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.

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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."

Moleculin Doses First EU Patient in Phase 3 Pivotal MIRACLE Trial for Treatment of Acute Myeloid Leukemia

On September 8, 2025 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a late-stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat cancers and viral infections, reported that it has enrolled the first two subjects, and treated one, in the European Union (EU) in its pivotal Phase 2B/3, multi-center, randomized, double-blind, placebo-controlled, adaptive design study of Annamycin in combination with cytarabine (also known as "Ara-C" and for which the combination of Annamycin and Ara-C is referred to as "AnnAraC") for the treatment of adult patients with acute myeloid leukemia (AML) who are refractory to or relapsed (R/R) after induction therapy (R/R AML) (Press release, Moleculin, SEP 8, 2025, View Source [SID1234655831]). This Phase 3 "MIRACLE" trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) is a global approval trial, including sites in the US, the EU, and other parts of Europe.

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"We now have active sites recruiting in the US, Spain, Ukraine, Georgia, and Romania with more sites expected to come online by the end of September. For our first site in Spain to have opened up with two subjects enrolled, we believe, indicates the unmet need in treating second line R/R AML," said Walter Klemp, Chairman and CEO of Moleculin. "All of this, importantly, supports our goal to recruit the first 45 subjects for Part A before the end of 2025 for which efficacy and safety will be unblinded."

The MIRACLE study is a Phase 2B/3 clinical trial whereby data from the 2B portion will be combined with the Phase 3 portion for purposes of measuring its primary efficacy endpoint. MIRACLE is subject to appropriate future filings with and potential additional feedback from the FDA and their foreign equivalents, utilizes an adaptive design whereby the first 75 to 90 subjects will be randomized (1:1:1) in Part A of the trial to receive high dose cytarabine (HiDAC) combined with either placebo, 190 mg/m2 of Annamycin, or 230 mg/m2 of Annamycin, which Annamycin doses were specifically recommended by the FDA in the Company’s end of Phase 1B/2 meeting.

The protocol for the MIRACLE trial allows for the unblinding of preliminary primary efficacy data (Complete Remission or CR) and safety/tolerability of the three arms at 45 subjects, in addition to the conclusion of Part A (at 75 to 90 subjects). The first early unblinding is expected to yield 30 subjects treated with Annamycin (190mg/m2 and 230 mg/m2) in combination with HiDAC and 15 subjects treated with just HiDAC plus placebo. The Company expects to reach the first unblinding (45 subjects) in the second half of 2025, in addition to the second unblinding, which is expected in the first half of 2026. This accelerated estimated timeline is due in part to the positive response the Company received in meetings during December with potential investigators regarding recruitment for the trial.

As previously announced with regard to the EU, the clinical trial approval with EMA was granted under the condition that the Company present results of appropriate nonclinical GLP studies before initiating the Phase 3 portion (Part B) of the study. Results will be submitted as a substantial modification to the existing approved CTA.

For Part B of the trial, approximately 220 additional subjects will be randomized to receive either HiDAC plus placebo or HiDAC plus the optimum dose of Annamycin (randomized 1:1). The selection of the optimum dose will be based on the overall balance of safety, pharmacokinetics and efficacy, consistent with the FDA’s new Project Optimus initiative.

Patient dosing has commenced, and the initial data readout is on track for the second half of 2025. For more information about the MIRACLE trial, visit clinicaltrials.gov and reference identifier NCT06788756. Additionally, the clinical trial in the EU is on euclinicaltrials.eu and the reference identifier there is 2024-518359-47-00.

Annamycin, also known by its non-proprietary name of naxtarubicin, currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the EMA.

Cellworks Study Reveals Tumor Microenvironment and TLS Dynamics Together Predict Patient-Level Immunotherapy Response in NSCLC

On September 8, 2025 Cellworks Group Inc., a leader in Personalized Therapy Decision Support and Best-in-Class PTRS, reported results from a new study showing that the combination of tumor microenvironment (TME) composition and tertiary lymphoid structure (TLS) dynamics is a key predictor of how individual patients with non-small cell lung cancer (NSCLC) respond to immunotherapy (Press release, Cellworks, SEP 8, 2025, View Source [SID1234655846]). The study introduces a novel prediction model that integrates TME cell composition with a 34-gene TLS score. Together, these measures enabled the Cellworks Platform to accurately predict patient-level survival outcomes and reveal meaningful differences among NSCLC patients treated with checkpoint inhibitors.

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Results from the study were showcased in a poster presentation titled, "Cellular Heterogeneity and Tertiary Lymphoid Structure Dynamics Predict Overall Survival in Immune Checkpoint Therapy-Treated NSCLC Patients," as part of the IASLC 2025 World Conference on Lung Cancer (#WCLC25) hosted by the International Association for the Study of Lung Cancer held from September 6-9, 2025 in Barcelona, Spain.

"Despite the promise of immune checkpoint inhibitors (ICIs), only a subset of NSCLC patients benefit from these therapies," said Charu Aggarwal, MD, MPH, FASCO, Leslye M. Heisler Professor of Lung Cancer Excellence in the Perelman School of Medicine at the University of Pennsylvania, and co-author on the study. "This study provides new insights into how the structural organization of tertiary lymphoid structures and the immune cell composition of the tumor microenvironment jointly determine immunotherapy response. By moving beyond single biomarkers, this approach holds promise as a more comprehensive way to guide personalized treatment decisions in NSCLC."

"Our findings highlight that both cellular heterogeneity and TLS dynamics play critical roles in determining whether patients respond to checkpoint inhibitor therapy," said James Wingrove, PhD, Chief Development Officer at Cellworks and presenting author of the study. "By integrating these factors, we created a personalized model that can offer oncologists new insight into which patients are most likely to benefit from checkpoint inhibitors. This study underscores how computational modeling of the tumor microenvironment can advance personalized decision support in NSCLC."

"What makes this work exciting is the ability to connect molecular signals within the tumor microenvironment to real patient outcomes," said Michael Castro, MD, Chief Medical Officer at Cellworks. "By biosimulating how both cellular heterogeneity and TLS dynamics shape immunotherapy response, we move closer to a future where treatment selection is not just based on broad population markers, but on each patient’s unique tumor biology. This level of personalization has the potential to identify which patients benefit from combination chemotherapy and immunotherapy while also sparing other patients from receiving chemotherapy when it is unlikely to benefit."

Key Findings

Strong Predictive Value – The integrated TLS + TME model demonstrated high predictive significance for overall survival in both the training (HR=0.36, C-Index=0.768) and validation cohorts (HR=0.66, C-Index=0.628).
Clear Survival Differences – Patients predicted to have a high benefit from immune checkpoint inhibition showed a significant increase in overall survival, living a median of 30.8 months versus 12 months for patients predicted to have low benefit.
Immune Balance Matters – Survival benefit was tied to immune balance: pro-inflammatory environments enhanced TLS benefit, while suppressive immune cells (like neutrophils and M2-like macrophages) reduced or reversed it.
New Insights for Personalization – The integration of TLS dynamics with TME immune and stromal cell composition provided independent yet complementary insights, showing how structural organization and cellular balance cooperatively determine immunotherapy efficacy and can guide personalized treatment decisions.
Study Design

Cellworks developed and cross-validated an algorithm that deconvolutes bulk transcriptomic data to estimate cell proportions and cell-type–specific gene expression within the TME. This approach was enhanced with a TLS Score based on 34 genes representing cellular interplay and maturity, derived from bulk RNA-sequencing data of tumor samples. By integrating TLS dynamics with immune and stromal cell populations, the model captured complementary and independent contributions, providing collective insight into how tumor structure and cellular composition determine ICI efficacy. A Cox proportional hazards model was trained on advanced NSCLC patients treated with ICIs (n=63, SU2C-MARK cohort) and validated in an independent cohort of 66 patients from the same study. The locked model confirmed predictive performance at the individual patient level, underscoring its potential clinical utility.

The Cellworks Platform

The Cellworks Platform performs computational biosimulation of protein-protein interactions, enabling in silico modeling of tumor behavior using genomic data derived from next-generation sequencing (NGS). This allows for the evaluation of how personalized treatment strategies interact with the patient’s unique tumor network. Multi-omic data from an individual patient or cohort is used as input to the in silico Cellworks Computational Biology Model (CBM) to generate a personalized or cohort-specific disease model.

The CBM is a highly curated mechanistic network of 6,000+ human genes, 30,000+ molecular species and over 600,000 molecular interactions. This model along with associated drug models are used to biosimulate the impact of specific compounds or combinations of drugs on the patient or cohort and produce therapy response predictions, which are statistically modeled to produce a qualitative therapy response score for a specific therapy. The Cellworks CBM has been tested and applied against various clinical datasets with results provided in more than 125 presentations and publications with global collaborators.

Immutep Announces Data from EFTISARC-NEO Phase II Evaluating Neoadjuvant Efti in Soft Tissue Sarcoma Accepted for Oral Presentation at CTOS 2025

On September 8, 2025 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a late-stage immunotherapy company targeting cancer and autoimmune diseases, reported an abstract for the EFTISARC-NEO Phase II investigator-initiated trial has been accepted for oral presentation at the Connective Tissue Oncology Society (CTOS) 2025 Annual Meeting taking place 12-15 November 2025, in Boca Raton, Florida (Press release, Immutep, SEP 8, 2025, View Source [SID1234655800]).

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EFTISARC-NEO is the first study to evaluate eftilagimod alpha (efti) in a neoadjuvant setting (prior to surgery) administered in combination with radiotherapy plus KEYTRUDA (pembrolizumab) for patients with soft tissue sarcoma (STS).

Presentation Details
Title: Primary endpoint and translational correlates from EFTISARC-NEO: phase II trial of neoadjuvant eftilagimod alpha (efti), pembrolizumab, and radiotherapy in patients with resectable soft tissue sarcoma
Session: Immunotherapy & Cell Therapy in Sarcoma: Emerging Frontiers
Presenter: Pawel Sobczuk, M.D., Ph.D., Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie National Research Institute of Oncology
Date: Thursday, 13 November 2025, 1:30 PM – 3:00 PM ET
Format: Oral Presentation
STS is an orphan disease with high unmet medical need and a poor prognosis for patients. The incidence of STS varies in different regions globally. In the United States, the number of new STS cases in 2025 is estimated to be ~13,520 with ~5,420 deaths, according to the American Cancer Society.1

EFTISARC-NEO is is being conducted by the Maria Skłodowska-Curie National Research Institute of Oncology in Warsaw, Poland. The study is primarily funded with an approved grant from the Polish government awarded by the Polish Medical Research Agency program. For more information on the trial visit clinicaltrials.gov (NCT06128863).

The presentation slides will be available on the Posters & Publications section of Immutep’s website after the presentation at CTOS 2025.

Oncolytics Biotech® Highlights Strong Efficacy and Translational Data in Metastatic Colorectal Cancer; Will Advance Regulatory Pathway Discussions

On September 8, 2025 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported clinical and translational data from three metastatic colorectal cancer ("mCRC") studies demonstrating consistent efficacy signals, immune activation, and survival outcomes that exceed historical benchmarks in multiple mCRC treatment settings (Press release, Oncolytics Biotech, SEP 8, 2025, View Source [SID1234655832]).

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In the REO 022 trial, pelareorep in combination with FOLFIRI and bevacizumab achieved the following results in platinum refractory 2L mCRC KRAS mutant patients:
•Median progression-free survival ("PFS"): 16.6 months vs. 5.7 months with standard 2L regimen1
•Median overall survival ("OS"): 27.0 months vs. 11.2 months with standard 2L regimen1

In the GOBLET study’s 3L mCRC Cohort 3, pelareorep combined with atezolizumab and TAS-102 met its predefined efficacy endpoint. The regimen achieved durable disease control and survival rates greater than historical benchmarks for 3L mCRC treated with TAS-102.

In the REO 022 trial and the REO 013 translational study, viral replication and immune activation were demonstrated in tumors from mCRC patients, including dendritic cell maturation and CD8+ T cell activation. These findings confirm pelareorep’s mechanism of action, including its ability to modify mCRC tumors to be immune responsive and amenable to checkpoint inhibition.

"These studies validate pelareorep’s mechanism of action and present a clear opportunity to accelerate the pursuit of a registration-enabled study in the underserved KRAS mutant subset of mCRC patients," said Jared Kelly, CEO of Oncolytics. "Given pelareorep’s activity in this difficult-to-treat cancer and other RAS-mutated gastrointestinal ("GI") tumors, including metastatic pancreatic and anal cancers, we believe pelareorep is positioned to become the premier platform immunotherapy in the GI space."

"The efficacy data for pelareorep in the hard-to-treat KRAS mutant population of mCRC are very encouraging," said Dr. Sanjay Goel, professor and attending physician at Rutgers University. "We plan to initiate an investigator-sponsored trial to further explore pelareorep’s promising potential in KRAS mutant mCRC, building on the robust immune activation demonstrated in REO 013 and the survival benefit seen in REO 022."

In addition to establishing an executable investigator-sponsored trial, the company plans to work with leading investigators and engage with regulators to define a clear path to registration in mCRC, including the design of a confirmatory study, leveraging the data in the KRAS mutant patient setting.