On February 10, 2025 Foresee Pharmaceuticals (TPEx: 6576) ("Foresee") reported the acceptance of an abstract for presentation at the prestigious American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), Genitourinary (ASCO-GU) Cancers Symposium conference, which will be held at the Moscone Convention Center West in San Francisco, CA, from February 13 to 15, 2025 (Press release, Foresee Pharmaceuticals, FEB 10, 2025, View Source [SID1234650145]).

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The abstract is titled: "Global, Phase 3, Open-Label, Single-Arm Studies to Evaluate the Efficacy, Safety, and Pharmacokinetics of FP-014, 11.25 mg (Triptorelin Mesylate Injection, 11.25 mg) and FP-014, 22.5 mg (Triptorelin Mesylate Injection, 22.5 mg) in Patients with Advanced Prostate Cancer (KATANA studies).", and highlights our commitment to improve advanced prostate cancer treatment. Building on the success of CAMCEVI and our SIF-LAI technology, the KATANA studies will help evaluate the efficacy and safety of FP-014 11.25 mg every 3 months and 22.5 mg, every 6-months injections which have the potential to provide significant benefits for patients with advanced prostate cancer, with its unique and differentiated profile offer substantial benefits for an opportunity to become the only available ready-to-use triptorelin long-acting injectable ("LAI").

Poster Board Number: M3

Abstract Number: TPS284

Session Title: Trials in Progress Poster Session A: Prostate Cancer

Date and Time: Thursday, February 13, 2025, from 11:25 AM-12:45 PM PT

Location: Level 1, West Hall

(View Source)

"This prestigious event brings together leading urology, oncology, and cancer research experts to discuss the latest advancements and findings related to prostate cancer," said Dr. Yisheng Lee, Chief Medical Officer at Foresee. "The accepted abstract presents our differentiated FP-014 Phase 3 clinical program and highlights our broad efforts in developing new treatment modalities and differentiated treatments for prostate cancer patients, contributing to the ongoing dialogue surrounding prostate cancer care and research," added Dr. Lee.

"This acceptance demonstrates the success of Foresee’s pioneering SIF-LAI technology across several product types and indications, further highlighting the broad potential of this technology in developing best-in-class ready-to-use LAI’s," said Dr. Yuhua Li, Chief Technology Officer at Foresee.

"It represents an important opportunity for our work to be recognized globally," said Dr. Ben Chien, Foresee’s Chairman and CEO. "We are excited to initiate our studies later this year, as we see a remarkable opportunity to capture a significant share of the triptorelin market around the world in view of FP-014’s best-in-class profile."

The abstract will become available on the Foresee website after the conference.

About FP-014 (triptorelin)

FP-014 (triptorelin) is a ready-to-use, subcutaneous, long-acting injectable dosage form administered every three months or six months, thereby reducing the frequency of administration to patients to ensure better compliance.

Triptorelin is a common palliative treatment for men with advanced or metastatic prostate cancer. It is also prescribed for the treatment of premenopausal breast cancer, precocious puberty, endometriosis, uterine fibroids, etc.

On February 10, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported the addition of a new asset, 64/67Cu-SAR-trastuzumab, into the Targeted Copper Theranostic (TCT) portfolio (Press release, Clarity Pharmaceuticals, FEB 10, 2025, View Source [SID1234650130]). Pre-clinical data on SAR-trastuzumab has recently been published and Clarity has signed a Supply Agreement with EirGenix, Inc. ("EirGenix") for the clinical development and future commercial supply of clinical-grade GMP trastuzumab biosimilar, EG12014. The supply enables the development of a radiolabelled product using Clarity’s SAR Technology.

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Trastuzumab is an antibody that targets HER2, which is expressed in many cancers, including some types of lung, gastric and breast cancers4. This novel theranostic asset will initially focus on breast cancer and, combined with SAR-Bombesin, SARTATE and SAR-bisPSMA, bolster Clarity’s renewed focus on this important indication.

Through pioneering work in collaboration with the University of Melbourne, the trastuzumab antibody was combined with Clarity’s proprietary SAR chelator and radiolabelled with copper-64 (Cu-64 or 64Cu) for diagnostic imaging and copper-67 (Cu-67 or 67Cu), forming an RIT3. 64Cu-SAR-trastuzumab was shown to target HER2-positive cancer cells to a very high level pre-clinically. 67Cu-SAR-trastuzumab was shown to significantly reduce the growth of HER2-expressing tumours in a dose-dependent manner, as well as to improve the survival of mice treated with the product.

Clarity intends to conduct a Phase 1/2a theranostic study with 64/67Cu-SAR-trastuzumab in HER2-positive breast cancer patients to address a significant unmet clinical need. This subtype of breast cancer is characterised as being aggressive and has a poor prognosis5. Despite recent advances in the treatment of patients with early HER2-positive breast cancer, relapse still occurs in up to 25% of patients within 10 years6.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "The antibody revolution over the last few decades has transformed the treatment of many diseases and has also led to the development of the antibody-drug conjugate (ADC) market. However, the application of antibodies in radiopharmaceuticals, despite many potential benefits of radiation compared to the cytotoxic payloads used in ADCs, has been limited with the current strategies being sub-optimal, particularly in comparison with peptides. At Clarity, we continue to strive for excellence when it comes to science and treatment outcomes, working to firstly open up a broad range of targeting technologies for radiopharmaceuticals in a safe and effective manner, and secondly, broaden the use of radiopharmaceuticals outside of prostate cancer when looking at large cancer indications.

"We have been investigating a number of antibody strategies for many years, including the use of whole antibodies, antibody fragments and antibody pre-targeting in combination with our SAR Technology to develop a new class of treatments when combined with antibodies in RIT. The 64/67Cu-SAR-trastuzumab product is a result of this R&D process.

"The pre-clinical results we generated so far are very exciting and highlight the potential benefit of 64/67Cu-SAR-trastuzumab to image and treat patients with HER2-positive cancers. This is an area of high unmet need, as a considerable proportion of patients, most of whom are women, will relapse or develop resistance to standard treatments, and metastatic disease remains incurable. We are also committed to progressing our SAR-Bombesin, SARTATE and SAR-bisPSMA products in breast cancer, complementing the existing focus on prostate cancer, neuroblastoma and neuroendocrine tumours.

"We are uniquely placed at Clarity to address large markets, firstly with the proven background of using great science to make novel products, and secondly with the commercialisation of the "perfect pairing" of copper isotopes. Those factors combined have myriad advantages in relation to efficacy, supply and manufacturing. With regards to supply, particularly of copper-67, the simple manufacturing process on basic linear accelerators and plentiful precursor means that large markets can be served in a modular format, instead of the reliance on the small number of research reactors around the world and rare earth materials as feedstock in the case of lutetium-177 supply. The supply chains of chelatable alpha radioisotopes, that are yet to show safety and efficacy, are still in their infancy with many hurdles to overcome. Having abundant supply of diagnostic and therapeutic isotopes and finished products made under the one roof to treat large populations of patients in the same country the isotopes and products are made in is an ideal scenario quickly becoming reality and made possible with the perfect pairing of copper.

"We are excited to have entered into the Supply Agreement for trastuzumab with EirGenix, given their excellent capabilities to produce an approved biosimilar product, and progress to the next step in our RIT program. Having a reliable and secure supply of 67Cu-SAR-trastuzumab for future trials in breast cancer is essential as we continue to build a commanding pipeline of radiopharmaceuticals in order to reach our ultimate goal of better treating children and adults with cancer."

EirGenix’s Chairman & President, Dr. Liu, commented, "We are very pleased to be working with Clarity on this important program to develop a novel treatment option for breast cancer patients. At EirGenix we believe that RIT using copper-67 is a promising avenue for the next generation of antibody therapies, and we are thrilled to be contributing to the development of this unique product."

About SAR Technology
Clarity’s proprietary copper-chelating technology, called "sarcophagine" or SAR Technology, has enabled the Company to advance the TCT product pipeline into a range of theranostic clinical trials that use copper-64 for diagnostic imaging and copper-67 for therapy. Clarity is currently progressing three key product areas, SAR-bisPSMA, SAR-Bombesin and SARTATE, with three theranostic and four diagnostic clinical trials with a focus on prostate cancer indications.

64Cu-SAR-trastuzumab and 67Cu-SAR-trastuzumab are unregistered products. The data outlined in this announcement has not been assessed by health authorities such as the US Food and Drug Administration (FDA) or the Therapeutic Goods Administration (TGA). Outcomes from human clinical trials may differ from pre-clinical findings. A clinical development program is currently undergoing feasibility assessment. There is no guarantee that these products will become commercially available.

About Breast Cancer
Breast cancer is the most common cancer in women in the US, excluding skin cancers, although it can also affect some men. It accounts for about 30% of all new cancer diagnoses in women each year7. In 2025 in the US, an estimated 319,750 individuals are projected to be diagnosed with invasive breast cancer, with 316,950 of them being women1. Breast cancer remains the second leading cause of cancer death in women, after lung cancer. It is estimated that 42,170 women will die from breast cancer in 2025 in the US1. The lifetime risk of a woman developing breast cancer is about 13%, or 1 in 87. Incidence rates have increased slightly in recent years, especially in women under 507. Approximately up to 20% of breast cancers are HER2-positive, meaning they have higher levels of the HER2 protein, which promotes faster growth of the cancer.

On February 10, 2025 BioRay Pharmaceutical Co., Ltd. ("BioRay") reported that the National Medical Products Administration (NMPA) has accepted the clinical trial application for its self-developed Class 1 innovative therapeutic biological product, BR111 for injection (Press release, BioRay Pharmaceutical, FEB 10, 2025, View Source [SID1234650146]). BR111 is an antibody-drug conjugate (ADC) targeting dual epitopes of ROR1, intended for the treatment of ROR1-positive hematological malignancies and solid tumors.

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ROR1 is a transmembrane receptor tyrosine kinase protein that is either not expressed or expressed at low levels in normal tissues, but is highly expressed in various hematological malignancies and solid tumors, such as lymphoma, breast cancer, ovarian cancer, and lung cancer. ROR1 is involved in the non-canonical Wnt signaling pathway mediated by Wnt5a, regulating the growth and invasion of tumor cells. It is closely associated with tumorigenesis and drug resistance, making it a potential target for oncology drug development. To date, no ROR1-targeting drugs have been marketed.

BR111 utilizes BioRay’s next-generation CysX irreversible site-specific conjugation technology platform to conjugate an antibody targeting dual epitopes of ROR1 with the small-molecule toxin eribulin. It is the world’s first anti-ROR1 Bi-paratopic ADC to enter clinical trials. BR111 can recognize two non-overlapping epitopes of ROR1 on the surface of tumor cells, and dual-epitope recognition brings stronger affinity and endocytosis. Once endocytosed into ROR1-positive tumor cells, BR111 releases the small-molecule toxin in the lysosome, effectively killing tumor cells. Developed using the CysX platform, BR111 has higher homogeneity and circulating stability, significantly reducing toxin release in circulation, which enhances safety and optimizes the therapeutic window.

In preclinical studies, BR111 demonstrated superior in vivo anti-tumor efficacy compared to its clinical counterparts in multiple animal models and exhibited better safety. Additionally, BR111 can induce a bystander effect and activate immune response in the tumor microenvironment, showing potential for combination therapy with various drugs, including targeted therapies and immunotherapies.

The acceptance of this project application is a testament to BioRay’s R&D capabilities and a validation of the CysX platform technology. Moving forward, BioRay will continue to focus on clinical needs, drive innovative research, and advance biopharmaceutical technology, with the goal of delivering more effective and safer treatment options to patients through innovative drugs.

On February 10, 2025 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, reported the following update on FLAMINGO-01 open label HLA data (Press release, Greenwich LifeSciences, FEB 10, 2025, View Source [SID1234650131]).

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Analysis of the open label data from FLAMINGO-01 has commenced and has been conducted in a manner that maintains the study blind. A preliminary review of FLAMINGO-01 HLA data in both the HLA-A*02 treated and placebo arms and the third open label arm with all other HLA types, shows that approximately 46% of all screened patients have at least one HLA-A*02 allele from either parent.

The main purpose of the open label arm is to investigate the safety and efficacy of GLSI-100 vaccination in patients who do not have an HLA-A*02 allele. It is possible that the open label arm may be large enough to draw immune response and efficacy conclusions. As discussed below, the HLA type can be analyzed by race and ethnicity in those patients who self-reported such information.

CEO Snehal Patel commented, "The review of open label data and the ability to look at multiple patient populations in the Phase III trial will be much greater than was possible in the Phase IIb trial. The HLA-A*02 prevalence of 46% in all screened patients meets our expectations of 40-50% prevalence and supports our sample size estimates for the trial and the interim analysis. We are also interested in studying the 8% of patients who have received HLA-A*02 alleles from both parents, as the mechanism of action in these double HLA-A*02 patients could lead to greater immune response and efficacy."

Mr. Patel further added, "There may be other subgroups of HLA types that can be analyzed in addition to the main arms. Approximately 92% of the patients that are in the HLA-A*02 arms have a second HLA-A type from the other parent that is not HLA-A*02 and could be any of 6 or more other prevalent HLA-A types. We can compare these HLA combinations against each other for immune response and clinical outcome, which could allow for subgroup analysis of HLA-A combinations. The prevalence of various HLA-A types by race or ethnicity may also help to inform the Company in its initial commercial development strategy by suggesting those markets where the most efficacious HLA patient populations may reside."

Background on FLAMINGO-01 Trial Design and HLA Testing

The design of the Phase III trial can be seen here. The trial is a prospective, randomized, double-blinded, multi-center study. The patient population is defined by major screening criteria and is stratified to balance the patient population between the treated and placebo arms of the trial.

As currently designed, approximately 500 patients with the HLA-A*02 allele will be randomized to receive GLSI-100 (GP2 and GM-CSF) or placebo control in the first two pivotal arms of the trial with a planned interim analysis.

In addition, patients without the HLA-A*02 allele will be enrolled in the third open label arm where all patients will receive GLSI-100 and where all endpoints will be open label. This non-HLA-A*02 arm was recently expanded from 100 to 250 patients based on recommendation of the steering committee and review/approval by the FDA and EMA.

HLA-A*02 blinded arms: A patient has 2 HLA-A genes, one from each parent, thus a single HLA-A*02 patient has received the HLA-A*02 allele from one parent. A double HLA-A*02 patient has received the HLA-A*02 allele from both parents. Both single and double HLA-A*02 patients are enrolled in the HLA-A*02 treated and placebo arms, which are blinded. Those patients who have a single HLA-A*02 allele will also have a second HLA-A gene of any other type.
Double HLA-A*02 Potential Mechanism of Action: Theoretically, a double HLA-A*02 patient may have double the amount of HLA-A*02-GP2 complex presented to the immune system to create cancer killing T-cells during the GLSI-100 vaccinations, and as a cancer cell recurs, the HER2 positive recurring cancer cells may have double the amounts HLA-A*02-GP2 complex for the trained T-cells to target and kill. It may be interesting to investigate immune or clinical response differences between single and double HLA-A*02 patients.
Open Label non-HLA-A*02 Third Arm: If a patient has no HLA-A*02 alleles, they will have 2 different or identical non-HLA-A*02 alleles. These non-HLA-A*02 patients are enrolled in the open label arm, where the immune or clinical response can be assessed as a group or by each HLA-A type, including double HLA-A types, providing the number of patients is sufficiently high to draw conclusions or trends.
Additional Information: A central laboratory in the US is sequencing the DNA of patients to determine both HLA-A allele types. The technology is available to sequence the HLA-B and HLA-C alleles, in addition to the HLA-A allele, to further assess other HLA types that may associate with GP2 to create a positive therapeutic effect. GP2 prediction binding algorithms may suggest that some HLA-B or HLA-C alleles may associate similarly to or stronger than HLA-A*02.
Phase IIb Clinical Trial Results

A variety of HLA types are predicted to associate with GP2 based on binding algorithms, and such binding can be tested in preclinical experiments. However, HLA-A*02 is the most common HLA type, thus it was studied first, and all patients in the Phase IIb trial had at least one HLA-A*02 allele. The HLA data collected did not identify if a patient was double HLA-A*02, nor were any other non-HLA-A*02 alleles identified.

Preliminary Review of FLAMINGO-01 HLA Data

Estimates of HLA prevalence by race are available in literature. As there are many sources and population studies to reference, a general consensus is that HLA-A*02 is prevalent in about 40-50% of the Caucasian population, which is the majority of the population in the US and Europe where the study is being conducted. To assess the prevalence of various HLA-A alleles by race, we have been collecting race and ethnicity data on all patients screened. We have summarized the preliminary data available to date in a blinded manner and have observed the results below. It is important to note that this preliminary summary may not reflect results at the end of the study.

Across all screened patients, HLA-A*02 prevalence is about 46%. The double HLA-A*02 prevalence, in patients who have received HLA-A*02 alleles from both parents, is about 8%. Because there are 2 HLA-A genes, one from each parent, the total of all prevalence percentages exceeds 100% and is less than 200% because of double HLA-A types. The HLA-A*03, HLA-A*24, and HLA-A*01 prevalences are about 20-25% for each allele. The HLA-A*11, HLA-A*68, HLA-A*29, and HLA-A*30 prevalences are about 9-12% for each allele.
In those screened patients who self-report as White, at least single or double HLA-A*02 genes are prevalent in approximately 50% of the patients. The double HLA-A*02 alleles are prevalent in 10% of these patients screened. The next most prevalent HLA-A types in the White populations are HLA-A*01 (29%), HLA-A*03 (21%), HLA-A*24 (19%), HLA-A*68 (10%), HLA-A*29 (13%), and HLA-A*11 (9%).
In those screened patients who self-report as Hispanic or Latino, at least single or double HLA-A*02 alleles are prevalent in approximately 50% of the patients. The double HLA-A*02 genes are prevalent in 7% of these patients screened. The next most prevalent HLA-A types in the Hispanic or Latino populations are HLA-A*01 (20%), HLA-A*24 (22%), HLA-A*68 (22%), HLA-A*30 (18%), HLA-A*29 (13%), and HLA-A*11 (13%).
In those screened patients who self-report as Black or African-American, at least single or double HLA-A*02 alleles are prevalent in approximately 40% of the patients. The next most prevalent HLA-A types in the Black or African-American populations are HLA-A*68 (33%), HLA-A*03 (27%), HLA-A*30 (27%), HLA-A*24 (13%), HLA-A*29 (13%), and HLA-A*23 (13%).
In those screened patients who self-report as Asian, at least single or double HLA-A*02 alleles are prevalent in approximately 17% of the patients. The other prevalent HLA-A types are HLA-A*24 (42%), HLA-A*33 (42%), HLA-A*11 (25%), and HLA-A*03 (25%).
The above preliminary Flamingo-01 open label data on HLA-A alleles by race and ethnicity is similar to the data available in literature. If any of the non-HLA-A*02 alleles have a strong association to GP2, it may be interesting to study the immune response and efficacy of GLSI-100 in patients with one allele of that type and one allele that is HLA-A*02 in addition to in patients with the double HLA-A*02 alleles.

About FLAMINGO-01 and GLSI-100

FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US clinical sites from university-based hospitals and cooperative networks with plans to expand into Europe and to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.

For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On February 10, 2025 iBio, Inc. (NYSEA:IBIO), reported financial results for the second quarter ended Dec. 31, 2024, and provided a corporate update on its progress (Press release, iBioPharma, FEB 10, 2025, View Source [SID1234650132]).

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"In our second fiscal quarter we further strengthened our leadership with key Board appointments, reinforcing our commitment to innovation and execution as we work to develop next-generation therapeutics," said CEO and Chief Scientific Officer Dr. Martin Brenner, Ph.D. "Following more recent developments, we also want to highlight the significant strides we have made in advancing our preclinical pipeline with the in-licensing of potentially best-in-class IBIO-600, the notable discovery of a novel Activin E antibody, and the launch of a bispecific antibody program targeting myostatin/activin A. We are excited by the momentum we have built through these results and remain focused on leveraging our AI-driven platform as we aim to transform the treatment landscape for patients with cardiometabolic diseases and obesity, offering hope for more effective, targeted therapies addressing the underlying causes of these conditions while improving overall metabolic health and quality of life."

Fiscal Second Quarter 2025 & Recent Corporate Updates:

Discovered a novel antibody targeting activin E in collaboration with AstralBio, leveraging iBio’s Machine-Learning Antibody Engine to overcome significant technical challenges, demonstrating the platform’s ability to engineer innovative therapeutics potentially for cardiometabolic disease and obesity.

Expanded iBio’s cardiometabolic and obesity program with IBIO-600, the long-acting anti-myostatin antibody in-licensed from AstralBio in January. IBIO-600 was discovered by AstralBio through the use of iBio’s Machine-Learning Antibody Engine and was designed for subcutaneous administration with the potential for an extended half-life.

Initiated a bispecific antibody program targeting myostatin/activin A to promote weight loss, muscle preservation, and prevent weight regain with plans for clinical investigation in obesity and cardiometabolic disorders in 2026. The program leverages iBio’s Machine-Learning Antibody Engine as well as the technology of IBIO-600.
Strengthened the Board of Directors with the appointments of biotech industry veterans David Arkowitz and António Parada on November 25, 2024.
In January we further extended our cash runway with the closing of a private placement offering with members of our Board of Directors and Officers, underscoring their confidence and support in our strategy to advance as a clinical-stage biotech.

Fiscal Second Quarter 2025 Financial Results:

Revenue of $0.2 million was reported for services provided to a collaborative partner during the quarter ended Dec. 31, 2024.

R&D and G&A expenses for the second quarter of fiscal 2025 totaled approximately $4.6 million as compared to $4.5 million in the same period of fiscal year 2024, an increase of approximately 3%. This slight increase is a result of additional spending on consumables supplies and research related activities offset by lower G&A personnel related costs, consulting fees and outside services spending. Net loss from continuing operations for the second quarter ended Dec. 31, 2024, was approximately $4.4 million, or $0.48 per share, compared to a net loss of approximately $4.5 million, or $2.42 per share, in the same period of fiscal 2024.

Cash, cash equivalents and restricted cash as of Dec. 31, 2024, was approximately $7.2 million, inclusive of $0.2 million of restricted cash.