On August 24, 2022 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that the Janssen Biotech, Inc. (Janssen) received conditional marketing authorization (CMA) from the European Commission for TECVAYLI (teclistamab) as monotherapy for the treatment of patients with relapsed or refractory (R/R) multiple myeloma (Press release, Ligand, AUG 24, 2022, View Source [SID1234618609]). Teclistamab is a T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3 that was discovered 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 $10 million milestone payment upon the first commercial sale of teclistamab in the United Kingdom, Italy, Germany, France, or Spain.

"Approval of Janssen’s TECVAYLI by the European Commission adds another important medicine for the treatment of relapsed or refractory multiple myeloma. This marks the first European approval of an OmniAb-derived antibody, and the first approval of an OmniAb-derived bispecific antibody," said Matt Foehr, President and COO of Ligand. "We look forward to the continued advancement of therapies our collaborators have discovered using the OmniAb platform."

Ligand’s previously announced spin-off of OmniAb and merger (Business Combination) with Avista Public Acquisition Corp. II (APAC) (NASDAQ: AHPA), a publicly traded special purpose acquisition company (SPAC), remains on track to close in the fourth quarter of 2022. 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 the OmniAb business regardless of timing and achievement of the milestone and the timing of the merger closing. The license agreement between OmniAb and CNA Development LLC does not include royalty payments, and OmniAb will not receive royalties on sales of TECVAYLI.

About OmniAb

The OmniAb discovery platform provides Ligand’s 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.

On August 24, 2022 Alaunos Therapeutics, Inc. ("Alaunos" or the "Company") (Nasdaq: TCRT), a clinical-stage oncology-focused cell therapy company, reported that it has been accepted to present a proffered talk at the CRI-ENCI-AACR Sixth International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) (CICON) being held in New York, NY from September 28 – October 1, 2022 (Press release, Alaunos Therapeutics, AUG 24, 2022, View Source [SID1234618608]).

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!

Details of the presentation are as follows:

Title: Objective clinical response by KRAS mutation-specific TCR-T cell therapy in previously treated advanced Non-small cell lung cancer

Presenter: Marcelo V. Negrao, MD, Department of Thoracic-Head & Neck Med Onc, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center

Date and Time: Friday, September 30, 2022, 8:30am ET

Session Title: Session 6: Cellular Therapies: Engineering T cells

On August 24, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune and Infectimune T cell activating technologies, reported that it has entered into a debt financing agreement led by Horizon Technology Finance Corporation (NASDAQ: HRZN) ("Horizon") to provide up to a $35.0 million term loan (Press release, PDS Biotechnology, AUG 24, 2022, View Source [SID1234618607]).

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!

"We are pleased to partner with Horizon, a leading specialty finance company that has an extensive history of supporting innovative life science companies," said Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. "We anticipate a number of important milestones across our oncology and infectious disease programs. This transaction immediately strengthens our balance sheet and provides the financial resources necessary to advance the company’s clinical pipeline. We look forward to our meeting with the U.S. Food and Drug Administration this quarter to discuss the registrational trial design for our lead program."

As part of the financing, PDS Biotech received an initial tranche of $25 million at the close. The Company has an option to receive an additional $10 million. Each advance of the loan will be repaid in 48 monthly payments consisting of 24 monthly payments of interest only, followed by 24 monthly payments of principal and accrued interest. In connection with the financing, PDS Biotech issued Horizon warrants to purchase up to 4% of the loan amount, 381,625 of its common shares at an exercise price of $3.6685 per share. Proceeds will be used to support the ongoing clinical development of PDS0101 and other product candidates within the company’s pipeline and for general working capital purposes.

Further information with respect to the debt financing agreement with Horizon will be contained in a current report to be filed on Form 8-K by PDS Biotechnology with the Securities and Exchange Commission.

Conference Call and Webcast
The conference call is scheduled for Thursday, August 25, 2022 at 8:00 AM EDT. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13732262. To access the webcast, please use the following link. The event will be archived in the investor relations section of PDS Biotech’s website for six months.

On August 24, 2022 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that Rob Ross, M.D., chief executive officer, will participate in a fireside chat at the virtual Gilmartin Group Emerging Growth Company Showcase on Wednesday, August 31, 2022 at 2:30 p.m. ET (Press release, Surface Oncology, AUG 24, 2022, View Source [SID1234618606]).

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!

A live webcast of the presentation may be accessed by visiting the Investors & Media section of the Surface Oncology website at View Source In addition, a replay of the webcast will be available on the company’s website following the presentation.

On August 24, 2022 GNS, the leader in the use of "Digital Twins" and Causal AI & biosimulation technology for biopharmaceutical drug discovery and development, and Servier, a global pharmaceutical group, reported a collaboration to advance drug discovery, translational, and clinical development efforts in Multiple Myeloma (MM) (Press release, Servier, AUG 24, 2022, View Source [SID1234618605]).

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!

"This collaboration furthers Servier’s goal to accelerate its drug discovery and clinical development efforts through AI and biosimulation and other digital initiatives," said Claude Bertrand, EVP of Research and Development at Servier. "We believe GNS’ Digital Twin and unique causal AI models will help our research and early development group improve our understanding of MM disease biology and, ultimately, transform our drug discovery and clinical development process".

"We are delighted to collaborate with Servier to help advance research in MM and leverage our Gemini Digital Twin patient models to help uncover novel insights and reveal the hidden biological circuity of this disease," said Joe Donahue, Chief Business Officer at GNS. "Working together with the outstanding Servier team, we hope to make a difference in the lives of patients with MM."

The collaboration will address key questions about how MM progresses in different patient subpopulations, including discovering what are the most synergistic pathways for new combination therapies and will help Servier gain insights that can advance their translational and clinical development efforts. This work will initially leverage the GNS Gemini Digital Twin for MM developed using the rich clinico-genomic data from the Multiple Myeloma Research Foundation (MMRF) CoMMpass study.

GNS’ MM Digital Twin leverages the rich patient multi-modal data generated by MMRF to create a transparent, accurate, quantified representation of complex biological mechanisms, revealing new circuitry of human disease. By conducting biosimulations, which are essentially computational experiments, one can discover new drug targets and disease mechanisms, and can also determine which drug candidates are more effective than others and why certain molecular profiles of patients lead to better and more durable response. Ultimately, the MM Digital Twins will radically change how Pharma R&D is conducted by helping to accelerate the identification of new targets and target combinations, new biomarkers, and enabling the in silico design of better trials.