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Delta-Fly Pharma Inc.: Phase I/II Study of DFP-10917 and Venetoclax in AML Patients Begins with Promising Initial Data

On October 28, 2024 Delta-Fly Pharma reported following to the previous information on September 10th. 2024, we are excited to share our latest development status (Press release, Delta-Fly Pharma, OCT 28, 2024, View Source [SID1234647463]).

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Enrollment of patients is progressing smoothly into the Phase I portion of the Phase I/II study of DFP-10917 combined with Venetoclax in AML patients previously treated with Venetoclax, one regimen. The first three patients are showing encouraging safety and efficacy results suggested further promising development.

The existing standard combination chemotherapy for AML patients is Azacitidine and Venetoclax, but it is not comfortable for AML patients. We’re trying to do a combination of DFP-10917 with Venetoclax, as an alternative safer AML therapy, objective NDA approval from the FDA in the US under possible collaboration with a global mega-pharma.

The Phase III study of DFP-10917 in relapsed/refractory AML patients is planned data cut-off as decreasing in the number of long-term survivors since then.

Guardant Health to Share Data Supporting Critical Role of Blood-Based Testing in Colorectal Cancer Screening at ACG 2024

On October 28, 2024 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company and its research collaborators will present data supporting the critical role of blood-based testing in increasing overall colorectal cancer (CRC) screening adherence at the American College of Gastroenterology (ACG) 2024 Annual Meeting in Philadelphia, Oct. 25-30, 2024 (Press release, Guardant Health, OCT 28, 2024, View Source [SID1234647462]).

Guardant and its research partners will share real-world data demonstrating poor patient compliance with repeat stool-based screening. A study of more than 350,000 patients shows that less than half of patients who underwent stool-based CRC screening completed the retesting recommended in clinical guidelines over the following four-year period, highlighting the need for alternative options to improve overall compliance to repeat testing.

A second presentation will report on the one-year outcomes of individuals tested with Guardant’s Shield blood test for CRC screening in the ECLIPSE study to understand the implications of "false positive" results. Study results demonstrate that the rate of non-colorectal malignancies does not differ in those who tested positive with Shield compared to those who tested negative.

"Research has clearly demonstrated the value of colorectal cancer screening in detecting cancer early, when it is most treatable, but screening is only effective if an individual completes the test," said Craig Eagle, MD, chief medical officer at Guardant Health. "We look forward to sharing findings at the ACG meeting that support the potential of a blood-based screening option like the Shield test to improve overall screening rates among the millions of eligible individuals who may prefer a more pleasant screening option."

Guardant Health and collaborator presentations at ACG 2024

Presentation

Title

Time / Location

Tuesday, October 29

Evaluating the Risk of Non-Colorectal Cancers in Individuals With a False Positive Blood-Based Colorectal Cancer Screening Test

8:30am ET /

Terrace Ballroom 2-3

P3672

Real-World Adherence to Repeat Testing for Stool-Based Non-Invasive Colorectal Cancer Screening Tests Among Individuals With Average Risk – ACG Presidential Poster Award winner

10:30am-4:00pm ET / Exhibit Hall E

The full abstracts for Guardant Health and a list of all abstracts being presented at the ACG Annual Meeting can be found on the ACG meeting website.

For information and updates from the conference, follow Guardant Health on LinkedIn, X (Twitter) and Facebook.

Tempus Announces Collaboration With JW Pharmaceutical to Apply Real-World Data and Biological Modeling to Enhance Early Research and Development

On October 28, 2024 Tempus, a leader in artificial intelligence and precision medicine, reported a collaboration with JW Pharmaceutical, one of the most established pharmaceutical companies in Korea, to leverage both real-world data (RWD) and biological modeling to support efficient hypothesis generation and rapid validation in early therapeutic research in oncology (Press release, JW Pharmaceutical, OCT 28, 2024, View Source [SID1234647461]). JW Pharma is an early adopter of integrating RWD into drug research and development programs, and it is now tapping into Tempus’ rich multimodal dataset and extensive repository of organoid models to accelerate its efforts in multiple indications.

With this collaboration, JW Pharmaceutical researchers are leveraging Tempus’ biological modeling platform and an extensive panel of pan-indication and richly characterized, patient-derived organoid models to screen early pipeline assets, identify biomarkers of response, and guide asset prioritization decisions. Each organoid model reflects the biology of a distinct patient tumor, and is linked to Tempus’ expansive, real-world, multimodal dataset through the company’s next-generation sequencing assay, xT. This enables projection of organoid screening findings onto real-world patient populations, which has the potential to unlock even richer multimodal insights.

"We are excited to work with a forward-looking collaborator like JW Pharmaceutical, a pioneer in Korea that is embracing the power of RWD and AI to advance the next generation of cancer therapeutics," said Ryan Fukushima, Chief Operating Officer of Tempus. "We are taking it one step further by curating a panel of organoids across specific cancer indications that closely reflect real-world patients to evaluate select preclinical candidates, and we are excited to understand the full potential of this innovative approach to early research."

"We are excited to collaborate with Tempus, a leader in AI and precision medicine, capable of conducting end-to-end translational research from preclinical to clinical stages. As the first in Korea to initiate this partnership, JW anticipates promising outcomes," said Chan-Hee Park, Chief Technology Officer of JW Pharmaceutical. "This collaboration marks a turning point in data-driven drug development using RWD in Korea, aligning with global trends and expected to positively impact the domestic drug development landscape."

MAIA Biotechnology Announces $2.44 Million Private Placement

On October 28, 2024 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that it has entered into definitive agreements for the purchase and sale of an aggregate of 1,079,784 shares of common stock at a purchase price of $2.259 per share, in a private placement to accredited investors and certain Company directors (Press release, MAIA Biotechnology, OCT 28, 2024, View Source [SID1234647460]). Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $2.51 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing six months following issuance and have a term of five years from the initial exercise date. The securities being sold to the Company director participating in the offering are being issued pursuant to the Company’s 2021 Equity Incentive Plan. The private placement is expected to close on or about October 30, 2024, subject to the satisfaction of customary closing conditions.

The gross proceeds from the offering are expected to be approximately $2.44 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering to fund manufacturing of THIO to be used in the Phase 2 THIO-101 trial in non-small cell lung cancer (NSCLC) and as working capital.

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

IDEAYA Biosciences Announces IND-Clearance for Werner Helicase Development Candidate IDE275 (GSK959) for a Phase 1 Study in MSI-High Solid Tumors

On October 28, 2024 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported the clearance of an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial to evaluate IDE275 (GSK959), a potential first-in-class and best-in-class Werner Helicase (WRN) inhibitor (Press release, Ideaya Biosciences, OCT 28, 2024, View Source [SID1234647459]). IDE275 (GSK959) has demonstrated robust and selective synthetic lethality preclinically in the high microsatellite instability (MSI-High) biomarker setting, and the Phase 1 clinical trial will enroll patients having tumors characterized by MSI-High.

"IDE275 represents IDEAYA’s fifth potential first-in-class clinical program in our precision medicine oncology pipeline and has a potentially differentiated best-in-class profile that we are targeting to present at a future medical conference with GSK. The robust preclinical efficacy observed by IDE275 selectively in the MSH-High biomarker setting, including monotherapy regressions, provides a double-digit % prevalence target patient population across several major solid tumor types, including endometrial, colorectal and gastric cancer," added Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

IDE275 (GSK959) is a potential first-in-class small molecule inhibitor of Werner Helicase that was discovered by IDEAYA in collaboration with GSK. In preclinical studies, IDE275 has demonstrated robust and selective synthetic lethality in the MSI-High biomarker setting, including single-agent tumor regressions in-vivo in MSI-High CDX and PDX models derived from colorectal, endometrial and gastric cancers. Initiation of the Phase 1 trial for IDE275 is projected in the fourth quarter of 2024. GSK is the sponsor of the IND application and plans to develop IDE275 (GSK959) as both a monotherapy agent and in combination with a PD-1 inhibitor in a Phase 1 clinical trial for patients having MSI-High tumors. The percent prevalence of MSI-High in solid tumors, including endometrial, colorectal, and gastric cancers, has been reported at approximately 31%, 20%, and 19%, respectively (JCO Precision Oncology, September 2017).

GSK is responsible for 80% of global research and development costs for IDE275 (GSK959) and IDEAYA is responsible for 20% of such costs. IDEAYA is eligible to receive a $7 million milestone payment upon acceptance of the IND by the U.S. Food and Drug Administration (FDA), and a potential additional $10 million milestone payment upon initiation of Phase 1 clinical dose expansion. IDEAYA may potentially also receive up to $465 million in further later-stage development and regulatory milestones. Upon potential commercialization, IDEAYA will be eligible to receive up to $475 million of commercial milestones 50% of U.S. net profits and tiered royalties on global non-U.S. net sales of IDE275 (GSK959) – ranging from high single-digit to sub-teen double-digit percentages, subject to certain customary reductions.