On May 3, 2022 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will present at the Bank of America Securities 2022 Healthcare Conference at 11:20 a.m. Pacific Time (2:20 p.m. Eastern Time) on Tuesday, May 10, 2022 in Las Vegas (Press release, Neurocrine Biosciences, MAY 3, 2022, View Source [SID1234613462]). Kevin Gorman, Chief Executive Officer, and Matt Abernethy, Chief Financial Officer, will present at the conference.

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The live presentation will be webcast and may be accessed on the Company’s website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the events and will be archived for approximately one month.

On May 3, 2022 NanOlogy LLC, a clinical-stage interventional oncology drug company, reported that results from a clinical trial of topical submicron particle paclitaxel (SOR007) in cutaneous metastases of breast cancer (CMOBC) have been published in Breast Cancer Research and Treatment (Press release, NanOlogy, MAY 3, 2022, View Source;utm_medium=rss&utm_campaign=nanology-publishes-results-from-a-phase-1-2-clinical-trial-of-its-topical-investigational-drug-in-the-treatment-of-cutaneous-metastases-of-breast-cancer [SID1234613461]).

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The research article entitled Phase 1/2 Study of Topical Submicron Particle Paclitaxel for Cutaneous Metastases of Breast Cancer presents final safety and response data from the multi-site study (NCT03101358). Clinical investigators included Mario Lacouture, MD (Memorial Sloan Kettering Cancer Center), Julie Lang, MD (formerly USC Norris Comprehensive Cancer Center; currently Cleveland Clinic), and Sant Chawla, MD (Sarcoma Oncology Research Center).

The dose escalation/expansion trial enrolled 23 subjects across the three sites, 21 of whom had CMOBC. Three concentrations of SOR007 were evaluated (0.15%, 1.0%, and 2.0%) applied twice daily for 28 or 56 days. The primary endpoint of the study was safety and tolerability. Secondary endpoints included lesion response, lesion pain reduction, and pharmacokinetic (PK) analysis.

SOR007 was well tolerated at all concentrations allowing the 2.0% concentration to continue to the dose expansion phase of the trial. No confirmed drug-related serious adverse events were recorded, local skin reactions were minor, and systemic absorption of paclitaxel was negligible.

Lesion response was evaluated by dimensional change (RECIST 1.1) with 19 subjects evaluable at 28 days and 8 evaluable at 56 days. At the 28-day and 56-day assessments, overall response rate was 16% (3/19) and 25% (2/8), respectively. Similarly, 15/19 (79%) and 6/8 (75%) were progression free. Some lesion pain reduction was observed in 7/11 (64%) of subjects who reported pain at baseline.

Approximately 168,000 people are living with metastatic breast cancer in the United States and up to a quarter (40,000) may develop cutaneous metastases (BCRF [2021]; Krathen [2003] South Med J). CMOBC are progressive malignant skin lesions that can cause severe local pain, ulceration, disfigurement, discharge, malodor, bleeding, and infection. The negative impact to quality of life for these patients can be devastating.

NanOlogy is considering partnership strategies for further development and commercialization of SOR007, which has therapeutic potential in CMOBC and other dermal cancers.

"Cutaneous metastases are extremely troublesome for the patient and oncologist alike as the lesions are a daily reminder of the underlying metastatic disease and there are few treatment options currently available," said Mario Lacouture, MD, Director, Oncodermatology Program, Memorial Sloan Kettering Cancer Center. "In this Phase 1/2 clinical trial, SOR007 showed promising signs of preventing lesion progression and reducing lesion pain. Further clinical research is warranted to confirm these findings."

In addition to SOR007, NanOlogy clinical programs have advanced tumor-directed investigational drugs in pancreas, lung, bladder, peritoneal, ovarian, and prostate cancers.

The NanOlogy therapeutic platform is based on a proprietary supercritical precipitation technology that converts oncology active ingredients into stable large surface area microparticles of pure drug optimized for tumor-directed therapy and continuous drug release. Taxane particles are covered by composition of matter patents issued in the US (US 9,814,685, US 10,507,195, US 10,993,927, and US 11,123,322) Canada, Europe, Japan, China, Russia, and Australia all valid through June 2036. The topical formulation is covered by formulation and method of treatment patents issued in the US (US 10,449,162, US 10,918,606, US 10,555,898, US 10,842,736, & US 11,191,717) and Japan. The composition and formulation patents form the foundation of an extensive intellectual property portfolio protecting NanOlogy investigational drugs, methods, and technology.

On May 3, 2022 Nordic Nanovector ASA (OSE: NANOV), a clinical-stage biotech company focused on CD37-targeted therapies for haematological cancers and immune diseases, reported the publication of two new research papers highlighting approaches to improve the potential therapeutic effect of its novel CD37-targeting radioimmunoconjugate Humalutin (177Lu-DOTA-NNV003) in B-cell malignancies, such as Non-Hodgkin Lymphoma (NHL) (Press release, Nordic Nanovector, MAY 3, 2022, View Source [SID1234613451]).

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The first publication by the Company’s scientists and its collaborators, published in PLOS One (Ref. 1), reports on the combined effect of Humalutin with olaparib, a member of the class of anticancer therapies known as PARP inhibitors, on NHL cell lines.

In the studies, the combination of Humalutin and olaparib was found to be synergistic or conditionally synergistic leading to cell death in 6 of 7 NHL cell lines (diffuse large B cell lymphoma and mantle cell lymphoma). Where the combination was conditionally synergistic (i.e. both synergistic and antagonistic), the effect was dependent on the concentration of each drug, showing the importance of optimising the parameters for further studies.

Humalutin acts by inducing potentially cytotoxic DNA breaks in the NHL cells, sensitising these cells to olaparib, which prevents the repair of DNA breaks by blocking the activity of DNA repair enzymes poly (ADP ribose) polymerase 1 and 2 (PARP1 and PARP2). Olaparib is approved in the US and most markets globally for BRCA mutated ovarian and breast cancer.

The authors concluded that further in vivo studies evaluating the anti-tumour effect of the combination of radioimmunotherapies, including Humalutin, and PARP inhibition are warranted.

Separately, Nordic Nanovector reports the publication of a paper in the high-impact open access journal Scientific Reports (Ref. 2) on the potential of a non-invasive diagnostic imaging approach to select NHL patients who are more likely to respond to or are at risk for developing CD37-induced haematological toxicities from CD37-targeted radioimmunotherapy.

The imaging approach used a radioimmunoconjugate ([89Zr]Zr-N-sucDf-NNV003) comprising the Company’s proprietary anti-CD37 antibody NNV003 (a component of Humalutin), and zirconium-89, a radioisotope that is well-suited to commonly used positron emission tomography (PET) imaging, to assess CD37-expression, biodistribution and tumour-uptake levels in mice bearing human B cell lymphomas and to predict the possible therapeutic effects of Humalutin in NHL patients.

A good manufacturing practice (GMP)-compliant production process has also been established to enable administration to patients in future studies.

Jostein Dahle, Nordic Nanovector’s Chief Scientific Officer, said: "These two publications add to the growing scientific evidence supporting CD37 as a valuable tumour target both for therapeutic and diagnostic applications in NHL. This evidence provides important validation of our pipeline approach, building on the significant data we have collected from our preclinical and clinical studies with Betalutin and now expanding to our next-generation CD37-targeting radioimmunoconjugate Humalutin. We look forward to continuing to grow our understanding around CD37 and the potential of our emerging pipeline."

References

1. Malenge, M.M. et al. Anti-CD37 radioimmunotherapy with 177Lu-NNV003 synergizes with the PARP inhibitor olaparib in treatment of non-Hodgkin’s lymphoma in vitro. PLOS One (2022): 17(4): e0267543

2. Giesen, D. et al. 89Zr-PET imaging to predict tumor uptake of 177Lu-NNV003 anti-CD37 radioimmunotherapy in mouse models of B cell lymphoma. Sci Rep 12, 6286 (2022). View Source

On May 3, 2022 Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) reported financial results for the quarter ended March 31, 2022 (Press release, Zimmer Holdings, MAY 3, 2022, View Source [SID1234613450]). The Company reported first quarter net sales from continuing operations of $1.663 billion, an increase of 3.9% over the prior year period, and an increase of 6.8% on a constant currency basis. Net earnings from continuing operations for the first quarter were $73.0 million, or $337.4 million on an adjusted1 basis.

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Diluted earnings per share from continuing operations were $0.35 for the first quarter, and adjusted diluted earnings per share from continuing operations were $1.61.

"We are encouraged by the better than expected results seen in Q1, driven by COVID recovery and continued execution by the Zimmer Biomet team. This performance increases our confidence level for 2022 and we are raising and tightening our guidance accordingly," said Bryan Hanson, Chairman, President and CEO of Zimmer Biomet. "Our underlying business remains strong, fueled by innovation in our portfolio and an acceleration of our transformation activities. I continue to be proud of how the Zimmer Biomet team is executing against our mission so that we can serve healthcare providers and their patients while delivering value for shareholders."

1 Reconciliations of these measures to the corresponding U.S. generally accepted accounting principles measures
are included in this press release.

Recent Highlights

Aligned with the ongoing transformation of Zimmer Biomet’s business, key first quarter highlights include:

Successful completion of the spinoff of ZimVie, Zimmer Biomet’s former spine and dental businesses, on March 1, 2022.
Launch of WalkAI, a dynamic artificial intelligence (AI) model designed to predict which patients will have a lower walk speed at 90 days after hip or knee surgery. WalkAI, Zimmer Biomet’s first AI-based solution, adds powerful predictive analytic capabilities to ZBEdge, a suite of integrated smart, digital and robotic technologies purposefully engineered to deliver transformative data-powered clinical insights with the goal of improving patient outcomes.
Receipt of key recognition and awards including: earning a 100 percent rating on the 2022 Human Rights Campaign (HRC) Foundation’s Corporate Equality Index, a globally recognized, national benchmarking survey on corporate policies, practices and benefits pertinent to LGBTQ+ workplace equity; ranking among the top 500 companies on Forbes’ list of America’s Best Large Employers for 2022; and inclusion in Fast Company’s list of Most Innovative Robotics Companies in 2022 for ROSA Robotics, a multi-application platform that utilizes Zimmer Biomet’s leading implants and data technologies to redefine robotics by providing real-time insights to optimize patient outcomes.
ZimVie Spinoff Transaction

The Company completed the spinoff of ZimVie Inc. (ZimVie) on March 1, 2022. The historical results of the spine and dental businesses that were contributed to ZimVie in the spinoff are excluded from net sales and expenses and reflected as discontinued operations in the Company’s Condensed Consolidated Statements of Earnings for the periods presented in this release. The financial information presented in this release reflects the Company’s results on a continuing operations basis, and prior periods have been recast to conform to this presentation.

Geographic and Product Category Sales

In the three-month period ended March 31, 2022, the Company updated its geographic sales reporting. Geographic results now are presented by a United States geography and an International geography. Previously, net sales were reported by three geographies: Americas, EMEA, and Asia Pacific.

Prior period net sales have been reclassified to the current presentation, including reclassification of net sales related to the spine and dental businesses to discontinued operations.

Please see the attached schedules accompanying this press release for additional details on performance in the quarter, including net sales by Zimmer Biomet’s two geographies and four product categories.

The following sales table provides results by geography and product category for the three-month period ended March 31, 2022, as well as the percentage change compared to the prior year period, on both a reported basis and a constant currency basis.

Financial Guidance

The Company is updating its full-year 2022 financial guidance to raise and tighten its previous projected ranges for revenue growth, foreign currency exchange impact and adjusted diluted EPS from continuing operations:

Conference Call

The Company will conduct its first quarter investor conference call today, May 3, 2022, at 8:30 a.m. ET. The audio webcast can be accessed via Zimmer Biomet’s Investor Relations website at https://investor.zimmerbiomet.com. It will be archived for replay following the conference call.

On May 3, 2022 Byondis B.V., an independent, Dutch clinical stage biopharmaceutical company creating precision medicines, reported that it has entered into a License and Collaboration Agreement and a Supply Agreement with medac GmbH, a privately owned pharmaceutical company based in Germany (Press release, Byondis, MAY 3, 2022, View Source [SID1234613449]). Byondis and medac will partner to commercialize Byondis’ lead program, anti-HER2 antibody-drug conjugate (ADC) trastuzumab duocarmazine (SYD985), pending approval by the European Medicines Agency (EMA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA), as well as other regulatory authorities in Europe.

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Under the terms of the agreement, medac receives an exclusive license to commercialize SYD985 in the EU, the UK and further European countries, in all approved indications. Byondis will receive an undisclosed upfront payment and sales royalties. Byondis will also be eligible for payments upon achievement of certain development and sales milestones.

"This collaboration with medac on SYD985 is a crucial step in ensuring that the therapy, once approved, is available to patients, who desperately need other treatment options," said Byondis Founder and Chairman Jacques Lemmens, Ph.D.

"Like Byondis, medac is committed to developing novel therapies, especially in areas of unmet medical need. We believe in the potential of Byondis and SYD985 and look forward to bringing this next generation ADC to patients who need it," said medac Managing Director, CEO Jörg Hans.

Byondis CEO Marco Timmers, Ph.D. added: "We are pleased to have found in medac a true partner who shares our passion for innovation and making a difference in the lives of patients."

SYD985 targets a range of HER2-expressing cancers such as metastatic breast and endometrial (uterine) tumors. Data from the SYD985 pivotal Phase III TULIP study (SYD985.002) in HER2-positive unresectable locally advanced or metastatic breast cancer showed statistically significant progression-free survival (PFS) results compared to physician’s choice (PC) treatment. TULIP continues to study overall survival and a Marketing Authorization Application (MAA) for this initial clinical indication will soon be submitted to the EMA. The ADC is also in a Phase II multiregional clinical trial to evaluate its safety and efficacy in patients with HER2-expressing recurrent, advanced or metastatic endometrial cancer (SYD985.003).

About trastuzumab duocarmazine (SYD985), a Next Generation Antibody-Drug Conjugate
Trastuzumab duocarmazine (SYD985) incorporates Byondis’ distinctive, proprietary duocarmazine linker-drug (LD) technology ByonZine. The ADC is comprised of the anti-HER2 monoclonal antibody trastuzumab, and a cleavable linker-drug called valine-citrulline-seco-DUocarmycin-hydroxyBenzamide-Azaindole (vc-seco-DUBA).

The antibody part of trastuzumab duocarmazine binds to HER2 on the surface of the cancer cell and the ADC is internalized by the cell. After proteolytic cleavage of the linker, the inactive cytotoxin is activated and DNA damage is induced, resulting in tumor cell death. SYD985 is considered a form of targeted chemotherapy.