On August 20, 2024 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid" or the "Company") a commercial-stage, cancer prevention medical diagnostics company and subsidiary of PAVmed Inc. (Nasdaq: PAVM), reported the peer-reviewed publication of an analytical validation study of its EsoGuard Esophageal DNA test for the diagnosis of esophageal precancer (Barrett’s Esophagus or BE) and esophageal adenocarcinoma (EAC) on samples collected non-endoscopically using Lucid’s EsoCheck Esophageal Cell Collection Device (Press release, Lucid Diagnostics, AUG 20, 2024, View Source [SID1234646017]). The manuscript, entitled Analytical Validation of a DNA Methylation Biomarker Test for the Diagnosis of Barrett’s Esophagus and Esophageal Adenocarcinoma from Samples Collected Using EsoCheck, a Non-Endoscopic Esophageal Cell Collection Device, has been published in the peer-reviewed journal Diagnostics, and is currently available via open access online.

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"This analytical validation study strongly complements EsoGuard’s extensive peer-reviewed, published clinical validity and clinical utility evidence base," said Suman Verma, M.D., PhD, Lucid’s Chief Scientific Officer. "The results demonstrate very robust analytical performance of the EsoGuard assay performed in our CLIA-certified, CAP-accredited, NY State-approved commercial laboratory."

The publication details comprehensive studies demonstrating excellent analytical performance of the EsoGuard assay on samples collected with EsoCheck, including 89% analytical sensitivity, 100% analytical specificity, 96% analytical accuracy, and 100% inter- and intra-assay precision. EsoGuard utilizes next-generation sequencing (NGS) to detect DNA methylation at 31 sites on two genes, vimentin (VIM) and cyclin A1 (CCNA1), which have been shown to be associated with conditions along the BE-EAC spectrum.

On August 20, 2024 Adcendo ApS ("Adcendo") and Multitude Therapeutics Inc. ("Multitude") jointly reported that they have signed a licensing agreement for the development of a novel, highly differentiated antibody-drug conjugate (ADC) targeting Tissue Factor (TF) with the development code ADCE-T02 (Press release, ADCendo, AUG 20, 2024, View Source [SID1234646018]). Under this agreement, Adcendo will obtain the exclusive development and commercialization rights for the asset globally, except for the Greater China region (Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region, and Taiwan) where Multitude will retain development and commercialization rights.

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According to the financial terms of the agreement, Multitude would receive upfront and milestone payments upon achieving development, regulatory, and commercial milestones totally over $1 billion, as well as single-digit to low double-digit tiered royalties on potential future product sales.

TF is a clinically validated ADC target that is highly expressed in indications such as non-small cell lung cancer, colorectal cancer, cervical cancer, oesophageal cancer, head and neck cancer, bladder cancer and certain gastrointestinal cancers, but its expression is limited in normal tissues.

ADCE-T02 is a highly differentiated anti-TF ADC, and the first ADC with a Topoisomerase I inhibitor-based linker/payload, to enter into clinical development in Australia, US and Europe. Its unique antibody design minimizes the impact on the coagulation pathway, while the T1000-exatecan linker-payload technology platform has been shown to amplify the bystander effect, improve linker stability, and has the potential to overcome potential resistance mechanisms. These differentiated features promise to translate into a superior therapeutic window, a better safety profile, enhanced response rates and longer response durations through reduced toxicity driven treatment terminations, interruptions or dose reductions.

Clinical Trial Notification for ADCE-T02 has been submitted in Australia, and an IND application in the United States is planned in the near future. The start of the Phase I study in Australia is expected in Q4 2024.

Michael Pehl, Chief Executive Officer of Adcendo, stated: "We are highly impressed by the deep science behind Multitude Therapeutics’ linker/payload platforms and are delighted about our licensing agreement on ADCE-T02, which perfectly complements our existing unique first-in-class ADC pipeline and allows Adcendo to become a clinical-stage biotech company in Q4 2024. TF is an excellent ADC target with ample opportunity in high unmet need indications, as was recently reported at the annual ASCO (Free ASCO Whitepaper) congress. The highly differentiated profile of ADCE-T02 will enable a full capture of the potential of this target and will hopefully bring tangible progress to cancer patients in need".

Dr. Xun Meng, Chief Executive Officer of Multitude, stated: "We are delighted to collaborate globally with Adcendo. The successful cooperation demonstrates that the T1000-exatecan linker-payload platform has played a significant role in multiple successful ADC pipelines. We look forward to Adcendo’s experienced global clinical development team bringing ADCE-T02 to cancer patients in need as soon as possible."

On August 20, 2024 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported a collaboration with Tempus, a technology company leading the adoption of AI to advance precision medicine and patient care, to advance the clinical development of BerGenBio’s selective AXL inhibitor bemcentinib in first line (1L) Non-Small Cell Lung Cancer (NSCLC) patients with STK11 mutations (STK11m) (Press release, BerGenBio, AUG 20, 2024, View Source [SID1234646019]). BerGenBio’s on-going BGBC016 Phase 1b/2a trial is designed to assess the benefit of adding bemcentinib to the current standard of care treatment (immunotherapy + doublet chemotherapy) in 1L STK11m patients, a population with poor outcomes and no specific therapies today.

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The collaboration will provide BerGenBio with access to a tailored cohort of Tempus’ real-world clinical and molecular data that is intended to establish a synthetic control to provide a contextual benchmark for BerGenBio’s innovative study, which aims to address the urgent medical need for effective treatments in STK11m NSCLC patients. Tempus’ comprehensive, AI-enabled platform will enable BerGenBio to receive customized analyses of Tempus data and gain deeper insights into the genomic landscape and therapeutic responses of NSCLC patients with STK11m.

Upon conclusion of the BGBC016 study, the parties intend to present insights derived from the resulting data to appropriate regulatory agencies as a next step in the further development of bemcentinib.

Martin Olin, CEO of BerGenBio, expressed enthusiasm about the collaboration, stating, "We are excited to partner with Tempus to harness the power of their advanced technology in our mission to improve outcomes for NSCLC patients with STK11 mutations. By integrating Tempus’ platform into our study, we aim to enhance our understanding of the disease biology and treatment outcomes, ultimately driving our ability to accelerate further development of bemcentinib".

"We are excited to collaborate with BerGenBio to accelerate the development of precision therapies for STK11m NSCLC patients," said Kate Sasser, Chief Scientific Officer at Tempus. "Together, we aim to unlock new insights that will ultimately improve patient outcomes and redefine the standard of care in this challenging disease setting."

On August 19, 2024 ImmunoPrecise Antibodies Ltd. (the "Company" or "IPA") (NASDAQ: IPA), an AI-driven biotherapeutics company, reported a groundbreaking achievement: the ability to engineer antibodies entirely through computer simulations using LENSai (Press release, ImmunoPrecise Antibodies, AUG 19, 2024, View Source [SID1234645982]). This marks a significant milestone for the biotechnology industry. Additionally, the antibodies produced by IPA are highly specific to a challenging oncology target located within the Tumor Microenvironment (TME).

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This achievement was made possible by the patented LENSai technologies, which began from an exceptionally challenging starting point: the target protein had no previously known structural information. Despite this, the LENSai platform was able to model the protein’s structure and accurately engineer antibodies specifically tailored to bind to it. This is particularly significant because designing effective therapeutics without prior structural knowledge of the target is a major hurdle in drug discovery, often requiring extensive experimentation and resources. LENSai’s ability to overcome this challenge entirely in silico highlights its advanced capabilities in computational biology and its potential to revolutionize the field of antibody engineering.

The potential therapies were engineered to bind exclusively to the oncology target under specific conditions. Importantly, it was demonstrated that these therapies do not bind to similar proteins known to be present on healthy cells and tissues, which is crucial because such binding typically leads to the negative side effects seen in chemotherapy. These findings highlight LENSai’s ability to address one of the toughest challenges in optimizing antibodies for oncology.

"This marks a significant milestone for the biotechnology industry, demonstrating LENSai’s ability to engineer highly specific and validated antibodies for the exceedingly difficult environment around tumors, and doing so entirely on a computer," said Dr. Jennifer Bath, President and CEO of IPA. "This success, elevated by the fact that important details of the protein being targeted were unknown, represents a major feat in the application of LENSai in generating targeted and specific therapies for the potential treatment of cancer. Moreover, our continuous advancements and integrations have significantly enhanced our ability to develop these therapies faster, more efficiently, and at a reduced cost compared to traditional methods."

Historically, biologic drug discovery has been a risky, time-consuming, and expensive endeavor, with failure rates exceeding 90%. Recent data indicates that it now costs approximately $1.3 billion and takes an average of 10 to 15 years to bring a single new drug to market, with costs potentially rising even higher depending on the complexity of the drug and therapeutic area​. The market has seen major successes like Humira, which has shown potential in the tumor microenvironment and has generated over $20 billion in annual sales. Similarly, Keytruda has demonstrated effectiveness in modulating the tumor microenvironment and has generated over $14 billion annually. However, the time, cost, and risk associated with developing such biologics have historically limited the number of these therapies that can be pursued, creating a bottleneck in the availability of life-saving treatments.

"The successful application of LENSai, along with laboratory validation of these novel antibodies, underscores LENSai’s potential to accelerate the development of precision-targeted treatments, aimed at more effective cancer therapies with fewer side effects," stated Dr. Dirk Van Hyfte, MD, PhD, Co-Founder and Head of Innovation at BioStrand, an IPA subsidiary. "What LENSai has accomplished today is just one of the reasons we firmly believe in its ability to bring potentially life-changing biologics to patients with the power of our AI."

On August 19, 2024 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported that enrollment has resumed for the Company’s ongoing VISTA-101 Phase 1/2 clinical trial, effective immediately (Press release, Kineta, AUG 19, 2024, View Source;utm_medium=rss&utm_campaign=kineta-reopens-enrollment-for-the-vista-101-clinical-trial-evaluating-kva12123-in-patients-with-advanced-solid-tumor-cancer [SID1234645983]). As previously announced on March 12, 2024, patient enrollment in the clinical trial was suspended due to certain investors indicating that they would not fulfill their funding obligation due in April 2024 pursuant to the previously disclosed private placement financing.

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To date, KVA12123 has cleared the fifth of six monotherapy dose levels and two of the four cohorts in combination with pembrolizumab. Initial results demonstrating partial response and stable disease in the combination cohorts and durable stable disease in the monotherapy cohorts were reported earlier this year at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024. Additionally, the initial results of KVA12123 showed a favorable clinical safety and tolerability profile with no dose limiting toxicities and no evidence of CRS-associated cytokines at any dose level.

"We are very pleased to resume enrollment for VISTA-101. KVA12123 has been well tolerated with no dose limiting toxicities and no cytokine release syndrome and we continue to be encouraged by the initial data demonstrated. With enrollment now recommenced, we are focused on successful execution and working towards completing enrollment which we expect to do by the end of 2024," said Thierry Guillaudeux, Chief Scientific Officer of Kineta.

On July 8, Kineta announced that it had entered into an exclusivity and right of first offer agreement (the "Agreement") with TuHURA Biosciences, Inc. ("TuHURA"), a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy. As part of the Agreement, Kineta received a concurrent $5 million nonrefundable payment from TuHURA. Kineta and TuHURA are cooperating on the reinitiation of patient enrollment into this trial.

"KVA12123 is a novel, differentiated new treatment alternative for patients with cancer. The completion of the enrollment in the Phase 1 portion of the trial this year is an important milestone for this exciting development program and we are pleased to work closely with the Kineta team to resume enrollment," said James A. Bianco, Chief Executive Officer of TuHURA.

Pursuant to the Agreement, among other things, Kineta has granted TuHURA an exclusive right to acquire Kineta’s worldwide patents, patent rights, patent applications, product and development program assets, technical and business information, and other rights and assets associated with and derived from its development program related to KVA12123, Kineta’s VISTA blocking immunotherapy. This exclusive right shall continue through the first to occur of (a) the execution of any definitive agreement with respect to a potential transaction by TuHURA or one or more of its affiliates and (b) 11:59 PM Eastern Time on October 1, 2024, subject to extension.

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