Monopar Announces Filing of Patent Protecting MNPR-101 Radiopharma Optimization Findings

On April 16, 2024 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for cancer patients, reported that it has filed a provisional patent application pertaining to the recent advancements and optimizations Monopar has achieved with its MNPR-101 radiopharmaceutical program (Press release, Monopar Therapeutics, APR 16, 2024, View Source [SID1234642097]).

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 provisional patent titled "Antibody Radioisotope Constructs" that was filed with the United States Patent and Trademark Office (USPTO) outlines the MNPR-101-Zr construct, including variations on the radioisotopes, linkers, and antibody which could enhance the clinical profile of the construct, including properties such as its stability and biodistribution. It also covers the formulations and uses of MNPR-101-Zr, a zirconium-89 imaging radioisotope labeled version of MNPR-101, Monopar’s proprietary first-in-class humanized monoclonal antibody that is highly-selective against the urokinase plasminogen activator receptor (uPAR).

Monopar expects this provisional patent application to further strengthen its intellectual property around the MNPR-101 radiopharma program, under which the Company is aiming to develop therapies for numerous hard-to-treat advanced cancers that express uPAR. Monopar recently announced the initiation of its Phase 1 dosimetry clinical trial for MNPR-101-Zr in patients with advanced cancers.

"Filing of this provisional patent application is aimed at further protecting our novel MNPR-101 radiopharmaceutical program," said Chandler Robinson, MD, Monopar’s Chief Executive Officer. "This patent filing along with our earlier patent filings helps to create a broad portfolio of intellectual property around this program and potential future programs."

Johnson & Johnson Reports Q1 2024 Results

On April 16, 2024 Johnson & Johnson (NYSE: JNJ) reported results for first-quarter 2024. "Johnson & Johnson’s solid first quarter performance reflects our sharpened focus and the progress in our portfolio and pipeline," said Joaquin Duato, Chairman and Chief Executive Officer (Press release, Johnson & Johnson, APR 16, 2024, View Source [SID1234642096]). "Our impact across the full spectrum of healthcare is unique in our industry, and the milestones achieved this quarter reinforce our position as an innovation powerhouse."

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!

Unless otherwise noted, the financial results and earnings guidance included below reflect the continuing operations of Johnson & Johnson.

Overall Financial Results
a1q24overallresultsv2.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
4 Excludes intangible amortization expense and special items
5 Excludes COVID-19 Vaccine
6 Basic shares are used to calculate loss per share in the first quarter of 2023 as use of diluted shares when in a loss position would be anti-dilutive
Note: values may have been rounded

Regional Sales Results
a1q24regionalsalesresultsv2.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
a1q24segmentsalesperforman.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

First Quarter 2024 Segment Commentary:
Operational sales* reflected below excludes the impact of translational currency. Adjusted operational sales* reflected below excludes the net impact of acquisitions and divestitures and translational currency.

Innovative Medicine
Innovative Medicine worldwide operational sales, excluding the COVID-19 Vaccine, grew 8.3%*. Growth was driven by DARZALEX (daratumumab), ERLEADA (apalutamide), CARVYKTI (ciltacabtagene autoleucel), TECVAYLI (teclistamab-cqyv) and Other Oncology in Oncology, UPTRAVI (selexipag) and OPSUMIT (macitentan) in Pulmonary Hypertension, TREMFYA (guselkumab) in Immunology, and SPRAVATO (esketamine) in Neuroscience. Including the COVID-19 Vaccine, Innovative Medicine worldwide operational sales grew 2.5%*.

MedTech
MedTech worldwide operational sales grew 6.3%* driven primarily by electrophysiology products and Abiomed in Cardiovascular, previously referred to as Interventional Solutions, and wound closure products in General Surgery.

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 Innovative Medicine News Center, MedTech News & Events, www.factsabouttalc.com, and www.LLTManagementInformation.com.

Regulatory
CARVYKTI is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received At Least One Prior Line of Therapy1
Press Release
Johnson & Johnson’s nipocalimab granted U.S. FDA Fast Track designation to reduce the risk of fetal neonatal alloimmune thrombocytopenia (FNAIT) in alloimmunized pregnant adults Press Release
Biosense Webster Submits Application to U.S. FDA Seeking Approval of the VARIPULSE Platform for the Treatment of Paroxysmal Atrial Fibrillation Press Release
U.S. FDA Approves OPSYNVI (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH) Press Release
U.S. FDA Oncologic Drugs Advisory Committee recommends CARVYKTI (ciltacabtagene autoleucel) for the earlier treatment of patients with relapsed or refractory multiple myeloma Press Release
Johnson & Johnson submits supplemental Biologics License Application to U.S. FDA seeking approval of TREMFYA (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis Press Release
Johnson & Johnson submits application to the European Medicines Agency for DARZALEX (daratumumab)-based quadruplet therapy for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma Press Release
RYBREVANT (amivantamab-vmjw) in Combination With Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations Press Release
Janssen Receives Positive CHMP Opinion for CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for Treatment in Earlier Lines of Relapsed and Refractory Multiple Myeloma Press Release
TECVAYLI (teclistamab-cqyv) biweekly dosing approved by the U.S. FDA for the treatment of patients with relapsed or refractory multiple myeloma Press Release
Johnson & Johnson’s nipocalimab granted U.S. FDA Breakthrough Therapy Designation for the treatment of individuals at high risk for severe hemolytic disease of the fetus and newborn (HDFN) Press Release
Johnson & Johnson submits supplemental Biologics License Application to U.S. FDA seeking approval of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) based regimen for the treatment of patients with transplant-eligible, newly diagnosed multiple myeloma Press Release
Data Release
Unique molecular properties of nipocalimab enabling differentiated potential in treating generalized myasthenia gravis to be presented at American Academy of Neurology’s 2024 Annual Meeting1
Press Release
Johnson & Johnson to Showcase its Broad Scientific Leadership and Latest Innovations to Combat Cardiovascular Disease at ACC.241
Press Release
RYBREVANT (amivantamab-vmjw) data at ELCC advance Johnson & Johnson’s ambition to transform the standard of care for patients with EGFR-mutated non-small cell lung cancer Press Release
New data shows JNJ-2113, the first and only investigational targeted oral peptide, maintained skin clearance in moderate-to-severe plaque psoriasis through one year Press Release
Investigational targeted oral peptide JNJ-2113 demonstrated positive results in moderate-to-severe plaque psoriasis in Phase 2b study published in New England Journal of Medicine Press Release
Johnson & Johnson reports positive topline results for Nipocalimab from a Phase 3 pivotal study in generalized myasthenia gravis (gMG) and a Phase 2 study in Sjögren’s Disease (SjD) Press Release
Johnson & Johnson Highlights Ambition to Transform the Treatment of Prostate Cancer and Bladder Cancer through Data Presentations at ASCO (Free ASCO Whitepaper) GU Press Release
Product Launch Biosense Webster Announces CE Mark approval in Europe for VARIPULSE Pulsed Field Ablation (PFA) Platform Press Release
Other
Johnson & Johnson to Acquire Shockwave Medical1
Press Release
Johnson & Johnson Completes Acquisition of Ambrx Press Release

1 Subsequent to the quarter

Full-Year 2024 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.

($ in Billions, except EPS)
April 2024
January 2024
Adjusted Operational Sales1,2,5
Change vs. Prior Year / Mid-point
5.5% – 6.0% / 5.8% 5.0% – 6.0% / 5.5%
Operational Sales2,5/ Mid-point
Change vs. Prior Year / Mid-point
$88.7B – $89.1B / $88.0B
5.5% – 6.0% / 5.8% $88.2B – $89.0B / $88.6B
5.0% – 6.0% / 5.5%
Estimated Reported Sales3,5/ Mid-point
Change vs. Prior Year / Mid-point
$88.0B – $88.4B / $88.2B
4.7% – 5.2% / 5.0% $87.8B – $88.6B / $88.2B
4.5% – 5.5% / 5.0%
Adjusted Operational EPS (Diluted)2,4/ Mid-point
Change vs. Prior Year / Mid-point
$10.60 – $10.75 / $10.68
6.9% – 8.4% / 7.7%
$10.55 – $10.75 / $10.65
6.4% – 8.4% / 7.4%
Adjusted EPS (Diluted)3,4 / Mid-point
Change vs. Prior Year / Mid-point
$10.57 – $10.72 / $10.65
6.6% – 8.1% / 7.4%
$10.55 – $10.75 / $10.65
6.4% – 8.4% / 7.4%

1 Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures
2 Non-GAAP financial measure; excludes the impact of translational currency
3 Calculated using Euro Average Rate: April 2024 = $1.08 and January 2024 = $1.09 (Illustrative purposes only)
4 Non-GAAP financial measure; excludes intangible amortization expense and special items
5 Excludes COVID-19 Vaccine
Note: percentages may have been rounded

Other modeling considerations will be provided on the webcast.

Webcast Information:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investor Relations section of the company’s website at events-and-presentations.

ISA Pharmaceuticals to present at the ASCO Annual Meeting 2024

On April 16, 2024 ISA reported acceptance of its ISA101b study abstract as an oral presentation at the upcoming 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting (Press release, ISA Pharmaceuticals, APR 16, 2024, View Source [SID1234642095]). This abstract describes results of a randomized trial in advanced head and neck cancer with its lead therapeutic vaccine ISA101b. These results provide key insights in the clinical application of cancer vaccines.

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!

ISA101b is a cancer vaccine that targets human papillomavirus type 16 (HPV16) positive cancers. It induces strong and specific T-cell immune responses to the HPV16 virus, and (re-)establishes a powerful and targeted T-cell immune response against infected and/or cancerous cells and tissues. ISA Pharmaceuticals sees a clear path forward and is looking to partner ISA101b for Phase 3 clinical development.

Head-and-neck cancer can be a severe and life-threatening disease. HPV16 is a major cause of head-and-neck cancer. Recurrent and metastatic HPV16 positive OPC is a form of head-and-neck cancer with a high unmet medical need. In September 2021 ISA101b was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of recurrent and metastatic HPV16 positive OPC.

IN8bio to Present at Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference

On April 16, 2024 IN8bio, Inc. (Nasdaq: INAB) a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported that William Ho, CEO and Co-founder, will present at the Noble Capital Markets’ Emerging Growth Virtual Healthcare Equity Conference on Thursday, April 18th at 12:30pm ET (Press release, In8bio, APR 16, 2024, View Source [SID1234642094]).

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 formal presentation will feature a fireside style Q&A session with questions welcome from the live virtual audience. Attendees interested in viewing the live presentation can register for this event here: Virtual Healthcare Equity Conference Registration.

The IN8bio management team will also be hosting one-on-one meetings during the virtual event with registered, qualified investor attendees. Interested parties should contact their Noble representative to schedule a meeting.

A video webcast of the presentation will be available following the event on the Company’s website View Source, and as part of a complete catalog of presentations available on Channelchek www.channelchek.com, the investor portal created by Noble. The webcast will be archived on the company’s website and on Channelchek.com for 90 days following the event.

Genmab Announces Net Sales of DARZALEX® (daratumumab) for First Quarter of 2024

On April 16, 2024 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 2,692 million in the first quarter of 2024 (Press release, Genmab, APR 16, 2024, View Source [SID1234642093]). Net trade sales were USD 1,464 million in the U.S. and USD 1,228 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!