On April 16, 2024 Propanc Biopharma, Inc. (OTC Pink: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that a certificate of grant for the Company’s "composition of proenzymes for cancer treatment," patent was received from the European Patent Office (Press release, Propanc, APR 16, 2024, View Source [SID1234642100]). The patent covers lower dosage ratios of the two proenzymes (trypsinogen and chymotrypsinogen) contained in the PRP formulation. This is the fourth European patent granted and after validation in selected countries across Europe, will result in the Company’s IP portfolio growing to 94 patents filed in major global jurisdictions.

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This PRP dosing patent is an important part of the IP portfolio as it covers possible future clinical dosage ranges for PRP as the Company advances into early-stage clinical development. Furthermore, Europe is considered a major global region which accounted for 23.4% of global pharmaceutical sales in 2021, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA). This is a significant percentage when you consider that in 2022, the worldwide pharmaceutical market was valued at approximately $1.48 trillion by Statista.com.

"The PRP dosing patent at lower dosage ratios is an important part of our growing IP portfolio, as we seek to protect our novel invention and create future value for our shareholders," said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. "We look forward to advancing PRP into the clinic, and together with our growing IP portfolio, establishing the Company as a pioneer in the way we treat this killer disease."

About PRP:

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas, administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include pancreatic, ovarian, kidney, breast, brain, prostate, colorectal, lung, liver, uterine, and skin cancers. Orphan Drug Designation status of PRP has been granted from the US Food and Drug Administration (FDA) for treatment of pancreatic cancer.

To view the Company’s "Mechanism of Action" video on the Company’s lead asset, PRP, please click on the following link: View Source

On April 16, 2024 Precision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company, reported the anticipated return of three programs from Prevail Therapeutics Inc., a wholly owned subsidiary of Eli Lilly and Company (Press release, Precision Biosciences, APR 16, 2024, View Source [SID1234642099]). Precision exercised its option to regain rights for the programs following Prevail Therapeutics’ decision to conclude the collaboration. Precision uses its novel proprietary ARCUS platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, insertion, and excision. The collaboration began in January 2021 and was amended in June 2023 to transfer certain preclinical research, manufacturing, and investigational new drug (IND)-enabling activities from Precision BioSciences to Prevail Therapeutics.

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"We enjoyed a productive gene editing collaboration with Prevail Therapeutics and appreciate their contributions to the success of these programs. Together, we advanced three programs from concept toward clinical candidates, and Precision completed its workplan for these programs to the next stage gate, taking us to an important development decision point," said Michael Amoroso, President and Chief Executive Officer of Precision BioSciences. "Our decision to regain control of the programs brings exciting development opportunities to Precision’s pipeline with a focus on benefiting people born with incurable genetic diseases."

"These in vivo gene editing programs are designed to take advantage of unique attributes of ARCUS, namely its cut, size, and simplicity. Our next steps will be to prepare for GLP toxicology studies followed by potential IND and clinical trial application (CTA) submissions," said Jeff Smith, PhD, Co-Founder and Chief Research Officer. "We are excited about the compelling in vivo proof-of-concept data generated for ARCUS gene excision of a "hot spot" region of the dystrophin gene in the DMD program. Additionally, in vivo data for the gene insertion program demonstrated up to 45% high efficiency gene insertion in non-dividing cells of non-human primates measured by total liver tissue. This is important and differentiating proof-of-concept data for ARCUS compared to CRISPR, base editors and prime editors, which have not demonstrated such high levels of gene insertion efficiency in dividing or non-dividing cells in vivo, potentially enabling broader therapeutic applicability for ARCUS."

As a result of the strong proof of concept data generated to date, Precision is exploring opportunities to develop the returned programs independently or in partnership with others. Importantly, the return of these programs does not impact the Company’s near-term clinical priorities in ornithine transcarbamylase (OTC) deficiency, HBV, and PMM or its expected cash runway to achieve these clinical data milestones.

"Turning to our fundamental story, Precision continues to make progress with our wholly owned programs for HBV and PMM as well as through partnerships with Novartis and iECURE. Most recently, iECURE has commenced regulatory and clinical activities in major markets around the world to use the ARCUS platform for gene insertion to address OTC deficiency using an ARCUS nuclease," added Mr. Amoroso.

Precision BioSciences remains focused on its most important near-term priorities and clinical data milestones with several opportunities to validate ARCUS for both wholly owned and the lead partnered program in 2024 and 2025.

The OTC deficiency program partnered with iECURE is the most advanced ARCUS in vivo gene editing program with first-in-human clinical dosing expected to commence in 2024. IND and CTAs have been approved in the United States, United Kingdom, and Australia for the Phase 1/2 OTC-HOPE study.
Following receipt of regulatory guidance in and outside of the United States, Precision’s wholly owned PBGENE-HBV viral elimination program has commenced final IND and CTA enabling studies and is rapidly progressing toward the clinic with submissions planned in 2024.
The PBGENE-PMM mutant mitochondrial DNA elimination program is on track for IND and/or CTA submission in 2025.
The cash received from our recent public offering, upfront and potential near-term cash from cell therapy transactions, along with existing cash and cash equivalents, expected operational receipts, continued fiscal and operating discipline, availability of our at-the-market facility, and available credit, are expected to provide Precision with a cash runway into the second half of 2026. The completion of the collaboration does not impact Precision’s expected cash runway as no milestones from Prevail Therapeutics were assumed in our cash runway through 2026.

Company-Hosted Webcast and Conference Call Information

Precision will host a conference call and webcast on Tuesday, April 16, 2024, at 5:00pm EDT to discuss its in vivo gene editing business. The dial-in conference call number is (800) 715-9871 and the conference ID number for the call is 2110172. Participants may access the live webcast, and accompanying presentation materials, as well as the archived webcast on Precision’s website in the Investors section under Events & Presentations: View Source

On April 16, 2024 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company developing monoclonal antibodies targeting various cancer types, reported that it is embarking on a fresh manufacturing run to ensure Pritumumab ("PTB") supplies are at maximum potency when patient dosing begins in the upcoming Phase II clinical trial (Press release, Nascent Biotech, APR 16, 2024, View Source [SID1234642098]).

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"Taking the time to navigate this opportunity with proper care and diligence is a step that demonstrates our commitment to the best interests of our investors, partners, shareholders, and potential future patients," remarked Sean Carrick, CEO of NBIO. "No one likes delays, but patience and care at this critical stage is necessary in maximizing patient outcomes and long-term shareholder value. We want to be careful not to make hasty decisions while exploring all options.

This announcement comes as the Company prepares for a Phase II trial that follows a very successful Phase I trial-where safety at five ascending dose cohorts was observed-involving 15 patients who received PTB for various types of brain tumors. The most common and most challenging to treat tumor type in the trial was Glioblastoma. 12 of 15 patients had this diagnosis.

There were no dose-related toxicities. Overall, the study found that single agent Pritumumab is safe up to a dose of 16.2 mg/kg every 7 days in brain tumor patients. One partial response showed a 98.0% and 40.8% reduction in 2 tumor lesions for 21 months on study.

Mr. Carrick continued, "Phase I demonstrated an excellent safety profile at various doses. Phase II will be focused on clinical outcomes, and we are taking no shortcuts. We have been in discussions with potential Phase II study sites to ensure patients are being actively recruited and the most efficient process in place once we are ready to begin dosing."

Management anticipates that some research sites will open for the start of Phase II testing late this summer with actual patients involved later in 2024.

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]).

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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."

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."

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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.