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Nimbus Therapeutics Appoints Nathalie Franchimont, M.D., Ph.D., as Chief Medical Officer

On October 26, 2022 Nimbus Therapeutics, a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, reported the appointment of Nathalie Franchimont, M.D., Ph.D., as Chief Medical Officer (Press release, Nimbus Therapeutics, OCT 26, 2022, View Source [SID1234622414]).

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"I am delighted to welcome Nathalie to our leadership team as Nimbus advances multiple potential breakthrough candidates into their next phase of development, including our clinical TYK2 and HPK1 inhibitors," said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus. "Nathalie’s strategic leadership and extensive clinical experience will be an asset to our growing clinical development team, and her wide range of experience in the development and commercialization of both small and large molecules in various therapeutic areas is an ideal fit for the breadth of Nimbus’ pipeline."

Dr. Franchimont joins Nimbus from Biogen, where she served as Senior Vice President, Head of Multiple Sclerosis and Immunology Development Unit. She previously held a variety of other leadership roles at Biogen, including leading the Multiple Sclerosis Research and Early Development Unit, the New Indications Research and Early Development Unit and the Immunology Drug Innovation Unit. Prior to joining Biogen, Dr. Franchimont held Medical Affairs and Clinical Development roles at Amgen. A rheumatologist by background, Dr. Franchimont trained at the University of Liège and has held research fellow and research associate roles at the University of Connecticut School of Medicine, Yale University School of Medicine and University of Liège. Dr. Franchimont has served on the Board of Directors of OMass Therapeutics since 2020.

"I am incredibly pleased to join Nimbus at a very exciting time in the company’s history and work with this accomplished team to bring new treatment possibilities to patients," said Dr. Franchimont. "Nimbus has advanced compelling medicines targeting TYK2 and HPK1 to the clinic and is developing strategies to address multiple other highly sought-after targets. NDI-034858, in ongoing Phase 2b trials, is a great example of the power of Nimbus’ approach and I believe it has potential to be a differentiated, best-in-class oral allosteric TYK2 inhibitor for the treatment of psoriasis, psoriatic arthritis and other immune-mediated diseases."

Pieris Pharmaceuticals To Host Third Quarter 2022 Investor Call and Provide Corporate Update on November 2, 2022

On October 26, 2022 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported that it will host a third quarter 2022 investor call on Wednesday, November 2, 2022 at 8:00 AM EDT to discuss financial results and provide a corporate update (Press release, Pieris Pharmaceuticals, OCT 26, 2022, View Source [SID1234622413]).

To access the call, participants may dial (888) 645-4404 (Toll Free US & Canada) or (862) 298-0702 (International) at least five minutes prior to the start of the call. Alternatively, a listen-only audio webcast of the call can be accessed here.

For those unable to participate in the conference call or listen to the webcast, a replay will be available on the Investors section of the Company’s website, www.pieris.com.

BeiGene Expands Reach of its Innovative BTK Inhibitor with Recent Regulatory Approvals in Latin America

On October 26, 2022 BeiGene, (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company focused on developing innovative and affordable oncology medicines to improve treatment outcomes and access for patients worldwide, reported significant progress in efforts to unlock global opportunities for BRUKINSA (zanubrutinib) with recent regulatory approvals in six Latin American countries (Press release, BeiGene, OCT 26, 2022, View Source [SID1234622412]):

Argentina Relapsed/refractory (r/r) mantle cell lymphoma (MCL)
Chile r/r marginal zone lymphoma (MZL) and Waldenström’s macroglobulinemia (WM)
Ecuador r/r MZL and WM
El Salvador r/r MCL, r/r MZL, and WM
Mexico r/r MCL
Paraguay r/r MCL
"It has only been one year since the first approval for BRUKINSA in Latin America and these approvals, including the most recent in Argentina, demonstrate our drive to accomplish our mission and broaden access to innovative medicines," said Eduardo Molinari, Senior Director of New Market Development in Latin America at BeiGene. "I look forward to collaborating with our partner, Adium, on commercialization activities to provide this important treatment option to people living with MCL, MZL, and WM in Latin America."

Dr. Maria Silvana Cugliari, Head of Hematology, Angel Roffo Institute of Oncology University of Buenos Aires, Argentina commented, "BTK inhibition has proven to be a highly effective treatment strategy for a number of indolent B-cell malignancies and BeiGene’s expansive clinical development program for BRUKINSA in multiple indications has provided evidence of strong efficacy and durable response rates, along with a consistent safety profile."

The announcement of regulatory approvals for BRUKINSA in Latin America follows a recent positive CHMP Opinion for BRUKINSA as a treatment for chronic lymphocytic leukemia (CLL) in the European Union.

About BRUKINSA

BRUKINSA is a small-molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. BRUKINSA was specifically designed to deliver targeted and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.

BRUKINSA is supported by a broad clinical program which includes more than 4,500 subjects in 35 trials across 28 markets. To date, BRUKINSA has received approvals covering more than 55 countries and regions, including the United States, China, the EU, Switzerland, Great Britain, Canada, Australia, and additional international markets.

BeiGene Oncology

BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 3,300 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 16,000 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology, and solid tumor targeted therapies, and immuno-oncology are key focus areas for the Company, with both monotherapies and combination therapies prioritized in our research and development. BeiGene currently has three licensed medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the U.S., China, the European Union, Switzerland, Great Britain, Canada, Australia, and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the poly adenosine diphosphate-ribose polymerase (PARP) inhibitor pamiparib in China.

BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma, and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including Mirati Therapeutics, Seagen, and Zymeworks.

In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD-1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, BeiGene and Novartis announced an option, collaboration, and license agreement in December 2021 for BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis oncology products across designated regions of China.

Oncopeptides phase 3 LIGHTHOUSE study further confirms clinical benefit of melflufen

On October 26, 2022 Oncopeptides AB (publ) (NASDAQ Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, reported that data from the phase 3 LIGHTHOUSE study that further confirms the clinical benefit of melflufen in patients with relapsed refractory multiple myeloma (RRMM) (Press release, Oncopeptides, OCT 26, 2022, View Source [SID1234622411]). The LIGHTHOUSE study investigated the efficacy and safety of the combination of melflufen plus daratumumab subcutaneous (sc) plus dexamethasone in comparison with daratumumab sc. (with supportive dexamethasone) in patients who were refractory to at least an immunomodulatory agent and a proteasome inhibitor or have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent.

LIGHTHOUSE is a randomized, open label phase 3 trial, designed as a confirmatory study in addition to the phase 3 OCEAN study. The primary endpoint was progression free survival (PFS). The study started in December 2020 and was planned to include 240 patients. In July 2021, the US Food and Drug Administration (FDA) requested a partial clinical hold of all studies with melflufen. Consequently, patient recruitment in LIGHTHOUSE was halted after 54 patients had been randomized. The clinical study was prematurely terminated in February 2022. Twenty-seven patients were randomized to each treatment arm. Patient characteristics were balanced between the two study arms. The observed efficacy and safety profile for the daratumumab sc. control arm in LIGHTHOUSE was in line with the approval labels in EU and USA with numerically higher PFS and Overall Response Rate (ORR).

Despite the small number of patients enrolled in LIGHTHOUSE at the time of study termination (n=54), the PFS in the ITT population was superior for the melflufen treatment arm in comparison with the control arm with a hazard-ratio (HR) of 0.18 and a nominal p-value of 0.0032. The ITT ORR was superior with a nominal p-value of 0.030, and the ITT Overall Survival (OS) HR was 0.47 with a nominal p-value of 0.37.

"Data from the phase 3 LIGHTHOUSE study are very encouraging and clearly indicate that the combination of melflufen and daratumumab has a clinical benefit in patients with RRMM," says María-Victoria Mateos, MD, PhD, from Salamanca’s University Hospital Haematology Department, and Lead Investigator of the LIGHTHOUSE study. "Multiple myeloma is still an incurable disease for most patients, and we welcome additional evidence on how to combine treatment options with different mode of actions in clinical practice."

In the patient population where the European Medicines Agency (EMA) confirmed melflufen clinical benefit based on the OCEAN trial, the LIGHTHOUSE study (n=29) demonstrated superior PFS with a HR of 0.062 with a nominal p-value of 0.0005, superior ORR with a nominal p-value of 0.0051, and superior OS with a HR of 0.00 with a nominal p-value of 0.037. This patient population excludes patients with post-ASCT time-to-progression <36 months.

"LIGHTHOUSE is the second phase 3 study to confirm the clinical benefit of melflufen in multiple myeloma patients with a treatment history with no stem-cell transplant or a successful prior stem-cell transplant in line with the recent full European approval," said Jakob Lindberg, CEO, Oncopeptides. "In addition, the LIGHTHOUSE data support the EMA conclusion that there is no indication of absolute overall survival harm from treatment with melflufen."

The safety profile of the melflufen and daratumumab sc combination was in line with what was observed in the phase 1/2 ANCHOR study, with predominantly clinically manageable cytopenias. The ANCHOR study was evaluating safety and efficacy of melflufen plus dexamethasone in combination with either daratumumab sc or bortezomib in patients with RRMM.

The information in the press release is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person above, on October 26, 2022, at 08:00 (CET).

Ascendis Pharma A/S Announces Third Quarter 2022 Financial Results and Business Update Conference Call on November 2

On October 26, 2022 Ascendis Pharma A/S (Nasdaq: ASND) reported that the company will hold a conference call and live webcast on Wednesday, November 2, 2022, at 4:30 p.m. Eastern Time (ET) to review its third quarter 2022 financial results and provide a business update (Press release, Ascendis Pharma, OCT 26, 2022, View Source [SID1234622410]).

Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at View Source A replay of the webcast will be available on this section of our website shortly after conclusion of the event for 30 days.