Theseus Pharmaceuticals Nominates THE-349, a Fourth-Generation EGFR Inhibitor Development Candidate in Non-Small Cell Lung Cancer

On October 3, 2022 Theseus Pharmaceuticals, Inc. (NASDAQ: THRX) (Theseus or the Company), a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients through the discovery, development, and commercialization of transformative targeted therapies, reported that it has nominated THE-349 as the development candidate for its epidermal growth factor receptor (EGFR) inhibitor program in non-small cell lung cancer (NSCLC) (Press release, Theseus Pharmaceuticals, OCT 3, 2022, View Source [SID1234621656]). THE-349 is designed to address treatment resistance to existing EGFR inhibitors by targeting the common activating mutations in exons 19 and 21 alone or in combination with the most frequently observed resistance mutations, T790M and C797X. In preclinical models, THE-349 potently inhibits single-, double-, and triple-mutant EGFR variants with these mutations that are observed in a post-first- or later-line osimertinib setting.

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!

Preclinical characterization of THE-349 as a fourth-generation EGFR, central nervous system- (CNS) active, and mutant-selective inhibitor with potent activity against single-, double-, and triple-mutant EGFR variants, including T790M and C797X, will be shared in a poster presentation at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium taking place in Barcelona on October 26-28, 2022.

"We are delighted to announce THE-349 as the Company’s second development candidate and we look forward to evaluating its potential in patients with EGFR-mutant NSCLC," said William Shakespeare, Ph.D., President of Research and Development at Theseus. "Clonal heterogeneity in patients who develop resistance to osimertinib is complex, and we believe a single EGFR inhibitor capable of targeting all major mutant forms of EGFR activating and resistance mutations is the optimal way to address this urgent medical need."

NSCLC is the most common form of lung cancer. Activating mutations in EGFR occur in 10-15% of Caucasian and up to 50% of Asian NSCLC patients, with up to 90% of those mutations found in exons 19 and 21. Although patients may initially respond to treatment with a first-, second- or third-generation EGFR tyrosine kinase inhibitor (TKI), their tumors eventually develop resistance to therapy. In patients whose tumors progress on osimertinib, point mutations at the C797 position (C797X) in EGFR have been observed at a frequency of up to approximately 12% after first-line osimertinib and 20% after second-line osimertinib. Patients presenting with these mutations have no available targeted therapy options due to current therapies lacking the necessary activity that can address both activating and resistance mutations.

Details for the presentation are as follows:

Title: Preclinical characterization of CNS-active, mutant-selective fourth-generation EGFR inhibitors with potent activity against single, double, and triple mutant EGFR variants including T790M and C797S
Abstract Number: 236
Session: Molecular Targeted Agents 2
Session Date and Time: Thursday, October 27, 2022: 10:00am-5:00pm (CEST)
Presenter: Sen Zhang, Ph.D. (Theseus Pharmaceuticals, Cambridge, USA)

About EGFR-mutant NSCLC
Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, accounting for approximately 85% of the estimated 2.2 million cases of lung cancer diagnosed globally in 2020. Activating mutations in EGFR occur in 10-15% of Caucasian and up to 50% of Asian NSCLC patients, with up to 90% of those mutations found in exons 19 and 21. In response to treatment, patients’ tumors can develop one or more additional EGFR mutations, causing resistance and rendering current therapies ineffective.

Oxford BioTherapeutics enters into Commercial License Agreement with Genmab

On October 3, 2022 Oxford BioTherapeutics (OBT), a clinical stage oncology company with a pipeline of immuno-oncology (IO) and antibody drug conjugate (ADC)-based therapies, reported that global oncology leader, Genmab has licensed a novel antibody related to one of OBT’s IO programs (Press release, Oxford BioTherapeutics, OCT 3, 2022, View Source [SID1234621655]). The target was discovered using Oxford BioTherapeutics’ proprietary OGAP drug discovery platform, which incorporates one of the world’s largest proteomic databases, integrating clinical, experimental and expression data.

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 agreement, Genmab will be responsible for the future development and commercialization of any products incorporating this antibody. In addition to the upfront payment, OBT will receive additional development and regulatory milestone payments as well as royalties on any future product sales. This represents the first major license agreement for OBT’s IO programs to a world leader in the field of antibody-based oncology medicines.

"We are pleased to license one of our leading immuno-oncology assets to a world leading biotechnology company like Genmab, who have a wealth of internationally renowned expertise in the fields of antibody development and oncology," said Christian Rohlff, PhD, Chief Executive Officer (CEO) of Oxford BioTherapeutics. "This licensing deal enables OBT to add further depth and momentum into its drug pipeline by having this innovative asset developed by a partner."

TC BioPharm to Present at Upcoming Investor Conferences

On October 3, 2022 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer, reported that management will be presenting at the Dawson James 7th Annual Small Cap Growth Conference and LD MICRO Main Event XV (Press release, TC Biopharm, OCT 3, 2022, View Source [SID1234621654]).

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!

TC BioPharm management will host one-on-one meetings with institutional investors at these conferences. Meetings can be scheduled through the firm hosting each event or by contacting TC BioPharm directly at [email protected]

Upcoming Conferences

The Dawson James 7th Annual Small Cap Growth Conference

LD MICRO Main Event XV

AIkido Pharma Continues Share Repurchase Program

On October 3, 2022 AIkido Pharma Inc. (Nasdaq: AIKI) ("AIkido" or the "Company") reported an update on the $3 million share repurchase program (the "Share Repurchase Program") authorized by the Company’s Board of Directors on January 21, 2022 (Press release, AIkido Pharma, OCT 3, 2022, View Source [SID1234621653]).

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!

The Company reported that on September 30, 2022, the Company purchased 41,096 shares of common stock at $ 7.1034 per share.

Anthony Hayes, CEO of Aikido stated, "The Company’s stock price is still below our book value, so we are continuing to allocate capital under our repurchase plan. The board believes in the Company and our plans moving forward."

Additional shares may be repurchased from time to time in open market transactions, or other means in accordance with Rule 10b5-1 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and Rule 10b -18 of the Exchange Act. The timing, number of shares repurchased, and prices paid for the stock under this program will depend on general business and market conditions as well as corporate and regulatory limitations, including blackout period restrictions.

Oncopeptides starts commercialization of Pepaxti in Europe – Germany first market

On October 3, 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 the Company has submitted the AMNOG dossier to "The Federal Joint Committee" (G-BA) in Germany (Press release, Oncopeptides, OCT 3, 2022, View Source;germany-first-market-301639005.html [SID1234621651]). This initiates the commercial launch of Pepaxti (melphalan flufenamide) and thus Germany will be the first market in Europe where the drug is launched.

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!

On August 18, the European Commission granted Pepaxti, in combination with dexamethasone, Marketing Authorization in the European Union and countries in the European Economic Area, for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation.

"The launch of Pepaxti in Germany is an important milestone for Oncopeptides and very good news for patients with triple class refractory disease," says Jakob Lindberg, CEO of Oncopeptides. "Multiple myeloma is an incurable disease, and despite the recent introduction of several novel therapies, there is a high unmet medical need that Pepaxti may satisfy, in particular in the large population of elderly patients with relapsed refractory multiple myeloma."

Oncopeptides will launch Pepaxti with a focused and lean organization, dedicated to providing patient access for the drug in Germany and Austria. The ex-manufacturer price amounts to 5.450 € per vial, concluding an average price of 10.900 € per cycle/month. The price reflects the clinical benefit for patients in the approved indication. The price is valid for one year and will be subject to negotiations with the National Association of Statutory Health Insurance Funds to set a reimbursed price for German sick funds.

According to data from more than 60 sick funds in Germany in 2020, the prevalence of multiple myeloma is estimated to 59.000 patients and the annual incidence of diagnosed patients is approximately 9.200 cases. The indicated population for Pepaxti in Germany amounts to around 2.500 patients.