On July 01, 2024 Syncromune Inc., a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for solid tumor cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for SYNC-T SV-102 therapy, its lead candidate for the treatment of patients with metastatic castrate-resistant prostate cancer (mCRPC) (Press release, Syncromune, JUL 1, 2024, View Source [SID1234644626]). SV-102 is part of Syncromune Inc.’s innovative SYNC-T platform, an in situ personalized therapy that uniquely employs a combination multi-target approach to cancer treatment, aiming to improve outcomes and quality of life for patients.

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The Fast Track designation was granted based on the potential of SYNC-T SV-102 therapy to address the significant unmet need in treating patients with mCRPC. This advanced form of prostate cancer affects over 40,000 men in the U.S. alone and is associated with a very poor prognosis. The Fast Track process is designed to facilitate the development and expedite the review of therapies that treat serious conditions and fulfill an unmet medical need, with the goal of getting important new treatments to patients sooner. Fast Track designation provides Syncromune with several key benefits, including more frequent FDA interactions, eligibility for accelerated approval, and priority review.

"The Fast-Track designation for SYNC-T SV-102 therapy signifies another step forward in bringing our potentially groundbreaking therapy to patients who need it most," said Eamonn Hobbs, Chief Executive Officer and co-founder of Syncromune. "This accomplishment builds upon the foundation of positive Phase 1 clinical data and recent IND clearance."

Syncromune’s lead candidate, SYNC-T SV-102, is a platform therapy that combines an in situ vaccine via partial oncolysis of a tumor followed by intratumoral infusion of the SV-102 fixed-dose multi-target biologic drug into the lysed tumor. This combination is designed to provide both immune stimulation and block immune suppression to activate and proliferate T cells to elicit a systemic anti-tumor response. Interim data from a Phase 1 study of SV-102 in males with mCRPC demonstrated an overall response rate of 85% with a favorable safety profile and tolerability. The Fast-Track designation comes on the heels of clearance of the company’s investigational new drug (IND) application, with studies expected to begin in the US this year.

Charles Link, M.D., Executive Chairman of Syncromune added, "We believe that Fast-Track designation for SYNC-T SV-102 will significantly aid our development goals for this therapy for men with difficult to treat prostate cancer. We look forward to initiating trials at multiple US sites later this year to expand our efforts to develop the SYNC-T SV-102 Therapy."

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 TRACON Pharmaceuticals (NASDAQ: TCON) reported the objective response rate (ORR) by blinded independent central review (BICR) in the fully enrolled ENVASARC pivotal trial in the 82 evaluable patients is 5% (four responders), which is lower than the primary endpoint of the study of 11% ORR by BICR needed to support a biologics license application (BLA) (Press release, Tracon Pharmaceuticals, JUL 1, 2024, View Source [SID1234644627]). As a result, the Company is terminating further development of envafolimab and is focusing entirely on exploring strategic alternatives in the near term that may include, but are not limited to, a merger, reverse merger, acquisition, other business combination, sales of assets, licensing or other strategic transactions involving the Company.

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In pursuit of any potential strategic transaction, TRACON plans to leverage its turnkey in-house Product Development Platform (PDP) utilizing integrated Veeva systems that has been used to conduct more than 15 Phase 1, 2 or 3 oncology trials at more than 120 sites in the U.S. and Europe across more than ten tumor types over 12 years, at a fully burdened cost of less than $100,000 per patient. TRACON offers cost-savings, time savings and enhanced quality of clinical trials using its PDP.

There can be no assurance the exploration of strategic alternatives will result in any agreements or transactions, or, if completed, any agreements or transactions will be successful or on attractive terms. To the extent that it cannot complete a strategic transaction, there is no guarantee that the Company will continue as a going concern. TRACON does not expect to disclose developments with respect to this process until the evaluation of strategic alternatives has been completed or the Board of Directors has concluded disclosure is appropriate or legally required.

"We are proud of our execution of the largest trial ever done in the sarcoma subtypes of undifferentiated pleomorphic sarcoma and myxofibrosarcoma using TRACON’s Product Development Platform," said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. "While individual patients derived benefit from envafolimab, the response rate by blinded independent central review in the ENVASARC trial of envafolimab as a single agent does not support a BLA. We are therefore discontinuing all of our clinical development activities and intend to take action to immediately reduce cash burn to better position the company for this strategic alternative process. We plan to leverage the value of our PDP in pursuing strategic alternatives."

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. The primary endpoint is ORR by blinded independent central review of nine responses in cohort C of approximately 80 patients with duration of response a key secondary endpoint. The trial was fully enrolled and the primary endpoint was not met. As a result, TRACON discontinued further development of envafolimab.

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 Vivesto AB, an oncology-focused research and development company, reported that new positive preclinical efficacy data was obtained further supporting the continued development of the candidate drug Cantrixil for hematological cancer (Press release, Vivesto, JUL 1, 2024, View Source [SID1234644628]). The new in vitro data in hematological cancer cell lines show clear positive effects in combination with other anti-cancer drugs.

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"The results obtained provide essential information about the action of Cantrixil in combination with other anti-cancer drugs and gives good guidance in the continued preclinical evaluation and moving of the program towards clinical studies in hard-to-treat hematological cancer indications. An understanding of the effects of combinations is important since Cantrixil, as almost all other new cancer therapies, would be developed in the clinic and initially used when marketed in combination with other anti-cancer agents," said Erik Kinnman, CEO of Vivesto.

The new preclinical data further strengthens previous positive results with Cantrixil, which has shown strong cytotoxic effects at low doses in cell lines derived from patients with hematological cancers. Furthermore, the data provide guidance to upcoming in vivo experiments, as well as towards clinical development. Specifically, the data adds input to the dosing selection and regime in the planning of the next set of experiments, which will include in vivo hematological cancer models and patient sample testing.