On May 3, 2022 Enveric Biosciences Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, reported that its Board of Directors declared a dividend of one one-thousandth of a share of newly-designated Series C Preferred Stock, par value $0.01 per share, for each outstanding share of Enveric common stock held of record as of 5:00 p.m. Eastern Time on May 13, 2022 (Press release, Enveric Biosciences, MAY 3, 2022, View Source [SID1234613464]). The outstanding shares of Series C Preferred Stock will vote together with the outstanding shares of the Company’s common stock, as a single class, exclusively with respect to a proposal to increase the number of authorized shares of the Company’s common stock, a proposal giving the Board of Directors the authority, as it determines appropriate, to implement a reverse stock split within twelve months following the approval of such proposal by the Company’s stockholders, as well as any proposal to adjourn any meeting of stockholders called for the purpose of voting on the foregoing matters, and will not be entitled to vote on any other matter, except to the extent required under the Delaware General Corporation Law. Subject to certain limitations, each outstanding share of Series C Preferred Stock will have 1,000,000 votes per share (or 1,000 votes per one one-thousandth of a share of Series C Preferred Stock).

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All shares of Series C Preferred Stock that are not present in person or by proxy at the meeting of stockholders held to vote on the above described proposals as of immediately prior to the opening of the polls at such meeting will automatically be redeemed by the Company. Any outstanding shares of Series C Preferred Stock that have not been so redeemed will be redeemed if such redemption is ordered by Enveric’s Board of Directors or automatically upon the approval by Enveric’s stockholders of the above described proposals.

The Series C Preferred Stock will be uncertificated, and no shares of Series C Preferred Stock will be transferable by any holder thereof except in connection with a transfer by such holder of any shares of the Company’s common stock held by such holder. In that case, a number of one one-thousandths of a share of Series C Preferred Stock equal to the number of shares of Enveric’s common stock to be transferred by such holder would be transferred to the transferee of such shares of common stock.

Further details regarding the Series C Preferred Stock will be contained in a report on Form 8-K to be filed by Enveric with the Securities and Exchange Commission.

On May 3, 2022 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultra-rare genetic diseases, reported that Camille Bedrosian, M.D., the company’s Chief Medical Officer, and Mardi Dier, the company’s Chief Financial Officer, will present at the BofA Securities 2022 Healthcare Conference on Tuesday, May 10, 2022 at 5:40 PM ET (Press release, Ultragenyx Pharmaceutical, MAY 3, 2022, View Source [SID1234613463]).

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The live and archived webcast of the presentation will be accessible from the company’s website at View Source The replay of the webcast will be available for 90 days.

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