On July 1, 2024 Monta Biosciences reported the successful completion of the current dose level study involving our immunotherapeutic drug, MBS8, at clinical sites in Denmark, Belgium, and Spain (Press release, MonTa Biosciences, JUL 1, 2024, View Source [SID1234644686]). Our findings demonstrate good safety and strength of MBS8, as evidenced by an increased Therapeutic Index compared to benchmark compounds. The unique formulation of our small molecule drug within lipid nanoparticles allows targeting immune cells involved in anti-tumor activity. Importantly, this formulation minimizes effects on non-target cell types, reducing toxicity of MBS8 in patients. In preclinical models, MBS8 has exhibited superior antitumor activity compared to benchmark compounds, resulting in an impressive twentyfold expansion of the therapeutic window. Monta Biosciences’ CEO, Simon Jensen, emphasizes the significance of this dramatic increase in therapeutic index and expresses optimism about its potential impact in patients at the next dose level.

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On July 1, 2024 Kanvas Biosciences, a full-stack spatial biology company, reported it has raised $12.5 million in additional funding co-led by existing investors DCVC and Lions Capital LLC, and participation from FemHealth Ventures, Germin8, Ki Tua Fund, and Pangaea Ventures as well as existing investors. Paul Theunissen, Managing Partner at Lions Capital Partners LLC, will join the company’s Board, and Ashlie L Burkart, MD, Chief Scientific Officer of Germin8 Ventures, will join as a board observer (Press release, Kanvas Bioscience, JUL 1, 2024, View Source [SID1234644644]). The fresh capital closely follows a June 2023 round and brings Kanvas’s total funding to $29.5 million. The funding will be used to further develop the company’s spatial biology platform and advance two novel therapeutics in its Immuno-oncology Program, KAN-001 and KAN-003 — KAN-001 to an Investigational New Drug (IND) filing in 2025.

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The Kanvas platform is unique in its ability to spatially map gene expression and cellular function across all kingdoms of life. Its unprecedented capability to illuminate host-microbiome interactions marks a significant advancement in understanding diseases related to the microbiomes, finally unlocking the promise of microbiome-based therapies. The platform provides not only a path to breakthroughs in drug development, but also clinical diagnostics, agriculture and food safety.

Kanvas Bioscience’s spatial biology platform provides the unique ability to map host-microbiome interactions and leverage the resulting data to design live biotherapeutic products (LBPs), which can be used to create novel microbiome-based therapies that optimize the microbiome – a critical factor in human health. KAN-001, the company’s lead drug candidate, is an LBP demonstrating significant potential to improve outcomes for cancer patients who have been resistant to immune checkpoint inhibitors (ICIs). Designed with the goal of increasing the percentage of patients who respond to ICIs across all ICI-approved cancer types, KAN-003 will be a defined consortium for cancer patients, administered just before starting ICI treatment. Kanvas is collaborating with The University of Texas MD Anderson Cancer Center and its Platform for Innovative Microbiome and Translational Research (PRIME-TR) to conduct additional preclinical studies for KAN-001 to optimize the drug’s formulation and prepare it for an IND filing in 2025, preparatory to recruiting the first patients for a clinical trial the same year.

"We have a remarkable opportunity to help patients by offering them an effective, novel therapeutic approach to some of the most common and debilitating conditions, starting with improving the efficacy of immunotherapy in the treatment of solid organ cancer. I’m so proud of the extraordinary progress the Kanvas team has already achieved," said Matthew Cheng, co-founder and CEO of Kanvas Biosciences. "Because of this progress and with additional capital, Kanvas is positioned to accelerate its growth and build on its early success in illuminating host-microbiome interactions by launching a clinical pipeline of precision microbiome therapeutics."

With a market expected to grow at a 21% CAGR to over $3 billion by 2031, LBPs are living microbes and can improve treatment outcomes for microbiome-addressable conditions, including solid organ cancer, inflammatory bowel disease and metabolic disorders. By acting in a synergistic and complementary manner to existing therapies, LBPs provide a safe method for targeting underlying disease processes, but through different pathways and with greater efficacy. Historical approaches to LBP development have generally focused on single strains of bacteria – which don’t have an appropriate ecosystem to add therapeutic value – or fecal microbiota transplants (FMTs), which are complex and consist of many bacterial strains, but are difficult to scale commercially, highly variable and cannot be optimized. Kanvas has demonstrated the ability to develop and manufacture complex microbial consortia of 148 bacterial strains, providing the benefits of a complex community with multiple mechanisms of action, which make LBPs more effective.

"Not only does Kanvas’s spatial biology platform offer much-needed discovery capabilities, it also now enables the manufacturing of complex LBPs as a therapeutic modality. KAN-001 and KAN-003 have the potential to be breakthrough, complementary therapeutics for ICI-refractory and ICI-naive cancers," said Jason Pontin, General Partner at DCVC and chair of Kanvas’s board. "By providing the missing link between microbiome drug design rationale and therapeutic outcomes, Kanvas has the unique and exciting ability to provide a better mechanistic understanding of microbiome-addressable conditions, and ultimately improve clinical success for the next generation of LBPs."

"I’m thrilled to support Kanvas’s mission as a board observer," remarked Dr. Burkart, Germin8’s Chief Scientific Officer and a board-certified pathologist specializing in gastrointestinal pathology. "Their exceptional team and groundbreaking technology will revolutionize our understanding of host-microbiome interactions, driving transformative discoveries in human health and beyond. This tool isn’t just relevant for human health; it holds promise for sectors like animal health and agriculture. Understanding microbes in these areas is vital for global health and sustainability."

The past 12 months have been a period of momentous growth for Kanvas. This fall, the company opened a new research laboratory and drug manufacturing facility in South San Francisco. Kanvas also recently expanded its leadership team: Lee Swem, formerly Federation Bio’s Chief Science Officer, joined Kanvas as Chief Development Officer, Steve Kujawa, who previously led business development at 10x Genomics, joined as Vice President of Business Development, and Kevin Cutler joined the company as Lead Scientist with expertise in AI. Swem is driving the execution of Kanvas’s LBP portfolio, with a focus on KAN-001, and Kujawa is leading partnerships for the company’s spatial biology platform and licensing of non-core LBP assets. Cutler is spearheading the curation of a state-of-the-art training database for machine learning segmentation of microbes, development of deep learning models for spectral identification of microbes, and integration of advanced AI into the company’s analytical platform.

For more information on Kanvas Biosciences or to inquire about pharmaceutical discovery partnership opportunities, visit View Source

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