Delta-Fly Pharma, Inc.: Progress of Development Status of the Combination Study of DFP-10917 with Venetoclax

On February 28, 2025 Delta-fly Pharma reported that following to the previous information on Dec. 9th. in 2024, it is excited to share its latest development status (Press release, Delta-Fly Pharma, FEB 28, 2025, View Source [SID1234650764]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Regarding the Phase I/II clinical trial of DFP-10917 in combination with Venetoclax (VEN) in patients with acute myeloid leukemia (AML) in second-line therapy (NCT06382168), the Data Management Committee (DMC) has approved the tolerability of all six patients in the Phase I (dose finding) portion of the Phase I/II study, and we are moving to the Phase II portion of the trial for efficacy testing as of today, on 28th Feb., 2025. We are pleased to inform that we already have multiple potential patients waiting to participate in the trial.

Please take notice of our own innovative approach for miserable cancer patients and contact us.

BridgeBio Oncology Therapeutics (BBOT) and Helix Acquisition Corp. II Announce Business Combination Agreement to Create Publicly Listed Biotechnology Company Advancing a Pipeline of RAS and PI3Kα-Targeting Medicines

On February 28, 2025 TheRas, Inc. d/b/a BridgeBio Oncology Therapeutics ("BBOT"), a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3Kα malignancies, and Helix Acquisition Corp. II (Nasdaq: HLXB) ("Helix"), a special purpose acquisition company (SPAC) sponsored by affiliates of Cormorant Asset Management, reported that they have entered into a definitive business combination agreement (Press release, BridgeBio, FEB 28, 2025, View Source [SID1234650763]). Upon closing of the transaction, the combined company will be renamed "BridgeBio Oncology Therapeutics, Inc." The combined company’s common stock is expected to be listed on Nasdaq under the ticker symbol BBOT.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Management—Directors’ Fiduciary Duties and Conflicts of Interest"

Post this
In addition to approximately $196 million held in Helix Acquisition Corp. II’s trust account (assumed as of the closing and assuming no redemptions by Helix’s public shareholders), the transaction also includes commitments for an approximately $260 million PIPE from a group of premier institutional investors. The PIPE is led by Cormorant Asset Management and includes ADAR1 Capital Management, BC Capital, investment funds affiliated with Deerfield Management Company, Enavate Sciences, Eventide Asset Management, Novo Holdings A/S, Octagon Capital, Omega Funds, Paradigm BioCapital Advisors, StemPoint Capital LP, Surveyor Capital (a Citadel company), Wellington Management, and another leading mutual fund.

Eli Wallace, PhD, Chief Executive Officer of BBOT, said, "This financing and transaction mark a significant milestone for our company. We are profoundly grateful to the patients who participate in our trials, our dedicated BBOT team members, and our investors. We believe this transaction is the optimal path to advance our programs and make a meaningful impact on patients affected by deadly cancers."

Net proceeds from the transaction are expected to provide BBOT with the capital needed to accelerate the development of three lead programs: BBO-8520, BBO-10203, and BBO-11818. BBO-8520 is a direct inhibitor of KRASG12C in both the "ON" and "OFF" states and is currently being evaluated in the Phase 1 ONKORAS-101 trial (NCT06343402) for patients with KRASG12C mutant non-small cell lung cancer. BBO-10203 is an orally bioavailable small molecule with a novel mechanism of action that is designed to inhibit the physical interaction between RAS and PI3Kα, resulting in the inhibition of RAS-driven PI3Kα-AKT signaling in tumors. BBO-10203 is being evaluated in the Phase 1 BREAKER-101 trial (NCT06625775) for patients with locally advanced and unresectable or metastatic HER2+ breast cancer, HR+/HER2- breast cancer, KRAS mutant colorectal cancer and KRAS mutant non-small cell lung cancer. BBO-11818 is a pan-KRAS inhibitor targeting mutant KRAS in both the "ON" and "OFF" states with strong potency against KRASG12D and KRASG12V mutants. BBOT expects to dose the first patient with BBO-11818 in the first half of 2025.

Bihua Chen, Founder and Chief Executive Officer of Cormorant, and Chief Executive Officer of Helix, said, "BBOT’s team has some of the brightest minds in oncology, with a proven track record of developing new medicines. The company’s pipeline has the potential for paradigm-shifting impact on the treatment of some of the highest prevalence malignancies and we look forward to seeing patient impact further materialize as the clinical trials move forward."

Transaction Overview

Upon the closing of the business combination, BBOT expects it will have access to approximately $550 million in cash (prior to the payment of transaction costs of BBOT and Helix and assuming no redemptions by Helix’s public shareholders and existing BBOT cash at closing of $100 million). The proceeds will be funded through a combination of approximately $196 million held in a trust account by Helix (assumed as of the closing and assuming no redemptions by Helix’s public shareholders) and an approximately $260 million concurrent PIPE financing of common stock issued at the SPAC redemption price per share to leading institutional investors. Assuming a share price of $10.36 per share and no redemptions of Helix shares by Helix’s public shareholders, BBOT (as a combined entity) is expected to have an implied pro forma equity value of approximately $949 million at closing. BBOT shareholders will not receive any cash proceeds as part of the transaction and will roll 100% of their equity into the combined company.

The boards of directors of both BBOT and Helix have approved the proposed transaction, which is expected to be completed in the third quarter of 2025. The transaction is subject to, among other things, the approval of the stockholders of both BBOT and Helix, and satisfaction or waiver of the conditions stated in the definitive business combination agreement.

Leerink Partners, Morgan Stanley, Cantor, and Oppenheimer & Co. acted as placement agents for Helix in connection with the PIPE transaction. Leerink Partners also acted as lead capital markets advisor to Helix. Piper Sandler acted as capital markets advisor to BBOT. Goodwin Procter acted as legal counsel to BBOT. White & Case LLP acted as legal counsel to Helix. Kirkland & Ellis LLP acted as legal counsel to the placement agents.

Additional information about the transaction will be provided in a Current Report on Form 8-K to be filed by Helix with the SEC and will be available at the SEC’s website at www.sec.gov.

Fapon Biopharma Announces FDA Approval of IND for FP008, a First-in-Class Immunotherapy for Solid Tumors

On February 28, 2025 Fapon Biopharma, a biotech innovator in developing therapeutic antibodies and fusion proteins, reported that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for FP008, its first-in-class immunocytokine designed to address the unmet need in patients with solid tumors refractory to anti-PD-1 therapy (Press release, Fapon Biopharma, FEB 28, 2025, View Source [SID1234650762]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

FP008 is a novel anti-PD-1×IL-10M fusion protein with a unique mechanism of action (MOA) and therapeutic potential for anti-PD-1 naïve or resistant patients. IL-10 monomer (IL-10M) engineering significantly reduces its hematologic toxicity, while the anti-PD-1 antibody enhances IL-10M activity by PD-1 targeted enrichment and cis-activation.

PD1 targeted antibodies drive the differentiation of effector CD8(+) T cells into terminally exhausted status. In the latest pre-clinical experiment conducted by Fapon Biopharma, FP008 effectively counteracted this process through IL-10M, significantly reducing the anti-PD-1 antibody-mediated exhaustion of CD8(+) T cells. In mouse experiments, FP008 exhibited potent anti-tumor effects, significantly increased the infiltration of intratumoral CD8(+) T cells, reduced their terminal exhaustion differentiation and enhanced the ability of terminally exhausted CD8(+) T cells to produce and secrete IFN-γ and GZMB. In addition, FP008 showed encouraging safety and pharmacokinetics profile in cynomolgus monkey, and demonstrated favorable developability.

This breakthrough offers a new treatment choice for patients who have limited options and could potentially transform the treatment paradigm for solid tumors. Fapon Biopharma is actively seeking strategic partnerships with biopharmaceutical companies worldwide to co-develop FP008 through clinical trials or further commercialization.

"Global collaboration is central to our vision," stated President Vincent Huo. "We invite partners to leverage our robust preclinical data and clinical-stage asset to jointly advance innovative products in tumor immunotherapy."

Nuvalent to Participate in Upcoming March Investor Conferences

On February 28, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported that James Porter, Ph.D., Chief Executive Officer, and Alexandra Balcom, Chief Financial Officer, will participate in fireside chats during the following March investor conferences (Press release, Nuvalent, FEB 28, 2025, View Source [SID1234650761]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

TD Cowen 45th Annual Health Care Conference on Wednesday, March 5, 2025 at 9:50 a.m. ET in Boston;
Leerink Global Healthcare Conference 2025 on Monday, March 10, 2025 at 10:40 a.m. ET in Miami, FL; and,
Barclays 27th Annual Global Healthcare Conference on Wednesday, March 12, 2025 at 2:30 p.m. ET in Miami, FL.

Live webcasts will be available in the Investors section of the company’s website at www.nuvalent.com, and archived for 30 days following the presentations.

Magnet Biomedicine Enters into a Collaboration and License Agreement with Lilly to Discover and Develop Novel Molecular Glue Medicines

On February 28, 2025 Magnet Biomedicine, a leading biopharmaceutical company advancing molecular glue discovery with rational selection and design, reported a collaboration and license agreement with Eli Lilly and Company to discover, develop, and commercialize molecular glue therapeutics in oncology (Press release, Magnet Biomedicine, FEB 28, 2025, View Source [SID1234650760]). The collaboration will leverage Magnet’s TrueGlue discovery platform to identify molecular glues capable of inducing protein proximity and cooperativity, enabling novel mechanisms of action to address difficult-to-drug targets spanning multiple diseases with unmet medical need.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This collaboration supports our differentiated approach and efforts to reimagine what’s achievable through the next generation of molecular glues to drive breakthrough therapies," said Brian Safina, Ph.D., CEO of Magnet. "Lilly’s commitment to innovation and deep expertise in bringing transformative medicines to patients make it an ideal partner for Magnet as we harness the untapped potential of molecular glues."

Under the terms of the agreement, Magnet will receive upfront, near-term payments and an equity investment of up to $40 million. Magnet is also eligible to receive a total of more than $1.25 billion in milestones upon achievement of certain development, regulatory, and commercial milestones, as well as tiered royalties on global net sales.

About TrueGlue discovery platform
Magnet’s TrueGlue discovery platform utilizes state-of-the-art screening technologies, proprietary chemical libraries, and strategic selection of target and presenter proteins to rationally and systematically identify TrueGlues. These small molecules induce proximity and promote cooperativity between proteins, enabling precise drug targeting to disease-relevant tissues and addressing historically difficult-to-drug proteins.