On June 26, 2019 Medicenna Therapeutics Corp. ("Medicenna" or the "Company") (TSX: MDNA;OTCQB: MDNAF), a clinical stage immuno-oncology company, is reported new data on MDNA55 was published in the March 2019 issue of the journal Immunotherapy (Press release, Medicenna Therapeutics, JUN 26, 2019, View Source [SID1234537289]). The authors of the publication entitled "Combination immunotherapy with IL-4- Pseudomonas exotoxin and IFN-α and IFN-γ mediate synergistic antitumor effects in vitro and in a mouse model of human ovarian cancer", are investigators in different branches of the National Institutes of Health (NIH) and FDA’s Center for Biologics Evaluation & Research.

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In the published pre-clinical data, MDNA55 (IL-4 fused to Pseudomonas exotoxin) was shown to effectively target and kill ovarian cancer cells overexpressing the IL-4 receptor (IL4R), consistent with previous data showing the antitumor effect of MDNA55. New results have now shown that MDNA55, when combined with approved drugs called interferons (IFN-α and IFN-γ), act in a highly synergistic fashion to kill tumor cells and increase survival in an aggressive mouse model of metastatic ovarian cancer without causing damage to vital organs. These data suggest that this novel combination could provide a unique and effective approach to treating ovarian cancer.

Ovarian cancer is the seventh most common cancer in women worldwide with over 250,000 new cases diagnosed annually. Ovarian cancer is a difficult and trying disease where more than half of the patients treated with conventional therapy simply do not respond. Because it is most often diagnosed in its advanced stage, the prognosis for women with ovarian cancer has been very poor. Historical progression-free survival in ovarian cancer is 10 to 12 months for first-line treatment and 6 to 8 months for second-line treatment. The IL4R is known to be expressed in 60% of patients with ovarian cancer.

IL-4-Pseudomonas exotoxin was developed by Dr. Raj Puri (a co-author of the publication) at the USFDA and previously licensed to Medicenna and named MDNA55, a first-in-class, fusion cytotoxin that specifically targets the IL4R which is over-expressed by 20 different cancers affecting more than a million cancer patients every year. To date MDNA55 has been used to treat over 130 patients in multiple clinical trials, including over 110 patients with recurrent Glioblastoma (rGBM), building a significant safety profile, evidence of anti-tumor effect and mechanistic dataset in patients with the most aggressive form of brain cancer. MDNA55 has been the subject of a recently completed Phase 2b open-label study in patients with rGBM at first or second relapse. Promising interim top-line results from the rGBM study were announced last week.

On June 26, 2019 Veracyte, Inc. (Nasdaq: VCYT), a leading genomic diagnostics company, reported that it has begun making its next-generation Percepta Genomic Sequencing Classifier (GSC) available to physicians, providing them with expanded lung cancer risk information that can further guide next steps for patients with suspicious lung nodules, as compared to the original Percepta test (Press release, Veracyte, JUN 26, 2019, View Source [SID1234537273]). The RNA whole-transcriptome sequencing-based test is Veracyte’s first commercial product to emerge since entering into the long-term strategic lung-cancer collaboration with Johnson & Johnson Innovation LLC*, which was announced in January 2019.

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"Lung nodules are often challenging to diagnose using traditional tools, which can lead to unnecessary invasive procedures or to delayed treatment," said Giulia Kennedy, Ph.D., Veracyte’s chief scientific and medical officer. "The ability to use genomic testing – such as the Percepta GSC – to determine which patients need intervention and those who may be safely monitored with routine imaging can help improve patient outcomes."

Veracyte’s commercial introduction of the Percepta GSC follows the May 2019 presentation of clinical data showing that the genomic test down-classifies patients with suspicious lung nodules to "low risk" with a negative predictive value of 91 percent. This means these patients have a low likelihood of cancer and may therefore avoid unnecessary invasive procedures. The findings also show that the test up-classifies patients to high risk with a positive predictive value of 65 percent, suggesting that there is a higher likelihood these patients have cancer, which can help guide next intervention steps. The American College of Chest Physicians recommends lung nodule patients with a low risk of cancer undergo monitoring with CT imaging and that patients with a risk of 65 percent or greater undergo surgical treatment. The Percepta GSC study involved 412 lung-nodule patients whose results were inconclusive following bronchoscopy, a common nonsurgical procedure to assess lung nodules for cancer. The new study findings were shared during the American Thoracic Society 2019 International Conference.

The Percepta GSC utilizes machine learning and is built on novel "field of injury" science – which identifies genomic changes associated with lung cancer in current or former smokers using a simple brushing of the person’s airway. The test is performed on a sample from the patient’s main lung airway, which is collected during a bronchoscopy. Veracyte estimates that approximately 360,000 bronchoscopies are currently performed each year to evaluate suspicious lung nodules for cancer and that up to 60 percent of these produce inconclusive results.

"We are excited to make the Percepta GSC available to physicians as an important tool that will help them further guide next steps for patients undergoing evaluation for suspicious lung nodules," said Bonnie Anderson, Veracyte’s chairman and chief executive officer.

Veracyte is collaborating with the Lung Cancer Initiative at Johnson & Johnson to advance the development and commercialization of novel diagnostic tests to detect lung cancer at its earliest stages, when the disease is most treatable. The collaboration is accelerating two key lung cancer programs for Veracyte, including the commercialization of its Percepta classifier on the company’s RNA whole-transcriptome sequencing platform well as the development of the first non-invasive nasal swab test for early lung cancer detection. Veracyte continues to expect to unveil early data for the nasal swab test later this year. Under terms of the agreement, Veracyte and the Lung Cancer Initiative at Johnson & Johnson will combine clinical study cohorts involving more than 5,000 patients with multiple years of clinical outcome data. Veracyte will contribute bronchial and nasal samples from its clinical trials, which are part of the company’s extensive lung cancer-focused biorepository.

Lung cancer is the leading cause of cancer deaths worldwide. In the United States, lung cancer causes more than 154,000 deaths each year – more than the next three most prevalent cancers combined. Because lung cancer is difficult to diagnose before it has metastasized, only 16 percent of cases are detected at an early stage, when the disease is more treatable. Lung cancer’s five-year survival rate is only 18 percent, much lower than that of other common cancers. Approximately 80 percent of lung cancer deaths are caused by smoking.

On June 26, 2019 CBM BioPharma Inc. ("CBM") reported that the United States Patent & Trademark Office (USPTO) has issued a Notice of Allowance and Issue Fee Due in CBM’s patent application related to the treatment of pancreatic cancer (Press release, CBM BioPharma, JUN 26, 2019, View Source;trademark-office-allows-patent-claims-for-cbm-biopharma-incs-patent-application-for-pancreatic-cancer-treatment-300875038.html [SID1234537290]).

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CBM has received from the USPTO a Notice of Allowance for patent application 15/115,393. This application is licensed from the University of Texas by CBM. Once the patent issue fee is paid, the new patent will protect one of CBM’s lead drug candidates, Gem-DHA, a novel gemcitabine derivative intended for the treatment of pancreatic cancer. Preliminary data indicates that Gem-DHA is more effective than gemcitabine in mice pancreatic cancer models. This asset is to be sold to Spherix Inc. (NASDAQ: SPEX) as part of the previously announced Asset Purchase Agreement between CBM and Spherix. The transaction is subject to shareholder approval by Spherix shareholders and other customary closing conditions.

Anthony Hayes, Spherix CEO, stated, "I am very excited by the potential of this drug and especially by the data showing that Gem-DHA works better in reducing the growth of pancreatic tumors than the first-line chemotherapy drug gemcitabine. The data indicates that Gem-DHA preferentially concentrates itself in the pancreas relative to other organs, suggesting it may be a promising candidate for further trials in pancreatic cancer. We are constantly working to return value to our shareholders and this news is another data point that establishes the value of the CBM assets."

On June 26, 2019 3P Biopharmaceuticals (3P) and Norwegian biopharmaceutical company Nordic Nanovector have extended their collaboration agreement for the biopharmaceutical development of Betalutin late stage manufacturing for B-cell non-Hodgkin lymphoma (NHL) treatment (Press release, 3P Biopharmaceuticals, JUN 26, 2019, View Source [SID1234537291]).

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The non-Hodgkin lymphoma (NHL) is cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system.

3P and Nordic Nanovector started their collaboration in 2013 and successfully advanced Betalutin project through these years.

The current agreement is consolidating the relationship describing how both companies will successfully progress the project up to the regulatory submission of the product including development, clinical supply and late-stage activities, such as process characterization and validation.

"Our partnership with Nordic Nanovector is a great example of how together we can achieve more than planned and succeed in the late stage of Betalutin development," said Dámaso Molero, General Manager at 3P Biopharmaceuticals.

He also added, "this project demonstrates how we can bring together various parties to successfully reach the project goals by using complex technologies in this challenging project."

HH1 (Lilotomab) is a murine IgG1 antibody that targets the human glycoprotein CD37, which is found on the surface of B cells and B cell tumors.

The antibody is a component of Betalutin, a radioimmunoconjugate molecule (RIC) which is being developed for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).

On June 26, 2019 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported the pricing of an underwritten public offering of 4,750,000 shares of its common stock, offered at a price of $26.00 per share (Press release, Odonate Therapeutics, JUN 26, 2019, View Source [SID1234537275]). In addition, Odonate has granted the underwriters a 30-day option to purchase up to an additional 712,500 shares of its common stock on the same terms and conditions. All shares of common stock sold in the offering are being sold by Odonate. The offering is expected to close on or about June 28, 2019, subject to customary closing conditions.

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The gross proceeds from the proposed underwritten public offering are expected to be $123.5 million before deducting customary underwriting discounts and offering expenses. Odonate intends to use the proceeds from the proposed underwritten public offering of its shares of common stock for development and regulatory activities relating to tesetaxel, as well as for working capital and general corporate purposes.

Jefferies and Cowen are acting as joint book-running managers. LifeSci Capital is acting as lead manager for the offering.

The securities described above are being offered pursuant to a shelf registration statement (File No. 333-229785), which became effective on February 28, 2019. A final prospectus supplement relating to and describing the terms of the offering will be filed with the Securities and Exchange Commission (SEC). The securities described above have not been qualified under any state blue sky laws. 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. The offering can be made only by means of a prospectus supplement and an accompanying base prospectus, copies of which may be obtained at the SEC’s website at www.sec.gov, or by request to Jefferies LLC (Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022; telephone: 877-821-7388; email: [email protected]) or Cowen and Company, LLC (c/o Broadridge Financial Services, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717; telephone: 631-274-2806; email: [email protected]).