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SpagoPix Phase I study to the next dose level and extended to additional centers

On March 23, 2020 SpagoPix reported that Data from the first dose group in the phase I study show that SN132D is well tolerated and provides valuable information for optimizing MR images in the next step (Press release, Spago Nanomedical, MAR 23, 2020, View Source [SID1234555755]). As the study thus continues to the next dose level, Spago has taken steps to increase patient recruitment, including by engaging in another breast cancer center.

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The internal safety committee of the SPAGOPIX-01 clinical trial, after analyzing data from the first six patients, has determined that the initial dose of SN132D is safe. The Committee also notes that the dose should be increased to optimize contrast enhancement in the tumors. The study thus continues with the next group of six patients, after which a new interim analysis will be done.

The fact that the first dose group was completed and proved to be safe is expected to facilitate continued patient recruitment. To further increase the recruitment rate, Spago Nanomedical has decided to extend the study to another breast cancer center, Sahlgrenska Hospital, to increase the patient base.

"The results are fully in line with our expectations and we are now looking forward to the results from the next dose level. We also intend to expand with another center to create even better conditions for including patients and being able to run the study at a higher rate, "says CEO Mats Hansen.

The dose that patients have received in the study so far has a very broad safety margin to the levels that have resulted in preclinical studies. The initial dose was intended to document initial safety and provide a basis for optimizing the possibilities of showing effect on subsequent dose levels.

SpagoPix (SN132D) is a contrast agent with the potential to significantly improve cancer diagnostics with magnetic resonance imaging (MRI). Initially, Spago Nanomedical has chosen to focus on breast cancer, a disease that affects approximately 2.1 million people annually, where MRI is already routinely used today for screening, diagnostics, or follow-up in 15-30 percent of all patients and the need for better precision in diagnoses. is big.

The primary goal of the SPAGOPIX-01 study is to document safety at different dose levels, but another important goal is to initially investigate the MR contrast effect in clinical use in patients with confirmed breast cancer. Study details and updates are published at www.clinicaltrials.gov .

Fusion Pharmaceuticals Appoints James J. O’Leary, M.D. as Chief Medical Officer

On March 23, 2020 Fusion Pharmaceuticals Inc., a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines to treat a broad range of cancers, reported the appointment of James J. O’Leary, M.D., as chief medical officer (CMO) (Press release, Fusion Pharmaceuticals, MAR 23, 2020, View Source [SID1234555754]).

"With his extensive experience and skills as a medical oncologist and drug developer in the precision oncology space, Jim will make an immediate contribution to Fusion’s clinical strategy and lead the growth of our clinical team and programs," said John Valliant, chief executive officer. "Fusion is building a diverse pipeline of innovative radiopharmaceutical cancer therapy candidatesthrough our platform technology, and Jim’s ability to evaluate assets and tailor clinical studies will be invaluable as we execute our corporate plan. In addition, his background as a medical oncologist provides him with valuable insights and a focus on advancing innovative cancer therapies for patients."

Dr. O’Leary brings to Fusion more than 20 years of oncology industry experience including roles within biotechnology companies such as ImmunoGen, Idera Pharmaceuticals, Array Biopharma, and Deciphera, and pharmaceutical companies including Takeda, Bayer and Pfizer. During his time at Takeda, Dr. O’Leary was a global project team leader for a late stage asset directing global strategy and regulatory approvals. At ImmunoGen, he was the CMO and was responsible for guiding the strategic direction and execution of all clinical programs, including antibody-drug conjugates. Prior to joining the biopharmaceutical industry, Dr. O’Leary was a medical reviewer with the U.S. Food and Drug Administration. Before that, he was a practicing oncologist in New York. Dr. O’Leary obtained his doctor of medicine degree from the State University of New York, Health Science Center at Brooklyn and completed a fellowship in oncology/hematology at New York University Medical Center.

"I was eager to join the Fusion team because I believe we have an exciting opportunity to leverage novel science supported by robust manufacturing and supply chain capabilities to usher in a new therapeutic approach delivering precision cancer therapies to patients," said Dr. O’Leary. "Beginning with FPI-1434, which is currently in Phase 1 development, I look forward to growing and optimizing our clinical programs and guiding our short and long term development strategies."

Fortress Biotech Announces Up to $5 Million Series A Cumulative Redeemable Perpetual Preferred Stock Repurchase Program

On March 23, 2020 Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress" or "the Company"), an innovative biopharmaceutical company focused on acquiring, developing and commercializing high-potential marketed pharmaceutical products and development-stage pharmaceutical product candidates, reported that its Board of Directors authorized the repurchase of up to $5 million of its 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock (Nasdaq: FBIOP) (the "Preferred Stock") (Press release, Fortress Biotech, MAR 23, 2020, View Source [SID1234555753]).

Fortress appointed ThinkEquity, a division of Fordham Financial Management, Inc. to purchase the stock on behalf of the Company in conformity with the provisions of Rule 10b-18 under the Securities Exchange Act of 1934, as amended. ThinkEquity may commence purchasing the shares of the Preferred Stock beginning on March 23, 2020 until the earlier of the close of trading on May 31, 2020 or the date that the aggregate purchases reach a total of $5 million. The repurchase program does not obligate the Company to acquire any specific number of shares and may be suspended or terminated at any time.

The Company’s proposed repurchases may be made from time to time on the open market at prevailing market prices, in privately negotiated transactions, in block trades and/or through other legally permissible means, depending on market conditions and in accordance with applicable rules and regulations. The Company’s Board of Directors will review the share repurchase program periodically and may authorize adjustment of its terms and size. The Company plans to fund repurchases from its existing cash balance.

Vaccitech and Oxford University Announce Promising Phase 2a Data on Prostate Cancer Immunotherapy

On March 23, 2020 Vaccitech Limited and the University of Oxford reported initial efficacy and safety data for ADVANCE, a Phase 2a study testing VTP-800, an immunotherapeutic product candidate in patients with metastatic castration resistant prostate cancer (mCRPC) (Press release, Vaccitech, MAR 23, 2020, View Source [SID1234555747]). The study demonstrated that VTP-800 is safe and showed an encouraging efficacy trend in patients with mCRPC.

ADVANCE (NCT03815942) is an open-label, non-randomized study sponsored and conducted by the University of Oxford and funded by the European Commission FP7 programme and Vaccitech. The objectives of the study are to measure the safety of the immunotherapeutic VTP-800 when combined with an anti-PD-1 agent, and the reduction in serum prostate-specific antigen (PSA) levels as a surrogate biomarker used to evaluate the efficacy of prostate cancer treatments.

VTP-800 is comprised of Vaccitech’s Chimpanzee Adenovirus Oxford 1 vector (PRIME) encoding the oncofetal antigen 5T4 (ChAdOx.5T4), followed by a Modified Vaccinia Ankara vector (BOOST) encoding the same antigen (MVA.5T4) administered in a heterologous prime-boost regimen.

In the 23 mCRPC patients who received VTP-800 in conjunction with an anti-PD-1, 5 patients (22%) had a >50% reduction in PSA level at any timepoint compared to baseline (median of 88 ng/ml). This compares favourably to the 9% response rate reported from a previous anti-PD-1 monotherapy study, KEYNOTE-199, which evaluated 243 mCRPC patients with similar baseline PSA levels. Additionally, four of the five ADVANCE patients (17.4%) maintained their response when tested three weeks later versus 5.8% in the KEYNOTE-199 study. One ADVANCE patient had a response with a PSA level of 0 at 24 weeks.

Whilst full analysis is still pending, initial safety data is comparable to that seen from dosing anti-PD-1 alone and there are no serious adverse events attributable to VTP-800.

ADVANCE patients received two cycles of VTP-800 four weeks apart and 480 mg of an anti-PD-1 agent on weeks 4, 8 and 12 of treatment. KEYNOTE-199 patients received 200 mg of anti-PD-1 every three weeks for up to 35 weeks.

"We are encouraged by these data and we believe they validate the application of our platform in other oncology indications using different antigens," stated Bill Enright, Vaccitech CEO. "We look forward to continuing to work with Oxford University to explore options for future clinical studies to evaluate the added patient benefit VTP-800 can provide when combined with checkpoint inhibitors."

"We have seen promising clinical activity of VTP-800 in conjunction with an anti-PD-1, including responses in patients with advanced hormone resistant prostate cancer that are resistant to standard treatments. These encouraging data will hopefully lead to the initiation of a larger phase 2 clinical trial in patients with advanced prostate cancer," commented Dr Mark Tuthill, Chief Investigator of ADVANCE.

Previous VTP-800 studies

Phase 1 study (VANCE) in pre-surgical, early-stage prostate cancer patients. Data presented at ASCO (Free ASCO Whitepaper) 2018: View Source

INTELGENX TO REPORT FOURTH QUARTER AND FULL-YEAR 2019 FINANCIAL RESULTS ON MARCH 26; CONFERENCE CALL TO FOLLOW ON MARCH 27

On March 23, 2020 IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) ("IntelGenx"), a leader in pharmaceutical films, reported that it will release its fourth quarter and full-year 2019 financial results before market open on Thursday, March 26, 2020 (Press release, IntelGenx, MAR 23, 2020, View Source [SID1234555746]).

As previously announced, the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 26, 2020 for completion of its review of IntelGenx’s 505(b)(2) New Drug Application ("NDA") for RIZAPORT VersaFilm for the treatment of acute migraines.

In order to facilitate a discussion on both the financial results and the FDA’s anticipated decision on the RIZAPORT NDA, a conference call has been scheduled for Friday, March 27. The call will be hosted by Dr. Horst G. Zerbe, Chief Executive Officer, and Mr. Andre Godin, President and Chief Financial Officer. Details of the conference call and webcast are below:

Date: Friday, March 27, 2020

Time: 8:30 a.m. ET

Conference dial-in: (833) 231-8269

International dial-in: (647) 689-4114

Conference ID: 5685777

Live Webcast Registration: Click here