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 June 30, 2024 SCG Cell Therapy Pte Ltd (SCG), a biotechnology company developing novel immunotherapies for infectious diseases and their associated cancers, reported that U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application to initiate Phase 1/2 clinical trial for SCG142, a novel next-generation human papillomavirus (HPV) E7-specific T-cell receptor-engineered T (TCR T) cell therapy for patients with HPV-associated solid tumors (Press release, SCG Cell Therapy, JUN 30, 2024, View Source;hpv-specific-tcr-t-cell-therapy-for-patients-with-hpv-associated-solid-tumors-302186559.html [SID1234644617]).

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"This FDA IND approval of another TCR T cell therapy candidate generated from our proprietary GianTCRTM platform is an important milestone for SCG. It marks the advancement of our TCR-based therapeutic program to treat unmet needs in different major cancer indications", said Christy Ma, Chief Executive Officer of SCG Cell Therapy. "We are ready to commence multi-center Phase 1/2 clinical trials, assessing the potential benefits for patients via our proprietary TCR T technology."

SCG142 is a high-avidity fully natural HPV-specific TCR armoured with a TGFβRII-41BB chimeric switch receptor. In May 2024, SCG presented preclinical data of SCG142 at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting. The data indicates SCG142 had exhibited high polyfunctional avidity. It recognized both HPV-16 and HPV-52 genotypes, with a favourable safety profile with no alloreactivity or off-target toxicity. In addition, SCG142 demonstrated dual CD8 and CD4 TCR T cell proliferation and tumor inhibition in both in vitro and in vivo models, indicating CD8 co-receptor independent T cell functionality, as well as promoting long-term persistence of memory T cells.

"SCG142 is a novel and differentiated HPV-specific TCR T cell therapy. By armoring the TCR T cells with the chimeric switch receptor, it overcomes the hostile tumor microenvironment and converts inhibitory effects into a co-stimulatory signal. This process is essential for effective immunotherapy treatment of solid tumors. With this unique next-generation design, SCG142 represents a groundbreaking innovation that translates from our in-house discovery platforms into clinics", said Dr. Ke Zhang, Chief Scientific Officer of SCG Cell Therapy.

On June 28, 2024 Genmab A/S (Nasdaq: GMAB) reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of conditional marketing authorization of epcoritamab (TEPKINLY), a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy (Press release, Genmab, JUN 28, 2024, View Source [SID1234644593]). The final European Commission decision on this indication for epcoritamab is anticipated later this year.

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"Many people living with follicular lymphoma that has either relapsed or is refractory to existing therapies experience significant treatment challenges with poor prognosis," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "This positive opinion recognizes the unmet need in the European Union for patients whose follicular lymphoma is considered difficult-to-treat and that epcoritamab may represent a new therapeutic option."

The CHMP opinion is supported by overall and complete response data from the Phase 1/2 EPCORE NHL-1 clinical trial in 128 patients with R/R FL treated with epcoritamab after two or more lines of systemic therapy. The study included patients who were refractory to both anti-CD20 monoclonal antibody therapy and an alkylating agent, patients who were refractory to last prior treatment, and patients whose disease progressed within two years of first systemic therapy. In the trial, the most common (≥10%) adverse reactions were CRS, injection site reactions, pyrexia, neutropenia, anemia, thrombocytopenia, diarrhea, nausea, headache, upper respiratory tract infection, pneumonia, and rash.

An additional cohort of 86 patients evaluated an optimized step-up dosing (SUD) schedule to reduce the incidence and severity of cytokine release syndrome (CRS), which is an associated side effect from immune-engaging cancer treatments. Hospitalization was not mandatory in the optimization cohort. The incidence of CRS was 49% (42 of 86 patients; 9% were grade 2) and there were no grade 3 or higher CRS events in the optimization cohort. The EPCORE NHL-1 results, including results from the optimization cohort, were recently published in the Lancet Haematology. Additionally, data from the optimization cohort were presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, selected to be a part of Best of ASCO (Free ASCO Whitepaper) (July 19-20, Boston, MA), and were presented at the 2024 European Hematology Association (EHA) (Free EHA Whitepaper) Congress.

"Each year, thousands of people in Europe are diagnosed with follicular lymphoma and it’s an upsetting reality that many of them will experience relapse and refractory disease," said Catherine Thieblemont, M.D., Ph.D., head of the hemato-oncology department, Paris University, Hôpital Saint-Louis Assistance-Publique-Hopitaux de Paris (APHP) in Paris. "Patients deserve new treatment options, and this positive opinion is the first step to bringing epcoritamab to more patients who need it."

About the EPCORE NHL-1 Trial
EPCORE NHL-1 is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab that consists of three parts: a dose escalation part; an expansion part; and an optimization part. The trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma (B-NHL), including FL. In the expansion part, additional patients were enrolled to further explore the safety and efficacy of epcoritamab in three cohorts of patients with different types of relapsed/refractory B-NHLs who have limited therapeutic options. The expansion part generated pivotal data from patients with FL and DLBCL. The optimization part evaluated additional CRS mitigation strategies during cycle 1. The primary endpoint of the expansion part was overall response rate (ORR) as assessed by an Independent Review Committee (IRC). Secondary efficacy endpoints included duration of response, complete response rate, duration of complete response, progression-free survival, and time to response as determined by the Lugano criteria. Overall survival, time to next therapy, and rate of minimal residual disease negativity were also evaluated as secondary efficacy endpoints. The primary endpoint of the optimization part was the rate of ≥ Grade 2 CRS events and all grade CRS events from first dose of epcoritamab through 7 days following administration of the second full dose of epcoritamab.

About Follicular Lymphoma (FL)
FL is typically an indolent (or slow-growing) form of non-Hodgkin’s lymphoma (NHL) that arises from B-lymphocytes.i Although FL is an indolent lymphoma, it is considered incurable with conventional therapy and patients who achieve remission also often experience relapse.iii,iv,ii Generally, with each relapse, the remission and time to next treatment is shorter.iii,iv

About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.v

Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the EU) has received regulatory approval in certain lymphoma indications in several territories. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational R/R FL indication and additional approvals for the R/R DLBCL indication.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes four ongoing Phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult participants with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) in patients with R/R FL (NCT05409066), and a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit www.clinicaltrials.gov for more information.