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Nordic Nanovector Provides Update on LYMRIT 37-05 Phase 1 DLBCL Trial

On December 12, 2019 Nordic Nanovector ASA (OSE: NANO) reported an update on its LYMRIT 37-05 Phase 1 trial of Betalutin in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) who are not eligible for autologous stem cell transplantation (SCT) (Press release, Nordic Nanovector, DEC 12, 2019, View Source [SID1234552337]). DLBCL is an aggressive form of non-Hodgkin’s lymphoma (NHL) and accounts for up to 43% of all cases, making it the most common type of NHL.

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This open-label, dose-escalation safety trial is designed to assess the safety, tolerability, pharmacokinetic profile and preliminary anti-tumour activity of Betalutin in up to 24 patients. The primary goal of the trial is to identify the maximally tolerated dose of Betalutin which will then be further evaluated for safety and anti-tumour activity in an expansion cohort in order to select the recommended dose for phase 2. Three additional patients are currently being enrolled for further evaluation of the final dose cohort as one patient has experienced a reversible DLT (dose limiting toxicity).

On the three completed cohorts, no safety issues were identified. Evidence of disease control has been noted in some of the enrolled patients. We expect to complete the data read-out for the dose-escalation phase and submit the data to an international congress in 1H 2020.

Eduardo Bravo, Nordic Nanovector’s Chief Executive Officer, commented: "Patients with relapsed/refractory DLBCL who are not eligible for stem cell transplantation have very limited treatment options and a poor prognosis. As the safety profile of Betalutin will guide its potential for combination regimens as well as single agent consolidation therapy, we look forward to completing this part of the trial and proceeding with the expansion cohort."

CStone completes registration filing for the Phase I trial of its tumor immune microenvironment modulator CS3005 to enable study initiation in Australia

On December 12, 2019 CStone Pharmaceuticals ("CStone" or the "Company", HKEX: 2616) reported that the Company has recently received the approval from the Human Research Ethics Committee (HREC) in Australia, and the acknowledgement from Australia’s Therapeutic Goods Administration (TGA) on the Phase I clinical trial of CS3005 (Press release, CStone Pharmaceauticals, DEC 12, 2019, View Source [SID1234552336]). This Phase I trial is an open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of CS3005 in patients with advanced solid tumors.

The tumor microenvironment (TME) is a cellular space in which the tumor dynamically interacts with the surrounding blood vessels, immune cells, stromal components, signaling molecules, and the extracellular matrix. Studies showed that multiple compensatory immunosuppressive mechanisms exist in the TME not only contribute to the development of tumors but also affect the response to immunotherapies. The adenosine signaling pathway plays a critical role in immune modulation and is an important compensatory resistance mechanism against immune checkpoint inhibitors.

Discovered by CStone, CS3005 is an adenosine A2a receptor antagonist that modulates the tumor immune microenvironment. CS3005 could potentially activate antitumor immunity and improve the response to immune checkpoint inhibitors by blocking the binding of adenosine with adenosine A2a receptors and thereby reversing the immunosuppressive mechanism. At present, no adenosine A2a receptor antagonist has been approved for cancer treatment anywhere in the world.

"I am pleased that the clinical trial of CS3005 has been approved in Australia. This drug candidate is the Company’s first tumor immune microenvironment modulator entering clinical development as we have begun to roll out CStone’s Pipeline 2.0," said Dr. Frank Jiang, Chairman and CEO of CStone. "Immuno-oncology therapy has brought new hope to cancer patients in recent years, yet many patients fail to respond to those treatments. We are hopeful that the research and development of tumor microenvironment modulators will allow immunotherapies to benefit more patients."

CStone’s Chief Scientific Officer, Dr. Jon Wang, noted: "Early studies on adenosine A2a receptor antagonists have shown good safety profiles and antitumor activities, either as monotherapies or in combination with immune checkpoint inhibitors, in patients with advanced solid tumors. Interestingly, adenosine A2a receptor antagonists have also demonstrated antitumor activities in patients with low PD-L1 expressing tumors or who are resistant/refractory to anti-PD-(L)1. These observations implicate possible benefits to patients with solid tumors. CS3005 also adds to the depth and flexibility of CStone’s strategy in immuno-oncology combination therapy."

Ionis Pharmaceuticals announces private placement of $507.5 million principal amount of 0.125% convertible senior notes due 2024

On December 12, 2019 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) ("Ionis") reported that it has entered into privately negotiated exchange and/or subscription agreements, with certain holders of its outstanding 1.00% Convertible Senior Notes due 2021 (the "2021 Notes") and certain new investors pursuant to which Ionis will issue $398.0 million principal amount of 0.125% Convertible Senior Notes due 2024 (the "New Notes") in exchange for $340.2 principal amount of the 2021 Notes (the "Exchange Transactions") and issue $109.5 million principal amount of New Notes for cash (the "Subscription Transactions") (Press release, Ionis Pharmaceuticals, DEC 12, 2019, View Source;300973802.html [SID1234552335]). Following the closing of the Exchange Transactions, $344.8 million in aggregate principal amount of 2021 Notes will remain outstanding with terms unchanged. The Exchange Transactions and the Subscription Transactions are expected to close concurrently on or about December 19, 2019, subject to customary closing conditions.

The New Notes will represent senior unsecured obligations of Ionis and will pay interest semi-annually in arrears on each June 15 and December 15, commencing on June 15, 2020, at a rate of 0.125% per annum. The New Notes will mature on December 15, 2024, unless earlier converted or repurchased. The New Notes will be convertible at the option of the holders in certain circumstances into cash, shares of Ionis’ common stock or a combination of cash and Ionis’ common stock, at Ionis’ election. The initial conversion rate is 12.0075 shares of Ionis’ common stock per $1,000 principal amount of New Notes, which is equivalent to an initial conversion price of approximately $83.28 per share, and will be subject to customary anti-dilution adjustments. Ionis may not redeem the New Notes prior to the maturity date.

Ionis will not receive any cash proceeds from the Exchange Transactions. In exchange for issuing the New Notes pursuant to the Exchange Transactions, Ionis will receive and cancel the exchanged 2021 Notes. Ionis estimates that net cash proceeds from the Subscription Transactions will be approximately $99.2 million after deducting estimated offering expenses for both the Exchange Transactions and the Subscription Transactions. Ionis intends to use net cash proceeds from the Subscription Transactions to pay the cost of the convertible note hedge transaction described below and for general corporate purposes.

In connection with the exchange and/or subscription agreements, Ionis entered into convertible note hedge and warrant transactions with several financial institutions. These transactions may decrease or increase dilution of Ionis’ stock based on several factors that are outlined in further detail in the Company’s 8-K filing, which was filed contemporaneously with this press release.

The New Notes and any shares of common stock issuable upon conversion of the New Notes have not been registered under the Securities Act or under any state securities laws and may not be offered or sold without registration under, or an applicable exemption from, the registration requirements. This announcement does not constitute an offer to sell, nor is it a solicitation of an offer to buy, 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 registration or qualification under the securities laws of any state or any jurisdiction.

Biocept Announces Closing of $10.0 Million Underwritten Public Offering

On December 12, 2019 Biocept, Inc. (NASDAQ: BIOC) ("Biocept" or the "Company"), a leading commercial provider of liquid biopsy solutions, reported that on December 11, 2019 it closed its previously announced underwritten public offering of 24,600,000 shares of its common stock (or pre-funded warrants to purchase common stock in lieu thereof) and warrants to purchase up to 24,600,000 shares of its common stock (Press release, Biocept, DEC 12, 2019, View Source [SID1234552334]). Each share of common stock or pre-funded warrant was sold together with one warrant to purchase one share of common stock at a combined price to the public of $0.405 per share and warrant. Gross proceeds, before underwriting discounts and commissions and estimated offering expenses, were approximately $10.0 million. In addition, Biocept granted to Maxim Group LLC a 45-day option to purchase up to an additional 3,690,000 shares of common stock and/or warrants to purchase up to 3,690,000 shares of common stock, at the public offering price less discounts and commissions, of which Maxim Group LLC has partially exercised its option to purchase warrants to purchase up to 1,927,500 shares of common stock.

The warrants are immediately exercisable at a price of $0.405 per share of common stock and will expire five years from the date of issuance. Additionally, if the volume-weighted average price of our common stock is below the exercise price per share of the warrants on any trading day beginning the earlier of (i) January 8, 2020, and (ii) the trading day on which the aggregate trading volume of Biocept’s common stock is equal to more than three times the number of shares of common stock sold in the offering, then the warrantholders may elect to cashless exercise their warrants for a number of shares equal to 50% of the shares issuable upon cash exercise. Each pre-funded warrant has an exercise price of $0.01 per share, is exercisable immediately and will expire when exercised in full. The shares of common stock or the pre-funded warrants and the accompanying warrants, were sold together in the offering, but were issued separately and were immediately separable upon issuance.

Maxim Group LLC acted as the book-running manager and Dawson James Securities, Inc. acted as a co-manager in connection with the offering.

The offering was conducted pursuant to the Company’s registration statement on Form S-1 (File No. 333-234459), as amended, previously filed with and subsequently declared effective by the Securities and Exchange Commission ("SEC"). A final prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at View Source Electronic copies of the final prospectus relating to this offering may be obtained from Maxim Group LLC, 405 Lexington Avenue, 2nd Floor, New York, NY 10174, at (212) 895-3745.

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.

Medicenna Presents Additional Encouraging Phase 2b Clinical Data at the Inaugural Glioblastoma Drug Development Annual Summit

On December 12, 2019 Medicenna Therapeutics Corp. ("Medicenna" or "the Company") (TSX: MDNA,OTCQB: MDNAF), a clinical stage immuno-oncology company, reported updated clinical results from its Phase 2b trial of MDNA55, in patients with recurrent glioblastoma (rGBM), the most common and uniformly fatal form of brain cancer (Press release, Medicenna Therapeutics, DEC 12, 2019, View Source [SID1234552333]). The results were presented by Dr. Fahar Merchant, PhD, President and CEO of Medicenna Therapeutics, at the Inaugural Glioblastoma Drug Development Annual Summit on December 11 at the Westin Boston Waterfront Hotel in Boston, Massachusetts.

The presentation reported subgroup analysis from the first 40 patients treated with MDNA55 in a Phase 2b clinical trial for patients with rGBM. MDNA55 targets the interleukin 4 receptor (IL4R) known to be over-expressed in GBM, and a biomarker for more aggressive disease. Furthermore, unlike other trials, the MDNA55 study only enrolled patients with rGBM that have genetic features which make the tumor the most aggressive and resilient type of rGBM.

"We are very encouraged to see that by being the only oncology company to target the IL4R, which is over-expressed in 76% of patients with glioblastoma, we are achieving meaningful survival benefits with MDNA55 in a population where the majority of patients have the worst form of rGBM," said Dr. Fahar Merchant, President and CEO of Medicenna. "Our full data set will be complete early in the new year, allowing us to submit our package to the U.S. Food and Drug Administration in Q1, 2020 prior to an End of Phase 2 Meeting enabling us to reach a major milestone on the path to securing key partnerships."

The presentation highlighted that the patient characteristics in the clinical study excluded patients that are known to have a much better prognosis, such as patients that were, (a) eligible for surgery to remove the tumor, (b) had a lower grade of brain cancer at initial diagnosis (only de novo GBM patients were enrolled), and (c) had a known mutation associated with better prognosis (IDH mutation). Furthermore, the presentation emphasized that despite enrolling only patients known to have a very poor prognosis, patients actually did much better and were surviving significantly longer following only one treatment with MDNA55, particularly in patients with high expression of the IL4R target.

Of particular interest, subjects receiving lower doses of steroids (≤ 4mg of concurrent steroid per day) showed a trend towards improved survival, particularly in the IL4R High group, with a median overall survival (mOS) of 16.5 months with 88% of patients being still alive at 12 months. In patients resistant to approved chemotherapy Temodar (rGBM with unmethylated MGMT promoter), MDNA55 treatment in IL4R High patients had a median overall survival of 15.2 months and a 12 month survival rate of 69% versus 22% for Lomustine and less than 19% for Avastin.

Additional data comparing the various prognostic factors on MDNA55 outcome measures are provided in the slide presentation available on-line at View Source