On July 1, 2024 Anbogen Therapeutics, Inc., a clinical-stage company dedicated to developing breakthrough cancer therapies, reported the successful closing of a USD 7.3M oversubscribed A+ round financing, which is a direct continuation of the USD 12.5 Million Series A on 1st February, 2024, bringing the total raised to USD 19.8M (Press release, Anbogen Therapeutics, JUL 1, 2024, View Source [SID1234644643]). The funds from the A+ round will be specifically used to advance the Phase II clinical trial of ABT-301. The financing round was led by KGI Venture Capital and both new and existing investors.

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The capital raised in the A+ round will primarily be used to support the Phase II clinical trial of ABT-301 in combination with PD-1 inhibitors for treating microsatellite stable (MSS) metastatic colorectal cancer, which accounts for 95% of the metastatic colorectal cancer population that does not benefit from immune checkpoint inhibitors. Previous preclinical studies have repeatedly showed that ABT-301, when combined with immune checkpoint inhibitors, exhibits remarkable synergistic therapeutic effects in various solid tumor models, including subcutaneous xenograft and orthotopic models of colorectal cancer, liver cancer, triple-negative breast cancer, and head and neck cancer.

Given these promising results, Anbogen decided to proceed with the A+ round of financing to secure the necessary funds for ABT-301’s clinical trial, without impacting the ongoing Phase II development of ABT-101.

Leveraging ABT-301’s compelling immunomodulatory and synergistic effect combined with PD-1 treatment that Anbogen has observed, we have successfully engaged pharmaceutical companies who will agree to enter PD-1 drug-supply agreement with Anbogen. This collaboration will enable Anbogen to optimize its resource allocation and underscores the strong recognition of both ABT-301 and Anbogen.

"We are deeply grateful to our investors for their continued support and confidence in our mission," says Dr. Tsu-An Hsu, CEO of Anbogen Therapeutics. "This funding is crucial for the advancement of ABT-301 combo with immune checkpoint inhibitors treating solid tumors, and it validates our ongoing efforts to bring effective cancer treatments to patients in need."

On July 1, 2024 Innovent Biologics, Inc. ("Innovent"), 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 oral presentation of the latest Phase 1 clinical data of an innovative anti-CLDN18.2 ADC (IBI343) for the treatment of advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJ AC) at the ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers (ESMO GI) Congress 2024 (NCT05458219) (Press release, Innovent Biologics, JUL 1, 2024, View Source [SID1234644642]). The data demonstrates promising efficacy and a favorable safety profile for IBI343 in patients with advanced gastric cancer whose tumors express CLDN18.2.

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Gastric cancer is one of the most common malignant tumors in the world. According to the GLOBOCAN 2022 statistics[1], gastric cancer ranks as the 5th most common malignant tumor and the 5th leading cause of cancer death around the world. It accounts for an estimated 970,000 cases and 660,000 deaths worldwide. Each year, China reports 359,000 new cases and 260,000 deaths from gastric cancer, representing 37.0% and 39.4% of the global totals, respectively, highlighting a significant unmet medical need.

The data presented at this conference is from a Phase 1 study conducted in China and Australia with IBI343 and are as follows:

In participants with high expression of CLDN18.2 (≥75% tumor cells with membranous staining intensity ≥2+ by IHC) at the 6 mg/Kg dose (N=30), the ORR and DCR were 36.7% and 93.3%, respectively. At the 8 mg/kg dose (N=17), the ORR was 47.1% and the DCR was 88.2%.
With a median follow-up time of 7.2 months in the 6 mg/kg dose group, the median progression-free survival (mPFS) of participants with high CLDN18.2 expression was up to 6.8 months.
The majority of treatment emergent adverse events (TEAEs) were grade 1-2. In the 6 mg/kg dose group, 31.6% patients had ≥ Grade 3 treatment-related adverse events (TRAEs). ≥ Grade 3 gastrointestinal toxicities were extremely low (<5%). No interstitial lung disease (ILD) occurred.
Dr Jia (Jenny) Liu, translational lead of early phase clinical trials at The Kinghorn Cancer Centre, St Vincent’s Hospital Sydney, said: "As a next generation anti-CLDN18.2 antibody-drug conjugate that is Fc silenced, IBI343 has shown encouraging tolerability and clinical benefit in patients with advanced gastric and gastroesophageal junction adenocarcinomas that had moderate to high expression of CLDN18.2. Furthermore, the gastrointestinal toxicity of the drug we observed in the Phase 1 trial appears lower than that of other drugs targeting CLDN18.2, and there were no cases of interstitial lung disease. We look forward to seeing the results of ongoing Phase 3 trials comparing the efficacy and tolerability of IBI343 with standard-of-care treatments."

Dr. Hui Zhou, Senior Vice President of Innovent Biologics, said, "With a unique ADC platform designed to deliver effective and more tolerable therapeutics, the data in gastric cancer is a testimony to the molecular design of IBI343. We will further explore IBI343 in combination with other treatments, including immunotherapies, across different tumor types in order to benefit cancer patients worldwide. As a pioneer company in the field of oncology, Innovent is committed to advancing and promoting global innovation to develop and commercialize high quality biopharmaceuticals that are affordable to ordinary people."

Apart from gastric cancer, Innovent is also exploring IBI343’s therapeutic potential in solid tumors such as pancreatic cancer. Earlier this month, the data from the Phase 1 clinical study of IBI343 in the treatment of patients with pancreatic cancer were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Annual Meeting, demonstrating encouraging efficacy and a favorable safety profile. [details link]

About Gastric/ Gastroesophageal Junction Adenocarcinoma

Gastric cancer is one of the most prevalent malignant tumors worldwide and a leading cause of cancer-related deaths globally. The 5-year survival rate of patients with metastatic gastric cancer is less than 5%[2]. China and Japan have the highest incidence rates of gastric cancer[3]. Currently, the standard-of-care treatments for patients with advanced metastatic gastric cancer include a chemotherapy combination of fluoropyrimidine and platinum, as well as immune checkpoint inhibitor therapy. However, systemic therapy has limited efficacy in advanced gastric cancer. In particular, the prognosis for patients with third-line or higher gastric cancer is usually poor, with fewer treatment options and shorter survival expectations. The median survival times for these patients is only about 0.5 year[4].

Claudin, a member of the tight junction molecule family, is a key structural and functional component of epithelial tight junctions. Among them, CLDN18.2 is normally buried in the gastric mucosa, but the development of malignancy leads to disruption of tight junctions and exposure of CLDN18.2 epitopes on the membrane of tumor cells[5]. CLDN18.2 is expressed in up to 80% of patients with gastric cancer.

About IBI343（Anti CLDN18.2 ADC）

IBI343 is a recombinant human anti-CLDN18.2 monoclonal antibody-drug conjugate (ADC) developed by Innovent Biologics. IBI343 binds to the CLDN18.2-expressing tumor cells, the CLDN18.2 dependent ADC internalization will occur and the drug is released resulting in DNA damage and eventually apoptosis of the tumor cells. The freed drug can also diffuse across the plasma membrane to reach and kill the neighboring cells, resulting in "bystander killing effect".

As an innovative TOPO1i ADC, IBI343 has demonstrated tolerable safety and encouraging efficacy signals in this Phase 1 clinical studies. The therapeutic potential of IBI343 is currently being explored in tumor types such as gastric cancer and pancreatic cancer.

In May 2024, China’s National Medical Products Administration (NMPA) granted breakthrough therapy designation (BTD) to IBI343 for use as a single agent in patients with CLDN18.2–positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who experienced disease progression following two prior lines of systemic treatment. The multi-center Phase 3 trial of IBI343 for this indication is in preparation. In June 2024, IBI343 received Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) that has relapsed and/or is refractory to one prior line of therapy.

On July 01, 2024 Medincell reported the company will provide an overview of some of its R&D programs related to its cutting-edge Long-Acting Injectable technologies through several presentations and posters at the CRS 2024 conference, from July 8 to 12 in Bologna, Italy, including (Press release, MEDINCELL, JUL 1, 2024, View Source [SID1234644641]):

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Oncology field: Presentation of in vivo data showing the improved immunomodulatory potential of a tumor-targeting monoclonal antibody in melanoma using BEPO technology for peritumoral administration.

Introduction to BEPO STAR: Overview of the novel Medincell’s proprietary Long-Acting Injectable technology designed to enhance controlled delivery across a broader range of drugs and therapeutic areas.

Medincell proprietary in vitro release tool: Presentation of an innovative in vitro lab tool designed to accelerate formulation activities and preclinical candidates selection.

Adolfo Lopez-Noriega, Head of R&D at Medincell, said: "Innovation is our cornerstone, driving our advanced technologies and their groundbreaking applications. Our world-class R&D team is dedicated to continuously pushing the boundaries, enhancing our technology’s reach, and ensuring our position at the forefront of controlled and targeted drug delivery. Our advancements aim to deliver superior therapeutic options through systemic or local delivery in areas where we can make a significant impact, such as psychiatry, oncology, obesity, or pain management. Attending CRS allows us to share our recent achievements and underscores our commitment to forging strong partnerships with both academia and pharmaceutical companies."

Organized by the Controlled Release Society, the CRS Annual Meeting is a prominent conference in the field of controlled release science and technology. It covers a wide range of topics, including drug delivery systems, biomaterials, nanotechnology, polymers, and regulatory aspects of controlled release products. It’s a major event for all academics and pharmaceutical industry professionals involved in the development and application of controlled release technologies.

Event website: View Source

On July 01, 2024 Foundation Medicine, Inc. reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneLiquid CDx to be used as a companion diagnostic for AKEEGA (niraparib and abiraterone acetate) from Janssen Biotech, Inc, a Johnson & Johnson company, the first and only FDA-approved dual-action tablet combining PARP inhibition and hormone therapy for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC) (Press release, Foundation Medicine, JUL 1, 2024, View Source [SID1234644640]). This decision from the FDA follows the approval of FoundationOneCDx, Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) test, for the same therapy and indication in August 2023.

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Prostate cancer is one of the most common cancers in men.2 BRCA1- or BRCA2-mutated mCRPC is a particularly aggressive form of the disease,3 occurring in approximately 11% of diagnoses.4 Despite progress in developing new treatment options for this condition, BRCA1- or BRCA2-mutated mCRPC remains difficult to treat and patients often face a poor prognosis.5

While some BRCA1 and BRCA2 mutations are germline, somatic mutations are more common.4 While tumor tissue testing is the gold standard for identifying patients with BRCA1 or BRCA2 mutations in prostate cancer, not all patients with mCRPC have sufficient tumor tissue available for testing.6 With this approval, healthcare providers can now leverage a minimally invasive liquid biopsy to identify additional patients with BRCA mutations who may benefit from AKEEGA.

"We know how challenging it can be to obtain a tissue sample for testing in advanced cancers such as mCRPC, making liquid biopsy an incredibly important tool in a provider’s toolbox for the development of personalized treatment plans for their patients," said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. "The approval of our liquid biopsy test, along with the previous approval for our tissue biopsy test, will enable more patients to access this important therapy option. Additionally, with the ability to leverage a liquid-based test and reflex to a tissue-based test if needed, healthcare providers can feel confident they have accurate genomic information at their fingertips to guide treatment decisions for patients."

From a simple blood sample, FoundationOne Liquid CDx analyzes more than 300 cancer-related genes to provide genomic insights. The test has several companion diagnostic indications across non-small cell lung cancer (NSCLC), prostate cancer, breast cancer, and colorectal cancer, plus a pan tumor indication specific to NTRK1/2/3 fusions.

With today’s approval, Foundation Medicine is the only company that has five FDA-approved companion diagnostic indications for prostate cancer.7 Foundation Medicine is the global leader in companion diagnostic approvals. The company has 60% of all U.S. companion diagnostic approvals for next-generation sequencing (NGS) testing.8

"Men with aggressive prostate cancer need and deserve more options," said Courtney Bugler, President and CEO of ZERO Prostate Cancer. "We applaud Foundation Medicine’s liquid biopsy test because it empowers patients and families with more tools that can potentially help them lead longer, fuller lives."

Foundation Medicine and FoundationOne are registered trademarks of Foundation Medicine, Inc.

On July 01, 2024 KaliVir Immunotherapeutics, Inc., a biotech company developing cutting-edge, multi-mechanistic oncolytic viral immunotherapy programs, reported that the FDA has cleared the Investigational New Drug (IND) application for the STEALTH-001 study of VET3-TGI in patients with incurable, advanced solid tumors (Press release, KaliVir Immunotherapeutics, JUL 1, 2024, View Source [SID1234644639]).

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VET3-TGI is a novel oncolytic immunotherapy which in nonclinical studies specifically targets and preferentially kills tumor cells directly while stimulating anti-cancer immunity by expressing its therapeutic payload consisting of the transgenes for interleukin-12 and a TGFbeta inhibitor. The Phase 1/1b study (ClinicalTrials.gov ID NCT06444815) will evaluate the safety profile and efficacy of VET3-TGI when administered through intravenous infusion or intratumoral injection in patients with advanced, incurable solid tumors. The trial will assess VET3-TGI both as a monotherapy and in combination with checkpoint inhibitor therapy.

"The initiation of this Phase 1/1b clinical study marks a pivotal moment in our continued journey to redefine cancer treatment with oncolytic virus therapy and combat advanced, unresectable or metastatic solid tumors," said Helena Chaye, Ph.D., CEO of KaliVir Immunotherapeutics. "This marks our second initiation of a clinical trial from the VET platform, having announced in 2023 the progress with ASP1012 exclusively licensed to Astellas. We remain fully committed to pushing the boundaries on what is possible with cancer therapies and develop safer, more effective options that have the potential to transform the treatment landscape of oncology."