On October 12, 2023 Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for patients with mTOR pathway alterations, reported details of four poster presentations at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), taking place October 11-15, 2023, in Boston, MA (Press release, Aadi Bioscience, OCT 12, 2023, View Source [SID1234635901]).

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Abstracts and poster presentation details are below:

Title: "Inactivating TSC1 and TSC2 alterations, co-mutations, and genomic instability in advanced cancers: Analysis of a real-world (RW) patient population using the Foundation Medicine genomic database"
Poster Number: C019
Session Title: Poster Session C
Date/Time: Saturday, October 14, 2023, 12:30 pm-4:00 pm EDT
Authors: David J. Kwiatkowski, MD, PhD; Norma A. Palma, PhD; Willis H. Navarro, MD; Gopa Iyer, MD

Abstract highlights:

To appreciate the potential for TSC1 and TSC2 as therapeutic biomarkers, TSC1 and TSC2 mutational data from an RW genomic database were analyzed.
Next-generation sequencing data from Foundation Medicine’s genomic database of patients primarily with advanced cancer were analyzed using the FoundationInsights web-based platform.
In a large RW database of patients with advanced cancer, inactivating TSC1 and TSC2 variants occurred in 1.9% of patients. These occurred across common tumor types at rates as high as 8.6% (urinary bladder tumors).
These observations suggest cancers with TSC1 and/or TSC2 alterations may be candidates for targeted therapy.
Title: "Real-world (RW) characterization and frequency of TSC1 and/or TSC2 alterations collected from tumor tissue and liquid biopsies from the Tempus genomic database in patients with advanced cancer" Poster Number: B003
Session Title: Poster Session B
Date/Time: Friday, October 13, 2023, 12:30 pm-4:00 pm EDT
Authors: David J. Kwiatkowski, MD, PhD; Norma A. Palma, PhD; Willis H. Navarro, MD; Gopa Iyer, MD

Abstract highlights:

PRECISION1 will assess the clinical benefit of nab-sirolimus in patients with cancer with inactivating TSC1 or TSC2 alterations.
To appreciate the potential for TSC1 and/or TSC2 targeted therapy, TSC1 and TSC2 alterations across a large RW patient population with advanced cancer using data from tissue and liquid biopsies were analyzed.
In a large (N=154,965) NGS database of patients with cancer, inactivating TSC1 and/or TSC2 variants occurred in about 1.7% of patients overall and were frequently identified in commonly occurring cancers.
The frequency of TSC1 and/or TSC2 alterations and tumor types were generally consistent between tumor tissue samples and liquid biopsies.
Consistency between primary vs metastatic samples suggests TSC1 and TSC2 alterations may not be acquired, although samples were not longitudinal.
Title: "Evaluation of nab-sirolimus in combination with PI3K pathway inhibitors to overcome PI3K/mTOR resistance in PI3K-mutant breast cancer cell lines" Poster Number: A117
Session Title: Poster Session A
Date/Time: Thursday, October 12, 2023, 12:30 pm-4:00 pm EDT
Authors: Sean Wallace, PhD; Khine Nyein Myint, PhD; Shihe Hou, PhD; Maria Zalath, BA; Andrew Kwon, PhD; Brian McMorran, PhD; Igor Vivanco, PhD

Abstract highlights:

The PI3K-AKT-mTOR pathway is frequently activated in many cancer types and plays a central role in tumorigenesis. However, clinical use of therapies targeting this pathway is limited by compensatory vertical and horizontal feedback activation loops, which limit antitumor efficacy and lead to drug resistance.
Combination therapy strategies employing simultaneous inhibition of multiple PI3K-AKT-mTOR pathway elements may overcome these resistance mechanisms and improve antitumor activity. In these studies, we analyzed the effects of nab-sirolimus combinations in PI3K-mutant breast cancer (BrCa) cells.
The antitumor effects of PI3K and AKT inhibitors were enhanced by the addition of the novel mTOR inhibitor nab-sirolimus. The improved effectiveness of the PI3K and mTOR inhibitor combination was due to the reciprocal overcoming of resistance mechanisms induced by single agent treatment.
These data potentially support a vertical PI3K pathway inhibition strategy using nab-sirolimus and PI3K/AKT inhibitors in PIK3CA-mutated BrCa, regardless of hormone receptor status.
An encore presentation titled, "Phase 2, Multicenter, Open-label Basket Trial of nab-Sirolimus for Malignant Solid Tumors Harboring Pathogenic Inactivating Alterations in TSC1 and TSC2 (PRECISION1)" will also be presented during the late breaking session on Friday, October 13, 2023.

More information can be found on the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) meeting website.

On October 12, 2023 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported the closing of an exclusive license agreement with Guangzhou Gloria Biosciences Co., Ltd. (GloriaBio) and an associated investor for the development of motixafortide across all indications in Asia (Press release, BioLineRx, OCT 12, 2023, View Source [SID1234635900]). Motixafortide is a novel, high-affinity CXCR4 inhibitor that received approval for its first indication in September 2023 by the U.S. Food and Drug Administration (FDA) for stem cell mobilization (SCM) in autologous stem cell transplantation (ASCT) in patients with multiple myeloma. Motixafortide is also being studied for other potential uses in oncologic and hematologic diseases.

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The license agreement provides for a $15 million upfront payment (which was received at closing), up to $50 million in potential development and regulatory milestones in China and Japan, and up to $200 million in potential commercial milestones based on defined sales targets. BioLineRx is also eligible to receive tiered double-digit royalties on net sales.

In addition, the transaction included an equity investment of $14.6 million in BioLineRx through the purchase of newly issued American Depositary Shares (ADSs) at a price of $2.136 per ADS in a private placement. No warrants were issued in the transaction. Along with the investment, the purchaser received the right to appoint one representative to the BioLineRx Board of Directors.

Collaboration Details

Under the terms of the license agreement, GloriaBio will be responsible for development and commercialization of motixafortide in Asia initially in SCM. With the recent FDA approval of APHEXDA for this indication, GloriaBio plans to initiate a bridging study to support potential approval and commercialization of motixafortide in the licensed territories in SCM for ASCT in patients with multiple myeloma.

In addition, GloriaBio plans to initiate a Phase 2/3 first-line pancreatic cancer clinical trial evaluating motixafortide in combination with PD-1 inhibitor *zimberelimab and standard of care combination chemotherapy. BioLineRx has been developing motixafortide in combination with PD-1 inhibitors and standard of care combination chemotherapies in pancreatic cancer, and recently announced the initiation of a randomized Phase 2 clinical trial sponsored by Columbia University in first-line metastatic pancreatic cancer based on promising preliminary data from a single-arm pilot phase reported on September 29 at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Pancreatic Cancer.

"We are tremendously pleased by the swift closing of this significant licensing agreement for the Asian market, which brings substantial benefits to BioLineRx, and ultimately, to patients, including the advancement of our two leading development programs," said Philip Serlin, Chief Executive Officer of BioLineRx Ltd. "Given GloriaBio’s expertise and track record in the development and commercialization of cancer immunotherapies in China, we believe GloriaBio is well suited to further develop motixafortide in Asia. The combined initial investment of nearly $30 million through the upfront payment and equity investment demonstrates a clear commitment to the motixafortide programs in stem cell mobilization and pancreatic cancer in Asia, and provides us with additional capital to continue our aggressive launch plans in the U.S."

"We are very pleased to enter into this strategic partnership with BioLineRx and are committed to the development and commercialization of motixafortide in Asia, which we believe will bring additional value to GloriaBio’s portfolio via clear synergies with zimberelimab," said Jiman Zhu, Founder of GloriaBio. "There are very significant unmet patient needs in pancreatic cancer in Asia, especially in China. We are excited to see the encouraging clinical data of motixafortide in combination with PD-1 inhibitors and chemotherapy in pancreatic cancer and look forward to initiating a Phase 2/3 randomized trial in a first-line pancreatic cancer, as well as investigating additional indications for motixafortide in Asia."

MSQ Ventures served as advisor to BioLineRx on this transaction.

About Pancreatic Cancer in Asia
At nearly 240,000 reported cases in 2022, it is estimated that Asia had the largest number of pancreatic cancer cases globally (496,000 estimated cases worldwide). In China alone, the number of pancreatic cancer cases in 2020 reached approximately 125,000, with a 5-year survival rate of just 7.2%.

About Multiple Myeloma and Autologous Stem Cell Transplantation in Asia
Multiple myeloma is an incurable blood cancer that affects some white blood cells called plasma cells, which are found in the bone marrow. When damaged, these plasma cells rapidly spread and replace normal cells in the bone marrow.
In 2022, it is estimated that Asia had over 51,000 reported cases of multiple myeloma (MM), the largest number of MM cases globally. New cases of MM reached over 20,000 in Greater China in 2018, and MM incidence is predicted to increase at an annual growth rate of 2.9%.

Autologous stem cell transplantation (ASCT) can be an important treatment paradigm for a number of blood cancers, including multiple myeloma. In China, ASCTs are included in medical insurance reimbursement, and in 2019, the total number of ASCTs in China reached more than 10,000 for the first time (for comparative purposes, as many as 14,000 ASCTs are performed each year in the U.S.).

*About Zimberelimab (YuTuo)
Zimberelimab is a fully human anti-PD-1 monoclonal antibody. GloriaBio is developing and commercializing zimberelimab in Greater China, including mainland China, Hong Kong, Macao and Taiwan, where zimberelimab is approved for relapsed or refractory classical Hodgkin’s lymphoma and recurrent or metastatic cervical cancer. Arcus Biosciences, and development partner Gilead Sciences, have the exclusive rights to develop and commercialize zimberelimab throughout the world except in Greater China and certain territories.

On October 12, 2023 Akeso, Inc. (9926.HK) ("Akeso") reported that the results of the multicenter, open-label Phase Ib/II clinical trial (COMPASSION-03/AK104-201) for cadonilimab (PD-1/CTLA-4 bispecific antibody), the globally first bispecific IO drug used to treat advanced solid tumors, have been published in the October 2 issue of The Lancet Oncology (Press release, Akeso Biopharma, OCT 12, 2023, View Source [SID1234635899]). This multicenter clinical trial marks the first utilization of PD-1/CTLA-4 dual immune checkpoint inhibitors in the treatment of advanced solid tumors.

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Cadonilimab is the first-in-class PD-1/CTLA-4 bispecific antibody developed in China. Cadonilimab possesses high binding avidity especially to high density of PD-1 and CTLA-4 due to its tetravalent design and could simultaneously bind different cells expressing PD-1 and CTLA-4, respectively, thereby reducing the activation of the relevant immunosuppressive pathways by tumor cells and enhance the T-cell-mediated immune response. Previous clinical trials confirmed the synergistic anti-tumor effect of cadonilimab’s novel combination therapy of PD-1/CTLA-4. This, along with its favorable safety profile, offers promising prospects for ushering in the era of tumor immunotherapy 2.0.

The COMPASSION-03/AK104-201 trial assessed the efficacy and safety of cadonilimab, both as a monotherapy for advanced solid tumors and in combination with chemotherapy for unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. It represents a significant milestone in the global advancement of oncology treatment, particularly in patients diagnosed with advanced cervical cancer. The study produced important efficacy evidence for the clinical development and approval of cadonilimab, supporting further investigation of cadonilimab across multiple indications.

The results of combined therapy in patients with G/GEJ adenocarcinoma will be reported separately at a later date since the data from the combination treatment cohort are not yet mature. It is worth noting that the 2-year follow-up update data from the previous phase Ib/II clinical trial of cadonilimab in combination with chemotherapy for the first-line treatment of G/GEJ adenocarcinoma was presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The distinct and superior efficacy of cadonilimab in the PD-L1 low-expression or expression-negative population further suggests that cadonilimab holds promise for successive therapies in the first-line treatment of clinically advanced gastric cancer.

This publication in the Lancet Oncology presents data from a study involving 240 patients who received cadonilimab monotherapy. Among them, 83 patients with advanced solid tumors, including gastric cancer, cervical cancer, hepatocellular carcinoma, esophageal squamous cell carcinoma, colorectal cancer, non-small cell lung cancer, and renal cancer, were enrolled in phase Ib. A total of 157 patients were enrolled in phase II, which consisted of three cohorts. Cohort 1 consisted of 111 patients with recurrent or metastatic cervical cancer (CC) who had previously failed platinum-based chemotherapy; cohort 2 consisted of 24 patients with advanced hepatocellular carcinoma (HCC) who had received no more than one previous systemic therapy; and cohort 3 consisted of 22 patients with advanced esophageal squamous cell carcinoma (ESCC) who had received no more than one previous systemic therapy.

No dose-limiting toxicities occurred during the dose-escalation phase of Phase Ib, and the overall safety profile of cadonilimab was favorable. The incidence of grade 3-4 treatment-related adverse events (TRAEs) was 27.9%, and the most frequently reported grade ≥3 TRAEs consisted of anemia, decreased appetite, decreased neutrophil count, and infusion-related reactions.

The monotherapy of cadonilimab in phase II demonstrated promising antitumor activity, resulting in a notable long-term survival advantage.

After a median follow-up duration of 14.6 months, as assessed by the Independent Radiology Review Committee, the objective response rate (ORR) for cadonilimab monotherapy in patients with advanced CC who had previously failed platinum-based chemotherapy was 32.3%, 14 (14.1%) patients had a complete response (CR) and 18 patients (18.2%) had a partial response (PR). The median overall survival (OS) was not reached, and the 18-month OS reached 51.2%. These cohort data were presented at the 2022 American Society of Gynecologic Oncology (SGO) meeting, sparking extensive discussions within the global oncology scholarly community.
After a median follow-up duration of 17.9 months, the median OS was 9.4 months for cadonilimab monotherapy in patients with advanced ESCC who had received no more than one previous systemic therapy , and six patients were censored after 14 months.
After a median follow-up duration of 19.6 months, the median OS had not reached for cadonilimab monotherapy in patients with advanced HCC who had received no more than one previous systemic therapy, and the 18-month OS was 56.7%.
In June 2022, cadonilimab received conditional approval from the China National Medical Products Administration (NMPA) for commercialization, for the treatment of recurrent or metastatic cervical cancer. This milestone establishes cadonilimab as the first approved bispecific immunotherapy drug and marks its distinction as the first domestically-produced bispecific antibody to receive marketing approval in China. These achievements represent significant progress in bridging the global gap in bispecific antibody drugs for cancer immunotherapy and immunotherapy drugs for advanced cervical cancer in China.

In addition, the phase III clinical trial (AK104-302, NCT05008783) investigating cadonilimab in combination with chemotherapy as a first-line treatment for advanced G/GEJ adenocarcinoma, led by Prof. Jafu Ji and Prof. Lin Shen from Peking University Cancer Hospital, has completed enrollment and entered the follow-up phase. Additionally, the randomized, double-blind, placebo-controlled phase III clinical trial (AK104-303, NCT04982237) evaluating the efficacy of cadonilimab combined with platinum-based chemotherapy +/- bevacizumab for the first-line treatment of recurrent/metastatic cervical cancer has also completed enrollment and entered the follow-up phase.

On October 12, 2023 CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, reported the publication of two cases of long-term disease-free survival in the treatment of advanced hepatocellular carcinoma (HCC) with CARsgen’s innovative CAR-GPC3 T-cell therapy (Press release, Carsgen Therapeutics, OCT 12, 2023, View Source [SID1234635898]). These results were recently published in Cancer Communications as the cover story, titled "Combined local therapy and CAR-GPC3 T-cell therapy in advanced hepatocellular carcinoma: a proof-of-concept treatment strategy".

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Hepatocellular carcinoma is one of the most common malignant tumors, with approximately 780,000 annual incidence cases globally. There is an urgent need for new therapeutic techniques and strategies to improve the prognosis of these patients. Recurrence and metastasis are the primary factors impacting HCC patients’ lives. For HCC patients with concurrent inferior vena cava tumor thrombus, treatment options are limited, and overall prognosis is poor. Even with surgical resection, the median overall survival is only 17.8 months postoperatively [2]. For those undergoing other local or systemic treatments, the median overall survival ranges from 5.9 to 15.4 months [2-4].

In May 2015, the Department of Interventional Oncology of Renji Hospital in Shanghai collaborated with CARsgen Therapeutics to initiate the first clinical study with CAR T-cell therapy targeting the GPC3 (Glypican-3) protein in advanced hepatocellular carcinoma. (Partial data from this study was published in Clin Cancer Res. 2020[5]). At the time of enrollment, two patients already presented inferior vena cava tumor thrombus, and one of them also had retroperitoneal lymph node metastasis, a particularly poor prognosis factor for the outcome. However, both patients maintained a tumor-free status during long-term follow-up after receiving a combination of local and CAR T-cell therapies. Recently, the two patients returned to Renji Hospital for a follow-up examination, which confirmed the absence of tumor recurrence. Researchers at Renji Hospital held a brief celebration event together with these two patients.

Patient 1, upon confirmed diagnosis of liver cancer, underwent two rounds of interventional therapy and one session of microwave ablation. However, his disease rapidly progressed and he developed an inferior vena cava tumor thrombus. Following localized treatments (microwave ablation and gamma knife) targeting intrahepatic recurrent tumors and the inferior vena cava tumor thrombus, the patient was enrolled in the CAR-GPC3 T-cell clinical trial. Six months later, tumor biomarkers AFP returned to normal, and imaging showed no evident active tumors. To date, the patient has remained tumor-free for over 8 years (July 2015 to August 2023). Patient 2, following liver cancer resection, experienced intrahepatic tumor recurrence. Despite multiple intensive sessions of TACE and microwave ablation, the tumor could not be effectively controlled. Multiple recurrences (greater than 6 lesions) appeared within the liver, and the patient developed retroperitoneal lymph node metastasis and inferior vena cava tumor thrombus. Through localized treatments (microwave ablation and gamma knife) addressing intrahepatic tumors, the inferior vena cava tumor thrombus, and peritoneal lymph node metastases, combined with CAR T-cell therapy, the patient has currently achieved over 7 years of tumor-free survival (July 2016 to August 2023). Meanwhile, pyrexia, fatigue, transient leukopenia, thrombocytopenia, and grade 1 cytokine release syndrome were reported during CAR-GPC3 T-cell infusions in this patient.

Throughout the follow-up period, both patients only received oral anti-hepatitis B virus medication, with no other cancer treatments administered.

Professor Bo Zhai, the principal investigator of this study and the Director of the Department of Interventional Oncology of Renji Hospital, Shanghai Jiao Tong University School of Medicine, said, "The treatment of advanced hepatocellular carcinoma has always been a great challenge, particularly for patients with inferior vena cava tumor thrombus, a poor prognosis factor. In this case report, two patients achieved long-term tumor-free survival through a combination of localized treatment and CAR T-cell therapy targeting GPC3, offering new hope for advanced hepatocellular carcinoma patients. Despite the tremendous efforts of scientists, the development of CAR T-cell therapy for solid tumors still encounter various challenges, such as the inherent physical and immune barriers of solid tumors, tumor cell heterogeneity, antigen specificity, and the potential risks associated with CAR T-cell therapy."

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen, added, "With the mission of making cancer curable, CARsgen has been developing various innovative strategies for the treatment of solid tumors using CAR-T cells. For example, we firstly reported the combination of small-molecule drugs with CAR-GPC3 T-cell therapy to achieve sustained complete response in a subject with advanced hepatocellular carcinoma [6]. This time, after receiving local therapy and targeted CAR-GPC3 T-cell infusion, two patients with advanced hepatocellular carcinoma reported in the study have achieved disease-free survival for more than seven years, demonstrating that CAR T-cell therapies have the potential to cure solid tumors through innovative treatment strategies."

On October 12, 2023 Independent biopharmaceutical company Specialised Therapeutics Asia Pte Ltd (ST) reported to have signed a license deal with Korea-based CanariaBio Inc., acquiring the exclusive license to a new monoclonal antibody therapy for patients with ovarian cancer in Australia, New Zealand and in select Southeast Asian countries (Press release, Specialised Therapeutics Asia, OCT 12, 2023, View Source [SID1234635897]).

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The therapy, known as oregovomab, is currently in a pivotal phase III international clinical trial known as the FLORA-5 study.2 This investigation is examining oregovomab in combination with chemotherapy agents carboplatin and paclitaxel for patients with advanced ovarian cancer.

Under the terms of the arrangement, ST will be responsible for all commercial, medical, regulatory and distribution activities for oregovomab in its key territories of Australia, New Zealand, Singapore, Thailand, Vietnam, Brunei and Malaysia. CanariaBio will be responsible for the manufacture and supply of oregovomab to ST.

Announcing the partnership, ST Chief Executive Officer Carlo Montagner said he was pleased CanariaBio had selected ST as a partner for this highly promising therapy.

"ST has a portfolio of anti-cancer therapies targeting multiple solid tumours with the exception of ovarian cancer, and now oregovomab becomes our first ovarian cancer agent," Mr Montagner said.

"Despite great advances in recent years, there remains a high unmet need in all our regions to treat this patient population. We look forward to working closely with our new partners at CanariaBio and pending the results of the pivotal Phase III registration study, making oregovomab available to eligible patients."

CanariaBio Chairman and CEO Michael Na said the company had selected ST for its regional expertise and strong track record commercialising oncology products.

"Formalising this agreement is a pivotal moment for our program. This collaboration is more than just a deal – it’s a shared commitment as we develop novel therapies to address unmet medical needs. At CanariaBio, we’ve always believed in the transformative power of partnerships, and teaming up with ST reinforces this belief."

Oregovomab works by targeting and binding specifically to a surface protein known as CA-125 found on the surface of ovarian cancer cells, then activating the patient’s own immune system to respond.3

In the Phase 2 study, the addition of oregovomab to chemotherapy yielded a median progression-free survival of 41.8 months compared with 12.2 months with standard chemotherapy alone (HR, 0.46, P=0.0027). The overall survival hazard ratio was 0.35.1

The Phase 3 FLORA-5 study is fully enrolled and ongoing. Final results are expected in 2025.