NeuBase Therapeutics to Host a Virtual R&D Day on June 8th to Provide Updates on the Drug Development Pipeline Targeting Genetic Diseases

On April 8, 2021 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase" or the "Company"), a biotechnology company accelerating the genetic revolution with a new class of precision genetic medicines, reported that it will host a virtual R&D day for investors and analysts on Tuesday, June 8, 2021, from 12:30 p.m. to 2:30 p.m. EDT (Press release, NeuBase Therapeutics, APR 8, 2021, View Source [SID1234577768]).

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During the event, NeuBase will present new data, along with an in-depth review of the Company’s pipeline of drug candidates – including in Huntington’s disease, myotonic dystrophy type 1, and a new oncology program for a target that has previously been thought of as undruggable – as well as an introduction to the expanded management team.

Additional details will be made available prior to the event. The event will be webcast live on NeuBase’s website at View Source Following the live webcast, a replay will be available on the Company’s website and archived for approximately 90 days.

Secura Bio Announces Enrollment Completion of the COPIKTRA® (duvelisib) Study (PRIMO) in Peripheral T-cell Lymphoma

On April 8, 2021 Secura Bio, Inc. (Secura Bio) – (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, reported that it has completed enrollment, with 101 patients, into the PRIMO study, which is evaluating COPIKTRA for the treatment of patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL) (Press release, Secura Bio, APR 8, 2021, https://www.prnewswire.com/news-releases/secura-bio-announces-enrollment-completion-of-the-copiktra-duvelisib-study-primo-in-peripheral-t-cell-lymphoma-301264723.html [SID1234577765]). The completion of study enrollment is an important milestone in the continued development of COPIKTRA to treat T-cell lymphomas, a disease category for which it is not currently indicated.

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The PRIMO study is a global, multi-center, open-label, parallel cohort registration-directed Phase 2 study. In the dose optimization portion of the study, patients were randomized to receive COPIKTRA 25mg twice daily (cohort 1) or COPIKTRA 75mg twice daily continuously (cohort 2) until disease progression or unacceptable toxicity. Based on the dose optimization results, an expansion group was added in which COPIKTRA was dosed at 75mg twice daily for two cycles, followed by 25mg twice daily, until disease progression or unacceptable toxicity. The primary endpoint in the expansion phase of the study is independent review committee assessed overall response rate (ORR). Secondary endpoints include duration of response (DOR) and safety.

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and gamma pathways, which are involved in the proliferation and sustenance of malignant cells.

"Secura Bio will continue to aggressively support the development of COPIKTRA in the treatment of T-cell malignancies, because these patients often have limited therapeutic options and generally poor outcomes, and because PI3K inhibition appears to be a relevant, safe and promising mechanism of action" said Dr. David Cohan, Chief Medical Officer of Secura Bio.

For the treatment of PTCL, COPIKTRA monotherapy has received Fast Track status and Orphan Drug Designation, and investigations are imminently planned in combination with other proven anti-cancer agents.

"Secura Bio now has two meaningful oncology drugs with novel modes of action that offer the potential to build a broad portfolio of indications in hematologic and solid malignancies. We will also fully explore the combination of COPIKTRA with FARYDAK (panobinostat), Secura Bio’s pan-HDAC inhibitor" said Joseph M. Limber, President and CEO of Secura Bio.

Interim results of the PRIMO study are expected to be published later in 2021.

Ionis prices private placement of convertible senior notes

On April 8, 2021 Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) reported the pricing of $550.0 million aggregate principal amount of 0% Convertible Senior Notes due 2026 (the "notes") in a private placement (the "offering") to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Ionis Pharmaceuticals, APR 8, 2021, View Source [SID1234577764]). The aggregate principal amount of the offering was increased from the previously announced offering size of $500.0 million. Ionis also granted the initial purchasers of the notes an option to purchase, within the 13-day period beginning on, and including, the date on which the notes are first issued, up to an additional $82.5 million aggregate principal amount of notes from Ionis. The sale of the notes is expected to close on April 12, 2021, subject to customary closing conditions.

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The notes will be general unsecured obligations of Ionis, will not bear regular interest and the principal amount of the notes will not accrete. The notes will mature on April 1, 2026, unless earlier converted or repurchased.

Ionis estimates that the net proceeds from the offering will be approximately $536.2 million (or approximately $616.8 million if the initial purchasers exercise their option to purchase additional notes in full), after deducting the initial purchasers’ discounts and commissions and estimated offering expenses payable by Ionis. Ionis expects to use approximately $257.0 million of the net proceeds from the offering to repurchase approximately $247.9 million in aggregate principal amount of its 1% Convertible Senior Notes due 2021 (the "2021 notes") in privately negotiated transactions. In addition, Ionis expects to use approximately $40.8 million of the net proceeds from the offering to pay the cost of the convertible note hedge transactions described below (after such cost is partially offset by the proceeds to Ionis from the sale of the warrant transactions described below). Ionis expects to use the remaining net proceeds from the offering for general corporate purposes, including expansion of manufacturing, research and development, and commercial infrastructure to support its wholly owned pipeline.

Before January 1, 2026, holders will have the right to convert their notes only upon the satisfaction of specified conditions and during certain periods. On or after January 1, 2026 until the close of business on the second scheduled trading day immediately preceding the maturity date, holders may convert all or any portion of their notes at any time. Upon conversion, Ionis will pay or deliver, as the case may be, cash, shares of its common stock or a combination of cash and shares of its common stock, at its election. The conversion rate will initially be 17.2902 shares of Ionis’ common stock per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $57.84 per share of Ionis’ common stock). The initial conversion price represents a premium of approximately 32.5% over the last reported sale price of $43.65 per share of Ionis’ common stock on April 7, 2021. The conversion rate will be subject to adjustment in some events but will not be adjusted for any accrued or unpaid special interest.

Ionis may not redeem the notes prior to the maturity date, and no sinking fund is provided for the notes.

If Ionis undergoes a "fundamental change" (as defined in the indenture for the notes), then, subject to certain conditions and limited exceptions, holders may require Ionis to repurchase for cash all or any portion of their notes at a fundamental change repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid special interest, if any, to, but excluding, the fundamental change repurchase date. In addition, following certain corporate events that occur prior to the maturity date, Ionis will, in certain circumstances, increase the conversion rate for a holder who elects to convert its notes in connection with such a corporate event.

In connection with the pricing of the notes, Ionis entered into convertible note hedge transactions with certain of the initial purchasers or their affiliates and other financial institutions (the "Option Counterparties"). Ionis also entered into warrant transactions with the Option Counterparties. The convertible note hedge transactions are generally expected to reduce potential dilution to Ionis’ common stock upon any conversion of notes and/or offset any cash payments Ionis is required to make in excess of the principal amount of converted notes, as the case may be. However, the warrant transactions would separately have a dilutive effect to the extent that the market price per share of Ionis’ common stock exceeds the strike price of any warrants. The strike price for the warrant transactions will initially be equal to approximately $76.39 per share, which represents a 75.0% premium to the closing sale price of Ionis’ common stock on April 7, 2021. If the initial purchasers exercise their option to purchase additional notes, Ionis expects to enter into additional convertible note hedge transactions and additional warrant transactions relating to the additional notes with the Option Counterparties.

In connection with establishing their initial hedges of the convertible note hedge and warrant transactions, Ionis expects that the Option Counterparties or their respective affiliates will purchase shares of Ionis’ common stock and/or enter into various derivative transactions with respect to Ionis’ common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of Ionis’ common stock or the notes at that time.

In addition, the Option Counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Ionis’ common stock and/or by purchasing or selling Ionis’ common stock or other securities of Ionis in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so during any observation period related to a conversion of notes or in connection with any repurchase of notes by Ionis on any fundamental change repurchase date or otherwise). This activity could also cause or avoid an increase or a decrease in the market price of Ionis’ common stock or the notes, which could affect the ability of noteholders to convert the notes and, to the extent the activity occurs during any observation period related to a conversion of notes, it could affect the amount and value of the consideration that noteholders will receive upon conversion of such notes.

Further, in connection with any repurchases of the 2021 notes, Ionis expects that holders of the 2021 notes who agree to have their 2021 notes repurchased and who have hedged their equity price risk with respect to such notes (the "hedged holders") will unwind all or part of their hedge positions by buying Ionis’ common stock and/or entering into or unwinding various derivative transactions with respect to Ionis’ common stock. The amount of Ionis’ common stock to be purchased by the hedged holders may be substantial in relation to the historic average daily trading volume of Ionis’ common stock. This activity by the hedged holders could increase (or reduce the size of any decrease in) the market price of Ionis’ common stock, including concurrently with the pricing of the notes, resulting in a higher effective conversion price of the notes. Ionis cannot predict the magnitude of such market activity or the overall effect it may have had on the price of the notes in the offering or Ionis’ common stock.

The notes, the warrants and any shares of common stock issuable upon conversion of the notes or exercise of the warrants have not been and will not be registered under the Securities Act, any state securities laws or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any of these securities nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification thereof under the securities laws of any such state or jurisdiction.

GT Biopharma Announces Enrollment Of Patient 10 in GTB-3550 TriKE™ Phase I/II Clinical Trial

On April 8, 2021 GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary NK cell engager (TriKE) protein biologic technology platform, reported the enrollment of Patient 10 in its GTB-3550 TriKE first-in-human Phase I/II clinical trial for the treatment of high-risk myelodysplastic syndromes (MDS) and refractory/relapsed acute myeloid leukemia (AML) (Press release, GT Biopharma, APR 8, 2021, View Source [SID1234577763]). Patient 10 will be dosed at 100mcg/kg/day.

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Highlights from the first nine patients treated with GTB-3550 TriKE include:

Up to 63.7% Reduction in Bone Marrow Blast Levels
Restores Patient’s Endogenous NK Cell Function, Proliferation and Immune Surveillance
No Progenitor-derived or Autologous/Allogenic Cell Therapy Required
No Cytokine Release Syndrome Observed
3 out of the Last 5 Patients Treated (25mcg/kg/day to 100mcg/kg/day) Respond
"We are pleased with the continued clinical performance of our lead TriKE product candidate, and in reaching this important patient enrollment milestone," said Anthony J. Cataldo, GT Biopharma’s Chairman and Chief Executive Officer. "The data from the first nine patients treated with GTB-3550 indicates significant bone marrow blast level reductions in AML and MDS patients without the need for expensive progenitor-derived or autologous/allogenic cell therapies."

About High-Risk Myelodysplastic Syndromes
MDS is a rare form of bone marrow-related cancer caused by irregular blood cell production within the bone marrow. As a result of this irregular production, MDS patients do not have sufficient normal red blood cells, white blood cells and/or platelets in circulation. High-risk MDS is associated with poor prognosis, diminished quality of life, and a higher chance of transformation to acute myeloid leukemia. Approximately 40% of patients with High-Risk MDS transform to AML, another aggressive cancer with poor outcomes.

About Acute Myeloid Leukemia
Acute myeloid leukemia is a type of cancer in which the bone marrow makes abnormal myeloblasts (a type of white blood cell), red blood cells, or platelets. According to the National Cancer Institute (NCI), the five-year survival rate is about 35% in people under 60 years old, and 10% in people over 60 years old. Older people whose health is too poor for intensive chemotherapy have a typical survival of five to ten months. AML accounts for roughly 1.8% of cancer deaths in the United States.

About GTB-3550 TriKE
GTB-3550 is the Company’s first TriKE product candidate being initially developed for the treatment of AML and MDS, and other CD33+ hematologic cancers. GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of Interleukin 15 (IL-15). The natural killer (NK) cell-stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill. We intend to study GTB-3550 in CD33 positive leukemias such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies.

About GTB-3550 TriKE Clinical Trial
Patients with CD33+ malignancies (primary induction failure or relapsed AML with failure of one reinduction attempt or high-risk MDS progressed on two lines of therapy) age 18 and older are eligible (NCT03214666). The primary endpoint is to identify the maximum tolerated dose (MTD) of GTB-3550 TriKE. Correlative objectives include the number, phenotype, activation status and function of NK cells and T cells.

Viracta Therapeutics to Present at the 20th Annual Needham Virtual Healthcare Conference

On April 8, 2021 Viracta Therapeutics, Inc. (Viracta or the Company), a precision oncology company targeting virus-associated malignancies, reported that Company management will present at the 20th Annual Needham Virtual Healthcare Conference taking place April 12-15, 2021 (Press release, Viracta Therapeutics, APR 8, 2021, View Source [SID1234577762]). The Company will also participate in one-on-one investor meetings at the conference.

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