On October 3, 2023 SciTech reported that it has successfully manufactured the clinical supply of its lead drug candidate, ST-001 nanoFenretinide, to initiate its upcoming clinical trial in T-cell non-Hodgkin lymphomas (NCT04234048) (Press release, SciTech Development, OCT 3, 2023, View Source [SID1234635608]).

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SciTech’s contract drug manufacturing partner has successfully manufactured ST-001 under strict QA/QC quality standards. Through a combination of innovative science and advanced nanotechnology, SciTech has developed ST-001, a new and patented formulation that enables the safe and rapid infusion of high-dose fenretinide for cancer treatment. SciTech’s Delivery Platform maximizes the bioavailability of water-insoluble drugs. ST-001 has passed extensive testing required for IV-administered drug products, including United States Pharmacopeia (USP) testing for sterility, endotoxins, particle sizing, and particulate matter as well as International Conference on Harmonization (ICH) guidelines for heavy metals and drug impurities.

"SciTech is thrilled to announce the successful manufacturing of ST-001 as we begin our human clinical trials. This is another major milestone for the company. Our team and investors are passionate about bringing ST-001 to the market for the treatment of T-cell lymphomas and other broader indications," said Earle Holsapple, President of SciTech Development. "We know that both patients and clinicians are looking for innovative and cost-effective ways to solve this cancer epidemic. SciTech is proud to be part of the medical community offering a new therapeutic and a giant step forward to help conquer cancer."

SciTech’s specialized drug formulation increases the bioavailability of fenretinide, which allows more of the active drug to reach the cancer cells. ST-001 binds to the cancer cells and disrupts the nucleus, causing the cancer cells to die. With ST-001, our goal is to reduce drug-related toxicities and achieve optimal drug concentrations for better patient outcomes.

To learn more, watch the video on How ST-001 Works.

On October 3, 2023 Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, reported that FDA has granted it clearance to proceed with TranStar 301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy as first-line treatment in patients with HER2-negative, CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma (Press release, Transcenta, OCT 3, 2023, View Source [SID1234635607]). This clearance marks a major step forward in the global development of Osemitamab (TST001) and another important milestone following the approvals by the Center for Drug Evaluation (CDE) in China and MFDS in South Korea for the Phase III pivotal trial of Osemitamab (TST001) in July 2023.

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This milestone marks a crucial advancement in the progression of Osemitamab (TST001) toward becoming a global therapy that elevates the current standard of care for HER2-negative metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma. By specifically targeting CLDN18.2 and combining it with Nivolumab and chemotherapy, Osemitamab (TST001) is poised to reshape the treatment paradigm for G/GEJ cancer.

Stomach cancer remains an important cancer worldwide and is responsible for over one million new cases in 2020 and an estimated 769,000 deaths (equating to one in every 13 deaths globally), ranking fifth for incidence and fourth for mortality globally1. Combinations of platinum and fluoropyrimidine represent the backbone chemotherapy regimen for patients with HER2-negative advanced gastric cancer2. Nivolumab was approved in combination with chemotherapy for first-line treatment of patients with advanced or metastatic gastric cancer. Though treatment outcomes have improved, the median overall survival of nivolumab plus chemotherapy is still less than 14 months3.

Osemitamab (TST001) is a second-generation humanized CLDN18.2 targeting antibody with improved CLDN18.2 binding affinity and enhanced antibody-dependent cellular cytotoxicity ("ADCC"). It has shown anti-tumor activities in preclinical tumor models with a broad range of CLDN18.2 expression.

To support the global Phase III trial application and FDA EOP2 meeting, Transcenta has conducted Phase II clinical trials in both the U.S. and China of the combination of Osemitamab (TST001) with chemotherapy or nivolumab and chemotherapy with multiple Osemitamab (TST001) doses cohorts to optimize the dose for the global Phase III trial. Furthermore, Transcenta has developed a CLDN18.2 specific companion diagnostic assay with a credible CDx developer in the U.S.

At the 2023 ASCO (Free ASCO Whitepaper) annual meeting and 2023 ESMO (Free ESMO Whitepaper) GI conference, Transcenta presented encouraging efficacy data of Osemitamab (TST001) in combination with CAPOX as the first-line treatment of G/GEJ cancer. A total of 64 patients were enrolled and treated with Osemitamab (TST001) at doses ranging between 1 and 8mg/kg Q3W in a dose escalation and dose expansion cohort. CLDN18.2 positivity (defined as: IHC membrane staining ≥10% tumor cells with ≥1+ intensity per LDT assay, selecting approximately 55% of the screened patients) was required for the efficacy expansion. The data showed that the estimated median progression-free survival (PFS) was 9.5 months for all dose groups, consistent across all CLDN18.2 expression levels, with a median duration of response (DOR) of 9.9 months. PFS and DOR data for the 49 patients treated at the dose of 6mg/kg Q3W in the efficacy expansion will be presented at ESMO (Free ESMO Whitepaper) 2023. These data also show that the CLDN18.2 positive patients benefiting from the addition of Osemitamab (TST001) to standard of care could represent more than 55% of all G/GEJ adenocarcinomas.

"We are delighted with the positive outcome of the EOP2 meeting," said Dr. Caroline Germa, Transcenta Executive Vice President, Global Medicine Development and Chief Medical Officer. "The interim safety, clinical pharmacology and efficacy data we presented fostered a productive dialogue with the FDA. Securing FDA endorsement on critical program elements represents a pivotal milestone in advancing our Phase III trial in the U.S."

References:
[1] Hyuna Sung, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185
Countries. CA CANCER J CLIN 2021;71:209–249
[2] NCCN guideline for Gastric Cancer Version 2.2022
[3] Janjigian YY, Shitara K, Moehler M, et al. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet 2021;398:27-40

About Osemitamab (TST001)
Osemitamab (TST001) is a high affinity humanized anti- CLDN18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity ("ADCC"). It has shown potent anti-tumor activities in tumor xenograft models. Osemitamab (TST001) is the second most advanced CLDN18.2 targeting antibody being developed globally. Osemitamab (TST001) was generated using Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. Osemitamab (TST001) kills CLDN18.2 expressing tumor cells by mechanisms of ADCC. Leveraging advanced bioprocessing technology, the fucose content of Osemitamab (TST001) was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of Osemitamab (TST001). Clinical trials for Osemitamab (TST001) are ongoing in the U.S. and China (NCT05190575, NCT04396821, NCT04495296, NCT05608785 / CTR20201281). Osemitamab (TST001) was granted Orphan Drug Designation in the U.S. by FDA for the treatment of patients with gastric or gastroesophageal junction (G/GEJ) and pancreatic cancer.

On October 3, 2023 The U.S. Food and Drug Administration (FDA) reported that it has granted approval for EntroGen’s CRCdx RAS Mutation Detection Kit as a companion diagnostic for Vectibix (panitumumab), a targeted therapy used in the treatment of colorectal cancer (Press release, EntroGen, OCT 3, 2023, View Source [SID1234635606]). This landmark premarket approval (PMA) marks a significant advancement in precision medicine for colorectal cancer patients in that CRCdx is the first approved real-time PCR-based test in the U.S. that fully meets the biomarker identification requirement for Vectibix.

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The CRCdx RAS Mutation Detection Kit is a cutting-edge molecular diagnostic tool designed to accurately detect KRAS and NRAS exon 2, 3, and 4 mutations in colorectal cancer patients. The kit’s high sensitivity and specificity enable clinicians to quickly and easily identify patients most likely to benefit from Vectibix therapy and avoid unnecessary side effects and costs from treatment.

"We expect CRCdx to improve access to RAS testing at small and mid-size laboratories by simplifying the testing procedure while improving the turnaround time and lowering the diagnostic costs," said Matthew Minkovsky, CEO of EntroGen. "CRCdx is available immediately," he added.

On October 3, 2023 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted and transformative cancer therapies using its proprietary AI and machine learning (ML) platform, RADR, with multiple clinical stage drug programs, reported that in vivo data highlighting the enhanced efficacy of Lantern’s drug candidate LP-184 in glioblastoma (GBM) were published in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Lantern Pharma, OCT 3, 2023, View Source [SID1234635604]). LP-184 is a unique small molecule with low nanomolar activity and favorable CNS penetration. LP-184 utilizes its powerful mechanism of action, known as synthetic lethality, to exploit common vulnerabilities in solid tumor and CNS cancers with DNA damage repair (DDR) deficiencies. In addition, Lantern’s AI platform, RADR, has highlighted overlapping gene dependency profiles between GBM tumorigenesis and sensitivity to LP-184, such as EGFR activation pathways.

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"The data highlighted in Clinical Cancer Research solidify LP-184 as a promising therapeutic for GBM, with LP-184 having inhibited the viability and growth of multiple GBM models including temozolomide-resistant and MGMT-expressing cells," stated Panna Sharma, Lantern’s President and CEO. "The rapid advancement of LP-184 into a first-in-human Phase 1 trial provides strong validation of the power of our AI-enabled approach to drug development. This approach is about more than just developing new treatments, it’s about making them more targeted, more effective, and ultimately doing all of this more efficiently. This publication demonstrates our ability to deliver on these aspirations and introduce new therapeutic programs in areas where there is significant unmet patient need."

The article, entitled "Preclinical Efficacy of LP-184, a Tumor Site Activated Synthetic Lethal Therapeutic, in Glioblastoma" can be accessed here.

A Phase 1 clinical trial (NCT05933265) evaluating LP-184 in patients with advanced solid tumors is underway. The single arm multicenter trial is assessing the safety and tolerability of escalating doses of LP-184 to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) in patients with advanced solid tumors and recurrent high-grade gliomas, including GBM. The study has been designed as a 35 patient trial with patients receiving LP-184 infusion on Day 1 and Day 8 of each 21-day cycle, for a minimum of two cycles. Patients will be monitored for safety, pharmacokinetics, and clinical activity, and dose escalation is planned with a minimum of three patients per cohort. Lantern anticipates the Phase 1A portion of the trial to be completed in the first half of 2024 and a Phase 2 trial in GBM and other CNS cancers to begin in the second half of 2024. The anticipated Phase 2 trial will be conducted by Starlight Therapeutics, a wholly owned subsidiary of Lantern focused entirely on CNS and brain cancer indications. Lantern estimates that LP-184 has a global aggregate market potential of approximately $11-13 billion, consisting of $6-7 billion for solid tumors and $5-6 billion for CNS cancers.

About LP-184:

LP-184 is a unique small molecule that utilizes its powerful mechanism of action, known as synthetic lethality, to exploit common vulnerabilities in solid tumor and CNS cancers with DNA damage repair (DDR) deficiencies. The anti-tumor potential of LP-184 has been demonstrated across an extensive number of in-vitro and in-vivo cancer models, including pancreatic, prostate, lung, triple-negative breast cancer (TNBC), glioblastoma (GBM), brain metastases, and ATRT. In addition to LP-184’s promise as a single agent, its antitumor potency has the potential to be enhanced when used in combination with existing FDA-approved agents and other treatment modalities including spironolactone, PARP inhibitors, and radiation therapy. Results validating LP-184’s anti-tumor potential have been published at leading conferences and journals including, the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, Clinical Cancer Research, an AACR (Free AACR Whitepaper) journal, the Society for Neuro-Oncology annual meeting, the San Antonio Breast Cancer Symposium, and the Frontiers in Drug Discovery Journal.

On October 3, 2023 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, reported that it has reached agreement with the U.S. Food and Drug Administration (FDA) on plans for submission of a New Drug Application (NDA) for UGN-102 (mitomycin) for intravesical solution (Press release, UroGen Pharma, OCT 3, 2023, View Source [SID1234635603]). The FDA indicated that the current clinical development plan for UGN-102, which includes evaluation of duration of complete response (CR) at 12 months from the pivotal ENVISION trial, will support submission of an NDA for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA also agreed that the UGN-102 NDA can utilize a rolling review, allowing for early submission of the Chemistry, Manufacturing and Controls (CMC) sections of the NDA, which is planned for January 2024. If approved, UGN-102 has the potential to introduce a new non-surgical treatment paradigm for LG-IR-NMIBC, a subset of bladder cancer patients characterized by high recurrence rates and the need for multiple surgeries.

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"We are very pleased with the outcome of our pre-NDA meeting where the FDA agreed with our plan to submit our NDA for UGN-102 once all patients reach 12 months post CR. Our dialogue with the FDA during our recent pre-NDA meeting was very constructive and underscores the strength of our clinical program for UGN-102," said Liz Barrett, President and CEO, UroGen. "With the announcement of positive Phase 3 topline results from the ATLAS and ENVISION studies earlier this year, this meeting was a significant step in defining the path forward for NDA submission and potential approval for UGN-102. UroGen is committed to developing innovative treatments for those battling bladder cancer, one of the most recurrent malignancies, and UGN-102 stands at the forefront of that mission."

The UGN-102 clinical development plan centers around the Phase 3 ENVISION pivotal trial and is supported by robust clinical data from the ATLAS Phase 3 and OPTIMA Phase 2b trials.

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, currently in Phase 3 development for the treatment of LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter in an outpatient setting. Assuming positive findings from the durability of response endpoint from the ENVISION Phase 3 study, UroGen anticipates submitting an NDA for UGN-102 in 2024.