On August 29, 2024 Nuvectis Pharma, Inc. (NASDAQ: NVCT) ("Nuvectis" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, reported that NXP800 was granted Orphan Drug Designation by the United States Food and Drug Administration ("FDA") for the treatment of AT-rich interactive domain-containing protein 1a (ARID1a) ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers (Press release, Nuvectis Pharma, AUG 29, 2024, View Source [SID1234646206]).

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Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "We are very pleased to have received this designation from the FDA for NXP800. The prevalence of ovarian cancer, which is comprised of ovarian, fallopian tube and primary peritoneal cancers, exceeds the 200,000 patient threshold below which drugs may be eligible to receive orphan drug designation in the United States and in ovarian cancer it has been uncommon to receive this designation for the treatment of a subset of the disease. We therefore believe that this Orphan Drug Designation granted by the FDA for NXP800 for the treatment of a subset of ovarian cancer, specifically for patients with an ARID1a deficiency, provides further validation for NXP800’s mechanism of action and the target patient population in our ongoing Phase 1b clinical trial in patients with platinum resistant, ARID1a-mutated ovarian cancer. We expect to provide a data update from this study this coming fall."

About Orphan Drug Designation

Orphan Drug Designation is granted by the FDA to drugs or biologics intended to treat a rare disease or condition, defined as one that affects fewer than 200,000 people in the United States. Orphan Drug Designation provides certain financial incentives to support clinical development, and the potential for up to seven years of marketing exclusivity for the product for the designated orphan indication in the United States if the product is approved for its designated indication.

On August 29, 2024 Median Technologies (FR0011049824, ALMDT, PEA/PME scheme eligible, "Median" or "The Company") reported that eyonis LCS, its proprietary Artificial Intelligence (AI)/machine learning (ML) powered Software as Medical Device (SaMD) for lung cancer screening (LCS), met the primary and all secondary endpoints in REALITY, the first of two pivotal studies required for marketing authorizations in U.S. and Europe (Press release, MEDIAN Technologies, AUG 29, 2024, View Source [SID1234646224]).

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Median’s eyonis LCS SaMD is designed for improving the detection and diagnostic accuracy of low-dose computed tomography (LDCT). LDCT imaging is the standard of care globally and is currently the only approved lung cancer screening modality in U.S. and Europe.

Fredrik Brag, CEO of Median Technologies said: "These data met our ambition for improving the performance of LDCT with eyonis LCS. Now, we are even more excited to report the upcoming RELIVE pivotal data and file for marketing authorizations in H1 2025. We believe that broad implementation of LDCT with eyonis LCS has the potential to vastly improve early detection and lead to far more cures, dramatically reducing lung cancer mortality."

The average five-year survival rate for all lung cancer patients is 18.6 percent because only 16 percent of lung cancers are diagnosed at an early stage2. Conversely, Stage 1 lung cancer can be cured when detected, with an 80% survival rate after 20 years, where many die from other causes. For Stage 1A cancers that measure 10 mm or less, the 20-year survival rate has been shown to be 92%.

Consequently, there is tremendous momentum behind efforts in the U.S., Europe and Asia to increase lung cancer screening and improve its accuracy. Enabling the accurate early detection of lung cancer with eyonis LCS could dramatically improve lung cancer survival.

Thomas Bonnefont, COO and CCO eyonis Business Unit said: "The high performances of our device can not only save lives but also prevent healthy patients undergoing unnecessary medical procedures. This will avoid unnecessary distress for patients and reduce healthcare costs."

Lung cancer screening is recommended by the U.S. Preventive Services Task Force (USPSTF) in adults aged 50 to 80 years who have a 20 pack-year smoking history. The market opportunity includes a population of 14.5 million people in the US alone, currently eligible for a lung cancer screening exam, with an existing potential reimbursement of $650 per exam with a SaMD postprocessing for characterization of malignant vs benign nodules. This represents a total addressable annual market of over $9 billion. The eligible U.S. patient number is expected to rise in the coming years, driven by planned broadening of the eligibility criteria. Similarly, new lung screening program deployments are planned in Europe and Asia. Around $230bn were spent on cancer medical care in 2023 in the US. The vast majority of cancer care costs are incurred in treating advanced cancer patients, versus preventive care such as screening that can save patients’ life.

Definitive results from REALITY show that eyonis LCS can accurately detect and characterize cancerous nodules. The novel SaMD achieved exceptional results, with an area under the curve (AUC) value of 0.904 at patient level versus an AUC of 0.80 – the minimum value set as a primary endpoint for REALITY. Importantly, 80% of the cancers in the analyzed cohort of REALITY were difficult-to-diagnose Stage 1 cancers. Moreover, the REALITY cohort was enriched compared to real life with small non-spiculated cancers, and large spiculated benign nodules, both of which are challenging for radiologists to diagnose.

The pivotal REALITY study (Clinicaltrials.gov identifier: NCT0657623), initiated in July 2023, collected retrospective imaging and clinical data from 1,147 patients from five major cancer centers and hospitals in the US and Europe and two clinical data providers. REALITY evaluated eyonis LCS ability to diagnose lung cancer. The objectives were to assess eyonis LCS standalone performance in characterizing cancerous vs non-cancerous patients (i.e. "performance at patient level"), and in detecting and characterizing suspicious versus malignant nodules. The primary endpoint of REALITY was determined after consultation with the U.S. regulatory authorities and the primary endpoint was selected to show that eyonis LCS would achieve an AUC superior to 0.8.

The second pivotal trial, RELIVE, is a Multi-Reader Multi-Case (MRMC) study that will offer clinical validation of eyonis LCS to complement the analytical validation already achieved and communicated today with REALITY. All the patient recruitment and relevant patient clinical data for the RELIVE study have already successfully been collected from the participating sites. RELIVE is scheduled for completion in the coming months, with an anticipated data read-out in Q1 2025 and regulatory filings in H1 2025.

About eyonis LCS: eyonis Lung Cancer Screening (LCS) is an artificial intelligence (AI) powered diagnostic tool that uses machine learning (ML) to help analyze imaging data generated with low-dose computational tomography (LDCT) to diagnose cancer at the earliest stages, when it can still be cured in the majority of patients. eyonis LCS has been classified by regulators as "Software as Medical Device", or SaMD, and is the subject of two pivotal studies required for marketing approvals in the U.S. and Europe: REALITY (successfully completed – Clinicaltrials.gov identifier: NCT0657623) and RELIVE (ongoing). Filing applications including these pivotal data are scheduled to be submitted for FDA 510(k) premarket clearance and CE marking in H1 2025. In the interim, eyonis technology is being used in at clinical research centers. Separately, Median’s AI technology is being sold and deployed via Median’s iCRO business unit, to biopharmaceutical companies performing clinical trials of experimental therapeutics, including the world’s leading pharmaceutical companies in cancer.

On August 28, 2024 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported the closing of its previously announced public offering, upsized to 6,000,000 shares of its American Depository Shares ("ADSs")(or pre-funded warrants in lieu thereof), together with Series H warrants ("Series G Warrants") to purchase up to 6,000,000 ADSs at a combined public offering price of $1 per ADS (or pre-funded warrant in lieu thereof) and associated Series H Warrant (Press release, TC Biopharm, AUG 28, 2024, View Source [SID1234646168]). The Series H Warrants have an exercise price of £0.76 per ADS, are exercisable upon issuance and will expire one year from the date of issuance. Each ADS represents two hundred ordinary shares of the Company.

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The gross proceeds to the Company from the offering are $6.0 million, before deducting offering expenses payable by the Company. The Company intends to use the net proceeds from this offering to support its upcoming clinical trial focusing on relapse/refractory Acute Myeloid Leukemia, for market awareness and for continuing operating expenses and working capital.

The securities described above are being offered by the Company pursuant to a registration statement on Form F-1 (File No. 333-281613) previously filed with and declared effective by the U.S. Securities and Exchange Commission ("SEC") on August 28, 2024 and an additional registration statement on Form F-1 filed pursuant to Rule 462(b) which became automatically effective on August 28, 2024. . The offering was made only by means of a prospectus, which is part of the effective registration statement. A final prospectus relating to the offering will be filed with the SEC. Electronic copies of the final prospectus may be obtained for free on the SEC’s website located at View Source

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

On August 28, 2024 Delcath Systems, Inc. (Nasdaq: DCTH) (the "Company" or "Delcath"), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported the publication of a clinical study in the journal Therapeutic Advances in Medical Oncology (Press release, Delcath Systems, AUG 28, 2024, View Source [SID1234646153]). The publication, entitled "Melanoma-specific survival of patients with uveal melanoma and liver metastases diagnosed between 2005 and 2021", was based on an independent retrospective clinical study conducted by investigators from the University of Tübingen, Germany. The study demonstrates that first-line liver-directed therapies, including Delcath’s CHEMOSAT Hepatic Delivery System, significantly improve melanoma-specific survival (MSS) in patients with liver metastases from uveal melanoma, compared to first-line systemic therapies.

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Key Findings from the Study:

Positive Trends in Survival with First-Line Liver-Directed Therapies: The study analyzed 167 patients diagnosed with metastatic uveal melanoma between 2005 and 2021. Among those receiving first-line liver-directed therapy (N=89), the median MSS was 28 months, compared to 10 months for patients who received first-line systemic therapy (N=45).
Comparison of Outcomes Over Time with First-Line Liver-Directed Therapies: The study found that patients diagnosed with liver metastases between 2016 and 2021 (N=56) and treated with first-line liver-directed therapy, including CHEMOSAT, had a median MSS of 30 months. In comparison, patients diagnosed between 2005 and 2015 (N=33) who received first-line liver-directed therapy had a median MSS of 20 months.

During the 2005-2015 period, 33 patients received liver-directed therapy, with 8 of those receiving CHEMOSAT. In the 2016-2021 period, 56 patients received liver-directed therapy, with 30 of those receiving CHEMOSAT.
Dr. Vojislav Vukovic, Chief Medical Officer of Delcath Systems, commented, "We are encouraged by the findings from this independent study, which reinforce the critical role of liver-directed therapies in the first-line setting, including our CHEMOSAT system, in treating patients with liver metastases from uveal melanoma."

On August 28, 2024 Akeso, Inc. (9926.HK) reported its interim results, highlighting the Company’s continued innovation and commercial execution (Press release, Akeso Biopharma, AUG 28, 2024, View Source [SID1234646169]). The Company has solidified its lead in cancer immunotherapy bispecific antibodies with the successful market approval of cadonilimab(PD-1/CTLA-4) and ivonescimab(PD-1/VEGF). In the first half of 2024, 4 new drugs were launched, and applications for market approval were submitted for 7 indications across 5 new drugs, and 12 products are in Phase lll clinical trials or commercial stage. Over 20 phase III clinical trials have been completed or are in progress.

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Akeso is propelling forward with innovative therapies to drive global oncology treatment advancements: 6 novel bispecific antibodies have entered clinical trials, and the Company’s first differentiated ADC, AK138D1, is now in clinical development. Upcoming are new drugs featuring ADCs, bispecific ADCs, trispecific antibodies, and other novel targets and mechanisms.

In the first half of the year, Akeso achieved strong commercial growth with innovative drug sales reaching RMB939.4 million, representing an increase of 23.96% for the same period last year. Cadonilimab remained strong and recorded approximately RMB705.7 million, representing an increase of 16.5% for the same period last year, despite having only one 2/3 line cervical cancer indication. Ivonescimab was successfully approved on May 24, 2024 with achieved net product sales exceeding RMB100 million. The Company’s total cash and short-term financial assets, including time deposits, are RMB5.69 billion.

Dr. Michelle Xia, Founder, Chairwoman, President, and CEO of Akeso, said: "In 2024, Akeso has become a major contributor to the field of cancer immunotherapy, outperforming our goals for the year’s first half. The approval of cadonilimab has affirmed our innovative strategy and efficiency in bispecific antibody development, setting a strong foundation for drug commercialization. The success of ivonescimab’s approval further demonstrates our consistent ability to innovate, providing essential support for its international launch and our global drug commercialization efforts.

We’ve launched over 50 clinical trials for combination therapies leveraging the clinical potential of cadonilimab and ivonescimab. Our ongoing exploration includes integrating our two cornerstone bispecific assets with ADCs/bispecific ADCs and innovative treatment approaches for multiple tumor types. This drive will enhance global cancer treatment standards and fuel our sustained, high-quality global expansion over the next five years.

In addition, we’re rapidly advancing research and clinical development across a diverse range of targets including ADCs, bispecific ADCs, tri-specific antibodies, and other innovative therapeutic modalities. Our robust clinical pipeline enhances our product portfolio, maximizes the clinical impact of our key offerings, and establishes a strong base for Akeso’s medium to long-term global growth."

Global Leading Bispecific Antibodies Achieve Major Breakthroughs

Ivonescimab (PD-1/VEGF Bispecific Antibody)

In May 2024, following the HARMONi-A study, ivonescimab was approved in China for the treatment of epidermal growth factor receptor ("EGFR") mutated locally advanced or metastatic non-squamous non-small cell lung cancer ("nsq-NSCLC"). HARMONi-A is the only phase III study that demonstrates significant benefit across all subgroups for PFS, and is also the only study to achieve the primary endpoint while showing a positive trend in OS benefit. Ivonescimab became the world’s first approved PD-1/VEGF bi-specific antibody.

Following the HARMONi-2 study’s positive interim analysis results, which demonstrated that ivonescimab monotherapy decisively beats pembrolizumab monotherapy head-to-head in patients with PD-L1 positive (TPS≥1%) locally advanced or metastatic NSCLC, ivonescimab has been recognized as the only drug to achieve this milestone in this setting. The interim analysis results have led to the NMPA’s priority review of the sNDA for ivonescimab for this indication. The ongoing Phase III studies are strengthening confidence in the HARMONi and HARMONi-3 trials’ outcomes and global market potential.Ivonescimab will become the new standard treatment for first-line lung cancer, offering patients a novel and superior "chemotherapy-free" option.

Currently, ivonescimab has 1 approved lung cancer indication in China, 1 under priority review, and 6 Phase III lung cancer trials completed or ongoing, including 4 head-to-head studies with PD-1. In addition, Akeso has launched or is about to launch 3 Phase III clinical trials for ivonescimab:

Ivonescimab combined with ligufalimab (CD47) for first-line treatment of PD-L1 positive head and neck squamous cell carcinoma (vs. pembrolizumab).
Ivonescimab combination therapy for first-line treatment of biliary tract cancer (vs. durvalumab combination ).
Ivonescimab combination therapy for first-line treatment of pancreatic cancer.
Ivonescimab has been involved in more than 25 clinical trials across 17 indications, including lung, pancreatic, breast, hepatocellular, colorectal, and other cancers.

Cadonilimab（PD-1/CTLA-4 Bispecific Antibody)

Since approval, cadonilimab has received widespread clinical and patient acclaim in cancer immunotherapy, backed by strong clinical evidence. Its role as a cornerstone drug in next-gen immunotherapy is becoming more apparent. Besides its approved use for 2/3 line cervical cancer, submissions for first-line advanced gastric and cervical cancer treatments are under regulatory review. Ongoing Phase III trials reveal substantial benefits for diverse PD-L1 expressing patients, offering new options to address critical unmet need in this patient population.

Additionally, cadonilimab has been involved in 8 ongoing or completed pivotal/Phase III clinical trials: Trials for postoperative adjuvant therapy in hepatocellular carcinoma, intermediate-stage hepatocellular carcinoma, and unresectable NSCLC are swiftly progressing. Trials for gastric cancer that has progressed after PD-1/L1 treatment and first-line treatment for PD-L1 negative NSCLC are also steadily enrolling patients, showcasing cadonilimab’s potential to offer unique clinical advantages and address the limitations of single-target antibody therapies. To date, cadonilimab as a monotherapy or in combination has been engaged in over 23 clinical trials for 16 indications, including gastric, lung, liver, cervical, and pancreatic cancers.

Ligufalimab (CD47 Monoclonal Antibody, AK117)

The Phase III trial of ligufalimab for first-line head and neck squamous cell carcinoma (vs. pembrolizumab) has begun, making it the first CD47 mAb to enter Phase III for solid tumors. The international multi-center Phase II trial of ligufalimab, AK117 for treating myelodysplastic syndromes (MDS) is also underway as part of AK117’s global approval process. Ligufalimab is also being investigated for acute myeloid leukemia (AML), and Phase I/II trials have also been initiated for ligufalimab combined with AK129 (PD-1/LAG-3) in classic Hodgkin lymphoma (cHL). Additionally, several clinical studies for solid tumors are underway.

The Phase III clinical trial for AK109, a novel VEGFR-2 monoclonal antibody, has been initiated in combination with cadonilimab for PD-1/L1-resistant gastric cancer. Clinical trials of other self-developed new drugs in combination with AK109 are also progressing efficiently.

Pursuing More Innovative Therapies

In the first half of the year, Akeso advanced over 10 new therapies into clinical trials, including bispecific antibodies like ivonescimab, cadonilimab, AK129 (PD-1/LAG-3), and AK130 (TIGIT/TGF-β), either in combination with each other or with other high-potential therapies. The Company also introduced its first differentiated ADC product, AK138D1 (HER3 ADC), as well as other innovative therapies into clinical research. Development is ongoing for preclinical candidates such as bispecific antibody AK137 (CD73/LAG-3), bispecific ADC trispecific antibody AK150, and new drug AK135 (IL-1RAP) for chemotherapy-induced peripheral neuropathy. Additionally, multiple candidates in ADC, mRNA, and cell therapies are actively advancing in development.

Non-Oncology Business Enters Commercialization Phase on a Large Scale

Ebdarokimab(IL-12/IL-23) for moderate to severe plaque psoriasis, ebronucimab (PCSK9) for primary hypercholesterolemia and mixed hyperlipidemia, and heterozygous familial hypercholesterolemia (HeFH), have been accepted by NMPA, with anticipated approvals in 2024-2025. Following positive Phase III outcomes, gumokimab (AK111, IL-17) for plaque psoriasis is ready for an NDA submission. Additionally, Phase III trials for gumokimab in ankylosing spondylitis and manfidokimab (AK120, IL-4R) for atopic dermatitis are progressing, with the latter having enrolled its first patient.