On April 18, 2023 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported that promising initial Phase 1b dose escalation data from FLAGSHP-1 for ERAS-601 in combination with cetuximab (ERBITUX) in patients with advanced solid tumors as part of a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Orlando, Florida. ERAS-601 is a potent, selective, oral small molecule SHP2 inhibitor with best-in-class potential (Press release, Erasca, APR 18, 2023, View Source [SID1234639359]). The poster is available online at Erasca.com/science/presentations.

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"We are pleased with the outcome of the FLAGSHP-1 dose escalation evaluation of ERAS-601 plus cetuximab, which supports ERAS-601 being a backbone for combination therapy. The combination with cetuximab was well-tolerated with favorable pharmacokinetics and no apparent drug-drug interactions. In addition, to our knowledge, this is the first clinical evaluation of a SHP2 inhibitor and EGFR monoclonal antibody, the combination of which effectively inhibits oncogenic receptor tyrosine kinase signaling," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "That we saw predominantly low-grade adverse events (AEs) reinforces our hypothesis that a ‘three weeks on, one week off’ dosing regimen for ERAS-601 in combination may lead to fewer and milder AEs."

Dr. Lim continued, "The stable disease observed during this initial all comers dose escalation evaluation in heavily pretreated patients supports our plan to explore preliminary efficacy in human papillomavirus (HPV)-negative head and neck squamous cell carcinoma (HNSCC), an indication of high unmet need, with the now identified maximum tolerated dose (MTD) for the combination. We believe this patient population may be particularly responsive to this combination based on encouraging synergistic activity observed in preclinical studies. We expect to share initial Phase 1b dose expansion combination data in the first half of 2024."

Poster Presentation Highlights
Preliminary dose escalation results of ERAS-601 in combination with cetuximab in FLAGSHP-1: A Phase I study of ERAS-601, a potent and selective SHP2 inhibitor, in patients with previously treated advanced or metastatic solid tumors
ERAS-601 in combination with cetuximab inhibits RAS/MAPK signaling at multiple nodes which is predicted to limit the development of treatment resistance and offer more robust synergistic anti-tumor activity over monotherapy alone. Characterization of the safety profile, determination of the maximum tolerated dose (MTD)/recommended dose (RD), and characterization of the pharmacokinetic profile of ERAS-601 in combination with cetuximab was evaluated as part of the Phase 1/1b FLAGSHP-1 trial in patients with advanced or metastatic solid tumors.

ERAS-601 in combination with cetuximab shows promising preliminary safety and tolerability with reversible and manageable treatment-related adverse events (TRAEs)
Only grade 1 or 2 TRAEs occurred at or below the combination MTD for ERAS-601
ERAS-601 MTD was determined to be 40 mg BID 3/1 (three-week dosing followed by a one-week break) in combination with cetuximab (500 mg/m2) administered every 2 weeks
Initial Phase 1b dose expansion data in HPV-negative HNSCC tumors (NCT04670679) is expected in H1 2024

On April 18, 2023 20Med Therapeutics, a leader in non-viral delivery and development of gene therapies and vaccines, and Touchlight, a biotechnology company pioneering enzymatic DNA production to enable the genetic medicine revolution, reported that both parties will collaborate on establishing a novel vaccination platform that combines Touchlight’s rapid enzymatic doggybone DNA platform with 20Med Therapeutics’ bioresponsive polymer nanoparticle technology (Press release, 20Med Therapeutics, APR 18, 2023, View Source [SID1234635873]).

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"Today’s news further underscores the flexibility of our platform in delivering both a range of RNA or DNA-based therapeutic payloads that are sourced either through partnerships or are based on our proprietary activities. We are looking forward to collaborating with Touchlight on this promising project, which will strengthen both companies’ platforms and increase the body of evidence around our nanoparticle technology," commented Michiel Lodder, Ph.D., CEO of 20Med Therapeutics.

"Our collaboration with 20Med Therapeutics has already delivered promising preclinical data showing the potential of nanoparticle-formulated doggybone DNA to produce strong neutralising antibodies and durable T cell responses following vaccine administration in nanoparticles. Both companies’ platforms offer distinct conceptual advantages in terms of speed, scalability, thermostability and avoiding the potentially harmful and cumbersome bacterial or viral process steps of traditional methods in the space. Touchlight, as part of its funding from the Bill & Melinda Gates Foundation, will be able to further evaluate and determine the potential applicability of this technology combination. Successful demonstration of the doggybone DNA platform’s effectiveness in DNA vaccine and gene therapy applications has the potential to support the global availability of innovative medicines and to further the application of the doggybone DNA platform in enabling rapid pandemic response." commented Helen Horton, Ph.D., Chief Research Officer of Touchlight.

Named after its schematic structure, dbDNA is a minimal, linear, double-stranded and covalently closed DNA construct. dbDNA can encode long, complex, or unstable DNA sequences, eliminates bacterial sequences and has a strong expression profile.

20Med Therapeutics’ nanoparticles have been specifically designed for efficient intracellular delivery of oligonucleotide-based vaccines and therapeutics. The technology platform is based on 20Med’s proprietary bioresponsive polymeric nanoparticles which provide protection of fragile payloads during administration and circulation but allow for rapid bioresponsive release of that payload as soon as the particles enter the cytosol.

On April 18, 2023 BullFrog AI Holdings, Inc. (Nasdaq: BFRG) ("Bullfrog AI" or the "Company"), a digital technology company using machine learning to usher in a new era of precision medicine, reported an exclusive license agreement with Johns Hopkins University for prodrug compositions of mebendazole (Press release, Bullfrog AI, APR 18, 2023, View Source [SID1234635572]). The exclusive license was signed on October 13, 2022.

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The world-wide, royalty-bearing license includes the rights to commercialize N-substituted prodrugs of mebendazole that demonstrate improved solubility and bioavailability relative to the parent compound. The license covers prodrug compositions and use for treating disease as claimed in multiple US and worldwide patent applications.

"This asset is another key addition to our oncology development pipeline and provides us with an opportunity to demonstrate how our AI/ML technology can turn promising drug candidates into tangible therapies in a cost-effective and efficient manner," said BullFrog AI’s founder and CEO, Vin Singh, "We are extremely proud of our expanding relationship with Johns Hopkins. We look forward to working with strategic partners to advance the development and monetize this promising asset for the treatment of glioblastoma and possibly additional oncology indications."

On April 13, 2023 Kelun-Biotech, a subsidiary of China’s Kelun Pharmaceutical is collaborating with Panolos Bioscience, a South Korean biotech company, join forces to develop a dual-targeted immune-oncology drug named PKB01 (Press release, Kelun, APR 18, 2023, View Source [SID1234633690]). The partnership aims to combine Kelun-Biotech’s immunotherapy candidate with Panolos’ multiple specific drug generation platform. The focus will be on optimizing the candidate material for preclinical studies, with clinical trials planned for the following years.

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Panolos will acquire global development and commercialization rights for the candidate material, excluding China, and will secure a portfolio of immune-oncology pipelines with First-In-Class potential. Kelun-Biotech’s immunotherapy candidate material is an immune checkpoint inhibitor that targets immune checkpoint molecules expressed in immune and cancer cells. The specific target information for this candidate material has not yet been released.

The dual-targeted therapy PKB01 aims to suppress tumor growth by targeting VEGF family members and enhance immune activation by inhibiting immune checkpoint molecules. This therapy may also overcome drug resistance, a limitation of current monotherapy treatments. Panolos and Kelun-Biotech hope to develop next-generation dual-targeted anti-cancer drugs that combine the advantages of both companies’ technologies to help cancer patients.

In Apr 06, Kick off ceremony, Panolos CEO, Dr. Hyeseong Lim said "Our collaboration aims to revolutionize immuno-oncology and give new hope to cancer patients around the world. Created by the combination of Panolos’ αART platform and Kelun-Biotech’s proprietary information of anti-PD-1, PKB01 will have an unique opportunity to create a strong dual-target therapy that will overcome current treatment limitations. This close partnership will benefit both companies, and ultimately benefit all the patients we serve".

On April 18, 2023 Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, reported a Premarket Approval (PMA) application for its Lumicell Direct Visualization System (DVS) has been submitted to the U.S. Food and Drug Administration (FDA) (Press release, Lumicell Diagnostics, APR 18, 2023, View Source [SID1234630292]).

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The Lumicell DVS is an investigational system designed for use in patients with breast cancer to assist in the detection of residual cancerous tissue within the lumpectomy cavity following removal of the primary specimen during breast conserving surgery. The Lumicell DVS is intended for use with LUMISIGHT (pegulicianine) for fluorescence imaging of the lumpectomy cavity. The New Drug Application (NDA) for LUMISIGHT was submitted to the FDA in March 2023.

"The PMA submission for our Lumicell Direct Visualization System is the culmination of years of hard work from all of our clinical trial investigators and the Lumicell team," said Kevin Hershberger, president and chief executive officer of Lumicell. "This major milestone brings us one step closer to revolutionizing the way breast cancer surgery is performed and delivering meaningful clinical benefits to surgeons and patients."

The Lumicell DVS submission is supported by data from more than 700 breast cancer patients across five clinical studies at top academic and regional community cancer centers. Results from the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial (NCT03686215) of 406 patients at 14 sites will be presented at the upcoming American Society of Breast Surgeons (ASBrS) annual meeting. The FDA granted LUMISIGHT Fast Track designation and the Lumicell DVS Breakthrough Device designation in recognition of the potential important benefit of identifying residual cancer during the initial lumpectomy.

"The current standard of care focuses on tissue that has already been removed instead of inside the patient where it matters," said Irene Wapnir, MD, professor of surgery at Stanford University School of Medicine and investigator of the INSITE clinical trial. "A device like the Lumicell DVS which can look inside the breast cavity for residual cancer could be a crucial tool to help improve patient outcomes."

About the Lumicell Direct Visualization System

The investigational Lumicell Direct Visualization System (DVS) is intended for use with the investigational LUMISIGHT Optical Imaging Agent and features a hand-held imaging probe that is designed to go inside the breast cavity and a patient-calibrated cancer detection software to assist in the detection of residual cancer, thereby enabling a more complete resection. The safety and efficacy of the Lumicell DVS in detecting residual cancer left behind by standard of care surgical procedures has been evaluated in two studies: INSITE and a feasibility study of 234 patients at 16 sites, results of which were published in JAMA Surgery.

The Lumicell DVS and LUMISIGHT are limited by Federal (or United States) law to investigational use only. The Lumicell DVS and LUMISIGHT are not commercially available.