Xeptiva Therapeutics
Partnering

Two products ready for pivotal development. One platform ready for its next antigen.

Xeptiva has taken active immu­niza­tion against NGF and IL-31 from immuno­gen design to pos­i­tive placebo-con­trolled trials in client-owned dogs, with a trans­fer­able man­u­fac­tur­ing process and a patent family with 2022 pri­or­ity. We are looking for a partner to take Xep01 and Xep02 through pivotal devel­op­ment and reg­is­tra­tion in the United States and Europe.

Request data room accessSee what has been de-risked
200+dogs treated across eight clinical studies
2randomized, double-blind, placebo-controlled trials, both positive
> 90%of dogs seroconvert with the selected dose of either product
1chromatography step, with scale-up to industrial batches demonstrated
≈ USD 1fully loaded cost per dose at commercial scale
2022priority date of the core patent family
De-risking

What was uncertainty is now quantified risk

An active immu­niza­tion program against a self-antigen starts with ques­tions that no model answers: only the target species does. Each of them has been answered in dogs. What remains is risk with a mea­sured size, which a pivotal program is built to carry.

Open question at the outsetMeasured answer today
Will a dog raise antibodies against its own NGF or IL-31?
Yes. More than 90% seroconvert, and the antibodies recognize the native targets and Substance P.
Is immunization against a self-antigen safe?
No serious systemic event in more than 200 dogs treated. Local, transient reactions only, declining with successive doses.
Is there a clinical effect against placebo?
Yes, in both products: about half the rescue NSAID of placebo in osteoarthritis, and a completed double-blind trial with positive efficacy results in atopic dermatitis.
How long does it last, and can it be boosted?
Months of effect per dose. A single booster, given when clinical signs return, re-induces the response.
Can it be manufactured, stored and costed?
Scale-up to industrial batches demonstrated, stable for at least a year refrigerated, about one dollar per dose.
Which endpoint carries a pivotal program?
Two endpoints that separated active from placebo, with known effect size and variance.

Effect sizes, con­fi­dence inter­vals, pro­to­cols and sta­tis­ti­cal anal­y­sis plans are avail­able under a con­fi­den­tial­ity agree­ment.

Two pipelines

The products transfer, and so does the capability that produced them

A devel­op­ment orga­ni­za­tion runs two pipe­lines at once. One deliv­ers prod­ucts. The other deliv­ers the mea­sure­ment methods, the models, the deci­sion rules and the clin­i­cal expe­ri­ence that make the next product faster. Both are part of what a partner receives.

Product pipeline

Com­pleted by Xeptiva
Exe­cuted with the partner

Discovery

Two immuno­gens, NGF + SP and IL‑31 + 3 SP

Process

E. coli, one chro­matog­ra­phy step, indus­trial scale-up demon­strated

Clinical trials

Two placebo-con­trolled trials and real-world cohorts

CMC

Com­mer­cial GMP batch at the partner’s plant

Pivotal

Field studies under FDA, USDA and EMA stan­dards

Registration

And launch through the partner’s channel

Learning pipeline

Trans­fers with the company and serves every sub­se­quent antigen

Measure

Immune response, product quality and clin­i­cal effect, each with its own val­i­dated method.

Model

How the anti­body response rises, decays and re-induces, and how it relates to dose and effect.

Decide

Dose, regimen and end­point for each indi­ca­tion, with the data to defend each choice.

Clinical experience

Which trial to design for this tech­nol­ogy: a priming window, a con­sol­i­da­tion window and a rescue-based end­point. From pilot to con­trolled proof of concept in under a year.

Retain

Pro­to­cols, SOPs, batch records, cell banks, locked data­bases and manuscripts.

Every new antigen starts from what the last one taught

The development package

What a partner receives, and what it does with it

From Xeptiva

What transfers

  • Two lead prod­ucts with placebo-con­trolled effi­cacy in dogs
  • A val­i­dated plat­form: one con­struct logic, one process, one regimen, applied across species
  • An opti­mized, trans­fer­able man­u­fac­tur­ing process with cell banks, batch records and qual­i­fied methods
  • A devel­op­ment pipe­line beyond the lead prod­ucts
  • The patent family with 2022 pri­or­ity, free of roy­al­ties
  • The founders and the clin­i­cal team through the trans­fer
With the partner

What the partner does

  • Com­mer­cial GMP trans­fer and engi­neer­ing batch in its own plant
  • Pivotal field studies under FDA, USDA and EMA stan­dards
  • Reg­is­tra­tion and launch through its own channel

Where it leads

  • Pivotal pro­grams 2027 to 2029
  • Market around 2030
  • About five years ahead of an in-house active immu­niza­tion program

The prod­ucts are ready to enter pivotal devel­op­ment, not to enter the market. Xeptiva has no man­u­fac­tur­ing or licens­ing com­mit­ments with third parties.

Time to market

Five years of development already gained

Esti­mated time­lines for a large animal health company start­ing in January 2027. The second lane assumes no exist­ing active immu­niza­tion plat­form.

With the Xeptiva package

Trans­fer, pivotal studies, reg­is­tra­tion

202720282029203020312032203320342035
GMP transfer
Pivotal field studies
Registration
Market 2030

In-house program from scratch

Dis­cov­ery, pilots, proof of concept, pivotal, reg­is­tra­tion

202720282029203020312032203320342035
Discovery and process
Pilots and proof of concept
Pivotal field studies
Registration
Market 2035
Partnering routes

Three ways to work with us

Acquisition

The company, the prod­ucts, the plat­form, the patents and the team, with full tech­nol­ogy trans­fer.

Licensing by territory

Rights to Xep01 or Xep02 in defined markets, with the devel­op­ment package and man­u­fac­tur­ing trans­fer.

Co-development

A new antigen for a new indi­ca­tion or species, run through the same pipe­line in Mon­te­v­ideo.

Data room

Available under confidentiality

  • Trial reports, pro­to­cols and sta­tis­ti­cal anal­y­sis plans for both con­trolled trials
  • Safety sets of every study and of the ongoing 120-dog safety study
  • Batch records and the com­mer­cial process design
  • Patent pros­e­cu­tion files and the freedom-to-operate assess­ment
  • Out­lines of the US and EU pivotal pro­grams

We answer every inquiry within five busi­ness days.

JC
Josefina Correa, CEOMontevideo, Uruguay · info@xeptiva.com

Request data room access

Data room access is granted after a signed con­fi­den­tial­ity agree­ment.