On September 3, 2024 Acepodia (6976:TT), a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) and allogeneic gamma delta 2 (γδ2) T cell platforms, reported that it has entered a strategic clinical collaboration with Pfizer Ignite to support the development of its therapies in autoimmune diseases (Press release, Acepodia, SEP 3, 2024, View Source [SID1234646320]). Pfizer Ignite is an end-to-end offering that leverages Pfizer’s significant resources, scale, and expertise, alongside a proven track record in the development of breakthroughs, to support biotechs seeking to accelerate their innovations from preclinical R&D through the development lifecycle. Under this new agreement, Pfizer Ignite will provide strategic guidance and resources to Acepodia as the company develops its cell therapies for oncology and autoimmune diseases.

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Acepodia’s ACC platform, which uses bioorthogonal chemistry and is based on the pioneering work of 2022 Nobel laureate Dr. Carolyn Bertozzi, who applied click chemistry to living systems, creates an off-the-shelf, non-genetically engineered version of CAR-T cell therapy that is more easily scaled and avoids cytokine release storms, neurotoxicity, and other side effects associated with CAR-T cell therapies. Acepodia’s lead clinical candidate, ACE1831, is currently being evaluated in a Phase 1 first-in-human clinical trial for patients with non-Hodgkin’s lymphoma and has demonstrated a robust and durable effect after a single treatment at the lowest dose.

"The significant unmet needs that exist in autoimmune diseases combined with the early positive results that have been seen with CAR-T therapies have opened the door for potential innovations that could provide the efficacy of CAR-T therapy without the challenges that have made routine use of CAR-T in autoimmune diseases difficult," said Sonny Hsiao, Ph.D., chief executive officer of Acepodia. "We see a significant opportunity to bring the benefits of our ACC platform to autoimmune diseases, and working with Pfizer Ignite will position us well to deliver our immunotherapies to patients in desperate need of new options."

By collaborating with Pfizer Ignite, Acepodia will benefit from Pfizer’s resources, deep expertise and R&D capabilities, covering multiple stages such as clinical trial design and regulatory strategies to improve the process of developing innovative drugs.

"Pfizer Ignite is focused on supporting the delivery of innovative therapies that are strategically aligned with Pfizer’s priority areas and have the potential to address significant gaps in patient care, " said Kathy Fernando, SVP, Head of Pfizer Ignite. "Drawing on Pfizer’s deep expertise in oncology and immunology, we look forward to collaborating with Acepodia to help translate their compelling scientific platform into impactful new medicines for patients with unmet need."

On September 4, 2024 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported that the Company’s IPAX-1 Phase I study has been published in Neuro-Oncology Advances, confirming the safety and tolerability profile, and early efficacy of TLX101 therapy, in combination with external beam radiation therapy (EBRT) in recurrent glioblastoma (GBM), the most common and aggressive form of primary brain cancer (Press release, Telix Pharmaceuticals, SEP 3, 2024, View Source [SID1234646319]).

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TLX101 (4-L-[ 131I] iodo-phenylalanine, or 131I-IPA) is a systemically administered targeted radiation therapy that targets L-type amino acid transporter 1 (LAT1), which is typically over-expressed in GBM.

In the first peer-reviewed publication of the IPAX-1 study, Professor Josef Pichler and colleagues report that single or fractionated doses of TLX101 plus EBRT were associated with acceptable tolerability and specific tumour-targeting in patients with recurrent GBM. Authors explain that the study delivered encouraging preliminary efficacy data, demonstrating a median overall survival (OS) of 13 months from the initiation of treatment, or 23 months from initial diagnosis. Given that GBM has a median survival from initial diagnosis of 12-15 months, authors conclude that findings from the IPAX-1 study "support further investigation into the use of TLX101 plus EBRT, including its potential as a first line treatment".

Key findings of the IPAX-1 study, outlined in the paper, include:

All dosing regimens were well tolerated.
Organ-absorbed radiation doses in the red bone marrow (0.38 Gy) and kidney (1.28 Gy) confirmed no radiation-based toxicity.
Stable disease with MRI[1] assessment was observed in 4 of 9 patients at 3 months post-treatment (3-month follow-up, 1 patient did not reach protocol-mandated end of study), yielding a response rate of 44.4%.
At the 3-month follow-up, 6 patients demonstrated metabolic stable disease with 18F-FET PET imaging.
Median progression-free survival was 4.3 months (95% confidence interval, 3.3–4.5), while median OS was 13 months from the initiation of treatment (95% confidence interval, 7.1–27), or 23 months from initial diagnosis.
Metabolic tumour responses were determined using Telix’s investigational PET[2] agent for glioma imaging, TLX101-CDx (Pixclara[3], 18F-floretyrosine or 18F-FET).

Professor Josef Pichler, Kepler University Hospital, Austria, Principal Investigator in the IPAX-1, IPAX-2 and IPAX-Linz studies, and lead author, commented, "A significant unmet need exists for well-tolerated and efficacious treatments for patients with glioblastoma. The results from this Phase I study demonstrate the favourable safety and tolerability profile and preliminary efficacy of TLX101 in combination with second-line EBRT, in patients with recurrent glioblastoma. Following treatment with TLX101 plus EBRT, stable disease was observed in 44% of patients at 3 months post-treatment and median progression-free survival was 4.3 months, with no confirmed radiation toxicity. The overall survival improvement trend seen in this patient population clearly warrants further investigation into the use of TLX101 plus EBRT, including its potential as a first-line treatment. These studies are now well advanced."

Dr David N Cade, Chief Medical Officer at Telix said, "We believe that TLX101 has significant potential to improve outcomes for patients living with glioblastoma – a disease in urgent need of new treatment options. In the front-line setting, the standard of care has not advanced materially in almost two decades, and in recurrent disease, no standard treatment exists. We are encouraged by these data, which show that TLX101, in combination with EBRT, is well tolerated at the doses tested, with preliminary clinical evidence demonstrating an anti-tumour effect and disease stabilisation – outcomes that are very important for this advanced patient population. Telix is pleased to be at the forefront of developing a new therapy for glioblastoma, and we welcome the excellent work conducted by Professor Pichler and his colleagues to progress this."

The IPAX-2 and IPAX-Linz studies in the front-line and recurrent settings continue to progress well in combination with standard of care, and using Telix’s Pixclara3 investigational PET agent as companion diagnostic. Data from IPAX-1, together with these studies, will inform the design of Telix’s future registration-enabling trial for TLX101.

The Neuro-Oncology Advances publication is available online at: View Source

About TLX101

TLX101 is Telix’s LAT1-targeting investigational therapy for patients with brain cancer. TLX101 therapy utilises a small molecule approach due to the need to cross the blood brain barrier, the normal protective barrier that prevents many potential drug candidates entering the brain. TLX101 has received orphan drug designation in the U.S. and Europe for the treatment of glioma.

About the IPAX series of studies

IPAX-1 was a multicenter, open-label, single-arm Phase I study to evaluate TLX101 plus EBRT in patients with recurrent GBM. The primary objective of the IPAX-1 study was to evaluate the safety and tolerability profile of intravenous TLX101 administered concurrently with second line EBRT. Secondary objectives were to determine optimal dosing, biodistribution and radiation absorption into the tumour, as well as assess preliminary efficacy through clinical and imaging-based assessment of tumour response. ClinicalTrials.gov ID: NCT03849105.
IPAX-2 is a Phase I study of TLX101 in combination with post-surgical standard of care treatment in patients with newly diagnosed GBM. Active, dosing patients. ClinicalTrials.gov ID: NCT05450744.
IPAX-Linz is a Phase II investigator-initiated trial of TLX101 in combination with EBRT in patients with recurrent high-grade gliomas (HGG), including GBM. Active, dosing patients.

On September 3, 2024 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its PD-1/IL-2α Bispecific Antibody Fusion Protein (R&D code: IBI363) for the treatment of unresectable locally advanced or metastatic melanoma (except choroidal melanoma) in patients who have progressed after at least one line of systemic therapy, which must include a PD-1/L1 inhibitor (Press release, Innovent Biologics, SEP 3, 2024, View Source [SID1234646318]). Phase 1/2 clinical trials are currently underway in China, the U.S., and Australia to assess IBI363’s efficacy and safety in various advanced malignant tumors.

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At the ESMO (Free ESMO Whitepaper) Plenary meeting on June 14, 2024, Innovent presented promising efficacy signals in melanoma patients who had previously undergone immunotherapy: 37 patients with melanoma who had previously received immunotherapy received 1mg/kg of IBI363 and underwent at least one tumor evaluation after baseline, and 11 patients achieved objective responses, including 1 CR and 10 PR, with ORR and DCR of 29.7% and 73.0%, respectively. (Link)

Dr. Hui Zhou, Senior Vice President of Innovent, said, "Melanoma is the most common fatal skin cancer in Europe and the United States. In China, while melanoma is a rare malignant tumor, it has a high fatality rate, and its incidence is steadily increasing each year. Despite the success of immune checkpoint inhibitors in the treatment of melanoma, there is currently no drug approved for immunotherapy failed melanoma around the world, and the ORR of traditional chemotherapy ± anti-vascular therapy for immunotherapy failed melanoma is only 3.8% to 6.8%, with a median PFS of less than 3 months, and the benefit is very limited[1]-[2]. Therefore, there is an urgent clinical need for patients who have previously failed immunotherapy. As a First in-class PD-1/IL-2α-bias bispecific antibody fusion protein, IBI363 monotherapy has shown encouraging efficacy and a favorable safety profile in melanoma subjects who have previously received immunotherapy. We will continue to explore the efficacy and safety of IBI363 in melanoma to provide more effective clinical treatment for patients with immune-resistant melanoma."

Fast Track Designation (FTD) is a rapid review process designed to facilitate the clinical development of a drug that may treat serious conditions and fulfill an unmet medical need. According to regulations, drug candidates that obtain FTD qualifications will have more opportunities to communicate with the FDA during subsequent drug development and review processes, which will help speed up the clinical development and approval of the drug.

About Melanoma

Melanoma is a malignant tumor that develops from melanocytes and is the fifth most common cause of cancer in the United States[3]. Although melanoma represents only 3% of all skin cancer cases, it has the highest mortality rate and is the most prone to metastasize. In China, both the incidence and mortality rates of melanoma have been steadily rising over the years. According to the classification of the disease site, melanoma is mainly divided into skin melanoma, acral and mucosal melanoma. Chinese melanoma differs greatly from European and American Caucasian melanoma in pathogenesis, biological behavior, histological morphology, treatment and prognosis[4]. For advanced cutaneous and acral melanomas, for those carrying BRAF V600 mutation, BRAF inhibitor combined with MEK inhibitor is the preferred molecular targeted therapy. For patients without a BRAF V600 mutation, comination of chemotherapy and anti-angiogenic drugs may be considered as the first-line treatment. Immunotherapy has not been approved as the first-line treatment indication for advanced melanoma in China. For second-line treatment, therapies not used in the first-line are recommended. If a PD-1 monoclonal antibody was not administered initially, it can be selected for the second-line. In advanced mucosal melanoma, chemotherapy or a combination of PD-1 monoclonal antibody and anti-angiogenic drugs may be considered as first-line options. For patients with BRAF V600 mutation, a BRAF inhibitor ±MEK inhibitor can be chosen. Currently, posterior treatment options for melanoma are very limited[5].

About IBI363 (PD-1/IL-2α)

IBI363 is a first-in-class drug candidate independently developed by Innovent Biologics. Its active ingredient is PD-1/IL-2 bispecific antibody fusion protein. The IL-2 arm of IBI363 has been engineered to maximize efficacy and reduce toxicity, whereas the PD-1 binding arm achieves PD-1 blockade and selective IL-2 delivery. Therefore, IBI363 functions by simultaneously blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway, enabling more precise and efficient targeting and activation of tumor specific T cells. IBI363 has demonstrated notable anti-tumor activity across various tumor-bearing pharmacological models and showed significant antitumor efficacy in both PD-1 resistant and metastatic models. Additionally, IBI363 exhibited a favorable safety profile in preclinical models. Clinical studies of IBI363 are currently underway in China, the United States, and Australia to evaluate its safety, tolerability and preliminary efficacy in subjects with advanced malignancies.

On September 3, 2024 Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, reported that Joel Lewis, Chief Executive Officer and Khurram Jamil, M.D., Chief Medical Officer, will be attending the H.C. Wainwright 26th Annual Global Investment Conference being held September 9-11, 2024 in New York, NY (Press release, Galectin Therapeutics, SEP 3, 2024, View Source [SID1234646317]).

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Dr. Jamil will be providing a company presentation on September 9, 2024 at 12:00 PM ET. The webcast of the presentation can be accessed here or through the Company’s website on the Events & Presentation page of the investors section.

Additionally, Galectin management team will be available for one-on-one meetings during the conferences. Interested investors should contact their representative at H.C. Wainwright.

On September 3, 2024 Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, reported that Paul Peter Tak, MD, PhD, FMedSci, Candel’s President and Chief Executive Officer, will present at the 26th Annual Global Investment Conference being held in-person and virtually on September 9-11, 2024 (Press release, Candel Therapeutics, SEP 3, 2024, View Source [SID1234646316]).

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Time: Available from 7:00 a.m. ET onwards
Date: Monday, September 9, 2024
Webcast Link: View Source

A webcast of the H.C. Wainwright presentation will be available by selecting Events and Presentations under the News & Events tab in the Investors section on candeltx.com. A replay of the webcast will be archived for up to 90 days following the session date.