On March 22, 2024 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported that new data highlighting the performance of its DecisionDx-Melanoma test in predicting risk of sentinel lymph node (SLN) positivity in patients with CM is being presented at the Society of Surgical Oncology 2024 (SSO 2024) Annual Meeting, being held March 20-23 in Atlanta (Press release, Castle Biosciences, MAR 22, 2024, View Source [SID1234641395]).

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"We have previously demonstrated that our DecisionDx-Melanoma test identifies patients who are eligible for an SLNB but have less than a 5% likelihood of being SLN positive, and could therefore consider avoiding the procedure," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We have also demonstrated that our test is a strong and independent predictor of metastasis. The study that was orally presented at SSO 2024 demonstrates that patients who did avoid an SLNB procedure had excellent outcomes to date. This demonstration is highly important as it showed that our test can help patients avoid an unnecessary procedure."

DecisionDx-Melanoma is supported by 50 peer-reviewed publications involving more than 10,000 patient samples, demonstrating its robust value in guiding risk-aligned patient care. The test has been designed and validated to inform two clinical questions in the management of melanoma: a patient’s risk of melanoma recurrence and metastasis, and their individual risk of SLN positivity, as highlighted in Castle’s SSO 2024 abstracts outlined below.

DecisionDx-Melanoma

Oral Presentation Number and Title: 62: Prospective validation of the i31-gene expression profile test for cutaneous melanoma to select patients who may consider foregoing sentinel lymph node biopsy
Session: Melanoma Parallel Session
Presenter and Lead Author: J. Michael Guenther, M.D., St. Elizabeth Physicians, Edgewood, Kentucky
Summary: This study shares three-year outcomes data from Castle’s prospective, multicenter study of patients with CM who were being considered for an SLNB (n=322). SLNB is an invasive surgical procedure used to determine whether a patient’s cancer has spread to nearby lymph nodes; the procedure returns a surgical result that is negative for metastasis in approximately 88% of patients. Current National Comprehensive Cancer Network guidelines use a 5% likelihood of SLN positivity as the threshold to avoid versus consider/recommend an SLNB due to an increased risk of metastasis. DecisionDx-Melanoma has been validated to provide a patient’s individualized risk of SLN positivity (i31-GEP for SLNB) by integrating clinical and pathologic risk factors with the patient’s tumor biology. In the study, no patients with a DecisionDx-Melanoma predicted risk of SLN positivity less than 5% had a positive SLN (among all tumor stages studied). If DecisionDx-Melanoma was used to inform management decisions, the test’s results could have further reduced the number of patients with T1-T2 tumors who could have avoided SLNB by 25%. Additionally, at three years, all patients with a low-risk DecisionDx-Melanoma test result were recurrence free (recurrence free survival of 100%). These data demonstrate that use of DecisionDx-Melanoma test results can guide accurate, risk-aligned clinical decision-making regarding the SLNB surgical procedure, within current guidelines. Further, the test can identify low-risk patients who can safely consider foregoing SLNB, thereby reducing unnecessary SLNB procedures (by approximately 25% in this study alone) and the associated costs and risks of complications that accompany them.

ePoster Number and Title: E309: Utility of 31-gene expression profile test in identifying patients with T1 cutaneous melanoma at high risk of SLN positivity and recurrence
Session: Melanoma Parallel Session

Summary: In a pooled cohort of 979 patients with thin (T1) tumors, a DecisionDx-Melanoma Class 2B result was the strongest predictor of a positive SLN, among other risk factors that included patient age, tumor location, Breslow thickness, tumor ulceration and more. While the study outlined above demonstrates the ability of the test to identify patients at low risk of SLN positivity who can safely forgo SLNB, this study shows that it can also identify patients at high risk who should consider it. By identifying patients who have a higher risk of SLNB positivity and recurrence, DecisionDx-Melanoma can help determine which patients should be considered for more intensive management, such as SLNB, increased follow-up frequency and imaging surveillance, to improve patient outcomes.

ePosters are available for conference attendees in the ePoster Online Gallery.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node (SLN) positivity and a patient’s personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by 50 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through Dec. 31, 2023, DecisionDx-Melanoma has been ordered more than 150,000 times for patients diagnosed with cutaneous melanoma.

On March 22, 2024 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported promising data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, that is being presented today at the 2024 European Lung Cancer Congress (ELCC 2024) in Prague, Czech Republic (Press release, Summit Therapeutics, MAR 22, 2024, View Source [SID1234641394]). Two posters featuring updated ivonescimab data will be displayed from 12:00 to 12:45pm Central European Time. The posters will also be made available on our website after the presentation period.

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The first poster, "Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases" includes data from patients with asymptomatic brain metastases at baseline. These patients were enrolled in either AK112-202 (NCT04900363), in which ivonescimab is delivered as monotherapy, or AK112-201 (NCT04736823), in which ivonescimab is delivered in combination with platinum doublet chemotherapy, both of which are Phase II clinical trials for patients with advanced or metastatic NSCLC. This analysis consisted of the 35 patients with advanced or metastatic NSCLC who had asymptomatic brain metastases at baseline; 28 patients were treated with ivonescimab plus chemotherapy in AK112-201, and seven patients were treated with monotherapy ivonescimab in AK112-202.

Notably, median intracranial progression-free survival was 19.3 months across all patients analyzed. Patients across both cohorts experienced an intracranial response rate of 34%, and eight patients (23%) experienced a complete response by RANO criteria. All patients who did not achieve a response demonstrated stable disease or non-progression; no patients experienced intracranial disease progression at the time of the initial follow-up scan. No cases of intracranial bleeding complications were observed in these patients.

"We are pleased to see ivonescimab’s favorable intracranial response rates and median intracranial progression-free survival as well as promising anti-tumor activity and safety profile in the subgroup of patients with brain metastases from NSCLC," said Dr. H. Jack West, Vice President of Clinical Development at Summit. "We are grateful for the patients and clinical investigators supporting these trials, and our ongoing collaboration with our partners at Akeso."

The second poster titled, "Phase 2 Results of Ivonescimab a Novel PD-1/VEGF Bispecific in Combination with Chemotherapy for First Line Treatment of Patients with Advanced / Metastatic Non-Small Cell Lung Cancer" includes updated data from the Phase II trial AK112-201 centered around the cohort of patients in which ivonescimab is combined with chemotherapy for first-line treatment of squamous and non-squamous advanced or metastatic NSCLC in patients without actionable genomic alterations (e.g., positive for endothelial growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK)). Summarized updates in NSCLC patients with EGFR mutations after a tyrosine kinase inhibitor (TKI) and NSCLC patients who have received prior PD-(L)1 plus doublet chemotherapy treatment are included as well.

Of significance, first-line advanced or metastatic squamous NSCLC patients experienced a median PFS of 11.1 months (95% CI: 9.5 – 16.3 months). In addition, first-line patients with advanced or metastatic non-squamous tumors experienced a median PFS of 13.3 months (95% CI: 8.3 – 16.4 months). Median overall survival was not reached in either subset of patients after a median follow-up time of 22.1 months. The frequency of treatment-emergent adverse events (TEAEs) leading to the discontinuation of ivonescimab was 11.1% and 2.8%, respectively, in patients with squamous and non-squamous tumors. The most frequent TEAEs were anemia and decreased neutrophil counts in squamous patients and anemia and constipation in non-squamous patients.

The posters will be presented by, amongst others, Dr. Li Zhang, Sun Yat-Sen University Cancer Center, and Dr. West, with data generated and analyzed by our collaboration and licensing partner, Akeso Inc. (HKEX Code: 9926.HK) with contribution by Summit staff.

Summit continues its clinical development of ivonescimab in order to establish its efficacy and safety in two NSCLC indications:

HARMONi Phase III trial: ivonescimab combined with chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR TKI (NCT05184712)
HARMONi-3 Phase III trial: ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients (NCT05899608)
About the ELCC 2024 Posters

Poster Title: Phase 2 Results of Ivonescimab a Novel PD-1/VEGF Bispecific in Combination with Chemotherapy for First Line Treatment of Patients with Advanced / Metastatic Squamous Non-Small Cell Lung Cancer
ELCC Presentation No.: 68P
Session Date & Time: Friday, March 22, 2024, 12:00 to 12:45pm CET

Poster Title: Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer and Brain Metastases
ELCC Presentation No.: 174P
Session Date & Time: Friday, March 22, 2024, 12:00 to 12:45pm CET

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, the United States, Canada, Europe, and Japan, and as AK112 in China and Australia, is an investigational, novel, potential first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays cooperative binding with each of its intended targets with higher affinity when in the presence of both PD-1 and VEGF.

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the tumor microenvironment with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro (Zhong, et al, SITC (Free SITC Whitepaper), 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.

Ivonescimab was discovered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 1,600 patients have been treated with ivonescimab in clinical studies globally. Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two Phase III clinical trials.

Ivonescimab is an investigational therapy that is not approved by any regulatory authority.

On March 22, 2024 AbbVie (NYSE: ABBV) reported that the U.S. Food and Drug Administration (FDA) has granted full approval for ELAHERE (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal adult cancer patients treated with up to three prior therapies (Press release, AbbVie, MAR 22, 2024, View Source [SID1234641393]). Patients with these cancers often present with late-stage disease, undergo surgery and are then treated with platinum-based chemotherapy. They may become resistant to this treatment and require another therapy, such as ELAHERE.

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"The full FDA approval of ELAHERE for eligible patients with ovarian cancer represents the culmination of years of work by the ImmunoGen team. ELAHERE is the first and only antibody-drug conjugate (ADC) approved in the U.S. for this difficult-to-treat malignancy," said Roopal Thakkar, M.D., senior vice president, chief medical officer, global therapeutics, AbbVie.

ELAHERE was first granted FDA accelerated approval in November 2022 and the conversion to full approval is based on data from the confirmatory Phase 3 MIRASOL trial. This trial compared ELAHERE to investigator’s choice (IC) of chemotherapy in patients with platinum-resistant ovarian cancer (PROC) whose tumors express high levels of FRα and who have been treated with up to three prior therapies. The primary endpoint of MIRASOL was progression-free survival (PFS) by investigator assessment and key secondary endpoints included objective response rate (ORR) and overall survival (OS).

"As the first treatment to show a statistically significant overall survival benefit in patients with platinum-resistant ovarian cancer, ELAHERE provides an effective new option for patients with folate receptor alpha positive tumors. These patients previously had very limited options and ELAHERE changes that," said Kathleen Moore, deputy director and associate director of clinical research at the Stephenson Cancer Center of The University of Oklahoma and MIRASOL principal investigator.

ABOUT THE PHASE 3 MIRASOL TRIAL
MIRASOL is a randomized Phase 3 trial of ELAHERE versus investigator’s choice (IC) of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan). Eligibility criteria include patients with PROC whose tumors express high levels of FRα, using the Ventana FOLR1 Assay, and who have been treated with up to three prior regimens. The primary endpoint of this trial is progression-free survival (PFS) by investigator assessment. Key secondary endpoints include objective response rate (ORR) and overall survival (OS). The trial enrolled 453 patients. Patients were stratified by number of prior lines of therapy (14% had one prior line of therapy, 39% had two prior lines of therapy, and 47% had three prior lines of therapy) and by IC chemotherapy, with paclitaxel as the most commonly chosen (41%), followed by PLD (36%) and topotecan (23%). 62% of patients received prior bevacizumab; 55% received a prior PARP inhibitor.

Based on current results:

OS hazard ratio (HR) was 0.67 (95% confidence interval [CI]: 0.50, 0.88; p=0.0046), representing a 33% reduction in risk of death in the ELAHERE arm compared to the IC chemotherapy arm.
PFS HR was 0.65 (95% CI: 0.52, 0.81; p<0.0001), representing a 35% reduction in the risk of tumor or cancer progression in the ELAHERE arm compared to IC chemotherapy.
ELAHERE showed overall fewer Grade 3+ adverse events and a lower rate of discontinuations due to adverse events when compared to the IC chemotherapy control group.
The most common (≥20%) adverse reactions, including lab abnormalities, were increased aspartate aminotransferase, fatigue, increased alanine aminotransferase, blurred vision, nausea, increased alkaline phosphatase, diarrhea, abdominal pain, keratopathy, peripheral neuropathy, musculoskeletal pain, decreased lymphocytes, decreased platelets, decreased magnesium, decreased hemoglobin, dry eye, constipation, decreased leukocytes, vomiting, decreased albumin, decreased appetite, and decreased neutrophils.

ABOUT OVARIAN CANCER
Ovarian cancer is the leading cause of death from gynecological cancers in the United States. Each year, approximately 20,000 patients are diagnosed. Most patients present with late-stage disease and will typically undergo surgery followed by platinum-based chemotherapy. Unfortunately, the majority of patients eventually develop platinum-resistant disease, which is difficult to treat. In this setting, standard of care single-agent chemotherapies are associated with low response rates, short durations of response, and significant toxicities.

ABOUT ELAHERE
ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells. Patients requiring access support may call 1-833-ELAHERE or visit www.elahere.com.

The Marketing Authorization Application (MAA) for ELAHERE in Europe has been accepted by the European Medicines Agency (EMA). Regulatory submissions for ELAHERE are also under review in multiple other countries.

INDICATION
ELAHERE is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test.

IMPORTANT SAFETY INFORMATION

WARNING: OCULAR TOXICITY

ELAHERE can cause severe ocular toxicities, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis.
Conduct an ophthalmic exam including visual acuity and slit lamp exam prior to initiation of ELAHERE, every other cycle for the first 8 cycles, and as clinically indicated.
Administer prophylactic artificial tears and ophthalmic topical steroids.
Withhold ELAHERE for ocular toxicities until improvement and resume at the same or reduced dose.
Discontinue ELAHERE for Grade 4 ocular toxicities.
WARNINGS and PRECAUTIONS
Ocular Disorders

ELAHERE can cause severe ocular adverse reactions, including visual impairment, keratopathy (corneal disorders), dry eye, photophobia, eye pain, and uveitis.

Ocular adverse reactions occurred in 59% of patients with ovarian cancer treated with ELAHERE. Eleven percent (11%) of patients experienced Grade 3 ocular adverse reactions, including blurred vision, keratopathy (corneal disorders), dry eye, cataract, photophobia, and eye pain; two patients (0.3%) experienced Grade 4 events (keratopathy and cataract). The most common (≥5%) ocular adverse reactions were blurred vision (48%), keratopathy (36%), dry eye (27%), cataract (16%), photophobia (14%), and eye pain (10%).

The median time to onset for first ocular adverse reaction was 5.1 weeks (range: 0.1 to 68.6). Of the patients who experienced ocular events, 53% had complete resolution; 38% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade at last follow up). Ocular adverse reactions led to permanent discontinuation of ELAHERE in 1% of patients.

Premedication and use of lubricating and ophthalmic topical steroid eye drops during treatment with ELAHERE are recommended. Advise patients to avoid use of contact lenses during treatment with ELAHERE unless directed by a healthcare provider.

Refer patients to an eye care professional for an ophthalmic exam including visual acuity and slit lamp exam prior to treatment initiation, every other cycle for the first 8 cycles, and as clinically indicated. Promptly refer patients to an eye care professional for any new or worsening ocular signs and symptoms.

Monitor for ocular toxicity and withhold, reduce, or permanently discontinue ELAHERE based on severity and persistence of ocular adverse reactions.

Pneumonitis

Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ELAHERE.

Pneumonitis occurred in 10% of patients treated with ELAHERE, including 1% with Grade 3 events and 1 patient (0.1%) with a Grade 4 event. One patient (0.1%) died due to respiratory failure in the setting of pneumonitis and lung metastases. One patient (0.1%) died due to respiratory failure of unknown etiology. Pneumonitis led to permanent discontinuation of ELAHERE in 3% of patients.

Monitor patients for pulmonary signs and symptoms of pneumonitis, which may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams. Infectious, neoplastic, and other causes for such symptoms should be excluded through appropriate investigations. Withhold ELAHERE for patients who develop persistent or recurrent Grade 2 pneumonitis until symptoms resolve to ≤ Grade 1 and consider dose reduction. Permanently discontinue ELAHERE in all patients with Grade 3 or 4 pneumonitis. Patients who are asymptomatic may continue dosing of ELAHERE with close monitoring.

Peripheral Neuropathy (PN)

Peripheral neuropathy occurred in 36% of patients with ovarian cancer treated with ELAHERE across clinical trials; 3% of patients experienced Grade 3 peripheral neuropathy. Peripheral neuropathy adverse reactions included peripheral neuropathy (20%), peripheral sensory neuropathy (9%), paraesthesia (6%), neurotoxicity (3%), hypoaesthesia (1%), peripheral motor neuropathy (0.9%), polyneuropathy (0.3%), and peripheral sensorimotor neuropathy (0.1%). Monitor patients for signs and symptoms of neuropathy, such as paresthesia, tingling or a burning sensation, neuropathic pain, muscle weakness, or dysesthesia. For patients experiencing new or worsening PN, withhold dosage, dose reduce, or permanently discontinue ELAHERE based on the severity of PN.

Embryo-Fetal Toxicity

Based on its mechanism of action, ELAHERE can cause embryo-fetal harm when administered to a pregnant woman because it contains a genotoxic compound (DM4) and affects actively dividing cells.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ELAHERE and for 7 months after the last dose.

ADVERSE REACTIONS

The most common (≥20 %) adverse reactions, including lab abnormalities, were increased aspartate aminotransferase, fatigue, increased alanine aminotransferase, blurred vision, nausea, increased alkaline phosphatase, diarrhea, abdominal pain, keratopathy, peripheral neuropathy, musculoskeletal pain, decreased lymphocytes, decreased platelets, decreased magnesium, decreased hemoglobin, dry eye, constipation, decreased leukocytes, vomiting, decreased albumin, decreased appetite, and decreased neutrophils.

DRUG INTERACTIONS

DM4 is a CYP3A4 substrate. Closely monitor patients for adverse reactions with ELAHERE when used concomitantly with strong CYP3A4 inhibitors.

USE IN SPECIAL POPULATIONS

Lactation
Advise women not to breastfeed during treatment with ELAHERE and for 1 month after the last dose.

Hepatic Impairment
Avoid use of ELAHERE in patients with moderate or severe hepatic impairment (total bilirubin >1.5 ULN).

Please see full Prescribing Information, including BOXED WARNING

On March 22, 2024 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, reported its full year results for the period ended December 31, 2023, and provided an update on the impressive progress of its clinical development pipeline over the last several months (Press release, Antengene, MAR 22, 2024, View Source [SID1234641392]).

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"2023 has been a breakout year for Antengene, with excellent pipeline momentum across multiple first/best-in-class programs marked by encouraging clinical activities and efficacies during dose escalations for our four lead global-rights programs, namely ATG-031, ATG-022, ATG-037, and ATG-101 which are designed to target CD24, Claudin 18.2, CD73, and PD-L1/4-1BB. With respect to our APAC-rights programs, our second generation mTORC1/2 inhibitor ATG-008 has made steady progress towards registrational path for the indication of cervical cancer, complemented by the inclusion of XPOVIO in the 2023 China National Reimbursement Drug List. Furthermore, we have entered into a partnership with Hansoh Pharma, a leading Chinese pharmaceutical company, for the commercialization of XPOVIO in the Mainland of China," said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO. "Looking into 2024 and beyond, we are confident that out four lead global rights programs will continue to deliver encouraging results and emerge as category leaders. Our current cash balance totaling RMB1.188 billion is expected to fund planned operations and product development. We look forward to report on our progress throughout the year, starting with the presentation of several abstracts at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR 2024)."

1. Momentous clinical development across four lead global-rights programs

ATG-031 (anti-CD24 monoclonal antibody): Promising Activity at Starting Doses: ATG-031 is the first-in-class humanized anti-CD24 monoclonal antibody to enter the clinic for cancer in the U.S. ATG-031 acts by inhibiting the "don’t eat me" signal while stimulating the "eat me" signal and enhances macrophage-mediated phagocytosis of cancer cells.
Phase I "PERFORM" study: To date, a total of 5 late-stage cancer patients have been treated with ATG-031 in the Phase I dose escalation study. To date, no dose-limiting toxicities (DLTs) have been observed among the 5 patients. Tumor shrinkage based on CT scan was observed in one heavily pre-treated patient (7 prior lines of therapy). Key study sites include four major U.S. cancer centers: The University of Texas MD Anderson Cancer Center, the University of California San Francisco, the University of Colorado, and Yale University Cancer Center.
Next ATG-031 Milestone: Completion of the dose escalation portion of the Phase I "PERFORM" Study in H1 2025.
ATG-022 (Claudin 18.2 antibody-drug conjugate, "ADC"): Potential to Target Claudin 18.2 Low Expressors: ATG-022 is differentiated by its potential ability to be active across a range of Claudin 18.2 expression levels, including in low expressors. Antengene has also developed a companion diagnostic assay to support the clinical program. The ADC has been awarded two Orphan Drug Designations (ODD) by the U.S. Food and Drug Administration (FDA) for treatment of gastric and pancreatic cancers.
Phase I "CLINCH" study: To date, 7 gastric cancer patients (without pre-screening patients’ Claudin 18.2 expression levels) have been treated with ATG-022. Antengene has observed one complete response (CR) and one partial response (PR) in 2 patients with metastatic gastric cancer. In the 2.4 mg/kg dose cohort, one patient with extremely low expression of Claudin 18.2 achieved CR, while one patient from the 1.8 mg/kg dose cohort achieved PR. The study has already completed the dose escalation portion and initiated the dose expansion portion.
Next ATG-022 Milestone: Clinical data readout of Phase I "CLINCH trial", including preliminary efficacy and safety in H2 2024.
ATG-037 (CD73 small molecule inhibitor): Early Combination Activity Shown Potential in Reversing Prior PD-1 Resistance: Inhibiting CD73 is intended to stop the production of adenosine, a key immunosuppressive molecule in the tumor microenvironment. As a small molecule inhibitor of CD73, ATG-037 has demonstrated pre-clinically the ability to overcome the "hook effect" that can limit efficacy and is commonly seen in anti-CD73 antibodies. Antengene entered into a global clinical collaboration with MSD and is currently evaluating this molecule in combination with the anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with locally advanced or metastatic solid tumors.
Phase I "STAMINA" study: In the dose escalation segment of ATG-037 combined with pembrolizumab, Antengene has observed PRs in two patients with melanoma and one patient with non-small cell lung cancer (NSCLC), all of whom were refractory to prior treatment with checkpoint inhibitors (CPIs). To date, 23 patients have been enrolled and received a first tumor assessment.
Next ATG-037 Milestone: Completion of Phase I dose escalation and proceed to dose expansion in H1 2024.
ATG-101 (PD-L1/4-1BB bispecific antibody): Durable Responses at Low Doses with No Off-Target Hepatotoxicity Observed and Efficacy in Cold Tumors: ATG-101’s differentiated approach to targeting PD-L1 resistant cancers incorporates the T-cell co-stimulatory receptor 4-1BB. The bispecific antibody utilizes high PD-L1 affinity and conditional 4-1BB activation, to reduce the risk of hepatotoxicity.
Phase I "PROBE" study: Antengene has observed a PR in a patient with metastatic colon adenocarcinoma (microsatellite stability biomarker [MSS], liver metastasis, and three prior lines of therapy). In addition, SD has been observed in two patients for longer than 1 year.
Next ATG-101 Milestone: Completion of Phase I dose escalation and proceed to dose expansion in H1 2025.
Progressing Early programs: Antengene continues to advance IND candidate, ATG-042 (MTAPnull-selective PRMT5 Inhibitor), and the proprietary AnTenGagerTM "2+1" T cell engager platform.
2. Steadily progressing mid/late-stage clinical programs continue to demonstrate clinical potentials

ATG-008 (mTORC1/2 small molecule inhibitor): Positive, Robust Cervical Cancer Data -The mTOR complex regulates different cellular processes and is upregulated in multiple tumors. mTORC1 and mTORC2 have to be inhibited simultaneously to maximize efficacy and minimize the development of resistance. ATG-008 was designed to inhibit both.
Phase II "TORCH-2" study: ATG-008 has demonstrated positive Phase II results in cervical cancer that position the program to have a competitive profile compared to other agents approved across different global markets. The Phase II "TORCH-2" study is currently enrolling both checkpoint inhibitor (CPI)-naïve and CPI-pre-treated patients. Based on the latest data review as of March 14th, 2024, out of the 31 CPI-naïve patients who received treatment (30 had at least one tumor assessment), the objective response rate (ORR) was observed to be 53.3%, the disease control rate (DCR) was 86.7%. Among the 30 patients with prior CPI treatment (26 patients had at least one tumor assessment), the ORR was 23.1%, with a DCR of 84.6%.
Next ATG-008 Milestone: Confirm registrational pathway in cervical cancer with health authorities.
3. Solidifying presence in APAC markets through accelerating commercialization

Antengene and Hansoh Pharma entered into a collaboration for the commercialization of XPOVIO in the Mainland of China in August 2023.
XPOVIO has been added to the NRDL (2023 Version) as announced on December 14th, 2023. The updated NRDL, taking effect on January 1st, 2024, will significantly improve the accessibility of XPOVIO in Mainland of China.
As of December 2023, Antengene has successfully secured XPOVIO regulatory approvals in seven markets: Mainland of China, Taiwan China, Hong Kong China, Macau China, Australia, South Korea, and Singapore. National reimbursement has been secured in 3 markets: Mainland of China (NRDL), Australia (Pharmaceutical Benefits Scheme), and Singapore (Cancer Drug List). In June 2023, the coverage of XPOVIO by the Australian Pharmaceutical Benefits Scheme (PBS) was extended from Xd to include both XVd and Xd regimens..
4. Strong cash and bank balance enabling continuous growth

As of December 31, 2023, the company’s cash resources of about RMB1.188 billion, coupled with careful spending to support the continuous growth, development, and operations of Antengene.

To learn more about the annual financial results of 2023, please see the full announcement on the "Investor Relations" section of the website.

On March 22, 2024 BioVaxys Technology Corp. (CSE: BIOV) (FRA: 5LB) (OTCQB: BVAXF) ("BioVaxys" or "the Company") reported that it intends to complete a non-brokered private placement (the "Private Placement") consisting of up to 15,384,615 units ("Units") at a price of $0.065 per Unit for total gross proceeds of up to CAD$1,000,000, before deducting any offering-related expenses (Press release, BioVaxys Technology, MAR 22, 2024, View Source [SID1234641391]). Each Unit consists of one common share (a "Common Share") and one whole Common Share purchase warrant (a "Warrant"). Each Warrant is exercisable for one additional Common Share at an exercise price of $0.15 for a period of 24 months.

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Closing of the private placement is conditional upon finalizing all contractual documentation and receipt of all applicable regulatory approvals and the policies of the Canadian Securities Exchange ("CSE"). All securities issued pursuant to the Private Placement are subject to a statutory hold period of four months and one day from the date of issuance. The Company intends to use the net proceeds of the Private Placement for general working capital purposes, including, enabling the Company to fund and advance its business plans in regard to its successful recent acquisition of the entire portfolio of discovery, preclinical and clinical development stage assets in oncology, infectious disease, antigen desensitization, and other immunological fields based on the DPX immune educating platform technology, developed by the former Canadian biotechnology company, IMV Inc., Immunovaccine Technologies Inc., and IMV USA ("IMV") on February 16th, 2024.The Company may pay a finder’s fee related to the financing.