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.

On October 28, 2024 EpicentRx, a clinical-stage biopharmaceutical company, reported a poster presentation on the combination of AdAPT-001 plus a checkpoint inhibitor in checkpoint inhibitor-resistant tumors at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 39th Annual Meeting (SITC) (Free SITC Whitepaper) in Houston, Texas from November 6-10, 2024 (Press release, EpicentRx, OCT 28, 2024, https://www.epicentrx.com/press-release/epicentrx-to-present-compelling-phase-2-clinical-data-on-adapt-001-plus-a-checkpoint-inhibitor-in-pd-1-l1-resistant-tumors-at-the-sitc-39th-annual-meeting/ [SID1234647448]). Primary resistance to immune checkpoint blockade therapy (ICBT) is widespread, and so are cases where tumors initially respond but subsequently acquire resistance and relapse. A central mechanism of ICBT resistance is overexpression of the immunosuppressive cytokine, transforming growth factor-beta (TGFβ). AdAPT-001 expresses a TGFβ trap that selectively neutralizes TGFβ isoforms 1 and 3.

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"Checkpoint blockade immunotherapies are effective in a minority of patients with tumors that are infiltrated by T cells," said EpicentRx CEO and oncologist, Dr. Tony Reid. "Results from the Phase 2 clinical trial with AdAPT-001 in multiple metastatic tumor types, including melanoma, sarcoma, triple negative breast cancer and squamous cell cancer of the head and neck strongly suggest that the TGFβ trap, which AdAPT-001 expresses, durably sensitizes previously checkpoint inhibitor-resistant tumors in many cases for six months or more to those same checkpoint inhibitors. These are potentially practice-changing results."

MD Anderson Sarcoma Specialist and Lead Investigator, Dr. Anthony Conley, concurred that, "Most of the tumors on this Phase 2 clinical trial are not only without driver mutations, but are also non-inflamed and non-immunogenic, which makes them broadly resistant to tyrosine kinase inhibitors, checkpoint inhibitors, and chemotherapy. My colleagues and I are very encouraged by the impressively durable overall response rates and long PFS with AdAPT-001 to date, which highlight its potential to redefine the standard of care for late-stage, therapy resistant patients."

Abstract Number 663: AdAPT-001, a first-in-class 2-in-1 TGF-beta inhibitor plus a checkpoint inhibitor: updated results from a Phase 2 study in solid tumors
Presenter: Anthony P. Conley, MD, Lead Investigator, MD Anderson Cancer Center.
Date: Friday, November 8, 2024

On October 28, 2024 BPGbio, Inc., a leading biology-first, AI-powered, clinical stage biopharma focused on mitochondrial biology and protein homeostasis, reported its participation in the inaugural Google Cancer AI Symposium, in Boston. BPGbio President and CEO Niven R. Narain, Ph.D., will deliver a presentation on "Making AI for Discovery Real – Prioritizing Biology before Tech," on October 30 at 2:45 pm (Press release, BPGbio, OCT 28, 2024, View Source [SID1234647464]).

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Dr. Narain’s session will delve into the evolving landscape of AI-driven drug discovery, highlighting both the opportunities and challenges. Drawing from BPGbio’s pioneering history in the intersection of AI and Biology and his lens of experience, Narain will share best practices that have fueled the company’s robust clinical pipeline, which includes its BPM31510, currently in a phase 2b for glioblastoma multiforme (GBM) and a phase 2a for pancreatic cancer, as well as a potential pivotal trial targeting multiple primary CoQ10 deficiency mutations.

"It is a privilege to be invited to speak at Google’s inaugural Cancer AI Summit, especially on a topic BPGbio has pioneered for the past decade," said Dr. Narain. "I look forward to sharing our journey, use cases, and wins with industry leaders and esteemed researchers. By combining the strengths of biology and AI technology, we can address the immense challenges of cancer research and accelerate the development of more effective therapeutics. I also plan to highlight the community of global partners who helped galvanize our road to success."

During the presentation, Dr. Narain will also provide updates on BPGbio’s robust portfolio of therapeutic candidates, many of which are in late-stage clinical trials. These candidates have been identified/guided using the company’s proprietary AI-powered NAi Interrogative Biology Platform, which facilitates target discovery, biomarker identification, and drug development through all stages—from preclinical to late-stage development. The NAi Platform is currently advancing key partnerships with pharmaceutical companies, academic institutions, and government organizations on various disease indications.

BPGbio’s therapeutic pipeline includes candidates for glioblastoma (orphan drug), pancreatic cancer (orphan drug), primary CoQ10 deficiency (rare pediatric disease designation), epidermolysis bullosa (orphan drug), squamous cell carcinoma (orphan drug), sarcopenia, solid and liquid tumors, Huntington’s disease, and Parkinson’s disease.

For more information on BPGbio’s participation in the Google Cancer AI Symposium, visit www.bpgbio.com.

About the NAi Interrogative Biology Platform

The NAi Interrogative Biology Platform combines BPGbio’s industry-leading, clinically annotated proprietary biobank, purpose-built Bayesian artificial intelligence, and the compute power of the world’s fastest supercomputer, Frontier, housed at Oak Ridge National Laboratory.

Collectively, these tools enable the company to bring artificial intelligence to biology, inspiring AI-driven target nomination, discovery, molecule design, and more. The platform has been used to identify more than 100 drug targets and diagnostic biomarkers and supported research collaborations with a range of government, industry and academic partners including the U.S. Department of Defense (DoD), Sanofi, and Harvard Medical School.

On October 28, 2024 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that research collaborators delivered poster presentations at the 2024 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics held October 23-25, 2024 in Barcelona, Spain (Press release, Genprex, OCT 28, 2024, View Source [SID1234647449]). The collaborators presented posters on positive preclinical data from studies of Genprex’s lead drug candidate, Reqorsa Gene Therapy (quaratusugene ozeplasmid), for the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.

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"We are pleased by this promising preclinical data, presented before a prestigious audience of oncology researchers, of REQORSA’s potential in serious and difficult to treat cancers including KRAS G12C mutant lung cancer, mesothelioma, and glioblastoma," said Ryan Confer, President and Chief Executive Officer at Genprex. "The role of TUSC2 in lung cancer has been well established, and TUSC2 restoration is being evaluated clinically. However, we are highly encouraged by our preclinical programs expanding the potential use of REQORSA to treat a variety of cancer indications, where patient populations have unmet medical needs."

Genprex has filed two provisional patent applications based on data from two of the presentations. One application involves using REQORSA to treat mesothelioma and the other uses REQORSA to treat glioblastoma. Genprex is a co-owner of the applications along with the respective institutions. TUSC2 is the tumor suppressor gene used in REQORSA. Last month, Genprex announced the formation of its Mesothelioma Clinical Advisory Board to support the Company’s preclinical mesothelioma oncology program. The Board is comprised of four world-renown researchers from major research institutions specializing in the treatment of mesothelioma.

Featured Genprex-supported posters presented at the 2024 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics include:

Title: "TUSC2 Gene Therapy in KRASG12C Mutant NSCLC Overcomes Acquired Resistance to Sotorasib"

Collaborator: The University of Texas MD Anderson Cancer Center

Catalog Number: 384

Presentation Number: PB372

Title: "TUSC2 Suppresses Tumorigenic Properties in Malignant Pleural Mesothelioma Cells"

Collaborator: New York University Langone Health

Catalog Number: 364

Presentation Number: PB352

Title: "Efficacy of Quaratusugene Ozeplasmid (REQORSA) TUSC2 Gene Therapy in Glioblastoma"

Collaborator: The University of Texas Health Science Center at Houston

Catalog Number: 130

Presentation Number: PB118

To review the posters in detail, please visit Genprex’s website, where they are available to download.

About Reqorsa Gene Therapy

REQORSA (quaratusugene ozeplasmid) consists of a plasmid containing the TUSC2 gene encapsulated in non-viral lipid-based nanoparticles in a lipoplex form (the Company’s Oncoprex Delivery System), which has a positive charge. REQORSA is injected intravenously and specifically targets cancer cells. REQORSA is designed to deliver the functioning TUSC2 gene to negatively charged cancer cells while minimizing uptake by normal tissue. Laboratory studies conducted at MD Anderson show that the uptake of TUSC2 in tumor cells in vitro after REQORSA treatment was 10 to 33 times the uptake in normal cells.

On October 28, 2024 Kivu Bioscience, a biotech company developing next-generation antibody-drug conjugates to deliver best-in-class therapeutics, reported the close of a $92 million Series A financing round led by Novo Holdings, with participation from Gimv, Red Tree Venture Capital, HealthCap as well as existing investors BioGeneration Ventures, M Ventures, and Brabantse Ontwikkelings Maatschappij (BOM) (Press release, Kivu Bioscience, OCT 28, 2024, View Source [SID1234647465]). The funding will be used to advance multiple oncology programs into the clinic.

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"We’re excited to have the backing of this top-tier syndicate, who share our vision for developing kinder, gentler ADC therapies that are more effective and safer for cancer patients," said Mohit Trikha, Ph.D., President and Chief Operating Officer of Kivu Bioscience. "Our next-generation ADCs address key limitations of current treatments, particularly by engineering stable ADCs we have the potential to reduce off-target side effects which in turn widens the therapeutic window. This funding allows us to accelerate the development of our Topo1i-based ADC pipeline to the clinic, where we plan to quickly differentiate Kivu’s products from past endeavors. We are inspired by patients and driven by data to accelerate transformative medicines."

Kivu is utilizing the proprietary Synaffix site-specific linker-payload technology to deliver next-generation ADC therapeutics. The GlycoConnect technology, which couples the linker specifically to asparagine-297, delivers a clean, highly homogenous product. This technology not only offers a clear manufacturing advantage over other conjugation techniques, but also produces an ADC that is more stable, significantly reducing off-target side effects. This approach widens the therapeutic window, improving the safety profile for patients. Addressing the discontinuation and dose-reduction rates seen with ADCs will establish Kivu’s place in treating solid tumors.

"ADCs are an established modality for treating cancer, but tolerability issues limit the pace of advancement in the space. The early data from Kivu suggested superior stability of the constructs, clearly pointing toward targets that have been pursued by earlier generations of ADCs, but which failed due to high rates of drug discontinuation. That data in the hands of this outstanding management team tells an incredibly compelling story – one we are excited to support. We see tremendous opportunity for the Kivu pipeline to produce a new generation of targeted therapies as best-in-class novel ADCs across a broad range of cancers," said Daniel O’Connell, M.D., Ph.D., Partner, Novo Holdings.

Kivu’s assets are in late-stage preclinical studies and target areas of high unmet medical need. The company’s platform is differentiated by its superior ability to avoid the issues seen with currently marketed ADCs and addresses key limitations related to stability and therapeutic precision and delivery. The company is set to begin Phase 1 trials for its lead candidate in 2025.