MorphoSys’ Licensing Partner Roche Provides Update on Phase 3 GRADUATE Program for Gantenerumab in Early Alzheimer’s Disease

Rhea-AI Summary

MorphoSys AG announced that the GRADUATE I and II studies, partnered with Roche, did not meet their primary endpoint of slowing clinical decline in patients with early Alzheimer's disease. The studies evaluated gantenerumab, which showed lower than expected beta-amyloid removal. Despite this setback, gantenerumab was well tolerated during the trial. The Phase 3 program involved 1,965 participants over 27 months. The topline findings will be presented at the CTAD Conference on November 30, 2022.

Positive

• Gantenerumab was well tolerated during the studies.
• The GRADUATE Phase 3 program included nearly 2,000 participants across 30 countries.

Negative

• GRADUATE studies did not meet primary endpoint of slowing clinical decline.
• Beta-amyloid removal was lower than expected.

GRADUATE studies did not meet primary endpoint

PLANEGG / MUNICH, GERMANY / ACCESSWIRE / November 14, 2022 / MorphoSys AG (FSE:MOR)(NASDAQ:MOR) announced today that its licensing partner Roche (SIX: RO, ROG; OTCQX: RHHBY) provided an update on the GRADUATE I and II studies evaluating gantenerumab in people with early Alzheimer's disease (AD). The studies did not meet their primary endpoint of slowing clinical decline. The level of beta-amyloid removal, the protein that builds up to make plaques in the brains of people with Alzheimer's disease, was lower than expected. Gantenerumab was well tolerated, including the subcutaneous administration.

The GRADUATE Phase 3 program evaluated the safety and efficacy of gantenerumab in people with mild cognitive impairment (MCI) due to Alzheimer's and mild Alzheimer's dementia over 27 months. 1,965 study participants across 30 countries were randomized 1:1 to receive gantenerumab or placebo by subcutaneous injection titrated to reach a target dose of 510 mg administered every two weeks. Gantenerumab is a fully-human monoclonal IgG1 antibody that was discovered in collaboration with Roche.

"We are disappointed by these results as there are millions of people impacted every day by Alzheimer's disease," said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "We are grateful to Roche, our long-standing partner, for their work on the GRADUATE program and their commitment to the Alzheimer's community."

The topline findings of the GRADUATE I and II studies will be presented at the upcoming Clinical Trials on Alzheimer's Disease (CTAD) Conference on Wednesday, November 30, 2022 at 16:15 PT.

In September 2000, MorphoSys entered into a global collaboration agreement with Roche. As part of the agreement, Roche is fully responsible for the clinical development and potential commercialization of gantenerumab. MorphoSys is entitled to receive tiered royalties, ranging from 5.5% to 7.0%, on net product sales and potential success-based regulatory milestone payments related to gantenerumab. MorphoSys will retain 40% of future royalties on gantenerumab and pass 60% to Royalty Pharma. This is outlined in the funding agreement between MorphoSys and Royalty Pharma, which helped MorphoSys acquire Constellation Pharmaceuticals Inc. - expanding its potential best-in-class oncology pipeline.

About MorphoSys:

At MorphoSys, we are driven by our mission: More life for people with cancer . As a global commercial-stage biopharmaceutical company, we use groundbreaking science and technologies to discover, develop, and deliver innovative cancer medicines to patients. MorphoSys is headquartered in Planegg, Germany, and has its U.S. operations anchored in Boston, Massachusetts. To learn more, visit us at www.morphosys.com and follow us on Twitter and LinkedIn .

Forward Looking Statements

This communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are that MorphoSys' expectations may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

For more information, please contact:

Media Contacts:
Thomas Biegi
Vice President
Tel.: +49 151 74612318
thomas.biegi@morphosys.com

Investor Contacts:
Dr. Julia Neugebauer
Head of Investor Relations
Tel: +49 (0)89 / 899 27 179
julia.neugebauer@morphosys.com

Eamonn Nolan
Director, Communications
Tel: +1 617-548-9271
eamonn.nolan@morphosys.com

SOURCE: MorphoSys AG

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https://www.accesswire.com/725476/MorphoSys-Licensing-Partner-Roche-Provides-Update-on-Phase-3-GRADUATE-Program-for-Gantenerumab-in-Early-Alzheimers-Disease

FAQ

What were the results of the GRADUATE studies for gantenerumab?

The GRADUATE studies did not meet their primary endpoint of slowing clinical decline in early Alzheimer's disease.

What is gantenerumab and what was its role in the GRADUATE studies?

Gantenerumab is a fully-human monoclonal IgG1 antibody evaluated for efficacy and safety in early Alzheimer's disease within the GRADUATE studies.

When will the findings of the GRADUATE studies be presented?

The topline findings will be presented at the CTAD Conference on November 30, 2022.

What was the sample size of the GRADUATE Phase 3 program?

The GRADUATE Phase 3 program enrolled 1,965 participants across 30 countries.

What are the implications of the GRADUATE study results for MorphoSys investors?

The failure to meet the primary endpoint could impact future earnings from royalties and regulatory milestones associated with gantenerumab.