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]).

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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.

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]):

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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.

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.

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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).

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]).

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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.

On October 26, 2022 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that Janssen Biotech, Inc. (Janssen) has received approval from the U.S. Food and Drug Administration (FDA) for TECVAYLI (teclistamab) for the treatment of patients with relapsed or refractory (R/R) multiple myeloma (Press release, Ligand, OCT 26, 2022, View Source [SID1234622409]). Teclistamab is a T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3 discovered and developed by Janssen scientists using OmniAb’s OmniRat antibody discovery technology.

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Under the terms of the licensing agreement with an affiliate of Janssen, OmniAb is eligible to receive a $25 million milestone payment upon the first commercial sale of teclistamab in the United States.

"We are delighted Janssen’s TECVAYLI has been approved by the FDA, which follows its approval by the European Commission. This first FDA approval of an OmniAb-derived antibody is a major milestone for OmniAb as we continue to build momentum in the business," said Matt Foehr, President and COO of Ligand and planned CEO of OmniAb, Inc. following spin-off from Ligand. "Our strategic partners and collaborators have now received regulatory approvals for three different OmniAb-derived antibodies in three major geographies that include the U.S., Europe and China. We continue to see use of our platform increase for a variety of novel modalities, and are proud of the role we play within the industry and the contribution our technologies and team make to the discovery of therapeutics to improve human health on a global level."

The spin-off of OmniAb from Ligand remains on track with an expected closing on November 1, 2022, subject to the satisfaction or waiver of closing conditions for the business combination (Business Combination) of Avista Public Acquisition Corp. II (APAC) (NASDAQ: AHPA) and OmniAb. The record date for the dividend of shares of common stock of OmniAb to be distributed to Ligand shareholders (Distribution) is October 26, 2022, and the Distribution is expected to be made on November 1, 2022 immediately prior to the Business Combination, subject to the satisfaction or waiver of closing conditions. Following the closing of the Business Combination, OmniAb will begin trading on the Nasdaq Global Market under the stock ticker symbol "OABI." Under the terms of the separation and distribution agreement between Ligand and OmniAb, the milestone payments related to the first commercial sale of TECVAYLI will remain with OmniAb regardless of timing and achievement of the milestone and the timing of the closing of the Business Combination. The license agreement with an affiliate of Janssen does not include royalty payments, and OmniAb will not receive royalties on sales of TECVAYLI.

About OmniAb

OmniAb’s discovery platform provides pharmaceutical industry partners access to the diverse antibody repertoires and high-throughput screening technologies to enable discovery of next-generation therapeutics. At the heart of the OmniAb platform is the Biological Intelligence (BI) of our proprietary transgenic animals, including OmniRat, OmniChicken and OmniMouse that have been genetically modified to generate antibodies with human sequences to facilitate development of human therapeutic candidates. OmniFlic (transgenic rat) and OmniClic (transgenic chicken) address industry needs for bispecific antibody applications though a common light chain approach, and OmniTaur features unique structural attributes of cow antibodies for complex targets. We believe the OmniAb animals comprise the most diverse host systems available in the industry and they are optimally leveraged through computational antigen design and immunization methods, paired with high-throughput single B cell phenotypic screening and mining of next-generation sequencing datasets with custom algorithms to identify fully human antibodies with superior performance and developability characteristics. An established core competency focused on ion channels and transporters further differentiates our technology and creates opportunities in emerging target classes. OmniAb antibodies have been leveraged across modalities, including bispecific antibodies, antibody-drug conjugates and others. The OmniAb suite of technologies span from BI-powered repertoire generation to cutting edge antibody discovery and optimization offering a highly efficient and customizable end-to-end solution for the growing discovery needs of the global pharmaceutical industry.