IO Biotech Announces Initiation of Phase 3 Combination Trial of IO102-IO103 and KEYTRUDA® (pembrolizumab) as First-Line Treatment in Advanced Melanoma

Rhea-AI Summary

IO Biotech has dosed the first patient in the Phase 3 IOB-013 / KN-D18 trial for IO102-IO103, a cancer immunotherapy targeting advanced melanoma. This trial, initiated in collaboration with Merck, evaluates the drug in combination with KEYTRUDA and aims for a total enrollment of 300 patients across the US, Australia, and Europe. The treatment has received FDA Breakthrough Designation and builds on promising earlier trial results, including an overall response rate of 80% and a complete response rate of 43% in Phase 1/2 studies.

Positive

• First patient dosed in Phase 3 trial for advanced melanoma.
• IO102-IO103 received FDA Breakthrough Designation.
• Phase 1/2 trial showed 80% overall response rate and 43% complete response rate.
• Trial expansion across multiple countries indicates strong collaboration with Merck.

Negative

• None.

- First Patient Dosed in Proposed Registrational Trial in Melanoma
- Multiple Sites to be Opened Across the United States, Australia, and Europe|
- Trial Builds upon Phase 1 / 2 Results Recently Published in Nature Medicine

NEW YORK, May 18, 2022 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its T-win^® technology platform, announced today that it has dosed the first patient in its Phase 3 IOB-013 / KN-D18 trial (NCT05155254).

The IOB-013 / KN-D18 trial seeks to evaluate IO Biotech’s lead candidate, IO102-IO103, in combination with KEYTRUDA^® (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with previously untreated, unresectable or metastatic (advanced) melanoma.

“We are pleased to treat the first melanoma patient, kicking off in Florida and expanding this Phase 3 study with a therapy that has received an FDA Breakthrough Designation across multiple centers in the US, Europe and Australia. This is a strong manifestation of our broad, late-stage development program,” said Mai-Britt Zocca, Ph.D., President and CEO IO Biotech. “Executing this clinical trial builds on IO Biotech’s recent momentum including financial, international, and organizational expansion.”

“Although therapies are available to treat metastatic melanoma, the clinical outcomes for patients with advanced disease remain poor and novel therapeutic options are desperately needed,” said Eva Ehrnrooth, M.D., Ph.D., CMO of IO Biotech. “We look forward to expanding our data set on IO102-IO103 in combination with KEYTRUDA, which we believe could support the potential approval of IO102-IO103 as a first-line therapy for melanoma as part of a combination regimen.”

In a Phase 1/2 clinical trial of 30 patients with metastatic melanoma (MM1636), IO102-IO103, in combination with an anti-PD1 mAb, induced meaningful tumor regression and established durable antitumor response with a manageable tolerability profile for patients. In this study, there was an overall response rate (ORR) of 80% and a complete response (CR) rate of 43%. Grade 3-4 adverse events were seen in 13% of patients.

Publication of results from this trial in Nature Medicine can be found HERE.

Based on the results from this trial, IO102-IO103, in combination with pembrolizumab, was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for treatment of unresectable/metastatic melanoma.

About IOB-013 / KN-D18

IOB-013 / KN-D18 is an open label, randomized Phase 3 clinical trial being conducted in collaboration with Merck of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. Target enrollment will be 300 patients from centers spread across the United States, Australia, and Europe. Biomarker analyses will also be conducted. IO Biotech will sponsor the Phase 3 trial and Merck will supply pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

About IO102-IO103

IO102-IO103 is an investigational cancer immunotherapy designed to target the immunosuppressive mechanisms mediated by the key immunosuppressive proteins indoleamine 2,3-dehydrogenase (IDO) and PD-L1.

About IO Biotech

IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating cancer therapies based on its T-win^® technology platform. The T-win^® platform is a novel approach to cancer immunotherapy designed to activate naturally occurring T cells to target immunosuppressive mechanisms. IO Biotech is advancing in clinical studies its lead immuno-oncology candidate, IO102-IO103, targeting IDO and PD-L1, and through clinical and preclinical development its other pipeline candidates.  IO Biotech is headquartered in Copenhagen, Denmark and has additional offices within the United States (New York, New York and Rockville, Maryland) and United Kingdom (Monmouthshire).

For further information, please visit www.iobiotech.com

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including regarding future clinical trials, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise.

Company Contact:

Mai-Britt Zocca, Ph.D.
President and CEO
IO Biotech, Inc.
mz@iobiotech.com

Investor Contact:
Corey Davis, Ph.D.
LifeSci Advisors
212-915-2577
cdavis@lifesciadvisors.com

Media Contact:
Raena Mina, Ph.D.
LifeSci Communications
646-606-1438
rmina@lifescicomms.com

FAQ

What is the objective of the IOB-013 / KN-D18 trial for IOBT?

The trial aims to evaluate IO Biotech’s IO102-IO103 in combination with KEYTRUDA for patients with previously untreated, unresectable or metastatic melanoma.

When did IO Biotech dose its first patient in the trial?

The first patient was dosed on May 18, 2022.

What were the results of the Phase 1/2 trial for IO102-IO103?

The Phase 1/2 trial revealed an 80% overall response rate and a 43% complete response rate.

What is the significance of FDA Breakthrough Designation for IOBT?

The FDA Breakthrough Designation recognizes the potential of IO102-IO103 as a first-line therapy for melanoma, expediting its development process.

How many patients are targeted for enrollment in the IOB-013 / KN-D18 trial?

The trial targets an enrollment of 300 patients across multiple centers.