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]).

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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.

Ligand Announces that Janssen has Received Approval from U.S. FDA for TECVAYLI™ (teclistamab) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

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.

Theratechnologies Reports Data Showing High Expression of Sortilin (SORT1) in Multiple Solid Tumors from Tissue Microarrays

On October 26, 2022 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies reported that data from a tissue microarrays (TMAs) study demonstrating high expression of sortilin 1 (SORT1) in several solid tumors when compared to normal tissues, to be presented as a poster at the 34th European Organisation for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI), and the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Symposium on molecular targets and cancer therapeutics being held October 26-28, 2022, in Barcelona, Spain (Press release, Theratechnologies, OCT 26, 2022, View Source [SID1234622408]). The data highlight the potential of SORT1 as a new target for internalization of anticancer therapy and will be used to support the ongoing preclinical and clinical programs of Theratechnologies’ SORT1+ Technology platform.

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SORT1 is a receptor protein that binds to circulating proteins and peptides prior to their intracellular internalization. It is involved in the rapid transport of molecules across the cell membrane. SORT1 internalization function can be exploited to internalize a peptide-drug conjugate (PDC) to which docetaxel is attached and potentially inhibit the proliferation of cancer cells . Up to now, the pattern and prevalence of SORT1 expression in different healthy tissues have not been well understood, but SORT1 has been shown to be highly expressed in certain malignancies such as breast and ovarian cancers.

"Our study, the first to assess SORT1 expression across a variety of tissue microarrays representing several malignancies, shows that this receptor is highly expressed in cancer compared to normal tissues," said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer, Theratechnologies. "To our knowledge, no other group has conducted such an extensive screening of tumor or normal tissue biopsies to evaluate the level of SORT1 expression, which is elevated in multiple tumor types and maintained in stages 1 to 4. That makes SORT1 an attractive receptor for targeted delivery and rapid internalization of cancer therapeutic agents."

Researchers reported data on a total of 1,446 cancer cores, using the same immunohistochemistry (IHC) method and scored them using an H-score (an accurate method of describing reactivity in homogeneous tissue such as cancer) ranging from 0 to 300, whereby 0 corresponds to no cell stained for SORT1 and 300 corresponds to strong SORT1 staining in all cells.

The investigators observed high SORT1 expression in multiple solid tumors, as illustrated in the following table:

Interestingly, across 257 normal or adjacent tissue evaluable cores, SORT1 staining was either negative (null) or low for most healthy tissues including lung, stomach, liver, ovary, prostate, lymph node, esophagus, small intestine, cervix, skin, spleen, bone marrow, and thymus. Some healthy tissues had moderate or strong staining in >10% of cells, including the colonic mucosa, rectal epithelium, pancreatic islets and vessels, breast lobules, testicular spermatids and Sertoli cells, kidney tubules, and cerebral neuronal cells and astrocytes. The full poster can be found on Theratechnologies’ website.

"These findings further strengthen the evidence to support the development of our SORT1+ Technology platform, including our ongoing first-in-human study of TH1902, a SORT1-targeted PDC, currently in eight solid tumor types," added Dr. Marsolais. "They could also lay the groundwork for additional PDCs that are in early development."

The Company intends to further evaluate additional tissue microarrays to increase the biopsy sample size and to broaden the range of tumor types and sub-types that may be susceptible to SORT1, such as in prostate, small-cell lung carcinoma and thyroid cancers.

About TH1902 and SORT1+ Technology

Theratechnologies is currently developing a platform of proprietary peptides called SORT1+ TechnologyTM for cancer drug development targeting SORT1 receptors. The SORT1 receptor plays a significant role in protein internalization, sorting and trafficking. It is highly expressed in cancer cells compared to healthy tissue, which makes SORT1 an attractive target for cancer drug development. Expression of SORT1 is associated with aggressive disease, poor prognosis and decreased survival. It is estimated that the SORT1 receptor is expressed in 40% to 90% of cases of endometrial, ovarian, colorectal, triple-negative breast and pancreatic cancers.

TH1902 is currently Theratechnologies’ lead investigational PDC candidate for the treatment of cancer derived from its SORT1+ Technology. It is the Company’s proprietary peptide linked to docetaxel – a commonly used cytotoxic agent used to treat many cancers. The U.S. FDA granted fast track designation to TH1902 as a single agent for the treatment of all sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy.

Arbutus to Report Third Quarter 2022 Financial Results and Provide Corporate Update

On October 26, 2022 Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop novel therapeutics that target specific viral diseases, reported that it has scheduled its third quarter 2022 financial results and corporate update for Wednesday, November 9, 2022 (Press release, Arbutus Biopharma, OCT 26, 2022, View Source [SID1234622407]). The schedule for the press release and conference call/webcast are as follows:

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To dial-in for the conference call by phone, please register using the following link: Registration Link. A live webcast of the conference call can be accessed through the Investors section of Arbutus’ website at www.arbutusbio.com.

An archived webcast will be available on the Arbutus website after the event.

Actinium Pharmaceuticals to Participate in the 2022 Bio-Europe Conference

On October 26, 2022 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company) a leader in the development of targeted radiotherapies, reported that it will be participating in the Bio-Europe conference being held virtually November 2 – 4, 2022 (Press release, Actinium Pharmaceuticals, OCT 26, 2022, View Source [SID1234622406]).

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Members of Actinium’s business development team will be participating in 1-on-1 meetings during the conference. Meetings with Actinium can be requested through the partneringONE system https://informaconnect.com/bioeurope/ or by contacting Andrew Olsen, Ph.D., Senior Associate, Scientific and Business Analysis at [email protected].

Bio-Europe is the largest European biopharma partnering meeting with over 4,000 attendees from 2,200 companies and over 27,000 1-on-1 meetings scheduled.