On October 17, 2023 Kineta, Inc. (Nasdaq: KA), a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, reported that the first patient has been dosed in Part B of its Phase 1/2 VISTA-101 clinical trial that will evaluate the safety and tolerability of the company’s VISTA blocking immunotherapy, KVA12123, in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors (Press release, Kineta, OCT 17, 2023, View Source;utm_medium=rss&utm_campaign=kineta-announces-first-patient-dosed-in-phase-1-2-vista-101-clinical-trial-of-kva12123-in-combination-with-keytruda-pembrolizumab-in-patients-with-advanced-solid-tumors [SID1234636066]).

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"Dosing the first patient in the combination arm with KEYTRUDA and KVA12123 is a significant milestone for Kineta, and we are very pleased with the progress of our differentiated VISTA blocking immunotherapy," said Shawn Iadonato, Ph.D., Chief Executive Officer of Kineta. "We anticipate that the results from the combination arm will further build on the already encouraging initial safety, tolerability, and pharmacokinetic profile of KVA12123 observed in the monotherapy arm. We look forward to reporting initial clinical data for the combination treatment next year."

The Phase 1/2 clinical study (NCT05708950) is designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and tumor response of KVA12123 alone and in combination with pembrolizumab in patients with advanced solid tumors. The study will be conducted in 4 parts. The Phase 1 study (Parts A and B) will focus on dose escalation of KVA12123 as a monotherapy and in combination with pembrolizumab which has now been initiated. Additionally, Parts A and B will be used to determine a recommended Phase 2 dose (RP2D) for Parts C and D. The clinical trial will transition into a Phase 2 study (Parts C and D) that will focus on dose expansion with an optimized dose.

KVA12123 is a VISTA blocking immunotherapy in development as a twice weekly infusion. The drug is being evaluated in a Phase 1/2 clinical trial for patients with advanced solid tumors. Competitive therapies targeting VISTA have demonstrated either poor monotherapy anti-tumor activity in preclinical models or induction of cytokine release syndrome (CRS) in human clinical trials. Through the combination of unique epitope binding and an optimized IgG1 Fc region, KVA12123 demonstrates strong monotherapy tumor growth inhibition in preclinical models without evidence of CRS in clinical trial participants. KVA12123 effectively de-risks the VISTA target and provides a novel approach to address immune suppression in the tumor microenvironment (TME) with a mechanism of action that is differentiated and complementary to T cell focused therapies. KVA12123 may be an effective immunotherapy for many types of cancer including non-small cell lung (NSCLC), colorectal, renal cell carcinoma, head and neck, and ovarian cancer.

Initial combination therapy clinical data as well as additional monotherapy safety and efficacy data are expected in Q2 2024.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On October 17, 2023 Johnson & Johnson (NYSE: JNJ) reported results for third-quarter 2023. "Johnson & Johnson delivered strong results and significant pipeline advances in the third quarter, providing a solid foundation for future sustained growth," said Joaquin Duato, Chairman of the Board and Chief Executive Officer (Press release, Johnson & Johnson, OCT 17, 2023, View Source [SID1234636065]). "With a sharpened focus on Innovative Medicine and MedTech solutions, Johnson & Johnson is innovating across the spectrum of healthcare and is poised to deliver the medical breakthroughs of tomorrow."

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Unless otherwise noted, the financial results and earnings guidance included below reflect the continuing operations of Johnson & Johnson. The Company recognized a one-time, non-cash gain of approximately $21 billion in the quarter as part of discontinued operations related to the final separation of its Consumer Health business.

Overall Financial Results

1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
4 Excludes intangible amortization expense and special items
5 Excludes COVID-19 Vaccine
Note: values may have been rounded

REGIONAL SALES RESULTS:
regionupdated.jpg
1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

SEGMENT SALES RESULTS:
segmentsupdated.jpg

1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
Note: The Innovative Medicine segment was previously referred to as the Pharmaceutical segment
Values may have been rounded

Third Quarter 2023 Segment Commentary:

Adjusted operational sales* reflected below excludes the net impact of acquisitions and divestitures and translational currency.

Innovative Medicine

Innovative Medicine worldwide adjusted operational sales grew 4.4%*. Excluding the COVID-19 Vaccine, operational sales grew 8.2%*. Growth was driven by DARZALEX (daratumumab), ERLEADA (apalutamide), Other Oncology, and CARVYKTI (ciltacabtagene autoleucel) in Oncology, STELARA (ustekinumab), TREMFYA (guselkumab), and SIMPONI/SIMPONI ARIA (golimumab) in Immunology, SPRAVATO (esketamine) in Neuroscience, and UPTRAVI (selexipag) in Pulmonary Hypertension. Growth was partially offset by COVID-19 Vaccine (Ad26.COV2.S) in Infectious Diseases, ZYTIGA (abiraterone acetate) and IMBRUVICA (ibrutinib) in Oncology, and REMICADE (infliximab) in Immunology.

MedTech

MedTech worldwide adjusted operational sales grew 6.0%*, driven primarily by electrophysiology products in Interventional Solutions, wound closure products in General Surgery, contact lenses in Vision, and biosurgery in Advanced Surgery. MedTech worldwide operational sales grew 10.4%*, with the acquisition of Abiomed contributing 4.6%.

Notable New Announcements in the Quarter:

The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investor Relations section of the company’s website at news releases, as well as www.factsabouttalc.com, www.factsaboutourprescriptionopioids.com, and www.LTLManagementInformation.com.

Regulatory Biosense Webster Receives FDA Approval for Multiple Atrial Fibrillation Ablation Products to be Used in a Workflow Without Fluoroscopy Press Release
U.S. FDA Approves TALVEY (talquetamab-tgvs), a First-in-Class Bispecific Therapy for the Treatment of Patients with Heavily Pretreated Multiple Myeloma Press Release
European Commission Approves TALVEY (talquetamab), Janssen’s Novel Bispecific Therapy for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma Press Release
European Commission Approves Reduced Dosing Frequency for Janssen’s Bispecific Antibody TECVAYLI (teclistamab) Press Release
Janssen Submits Application to the European Medicines Agency for RYBREVANT (amivantamab) in Combination with Chemotherapy for the First-Line Treatment of Adult Patients with Advanced Non-Small Cell Lung Cancer with Activating EGFR Exon 20 Insertion Mutations1
Press Release
Janssen Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of BALVERSA (erdafitinib) for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Carcinoma and Selected Fibroblast Growth Factor Receptor Gene Alterations Press Release
Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of Erdafitinib for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Cancer with Susceptible FGFR Alterations Press Release
U.S. FDA Approves AKEEGA (Niraparib and Abiraterone Acetate), the First-And-Only Dual Action Tablet for the Treatment of Patients with BRCA-Positive Metastatic Castration-Resistant Prostate Cancer Press Release
Data Release
Janssen to Highlight Latest Research from Nipocalimab Clinical Development Program to Address Unmet Need in Myasthenia Gravis at AANEM 2023 Meeting1
Press Release
Janssen Aims to Define New Standards of Care in the Treatment of Solid Tumor Cancers with Transformative Data Planned for Presentation at ESMO (Free ESMO Whitepaper)1
Press Release
TREMFYA (guselkumab) Maintains Key Efficacy Endpoints Through Three Years for Adults with Moderately to Severely Active Crohn’s Disease in a Phase 2 Study1
Press Release
Janssen Highlights Latest Research for TREMFYA (guselkumab) and Investigational Targeted Oral Peptide JNJ-2113 in Moderate to Severe Plaque Psoriasis at the European Academy of Dermatology and Venereology (EADV) Congress1
Press Release
Landmark Phase 3 MARIPOSA Study Meets Primary Endpoint Resulting in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival for RYBREVANT (amivantamab-vmjw) plus Lazertinib Versus Osimertinib in Patients with EGFR-Mutated Non-Small Cell Lung Cancer Press Release
Phase 3 MARIPOSA-2 Study Meets Dual Primary Endpoint Resulting in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival for RYBREVANT (amivantamab-vmjw) Plus Chemotherapy with and without Lazertinib versus Chemotherapy Alone in Patients with EGFR-Mutated Non-Small Cell Lung Cancer after Disease Progression on Osimertinib Press Release
Treatment with RYBREVANT (amivantamab-vmjw) and Lazertinib Plus Chemotherapy Showed Durable Progression-Free Survival in Patients with Previously Treated EGFR-Mutated Advanced Non-Small Cell Lung Cancer Press Release
Janssen to Highlight Latest Advances in Retina Portfolio at the European Society of Retina Specialists (EURETINA) 2023 Annual Meeting1
Press Release
Product Launch Biosense Webster Launches the OPTRELL Mapping Catheter with TRUEref Technology for Mapping of Complex Cardiac Arrhythmias Press Release
Other Johnson & Johnson Announces Final Results of Exchange Offer and Finalizes Separation of Kenvue Inc. Press Release
Johnson & Johnson Announces Updated Financials and 2023 Guidance Following Completion of the Kenvue Separation Press Release
Johnson & Johnson Marks New Era as Global Healthcare Company with Updated Visual Identity Press Release

1 Subsequent to the quarter

Full-Year 2023 Guidance:

Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.

On October 17, 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 2,499 million in the third quarter of 2023 (Press release, Genmab, OCT 17, 2023, View Source [SID1234636064]). Net trade sales were USD 1,369 million in the U.S. and USD 1,130 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.

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On October 17, 2023 Flamingo Therapeutics ("Flamingo") reported the presentation of a "Trials-in-Progress", or TiP, poster at the ESMO (Free ESMO Whitepaper) Congress 2023, taking place October 20-24, 2023, in Madrid, Spain (Press release, Flamingo Therapeutics, OCT 17, 2023, View Source;utm_medium=rss&utm_campaign=flamingo-therapeutics-announces-poster-presentation-at-esmo-congress-2023 [SID1234636063]). Members of the Flamingo leadership team, Andrew Denker, MD, PhD, Chief Medical Officer, and Morgane Perdomini, PhD, Director Development, will be present at the congress.

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Details of the TiP poster presentation are below:

Title: "PEMDA-HN, an Open-Label, Phase II, Randomized Controlled Study of Danvatirsen Plus Pembrolizumab Compared to Pembrolizumab Alone in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (RM HNSCC)"

Presentation #: 943 TiP

Date: Sunday, October 22, 2023

Presenting Author: Nabil F. Saba (Atlanta, United States of America)

More details can be found on the ESMO (Free ESMO Whitepaper) website.

On October 17, 2023 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, and Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma), one of China’s largest pharmaceutical companies, reported a global licensing agreement that grants Elevar rights to commercialize and develop Hengrui Pharma’s anti-PD-1 antibody camrelizumab in combination with rivoceranib for unresectable hepatocellular carcinoma (uHCC) worldwide, excluding Greater China Region and Korea (Press release, Elevar Therapeutics, OCT 17, 2023, View Source [SID1234636062]).

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Under the terms of the agreement, Elevar will pay Hengrui Pharma up to $600 million of sales milestones and a double-digit percentage royalty on camrelizumab net sales. The total estimated 10-year payout could be up to $1 billion.

In May 2023, a new drug application (NDA) for rivoceranib and a biologics license application (BLA) for camrelizumab were submitted to the U.S. Food and Drug Administration (FDA) for the combination of rivoceranib and camrelizumab as a first-line therapy for uHCC. The FDA accepted the submissions, assigning Prescription Drug User Fee Act (PDUFA) target action dates in May 2024.

Rivoceranib is developed by Hengrui Pharma in China. In January 2023, the combination was approved in China as a first-line treatment for uHCC. Elevar maintains development rights to rivoceranib outside of China and Korea.

"This agreement will boost our companies’ shared focus on advancing the standard of care in uHCC, as having both camrelizumab and rivoceranib under one portfolio will significantly streamline commercialization," said Saeho Chong, Elevar chief executive officer. "In our investigational Phase 3 CARES-310 study, the combination was shown to provide the highest reported median overall survival of any currently available uHCC treatment. Elevar’s alliance with Hengrui Pharma is a catalyst for our world-class team as we focus on bringing life-changing products to cancer patients."

Each year, liver cancer is the cause of more than 830,000 deaths worldwide1. HCC is the most common type of liver cancer and typically has a poor prognosis with a lack of treatment options.

With 14 research and development centers built around the world and several subsidiaries established in the U.S., EU, Australia and Japan, Hengrui Pharma is globally focused on innovation and open collaboration. The company has 13 in-house-developed innovative products and two in-licensed innovative products marketed in China, more than 80 proprietary innovative candidates in the R&D stage and nearly 20 under clinical development worldwide.

Hengrui has also demonstrated a clear commitment to HCC patients globally, as its initial efforts in China led to the 2020 approval of rivoceranib, under the name Aitan, as a single agent for a second-line treatment for advanced HCC.

Elevar and Hengrui Pharma first shared results for the CARES-310 study in September 2022 at the annual Congress of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper). The results were also published in The Lancet on July 24, 2023. Camrelizumab plus rivoceranib significantly prolonged overall survival and progression-free survival, and increased overall response rate versus sorafenib, a standard first-line treatment for uHCC.

About Hepatocellular Carcinoma (HCC)
HCC is the most common type of primary liver cancer. It most frequently occurs in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection. HCC typically has a poor prognosis and a lack of treatment options and is therefore a condition with an urgent medical need.

About Camrelizumab
Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the programmed death-1 (PD-1). Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Currently, more than 10 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer, and breast cancer) and treatment settings.

Camrelizumab, under the brand name AiRuiKa, is currently approved for eight indications in China, including monotherapy for the treatment of HCC (second-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma, nasopharyngeal carcinoma in the first-line setting, and uHCC in combination with rivoceranib as a first-line treatment. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021.

About Rivoceranib
Rivoceranib, a small-molecule tyrosine kinase inhibitor (TKI), is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression.

Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Ongoing clinical studies include uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf). Rivoceranib was the first TKI approved in gastric cancer in China (2014). It is also approved in China as a single agent for a second-line treatment for advanced HCC (2020) and in combination with camrelizumab for a first-line treatment for uHCC (2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in uHCC (U.S.).

Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is also approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, Jiangsu Hengrui Pharmaceuticals Company Ltd., (Hengrui Pharma), under the brand name Aitan.