1stOncology™: Cancer Intelligence Service – Page 5656 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

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.

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:

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]).

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.

Kura Oncology Reports Preliminary Proof of Mechanism in Phase 1/2 Clinical Trial of Tipifarnib Plus Alpelisib in Head and Neck Squamous Cell Carcinoma

On October 26, 2022 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today reported proof of mechanism in KURRENT-HN, the Company’s Phase 1/2 clinical trial of tipifarnib in combination with alpelisib in patients with HRAS- and/or PIK3CA-dependent head and neck squamous cell carcinoma (HNSCC) (Press release, Kura Oncology, OCT 26, 2022, View Source [SID1234622405]). The preliminary data are being presented at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium in Barcelona.

In a poster entitled, "HNSCCs overexpressing wild-type HRAS are sensitive to combined tipifarnib and alpelisib treatment," Kura highlights a patient with stage III squamous cell carcinoma of the tonsil, including a PIK3CA mutation and HRAS overexpression, who has achieved a durable partial remission on study. The 35-year-old patient enrolled in KURRENT-HN after failing two prior treatments, experienced an 81% reduction in target lesions after one cycle of tipifarnib and alpelisib and an 84% reduction after three cycles. As of September 14, 2022, the patient continued on study for more than 27 weeks. Treatment-related adverse events in the study have been consistent with the known safety profiles of each drug and are manageable, with no dose-limiting toxicities reported to date. A copy of the poster is available at www.kuraoncology.com.

Although tipifarnib has shown single-agent clinical activity in a highly selected population of HRAS mutant HNSCC1, and alpelisib has shown single-agent clinical activity in patients with PIK3CA-mutant, ER-positive/HER2-negative breast cancer2, no objective responses have been observed with either agent as a monotherapy in patients with PIK3CA-mutant HNSCC.

"These preliminary data from KURRENT-HN are encouraging, supporting the biologic rationale that combining a farnesyl transferase inhibitor with a PI3Kα inhibitor can achieve meaningful clinical responses in PIK3CA-dependent HNSCC," said Stephen Dale, M.D., Chief Medical Officer of Kura Oncology. "In addition, our new preclinical data support the potential of this combination to address approximately 45% of HNSCC tumors that harbor an actionable HRAS and/or PIK3CA mutation or overexpression. We are now working to identify a recommended Phase 2 dose and schedule for the combination and remain committed to bringing this important new treatment option to patients with recurrent or metastatic HNSCC who are in dire need of better therapies."

About KURRENT-HN

The KURRENT-HN trial is a biomarker-defined cohort study designed to evaluate the safety, determine the recommended combination dosing and assess early anti-tumor activity of tipifarnib and alpelisib for the treatment of HNSCC patients whose tumors are dependent on HRAS and/or PI3Kα pathways. The initial cohort in the trial is comprised of patients who have PIK3CA-dependent HNSCC. In August, Kura announced the first patient was dosed in a second cohort comprised of patients with HRAS overexpression. For more information about the trial, refer to www.kuraoncology.com/kurrent/.

About HNSCC

Head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer worldwide, accounting for more than 500,000 new cases each year. Despite advances in immunotherapy, the prognosis for advanced HNSCC patients remains poor, with an estimated median overall survival of 13-15 months in patients when stratified by PD-L1 expression. Although the anti-epidermal growth factor receptor (EGFR) antibody, cetuximab, was approved more than a decade ago, development of biomarker-directed therapies in HNSCC has been stymied by the limited number of druggable targets in the genomic landscape and the challenge of managing drug refractory, recurrent/metastatic HNSCC.