On September 27, 2024 Estrella Immunopharma, Inc. (NASDAQ: ESLA, ESLAW) ("Estrella" or the "Company"), a clinical stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS T-cell therapies to treat cancer and autoimmune diseases, reported that the first patient enrolled in its STARLIGHT-1 Phase I/II clinical trial has achieved a complete response (CR) one month after receiving an infusion of EB103 CD19- Redirected ARTEMIS T Cells (Press release, Estrella Biopharma, SEP 27, 2024, View Source;Redirected-ARTEMIS%C2%AE-T-cells [SID1234646896]).

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In a clinical trial, a complete response means that no detectable signs of disease or cancer remain after treatment. The patient, diagnosed with follicular lymphoma grade 3A with high-risk 3B symptoms, was enrolled in the STARLIGHT-1 trial at UC Davis Comprehensive Cancer Center and received EB103 therapy after relapsing three times following prior treatments. Given the patient’s high tumor burden and multiple comorbidities, the patient was considered at high-risk, which might have increased the severity of side effects like cytokine release syndrome (CRS) and neurotoxicity with commercially available CAR-T treatments. However, no treatment-related serious adverse events (SAEs) were observed in this case.

"We are cautiously optimistic about these early results and the favorable safety profile of EB103 observed in our first treated patient of this clinical trial," said Cheng Liu, Ph.D., President and CEO of Estrella Immunopharma. "Our goal is to develop ARTEMIS T-cell therapies that not only match but also surpass the efficacy of commercially available CAR-T therapies, while also addressing their safety shortcomings. By improving safety, we hope to reach a broader patient population and make T-cell therapy accessible in community hospitals, not just specialized cancer centers."

"We are excited to see the positive early safety and efficacy results in our first treated patient," said Naseem Esteghamat, M.D., Assistant Professor of Medicine at UC Davis Comprehensive Cancer Center and Principal Investigator of the trial. "We look forward to continuing our study to further validate these findings and expand access to this potentially curative therapy."

The Phase I/II STARLIGHT-1 clinical trial is an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of EB103 autologous T-cell therapy and to determine the Recommended Phase II Dose (RP2D) in adult subjects (≥ 18 years of age) who have relapsed/refractory (R/R) B-cell NHL. The study includes a dose escalation phase followed by an expansion phase. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06343311.

About EB103
EB103, a T-cell therapy, also referred to as Estrella’s "CD19-Redirected ARTEMIS T-Cell Therapy," utilizes ARTEMIS technology licensed from Eureka Therapeutics, Inc. ("Eureka"), Estrella’s parent company. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS T-Cell, like EB103 T-cell, allows it to be activated and regulated upon engagement with cancer targets that use a cellular mechanism more closely resembling the one from an endogenous T-cell receptor. Once infused, EB103 T-cells seek out CD19-positive cancer cells, bind to these cells, and destroy them.

On September 27, 2024 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data demonstrating the ability of its DecisionDx-SCC test to provide clinically impactful risk stratification in high-risk SCC patient sub-populations (i.e., patients with suppressed immune systems in this study) to guide potential treatment intensification, such as adjuvant radiation therapy (ART) (Press release, Castle Biosciences, SEP 27, 2024, View Source [SID1234646895]). The data will be shared in an oral presentation at the American Society for Radiation Oncology (ASTRO) 2024 Annual Meeting, being held Sept. 29-Oct. 2 in Washington, D.C. "The DecisionDx-SCC test has been validated to independently predict likelihood of metastasis beyond staging and clinicopathologic risk factors to help inform important treatment decisions for patients with SCC," said Shlomo A. Koyfman, M.D., lead study author and radiation oncologist at Cleveland Clinic.1-3 "The data we are sharing at ASTRO highlights the utility of the test in immune suppressed patients with lower-stage SCC tumors, who may have an elevated risk of metastasis due to their immune status and thus may benefit from intensified surveillance and adjuvant treatments, such as radiation, following tumor removal to reduce this risk."4,5

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Details regarding Castle’s oral presentation at ASTRO are included below:

Abstract title: Use of the 40-gene expression profile (40-GEP) test to identify immune suppressed patients with Brigham and Women’s Hospital (BWH) T1-T2a cutaneous squamous cell carcinoma (cSCC) at higher risk of metastasis: Implications for adjuvant radiation
Abstract ID: 1065
Lead Authors: Shlomo A. Koyfman, M.D., and Karina Brito, Cleveland Clinic
Session Type: Quick Pitch
Session: QP 12 – Sarcoma 2: Advancing Treatment Frontiers in Cutaneous Malignancies and Sarcoma
Date & Time: Tuesday, Oct. 1, 2:30-2:40 p.m. Eastern Time
Location: Room 151
Summary: Data from an independent validation cohort of 954 SCC patients with at least one National Comprehensive Cancer Network (NCCN) high-risk factor and DecisionDx-SCC test results were analyzed for patients with BWH T1 and T2a tumors with no residual tumor after Mohs surgery; 441 patients with BWH T1 tumors and 336 with BWH T2a tumors were included in the study cohort. Patients with T1 tumors had similar metastasis-free survival (MFS) rates regardless of immune status yet were further stratified by their DecisionDx-SCC test result (3-year MFS: Class 1 test result: 96.9% vs. Class 2A/2B test result: 88.6%, p<0.001). Immune suppressed patients with T2a tumors had significantly worse MFS than immune competent patients with T2a tumors (71.4% vs. 91.2%, p<0.001). DecisionDx-SCC further stratified immune suppressed patients with T2a tumors into those with more favorable (Class 1 test result; 3-yr MFS of 83%) and less favorable survival (Class 2A/2B test result; 3-yr MFS of 57%). Given the study data, treatment intensification such as ART should be strongly considered in immune suppressed patients with BWH T2a SCC tumors guided by DecisionDx-SCC test results.
The full text abstract is available in the ASTRO Annual Meeting Portal and will be published in the International Journal of Radiation Oncology • Biology • Physics (Red Journal).

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to stratify risk of metastasis in patients with cutaneous squamous cell carcinoma who have one or more NCCN high-risk factors. The test result, in which patients are stratified into a Class 1 (low), Class 2A (higher) or Class 2B (highest) risk category, predicts individual metastatic risk to inform risk-appropriate management and guide decision-making regarding the use of adjuvant radiation therapy. Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that the test can significantly improve risk-stratification when used with traditional staging systems and clinicopathologic risk factors to guide risk-aligned management and treatment decisions. Learn more at www.CastleBiosciences.com.

On September 27, 2024 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported that the Company will present on its lead-212 (212Pb)-labeled Radio-DARPin Therapeutic (RDT) targeting delta-like ligand 3 (DLL3) co-developed with Orano Med, at the European Assocation of Nuclear Medicine (EANM) Congress which runs October 19-23, 2024 in Hamburg, Germany (Press release, Molecular Partners, SEP 27, 2024, View Source [SID1234646884]).

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The presentation details are as follows:

Title: Preclinical Assessment of Lead-212 (212Pb) Radio-DARPin Therapeutic (RDT)
Targeting Delta-like Ligand 3 (DLL3) in Small Cell Lung Cancer (SCLC)
Presentation Number: OP-535
Session Number: 1204
Session Title: M2M Track – Top Rated Oral Presentation (TROP) Session: Radiopharmaceutical Sciences + Translational Molecular Imaging & Therapy Committee: From Radionuclide to Clinical Translation
Session Timing & Location: October 22, 2024; 8:00-9:30 a.m. CET, Hall X1–X4
Presentation Timing: October 22, 2024; 9:20-9:30 a.m. CET

The presentation will be made available on Molecular Partners’ website after the conference.

Molecular Partners is developing a unique and innovative RDT platform for targeted delivery of radioactive payloads to solid tumors. Due to their small size, high specificity and affinity, DARPins are well-suited as vector for efficient delivery of therapeutic radionuclides. In June 2024, Molecular Partners, together with Targeted Alpha Therapy pioneers Orano Med, announced MP0712, a 212Pb-labeled DLL3-targeting radiopharmaceutical as their first co-developed RDT candidate.

DLL3 is a priority target for radiopharmaceutical therapy thanks to its abundant expression in tumors of patients with SCLC (>85%) and other aggressive neuroendocrine tumors, while expression in healthy tissues is low.

At EANM 2024, Molecular Partners will present their preclinical results supporting MP0712 as a promising treatment candidate for SCLC, with an attractive biodistribution profile, potent antitumor activity and a good safety profile.

On September 26, 2024 OSE Immunotherapeutics reported its consolidated half-year financial results and provided updates on key milestones achieved during the H1 2024 as well as the Company’s outlook for its immunotherapies in immuno-oncology and immuno-inflammation (Press release, OSE Immunotherapeutics, SEP 26, 2024, View Source [SID1234646993]).

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Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, comments: "The major milestones achieved during H1 2024 are paving the way for a transformative year for OSE. During this period, thanks to the OSE teams, the Company made significant outstanding progress.

The half-year has seen continued execution of our partnership-focused business model through three strategic pharmaceutical agreements with major partners, AbbVie and Boehringer Ingelheim, related to our differentiated immunological pipeline. These key achievements trigger a solid financial position supporting the Company’s growth, relying on our promising clinical and preclinical proprietary programs in immuno-inflammation and immuno-oncology conducted and supported by highly skilled OSE teams

We also achieved two significant inflection points on our late-stage proprietary clinical assets. In immunoinflammation, the positive clinical efficacy and safety results for Lusvertikimab in ulcerative colitis represent a strong catalyst for potential future partnership opportunities. We have generated exciting data that we plan to communicate with our investigators at an upcoming global medical conference. In immuno-oncology, the international registration study Artemia for cancer vaccine Tedopi in second-line non-small cell lung cancer treatment is now on track globally. In parallel, in order to ensure continuous portfolio development, we continue accelerating and strengthening first-in-class preclinical programs from our innovative research platforms".

Anne-Laure Autret-Cornet, Chief Financial Officer of OSE Immunotherapeutics, said: "With more than €90 million non-dilutive cash-in in 2024, our financial visibility is strongly reinforced until 2027. This allows us to prioritize funding of our recently globally launched Artemia Phase 3 registration study for our cancer vaccine Tedopi in lung cancer and to further invest in our other proprietary clinical products and innovative R&D engine to increase the value and interest of our assets."

On September 26, 2024 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells, reported the pricing of an underwritten public offering of (i) 11,564,401 shares of its common stock and accompanying common stock warrants to purchase an aggregate of 2,891,100 shares of common stock and, (ii) to certain investors in lieu of common stock, pre-funded warrants to purchase 12,435,599 shares of common stock and accompanying common stock warrants to purchase an aggregate of 3,108,900 shares of common stock (Press release, Cue Biopharma, SEP 26, 2024, View Source [SID1234646893]). Each share of common stock and accompanying common stock warrant are being sold together at a combined public offering price of $0.50, and each pre-funded warrant and accompanying common stock warrant are being sold together at a combined public offering price of $0.499. The aggregate gross proceeds of the offering are expected to be approximately $12.0 million, before deducting underwriting discounts and commissions and other offering expenses. Each pre-funded warrant will have an exercise price of $0.001 per share, will be exercisable immediately and will be exercisable until all of the pre-funded warrants are exercised in full. Each common stock warrant will have an exercise price of $0.50 per share, will be exercisable immediately and will expire five years from the date of issuance. The offering is expected to close on or about September 30, 2024, subject to satisfaction of customary closing conditions. All of the securities are being offered by Cue Biopharma.

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Oppenheimer & Co. Inc. is acting as sole book-running manager for the offering. Newbridge Securities Corporation is acting as co-manager for the offering.

A shelf registration statement on Form S-3 (File No. 333-271786) relating to the securities to be offered in the public offering was filed with the Securities and Exchange Commission (the "SEC") on May 9, 2023 and declared effective on May 26, 2023. The offering was made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. A final prospectus supplement relating to the offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and final prospectus supplement relating to the offering may also be obtained by contacting: Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, by telephone at (212) 667-8055, or by email at [email protected].

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