On April 19, 2023 Amplia Therapeutics reported that dosing of the first patient in Cohort 3 of the Company’s ongoing Phase 1b/2a ACCENT clinical trial of FAK inhibitor AMP945 in pancreatic cancer has begun (Press release, Amplia Therapeutics, APR 19, 2023, View Source;[email protected] [SID1234630265]).

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Cohort 3 will consist of three patients receiving an increased dose of AMP945 after the safety committee’s recent assessment that the AMP945 dose used in Cohort 2 was safe and well-tolerated. In the ACCENT trial, AMP945 is dosed orally (as a capsule) in the lead-up to, and between, standardised weekly dosing of gemcitabine and nab-paclitaxel chemotherapy.

Amplia CEO and Managing Director, Dr Chris Burns, commented: "We are very pleased with the recent progress in the ACCENT trial and moving rapidly to Cohort 3 is the next step in identifying a safe and effective dose to take forward to the Phase 2 stage of the trial. We are extremely grateful to the clinical trial sites for their hard work in progressing the trial so quickly, and to the patients and their loved ones for agreeing to take part in this trial."

About the ACCENT Trial
The protocol for the ACCENT trial is entitled "A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients".

The trial is to be conducted in two stages. The first stage of the trial (Phase 1b) is an open-label study to select an optimal dose of AMP945 by assessing the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of AMP945 when dosed in combination with gemcitabine and nab-paclitaxel in first-line patients with advanced pancreatic cancer.

The second stage of the trial (Phase 2a) is also a single-arm, open-label study and is designed to determine the impact of AMP945 in combination with gemcitabine and nab-paclitaxel on patient outcomes. The primary endpoint of the Phase 2a trial is the Objective Response Rate (ORR) of patients to treatment. Further endpoints will assess efficacy by other means as well as safety and tolerability.

More information about the ACCENT trial, including a list of participating sites, can be found via our website and at ClinicalTrials.gov under the identifier NCT05355298. The Company will provide further updates on the trial as recruitment proceeds.

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

On April 18, 2023 Integra Therapeutics reported the company has been awarded a €335,000 non-refundable grant through the Spanish Ministry of Science and Innovation Neotec programme, managed by the Centre for the Development of Industrial Technology (CDTI) (Press release, Integra Therapeutics, APR 18, 2023, View Source [SID1234654533]).

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Neotec is a highly competitive programme that aims to foster technology and innovation for the development of companies based in Spain. In the 2022 call, the programme awarded grants to 135 projects. In this regard, it is significant that the Integra Therapeutics research project was among the top 20 because it highlights the company’s solid business model and the importance of developing more precise and effective advanced therapies for patients and the healthcare systems.

The grant will allow the company to continue the implementation of its FiCAT gene-writing platform for viral-free in vivo delivery to liver cells for gene therapy and generation of proof of concept data on its first therapeutic product, which will run until 2024.

The company will also reinforce its R&D team, hiring two senior scientists with a strong background protein engineering and bioinformàtics, respectively. Integra Therapeutics currently has a team of 13 highly qualified professionals at its headquarters in the Barcelona Biomedical Research Park (PRBB).

In addition to the grant, Integra Therapeutics will be able to take part in a training programme on Entrepreneurship, Innovation and Sustainability at the Georgia Institute of Technology in Atlanta (USA).

Integra Therapeutics is a global leader in creating next-generation gene-writing tools to make advanced therapies safer and more effective. Since it was established in 2020, the company has secured €8 million in venture capital (AdBio Partners, Columbus Venture Partners, Invivo Capital and Takeda Ventures) and through various competitive programmes of the European Union, Spanish Government and Government of Catalonia.

On April 18, 2023 Incurix, a company that develops anticancer drugs targeting transcription factors, reported the first pipeline clinical data (Approval number NCC2016-0208) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) held in April (Press release, Incurix, APR 18, 2023, View Source;idx=91&page=1&code=news [SID1234643574]).

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The AACR (Free AACR Whitepaper) is one of the largest conferences in the world, with participation from leading pharmaceutical and bio companies worldwide, and presentation is confirmed through selection by the organizers.

The research results to be presented were obtained through collaborative research with the National Cancer Center’s clinical research team.

Myc is a well-known factor that is overexpressed not only in solid tumors but also in blood cancers and is infamous for its role as a switch that promotes tumors. The activation of Myc in cancer leads to rapid resistance and progression to tumor promotion, making it a popular target in cancer treatment.

Incurix is developing a new anticancer drug designed to interfere with the Myc/Max complex’s approach to DNA binding sequences E-Box in cancer cells. At this conference, Incurix presented indication-related clinical data on the groundbreaking potential of a novel anticancer drug, ICX-101, targeting Myc, which is highly expressed in progressive lung cancer patients.

We confirmed the potential for ICX-101 to control cancer in connection with indications related to the high expression of myc in more than 100 clinical samples from about 80 lung cancer patients. They analyzed the myc expression rates for four types of lung cancer tissues (ADC, SQCC, NSCLC, SCLC) and confirmed the correlation between myc expression and tumor genes (ALK, BRAF, EGFR, MET).

We also confirmed the association of overall survival rates with the high level of myc expression. Furthermore, we showed the response rate to ICX-101 treatment using a patient-derived lung cancer cell model based on the level of myc expression.

ICX-101 showed a significant concentration-dependent inhibitory effect in vitro when administered to non-small cell lung cancer (NSCLC) overexpressing myc, and showed more than 50% improvement in anticancer effect compared to the positive control group in the final time zone. It is a drug that has been shown to have a clear inhibitory effect in direct analysis methods of interaction with Myc protein.

We confirmed the potential of ICX-101 as an effective targeted therapy for lung cancer and expect that it will become a critical treatment option for lung cancer patients who overexpress myc. ICX-101 can also be applied to various solid tumors and blood cancers, and a combination treatment strategy is also possible.

Dr. Jeong, the CEO of Incurix, stated, "We plan to strengthen our foundation for global market expansion by presenting our accumulated data at overseas academic conferences. We also plan to release data on other anti-cancer drug candidates early on to create an opportunity to promote the potential excellence of our pipeline externally."

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.