On January 23, 2024 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on next-generation antibody therapeutics, reported the initiation of patient dosing in the Phase 1a/b clinical trial of PMC-309 in patients with advanced or metastatic solid tumors (Press release, PharmAbcine, JAN 23, 2024, View Source [SID1234639435]).

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PMC-309 is an IgG1 monoclonal antibody with specific binding to VISTA in immunosuppressive cells, exhibiting excellent binding affinity at various pH conditions within the tumor microenvironment (TME). By inhibiting VISTA, PMC-309 presents a differentiated mechanism of action contributing to anti-cancer effects through activation of T cells, activation of monocytes, and proliferation of M1 macrophages.

This open-label clinical trial comprises two phases, Phase 1a and Phase 1b. Phase 1a involves PMC-309 monotherapy and combination therapy with KEYTRUDA (pembrolizumab), determining the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). In Phase 1b, safety and tolerability of PMC-309 monotherapy and combination therapy with KEYTRUDA at the RP2D will be evaluated. The clinical trial, spanning four institutions in Australia, aims to enroll a total of 67 patients.

Dr. Jin-San Yoo, President and Chief Executive Officer of PharmAbcine, stated, "This clinical trial aims to assess the human safety of PMC-309 and explore the potential of both monotherapy and combination therapy with KEYTRUDA. We are committed to developing new therapeutic options for cancer patients facing high unmet needs, emphasizing our dedication to advancing oncology treatments."

For more information on the clinical trial, please visit clinicaltrials.gov, identifier NCT 05957081.

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

On January 23, 2024 Harbour BioMed (the "Company", HKEX: 02142) reported that the Company has been granted the clearance of Investigational New Drug (IND) from the Food and Drug Administration (FDA) of the United States to initiate the first-in-human (FIH) clinical trial in the U.S. for bispecific antibody HBM9027 (Press release, Harbour BioMed, JAN 23, 2024, View Source [SID1234639434]). This is a phase I study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of HBM9027 in subjects with advanced solid tumors.

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HBM9027 is generated from Harbour BioMed’s proprietary fully human HBICE platform. It is a novel PD-L1xCD40 bispecific antibody, which is designed to activate CD40 relied on PD-L1 crosslinking for a promising safety profile. PD-L1 is overexpressed on a variety of solid malignancies, and with its crosslinking dependent specificity on tumors and potent immune modulation activity, HBM9027 has shown excellent and promising safety profile with strong anti-tumor efficacy in its pre-clinical studies.

"HBM9027, developed through our proprietary HBICE platform, has demonstrated a promising safety profile and robust anti-tumor efficacy," said Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed. "This achievement highlights the capability of our technology platform in developing novel solutions for advanced solid tumors. We firmly believe that our unweaving commitment to innovation will bring about meaningful advancements in cancer treatment."

About HBM9027

HBM9027 is a novel PD-L1xCD40 bispecific antibody, developed using the HBICE bispecific technology and Harbour Mice Platform. The development of PD-L1xCD40 bispecific HBICE further expands the Company’s bispecific immune cell engager into the cutting-edge DC/myeloid cell engager field and demonstrates HBICE platform’s versatile geometry formats and plug-and-play advantages.

On January 23, 2024 Papyrus Therapeutics Inc., a biotechnology platform company for the development of potent, multi-cancer, tumor suppressor precision therapies for solid cancers, reported that the United States Patent and Trademark Office (USPTO) granted approval of all 20 claims in Papyrus’ submitted Patent (Press release, Papyrus Therapeutics, JAN 23, 2024, View Source;utm_medium=rss&utm_campaign=papyrus-therapeutics-receives-approval-of-new-patent-claims-for-multi-cancer-tumor-suppressor-therapy-platform [SID1234639433]). That the USPTO approved all 20 claims is distinguishing given the infrequency patent grants are awarded without prior art being cited against the claims.

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The nature of the expanded patent recognizes the groundbreaking novelty and potential of Papyrus’ platform’s science, knowledgebase, and AI enablement to streamline the discovery of naturally occurring tumor suppressor proteins like OPCML as therapeutics. Such proteins, when identified as silenced in human cancer, can be restored in those cancers by Papyrus’ recombinant-OPCML (r-OPCML) protein replacement therapy through intravenous delivery. Unlike chemotherapy and other oncogene-focused therapeutics, r-OPCML targets only cancer cells deficient in this protein without damaging healthy cells that normally express it. Further, the data-to-date points to the therapeutic being a well-tolerated and effective treatment.

According to Papyrus’ co-founder / chief scientific officer, and renowned translational medical oncologist Hani Gabra, PhD FRCP, "Preclinical studies of Papyrus’ lead clinical asset PYTX-004, the r-OPCML-Fc fusion tumor suppressor analog, have demonstrated a high degree of tumor suppressor efficacy as a monotherapy and as a combination therapy in ovarian cancer with no adverse toxicities noted thus far. This, in concert with USPTO’s approval of all 20 claims reinforces the transformational potential of the Papyrus tumor suppressor discovery platform to enable a pipeline of novel, cancer-targeted protein-replacement tumor suppressor therapeutics." Similar results for this suppressor replacement therapy have been observed for HER2+ breast cancer and are projected for other cancers, with loss of this tumor suppressor noted in at least half of all human solid cancers.

OPCML, a member of the IgLON family of proteins, is a naturally occurring tumor suppressor protein. PYTX-004 is Papyrus’ r-OPCML-Fc lead tumor suppressor biotherapeutic in development that is outlined in the patent application. The Company expects to have continued success with upcoming patent filings based on unique synthetic alterations of OPCML and other related IgLON family members that will enable the development of a pipeline of pioneering unique synthetic tumor suppressor biotherapeutics with novel specificities for monotherapy and combination therapies in differing indications.

On January 23, 2024 Leap Therapeutics presented its corporate presentation (Presentation, Leap Therapeutics, JAN 23, 2024, View Source [SID1234639432]).

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On January 23, 2024 Johnson & Johnson (NYSE: JNJ) reported results for fourth-quarter and full year 2023. "Johnson & Johnson’s full year 2023 results reflect the breadth and competitiveness of our business and our relentless focus on delivering for patients," said Joaquin Duato, Chairman and Chief Executive Officer (Press release, Johnson & Johnson, JAN 23, 2024, View Source [SID1234639431]). "We have entered 2024 from a position of strength, and I am confident in our ability to lead the next wave of health innovation."

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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
a4q23overallresults.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
Note: values may have been rounded

Regional Sales Results
a4q23regionalsalesresultsv2.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
a4q23segmentsalesperforman.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

Full Year 2023 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 7.2%*. Growth was driven by DARZALEX (daratumumab), ERLEADA (apalutamide), TECVAYLI (teclistamab-cqyv) in Other Oncology, and CARVYKTI (ciltacabtagene autoleucel) in Oncology, STELARA (ustekinumab) and TREMFYA (guselkumab) in Immunology, and SPRAVATO (esketamine) in Neuroscience. Growth was partially offset by ZYTIGA (abiraterone acetate) and IMBRUVICA (ibrutinib) in Oncology, and REMICADE (infliximab) in Immunology. Including the COVID-19 Vaccine, Innovative Medicine worldwide operational sales grew 4.8%*.

MedTech
MedTech worldwide operational sales grew 12.4%*, with the acquisition of Abiomed contributing 4.7%. MedTech worldwide adjusted operational sales grew 7.8%*, driven primarily by electrophysiology products in Interventional Solutions, contact lenses in Vision, wound closure products in General Surgery, and biosurgery in Advanced 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, MedTech, www.factsabouttalc.com, www.factsaboutourprescriptionopioids.com, and www.LLTManagementInformation.com.

Regulatory
U.S. Food and Drug Administration Grants Full Approval for BALVERSA to Treat Locally
Advanced or Metastatic Bladder Cancer with Select Genetic Alterations1
Press Release
Biosense Webster Announces Regulatory Approval of VARIPULSE Pulsed Field Ablation (PFA) Platform in Japan1
Press Release
Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of Lazertinib, in combination with RYBREVANT (amivantamab), for the First-Line Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer Press Release
Johnson & Johnson Submits Supplemental Biologics License Application and New Drug Application to U.S. FDA Seeking Approval of RYBREVANT (amivantamab-vmjw) Plus Lazertinib for the Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) Press Release
Johnson & Johnson’s Investigational TAR-200 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer Press Release
Janssen Submits Application to the European Medicines Agency for RYBREVANT (amivantamab) in Combination with Chemotherapy for the Treatment of Adult Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer After Failure of Prior Therapy Press Release
Janssen Submits Supplemental Biologics License Application to U.S. FDA Seeking Approval of RYBREVANT (amivantamab-vmjw) Plus Chemotherapy for the Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer Who Progressed on or after Osimertinib Press Release
MONARCH Platform for Bronchoscopy Receives Regulatory License for China Press Release
Data Release Johnson & Johnson highlights its preeminent leadership in hematology through differentiated blood cancer portfolio and pipeline with new clinical and real-world data at ASH (Free ASH Whitepaper) Press Release
New Real-World Data Show TREMFYA (guselkumab) Was Associated With Clinically Meaningful Improvements in Patient-Reported Outcomes for Adults Living With Active Psoriatic Arthritis Press Release
Phase 2 Nipocalimab Data Establish Proof of Mechanism in Adults Living with Moderate to Severe Rheumatoid Arthritis, Supporting its Progression into a Combination Study Press Release
New Biosense Webster QDOT MICRO Catheter Data Demonstrate Very High-Power, Short-Duration Ablations Improved Quality of Life and Reduced Healthcare Utilization for AFib Patients Press Release
New Phase 3 TREMFYA (guselkumab) Results in Ulcerative Colitis Show a 77 Percent Overall Clinical Response Rate and Early Symptom Improvement 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) Press Release

Product Launch Ethicon Introduces ETHIZIA Hemostatic Sealing Patch, Clinically Proven to Stop Disruptive Bleeding Press Release
Other
Johnson & Johnson to Acquire Ambrx, Advancing Next Generation Antibody Drug Conjugates to Transform the Treatment of Cancer1
Press Release
Johnson & Johnson Announces Key Drivers for Long-Term Competitive Growth at Enterprise Business Review Press Release
Johnson & Johnson Names Eugene A. Woods, Chief Executive Officer of Advocate Health, to its Board of Directors Press Release
Johnson & Johnson MedTech Acquires Laminar, Inc. Press Release
Johnson & Johnson MedTech Provides Details and Timeline for General Surgery Robot Press Release
Johnson & Johnson Announces Departure of Ashley McEvoy, Tim Schmid Named Executive Vice President, Worldwide Chairman of MedTech 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)
January 2024
December 2023
Adjusted Operational Sales1,2,5
Change vs. Prior Year / Mid-point
5.0% – 6.0% / 5.5%
Operational Sales2,5/ Mid-point
Change vs. Prior Year / Mid-point
$88.2B – $89.0B / $88.6B
5.0% – 6.0% / 5.5% 5.0% – 6.0% / 5.5%
Estimated Reported Sales3,5/ Mid-point
Change vs. Prior Year / Mid-point
$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
$10.55 – $10.75 / $10.65
6.4% – 8.4% / 7.4% $10.55 – $10.75 / $10.65
7.3% Mid-point
Adjusted EPS (Diluted)3,4 / Mid-point
Change vs. Prior Year / Mid-point
$10.55 – $10.75 / $10.65
6.4% – 8.4% / 7.4%
Average Shares Outstanding (Diluted)6
~2,435 million

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: January 2024 = $1.09 and December 2023 = $1.09 (Illustrative purposes only)
4 Non-GAAP financial measure; excludes intangible amortization expense and special items
5 Excludes COVID-19 Vaccine
6 Full Year 2024 Projected Average Shares Outstanding (Diluted) reflects impact from the Kenvue exchange offer
Note: percentages may have been rounded

Other modeling considerations will be provided on the webcast.