On June 5, 2019 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that the Data and Safety Monitoring Board (DSMB) confirmed a partial response in one of the first chordoma patients recruited and treated with the combination of BN-Brachyury and radiation treatment at the first evaluation timepoint (Press release, Bavarian Nordic, JUN 5, 2019, View Source [SID1234536930]). As this meets the initial pre-defined threshold of activity for the first stage of the Phase 2 trial, recruitment will be expanded to enroll another 19 patients, while the first 10 patients continue to be treated and evaluated.

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The proof-of-concept Phase 2 trial was designed to determine if the combination of BN-Brachyury and radiation therapy, the current standard of care, results in a clinically meaningful objective response rate (ORR), measured as a percentage of patients with a decrease in tumor size within 12 months of radiation therapy. This is a timeframe during which historical controls show an ORR of less than 5% with radiation alone.

The first stage of the study enrolled 10 patients between November 2018 and January 2019. The study will now advance into stage 2, expanding enrollment to a total of 29 patients with an overall goal of achieving 4 patients with objective responses, corresponding to an ORR of ~14% for all patients enrolled for the study to be considered successful.

"We are excited to share these first Phase 2 data from our current immuno-oncology pipeline, and also the first data suggesting clinical activity of combining our targeted immunotherapy with standard of care," said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. "We are encouraged by the rapid progression of this trial, which may offer final results sooner than anticipated and hope this initial finding is confirmed in a larger number of patients and that BN-Brachyury may improve treatment options for patients with chordoma."

For more information on how to take part in this trial, please visit the website of the Chordoma Foundation, who is working to advance new therapies to improve the lives of chordoma patients, and is also actively supporting Bavarian Nordic in the study: View Source

About chordoma
Chordoma is a rare cancer that universally overexpresses brachyury and occurs in the base of the skull and spine. There are approximately 1,000 new cases of chordoma diagnosed in the U.S. and E.U. annually, and 10,000 people living with the disease. Current treatments have resulted in limited success against chordoma, with a historical objective response rate of less than 5% with radiation alone.

About BN-Brachyury
Bavarian Nordic’s novel immuno-oncology candidate, BN-Brachyury, targets a key prognostic indicator of several common (e.g. colorectal, prostate, small cell lung, and triple negative breast cancer) and rare or orphan (e.g. chordoma, thyroid, neuroendocrine) cancers. Brachyury is a transcription factor that is believed to play a prominent role the metastasis and progression of tumors. Expression of brachyury is highly correlated with metastatic disease, poor overall survival, multi-drug resistance, and decreased survival rates. BN-Brachyury utilizes a prime-boost vaccination regimen that has been optimized to include the gene for brachyury and other molecules known to increase immune activation. Patients will receive a primer of MVA-BN Brachyury followed by booster doses of the recombinant fowlpox virus. A previous phase 1 trial demonstrated that MVA-BN-Brachyury could safely target brachyury and induce brachyury-specific T-cell immune responses.

BN-Brachyury has received orphan drug status from the FDA.

On June 5, 2019 Medicenna Therapeutics Corp. ("Medicenna" or "the Company") (TSX: MDNA,OTCQB: MDNAF), a clinical stage Immuno-Oncology company, reported that it will present preliminary top-line results from the recently completed Phase 2b clinical trial of MDNA55 for the treatment of recurrent glioblastoma at the Inaugural Immuno-Oncology Pharma Congress to be held from June 18-20, 2019 during World Pharma Week in Boston, MA (Press release, Medicenna Therapeutics, JUN 5, 2019, View Source [SID1234536912]).

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The details of the oral presentation are as follows:

Presenter:

Dr. Fahar Merchant

Title:

The Art of War: Combating Recurrent Glioblastoma with MDNA55, an IL4 Guided Toxin – Interim Top-Line Phase 2b Results

Date/Time:

Tuesday, June 18, 2019 at 11:45am

Location:

Seaport World Trade Center, 200 Seaport Boulevard, Boston, MA 02210

In addition, Medicenna will be presenting new preclinical data on its pipeline compound MDNA109, an IL2 Superkine, in a poster entitled: "Engineering a long-acting CD122 biased IL-2 superkine displaying potent anti-tumoral response." The poster will be presented by Dr. Moutih Rafei, Head of Discovery at Medicenna Therapeutics.

On June 5, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, is reported that it was involved in two poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s (ASCO) (Free ASCO Whitepaper) Annual Meeting, in Chicago, Illinois taking place from May 31st – June 4, 2019 (Press release, Immutep, JUN 5, 2019, View Source [SID1234536898]). The two posters related to Immutep’s lead product candidate eftilagimod alpha ("efti" or "IMP321").

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The first poster (TPS2667 – #299b) provided an overview of the ongoing Phase II TACTI-002 (Two ACTive Immunotherapies) clinical trial. TACTI-002 is being conducted by Immutep in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). This multicenter Phase II clinical trial is evaluating the combination of efti with MSD’s KEYTRUDA (or pembrolizumab, an anti-PD-1 therapy) in up to 109 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.

This poster, presented by Dr. Julio Antonio Peguero, MD of Oncology Consultants PA, 2130 W. Holcombe Blvd. 10th Floor, Houston, TX 77030, outlined the ongoing TACTI-002 clinical trial, its design and primary end points.

The second poster related to efti (TPS2651 – #291b) provided an overview of the two additional INSIGHT clinical trial stratas of the prospective investigator-initiated phase I study. Stratum D of the clinical trial is being conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. This explorative, open-labeled Phase I study will evaluate the feasibility and safety of subcutaneous efti injections combined with either standard-of-care drug therapy or BAVENCIO (or avelumab, PD-L1 inhibitor) in patients with advanced-stage solid tumors. The Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt, Germany ("IKF") will be the sponsor of the clinical trial and it will be conducted under the existing protocol of the ongoing INSIGHT clinical study. Stratum D is open for recruitment.

This poster, presented by Dr. Daniel Wilhelm Mueller, PhD, of the Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt, Germany, outlined the planned two new strata of the INSIGHT clinical trial, its design and primary end points.

The ASCO (Free ASCO Whitepaper) poster regarding the Company’s TACTI-002 trial can be found at View Source

Avelumab Approved Indications

Avelumab (BAVENCIO) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

The US Food and Drug Administration (FDA) also granted accelerated approval for avelumab (BAVENCIO) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with MCC in more than 45 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

Avelumab Important Safety Information from the US FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis and hepatitis [including fatal cases], colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions [which can be severe and have included fatal cases]), infusion-related reactions, major adverse cardiovascular events (MACE), and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash. Additional common adverse reactions reported in patients receiving BAVENCIO in combination with axitinib include hypertension, mucositis, palmar-plantar erythrodysesthesia, dysphonia, hypothyroidism, hepatotoxicity, cough, dyspnea, abdominal pain, and headache. Clinical chemistry and hematology laboratory value abnormalities have been reported including but not limited to grade 3-4 lymphopenia, anemia, elevated cholesterol and liver enzymes.

For full Prescribing Information and Medication Guide for BAVENCIO, please see www.BAVENCIO.com.

About Immutep

On June 5, 2019 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing novel drugs to address treatment resistance, reported that President and CEO Athena Countouriotis, M.D., will participate in a question and answer session at the Goldman Sachs 40th Annual Global Healthcare Conference on June 11 in Rancho Palos Verdes, Calif (Press release, Turning Point Therapeutics, JUN 5, 2019, View Source [SID1234536899]).

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Dr. Countouriotis’ session is scheduled to begin at 1:20 p.m. PT/4:20 p.m. ET and will be accessible via an audio webcast through the Investors page of www.tptherapeutics.com.

On June 5, 2019 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported the closing of its previously announced registered direct offering of 1,170,000 shares of common stock and, in a concurrent private placement, warrants to purchase 760,500 shares of common stock at a combined purchase price of $3.10 per share and related warrant (Press release, DelMar Pharmaceuticals, JUN 5, 2019, View Source [SID1234536900]). The warrants have an exercise price of $3.10 per share, are immediately exercisable and have a term of exercise of five years. The gross proceeds from the offering, prior to deducting offering expenses and placement agent fees and expenses payable by the Company, were $3.6 million.

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Maxim Group LLC acted as the lead placement agent and Dawson James Securities, Inc. acted as co-placement agent in connection with the transaction.

The shares of common stock described above were offered pursuant to an effective shelf registration statement on Form S-3, as amended (File No. 333-213601), that was previously filed with the Securities and Exchange Commission ("SEC") and declared effective on September 27, 2016. A final prospectus supplement and accompanying prospectus relating to the terms of the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus may be obtained by contacting Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 895-3745.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may 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 registration or qualification under the securities laws of any such state or jurisdiction.