On June 13, 2023 HighField Biopharmaceuticals (HighField Bio), a clinical stage immuno-oncology company using immunoliposomes to treat cancer, reported that the U.S. Food and Drug Administration has granted clearance of the company’s Investigational New Drug (IND) application for HF158K1, a drug encapsulated immunoliposome containing doxorubicin (Press release, HighField Biopharmaceuticals, JUN 13, 2023, View Source [SID1234632682]).

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"It is recognition our immunoliposomes may offer effective alternatives to most current HER2 drugs that cannot target low HER2 tumors. HF158K1 is designed to bind and deliver the chemotherapeutic doxorubicin to tumor cells at even very low HER2 expression levels."

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The company will conduct a Phase 1 multi-regional, open-label, clinical trial in patients who have advanced refractory solid tumors with HER2 low and HER2+ expression. HER2 expressing solid tumors include breast, bladder, pancreatic, ovarian, stomach, colon, prostate, lung, uterus and cervix cancers.

The trial, expected to begin this summer, will be conducted in the U.S., China and other countries. A Phase 1a dose escalation portion of the study will enroll 24 patients followed by Phase 1b dose expansion trial with up to 60 patients. Both the Phase 1a and 1b studies will assess the safety and preliminary efficacy of HF158K1.

"The FDA’s clearance of this IND is another milestone for our company," said HighField Bio CEO Yuhong Xu. "It is recognition our immunoliposomes may offer effective alternatives to most current HER2 drugs that cannot target low HER2 tumors. HF158K1 is designed to bind and deliver the chemotherapeutic doxorubicin to tumor cells at even very low HER2 expression levels."

In addition, Dr. Xu said, "We believe our immunoliposomes represent a new generation of targeted chemotherapy drugs following the success of antibody drug conjugates (ADCs). Due to their unique features, our immunoliposomes may offer better safety with greater efficacy in treatment of a broad range of solid tumor types."

Unlike ADCs, HighField Bio’s immunoliposome can deliver larger doses of active drug and target tumor cells using multiple antibodies. This means they not only are suitable for less toxic API than ADCs, but may also deliver greater efficacy because they have larger drug to antibody ratios that result in wider therapeutic windows, targeting more cancer cells with less dose-limiting toxicities.

In the Phase 1a dose escalation portion of the clinical trial, patients will be enrolled into one of six dose groups to determine the highest tolerated dose. The Phase 1b study will assess HF158K1 in two types of solid tumors, and patients will be enrolled in one of two dose groups based on the Phase 1a findings. For more information visit NCT05861895 on clinicaltrials.gov.

On June 13, 2023 Feldan Therapeutics, a biopharmaceutical company that specializes in the development of treatments based on intracellular delivery of therapeutics, reported the initial closing of a $16.5 million Series B investment (Press release, Feldan Therapeutics, JUN 13, 2023, View Source [SID1234632681]). The funds will primarily be used to conduct clinical phases I/II for Feldan’s FLD-103, an intralesional treatment against basal cell carcinoma (BCC), and to advance its pulmonary program to the preclinical stage.

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New investors Investissement Québec, Amgen Ventures (United States), GC Cell (South Korea) and FSIT2 join the renewed support of GC Holdings (South Korea) and other existing shareholders to help Feldan bring breakthrough treatments to clinical development.

"Feldan is excited to welcome a new group of investors to our existing syndicate as we are reaching an important milestone in our development," said Francois-Thomas Michaud, Chief Executive Officer and co-founder of Feldan. "We are very proud that despite the challenges that arose from the COVID pandemic and the current economic environment, a Québec-based company has been able to create a promising clinical-stage therapeutic and is now positioned to accelerate its development towards clinical trials. This highlights the great talent and resilience of our team, in addition to further establishing the potential of our technology."

Since having engineered a revolutionary peptide-based intracellular delivery technology, Feldan is determinedly working towards the development of treatments for patients with unmet medical needs. Feldan’s proprietary technology has been proven highly effective at delivering different types of molecules to various organs, allowing them to reach untapped intracellular therapeutic targets. The company has made notable breakthroughs in the delivery of Antisense Oligonucleotides (ASOs) to skin basal cells and lung epithelial cells.

Feldan’s focus is on the completion of clinical phases I/II of intralesional FLD-103 to treat basal cell carcinomas (BCC). BCC, the most common skin cancer and most frequent form of all cancers, affects 3.6 million people in the US and Canada each year and results in the development of tumors mainly in sun-exposed skin areas such as the face, neck and scalp. Patients affected by BCC mostly rely on surgery for removal of tumors, an effective yet disfiguring and invasive procedure leaving patients to deal with scarring and long recovery time. With FLD-103, Feldan aims to improve patients’ quality of life by offering them a nonsurgical, effective and minimally invasive therapeutic option.

Feldan will also be working on advancing its pulmonary delivery program towards preclinical development and further leveraging its intracellular delivery technology to offer life-changing therapeutics to patients.

"The life sciences are a strategic industry for Québec’s economy, and Feldan is a promising company in this sector. Investissement Québec’s support illustrates the critical role we play in bolstering local biopharmaceutical companies and bridging gaps in the financing chain. We are proud to support Feldan as their first product enters clinical trials and they continue to develop their technology." Guy LeBlanc, President and CEO of Investissement Québec.

"We are delighted that Amgen is investing in this leading Quebec-based biotech company," stated Ugur Gunaydin, General Manager of Amgen Canada. "As one of the world’s leading biotechnology companies, Amgen is fundamentally value based and deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses. Feldan’s novel and unique drug delivery technology is an example of the important innovation coming from Quebec’s Life Sciences sector. We are very excited to see this technology’s potential expanding in the development of next generation therapies for patients everywhere with unmet medical needs.

On June 13, 2023 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of peptide therapeutics to address oncogenic and immune dysregulation that drive cancer, reported that the first patient has commenced treatment in its Phase 1-2 study evaluating the Company’s first-in-class antagonist of β-catenin, ST316 (Press release, Sapience Therapeutics, JUN 13, 2023, View Source;catenin-antagonist-st316-in-advanced-solid-tumors-301849508.html [SID1234632680]). Though a principal driver of many cancers, β-catenin has evaded drug discovery efforts for more than 30 years. ST316 is designed to selectively target oncogenic activation of the Wnt/β-catenin signaling pathway, without impacting its activity in normal cells.

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ST316-101 (NCT05848739) is a first-in-human, open-label, Phase 1-2 dose-escalation and expansion study designed to determine the safety, tolerability, PK, PD and early efficacy of ST316. The Phase 1 dose-escalation portion of the study will test various dose levels of ST316 in patients with select advanced solid tumors that are known to harbor abnormalities of the Wnt/β-catenin signaling pathway. With its first patient dosed on June 5, 2023, the Company expects to complete the Phase 1 portion of the study in the second half of 2024. Following completion of the study’s Phase 1 portion, the recommended dose will advance to the Phase 2 portion of the study, in which ST316 will be tested in four advanced solid tumor types that are known to harbor abnormalities of the Wnt/β-catenin signaling pathway. Sapience is conducting the Phase 1 study across several sites in the United States.

"Dosing our first patient with ST316 is a significant accomplishment for our team, which has remained undaunted by the challenge of drugging one of the most challenging cancer targets, the Wnt/β-catenin pathway," said Dr. Abi Vainstein-Haras, Sapience’s Chief Medical Officer. "We are thrilled to advance our second molecule from the bench to the clinic. Given the relevance of Wnt/β-catenin in the development of multiple cancers, we are excited about ST316’s potential to make a meaningful difference for the many patients suffering from cancers driven by abnormalities in this pathway."

In March 2023, Sapience announced that it received IND clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 1-2 clinical trial of ST316 for the treatment of solid tumors. At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, Sapience presented late-breaking data on ST316 highlighting its immunotherapeutic potential. In May 2023, Sapience was awarded a $2 million SBIR grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH) to support non-clinical studies for ST316.

About the Wnt/β-catenin Pathway
β-catenin is a critical member of the canonical Wnt signaling pathway, a well-known pathway that is critically involved in embryonic development and adult tissue homeostasis. Wnt pathway hyperactivity is known to play a role in greater than 50% of solid tumors, in which it is a driver of oncogenesis and immune suppression. Because of the importance of the Wnt pathway in normal functioning adult cells, development of β-catenin-targeted therapies that block the Wnt pathway has been hampered by toxicity and off-target effects. There are currently no approved drugs that target the Wnt/β-catenin pathway.

About ST316
ST316 is a first-in-class peptide antagonist of the interaction between β-catenin and its co-activator, BCL9, a complex that drives oncogene expression in multiple cancers where aberrant Wnt/β-catenin pathway signaling is observed. ST316 exposure in cancer cells prevents BCL9-driven nuclear localization of β-catenin and inhibits formation of the Wnt enhanceosome protein complex. Disruption of this interaction selectively suppresses the transcription of oncogenic Wnt target genes that regulate proliferation, migration, invasion and the metastatic potential of tumor cells, as well as genes that regulate the immunosuppression of the tumor microenvironment. ST316 creates a pro-immune tumor microenvironment and in preclinical models has shown to be synergistic with checkpoint inhibition. Due to its selectivity and downstream modulation of the Wnt/β-catenin pathway, ST316 presents an opportunity to safely and effectively target Wnt/β-catenin driven cancers without the toxicities previously seen with other Wnt pathway agents.

The Phase 1 dose-escalation portion of the Phase 1-2 study has begun enrolling and dosing patients with select advanced solid tumors that are known to harbor abnormalities of the Wnt/β-catenin signaling pathway. The Phase 2 dose-expansion portion will utilize the recommended ST316 dose to assess its safety and early efficacy in four specific tumor types that are known to harbor abnormalities of the Wnt/β-catenin signaling pathway.

On June 13, 2023 Foresight Diagnostics, the leader in ultrasensitive minimal residual disease (MRD) detection technology, reported that Mark Roschewski, MD, of the National Cancer Institute, part of the National Institutes of Health, will present pooled data from six recent clinical studies on June 14th at the 17th International Conference on Malignant Lymphoma in Lugano, Switzerland (Press release, Foresight Diagnostics, JUN 13, 2023, View Source [SID1234632679]).

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"We are thrilled to have the opportunity to share data from these impactful clinical studies at the upcoming International Conference on Malignant Lymphoma," said Jake Chabon, Ph.D., CEO and co-founder of Foresight Diagnostics. "Our goal at Foresight Diagnostics is to improve patient care by providing industry-leading MRD testing. The study being presented by Dr. Roschewski shows that our PhasED-Seq technology is on the path towards achieving that goal by providing information that physicians could potentially use to make important treatment decisions for their patients. We are grateful to Dr. Roschewski for presenting this important work and to all the authors, patients, and families who make studies like this possible."

The abstract to be presented by Dr. Roschewski is based on six pooled frontline clinical studies that used Foresight Diagnostics’ ultrasensitive PhasED-Seq technology to quantify MRD in 365 samples from 141 patients with diffuse large B-cell lymphoma (DLBCL). Samples were taken at timepoints before, during, or at the end of treatment and were profiled using PhasED-Seq at either Foresight Diagnostics’ CLIA laboratory or Stanford University. When MRD status at a variety of time points before, during, and after treatment were compared to clinical outcomes, the authors found that MRD status at the end of treatment identified patients at the highest risk of progression. Importantly, PhasED-Seq was significantly more sensitive than PET/CT imaging at the end of treatment for identifying patients who later relapsed, with PhasED-Seq correctly identifying 90% of patients who later relapse compared to 45% of patients identified by PET/CT. These results suggest that MRD measured using PhasED-Seq at the end of treatment is highly prognostic in patients with DLBCL and that ultrasensitive assays like PhasED-Seq should be considered in the revised Lugano response criteria.

Podium Presentation Information:

Abstract Number: 112
Abstract Title: MRD-Negativity After Frontline DLBCL Therapy: Pooled Analysis of 6 Clinical Trials
Presenting Author: Mark Roschewski, MD, Lymphoid Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD
Session Date: Wednesday, June 14, 2023, at 9:20 AM GMT (5:20 PM CEST); "Focus On…" Session – Liquid Biopsy and Minimum Residual Disease, Auditorium

On June 13, 2023 Biostar Pharma, Inc., the US subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of innovative oncology drugs, reported that the first patient has been enrolled today for a Phase 1 clinical study (BG02-2201; NCT05681000) of its proprietary oral formulation product of utidelone, UTD2 (utidelone capsule) in advanced solid tumor patients in the US (Press release, Biostar, JUN 13, 2023, View Source [SID1234632677]). This study will be conducted at multiple clinical research centers including Sarah Cannon Research Institute (Florida Cancer Specialists & Research Institute), University of Southern California, Washington University School of Medicine in St. Louis, et al.

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Unmet Medical Need

With the improvement of treatment regimen, the overall survival of cancer patients has increased significantly in the past years. Therefore, good patient compliance is an important factor for clinical efficacy in the long-term care of cancer patients. Chemotherapy, represented by microtubule inhibitors, remains the most common systemic treatment for cancer, However, most microtubule inhibitors are through I.V. administration, which may potentially cause allergic reactions and inconvenience. So far there have been barely oral dosage forms of microtubule inhibitors successfully developed due to low solubility and being a substrate of drug-resistant P-glycoprotein. Liporaxel is an oral taxane that has only been approved for marketing in South Korea, and its oral bioavailability was still quite low. Other oral dosage forms such as Tesetaxel and Oraxol have failed in clinical trials due to safety and other problems, suggesting a huge unmet medical need.

Advantage for Oral Administration

UTD2 is the world’s first oral epothilone microtubule inhibitor. Utidelone has the advantage for oral formulation since it’s not the substrate of P-glycoprotein. Pre-clinical studies of UTD2 demonstrated good PK and safety profiles and relatively high bioavailability. Compared with injections, utidelone capsules do not require the addition of organic solvents and surfactants. Thus, they may reduce the adverse events caused by intravenous administration, shorten the hospital stay of patients, improve administration convenience, enhance patient compliance and broaden the potential for combination therapy with other anti-cancer drugs.

Dr. Li Tang, Chairman of Biostar Pharma said: "The first patient enrollment of UTD2 in the US clinical trial is an important step for our international development strategy. We are honored to have a number of well-known research institutions and investigators in the US to carry out the study. We are confident that this breakthrough product will provide more benefits for numerous cancer patients and bring about a substantial change to microtubule inhibitors administration. The company is fully committed to advancing this study in order to meet substantial clinical needs around the world."

About UTD2 and Utidelone

UTD2 is the oral formulation of utidelone (utidelone capsule), which is developed through the proprietary microbial drug formulation platform of Beijing Biostar Pharmaceuticals Co., Ltd. Utidelone is a genetically engineered microtubule inhibitor and its injectable dosage has been launched in China in 2021 for the treatment of metastatic breast cancer (MBC). It is the only approved new molecular of microtubule inhibitor in the past 10 years around the world. Among all single agent or combination regimen of non-taxane chemotherapies, utidelone injectable is the only one to achieve both PFS and OS benefits for heavily pretreated MBC patients. It demonstrated several advantageous features, such as overcoming taxane-resistant, low hematological toxicity suitable for longer term exposure, ability to cross the blood-brain barrier that is able to prevent and treat tumor brain metastasis. The phase 3 study results of utidelone injectable were twice selected for oral presentations at ASCO (Free ASCO Whitepaper) annual meetings and invited to publish in Lancet Oncology and Annals of Oncology. It is also recommended by "2023 CSCO Guidelines for Diagnosis and Treatment of Breast Cancer" as Class I (category IA). Clinical studies for multiple indication expansion are in progress, including phase 3 trials for non-small-cell lung cancer and breast cancer neoadjuvant, respectively, as well as phase 2 trial for the first line treatment of advanced esophageal cancer and gastric cancer.

About BG02-2201 Study

BG02-2201 represents the "Phase I Clinical Study on the Tolerability of Utidelone Capsule in Patients with Advanced Solid Tumors" (NCT05681000), which is an open-label phase I dose escalation study and will be conducted at several clinical research centers in the United States. 16-28 patients with advanced solid tumors are expected to be enrolled. The primary objective is to evaluate the safety and tolerability of UTD2 to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT). The secondary objectives are to evaluate the pharmacokinetic profile of UTD2 and to preliminarily assess the anti-tumor efficacy of UTD2 in advanced solid tumor patients.