On February 2, 2024 Delta-fly Pharma reported that it is excited to share its latest development status (Press release, Delta-Fly Pharma, FEB 2, 2024, View Source [SID1234639806]).

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As presented at 2022 ASCO (Free ASCO Whitepaper) Annual Meeting on June 6, 2022, DFP-14323 in combination with afatinib (20 mg/day) in stage III/IV non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutation positive in a Phase II clinical trial, has demonstrated fascinating longer median progression-free survival (mPFS; 23.1 months).

Subsequently, based on these results, we have been in negotiation with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan with the aim of submitting a conditional approval application, resulting in our decision to conduct a Phase III clinical trial (superiority study) of DFP-14323 in combination with afatinib (20 mg/day) versus afatinib (40 mg/day) alone in stage III/IV non-small cell lung cancer patients with uncommon EGFR mutation positive based on the PMDA’s recommendation.

And finally, we are pleased to announce that the submission of the protocol for the Phase III study to the PMDA has been approved and are ready to initiate the study.

This Phase III clinical trial will be conducted at 30 sites in Japan and if the superiority of the add-on effect of DFP-14323 on progression-free survival (PFS) as primary endpoint, is confirmed in this trial, we believe that DFP-14323 will be a novel cancer immunotherapy drug with highly beneficial for patients and their families, as it is orally available, safe, and economical.

Furthermore, if non-inferiority to osimertinib (80 mg/day) can be confirmed in a comparative study, a huger market can be expected.

We intend to continue negotiations for out-licensing opportunities with pharmaceutical companies for the territory outside Japan.

Please find out the innovation for the miserable cancer patients by Delta-Fly Pharma Inc. (TOKYO:4598) and contact with us.

On February 1, 2024 Affirma Biotech reported the company obtained €1.75 Million to advance the development of its new broad spectrum anti-infectives.

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• The company has successfully closed its latest financing round led by NARA Capital and its current investors.

• Affirma Biotech leads a consortium with the University of Barcelona and IS Global that has received a total of €899,552 within the framework of the call Publico Private Collaboration projects from the Spanish State Research Agency for research into new immunomodulatory therapies against bacterial infections of unresolved severity.

• In addition, the company has received a CDTI-NEOTEC grant of €250,000 for the development of its candidates in the field of antiviral therapies. The development of new broad-spectrum anti-infective products represents an innovative strategy with great potential for economic and social impact in this area.

• Viral infections such as influenza and hepatitis B and resistant bacterial infections pose great challenges to global health systems and there is a great need for innovation and the development of new products in these indications.

The company Affirma Biotech has obtained a total of €1.75 million that will allow it to advance its candidates for the treatment of viral and bacterial infections through the activation of the immune system.

The application of this biological mechanism, that brought a revolution in its application in immuno-oncology treatments, has not been explored to date in the field of infectious diseases, where it could provide relevant advances for the improvement of global health. The therapeutic strategy consisting in reactivating the immune system is compatible with the use of other classic antivirals or antibacterials, and it could generate synergistic effects to benefit the resolution of serious infectious.

The company has successfully closed an investment round led by Nara Capital and the some of its current shareholders, like BCN Peptides, Reig Jofre Investments and Alfons Hidalgo, and some other new partners, like the investment vehicle GTTB, managed by the consulting firm Genesis Biomed and minority investors through the platforms Capital Cell and its international partner Seedblink.

Affirma Biotech has discovered a family of new immune activating compounds and has filed a patent to protect them in March 2023. Since there are multiple infectious diseases that can benefit from treatment through the activation of the immune system, these compounds can be used in a wide spectrum of indications. The first two that the company plans to develop are treatments for severe influenza and chronic hepatitis B. In the case of influenza, despite vaccination campaigns, the WHO estimates that annual deaths reach 650,000 patients. Chronic hepatitis B affects about 300 million patients worldwide and is the main cause of liver cancer, which causes mortality of up to 1 million people per year.

The company has also received support from the CDTI, with the NEOTEC grant worth €250,000 which will allow to advance in proof-of-concept tests in the antiviral indications, as well as reinforce the company’s business plan, with the aim of raising new financing at the beginning of 2025 for the preclinical development and clinical phase 1 of its candidates.

To advance in the proof-of-concept tests for infections caused by resistant bacteria, which also produce the exhaustion of the immune system, Affirma Biotech leads a research consortium with the participation of University of Barcelona and IS Global. This consortium has received a total of €899,552 within the framework of the call Publico Private Collaboration projects from the Spanish State Research Agency.

Maribel Berges, founder and CEO of the company, stated that "it crucial to innovate in areas such as infectious diseases, generating new drugs that contribute to solving the increasingly urgent challenge that these indications pose for global health systems" .She hopes that an innovative approach like the one they are currently investigating "will significantly improve the treatment of infections that currently do not have a complete medical solution." Berges points out that the company’s objective is to start clinical trials within a maximum period of two years.

(Press release, Affirma Biotech, FEB 1, 2024, View Source [SID1234662180])

On February 1, 2024 General Proximity reported the company has been awarded a NIH NCI SBIR Phase I grant (Press release, General Proximity, FEB 1, 2024, View Source [SID1234649814]). This $400k grant will drive our efforts to develop groundbreaking treatments targeting Triple Negative Breast Cancer (TNBC), one of the most challenging and aggressive forms of breast cancer.

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This award represents a pivotal step forward in our mission to innovate and develop transformative treatments for patients facing critical unmet needs.

On February 1, 2024 Hoffmann-La Roche reported its full year and fourth quarter 2023 results (Press release, Hoffmann-La Roche, FEB 1, 2024, View Source [SID1234639965]).

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On February 1, 2024 ArteraAI, the developer of multimodal artificial intelligence (MMAI) based predictive and prognostic cancer tests, reported that it has secured an additional $20 million in capital fueled by several prominent large investment funds including Prosperity7 Ventures, Singapore-based global investor EDBI, Walden Catalyst Ventures, Wilson Sonsini Goodrich & Rosati, and Trium Ventures, along with investors Navin Chaddha, Rajiv Khemani (AISpace VC), and Andrew & Elliott Tan (A&E Investment LLC) (Press release, Artera, FEB 1, 2024, View Source [SID1234639808]).

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"The infusion of this additional funding is a crucial catalyst, propelling ArteraAI forward in its mission to personalize cancer therapy through AI-enabled predictive and prognostic tests," said Andre Esteva, CEO and Co-Founder of ArteraAI. "We are committed to ushering in the era of precision medicine, and stewarding this investment strategically to aid in our international expansion and commercial growth."

This funding announcement follows closely on the heels of ArteraAI’s recent achievement of the Centers for Medicare and Medicaid Services (CMS) decision on the payment rate for the ArteraAI Prostate Test. The decision helps to ensure broader accessibility to AI-enabled personalized care, benefiting a larger population.

"Investing in ArteraAI wasn’t just a financial decision, but a testament to ArteraAI which is globally revolutionizing patient care," said Abhishek Shukla at Prosperity7 Ventures. "We are thrilled to be part of the journey as ArteraAI continues its mission to provide patients with access to personalized cancer treatment plans."

Less than a year ago, ArteraAI emerged from stealth mode with an initial funding of $90M. Since then, the company has made significant strides, obtaining a Medicare payment rate, growing distribution and establishing a solid foundation for international expansion through strategic global partnerships to continue its research.

"ArteraAI’s AI-driven tests represent a transformative approach to designing tailored cancer care regimens. This offers a glimpse into the future where cancer care is truly personalized, aligning with Singapore’s efforts to digitize healthcare and harness AI to enable precision medicine," said Dr. Jolene Ooi, Senior Principal at EDBI. "We are excited to be part of their growth story and look forward to supporting its foray into Asia."

To learn more about ArteraAI visit Artera.ai.