Pioneering a New Generation of Precision Oncology Therapeutics
Advancing differentiated, stereoselective small-molecule therapeutics designed to target cell-cycle and transcriptional pathways, aiming to address unmet medical needs in oncology.
SPV374 — Stereoselective CDK4/6/9 Inhibitor
An investigational ATP-competitive small molecule targeting distinct cell-cycle and transcriptional kinases.
- CDK4/6 · Cell-cycle regulation
- CDK9 · Transcriptional regulation
- Preclinical oncology program
Dashed lines with bar ends show SPV374 targeting (inhibition) of each kinase. They are not physical links between the kinases. Select a target to see its annotation.
CDK4 · Cyclin DRB-dependent G1 cell-cycle regulation.
CDK6 · Cyclin DRB-dependent G1 cell-cycle regulation.
CDK9 · Cyclin T / P-TEFbRNA polymerase II transcriptional elongation; MYC/MCL-1 pathways under investigation.
SPV374 shows greater biochemical inhibitory potency than its mirror-image enantiomer SPV373.
Conceptual representation of SPV374’s biochemical CDK4/6/9 target profile. CDK4/6 participate in cyclin D–RB cell-cycle signaling; CDK9 participates in P-TEFb-mediated transcriptional elongation. Proposed downstream antitumor mechanisms remain under investigation.
SPV374 is preclinical. Human safety, efficacy and clinical differentiation have not been established.
The Oncology Landscape & Resistance Crisis
Millions of patients face cancers that have outpaced first-generation therapies. SPV Therapeutics is engineered for the resistance frontier.
~480k Cases Globally
Triple-Negative Breast Cancer (ER-/PR-/HER2-) represents 15-20% of all breast cancer diagnoses with limited targeted therapy options and poor prognosis.
Receptor Absence = No Target
Absence of ER, PR and HER2 receptors means hormone-directed and HER2-directed therapies do not apply, so chemotherapy-based regimens remain central for many patients.
Metastatic Survival <2 Years
Median survival for metastatic TNBC remains critically low. SPV374's transcriptional-targeting approach is being investigated as a potential new option for this patient population.
1st-Gen CDK4/6 Resistance
Palbociclib, abemaciclib and ribociclib can lose effectiveness when tumors show RB1 loss, Cyclin E1/CDK2 upregulation or MYC/MCL-1 transcriptional signaling (published literature).
RB-Independent Mechanisms
RB loss is one reported route to resistance to first-generation CDK4/6 inhibitors, which depend on functional RB to arrest the cell cycle. Reported frequencies vary between studies.
Limited Options After CDK4/6 Resistance
Disease that progresses after CDK4/6 inhibitors remains an area of significant unmet need. SPV374's CDK9 activity is being investigated, in preclinical models only, as a way to address transcription-driven resistance (MCL-1, MYC).
SCLC — Transcriptional Dependency
Small Cell Lung Cancer is frequently associated with MYC amplification and transcriptional dependency, which may be sensitive to CDK9 inhibition. SPV374 has not yet been evaluated in SCLC patients.
TP53/KRAS Mutated Tumors
Pancreatic, colorectal and ovarian cancers with TP53/KRAS mutations are difficult to treat with standard approaches. Whether dual CDK4/6/9 inhibition helps is a hypothesis under preclinical investigation.
$20B+ Market Expansion
Extension of CDK inhibitors into solid tumors beyond HR+ breast cancer is a potential multi-billion-dollar market. Management estimate; source and date to be added before publication.
SPV374 — Balanced CDK4/6/9 Inhibitor
An orally bioavailable, stereoselective small molecule designed to block both cell-cycle progression and transcriptional oncogene survival pathways.
SPV374: A Differentiated CDK4/6/9 Inhibition Strategy for Resistant Tumor Biology
Designed to block Retinoblastoma (RB) protein phosphorylation, which is expected to hold cells in G1 and slow tumor cell proliferation.
Mechanistic hypothesisDesigned to inhibit RNA Pol II CTD phosphorylation, which is hypothesised to reduce short-lived survival proteins such as MCL-1 and MYC and promote tumor cell death. Observed in preclinical models; not yet tested in humans.
Mechanistic hypothesisSPV374 Preclinical Profile vs. Marketed CDK4/6 Therapies
| Feature | Palbociclib / Abemaciclib | SPV374 |
|---|---|---|
| Primary Targets | CDK4, CDK6 | CDK4 + CDK6 + CDK9Biochemical assayKinase target profile |
| RB1 Loss Efficacy | Reduced activity expected (RB-dependent mechanism) | Active in RB-null models (preclinical)Cell-based studyRB-deficient cell model (MDA-MB-436) |
| MCL-1 / MYC Suppression | Reported as a resistance pathway | Downregulated in preclinical modelsCell-based studyPreclinical cell models |
| TNBC Efficacy (in vivo) | Limited single-agent activity reported | TGI >76% in MDA-MB-436 xenograft (preclinical)Animal study (preclinical)MDA-MB-436 xenograft |
| Oral Bioavailability | Moderate / Variable | 44-46% (rat/dog PK)Animal study (preclinical)Rat and dog PK |
| Bone Marrow Safety | Neutropenia is a known class effect | Potential to preserve (preclinical)Animal study (preclinical)Rat and dog studies; human relevance unknown |
All SPV374 values are preclinical (laboratory and animal) results; SPV374 has not been tested in humans. Comparator entries describe published characteristics of the approved drug class and are not head-to-head results.
Company-reported preclinical findings from an MDA-MB-231 orthotopic triple-negative breast cancer xenograft study (2020). SPV374 was administered orally once daily for 24 days (n=6 mice per group), followed by approximately two weeks of post-treatment observation. Tumor-growth inhibition was dose-dependent in this study. These findings do not establish efficacy or safety in humans.
Integrated Medicinal Chemistry and AI-Enabled Discovery Strategy
SPV combines established medicinal chemistry and computational modeling with AI-assisted tools. Generative design, digital-twin tumor simulation and automated regulatory intelligence are capabilities in development, not yet validated.
Preclinical Oncology Pipeline
A multi-asset preclinical CDK inhibitor portfolio, from discovery through planned IND-enabling studies. Click any candidate to view its mechanism, IP status and development stage.
- Completed
- In progress
- Planned
Stage bars show completed, in-progress and planned work separately. Planned stages are intentions that depend on funding, regulatory feedback and study results. All programs are preclinical.
Diversified Precision Oncology Portfolio
Filled track = work completed or under way. Open track = planned activity, subject to funding and results.
Intellectual Property & Global Patents
Patent applications covering novel stereoselective CDK inhibitor compounds and therapeutic uses. Statuses are grouped as Granted, Allowed, Pending or Inactive and are subject to verification against the official registers.
United States (USPTO)
App No. 17/416,971 — Series D SPV374
Novel CDK4/6/9 inhibitor chemical composition, stereocenters, and treatment methods for TNBC and resistant solid tumors.
Searchable Global Patent Registry
| Patent Family | Target Scope | Jurisdiction | App / Patent No. | Status |
|---|---|---|---|---|
| Series D (SPV374) | CDK4/CDK6/CDK9 | United States (USPTO) | 17/416,971 | Notice of Allowance |
| Series D (SPV374) | CDK4/CDK6/CDK9 | Europe (EPO) | EP20738412.1 | Pending Examination |
Statuses are summarised by SPV Therapeutics and are subject to confirmation against the official patent registers. Granted = patent issued. Allowed = Notice of Allowance received, grant not yet issued. Pending = application under examination or published. Inactive = lapsed or abandoned.
Executive Leadership & Advisory Board
World-class biopharmaceutical executives, medicinal chemists, oncology pioneers, and enterprise AI leaders based at the Research Triangle Park innovation ecosystem.
Executive Leadership
Dr. Subba R. Katamreddy, PhD
Founder, President & Chief Executive OfficerRenowned medicinal chemist and biotech entrepreneur with deep expertise in kinase inhibitor design, stereoselective synthesis platforms, and leading preclinical oncology programs to IND filing. Architect of SPV374 and the broader CDK inhibitor portfolio.
LinkedInVijaya L. Katamreddy, B.Sc.
Co-Founder & Corporate SecretaryServes as Corporate Secretary of SPV Therapeutics, responsible for corporate records, board and shareholder administration, and governance and compliance matters.
Hired
Senior Vice President - AIOpen leadership roles
Prospective positions SPV intends to fill. These are not current appointments.
Hiring
Chief Scientific Officer (Biology)Hiring
Business Development DirectorInvestor Center
A preclinical-stage precision oncology company developing CDK inhibitors for resistant tumors. Detailed materials are available to qualified investors through an approval-based data room.
$20B+
Global Market Opportunity
Expanding beyond HR+ breast cancer into TNBC, lung, pancreatic, ovarian, and resistant solid tumors with unmet medical needs.
USPTO
Allowed Composition Claims
USPTO Notice of Allowance for SPV374 composition-of-matter claims, patent applications in several jurisdictions (status under verification).
Preclinical
Preclinical Data Package
In vivo efficacy in TNBC xenograft models, 7-day rat and dog toxicology and PK, and a planned biomarker-driven Phase 1a/1b strategy. 28-day GLP toxicology and CMC scale-up are the next IND-enabling steps.
4 Programs
Multi-Asset Pipeline
CDK4/6/9 inhibitors, selective CDK4, selective CDK9, and PROTAC degraders across multiple solid tumor indications.
Scientific Resources & Data Room
SPV374 Preclinical Overview (2026)
Comprehensive scientific deck detailing balanced CDK4/6/9 inhibition, xenograft efficacy, and PK/tox data across TNBC models.
Request PDF Download7-Day Rat & Dog Toxicology Report
Summary of the 7-day rat and dog studies: MTD, toxicokinetics and bone marrow observations. Available to approved investors on request.
Request Data Room AccessGlobal IP Portfolio Factsheet
Summary of the USPTO Notice of Allowance, patent applications in several jurisdictions (status under verification), and EPO and PCT claims, with expiry and geographic coverage details.
Download IP SummaryStrategic Partnerships
We welcome licensing inquiries, co-development collaborations, strategic investments, and IND-enabling clinical partnerships from institutional partners worldwide.
Partnership Opportunities
Co-Development & Licensing
Co-develop SPV374 for specific solid tumor indications, or in-license regional rights across Asia-Pacific, EU, or North American markets.
IND-Enabling & CMC Alliances
Partner with CRO/CDMO leaders on Phase 1 clinical supply scaling, regulatory filing strategy, and study management.
Strategic & Venture Investment
Participate in upcoming capital rounds to advance SPV374 through IND filing and Phase 1a clinical initiation in TNBC.
Institutional PE & Pharma Licensing
Engage institutional syndicates for structured equity financing, and out-license non-lead assets for strategic royalty income.
Contact Business Development
News & Milestones
Key scientific breakthroughs, patent grants, executive appointments, and corporate milestones driving SPV Therapeutics forward.
USPTO Issues Notice of Allowance
U.S. Patent Application No. 17/416,971 received a Notice of Allowance covering SPV374 compound structures and composition-of-matter claims.
IP MilestoneSPV Therapeutics Strengthens Oncology IP Portfolio with U.S. Patent Grant
U.S. Patent No. 12,760,023 B2, granted October 13, 2026, covers a differentiated bicyclo[1.1.1]pentane (BCP)-based CDK inhibitor chemotype, complementing SPV’s CDK4/6/9 inhibitor strategy and SPV113 backup program.
U.S. Patent