On February 11, 2020 NorthStar Medical Technologies, LLC (NorthStar), a global innovator in the production and distribution of radioisotopes used for medical imaging, and Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, reported the signing of a Letter of Intent for the commercial supply of copper-67 (Cu-67) as an active pharmaceutical ingredient for Clarity’s pipeline of copper-based radiopharmaceuticals (Press release, Clarity Pharmaceuticals, FEB 11, 2020, View Source [SID1234554164]). Under terms of the agreement, NorthStar will provide Clarity Pharmaceuticals with Cu-67, a beta-emitting radioisotope with potential applications as a targeted radiopharmaceutical for treatment of a range of cancers. NorthStar will be a major U.S. supplier of Cu-67 for Clarity.

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"NorthStar is committed to developing and commercializing innovative technologies for Cu-67 radioisotope production to advance medical research and meet patient needs," said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Technologies. "Clinical development of Cu-67 based radiopharmaceuticals has been limited to date due to lack of stable chelators for Cu-isotopes and limitations in supply. With Clarity Pharmaceuticals’ leading copper chelating technology and product pipeline advancing into a range of theranostic clinical trials that use Cu-64/Cu-67 pairing, industrialization of Cu-67 production is required. NorthStar is addressing this need and advancing towards commercial-scale production. This commercialization process will apply our proven expertise and innovative approach as demonstrated in the successful launch of the RadioGenix System (technetium Tc 99m generator), which provides our customers with reliable domestic Mo-99 supply and is increasingly helping to alleviate supply shortages. We look forward to working with Clarity and supporting its plans for further clinical development and commercialization to improve the lives of patients with serious disease."

"NorthStar is working towards scale-up of Cu-67 production in collaboration with select institutions and laboratories using its electron accelerator technology to produce Cu-67," said James T. Harvey, PhD, Senior Vice President and Chief Science Officer of NorthStar. "We will advance Cu-67 production technology, with the aim to produce high specific activity and high purity Cu-67, eliminate supply shortages and establish commercial production capacity sufficient to meet anticipated future market demands."

"We believe that NorthStar’s proven experience in the development and commercialization of innovative radioisotope technologies will be helpful for us to further advance our research and clinical development efforts," said Alan Taylor, PhD, Executive Chairman of Clarity Pharmaceuticals. "Having access to a reliable and scalable supply of Cu-67 in the United States will enable us to apply our proprietary copper-chelating technology to a range of targeting agents for potential treatment of neuroblastoma, prostate, breast and ovarian cancers. The perfect pairing of Cu-64 and Cu-67 labelled radiopharmaceuticals for diagnosis and therapy has been discussed for many years, but has been hampered by poor chelator technology that leaks copper isotopes in-vivo, and has led to limited demands for Cu-67. We have now overcome this issue, and the use of electron accelerator technology
enables Clarity to be free of reliance on the aging fleet of nuclear reactors which currently produce therapeutic radionuclides. This technology will also increase the speed of Clarity’s clinical trials across our SARTATE, SAR-bisPSMA and SAR-Bombesin programs."

About Copper-67 (Cu-67)
Copper-67 (Cu-67) is a short-range, beta-emitting radioisotope which is attractive for medical purposes due to its ability to carry sufficient radiation energy to cause cell death in targeted cells while having a sufficiently short half-life to limit unwanted radioactivity in patients. Cu-67 is being investigated for therapeutic purposes across a wide range of adult and childhood cancers. Potential radiotherapeutic targets include prostate cancer, breast cancer, neuroendocrine tumors (NETs), neuroblastoma, glioma, lymphoma, ovarian and bladder cancers. In order to develop safe and effective targeted therapies, a chelator, which strongly binds Cu-67 to the targeting agent, is required. Clarity Pharmaceuticals has successfully developed a highly specific and highly stable chelator for copper isotopes and is now progressing a range of radiopharmaceuticals based on its proprietary MeCOSar chelator. NorthStar is developing a proprietary process for commercial-scale production of Cu-67 to meet demand for clinical research and treatment.

On February 11, 2020 Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma" or the "Company"), a diversified biopharmaceutical company primarily focused on the discovery, development and commercialization of organ-selective medicines, reported the pricing of its underwritten public offering of 5,500,000 ordinary shares at a price to the public of $27.00 per share (Press release, Theravance, FEB 11, 2020, View Source [SID1234554182]). The gross proceeds to Theravance Biopharma from the offering are expected to be approximately $148.5 million, before deducting underwriting discounts and commissions and estimated offering expenses. In addition, Theravance Biopharma has granted the underwriters a 30-day option to purchase up to an additional 825,000 ordinary shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close on February 14, 2020, subject to customary closing conditions.

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Morgan Stanley, J.P. Morgan and Cowen are acting as the joint book-running managers for the offering. Credit Suisse, Cantor and Needham & Company are acting as co-managers for the offering.

A shelf registration statement (including a base prospectus) relating to the shares was filed with the SEC and is effective. A preliminary prospectus supplement related to the offering has been filed with the SEC and will be available on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 2nd Floor, 180 Varick Street, New York, New York 10014, United States of America, J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by calling 1-866-803-9204, or by email at [email protected]; or Cowen and Company, LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by calling 1-(833) 297-2926, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On February 11, 2020 Fortress Biotech, Inc. (Common Stock: Nasdaq: FBIO) (Preferred Stock: Nasdaq: FBIOP) ("Fortress"), an innovative biopharmaceutical company focused on identifying, in-licensing and developing high-potential marketed and development-stage drugs and drug candidates, reported that it has priced an underwritten public offering of 625,000 shares of its 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock at a price of $20 per share, with expected gross proceeds to Fortress of $12.5 million (Press release, Fortress Biotech, FEB 11, 2020, View Source [SID1234554221]). In addition, Fortress has granted the underwriters a 45-day option to purchase up to 93,750 additional shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about February 14, 2020, subject to customary closing conditions.

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The Benchmark Company, LLC and ThinkEquity, a division of Fordham Financial Management, Inc. are acting as joint bookrunning managers for the offering.

Fortress intends to use the net proceeds from the public offering for its operations, including, but not limited to, general corporate purposes, which may include research and development expenditures, clinical trial expenditures, manufacture and supply of product, and working capital.

The offering is being made by Fortress pursuant to an effective shelf registration statement on Form S-3 (File 333-226089) previously filed with the Securities Exchange Commission ("SEC"). The offering is being made only by means of a written prospectus and related prospectus supplement that form a part of the registration statement. A copy of the final prospectus supplement and accompanying prospectus related to this offering may be obtained from any of the underwriters, including the offices of The Benchmark Company, LLC, Attn: Prospectus Department, 150 E 58th Street, 17th floor, New York, NY 10155, 212-312-6700, Email: [email protected], and the offices of ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673 or by email at [email protected]. You may also obtain these documents for free when they are available by visiting the SEC’s website at www.sec.gov.

On February 11, 2020 Immune Therapeutics, Inc. (OTC Pink: IMUN) ("Immune" "IMUN" or the "Company"), a clinical late stage biopharmaceutical company focused on the development of therapies for the treatment of autoimmune diseases, inflammatory diseases reported an update on the pending 1000 to 1 reverse stock split and name change of Immune Therapeutics (Press release, Immune Therapeutics, FEB 11, 2020, View Source [SID1234554149]).

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Immune Therapeutics originally submitted the reverse and name request for a corporate action to FINRA and paid the applicable fees on November 27, 2019. Since then, the company has responded to FINRA’s requests for further information multiple times, and we continue in our efforts to work diligently and cooperatively with FINRA to process the reverse and name change. Please note that the Company has no control of the FINRA approval process and as such the timing of any decisions our not in the Company’s control.

Michael K. Handley, CEO of Immune, said, "We are disappointed in the delay in processing the reverse and name change and remain fully committed to the restructuring and success of IMUN. I would personally like to thank all of our shareholders for their patience in this process. We realize this delay has eroded share value, and confidence however, based on the extensive review by FINRA, we are optimistic that their approval could be given soon, at which time we will certainly inform shareholders immediately. Immune would like to thank our shareholders for standing behind us, as we continue to work in your interests with a commitment to the reverse and merger with Aletheia as soon as possible."

On February 11, 2020 Incyte (Nasdaq:INCY) reported that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the New Drug Application (NDA) for capmatinib, an investigational, selective MET inhibitor, as a treatment for first-line and previously treated patients with locally advanced or metastatic MET exon 14 skipping (METex14) mutated non-small cell lung cancer (NSCLC) (Press release, Incyte, FEB 11, 2020, View Source [SID1234554166]). If approved, capmatinib will be the first therapy to specifically target METex14 mutated advanced lung cancer, a type of lung cancer with a particularly poor prognosis2,3.

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There are currently no approved therapies that specifically target METex14 mutated advanced NSCLC. NSCLC accounts for approximately 85% of lung cancer diagnoses4. METex14 mutations occur in 3-4% of newly-diagnosed advanced NSCLC cases5 and is a recognized oncogenic driver6,7.

"Patients with METex14 mutated advanced NSCLC, an aggressive form of the disease, often face a poor prognosis due to lack of available treatment options," said Steven Stein, M.D., Chief Medical Officer, Incyte. "We are pleased the FDA has accepted the NDA for capmatinib for Priority Review – a critical step toward providing the first METex14 mutation targeted therapy to this subset of lung cancer patients."

The FDA grants Priority Review to medicines that may offer a major advance in treatment where none currently exists. This designation shortens the FDA review period following the acceptance of the NDA to six months compared to 10 months for Standard Review. Capmatinib was previously granted Breakthrough Therapy designation by the FDA.

The NDA submission for capmatinib was supported by results from the Novartis-sponsored GEOMETRY mono-1 Phase 2 study, which demonstrated overall response rates of 67.9% (95% CI, 47.6 – 84.1)1 and 40.6% (95% CI, 28.9–53.1)1 among treatment-naïve and previously treated patients, respectively, based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.1. The study also demonstrated that capmatinib provided durable responses among all patients: median duration of response was 11.14 months (95% CI, 5.55 – NE) in treatment-naïve patients and 9.72 months (95% CI, 5.55 – 12.98) in previously treated patients1.

All results were based on independent assessment by the BIRC, and all tumor CT scans were evaluated in parallel by two radiologists to confirm the response1. The most common treatment-related adverse events (AE) (≥ 10% all grades) across all cohorts (N=334), were peripheral edema (42%), nausea (33%), creatinine increase (20%), vomiting (19%), fatigue (14%), decreased appetite (13%) and diarrhea (11%). The majority of the AEs were grades 1/21.

About GEOMETRY mono-1

The Novartis-sponsored GEOMETRY mono-1 trial is an international, prospective, multi-cohort, non-randomized, open-label Phase 2 study to evaluate the efficacy and safety of single-agent capmatinib in adult patients with EGFR wildtype, ALK-negative rearrangement, advanced NSCLC harboring a MET amplification and/or mutation. Patients with locally advanced or metastatic NSCLC harboring a MET exon-14 skipping mutation (centrally confirmed) were assigned to Cohorts 4 (previously treated patients) or 5B (treatment-naïve), regardless of MET amplification/gene copy number and received 400 mg capmatinib tablets orally twice daily. The primary endpoint was ORR based on BIRC assessment per RECIST v1.1. The key secondary endpoint was DOR by BIRC.

About Capmatinib

Capmatinib (INC280) is an investigational, oral and selective MET inhibitor discovered by Incyte and licensed to Novartis in 2009. Under the terms of the Agreement, Incyte granted Novartis exclusive worldwide development and commercialization rights to capmatinib and certain back-up compounds in all indications. If capmatinib is successfully developed by Novartis, Incyte may become eligible for over $500 million in future milestones as well as royalties of between 12 and 14 percent on global sales by Novartis.