the first patient in the AFFINITY clinical study (Press release, Galvanize Therapeutics, SEP 20, 2023, View Source [SID1234635294]). This prospective trial is intended to demonstrate the safety and technical success of the Aliya Pulsed Electric Field (PEF) System in patients with stage IV non-small cell lung cancer (NSCLC) or metastasis to the lung who are not surgical candidates. Dr. Michael Pritchett, pulmonology specialist with Pinehurst Medical Clinic and Director of Chest Center of the Carolinas at FirstHealth in Pinehurst, North Carolina, used the Aliya Endobronchial Needle for the first time in the United States via robotic-assisted bronchoscopy to complete the procedure.

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The Aliya PEF System delivers high voltage, short duration electrical energy locally to alter the transmembrane potential of a cell, which results in loss of homeostasis, inducing non-thermal programmed cell death without denaturing cellular proteins and extracellular matrix. In addition to focal ablation, preclinical and prior clinical studies suggest this process may release antigens from the dying tumor cells that may stimulate an immune response for a potential systemic effect beyond focal ablation.

Dr. Pritchett commented: "Today’s procedure was a glimpse into the future. In a patient with two suspected oligometastatic lesions in the lung, we used the Intuitive Ion robotic platform to navigate to a 10mm lesion on the left and biopsy. Onsite pathologic evaluation confirmed malignancy, mostly likely secondary to metastatic renal cell carcinoma. We then maintained our position at the lesion and treated it with Aliya. After this we moved to a 5mm lesion on the right and completed treatment of this lesion as well, using Cone Beam CT to confirm accurate positioning within the small lesion. It’s exciting to be able to diagnose and treat in a single procedure, but we have the added prospect of creating a systemic response in a patient with metastatic disease which is a game changer. Best of all, the patient went home the same day with a recovery equivalent to a biopsy alone."

The AFFINITY study is a prospective, single-arm, non-randomized, multi-center, open-label, early feasibility study conducted at 3 centers in the U.S. The study will enroll up to 10 non-surgical patients with stage IV NSCLC or lung metastasis who are indicated for first line standard of care therapy. Aliya PEF may be delivered using either a bronchoscopic or percutaneous approach. The study will examine the safety of adding Aliya PEF treatment to the care pathway for these advanced disease patients and further assess the potential immune modulation and treatment effect.

"Our team spent years developing Aliya PEF to synergize with immunotherapy and other standard-of-care therapies in order to provide patients with solid tumors a biology-based therapy that extends beyond what is possible with focal thermal ablation," said Jonathan Waldstreicher, M.D., Founder and CEO of Galvanize Therapeutics. "The AFFINITY study represents a significant step towards treating a broad range of tumor types and in early and late-stage disease."

Galvanize’s INCITE-ES clinical study in NSCLC patients outside the U.S. demonstrated the safety and feasibility of Aliya to deliver PEF prior to surgery, as well as Aliya’s potential to stimulate an immune response.

The Aliya PEF System is 510(k) cleared in the United States for the surgical ablation of soft tissue. It is not currently commercially available in any other geography. The Aliya Endobronchial Needle, which enables delivery through a bronchoscope, is an investigational device in the U.S. Limited by Federal (or United States) law to investigational use only.

On September 20, 2023 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 that an abstract on ST101 has been accepted for a poster presentation at the upcoming AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), taking place October 11-15, 2023 in Boston, MA (Press release, Sapience Therapeutics, SEP 20, 2023, View Source [SID1234635293]).

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ST101 is a first-in-class antagonist of C/EBPβ that has demonstrated clinical proof-of-concept in advanced solid tumors. ST101 is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). The poster to be presented will summarize clinical data from ST101’s recurrent Glioblastoma (rGBM) Phase 2 expansion cohort of 30 patients.

Poster Presentation Details:

Title: "Clinical and Biological Activity of ST101, a Peptide Antagonist of C/EBPβ, in Recurrent Glioblastoma (rGBM) Patients. Results From the rGBM Cohort of a Multi-Cohort Phase 2 Study."
Poster Number: B038
Session Title: Poster Session B
Date/Time: Friday, October 13, 2023, 12:30 pm-4:00 pm
Session location: Level 2, Exhibit Hall D

More information can be found on the AACR (Free AACR Whitepaper)-NCI-EORTC website.

On September 20, 2023 Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for patients with mTOR pathway alterations, reported that four abstracts have been selected for presentation at the upcoming 2023 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), taking place October 11-15, 2023 in Boston, MA (Press release, Aadi Bioscience, SEP 20, 2023, View Source [SID1234635292]).

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The presentations include four posters: a Trials-in-Progress (TiP) update from the PRECISION1 trial in TSC1/2 alterations, two real-world clinical genomic analyses, and one preclinical study of nab-sirolimus combinations in breast cancer xenograft models.

Poster Presentation Details:

Title: "Evaluation of nab-sirolimus in combination with PI3K pathway inhibitors to overcome PI3K/mTOR resistance in PI3K-mutant breast cancer cell lines"
Poster Number: A117
Session Title: Poster Session A
Date/Time: Thursday, October 12, 2023, 12:30 pm-4:00 pm
Authors: Sean Wallace, PhD, Khine Nyein Myint, PhD, Shihe Hou, PhD, Maria Zalath, BA, Andrew Kwon, PhD, Brian McMorran, PhD, Igor Vivanco, PhD

Title: "Phase 2, Multicenter, Open-label Basket Trial of nab-Sirolimus for Malignant Solid Tumors Harboring Pathogenic Inactivating Alterations in TSC1 and TSC2 (PRECISION1)"
Poster Number: LB_B12
Session Title: Poster Session B
Date/Time: Friday, October 13, 2023, 12:30 pm-4:00 pm
Authors: Candace Haddox, MD; Gopa Iyer, MD; Michael J. Demeure, MD; Li Ding, MS, MA; Anita N. Schmid, PhD; Willis H. Navarro, MD; David J. Kwiatkowski, MD, PhD; Jordi Rodon Ahnert, MD, PhD

Title: "Real-world (RW) characterization and frequency of TSC1 and/or TSC2 alterations collected from tumor tissue and liquid biopsies from the Tempus genomic database in patients with advanced cancer"
Poster Number: B003
Session Title: Poster Session B
Date/Time: Friday, October 13, 2023, 12:30 pm-4:00 pm
Authors: David J. Kwiatkowski, MD, PhD, Norma A. Palma, PhD, Willis H. Navarro, MD, Gopa Iyer, MD

Title: "Inactivating TSC1 and TSC2 alterations, co-mutations, and genomic instability in advanced cancers: Analysis of a real-world (RW) patient (pt) population using the Foundation Medicine genomic database"
Poster Number: C019
Session Title: Poster Session C
Date/Time: Saturday, October 14, 2023, 12:30 pm-4:00 pm
Authors: David J. Kwiatkowski, MD, PhD, Norma A. Palma, PhD, Willis H. Navarro, MD, Gopa Iyer, MD

More information can be found on the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) meeting website.

On September 20, 2023 Kyverna Therapeutics ("Kyverna"), a clinical-stage cell therapy company with the mission of engineering a new class of therapies for serious autoimmune diseases, reported a non-exclusive, multi-year license and supply agreement with Oxford Biomedica plc (LSE:OXB) ("Oxford Biomedica"), a quality and innovation-led viral vector Contract and Development Manufacturing Organization (CDMO), enabling the use of LentiVector with any Kyverna product (Press release, Oxford BioMedica, SEP 20, 2023, View Source [SID1234635291]).

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The LentiVector platform is the first commercially approved lentiviral-based gene delivery system. The platform enables the successful development of breakthrough gene and cell-based medicines.

Kyverna’s anti-CD19 chimeric antigen receptor (CAR) T-cell therapies, KYV-101 and KYV-201, specifically target CD19, a protein expressed on the surface of B cells which are involved in various types of autoimmune diseases, including lupus nephritis. These novel therapies have the potential to offer new hope to patients who have exhausted current treatment options. Kyverna’s KYV-101 CAR T-cell product is currently being tested in a Phase 1 clinical trial in lupus nephritis in the U.S. and a Phase 1/2 trial in Germany.

"We are committed to quality and innovation. As a world-leading CDMO with expertise across all key viral vector types, we are committed to enabling our biopharma customers to discover and deliver transformative therapies", said Dr. Sebastien Ribault, chief commercial officer of Oxford Biomedica. "We are excited to work with Kyverna as an innovative leader in cell therapy for autoimmune diseases and look forward to a fruitful partnership."

"We are delighted to be working with Oxford Biomedica, a recognized leader in reliable, quality vector supply. We value Oxford Biomedica’s extensive capabilities and technologies to enable efficient and cost-effective manufacturing, which is critical in the vast market of B cell-driven autoimmune diseases that our therapies address," commented Karen Walker, chief technology officer at Kyverna.