Rhizen Pharmaceuticals AG Announces Upcoming Data Presentations at ESMO 2022 for Its Clinical Stage Assets; Tenalisib in Locally Advanced/ Metastatic Breast Cancer and RP12146 in Multiple Solid Tumors

• Tenalisib (RP6530, selective dual PI3K d/γ inhibitor with additional SIK3 inhibitory activity) showed encouraging results with a clinical benefit rate (CBR) of 57.5% from an ongoing phase II trial in patients with locally advanced or metastatic HR+/HER2- breast cancer (mBC)
• RP12146, Rhizen’s next generation PARP1/2 inhibitor concludes dose escalation phase with a favorable safety profile and has moved to the dose expansion phase in solid tumors

Rhizen Pharmaceuticals AG (Rhizen), a Swiss based privately held, clinical-stage biopharmaceutical company announced today that it is presenting data from an ongoing Phase 2 trial of Tenalisib in locally advanced or metastatic breast cancer and data from a concluded dose escalation phase of RP12146 at ESMO 2022, Paris from Sept 9-13, 2022.

The multi-centre, randomized phase II study evaluating two doses of Tenalisib, a differentiated PI3K δ/γ inhibitor with additional SIK3 inhibitory activity, has completed 24 weeks of treatment with an impressive Clinical Benefit Rate (CBR) of 57.5% and with no unexpected safety concerns.Treatment with orally dosed Tenalisib was found to be effective in a difficult to treat population where majority of patients had visceral disease and multiple metastatic lesions. In addition, a lone TNBC patient in the trial showed stable disease for more than 6 months and is continuing on the study.

Dose escalation of a Phase -I/Ib trial of RP12146, a next generation PARP 1/2 inhibitor designed to overcome the safety liabilities associated with first generation PARP inhibitors, was successfully completed and is enrolling at the RP2D dose for the expansion phase. RP12146 showed dose related exposures with robust target engagement and notable absence of haematological toxicities viz anaemia and cytopenia. The expansion phase at 400mg BID is currently in progress in genomically qualified ovarian, breast and prostate cancer patients with HRR mutations.

“We are pleased to report the clinical progress of our assets, particularly Tenalisib in a difficult to treat patient population of metastatic breast cancer showing sustained and beneficial disease control. In addition, our carefully designed next generation PARP1/2 inhibitor has successfully demonstrated the safety differential to first generation agents of this class and we are planning to rapidly progress into efficacy evaluations in various solid tumors as mono therapy and as rational combinations,” said Swaroop Vakkalanka, Founder & CEO of Rhizen Pharmaceuticals AG.

1. Tenalisib Poster Presentation schedule:
   224P – Efficacy and safety of Tenalisib, a PI3K delta/gamma and SIK3 inhibitor in patients with locally advanced or metastatic breast cancer: Results from a phase II study
   Presentation Number: 224P
   Speakers: Tamta Makharadze (Tbilisi, Georgia)
   Poster Session: Breast cancer, metastatic
   Date: Sat, 10.09.2022
   Hall 4: Presentation time: (12:00-13:00 CEST)
    
2. RP12146 Poster Presentation schedule:
   483P – Pre-clinical and early clinical assessment of the safety and anti-tumor activity of RP12146, a PARP1/2 inhibitor in solid tumors
   Presentation Number: 483P
   Speakers: Piotr Tomczak (Poznan, Poland)
   Poster Session: Developmental therapeutics
   Date: Mon, 12.09.2022
   Hall 4: Presentation time: (12:00-13:00 CEST)

About Rhizen Pharmaceuticals AG:

Rhizen Pharmaceuticals is an innovative, clinical-stage biopharmaceutical company focused on the discovery and development of novel oncology & inflammation therapeutics. Since its establishment in 2008, Rhizen has created a diverse pipeline of proprietary drug candidates targeting several cancers and immune associated cellular pathways.

Rhizen is headquartered in Basel, Switzerland. For additional information, please visit https://www.rhizen.com/

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