On September 15, 2023 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA, Merck’s anti-PD-1 therapy, for the adjuvant treatment of adults with non-small cell lung cancer (NSCLC), who are at high risk of recurrence following complete resection and platinum-based chemotherapy (Press release, Merck & Co, SEP 15, 2023, View Source [SID1234635183]).

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 recommendation is based on results from the Phase 3 KEYNOTE-091 trial, in which KEYTRUDA demonstrated a statistically significant improvement in disease-free survival (DFS) in patients with NSCLC who are at high risk of recurrence (stage IB [T2a ≥4 centimeters], II or IIIA), and clinically meaningful results in the patients who received adjuvant chemotherapy. The CHMP’s recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected in the fourth quarter of 2023.

"While KEYTRUDA is foundational in the treatment of metastatic non-small cell lung cancer, there continues to be an unmet need to help more patients with lung cancer in earlier stages of disease," said Dr. Gregory Lubiniecki, vice president, global clinical development, Merck Research Laboratories. "The CHMP’s positive recommendation brings us one step closer to providing a new adjuvant treatment option for patients in the European Union with earlier stages of non-small cell lung cancer, regardless of PD-L1 expression."

The KEYNOTE-091 trial, also known as EORTC-1416-LCG/ETOP-8-15 – PEARLS, was conducted in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC) and the European Thoracic Oncology Platform (ETOP).

In January 2023, KEYTRUDA was approved, as a single agent, for adjuvant treatment following surgical resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 centimeters), II, or IIIA NSCLC in the U.S.

About lung cancer
Lung cancer is the leading cause of cancer death worldwide. In 2020 alone, there were more than 2.2 million new cases and 1.8 million deaths from lung cancer globally. Non-small cell lung cancer is the most common type of lung cancer, accounting for about 81% of all cases. In recent decades, the overall five-year survival rate for patients diagnosed with lung cancer increased from 11% to 15% on average across EU countries. Improved survival rates are due, in part, to earlier detection and screening, reduction in smoking, advances in diagnostic and surgical procedures, as well as the introduction of new therapies. Early detection and screening remain an important unmet need, as 44% of lung cancer cases are not found until they are advanced. Only 5.8% of people in the U.S. who are eligible were screened for lung cancer in 2021.

On September 15, 2023 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a patient-focused biopharmaceutical company, reported that it has entered into a definitive agreement for the purchase and sale of 1,100,000 shares of its common stock (or common stock equivalents in lieu thereof) at a purchase price of $2.63 per share of common stock (or common stock equivalent in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Hoth Therapeutics, SEP 15, 2023, View Source [SID1234635182]). In addition, in a concurrent private placement, Hoth will issue unregistered warrants to purchase up to 1,100,000 shares of its common stock. The warrants will have an exercise price of $2.505 per share and will be immediately exercisable upon issuance for a period of five years. The closing of the registered direct offering and the concurrent private placement is expected to occur on or about September 15, 2023, subject to the satisfaction of customary closing conditions.

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!

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to Hoth from the offering are expected to be approximately $2.89 million, before deducting the placement agent’s fees and other offering expenses payable by Hoth. Hoth intends to use the net proceeds from the offering for general working capital needs.

The shares of common stock (or common stock equivalents in lieu thereof) being offered in the registered direct offering (but not the warrants being in the concurrent private placement or the shares of common stock underlying such warrants) are being offered by Hoth pursuant to a "shelf" registration statement on Form S-3 (File No. 333-272620) previously filed with the Securities and Exchange Commission (the "SEC") on June 13, 2023 and declared effective by the SEC on June 16, 2023. The offering of the shares of common stock (or common stock equivalents in lieu thereof) in the registered direct offering is made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 865-5711 or e-mail at [email protected].

The warrants described above are being issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying such warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On September 15, 2023 GSK plc (LSE/NYSE: GSK) reported that the US Food and Drug Administration (FDA) has approved Ojjaara (momelotinib) for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythaemia), in adults with anaemia (Press release, GlaxoSmithKline, SEP 15, 2023, View Source [SID1234635181]). Ojjaara is a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor. To date, it is the only approved medicine for both newly diagnosed and previously treated myelofibrosis patients with anaemia that addresses the key manifestations of the disease, namely anaemia, constitutional symptoms, and splenomegaly (enlarged spleen).[4]

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!

Nina Mojas, Senior Vice President, Oncology Global Product Strategy, GSK, said: "The vast majority of myelofibrosis patients eventually develop anaemia, causing them to discontinue treatments and require transfusions. Given this high unmet need, we are proud to add Ojjaara to our oncology portfolio and address a significant medical need in the community. We look forward to helping improve outcomes in this difficult-to-treat blood cancer."

Myelofibrosis is a blood cancer affecting approximately 25,000 patients in the US.[4],[5],[6] Myelofibrosis can lead to severely low blood counts, including anaemia and thrombocytopaenia; constitutional symptoms such as fatigue, night sweats, and bone pain; and splenomegaly. About 40% of patients have moderate to severe anaemia at the time of diagnosis, and nearly all patients are estimated to develop anaemia over the course of the disease.[7],[8],[9],[10] Physicians have had limited treatment options to treat myelofibrosis patients with anaemia. These patients often require transfusions and more than 30% will discontinue treatment due to anaemia.​ Patients who are transfusion dependent have a poor prognosis and shortened survival.[1],[11],[12],[13],[14],[15],[16],[17],[18]

Ruben A. Mesa, MD, FACP, President and Executive Director, Atrium Health Levine Cancer Center and Atrium Health Wake Forest Baptist Comprehensive Cancer Center, said: "With momelotinib we have the potential to establish a new standard of care for myelofibrosis patients with anaemia. Addressing key manifestations of myelofibrosis, including anaemia, constitutional symptoms and splenomegaly, makes a significant difference in the treatment regimen for these patients who have limited options to address these aspects of the disease."

The FDA approval of momelotinib is supported by data from the pivotal MOMENTUM study and a subpopulation of adult patients with anaemia from the SIMPLIFY-1 phase III trial. MOMENTUM was designed to evaluate the safety and efficacy of momelotinib versus danazol for the treatment and reduction of key manifestations of myelofibrosis in an anaemic, symptomatic, JAK inhibitor-experienced population. The MOMENTUM trial met all its primary and key secondary endpoints, demonstrating statistically significant response with respect to constitutional symptoms, splenic response and transfusion independence, in patients treated with momelotinib versus danazol.[2] SIMPLIFY-1 was designed to evaluate the efficacy and safety of momelotinib versus ruxolitinib in myelofibrosis patients who had not received a prior JAK-inhibitor therapy.[1] Safety and efficacy results for SIMPLIFY-1 were based upon a subset of patients with anaemia.

In these clinical trials, the most common adverse reactions were thrombocytopaenia, haemorrhage, bacterial infection, fatigue, dizziness, diarrhoea, and nausea.[19]

Kapila Viges, Chief Executive Officer, MPN (Myeloproliferative Neoplasms) Research Foundation, said: "We are thrilled to see momelotinib reach the clinic, giving patients and their physicians another option to help manage myelofibrosis. Any new treatment that takes steps toward unlocking the mysteries of this complex and chronic blood cancer represents great progress for the field."

Momelotinib is currently not approved in any other market.

About Ojjaara (momelotinib)

Ojjaara has a differentiated mechanism of action, with inhibitory ability along three key signalling pathways: Janus kinase (JAK) 1, JAK2, and activin A receptor, type I (ACVR1). [2],[6], [20],[21] Inhibition of JAK1 and JAK2 may improve constitutional symptoms and splenomegaly.[6],[21] Additionally, inhibition of ACVR1 leads to a decrease in circulating hepcidin, which is elevated in myelofibrosis and contributes to anaemia.[2],[6],[20],[21]

Please see accompanying US Prescribing Information.

About myelofibrosis

Myelofibrosis is a rare blood cancer that results from dysregulated JAK-signal transducer and activator of transcription protein signalling and is characterised by constitutional symptoms, splenomegaly, and progressive anaemia. Myelofibrosis affects approximately 25,000 patients in the US.[1],[5],[6]

About the pivotal MOMENTUM clinical trial

MOMENTUM was a phase III, global, multicentre, randomised, double-blind study investigating momelotinib versus danazol in patients with myelofibrosis who were symptomatic and anaemic and had been previously treated with an approved JAK inhibitor. The trial was designed to evaluate the safety and efficacy of momelotinib for treating and reducing key hallmarks of the disease: symptoms, blood transfusions (due to anaemia) and splenomegaly.2 Results from the 24-week treatment period were presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and subsequently published in The Lancet.[22],[23]

About the SIMPLIFY-1 clinical trial

SIMPLIFY-1 was a multicentre, randomised, double-blind, phase III study that compared the safety and efficacy of momelotinib to ruxolitinib in patients with myelofibrosis who had not received prior treatment with a JAK inhibitor. Safety and efficacy results for SIMPLIFY-1 were based upon a subset of patients with anaemia (haemoglobin <10 g/dL) at baseline. The efficacy of momelotinib in the treatment of patients with myelofibrosis in SIMPLIFY-1 was based on spleen volume response (reduction by 35% or greater).

On September 15, 2023 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported that in connection with the hiring of Dashyant Dhanak, Ph.D., Executive Vice President and Chief Scientific Officer, the Compensation Committee of Deciphera’s Board of Directors approved the grant of a stock option to purchase 65,900 shares of Deciphera’s common stock, 65,900 restricted stock units ("RSUs") and a special grant of 75,000 RSUs ("Special RSUs") to Dr. Dhanak with a grant date of September 15, 2023 (Press release, Deciphera Pharmaceuticals, SEP 15, 2023, View Source [SID1234635180]).

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 equity awards were granted under the Company’s 2022 Inducement Plan and were made pursuant to Nasdaq Listing Rule 5635(c)(4). The grants were an inducement material to Dr. Dhanak accepting employment with the Company. The options have a ten-year term, and the exercise price of the options is $13.42, equal to the fair market value of the Company’s common stock on the Nasdaq on September 15, 2023. The shares subject to the option vest over a four-year period, with 25 percent of the shares subject to the option vesting on the first anniversary of Dr. Dhanak’s date of hire and the remainder vesting in equal monthly installments over three years thereafter. The 65,900 shares underlying the RSU grant will vest in equal annual installments over a three-year period, beginning on or about the one-year anniversary of the grant date. The 75,000 shares underlying the special grant vest over a two-year period, with 50 percent vesting on or about the first anniversary of the grant date and the remainder vesting on or about the two-year anniversary of the grant date. The awards are subject to the terms and conditions of their applicable equity award agreements, including having a continued relationship with the Company on the vesting date.

On September 15, 2023 BeyondSpring Pharmaceuticals presented its corporate presentation (Press release, BeyondSpring Pharmaceuticals, SEP 15, 2023, View Source [SID1234635179]).

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!