On July 13, 2021 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the company will host a webcast on Tuesday, July 20, 2021 at 4:30 p.m. ET / 9:30 p.m. IST to provide an update on Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn), which was approved by the U.S. Food and Drug Administration (FDA) on June 30, 2021 (Press release, Jazz Pharmaceuticals, JUL 13, 2021, View Source [SID1234584827]).

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Jazz senior management will be joined by Dr. Luke Maese, associate professor of pediatrics, University of Utah – Huntsman Cancer Institute, Primary Children’s Hospital, to discuss the Rylaze FDA approval, commercial launch and an overview of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) and the need for recombinant, non-E. coli derived asparaginase treatments.

About Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn)
Rylaze, also known as JZP458, is approved in the U.S. for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) in pediatric and adult patients one month and older who have developed hypersensitivity to E. coli-derived asparaginase. Rylaze has orphan drug designation for the treatment of ALL/LBL in the United States. Rylaze is a recombinant erwinia asparaginase that uses a novel Pseudomonas fluorescens expression platform. JZP458 was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) in October 2019 for the treatment of this patient population. Rylaze was approved as part of the Real-Time Oncology Review program, an initiative of the FDA’s Oncology Center of Excellence designed for efficient delivery of safe and effective cancer treatments to patients.

The full U.S. Prescribing Information for Rylaze is available at: <View Source>

Important Safety Information

RYLAZE should not be given to people who have had:

Serious allergic reactions to RYLAZE
Serious swelling of the pancreas (stomach pain), serious blood clots, or serious bleeding during previous asparaginase treatment
RYLAZE may cause serious side effects, including:

Allergic reactions (a feeling of tightness in your throat, unusual swelling/redness in your throat and/or tongue, or trouble breathing), some of which may be life-threatening
Swelling of the pancreas (stomach pain)
Blood clots (may have a headache or pain in leg, arm, or chest)
Bleeding
Liver problems
Contact your doctor immediately if any of these side effects occur.

Some of the most common side effects with RYLAZE include: liver problems, nausea, bone and muscle pain, tiredness, infection, headache, fever, allergic reactions, fever with low white blood cell count, decreased appetite, mouth swelling (sometimes with sores), bleeding, and too much sugar in the blood.

RYLAZE can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Females of reproductive potential should use effective contraception (other than oral contraceptives) during treatment and for 3 months following the final dose. Do not breastfeed while receiving RYLAZE and for 1 week after the final dose.

On July 8, 2021 (the "Amendment Effective Date"), Navidea Biopharmaceuticals, Inc. (the "Company") reported that it entered into an Amendment to Stock Purchase Agreement and Letter of Investment Intent (the "Amendment") with Keystone Capital Partners, LLC ("Investor") pursuant to which Investor agreed to purchase 22,077 shares of Series D Redeemable Convertible Preferred Stock ("Series D Preferred Stock") on or before July 9, 2021 at 5 p.m. Eastern Time for an aggregate purchase price of $2,207,700 (Filing, 8-K, Navidea Biopharmaceuticals, JUL 13, 2021, View Source [SID1234584812]). The Amendment amends that certain Stock Purchase Agreement and Letter of Investment Intent (the "Purchase Agreement") dated August 31, 2020 between the parties, pursuant to which Investor agreed to purchase 150,000 shares of Series D Preferred Stock for an aggregate purchase price of $15,000,000 before the end of the nine-month period following the date when the Company’s registration statement on Form S-1 filed pursuant to the Purchase Agreement was declared effective. Prior to the Amendment Effective Date, Investor had purchased 72,500 shares of Series D Preferred Stock pursuant to the Purchase Agreement, leaving a remaining balance of 77,500 shares of Series D Preferred Stock. After purchasing 22,077 of the remaining shares, Investor has no further right or obligation to purchase shares of Series D Preferred Stock pursuant to the Purchase Agreement. The Amendment also contains a customary mutual release provision.

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On July 13, 2021 Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, reported that it has signed a development agreement with JOS Pharmaceuticals, a clinical stage biopharmaceutical company focusing on anesthesiology (Press release, Catalent, JUL 13, 2021, https://www.catalent.com/catalent-news/catalent-signs-agreement-with-jos-pharmaceuticals-to-develop-fast-dissolve-zydis-formulation-for-cannabidiol-as-an-anesthesia-premedication/ [SID1234584828]). Under the agreement, Catalent will undertake a feasibility study for the potential development of a licensed cannabidiol (CBD) product for use as an anesthetic premedication using Catalent’s proprietary Zydis orally disintegrating tablet (ODT) technology.

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Zydis technology creates a freeze-dried tablet that disperses almost instantly in the mouth without water, and is recognized as one of the world’s best-performing ODTs. In the feasibility study, scientists at Catalent’s facility in Swindon, U.K., will focus on establishing proof of concept and prototype development of a Zydis formulation of a highly purified, naturally derived CBD. JOS Pharmaceuticals extracts CBD from certified hemp and is developing its se•d8 prescription CBD wafer for awake sedation anesthesia administered for cataract surgery, as well as anxiolysis during magnetic resonance imaging (MRI) procedures.

"Our clinical trial product is specifically designed to provide rapid and reliable relaxation for the patient, while still allowing for awake cooperation during the procedure. It would be paradigm changing to replace the DEA controlled drugs used currently as premedication with a safe and effective botanical," said Stephen D. Ochs, M.D., Chief Executive Officer of JOS Pharmaceuticals.

"Zydis is an ideal dose form for the delivery of drugs, as it offers an easy and convenient route of administration for patients that can also assist in the rapid onset of effects," said Jonathan Arnold, President of Oral and Specialty Delivery at Catalent. "CBD derived from hemp is a rapidly evolving market, and our team in Swindon is looking forward to applying its experience and expertise in product development to this licensed program."

Catalent’s 250,000-square foot site in Swindon, U.K. houses the company’s Zydis development and manufacturing operation, which produces more than one billion ODTs annually.

On July 13, 2021 Nurix Therapeutics Inc. (Nasdaq: NRIX), a biopharmaceutical company developing targeted protein modulation drugs, reported financial results for the second quarter ended May 31, 2021 and provided a corporate update (Press release, Nurix Therapeutics, JUL 13, 2021, View Source [SID1234584813]).

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"Our first clinical trial to evaluate NX-2127, an orally bioavailable degrader of Bruton’s tyrosine kinase with immunomodulatory drug activity in patients with relapsed or refractory B-cell malignancies is actively recruiting, and we anticipate sharing preliminary data from the dose escalation by year-end 2021," said Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix. "The second half of 2021 promises to be an exciting time for Nurix as we prepare to deliver on our ambitious goal of initiating Phase 1 trials for three additional wholly owned and internally developed drug candidates."

Recent Business Highlights

Expanded the Leadership Team with the Addition of a Chief Operating Officer: Nurix announced the appointment of Stefani A. Wolff as chief operating officer and executive vice president of product development. Ms. Wolff brings to Nurix over 30 years of leadership experience in oncology and immunology most recently from Principia Biopharma Inc., where she served as chief development officer and formerly senior vice president of strategy and operations overseeing Principia’s portfolio including Bruton’s tyrosine kinase (BTK) targeted agents.
Strengthened the Board of Directors with a Highly Successful Biotechnology Executive: Nurix announced the appointment of Clay Siegall, Ph.D., president, chief executive officer and chairman of Seagen (formerly Seattle Genetics, Inc.), to its board of directors. Dr. Siegall is an industry leader with a remarkable track record of success in building Seagen from a drug discovery platform company to a commercial-stage oncology company with multiple products. Dr. Siegall co-founded Seagen in 1998, which today has three FDA-approved medicines and is an industry leader in antibody-drug conjugate technology and development.
Presented Preclinical Data Highlighting Activity of NX-5948 in Animal Models of Autoimmune Disease: Nurix presented preclinical data for NX-5948 at the European Alliance of Associations for Rheumatology (EULAR) 2021 Virtual Congress in June 2021. The data presented at the EULAR Congress demonstrate that NX-5948 is a highly selective and potent degrader of BTK in primary human B cells resulting in robust inhibition of B cell activation. Importantly, data obtained from a mouse model of collagen-induced arthritis (CIA) demonstrated that in mice treated with NX-5948, symptoms of arthritis improved, with a significant reduction in arthritis clinical score, superior disease-related symptom control relative to ibrutinib, and similar activity to that of dexamethasone. A copy of the poster can be found on Nurix’s website.
Upcoming Program Highlights

NX-2127: Nurix’s lead drug candidate from its protein degradation portfolio, NX-2127, is an orally bioavailable degrader of BTK with immunomodulatory drug (IMiD) activity for the treatment of relapsed or refractory B-cell malignancies. Nurix is actively recruiting patients at multiple clinical sites for a Phase 1 clinical trial of NX-2127. Initial pharmacokinetic (PK) and pharmacodynamic (PD) data from the dose escalation portion of the trial is anticipated by year-end 2021 (expected timing of events here and throughout the press release are based on calendar year quarters). Additional information on the clinical trial can be accessed at ClinicalTrials.gov (NCT04830137).
NX-1607: Nurix’s lead drug candidate from its E3 ligase inhibitor portfolio, NX-1607, is an orally bioavailable inhibitor of CBL-B for immuno-oncology indications. Nurix anticipates initiating a Phase 1 trial for NX-1607 in the second half of 2021.
NX-5948: Nurix’s second drug candidate from its protein degradation portfolio, NX-5948, is an orally bioavailable BTK degrader designed without IMiD activity for certain B-cell malignancies and autoimmune diseases. Nurix anticipates initiating a Phase 1 trial for NX-5948 in patients with hematologic malignancies in the second half of 2021 and is planning for the potential expansion of indications into selected autoimmune diseases in 2022.
DeTIL-0255: Nurix’s lead candidate in its cellular therapy portfolio, DeTIL-0255, is a drug-enhanced adoptive cellular therapy. Nurix anticipates initiating a Phase 1 trial for DeTIL-0255 in the second half of 2021.
Fiscal Second Quarter 2021 Financial Highlights

Collaboration revenue for the three months ended May 31, 2021 was $7.1 million compared to $4.2 million for the three months ended May 31, 2020. The increase was due to the continued scale up of internal resources and external spending for our collaborations with Sanofi and Gilead as compared to the prior period, resulting in a higher percentage of completion and therefore more revenue recognized in the current period.

Research and development expenses for the three months ended May 31, 2021 were $26.0 million compared to $14.1 million for the three months ended May 31, 2020. The increase was primarily related to an increase of $5.3 million in compensation and related personnel costs attributable to an increase in headcount and higher non-cash stock-based compensation expense. There was also an increase of $4.7 million attributable to increases in preclinical development activities and drug discovery research and an increase of $1.1 million in clinical costs due to the start of clinical trial patient enrollment.

General and administrative expenses for the three months ended May 31, 2021 were $7.5 million compared to $3.3 million for the three months ended May 31, 2020. The increase was primarily related to an increase of $3.0 million in compensation related expenses attributable to a higher headcount and higher non-cash stock-based compensation expense. There was also an increase of $1.1 million in consultant and other professional service expenses primarily related to becoming a public company.

Net loss for the three months ended May 31, 2021 was $26.4 million, or ($0.60) per share, compared to net income of $7.6 million for the three months ended May 31, 2020, or $0.00 per share attributable to common shareholders under accounting rules associated with Nurix preferred shares prior to their conversion to common shares on July 28, 2020.

Cash, Cash Equivalents and Investments: As of May 31, 2021, Nurix had cash, cash equivalents and investments of $496.5 million compared to $372.0 million as of November 30, 2020. The increase was primarily attributable to the net proceeds of $150.1 million from Nurix’s follow-on offering in March 2021.

On July 13, 2021 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a biotechnology company pioneering innovative medicines to overcome difficult-to-treat cancers and viral infections, and its collaboration partner, Manhattan BioSolutions (together, the "Partners"), reported that promising new preliminary preclinical results for the COVID-19 vaccine candidate now progressing under joint development by the Partners (Press release, Nascent Biotech, JUL 13, 2021, View Source [SID1234584829]).

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Under a research collaboration agreement signed in 2020, Nascent Biotech and Manhattan BioSolutions partnered to discover and develop a safe and affordable COVID-19 vaccination platform based on modifying licensed BCG vaccine technology originally developed for Tuberculosis ("TB"), but with broader utility in protecting against infection from other types of viruses, some of which may have the potential to cause major outbreaks in humans. The vaccine candidate currently in development is based on genetically engineered BCG bacteria, which have been modified by the addition of SARS-CoV-2 protein fragments. Next-generation vaccine candidates, each representing a different combination of a receptor binding domain ("RBD") fragment of a spike protein ("S") and a conserved nucleocapsid ("N") antigen, have been successfully constructed and validated for the expression of viral protein fragments in the BCG bacteria.

In a preclinical murine model, a single subcutaneous immunization of synthetic BCG-S generated cellular immune responses in BALB/c mice. T-cells from splenocytes isolated from BCG-S-immunized mice showed statistically significant antigen-specific IFN‐γ secretion, according to direct Enzyme-Linked ImmunoSpot ("ELISpot") T-cell analysis.

Based on this promising preliminary data, additional experiments are underway to better understand protective efficacy and other characteristics of the related immune response that follows immunization with the most promising BCG-vectored vaccine candidate demonstrated in mouse models.

Dr. Boris Shor, CEO of Manhattan BioSolutions, commented: "We successfully generated a versatile ‘plug-and-play’ BCG system that allows the expression of a large set of rationally selected SARS-CoV-2 polypeptide fragments previously identified to be immunogenic in a substantial study population. Current vaccine efforts are primarily focused on generation of humoral responses to vaccines. Our BCG-vectored vaccine candidates are designed to generate safe T-cell immunity against SARS-CoV-2, and these initial results are highly encouraging."

Sean Carrick, CEO of Nascent Biotech, added: ‘Published evidence suggests that BCG vaccination is safe and might be associated with a decrease in the incidence of sickness during the COVID-19 pandemic, and lower incidence of extreme fatigue. Through grant funding and additional investments, we are making progress toward building a Viral Infection business platform and providing meaningful treatment for patients. We continue to be excited about our partnership with Manhattan BioSolutions, and we look forward to working together to deliver innovative therapies with the power to improve patient outcomes."