Tag Archives: AI

Companies to Watch in 2026

16 Dec

By Dennis Ford, Founder & CEO, Life Science Nation (LSN)

DF-News-09142022Life Science Nation was built to connect scientist-entrepreneurs and fundraising CEOs with global capital, licensing, and product-collaboration partners. This work has created a unique vantage point into what truly drives successful matches between early-stage companies and the buy side, revealing not only the science itself but also how companies mature over time, where they stall, and what ultimately earns investor and partner confidence.

The life science landscape continues to evolve at a remarkable pace. Across therapeutics, devices, diagnostics, and digital health, new tools and technologies are fundamentally reshaping early-stage development. Advances in artificial intelligence, machine learning, organoid systems, next-generation screening methods, and predictive modeling now allow founders to generate clearer, more actionable data far earlier than was possible even a decade ago. These shifts are compressing timelines that once required years and large amounts of capital, and they are changing how and when global investors and strategic partners are willing to engage.

Across hundreds of investor conversations over the years, a consistent pattern has emerged in how risk is evaluated. While mandates differ, the underlying criteria tend to converge around a few fundamentals: the depth and credibility of the science, the quality and experience of the leadership team, the discipline of the development plan, and the strength of the data supporting forward momentum. Together, these factors determine whether a company is ready to engage meaningfully with the global market.

A similar lens is applied when evaluating companies referred to Life Science Nation through regional tech hubs, incubators, accelerators, universities, and national or state life science agencies. Many new technologies are, in reality, the product of decades of foundational research. When a founding scientist remains actively involved, it brings historical context, credibility, and continuity, materially reducing risk. Strong CEOs, particularly those with experience launching products inside established companies, add another layer of confidence through pragmatic decision-making and operational discipline.

Over time, this has shaped how we think about de-risking the stack. The strongest early-stage companies are not those that attempt to eliminate risk, but those that systematically convert unknown risk into understood risk. They address scientific, technical, regulatory, and commercial uncertainty in the correct order, with discipline and intent, before asking the global market to engage. They can clearly explain the remaining uncertainty, support it with data, and demonstrate steady forward progress.

At Life Science Nation, thousands of early-stage companies are encountered each year through the global partnering backbone, RESI conferences, and structured roadshow campaigns. Most are still early in their journey. Some have excellent science but are not yet ready to communicate it in a way that resonates with global investors. Others have passion and urgency but lack the data required for serious engagement. Many need more time to build the right team, define realistic milestones, and understand what it means to operate within a global partnering framework.

These companies demonstrate clarity of purpose and forward motion, articulate their science in ways that align with investor expectations, and execute against achievable milestones that generate data to support early decision making. They show signs of intentional de-risking, understand where uncertainty lives, and address it in the correct order with discipline and commitment. That is ultimately why they made this list. Without further ado…Drum roll, please….

Top Ten Companies to Watch in 2026

NeuroHope (CNS trauma and spinal cord injury)

NeuroHope is developing a PgP targeted nanoparticle delivery platform to enable sustained, targeted central nervous system drug exposure for acute spinal cord and brain injuries. The company’s lead asset, Polypram, is a rolipram-loaded nanotherapeutic designed to restore cAMP signaling, reduce inflammation, and improve functional recovery after spinal cord injury, addressing a long-standing delivery barrier that has prevented effective pharmacologic treatment in this setting.

NeuroHope stood out for its clear focus on the spinal cord injury bottleneck and its disciplined, translational data package demonstrating durable motor recovery in both rodent and large-animal models.

Website: https://www.neurohopetherapeutics.com


Bilix (clinical stage organ protection biotech)

Bilix is a clinical-stage biotechnology company developing synthetic PEGylated bilirubin nanoparticles for organ protection and inflammatory injury. Its lead program targets ischemia reperfusion injury by addressing oxidative stress, ferroptosis, and immune dysregulation following surgery and transplantation, with completed Phase 1 clinical testing and an ongoing Phase 2a study in cardiac surgery-associated acute kidney injury.

Bilix stood out for strong clinical execution, defensible chemistry, and a management team with demonstrated regulatory experience.

Website: https://www.bilix.com


Oncovita (measles-based oncolytic immuno-oncology)

Oncovita is developing MVdeltaC, an intratumoral measles virus-based oncolytic immunotherapy designed to convert immunologically cold solid tumors into targets the immune system can recognize and eliminate. By engineering a clinically familiar measles backbone with a C protein deletion, MVdeltaC drives potent immunogenic cell death and reshapes the tumor microenvironment, making previously hidden tumors visible to the immune system, much as PET imaging made occult disease visible to clinicians. Initial programs focus on pleural mesothelioma, with a clear strategy to expand into additional solid tumors such as triple-negative breast cancer.

Oncovita stood out for its mechanistic clarity and disciplined orphan-first strategy to establish clinical proof before broader expansion.

Website: https://www.oncovita.fr


Adaptyx (continuous cortisol monitoring platform)

Adaptyx is developing a continuous biomolecular monitoring platform designed to bring clarity to cortisol-driven disease. By enabling real-time measurement of cortisol dynamics, the company addresses a central blind spot in endocrinology: current diagnostics rely on static snapshots of a hormone that fluctuates throughout the day, which could change how conditions such as Cushing’s, Addison’s, and related disorders are diagnosed and managed.

Adaptyx stood out for reframing cortisol measurement as a clinical tool, much as continuous glucose monitoring has transformed diabetes care.

Website: https://adaptyx.bio/


Cureage (rare disease therapeutics for NF1)

Cureage is a rare disease-focused biotechnology company developing first-in-class therapeutics for Neurofibromatosis Type 1 and related disorders. The company targets the underlying biology driving tumor formation and disease progression in NF1, an area of significant unmet need. It works closely with the Children’s Tumor Foundation, reflecting deep alignment with the patient and clinical community.
Cureage stood out for its clear rare disease focus, strong biological rationale, and disciplined approach to de-risking development in a defined patient population.

Website: https://www.cureagetx.com


Qnity (Quantum computing drug discovery platform)

Qnity is a deep-tech life sciences company that applies quantum-electrochemical sensing to transform molecular screening and drug discovery. Its platform delivers ultra-sensitive, real-time measurements of molecular binding across a wide range of molecule types, enabling researchers and developers to identify and characterize interactions with greater precision and throughput than traditional methods like SPR or ELISA.

Qnity stood out for tackling a core bottleneck in early-stage drug development—the need for more accurate, accessible, and scalable binding data—by offering a single-chip quantum sensing solution that accelerates discovery and reduces risk in therapeutic and diagnostic pipelines.

Website: https://www.qnity.bio/


iQure(AAV gene therapy for rare CNS and metabolic disease)

iQure is developing a new class of treatments for brain disorders by restoring balance to glutamate, a key neurotransmitter that becomes toxic when dysregulated. What makes their technology unique is its focus on astrocytes—support cells in the brain—by enhancing the activity of EAAT2, the main transporter responsible for clearing excess glutamate.

iQure stood out for addressing a fundamental driver of neurological damage with a first-in-class, orally available small molecule advancing into the clinic.

Website: https://www.iqurepharma.com/


HiRO (global clinical development and APAC strategy partner)

HiRO is a global clinical research organization that supports emerging and established biotech companies in designing and executing clinical development programs across Asia Pacific and other regions. Beyond trial execution, HiRO works closely with clients to determine the most effective geography and sequencing strategy for each program, balancing regulatory pathways, patient access, cost, speed, and downstream partnering objectives. By helping companies deploy trials thoughtfully across markets such as Japan, Korea, Taiwan, Australia, Southeast Asia, and China, HiRO reduces geographic and execution risk early in development.

HiRO stood out for combining clinical rigor with global strategic judgement, enabling early stage programs to generate credible, partner ready data without single geography bias.

Website: https://en.harvestiro.com/


Qualisure Diagnostics (RNA-based thyroid classifiers)

Qualisure Diagnostics develops RNA-based classifiers that guide treatment decisions in thyroid cancer. Unlike tests focused solely on diagnosis, Qualisure’s assays inform post-diagnosis management. Clinical guideline citations support them, and the company has achieved international adoption through a decentralized deployment model.
Qualisure stood out for combining clinical relevance, guideline support, and capital-efficient international execution.

Website: https://qualisuredx.com/


Alterna Therapeutics (RNA-targeted splicing medicines)

Alterna Therapeutics develops RNA-targeted drugs designed to correct harmful cellular miscommunication driving disease. The company applies deep splicing biology to genetic and oncology indications with high unmet need, leveraging a platform with the potential to generate multiple differentiated assets over time.
Alterna stood out for its elite scientific pedigree and platform potential, with a clear opportunity to further strengthen its focus and lead-indication discipline.

Contact: Maria Buxade Fortuny maria.buxade@crg.eu

These ten companies illustrate how the bar for being partner-ready is rising across the life science ecosystem. All are early and face significant challenges ahead, but they are moving in the right direction. Taken together, this group highlights the depth of innovation and opportunity emerging across the life sciences today.

The companies highlighted in this article are not investment recommendations. Life Science Nation has not conducted formal due diligence on these technologies, finances, or operations, and no independent verification or vetting of these companies has been performed. This list reflects organizations that caught our attention through our work and travels and is intended solely for informational and educational purposes, not as a basis for any investment decision.

RESI JPM 2026 Investor Panels Announced 

16 Dec

Attendees voted with their RESI Cash alongside judges’ scores to determine this year’s winners.

By Claire Jeong, Chief Conference Officer, Vice President of Investor Research, Asia BD, LSN

Life Science Nation is pleased to announce the investor panelists for RESI JPM 2026, taking place January 12–13 during JPM Healthcare Week. Across two full days, RESI JPM will bring together active investors, strategic partners, and industry leaders for focused discussions on the funding environment, partnership strategies, and emerging opportunities across life sciences and healthcare. 

RESI investor panels are designed to provide founders and executives with direct insight from decision-makers who are actively deploying capital, forming partnerships, and shaping the future of the industry. Each panel features experienced investors and strategics sharing candid perspectives, followed by opportunities to continue conversations through RESI’s structured partnering platform. 

Investor Speakers on Day 1 (January 12)


Sharon Chan

Johnson & Johnson Innovation – JLABS Asia Pacific

Irene Cheong

A*STAR

Ansbert Gadicke

MPM BioImpact

Dushyant Pathak

Autobahn Labs

Andrew Krowne

Dolby Family Ventures

Robert Balfour

ALSA Ventures

Rick Berenson

Mass Medical Angels

Gunes Bozkurt

Beiersdorf

Jian Cao

Medtronic

Jeff Chu

Features Capital

Karen Chu

Harvest Integrated Research Organization (HiRO)

Rod Cotton

2Flo Ventures

Juan Cueva

Johnson & Johnson Innovation

Bettina Ernst

BERNINA BioInvest

Jack Florio

NuFund Venture Group

Nirdesh Gupta

Cedars-Sinai Technology Ventures

Karen Harris

Alzheimers Drug Discovery Foundation

Uplaksh Kumar

Foresite Capital

Ken Lin

ABIES Capital

Michael Loftus

PoC Capital

Brianna McDonald

Ecosystem Venture Group

Swati Mehta

25BIO

Ahmed Mousa

LAFANA

Mahesh Narayanan

Neuvation Ventures

Kenny Nova

Mid Atlantic Bio Angels

Jessica Owens

INITIATE Ventures

Jojo Platt

Corundum Neuroscience

Steven Saltzstein

FORCE Family Office

Garth Smith

Ontario Brain Institute

James Spann

Boyd Street Ventures

Jessica Tam

Baxter Healthcare

Lee Chuan Teck

Enterprise Singapore

Varun Turlapati

Chaanakya Capital 

Investor Speakers on Day 2 (January 13)


Friedemann Janus

Bayer

Jiaping Gu

Takeda Ventures

David Berry

Averin Capital

Ekaterine Kortkhonjia

Johnson & Johnson Innovation

Nick Naclerio

Illumina Ventures

Eric Schaefer

March of Dimes

Marc Appel

Pacific Bridge NY

Anjan Aralihalli

Raya Therapeutic

Yaron Daniely

aMoon Fund

Miriam Dong

ID3 Ventures

Cristina Escoda

Tachyon Ventures

Yinghong Gao

Viva BioInnovator

Gary Gershony

BayMed Venture Partners

Tom Gibbs

Debiopharm Innovation Fund

Rohit Jain

HBS Alumni Angels of Northern California

Sai Jasti

Bayer

Anula Jayasuriya

Kidron Capital

Gautam Kainth

TCP Health Ventures

Jin Lee

Oxonian Ventures

Brian Miglionico

Agios Pharmaceuticals

Ralph Morales III

Aquillius Ventures

Stephanie Oestreich

Myeloma Investment Fund

Donna Parr

Cross-Border Impact Ventures

Bibi Sattar Marques

Buenavista Equity Partners

Takehiko Sawabe

Beyond Next Ventures

Venkat Srinivasan

Innospark Ventures

Anthony Vallance-Owen

We Venture Capital

Chensu Wang

Yonjin Venture

Chris Yoo

Xcellerant Ventures

Qing Zhang

LDV Partners

Register for RESI JPM 2026 

RESI JPM 2026 offers more than panels. Attendees gain access to curated investor meetings through RESI’s partnering system, targeted networking, and programming designed to support meaningful connections during one of the most important weeks in healthcare investment. 

Register for RESI JPM 2026

Sunday Space + Two Full Days of RESI JPM

16 Dec

By Sougato Das, President and COO, LSN

Sougato-Das

RESI JPM 2026 expands the opportunity to connect by adding Sunday partnering and event space, giving attendees an early start to JPM Week. With RESI JPM running Monday–Tuesday, Sunday provides a strategic window to schedule investor meetings, host receptions, or bring teams together while momentum is already building across San Francisco.

RESI JPM is the only JPM conference where 700+ investors actively providing seed to Series B funding attend, alongside in-licensors seeking preclinical through Phase 2 assets. For preclinical and clinical-stage biotech, medtech, diagnostic, digital health, and AI companies, RESI JPM remains the most efficient way to connect with aligned investors and strategic partners during JPM Week. Many companies schedule 10–20 meetings in a single day, making partnering the core of the RESI experience.

New Sunday Partnering Opportunities Added

Life Science Nation is announcing additional partnering slots on Sunday, January 11, hosted at the Marriott Marquis. These meetings take place ahead of the main conference and allow attendees to secure valuable investor conversations before calendars fill up.

The Sunday Partnering Slot sign-up form is available to RESI attendees, allowing registered participants to request meetings and plan their schedules in advance.

Start JPM Week with Purpose

This added day gives companies a head start to:

  • Schedule investor or in-licensor meetings
  • Connect with fellow RESI attendees
  • Host private meetings or team gatherings

Located in the center of the JPM ecosystem, the Marriott Marquis offers a convenient and efficient setting to begin JPM Week with focused, high-value interactions.

With Sunday now in play, RESI JPM 2026 delivers more time, more access, and more opportunities to make meaningful connections before the week reaches full pace.

Register for RESI JPM 2026

Hot Investor Mandate: Global Pharma With Investment Subsidiary Seeks Companies Developing Novel Drugs, Open to Various Modalities

16 Dec

The firm is a publicly listed pharmaceutical company with a global workforce and an international footprint that includes over 40 branches and subsidiaries worldwide. The firm’s core businesses are active pharmaceutical ingredients and generic drugs, while the firm is rapidly expanding into innovative drug development, including small molecules, biologics, and cell and gene therapies. A U.S.-based subsidiary operates as an integrated platform with research and development, manufacturing, and commercial capabilities, supplying generic drugs to major pharmacy chains, mass retailers, and grocery channels. 

Another subsidiary of the firm is responsible for equity investments and business development activities, including in-licensing and supplier or distributor partnerships, across both the China and U.S. markets. 

The firm is most interested in companies developing novel drugs across biologics, cell therapy, gene therapy, repurposed drugs, and biosimilars. From a development-stage perspective, the firm prefers programs at or before the NDA stage, including preclinical, Phase I, Phase II, Phase III, and NDA-ready assets. 

In addition to general equity investment and business development opportunities, the firm has particular interest in late-stage clinical assets that can be in-licensed and introduced into the China market, technologies that improve API manufacturing and production efficiency, and injectable drug products. The firm is also interested in distribution rights in China for both innovative and generic drugs, as well as distribution rights in the United States, primarily for generic drugs. 

From a company and management team perspective, the firm generally favors partners with strong scientific and technical capabilities, clear development and regulatory strategies, and high-quality data packages that support clinical and commercial potential. The firm typically values management teams that demonstrate execution capability, openness to strategic collaboration, and a willingness to engage in cross-border partnerships aligned with manufacturing, regulatory, and commercialization objectives. 

If you are interested in more information about this investor and other investors tracked by LSN, please email salescore@lifesciencenation.com

How RESI Helps Investors Source Breakthrough Technologies: An Interview with Toru Jay Seo of Newsight Tech Angels 

9 Dec

By Joey Wong, Director of Investor Research, Hong Kong BD, LSN

Joey-New-Headshot

In this interview, Toru Jay Seo, Founder of Newsight Tech Angels, shares how the RESI conference series has become a reliable source for discovering high-potential early-stage life science startups. 

Toru highlights that RESI’s structured partnering, global pipeline, and clear alignment by sector and stage have directly contributed to several of his firm’s investments. 

He also reflects on the qualities he looks for in scientific founders, the value of clear communication during early investor conversations, and how entrepreneurs can best prepare to stand out in settings like RESI. 

Innovator’s Pitch Challenge Winners Announced at RESI London 2025 

9 Dec

Attendees voted with their RESI Cash alongside judges’ scores to determine this year’s winners.

By Claire Jeong, Chief Conference Officer, Vice President of Investor Research, Asia BD, LSN

Life Science Nation is pleased to announce the winners of the Innovator’s Pitch Challenge (IPC) at RESI London 2025. This year’s competition featured 26 participating companies, each showcasing early-stage technologies to a panel of experienced investors and an audience of global attendees. 

The IPC remains a cornerstone of every RESI conference, allowing founders to present to a coordinated group of investors who provide interactive questions and valuable feedback. Attendees cast votes using their RESI Cash, which was combined with judges’ assessments to select this year’s top companies. 

Congratulations to the RESI London 2025 IPC winners: 

These companies stood out among a highly competitive group of innovators spanning therapeutics, medical devices, diagnostics, and digital health. 

Congratulations, as well, to the companies from each session who received the highest judges scores:  

Looking ahead: Applications are now open for Life Science Nation’s next European conference, taking place in Portugal on March 23, 2026. Companies interested in pitching can apply here. 

Apply to Pitch at RESI Europe

The Needle Issue #20

9 Dec
Juan-Carlos-Lopez
Juan Carlos Lopez
Andy-Marshall
Andy Marshall

By our count, there are now 15 bi-specific antibodies approved by the US Food and Drug Administration (the last peer-reviewed count from 2024 we found chalked up 13). This year has been a bumper year for bi-specifics — antibodies that recognize two molecular targets. Several of 2025’s largest deals have involved assets in this class, including Genmab’s $8 billion acquisition of Merus in September and Takeda’s $11.4 billion splurge on an anti-Claudin18.2 bi-specific antibody and antibody-drug conjugate (ADC) from Innovent Biologics.

Not only is this trend likely to continue, but we predict that it will expand to encompass tri- and multi-specific antibodies, the development of which is an area of intense research activity. Just a couple of weeks ago, South Korea’s Celltrion clinched a $155 million (biobucks) deal for TriOar’s tri-specific ADCs for cold tumors. And at the SITC meeting last month (which we covered in issue 19) tri-specifics were highlighted by no less than five companies: Nextpoint (B7-H7 x CD3 x TMIGD2), CrossBow (cathepsin G peptide x CD3 x CD28), TJ Biopharma (CDCP1 x CD3 x 4-1BB), Biocytogen (DLL3 x CD3 x 4-1BB) and Radiant Therapeutics (potentially tri-specific/trivalent).

Building an antibody that recognizes three or more targets at the same time is not trivial, though. There are multiple technical, clinical and regulatory hurdles that developers need to overcome before the antibody reaches patients. Why, then, go through the trouble of creating a multi-specific antibody when a bi-specific may show clinical benefit? As it turns out, there are several reasons why a multi-specific antibody may be worth the effort.

First, as tumors often escape by downregulating or mutating a single target epitope, a multi-specific antibody may reduce the likelihood of escape by simultaneously targeting multiple tumor antigens. Second, multi-specifics could increase safety and reduce toxicity of a therapy. For example, a multi-specific antibody can be designed to require co-expression of two or more antigens on the same cell to bind effectively. Healthy cells expressing only one antigen would be spared, thereby reducing off-tumor toxicity. Similarly, targeting multiple mechanisms with a single antibody may reduce the need to use several separate drugs, simplifying dosing and reducing risks for patients. Third, and perhaps most important, a multi-specific antibody can simultaneously block several disease pathways, yielding synergistic effects that a bi-specific might not achieve. In solid tumors, for example, tumor heterogeneity, limited immune-cell infiltration and an immunosuppressive microenvironment often result in therapeutic failure. Multi-specific antibodies could combine tumor targeting, immune-cell recruitment and checkpoint modulation in a single molecule.

Perhaps the best example of this comes from the field of T-cell engagers (TCEs). A tri-specific antibody can incorporate not only tumor-cell binding and CD3 engagement, but also a co-stimulatory domain, such as CD28. This can boost T-cell activation, persistence and potency more than a bi-specific that only binds to CD3.

In this regard, a recent paper in PNAS is an excellent example of the power of the approach. A research team from EvolveImmune Therapeutics reports on the development of EVOLVE, a next-generation TCE that integrates CD3 binding with CD2-mediated co-stimulation to enhance T-cell activation, durability and tumor-killing capacity, while avoiding target-independent toxicity.

Conventional CD3-bi-specific TCEs activate T cells through a stimulation signal but often fail to provide the complementary co-stimulation necessary for sustained effector function. This can result in T-cell dysfunction, reduced persistence and limited clinical durability. To address this, Jeremy Myers and his colleagues systematically compared multiple costimulatory pathways and identified CD2 as a superior target owing to its broad expression on naïve, activated and exhausted CD8⁺ T cells, and its sustained expression within tumor-infiltrating lymphocytes.

The team engineered tri-specific antibodies that fuse a CD58 extracellular domain (the natural CD2 ligand — Lymphocyte Function-Associated Antigen 3;LFA-3) to affinity-tuned CD3 binders within an IgG-like format. They showed that integrated CD2 co-stimulation substantially improves T-cell viability, proliferation, cytokine production and cytotoxicity across tumor types.

When optimizing the molecule, they found that CD3 affinity must be attenuated: high-affinity CD3 domains cause target-independent T-cell activation and cytokine release (superagonism), whereas intermediate-affinity variants retain potent tumor-directed killing with reduced off-target activation.

The EVOLVE tri-specifics outperformed matched bi-specifics targeting HER2, ULBP2, CD20 and B7-H4, with increases up to >50-fold in potency, depending on the target. The optimized tri-specifics also showed superior tumor control in vivo, achieving durable tumor regression in humanized mouse models even after cessation of the treatment.

Even though tri- and multi-specific antibodies could offer clear advantages over bi-specifics, they are not without problems. From the technical standpoint, multi-specifics combine multiple binding specificities and often non-natural architectures. This feature increases complexity at every step from discovery to manufacturing. The assembly of IgG-like multi-specifics can result in heavy/light and heavy/heavy chain mispairing leading to heterogeneous products. Although antibody engineers have come up with strategies to address this issue, each solution adds constraints to developability.

Multi-specific antibodies can also have lower expression, cause more host-cell stress and require more advanced cell-line engineering or multi-vector expression systems. Moreover, downstream purification often needs additional steps to separate mis-paired species. Similarly, multi-specific antibodies are often less stable, more aggregation-prone, and more sensitive to formulation conditions, impacting shelf life and immunogenicity risk.

It is also important to show identity, purity and functional activity for each specificity and for the multi-specific activity (that is, simultaneous binding, cell-bridging). So, establishing robust potency assays is often the greatest challenge. What is a good model system to design a development candidate going after several targets at the same time? With each additional binder, complexity in discovery and development increases.

From the clinical standpoint, although multi-specifics can potentially be safer than bi-specific antibodies, as we mentioned above, other toxicological risks exist.

TCEs have been known to trigger cytokine-release syndrome, neurotoxicity, or unexpected tissue toxicity if targets are expressed on normal tissues. First-in-human dosing strategies are therefore critical. Moreover, multi-specifics may have non-linear pharmacokinetics (target-mediated clearance for each target), and dual-target engagement can alter distribution and half-life; selecting a safe, effective dose requires integrated PK/PD modeling and biomarker strategy.

And the headaches don’t stop there. Efficacy of a multi-specific may depend on co-expression of two or more targets. Stratifying patients may therefore complicate trial enrollment and endpoint definition, not to mention that it may be necessary to develop companion diagnostics (already expensive and complex for conventional monoclonal antibodies). And related to this point, when multiple targets are engaged, it can be hard to know which specificity caused an adverse event, complicating risk–benefit evaluation and mitigation.

Finally, from the regulatory perspective, although expectations are still evolving, agencies expect a pharmacological package that reflects multi-specific mechanisms, particularly with regards to toxicology. Regulators routinely require robust control strategies to ensure product consistency. Again, this is going to be more complicated for multi-specifics because small changes in manufacturing can alter pairing or potency.

Multi-specific antibodies are gaining momentum. They represent a potentially powerful technology, but many questions still surround their development. Success may depend on striking the right balance between choosing the appropriate therapeutic indication, identifying the simplest effective format, heavy upfront developability and analytical work, and early interactions with regulators to align on pre-clinical packages.