On September 3, 2024 Lunit (KRX:328130.KQ), a leading provider of AI-powered solutions for cancer diagnostics and therapeutics, reported that Lunit SCOPE IO has demonstrated significant potential in predicting immunotherapy response for patients with advanced biliary tract cancer (BTC), via AI-powered analysis of immune phenotype and tumor-infiltrating lymphocytes (TILs) (Press release, Lunit, SEP 3, 2024, View Source;new-publication-in-ccr-302236317.html [SID1234646324]). The groundbreaking study, conducted in collaboration with researchers from Asan Medical Center and Severance Hospital in Seoul, Korea, was recently published in Clinical Cancer Research (CCR), an AACR (Free AACR Whitepaper) journal.

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BTC is known for its poor prognosis, with limited treatment options available. While recent studies have shown promise in combining immunotherapy, such as anti-PD-1 inhibitors with standard chemotherapy, there has been a lack of effective predictive tools to guide treatment decisions.

The study analyzed pre-treatment pathology samples (H&E slides) from 339 patients with advanced BTC who received anti-PD-1 monotherapy as second-line or later treatment. Using Lunit SCOPE IO, researchers performed a detailed analysis of the tumor microenvironment, classifying patients’ immune phenotypes into three categories: inflamed (high intratumoral TIL), immune-excluded (low intratumoral TIL and high stromal TIL), and immune desert (low TIL overall). Immune phenotypes are an emerging pan-cancer biomarker with support from leaders of the immuno-oncology community.[1]

Key findings include:

Patients classified as having an "inflamed" immune phenotype showed significantly better treatment outcomes compared to those with non-inflamed phenotypes, as consistent with previously published studies.[2]
The inflamed group demonstrated both longer overall survival (12.6 vs. 5.1 months) and progression-free survival (4.5 vs. 1.9 months), as well as higher overall response rates (27.5% vs. 7.7%).
Lunit SCOPE IO provided objective and efficient assessment of the tumor microenvironment, overcoming limitations of manual evaluation demonstrating high feasibility for AI-powered analysis of immune phenotype and TIL.
Notably, this study suggests immune phenotyping can serve as a predictive biomarker for possible response to immunotherapy in BTC, addressing a long-standing gap in personalized treatment approaches for this class of cancers with a high unmet need.

"Lunit SCOPE IO represents a significant advancement in the precision medicine landscape for cancer treatment," said Brandon Suh, CEO at Lunit. "By providing a deeper understanding of the tumor microenvironment, particularly immune phenotyping, our AI technology empowers clinicians to make informed treatment decisions, identifying patients most likely to benefit from immunotherapy and opening new avenues for personalized treatment strategies in challenging cancer types."

On September 3, 2024 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) ("Jazz Pharmaceuticals") reported that Jazz Investments I Limited, its wholly-owned subsidiary (the "Issuer"), intends to offer, subject to market conditions and other factors, $850 million aggregate principal amount of exchangeable senior notes due 2030 (the "notes") in a private offering (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Jazz Pharmaceuticals, SEP 3, 2024, View Source [SID1234646323]). The Issuer also expects to grant the initial purchasers of the notes an option, exercisable within a period of 13 days from and including the date the notes are first issued, to purchase up to an additional $150 million aggregate principal amount of notes.

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The notes will be exchangeable under certain conditions. The Issuer will settle exchanges by paying cash up to the aggregate principal amount of the notes to be exchanged. The remainder, if any, of the Issuer’s exchange obligation in excess of the aggregate principal amount of the notes, will be settled in cash, ordinary shares of Jazz Pharmaceuticals ("ordinary shares") or a combination of cash and ordinary shares, at the Issuer’s election. The interest rate, initial exchange rate and other terms of the notes will be determined at the time of pricing of the offering.

The notes will be general unsecured obligations of the Issuer and will accrue interest payable semiannually in arrears. The Issuer’s obligations under the notes will be fully and unconditionally guaranteed on a senior unsecured basis by Jazz Pharmaceuticals; will rank pari passu in right of payment with the Issuer’s existing 2.000% exchangeable senior notes due 2026; will be effectively subordinated to the Issuer’s guarantees of the indebtedness under Jazz Pharmaceuticals’ credit agreement (the "credit agreement") and Jazz Pharmaceuticals’ 4.375% senior secured notes due 2029 (the "senior secured notes") to the extent of the value of the assets securing such guarantees; and will be structurally subordinated to the indebtedness and guarantees under the credit agreement and the senior secured notes of Jazz Pharmaceuticals’ other subsidiaries that are borrowers or have provided guarantees of such indebtedness.

Jazz Pharmaceuticals, together with its consolidated subsidiaries ("Jazz"), expects to use a portion of the net proceeds to prepay up to approximately $350 million of the term loans outstanding under the credit agreement and the remainder for general corporate purposes. If the initial purchasers exercise their option to purchase additional notes, Jazz expects to use the net proceeds from the sale of the additional notes for further prepayments of the term loans.

Jazz Pharmaceuticals also expects to repurchase up to $150 million of its ordinary shares from purchasers of the notes in privately negotiated transactions with or through one of the initial purchasers or its affiliate concurrently with the pricing of the offering (the "concurrent ordinary share repurchases"). Jazz Pharmaceuticals expects the purchase price per ordinary share repurchased in such concurrent ordinary share repurchases to equal the closing price per ordinary share on the date of the offering. To the extent Jazz Pharmaceuticals effects any such concurrent ordinary share repurchases, it will pay for such repurchases with existing cash on hand and such repurchases will be effected as part of Jazz Pharmaceuticals’ share repurchase program announced in July 2024. Accordingly, any such concurrent ordinary share repurchases will reduce the remaining amount authorized under the share repurchase program. No assurance can be given as to how much, if any, of Jazz Pharmaceuticals’ ordinary shares will be repurchased or the terms on which they will be repurchased. The concurrent ordinary share repurchases could increase, or reduce the size of any decrease in, the market price of the ordinary shares, including concurrently with the pricing of the notes, resulting in a higher effective exchange price for the notes. This press release is not an offer to repurchase the ordinary shares, and the offering of the notes is not contingent upon the repurchase of any ordinary shares.

None of the notes, the guarantee or the ordinary shares issuable upon exchange of the notes, if any, have been registered under the Securities Act or the securities laws of any other jurisdiction, and, unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of the securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

On September 3, 2024 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 subject recruitment of a US Phase 1 clinical study of Utidelone Capsule (UTD2), a company’s key pipeline product, for advanced solid tumors (NCT05681000) has been completed (Press release, Biostar, SEP 3, 2024, View Source [SID1234646322]).

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This study is an open-label, dose-escalation Phase 1 clinical study, and conducted in several institutions across the US including Sarah Cannon Research Institute (Florida Cancer Specialists & Research Institute), University of Southern California, and the Washington University in St. Louis. The primary objective of this study is to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT); the secondary objective is to evaluate the efficacy and pharmacokinetic profile of UTD2 monotherapy in patients with advanced solid tumors.

Five dose cohorts were explored in this study. After confirming the DLT (diarrhea) in the highest dose cohort, 75mg/m2/day x 5 days was determined as MTD. A total of 18 patients with more than 10 different types of advanced solid tumors were enrolled. The median age was 63 years old, and 2/3 of the patients had received ≥ 3 lines of prior treatments. As of now, efficacy evaluations were completed in 12 patients, and 1 complete response (CR, ovarian cancer), 1 partial response (PR, ovarian cancer), and 8 stable disease (SD, prostate cancer, testicular cancer, non-small cell lung cancer, pancreatic cancer, appendix adenocarcinoma, soft tissue sarcoma, etc.) were obtained with a clinical benefit rate of 83%. The results further demonstrated the broad-spectrum anti-tumor property of Utidelone. As for treatment duration, more than half of these patients received ≥3 cycles of treatments, and the maximum duration of response reached 36 weeks. In terms of safety, most treatment-related adverse events (TRAEs) were grade 1-2, and the most frequently seen TRAEs (incidence ≥ 20%, including all grades) were diarrhea (55.6%), fatigue (33.3%), and neutropenia (22.2%), all of which were manageable. The preliminary results of this study were also presented at the 2024 ASCO (Free ASCO Whitepaper) meeting.

Dr. Li Tang, Chairman of Biostar Pharma commented: "This is the first study of UTD2 that has completed enrollment globally. We successfully achieved the primary objectives and observed encouraging efficacy and safety profiles. We are very grateful for the joint engagement and dedication of our US clinical institutions and investigators. We are confident that this blockbuster product will substantially change the administration regimen of microtubule inhibitors. We will advance the following pipelines for UTD2 at full speed and hopefully bring it to the market to benefit global cancer patients as soon as possible".

Biostar is actively carrying out clinical studies of UTD2 in China and abroad. A pivotal study in China for advanced breast cancer led by Professor Xu Binghe, Cancer Hospital of Chinese Academy of Medical Sciences, is in recruitment. The preliminary findings of this study were also presented at the ASCO (Free ASCO Whitepaper) meeting in 2024; the China Phase 2 study for advanced solid tumors including ovarian cancer and cholangiocarcinoma, etc. is in initiation. In addition, US FDA has granted an Orphan Drug Designation (ODD) to UTD2 for the treatment of advanced gastric cancer, and Biostar is preparing for IND filing of a Phase 2/3 multi-reginal clinical study (MRCT) led by Professor Ruihua Xu of Sun Yat-sen University Cancer Center in both China and US simultaneously.

Utidelone is a new-generation genetically engineered microtubule inhibitor. Utidelone Injection (UTD1) has been launched in China in 2021 for the treatment of metastatic breast cancer (MBC) progressed after at least one anthracycline- or taxane-containing chemotherapy regimen. The phase 3 study data showed that UTD1 is the only one to achieve both PFS and OS benefits for heavily pretreated MBC patients, and the results were twice orally presented at ASCO (Free ASCO Whitepaper) annual meetings. Utidelone has similar mechanism of action with that of taxanes while demonstrating multiple advantages, including better anti-tumor activity, broader anti-tumor spectrum, better safety profile with very low hematologic toxicity, effective against multidrug-resistant tumors with less prone to develop drug resistance, capability of crossing the blood-brain barrier so as to prevent and treat brain tumor, and high oral bioavailability. Multiple indication expansion clinical studies for UTD1 are also in progress in China and US, including but not limited to MRCT Phase 3 study for non-small-cell lung cancer (NSCLC), Phase 2 pivotal study for breast cancer brain metastasis in US and NSCLC brain metastasis in China, and Phase 3 study for breast cancer neoadjuvant in China.

Compared to taxanes, which are difficult for oral formulation development, Utidelone is not susceptible to P-glycoprotein thus cannot be pumped out of the cancer cell by P-glycoprotein and has the advantage for higher oral bioavailability. By utilizing its synthetic biology technology platform, Biostar developed Utidelone Capsule, and its efficacy and safety have been confirmed in both US and China’s studies. Utidelone Capsule will significantly improve the convenience of administration, compliance of patients, decrease in treatment cost and ease of combination therapy with other oral anti-cancer drugs, meaning more suitable for adjuvant and maintenance therapy.

On September 3, 2024 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported dosing of 5 new patients in the ACHIEVE Phase 2b trial ongoing in the UK (Press release, TC Biopharm, SEP 3, 2024, View Source [SID1234646321]).

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Currently, the trial has successfully dosed 6 patients with their first of 4 possible doses at the higher dose level. Each 5mL dose contains up to 230 million gamma delta T cells, and a patient is expected to receive up to an approximate 1 billion gamma delta T cells over four doses. Five patients have received their second dose, with 2 of these patients having also received their third dose. This correlates with TCBP’s step-wise approach to process improvements, as implemented in Q4 2023, and further steps taken to amend the trial protocol in the first quarter of 2024. New patients will continue to be identified, screened, and enrolled into the study.

"TCBP is excited to announce our rapid progression in the ACHIEVE Phase 2b trial with very strong enrolment in the second part of the trial using the higher dose," stated, Bryan Kobel, CEO of TC BioPharm. "TCB008 is potentially a game-changing monotherapy for blood cancers, and the strong recruitment and patient retention rates are testament to clinician/physician interest in TCB008 as a monotherapy in leukemia. We’re proud of the milestones accomplished to date, having rapidly dosed 6 patients with an additional 10 patients lined up. It is encouraging to see re-dosing of several patients, which we believe reflects positively on the steps the organization took in 2023 and early 2024. TCBP remains poised to execute on our clinical trial plans in 2024 and into 2025, including ACHIEVE and ACHIEVE2, as well as our expanded manufacturing capabilities to enhance our operational capabilities and our economic efficiencies."

The ACHIEVE UK clinical trial is an open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB008 in patients with AML or MDS/AML, with either refractory or relapsed disease.

On September 3, 2024 Acepodia (6976:TT), a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) and allogeneic gamma delta 2 (γδ2) T cell platforms, reported that it has entered a strategic clinical collaboration with Pfizer Ignite to support the development of its therapies in autoimmune diseases (Press release, Acepodia, SEP 3, 2024, View Source [SID1234646320]). Pfizer Ignite is an end-to-end offering that leverages Pfizer’s significant resources, scale, and expertise, alongside a proven track record in the development of breakthroughs, to support biotechs seeking to accelerate their innovations from preclinical R&D through the development lifecycle. Under this new agreement, Pfizer Ignite will provide strategic guidance and resources to Acepodia as the company develops its cell therapies for oncology and autoimmune diseases.

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Acepodia’s ACC platform, which uses bioorthogonal chemistry and is based on the pioneering work of 2022 Nobel laureate Dr. Carolyn Bertozzi, who applied click chemistry to living systems, creates an off-the-shelf, non-genetically engineered version of CAR-T cell therapy that is more easily scaled and avoids cytokine release storms, neurotoxicity, and other side effects associated with CAR-T cell therapies. Acepodia’s lead clinical candidate, ACE1831, is currently being evaluated in a Phase 1 first-in-human clinical trial for patients with non-Hodgkin’s lymphoma and has demonstrated a robust and durable effect after a single treatment at the lowest dose.

"The significant unmet needs that exist in autoimmune diseases combined with the early positive results that have been seen with CAR-T therapies have opened the door for potential innovations that could provide the efficacy of CAR-T therapy without the challenges that have made routine use of CAR-T in autoimmune diseases difficult," said Sonny Hsiao, Ph.D., chief executive officer of Acepodia. "We see a significant opportunity to bring the benefits of our ACC platform to autoimmune diseases, and working with Pfizer Ignite will position us well to deliver our immunotherapies to patients in desperate need of new options."

By collaborating with Pfizer Ignite, Acepodia will benefit from Pfizer’s resources, deep expertise and R&D capabilities, covering multiple stages such as clinical trial design and regulatory strategies to improve the process of developing innovative drugs.

"Pfizer Ignite is focused on supporting the delivery of innovative therapies that are strategically aligned with Pfizer’s priority areas and have the potential to address significant gaps in patient care, " said Kathy Fernando, SVP, Head of Pfizer Ignite. "Drawing on Pfizer’s deep expertise in oncology and immunology, we look forward to collaborating with Acepodia to help translate their compelling scientific platform into impactful new medicines for patients with unmet need."