Annate Bitherapeutics is developing a therapeutic platform that utilizes ApoL1, a naturally occurring component of the innate immune system. It is guided by our proprietary bispecific antibodies to become selectively lethal to cancer cells. This innovative mechanism complements existing therapies, with strong efficacy in multiple myeloma and promising preclinical results in pancreatic cancer models, demonstrating the platform’s broad potential across multiple tumor types.
Annate Bitherapeutics is fundamentally reengineering a natural component of the human innate immune system to target and destroy cancer cells. Our approach focuses on Relapse Refractory Multiple Myeloma (RRMM), a difficult stage where patients become resistant to all available therapies, leaving them with few options and no cure. Rather than relying on traditional drugs, stem-cell transplants, or T-cell activation, our approach harnesses Apolipoprotein L1 (ApoL1), a protein that naturally protects humans against the parasite Trypanosoma brucei. Under normal physiological conditions, ApoL1 is non-toxic to human cells. However, when ApoL1 enters into the parasite’s endocytic pathway, the low-pH environment induces a conformational change, causing ApoL1 to insert into the parasite membrane and form ion channels that ultimately lead to parasite death. By engineering a bispecific antibody, we can redirect ApoL1 from its parasite target to cancer-specific receptors on MM cells. Upon binding to malignant cells, ApoL1 undergoes an environmental trigger that disrupts lysosomal membranes, leading to the selective destruction of cancer cells while sparing normal tissues. This approach bypasses the need for broad-spectrum cytotoxic agents and aims to offer a safer, more effective alternative. Our proof-of-concept studies have demonstrated promising in vitro efficacy against MM, and we are currently translating this work into preclinical models. Additionally, the inherent versatility of this platform holds potential for expanding beyond multiple myeloma into other hard-to-treat cancers, such as pancreatic cancer. In short, Annate Bitherapeutics is developing a new class of targeted therapies that co-opt evolutionary defenses to wage a more precise war on cancer.
Annate Bitherapeutics’ team unites experienced scientists, clinicians, and executives poised to advance our novel cancer therapy.
- Co-founders Eric DeJesus, PhD, and Michael Cipriano, PhD, contribute deep R&D expertise—DeJesus pioneered the idea of targeting ApoL1 and performed preliminary studies, while Cipriano expanded the work to include bsAb targeting.
- Stephen L. Hajduk, PhD (UGA), brings decades of research on innate immunity, specifically ApoL1.
- Gregory Lesinski, PhD, MPH (Emory), is a leading translational cancer immunologist
- Ajay Nooka, MD, MPH (Emory), offers multiple myeloma clinical expertise
- Shishir Maithel, MD, FACS, FSSO (Emory), delivers a patient-centered approach for pancreatic cancer.
- Martin Moore, PhD—former Emory faculty and founder of Meissa Vaccines—successfully transitioned vaccine technology into clinical trials, raising over $80M.
- Brian Longstreet provides global pharma and biotech leadership experience with expertise in strategic planning.
Together, this team’s complementary expertise positions Annate to advance its therapies into clinical applications with meaningful patient impact.
Our go-to-market strategy is anchored in strong early partnerships that have helped build a solid foundation of preclinical data. One foundational partnership we would like to develop: Looking ahead, we seek to partner with a pharmaceutical company that can guide us through GMP manufacturing, CMC development, GLP toxicology, and the regulatory steps needed for clinical trials. Our ApoL1-based platform will be licensed to biopharma companies, generating immediate income and validating our technology through partnerships with multiple revenue streams. To date, we have worked with:
- Promab: Conducting animal studies to establish in vivo proof-of-concept and refine dosing parameters. - Absolute Antibody: Supporting preliminary bispecific antibody development, accelerating the selection and optimization of our lead candidates.
- Emory Winship Cancer Institute: Providing academic insight and preclinical models for our pancreatic cancer program, helping validate our approach in another challenging indication.
- Georgia Research Alliance (GRA) Venture Fund: Offering initial funding and resources that enabled us to generate in vitro and pilot-level in vivo data for multiple myeloma. We seek collaborations with multiple myeloma researchers to refine our therapeutic design, strengthen preclinical rationale, and support clinical trial planning.
We also aim to partner with companies specializing in antibody targeting technologies to enhance our platform’s versatility and specificity. Recognizing the importance of intellectual property, we are open to licensing agreements to bring our technology to broader markets, including indications beyond our current development capacity. These partnerships will accelerate our transition from preclinical studies to clinical development, bringing us closer to delivering new therapeutic options for patients.
At Annate, we are building a sustainable revenue model by leveraging our platform technology, proprietary assets, and strategic partnerships.
Our initial revenue streams will focus on licensing opportunities and research collaborations:
Platform Licensing
We will license our ApoL1-based targeting platform to biopharma companies, generating revenue through upfront technology access fees, developmentally linked milestone payments, and royalties upon commercialization. These collaborations also provide service-based revenue and foster shared investment in development, enabling broad applications across liquid and solid tumors.
Asset Creation & Out-Licensing
By advancing therapeutics to proof-of-concept stages, we can out-license de-risked assets to pharmaceutical partners for clinical development. Effective in both liquid and solid tumors, our platform's versatility supports diverse oncological indications, offering significant growth potential. These collaborations unlock upfront and milestone payments as assets progress through trials, creating sustained value and expanding therapeutic opportunities.
Research Collaborations & Grants
We collaborate with academic institutions and industry partners to develop therapies targeting multiple myeloma and other hard-to-treat cancers. These partnerships provide research funding, milestone payments, and shared intellectual property. Additionally, we pursue grants from government and private foundations to accelerate innovation.
Venture Capital & Strategic Investors
We will engage with venture capital and strategic investors to support growth and pipeline expansion, bridging the gap until revenue from licensing and products becomes self-sustaining. As our company matures, we aim to move beyond licensing and collaboration-driven revenue toward commercializing our own products, capturing value throughout the therapeutic life cycle and building a robust, long-term revenue base.
We are seeking a $1 million investment through a SAFE to drive our platform toward critical milestones and position us for clinical development and subsequent funding rounds. This capital will directly support the establishment of our own laboratory space at the UGA Incubator, enhancing our ability to conduct core R&D activities in-house. With dedicated lab facilities and working with our partners at Contract Research Organizations (CROs), we can refine our antibody formulations and perform important in vivo work, ensuring that our therapeutic candidates meet the necessary specifications for future clinical applications. Additionally, part of the funding will be allocated toward hiring a full-time researcher, increasing our operational capacity and accelerating experimental timelines. To build a strong preclinical package, we will employ these resources to conduct large-scale in vitro efficacy assays, followed by studies on patient-derived tissues sourced through our partnership with the Emory School of Medicine’s EMPACT repository. Next, we plan in vivo proof-of-concept mouse studies to evaluate toxicology, pharmacokinetics, and efficacy, providing critical data needed to inform a successful Investigational New Drug application. We will engage with regulatory consultants to ensure our pre-IND strategy is robust and aligned with FDA expectations, smoothing our path into the clinic. We will also exercise our option for an exclusive license agreement through the UGA Research Foundation, securing our intellectual property portfolio. Finally, this funding will lay the groundwork for a subsequent Series A raise of approximately $6 million, aimed at advancing into clinical trials and ultimately delivering transformative therapy to cancer patients.
Our preliminary studies have demonstrated that ApoL1 is toxic to multiple myeloma (MM) cells at concentrations approximately 15 times higher than normal serum levels. Building on this, we developed a BCMA-ApoL1-specific bispecific antibody (bsAb) therapeutic that effectively targets MM cells.
Our findings show that:
- the bsAb specifically binds to ApoL1 and BCMA
- it significantly increases ApoL1 internalization by MM cells
- it enhances ApoL1-mediated cytotoxicity through a lysosome-dependent mechanism.
To explore the broader potential of this platform, we extended our approach to develop a bsAb targeting pancreatic cancer. Preliminary data reveal that these pancreatic-specific bsAbs significantly amplify ApoL1-mediated cytotoxicity, underscoring the platform’s versatility in addressing both solid and liquid tumors. We have initiated pilot-level studies in animal models to evaluate the safety and pharmacokinetics (PK) of both MM and pancreatic cancer bsAb therapeutics. Early results from toxicity assessments show no adverse effects from the bsAb-ApoL1 complex, supporting the safety of this approach. These studies are also establishing dosing parameters and therapeutic windows critical for advancing to efficacy trials. Together, these findings strongly support the potential of our ApoL1-delivery platform as an innovative therapeutic solution for treating a wide range of cancers.
To date, Annate Bitherapeutics has been supported by several key grants that have advanced our research and development efforts:
Georgia Research Alliance Innovation & Entrepreneurship Grant ($75,000)
This funding was instrumental in establishing the initial proof-of-concept for our ApoL1-guided therapeutics in multiple myeloma. It enabled the progression from in vitro efficacy studies to the initiation of in vivo mouse model testing, validating both feasibility and therapeutic potential.
Winship Invest$/UGA Cancer Center Pilot Grant ($50,000)
Awarded jointly by Emory University’s Winship Cancer Institute and the University of Georgia Cancer Center, this grant allowed us to extend our proven multiple myeloma approach into the pancreatic cancer setting. The resulting pilot studies have laid the groundwork for broader applicability of our platform in solid tumors.
NIH CTSA Pilot Grant ($50,000)
With support from the National Institutes of Health Clinical and Translational Science Award (CTSA) program, we have begun developing more robust mouse models optimized for ApoL1-targeted therapies. This investment ensures that our in vivo systems closely reflect clinical reality, accelerating translational readiness.
University of Georgia Research Foundation (UGARF)
With upfront investment from UGARF, we secured IP for our lead therapeutic through a patent attorney, covering initial fees via a licensing agreement. UGARF is also helping expand our patent portfolio to include additional cancer targets, ensuring robust IP protection and positioning our platform for broader therapeutic applications.
Capital Invested & Revenue Generated
Our venture is currently in the preclinical stage and thus not yet generating revenue. To date, capital has been primarily sourced through the aforementioned grants and founder contributions. These funds have focused on building core research capabilities, refining our technology, and reaching critical developmental milestones necessary for future clinical translation and investor engagement.
