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NanoCell Secures Seed-Extension Financing from The Institute for Follicular Lymphoma Innovation to Advance Lead Clinical Candidate for B Cell Malignancies

On June 16, 2025 NanoCell Therapeutics, Inc. ("NanoCell"), a biotechnology company developing a non-viral, DNA-based in vivo gene therapy platform, reported the successful closing of a seed-extension financing round, with participation from The Institute for Follicular Lymphoma Innovation ("IFLI"), a leading non-profit organization dedicated exclusively to funding innovative follicular lymphoma research and development (Press release, NanoCell Therapeutics, JUN 16, 2025, View Source [SID1234653920]).

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The funding will accelerate IND-enabling development of NanoCell’s lead clinical candidate, NCTX-01, a dual-CAR CD19/CD22 in vivo CAR-T therapy for B cell malignancies. NanoCell will use the capital to further evaluate NCTX-01’s safety, efficacy and durability in treating aggressive forms of lymphoma, including diffuse large B-cell lymphoma and follicular lymphoma.

"IFLI’s support enables us to accelerate NCTX-01 through preclinical development to clinical development," said Maurits Geerlings, MD, President & Chief Executive Officer of NanoCell. "This partnership provides crucial resources to generate the preclinical data package needed for regulatory discussions. IFLI shares our belief that non-viral in vivo approaches have transformative potential to address significant unmet medical needs for patients who currently have limited treatment options.

"NanoCell’s innovative platform offers a novel approach to treating both follicular lymphoma and diffuse large B-cell lymphoma and could potentially overcome many of the current barriers that limit patient access to CAR-T therapies," said Michel Azoulay, MD, MBA, Chief Medical Officer at IFLI. "Supporting this program aligns with IFLI’s mission to accelerate innovative therapies that can make a meaningful difference in the lives of patients."

Immuneering to Provide Updates from Phase 2a Clinical Trial of IMM-1-104 in First-Line Pancreatic Cancer Patients on Tuesday, June 17, 2025

On June 16, 2025 Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company outpacing cancer to help patients outlive their disease, reported that it will host a conference call and live webcast at 8:00 am ET on June 17, 2025 (Press release, Immuneering, JUN 16, 2025, View Source [SID1234653919]). The company is excited to provide updates from its ongoing Phase 2a clinical trial of IMM-1-104 in first-line pancreatic cancer patients.

The conference call will be webcast live and archived in the Investor Relations section of Immuneering’s website at Events & Presentations | Immuneering Corporation.

FibroBiologics Closes Third $5 Million Tranche of $25 Financing

On June 16, 2025 FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 275+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, reported it has closed the third $5 million tranche of the previously announced Standby Equity Purchase Agreement (the "SEPA") with YA II PN, Ltd. ("Yorkville"), an investment fund managed by Yorkville Advisors Global, LP (Press release, FibroBiologics, JUN 16, 2025, View Source [SID1234653918]). The agreement allows FibroBiologics, subject to customary conditions, to sell up to $25 million in the aggregate of its common stock to Yorkville over the course of two years.

Yorkville agreed to advance to FibroBiologics the first $15 million available under the SEPA in three equal tranches to be evidenced by convertible promissory notes. The first tranche in the amount of $5 million was funded upon entry into the SEPA and the second tranche of $5 million was funded after the filing of a registration statement covering the resale of the shares issuable to Yorkville under the promissory notes. The third tranche of $5 million was funded following the effectiveness of the registration statement and receipt of shareholder approval in satisfaction of certain Nasdaq rules. FibroBiologics can sell an additional $10 million of its common stock to Yorkville, subject to Yorkville’s consent and other conditions, while the convertible promissory notes remain outstanding.

The net proceeds of the financing are expected to be used for general corporate purposes, including funding for research and development programs and supporting the upcoming Phase 1/2 diabetic foot ulcer clinical trial expected to begin in the second half of 2025.

For more information, please visit FibroBiologics’ website or email FibroBiologics at [email protected]. For more information on the SEPA, including important terms and conditions, please see FibroBiologics’ filings with the Securities and Exchange Commission, including its Current Reports on Form 8-K filed with the Securities and Exchange Commission from time to time.

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

D. Boral Capital LLC acted as the exclusive placement agent in connection with the SEPA.

Enveric Biosciences Announces Participation in 2025 BIO International Convention

On June 16, 2025 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of psychiatric and neurological disorders, reported that the company is participating in the BIO International Convention being held June 16-19, 2025, in Boston, Massachusetts (Press release, Enveric Biosciences, JUN 16, 2025, View Source [SID1234653917]).

During the conference, CEO and Director of Enveric, Joseph Tucker, Ph.D., will conduct one-on-one meetings with registered investors and potential partners, showcasing the company’s business and development strategy, recent corporate achievements, and anticipated milestones.

Duke Street Bio Receives FDA Fast Track Designation for DSB2455

On June 16, 2025 Duke Street Bio, a clinical-stage biotechnology company focused on precision oncology, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to DSB2455, its next-generation, CNS-active selective PARP1 inhibitor, for the treatment of patients with brain metastases originating from primary triple-negative breast cancer (TNBC) tumors harboring BRCA1/2 and/or homologous recombination repair (HRR) alterations (Press release, Duke Street Bio, JUN 16, 2025, View Source [SID1234653916]).

DSB2455 is a potentially best-in-class agent within the PARP1-selective inhibitor space, offering a differentiated profile that may expand therapeutic possibilities in hard-to-treat indications. The compound is a next-generation, highly PARP1-selective inhibitor with demonstrated brain penetrance and potent anti-tumour activity in preclinical models of homologous recombination-deficient cancers, including brain metastases.

The Fast Track designation is intended to facilitate the development of new therapies for serious conditions where there is significant unmet medical need. It allows for more frequent interactions with the FDA, eligibility for rolling review of an NDA, and potential consideration for Priority Review or Accelerated Approval.

"Receiving Fast Track designation for DSB2455 represents an important milestone in our mission to develop more targeted and effective therapies for patients with limited treatment options," said Alan Wise, Chief Executive Officer of Duke Street Bio. "Next-generation PARP1-selective inhibitors such as DSB2455 are expected to offer a wider therapeutic window than earlier PARP inhibitors, potentially enabling broader use both as monotherapy and in combination with other anti-cancer agents across a range of tumors."

"DSB2455’s ability to achieve therapeutically relevant concentrations in the CNS represents a key differentiator," added Dónal Landers, Chief Medical Officer of Duke Street Bio. "This could offer a new treatment option for patients with secondary HRD brain metastases, where clinical need remains high and current therapeutic choices are limited."

About Fast Track Designation
The FDA’s Fast Track program is designed to accelerate the development and review of new drugs for serious or life-threatening conditions that demonstrate the potential to address unmet medical needs. Companies granted this designation benefit from more frequent communication with the FDA and eligibility for rolling submissions and other expedited review processes.