On May 6, 2024 Adcentrx Therapeutics ("Adcentrx"), a biotechnology company revolutionizing Antibody-Drug Conjugate (ADC) therapeutics for cancer and other life-threatening diseases, reported that China National Medical Products Administration (NMPA) has cleared Adcentrx’s Investigational New Drug (IND) application for ADRX-0706 which enables the company to include China-based clinical centers in the ongoing Phase 1a/1b study for the treatment of select advanced solid tumors (Press release, Adcentrx Therapeutics, MAY 7, 2024, View Source [SID1234642662]).

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ADRX-0706 is an ADC comprised of a novel fully human IgG1 antibody targeting human Nectin-4 linked to a proprietary tubulin inhibitor payload, AP052, through Adcentrx’s innovative i-Conjugation technology using a cleavable linker and stable conjugation chemistry. This novel platform technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) with a substantially expanded therapeutic window as demonstrated in preclinical studies. Nectin-4 is a validated target for ADCs with high expression in multiple solid tumors and limited expression in normal tissues. It plays a crucial role in tumor progression and has been associated with poor prognosis and resistance to conventional therapies.

"NMPA’s clearance of the ADRX-0706 IND is an important milestone for Adcentrx," said Hui Li, Ph.D., Founder and Chief Executive Officer of Adcentrx. "We now have the ability to recruit patients in both the U.S. and China to generate valuable data in different patient populations, and the data will enable us to further explore ADRX-0706 in treating patients with high unmet needs across multiple tumor types."

The first-in-human Phase 1a/b clinical trial of ADRX-0706 is an open-label, multicenter dose escalation and dose expansion study. The study is enrolling patients with select advanced solid tumors. The primary objectives of the study are to characterize the safety and tolerability and to determine the optimal dose of ADRX-0706. The company expects an initial data readout in mid-2024.

About ADRX-0706

ADRX-0706 is a fully proprietary ADC product candidate discovered by Adcentrx. The antibody component targets Nectin-4, a cell surface adhesion protein over-expressed in multiple human cancers and associated with poor disease prognosis. ADRX-0706 has a favorable pharmacokinetic and safety profile in preclinical models and has demonstrated significant efficacy across a variety of tumor indications in vitro and in vivo. ADRX-0706 is currently being evaluated in a Phase 1a/b clinical trial.

For more information about the ADRX-0706 Phase 1a/b clinical trial, please refer to the Study ID NCT06036121 on ClinicalTrials.gov.

On May 6, 2024 Assertio Holdings, Inc., a pharmaceutical company with comprehensive commercial capabilities offering differentiated products to patients, reported financial results for the first quarter ended March 31, 2024 (Press release, Assertio Holdings, MAY 6, 2024, View Source [SID1234644703]).

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"We are pleased to report a strong first quarter as our team continues to diligently execute our business plan and seeks to grow Assertio for the benefit of our stockholders," said Heather Mason, interim Chief Executive Officer. "Rolvedon generated its fifth consecutive quarter of demand growth since launch, driven by continued market penetration in the clinic setting. Additionally, we completed enrollment of Rolvedon’s same-day dosing trial, and expect the data readout by year-end, providing a potential opportunity for differentiation through medical society guidelines. We remain committed to our lean promotion platform and steadfast in our business development efforts as we work to secure additional new assets to fuel both sales growth and incremental cash flow generation."

"We are reiterating our guidance for 2024, calling for net product sales of $110 million to $125 million and adjusted EBITDA1 of $20 million to $30 million," concluded Mason.

On May 06, 2024 OverT Bio, a data-driven company working to unlock the curative potential of cell therapies in solid tumors, reported that it has raised $16 million in seed funding (Press release, OverT Bio, MAY 6, 2024, View Source [SID1234642713]). The round was co-led by ARTIS Ventures and Wing VC, with participation from Fusion Fund, OMX Ventures, Alexandria Venture Investments, Gaingels, Civilization Ventures, Hawktail, and Cancer Research Institute. The funding will go toward expanding discovery platforms focused on addressing the primary barriers for cell therapy, leading to durable and curative treatments for advanced solid tumors.

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OverT is the first to use patients’ immune response to cancer to find new receptors and targets that can be applied across the human population. The team searches the entire human genome to find new ways to make cell therapies more durable and capable of destroying cancers. The foundational science has been featured in leading scientific and medical journals, such as Nature and The New England Journal of Medicine.

"Cell therapies have shown, at least in blood cancers, that we can aim to completely cure patients that have even the most advanced diseases rather than just prolong their survival," said Dr. Mat Legut, co-founder and CEO of OverT. "With OverT’s ability to rapidly screen and engineer thousands of genes, we are building next-generation therapies to cure advanced cancers of the solid tissues."

OverT Bio combines cutting-edge cell engineering technologies with big data approaches to address major unmet medical needs in solid tumors. OverT has developed unique massively parallel genetic screening, single-cell multiomic, and synthetic biology platforms to build next-generation cell therapies. OverT’s core platform searches every gene in the genome to identify the best genetic modifications to endow immune cells with novel properties. The company has also built a similarly high-throughput approach to discover new receptors and targets that are both safe and efficacious.

"The OverT team is supercharging cell therapies and finding new cures for cancer," said Sara Choi, partner at Wing VC. "They’re a company that thinks differently and is guided by cutting-edge science – new ways to reprogram T cells, a new class of safe and broadly cancer-specific receptors often ignored by most immunologists. We look forward to supporting the team as they explore the edges of what’s possible in biotech."

"Everything OverT does is based on a patient-centric mission and focused on developing therapies that extend and enhance the lives of cancer patients," said Dr. Vasudev Bailey, partner at ARTIS Ventures. "OverT’s approaches to modifying cell behavior and for receptor discovery are highly differentiated from everything else out there. Instead of making incremental tweaks to existing therapies, OverT is making bold bets on how to create truly transformative cell therapies."

Leveraging decades of experience in cell therapy and immunology, OverT’s founding team has built a large intellectual property portfolio encompassing multiple discovery platforms and preclinical assets. Co-founder and CEO, Dr. Mat Legut, is an immunologist and entrepreneur with a track record of translating discoveries into clinical products, and co-founder, Dr. Neville Sanjana, is a faculty member at the New York Genome Center and NYU, and a pioneer in CRISPR and high-throughput functional genomics.

To learn more about OverT, please visit overt.bio.

On May 06, 2024 Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company interrogating extrachromosomal DNA (ecDNA) biology to deliver transformative therapies to patients with previously intractable oncogene amplified cancers, reported that Boundless Bio Chief Financial Officer, Jami Rubin, will present at the Citizens JMP Life Sciences Conference 2024 (Press release, Boundless Bio, MAY 6, 2024, View Source [SID1234642712]).

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The podium presentation is scheduled for Monday, May 13, in New York, NY, at 1:00 p.m. ET. A live and archived webcast of the presentation will be accessible under "Events & Presentations" in the Investors section of Boundless Bio’s website.

On May 06, 2024 Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported that the results from the company’s North American pivotal clinical study evaluating the performance of Bladder EpiCheck as a non-invasive and objective novel methylation-based PCR urine test for the surveillance of non-muscle invasive bladder cancer (NMIBC) recurrence were presented in a podium presentation at the American Urological Association (AUA) Annual Meeting 2024 in San Antonio, Texas (Press release, Nucleix, MAY 6, 2024, View Source [SID1234642711]). The data presented demonstrated Bladder EpiCheck’s potential to improve timely disease recurrence detection and compliance with NMIBC surveillance.

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"The results from our pivotal clinical study not only underscore the potential of Bladder EpiCheck as a non-invasive method for tumor recurrence detection in patients previously diagnosed with NMIBC but also signal a transformative shift in NMIBC surveillance," said Aharona Shuali, MD, MBA, Vice President of Medical Affairs at Nucleix. "The sensitivity, specificity and high predictive values demonstrated by Bladder EpiCheck are consistent with our European study and further support the utilization of the test to monitor for tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with NMIBC. These data supported Bladder EpiCheck’s 510(k) clearance from the U.S. Food and Drug Administration (FDA) in May 2023." Dr. Shuali added, "A strong anticipatory positive signal was demonstrated in patients with a positive Bladder EpiCheck result, despite negative cystoscopy and cytology, meaning these patients are at increased risk for recurrence in the following year."

"Due to its high recurrence rate, bladder cancer requires frequent and long-term surveillance with cystoscopy, and this is a burden both for patients and health systems," said Brant Inman, MD, MS, Chin-Hardie Chair of Urologic Oncology and Professor of Urology and Oncology at Western University (London, Canada). "The performance of Bladder EpiCheck in this clinical trial demonstrates its potential to be used as a non-invasive test for detecting bladder cancer recurrence. Ongoing research will determine if Bladder EpiCheck can be used to replace some cystoscopies and thereby reduce the burden of bladder cancer surveillance for patients and health systems alike."

During the AUA Annual Meeting on May 5, 2024, these results were presented by Dr. Inman in a podium presentation titled "Pivotal Study Evaluating Performance of Bladder EpiCheck, an FDA cleared test, in Non-Muscle Invasive Bladder Cancer."

About Bladder EpiCheck

Bladder EpiCheck provides physicians and their patients with a simple, objective urine test for recurrent bladder cancer. The test analyzes subtle disease-specific changes in DNA methylation markers, with high sensitivity and specificity. Bladder EpiCheck is intended for use as a non-invasive method for detection of NMIBC recurrence in conjunction with standard of care methods. Bladder EpiCheck is CE-marked and available in Europe for primary and recurrent bladder cancer and upper tract urinary cancer, and FDA 510(k) cleared for bladder cancer recurrence in the United States. It is commercially available in Europe and soon in the United States.