On January 24, 2023 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by Johnson & Johnson were USD 7,977 million in 2022 (Press release, Genmab, JAN 24, 2023, View Source [SID1234626502]). Net trade sales were USD 4,210 million in the U.S. and USD 3,767 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to Janssen to develop, manufacture and commercialize daratumumab.

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 January 24, 2023 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, reported that its Chief Executive Officer, Michael Castagna, PharmD, and Chief Financial Officer, Steven B. Binder, will participate in the Lytham Partners Investor Select Conference taking place virtually on Tuesday, January 31, 2023 (Press release, Mannkind, JAN 24, 2023, View Source [SID1234626495]).

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’s webcast presentation will be available for viewing at 9:00am ET on Tuesday, January 31, 2023, on the Company’s website at Events & Presentations or View Source The webcast will also be archived and available for replay.

Management will be participating in virtual one-on-one meetings. To arrange a meeting with management, please contact Lytham Partners at 1×[email protected].

On January 24, 2023 PharmaMar (MSE:PHM) has reported that its licensing partner, Adium Pharma, has received the full approval for commercialization for Zepzelca (lurbinectedin) by the Federal Commission for the Protection against Sanitary Risks of Mexico (COFEPRIS) for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression on or after platinum-based chemotherapy (Press release, PharmaMar, JAN 24, 2023, View Source [SID1234626497]).

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 new approval of lurbinectedin is based on the monotherapy clinical data from the open-label, multi-center, single-arm clinical trial in 105 adult patients with relapsed SCLC (including patients with platinum-sensitive and platinum-resistant disease), that the Food and Drug Administration (FDA) used to grant accelerated approval for lurbinectedin in the US.

In March 2021, PharmaMar and Adium Pharma signed a licensing agreement for lurbinectedin in Latin America. The Mexican approval of lurbinectedin has been preceded for Adium by the approval in November 2022 also in Ecuador.

These approvals allow Adium Pharma to commercialize lurbinectedin in Ecuador and Mexico in the following months. SCLC accounted for up to 15% of all lung cancer cases[1]. Most SCLC patients are already at the advanced stage upon diagnosis, resulting in poor prognosis.

On January 24, 2023 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the Board of Directors has declared a quarterly dividend of $0.73 per share of the company’s common stock for the second quarter of 2023 (Press release, Merck & Co, JAN 24, 2023, View Source [SID1234626496]). Payment will be made on April 10, 2023, to shareholders of record at the close of business on March 15, 2023.

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 January 24, 2023 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported the clearance by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for KO-2806, the Company’s next-generation farnesyl transferase inhibitor (FTI), for the treatment of advanced solid tumors (Press release, Kura Oncology, JAN 24, 2023, View Source [SID1234626493]). The Company intends to evaluate safety, tolerability and preliminary antitumor activity of KO-2806 in a Phase 1 first-in-human study as a monotherapy and in combination with other targeted therapies.

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!

"Although we have seen significant advances in the development of targeted therapies for the treatment of various solid tumors, the reality is that most patients still eventually develop resistance and their cancer progresses on therapy," said Troy Wilson, Ph.D., J.D., President & Chief Executive Officer of Kura Oncology. "Over the past several years, we have pioneered the development of farnesyl transferase inhibitors as combination agents to prevent or delay emergence of resistance to certain classes of targeted therapy. Clearance of the IND for KO-2806 marks an important next step for this program, and we look forward to starting the Phase 1 study later this year."

The Phase 1 first-in-human study is designed to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of KO-2806 when administered as a monotherapy and in combination therapy in adult patients with advanced solid tumors. Following completion of the dose escalation as a monotherapy, Kura plans to evaluate KO-2806 in dose escalation combination cohorts in advanced solid tumors. The Company expects to initiate the Phase 1 study in the third quarter of 2023.

About KO-2806

KO-2806 is a potent next-generation inhibitor of farnesyl transferase designed to improve upon potency, pharmacokinetic and physicochemical properties of earlier FTI drug candidates. Kura has demonstrated encouraging clinical activity in HRAS-mutant head and neck squamous cell carcinoma (HNSCC) via farnesyl transferase inhibition with tipifarnib and is currently evaluating tipifarnib in combination with the PI3Kα inhibitor alpelisib to address larger genetic subsets of HNSCC patients. In addition, preclinical data is supportive of FTIs in combination with other targeted therapies to potentially overcome or prevent emergence of drug resistance to certain classes of drugs.