Alligator announces publication in Cancer Immunology Research of preclinical data on ATOR-4066, a tumor-directed CD40×CEACAM5 bispecific antibody

On September 10, 2025 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported the publication of a peer-reviewed article in Cancer Immunology Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Alligator Bioscience, SEP 10, 2025, View Source [SID1234655916]). The paper presents preclinical data on ATOR-4066, a bispecific antibody targeting CD40 and CEACAM5 developed using Alligator’s proprietary Neo-X-Prime platform and RUBY format.

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!

The study, titled "ATOR-4066, a Neo-X-Prime bispecific antibody targeting CD40 and CEACAM5, induces strong myeloid and T cell dependent tumor immunity and synergizes with PD-1 blockade", highlights the potential of ATOR-4066 to overcome key resistance mechanisms in the tumor microenvironment. The data demonstrates that ATOR-4066 induces localized activation of myeloid cells and T cells within the tumor, while sparing healthy peripheral tissues, resulting in potent antitumor immunity.

Key findings from the publication include:

Tumor-localized activation: ATOR-4066 selectively activated CD40 in human tumor samples.
Potential to outperform other tumor targeting therapies: ATOR-4066 mediates strong anti-tumor activity also in tumors with heterogenous CEACAM5 expression.
Turning the tumor hot: Mechanistic analyses shows that ATOR-4066 efficiently activates the immune system in the tumor resulting in tumor rejection.
Synergy with checkpoint blockade: ATOR-4066 demonstrated synergistic activity with anti-PD-1 treatment.
"Publication of these data in Cancer Immunology Research underscores the potential of our Neo-X-Prime platform and RUBY format to generate bispecific antibodies capable of reshaping the tumor microenvironment and driving durable immune responses," said Søren Bregenholt, CEO of Alligator Bioscience. "As a follow-on to mitazalimab, ATOR-4066 represents a promising new therapeutic strategy for CEACAM5-expressing tumors and provides further evidence of Alligator’s strength in developing tumor-targeted CD40 agonists."

FDA Files Corcept’s New Drug Application for Relacorilant as a Treatment for Patients with Platinum-Resistant Ovarian Cancer

On September 10, 2025 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported that the U.S. Food and Drug Administration (FDA) has accepted Corcept’s New Drug Application (NDA) for relacorilant as a treatment for patients with platinum-resistant ovarian cancer (Press release, Corcept Therapeutics, SEP 10, 2025, https://ir.corcept.com/news-releases/news-release-details/fda-files-corcepts-new-drug-application-relacorilant-treatment-0 [SID1234655914]). The FDA has assigned a PDUFA date of July 11, 2026 for the application.

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!

Corcept’s NDA is based on positive data from its pivotal Phase 3 ROSELLA and Phase 2 trials. In these trials, patients who received relacorilant plus nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel monotherapy, with no need for biomarker selection. Relacorilant was well-tolerated, consistent with its known safety profile. Importantly, relacorilant conferred its benefit without increasing the safety burden of the patients who received it. The type, frequency and severity of adverse events in the combination arms were similar to those in the nab-paclitaxel monotherapy arms.

"The FDA’s acceptance of our NDA brings us closer to offering a much-needed treatment option to patients with this dire disease," said Joseph Belanoff, M.D., Corcept’s Chief Executive Officer. "Relacorilant has the potential to redefine how platinum-resistant ovarian cancer is treated."

About Relacorilant

Relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR but not to the body’s other hormone receptors. Corcept is developing relacorilant in ovarian cancer and a variety of other serious disorders, including endogenous hypercortisolism and prostate cancer. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 30, 2025 for relacorilant as a treatment for patients with hypercortisolism.

About Cortisol’s Role in Oncology

Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenes in the cells to which it binds. Cortisol also suppresses the body’s immune response, which weakens its ability to fight all diseases, including cancer.

About Platinum-Resistant Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. There are few treatment options for these women. Median overall survival following recurrence is approximately 12 months with single-agent chemotherapy. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.

Celcuity Announces Upsized Senior Secured Term Loan Facility of $500 Million with Innovatus Capital Partners and Oxford Finance

On September 9, 2025 Celcuity Inc. ("Celcuity"), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, reported that it has entered into an amendment to its existing senior secured credit facility with an affiliate of Innovatus Capital Partners, LLC ("Innovatus") and Oxford Finance LLC ("Oxford") (Press release, Celcuity, SEP 9, 2025, View Source [SID1234655918]). The amendment increases the total term loan facility size to $500 million, including $350 million in committed capital and up to $150 million at the mutual discretion of Celcuity and its lenders. At the closing of the Amendment, the initial funding under the amended credit facility was in a principal amount of $30 million, bringing the total term loan outstanding to $130 million.

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!

Highlights of the amended credit facility include:

● Increased Capital Availability: Adds $170 million in new committed capital, including an additional $50 million for a total of $100 million available upon U.S. Food and Drug Administration ("FDA") approval of gedatolisib in second-line wild-type advanced breast cancer ("ABC") patients post-CDK4/6 inhibitor therapy, and $120 million upon achievement of certain commercial revenue milestones. An additional up to $150 million is also available at the mutual discretion of Celcuity and its lenders.
● Improved Structure and Financial Flexibility: Extends the interest-only period by 14 months, with an additional seven-month extension available upon FDA approval. The maturity date of the facility was also extended by six months.

The amendment significantly enhances Celcuity’s financial flexibility and access to capital following the positive topline data from the PIK3CA wild-type cohort of the pivotal VIKTORIA-1 Phase 3 clinical study. The upsized facility strengthens Celcuity’s ability to manage its capital structure efficiently while providing additional funding to support the rolling submission to FDA of its New Drug Application ("NDA") via FDA’s RTOR program, commercial launch preparations for gedatolisib, and other strategic initiatives.

Actuate Therapeutics Announces Proposed Public Offering of Common Stock

On September 9, 2025 Actuate Therapeutics, Inc. (NASDAQ: ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, Actuate Therapeutics, SEP 9, 2025, View Source [SID1234655915]). The Company also expects to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of shares of its common stock offered in the public offering at the public offering price per share, less underwriting discounts and commissions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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!

The Company intends to use the net proceeds from the proposed offering for working capital and general corporate purposes.

Lucid Capital Markets is acting as sole book-running manager for the offering.

The common stock described above is being offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-289988), including a base prospectus, previously filed with and subsequently declared effective by the Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement relating to the offering has been filed with the SEC and is available on the SEC’s website at View Source A final prospectus supplement describing the terms of the offering will be filed with the SEC. The offering will be made only by means of the prospectus supplement and the accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that the Company may file with the SEC. Copies of the preliminary prospectus supplement, and accompanying base prospectus relating to this offering, may be obtained from Lucid Capital Markets, LLC, 570 Lexington Avenue, 40th Floor, New York, NY 10022.

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

Ridge Biotechnologies Emerges from Stealth with $25 Million in Seed Financing for AI-Enabled Precision Enzyme and Targeted Drug Design

On September 9, 2025 Ridge Biotechnologies (Ridge Bio), a company pioneering enzyme and targeted drug design to power the next wave of precision medicines, reported to have emerged from stealth with an oversubscribed $25 million in seed financing (Press release, Ridge Bio, SEP 9, 2025, View Source [SID1234655903]). Sutter Hill Ventures (SHV) incubated Ridge Bio and led the round, with participation from Overlap Holdings among others.

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!

The Ridge Bio platform uses proprietary machine learning models informed by high-throughput, cell-free experimentation for a wide range of applications in antibody-drug conjugates (ADCs), in vivo CAR-T therapies, targeted nucleic acid delivery, small molecule biocatalysis, radiotherapies, and enzyme-based therapeutics. Weston Kightlinger, PhD, a serial entrepreneur and pioneer in the fields of cell-free synthesis and enzyme design, is co-founder and Chief Executive Officer of Ridge Bio. Dr. Kightlinger previously co-founded and served as Chief Technology Officer of SwiftScale Biologics, a leader in cell-free manufacturing acquired by Resilience.

"Drug development should never be limited by the complexity of molecules we can precisely construct, off-target toxicities, or binding-based mechanisms of action. Machine learning has dramatically expanded our ability to design enzymatic systems that can solve these problems, but unlocking their full potential requires massive experimental datasets. At Ridge Bio, we generate those datasets at unprecedented speed and scale — up to a million-fold more sequence-function data than conventional methods in a fraction of the time. We use custom-built ML models to apply this data to enzyme and conditionally active drug design, giving our partners powerful tools to create safer, more precise medicines," said Kightlinger, who built Ridge as an Entrepreneur-in-Residence at SHV where he remains a Strategic Advisor. "With the support of great investors and a world-class founding team, we are scaling operations, expanding our technology partnerships in bioconjugates, and advancing our discovery programs towards our longer-term goal of developing a new class of precision-designed therapeutic enzymes. The strong, early interest from leading biopharma companies and CDMOs validates our vision and inspires us to accelerate the delivery of breakthrough medicines that make a real difference for patients." Ridge Bio has also announced its collaboration with a leading ADC-focused biotech to leverage Ridge Bio’s ProTrigger and NativeLink product lines to design and precisely attach linker systems that deliver therapeutic payloads specifically to tumor tissue, sparing healthy cells.

Powering Enzyme and Conditionally Active Prodrug Design

Ridge Bio’s initial offerings include NativeLink enzymes and ProTrigger linkers. NativeLink enzymes are designer biocatalysts that enable drugmakers to site-specifically modify therapeutic proteins, augment them with diverse payloads, extend their half-lives, and add precision targeting systems, all without changing the protein sequence, cell lines, or any upstream manufacturing processes. Ridge Bio’s first product, the NativeLink — AXC enzyme provides homogeneous modification of native antibodies without altering glycans, disulfide bonds, or amino acid sequences, avoiding stability, manufacturing, and functional challenges common with the previous generations of ADC, antibody-oligonucleotide conjugate (AOC), and other antibody conjugate synthesis strategies. The versatile system can achieve user-defined drug to antibody ratios (DARs) and multiple payloads or even upgrade an existing ADC drug product directly into a dual payload ADC without additional process changes. ProTrigger linkers are AI-designed protease-cleavable prodrug systems that release or activate therapeutic payloads at targeted sites in the body. Initial applications of ProTrigger linkers include unlocking new ADC targets, enhancing safety by reducing off-tumor toxicity, and targeting the tumor microenvironment and stroma.

"What used to take years can now be done in weeks, thanks to the combination of cell-free experimentation and machine learning. Together, they have created a step-change in our ability to design and leverage enzymes and prodrugs with exquisite specificity. That specificity is at the heart of Ridge Bio’s technologies and the next generation of precisely designed therapeutics," said Mike Jewett, Professor of Bioengineering at Stanford University and Ridge Bio’s Academic Co-founder and Scientific Advisory Board Chair.

World-Class Investors and Leadership Team

Ridge Bio’s founding team brings together deep expertise across ML-driven protein engineering, cell-free systems, and bioconjugation, combining groundbreaking work in academia with proven experience in industry.

"Ridge Bio is the perfect example of our approach to building companies: back world-class founders and help them attract the incredible teams they need to solve tough technical problems and unlock huge markets. Ridge Bio’s capabilities across machine learning and wet lab bioengineering positions the company to build drugs that no one else can and enable a new class of precisely engineered enzyme-based therapeutics," said Keith Loebner, PhD, Managing Director at SHV. "Each founding member of this team could have started something on their own, but they chose to join Ridge because they recognized that together they could do things no one else could do and, as a group, define the future of precision therapeutics." Founded in 1962, some of Sutter Hill Ventures’ previous investments and incubations include NVIDIA, Snowflake, PureStorage, Corcept Therapeutics, GRAIL, and Forty Seven.

Ridge Bio’s distinguished advisory board includes Carolyn Bertozzi, PhD (Stanford University, 2022 Nobel Laureate in Chemistry); Sangeeta Bhatia, MD, PhD (MIT/HHMI); Michael Jewett, PhD (Stanford University); Gabe Kwong, PhD (Georgia Tech); Mandana Honu, PhD (Atommap and Protillion, formerly Resilience); Hans Wandall, PhD (University of Copenhagen); and Vesna Mitchell, PhD (formerly Codexis). Their founding scientific team includes Grant Landwehr, PhD (pioneered ML-accelerated cell-free enzyme engineering approaches at Stanford University); Antje Kruger, PhD (launched cell-free enabled offerings for drug developers at Resilience); Francesca Li, PhD (built AI-driven protein engineering methods with Frances Arnold, PhD and Yisong Yue, PhD at Caltech); and Josh Walker, PhD (developed novel bioconjugation and ADC platforms at Bolt Therapeutics and insitro).

"Ridge Bio is at the forefront of three key trends, next-generation bioconjugates, protein design, and enzymatic therapeutics," said Dr. Bertozzi, whose work on biorthogonal chemistry won her a Nobel Prize and has been pivotal in guiding the development of modern bioconjugates. "Their AI and experimental platform are very unique and its already generating products that enable drug developers to differentiate themselves from competitors, not only through improved manufacturing but also through improved therapeutic indices while simultaneously unlocking the power of catalytic medicines."