SHANGHAI, China and MAINZ, Germany, October 26th  – DualityBiologics (Suzhou) Co., Ltd. (“DualityBio”, HKEX: 9606.HK) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that the DYNASTY-Breast02 global Phase 3 clinical trial (NCT06018337) met its primary endpoint demonstrating a statistically significant, yet modest improvement in progression-free survival (“PFS”) with trastuzumab pamirtecan (BNT323/DB-1303) compared to investigator’s choice of chemotherapy in chemotherapy-naïve patients with HR+/HER2-low metastatic breast cancer who have progressed on endocrine therapy. At this interim analysis for the secondary endpoint of overall survival (“OS”) data were not mature.

A higher rate of interstitial lung disease (“ILD”) was reported in this trial compared to prior trials with trastuzumab pamirtecan, with most cases being Grade 1 and 2. Severe and fatal events were reported in a small proportion of patients (Grade 3 – 5). Otherwise, the overall safety profile was consistent with prior clinical trials and no new safety signals were observed.

The available efficacy and safety data, as of this data cut-off date, suggest that the potential benefit to patients would be limited in the context of the HR+/HER2-low metastatic breast cancer treatment landscape. The companies will discuss the data and determine next steps.

BioNTech and DualityBio are developing trastuzumab pamirtecan in three ongoing clinical trials, including two global Phase 3 clinical trials, in HR+/HER2-low metastatic breast cancer (NCT06018337) and in HER2-expressing recurrent endometrial cancer (NCT06340568), as well as in a global Phase 1/2 clinical trial (NCT05150691) in patients with advanced/metastatic solid tumors.

About DYNASTY-Breast02

DYNASTY-Breast02 is a global Phase 3 randomized, multi-center, open-label clinical trial in patients living with HR+/HER2-low metastatic breast cancer whose disease has progressed on at least two lines of prior hormone therapy or within six months of first line hormone therapy plus cyclin-dependent kinase (CDK) 4/6 inhibitor in the metastatic setting. The primary endpoint of the clinical trial is PFS with a key secondary endpoint of OS. In the trial, 541 patients with HER2-low expression (IHC 2+/ISH- and IHC 1+) were randomized 1:1 to receive either trastuzumab pamirtecan or investigator's choice single-agent chemotherapy (capecitabine, paclitaxel or nab-paclitaxel).

About trastuzumab pamirtecan

Trastuzumab pamirtecan (BNT323/DB-1303) is a third-generation topoisomerase-1 inhibitor-based ADC targeting HER2 being developed by BioNTech and Duality Biologics. Trastuzumab pamirtecan was built from DualityBio’s proprietary Duality Immune Toxin Antibody Conjugates (“DITAC”) platform. HER2 is a surface-expressed protein on solid tumors and has been linked to the aggressive growth and spread of cancer cells.

Trastuzumab pamirtecan is being evaluated in an ongoing Phase 1/2 trial (NCT05150691) in patients with advanced/metastatic solid tumors and in Fern-EC-01, a randomized Phase 3 clinical trial (NCT06340568) evaluating trastuzumab pamirtecan compared with investigator's choice of single agent chemotherapy in previously treated patients with HER2-expressing advanced recurrent endometrial cancer, which is currently enrolling patients.

About DualityBio

DualityBio is a clinical-stage innovative biopharmaceutical company dedicated to developing next-generation antibody-drug conjugates (ADCs) for patients with cancer and autoimmune diseases. The Company has successfully built multiple next-generation ADC technology platforms with global intellectual property rights. Grounded in a deep understanding of disease biology, DualityBio has established a robust clinical-stage ADC pipeline and is conducting multiple global, multicenter clinical trials across nearly 20 countries, with over 3,500 patients enrolled to date. Furthermore, DualityBio has entered into several out-licensing collaborations with global pharmaceutical companies and leading innovative biotech firms. Serving as a global engine for ADC innovation, DualityBio continues to develop next-generation novel ADCs, including bispecific ADCs, ADCs with novel payloads, and autoimmune ADCs.    

For more information, please visit www.dualitybiologics.com.

About BioNTech

BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer.

For more information, please visit www.BioNTech.com.

DualityBio Forward-Looking Statements

This press release contains statements that may be deemed to be "forward-looking statements" within the meaning of applicable securities laws. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "aims," "intends," "plans," "believes," "may," and similar expressions. Statements that are not historical facts, including statements about the beliefs, plans, objectives, and expectations of Duality Biotherapeutics, Inc. (the "Company") regarding its business, research and development programs, and product candidates, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to risks related to the Company’s research and development, clinical trials, regulatory approvals, commercialization, and general economic and industry conditions.

All information provided in this press release is as of the date of this press release, and the Company does not undertake any obligation to update any forward-looking statement, except as required under applicable law or regulatory rules.

CONTACTS

DualityBio

Media Contact: PR@dualitybiologics.com

Investor Contact: IR@dualitybiologics.com

BioNTech

Media Relations

Jasmina Alatovic

Media@biontech.de

Investor Relations

Douglas Maffei, PhD

Investors@biontech.de