Background info:

- Original Rosetta@home Paper Announcement (January 2019)
Rosetta@home's role was "R@h participants provided computing for forward folding experiments used in this study which helped validate designs. We'd like to congratulate and thank all R@h volunteers who contributed to this work! Thank you!"

- New Yorker Article (September 2020)
In this article, David Baker announced that NL-201 would go into clinical trials.

- Neoleukin announcement on submitting an application in order to prepare a Human Phase 1 Clinical Trial (December 2020)
Neoleukin is the company working on the drug candidate. It's a spin-off company from the Institute of Protein Design (IPD), the home of Rosetta@home. Some of the authors of the paper work there now.

- Neoleukin announces it received approval to start the Phase 1 Clinical Trial (April 2021)

- Neoleukin announces it administered the candidate drug to the 1st patient (May, 5 2021)

- On May 6, the IPD tweets "Happy to share that our spinout @neoleukin today initiated dosing of NL-201 in its first clinical trial. NL-201 is a de novo protein designed to mimic the natural cytokines IL-2 and IL-15. The Phase 1 study will be conducted in Australia and N America."

The Phase 1 Clinical Trial will have 120 participants. NL-201 is aimed at fighting advanced solid tumours.


I created this thread so there's one single place with the relevant info and future updates.

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Neoleukin Therapeutics Presents NL-201 Preclinical Data at Society for Immunotherapy of Cancer’s 36th Annual Meeting (SITC 2021) (12-14 November)

Neoleukin Therapeutics, Inc., “Neoleukin” (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, today announced the presentation of new preclinical data on NL-201, an alpha-independent, de novo-designed IL-2 and IL-15 dual agonist, at the Society for Immunotherapy of Cancer’s 36th Annual Meeting (SITC 2021).

Further details from the presentations are as follows:

Poster/Abstract Number: 716
NL-201 Induces Inflammation in a ‘Cold’ Tumor Microenvironment through Upregulation of MHC-I, Expansion of the TCR Repertoire, and Potent Antitumor Activity when Combined with PD-1 Inhibition

NL-201 turns “cold” tumors “hot” by increasing pro-inflammatory T cells and an immune signature in the tumor microenvironment and upregulating MHC-1 in tumors.
NL-201 stimulates pro-inflammatory tumor reprogramming without the coincident Treg expansion observed with PD-1 antibodies and other immuno-oncology agents.
NL-201 drives anti-tumor efficacy in a manner that is cooperative with PD-1 inhibition, including increasing TCR repertoire diversity.

Poster/Abstract Number: 898
Intratumoral Administration of NL-201, an Alpha-Independent IL-2/15 Receptor Agonist, Inhibits the Growth of Both Injected and Uninjected Tumors in Preclinical Models

Intratumoral NL-201 administration demonstrated:
Dose-dependent antitumor activity in syngeneic murine tumor models;_
Improved tolerability compared to systemic administration at equivalent dose levels and;
Durable tumor-specific immunity.
Results support clinical investigation of intratumoral NL-201 administration to increase NL-201 concentration in accessible lesions and reduce systemic exposure.

Poster/Abstract Number: 509
A First-in-Human Phase 1 Study of NL-201 in Patients with Relapsed or Refractory Cancer (Trials in Progress)

Assessing the safety profile and recommended Phase 2 dose and treatment schedule of NL-201.
Dose escalation and dose expansion cohorts.
Enrollment ongoing at multiple sites in North America and Australia.

Poster/Abstract Number: 563
ICT01, an Anti-BTN3A Monoclonal Antibody, and NL-201, an Alpha-Independent IL-2/IL-15 Agonist, Combine to Elicit a Potent Anti-Tumor Response by Synergistically Stimulating g9d2 T Cell Activation and Proliferation

ICT01 plus NL-201 synergistically triggers gd T-cell activation, expansion and antitumor activity.
Data support clinical evaluation of this novel therapeutic approach.

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Great info. They probably can't say anything about the clinical trials, but this is the next best thing.

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Yeah, this is great news.
This is the link for the clinical trial they are running.

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Neoleukin Therapeutics Announces Clinical Collaboration with Merck to Evaluate NL-201 in Combination with KEYTRUDA® (pembrolizumab)


"Neoleukin will evaluate NL-201 plus pembrolizumab as part of the company’s ongoing Phase 1 trial in patients with advanced, relapsed or refractory solid tumors. Up to 132 patients will be enrolled in the combination arm of the study. The trial is assessing safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity."

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Very, very interesting. Thanks.

I think the requirements of the trial mean that they can't announce any results early, but this gives them a chance to show their confidence in it.
More importantly, Merck thinks it is worthwhile too.

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Yep, it's good news.
I hope we get know some early results "soon", maybe sometime around the 1 year anniversary of the trial (early May 2022).

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I hope we get know some early results "soon", maybe sometime around the 1 year anniversary of the trial (early May 2022).

That will be set by the government regulations, since it will influence the stock price.
I don't know what they allow, but maybe there is an interim report.

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I hope we get know some early results "soon", maybe sometime around the 1 year anniversary of the trial (early May 2022).

That will be set by the government regulations, since it will influence the stock price.
I don't know what they allow, but maybe there is an interim report.

Right, they're a public company.
In any case, I am eager for some Phase 1 results.

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