On August 6, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO) reported the closing of a private placement in the form of convertible bonds with an aggregate principal amount of 18 billion Korean Won (KRW) (approximately USD $15 million based on the current exchange rate) issued to institutional investors led by Korea Investment Partners (KIP), a global venture capital and private equity firm based in Seoul, Korea, with additional offices in Shanghai, China and Sunnyvale, California (Press release, Inovio, AUG 6, 2019, View Source [SID1234538249]). Inovio expects to use the proceeds of the investment for the continued advancement of development activities for its clinical-stage product pipeline and for working capital and other general corporate purposes. Inovio today also announced its intent to pursue a secondary listing of its securities on the KOSDAQ Market of the Korea Exchange (KOSDAQ) in the form of Korean Depositary Receipts (KDRs).

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Dr. J. Joseph Kim, Inovio’s President and CEO, said, "We are pleased to have received this investment from fundamental, long-only institutional investors led by KIP and we appreciate their conviction. This additional funding will help Inovio advance a number of our clinical programs toward commercialization as we continue to strengthen Inovio on becoming the ‘go-to’ immunotherapeutic solution provider for all major HPV-related conditions with VGX-3100 (Phase 3), MEDI0457 (Phase 2 with AstraZeneca) and INO-3107."

Dr. Kim added, "The Korean capital market represents an expanding opportunity for Inovio to secure a new and attractive source of capital. Given our history of strategic partnerships and clinical development in Asia, especially in Korea, Inovio is well-positioned to tap into this new source of capital. This opportunity will also expand Inovio’s presence in Asia and further our goal of becoming a global contributor to the fight against cancer and emerging infectious diseases."

Mahnsoon Hwang, Senior Managing Director specializing in Biotechnology and Healthcare for KIP, said, "We are excited by Inovio’s diverse portfolio and growth prospects of its transformative DNA Immunotherapy platform. Given the exponential growth that we have seen over the last couple of years in Korea for anti-cancer drugs and immunotherapies, we believe Inovio is well-positioned to capture the market opportunity, while continuing to build on its already established Asian partnerships."

The bonds, which are unsecured obligations of Inovio, were issued on August 1, 2019 and will accrue interest at a coupon rate of 1.00% per annum, payable quarterly. The bonds will mature on July 31, 2024, unless earlier converted or repurchased. Starting August 1, 2020, the bonds will be convertible at any time after the first anniversary of the issue date until the date that is one month prior to the maturity date. Upon conversion, Inovio will deliver KDRs, assuming Inovio has KDRs listed on KOSDAQ at that time, or otherwise shares of common stock, if KDRs are not listed on KOSDAQ at that time. The initial conversion rate will be 211.0595 shares per KRW1,000,000 principal amount of bonds (equivalent to an initial conversion price of approximately USD $4.00 per share based on the exchange rates as of July 30, 2019), subject to adjustment upon the occurrence of specified events. The bonds will be subject to repurchase by Inovio at the option of the noteholders from and including July 31, 2022 up to the maturity date at a repurchase price equal to the principal of the bonds to be repurchased plus a premium on such bonds in order to ensure an internal rate of return with respect to such bonds of 6.00%.

This press release shall not constitute, nor form any part of, an offer to sell, the solicitation of an offer to buy or solicitation activity relating to any of the securities mentioned herein (including, for the avoidance of doubt, any securities convertible from the convertible bonds), nor shall there be any sale of any such securities (including, for the avoidance of doubt, any securities convertible from the convertible bonds) in any state or other jurisdiction (including Korea) 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 (including Korea).

About Korea Investment Partners (KIP)

Korea Investment Partners (KIP), a member of Korea Investment Holdings, is a Venture Capital firm investing in and promoting growth of promising companies for the past 30 years. The venture capital firm operates from global offices situated in Seoul, Shanghai, Beijing, and Sunnyvale-California. KIP is managing over 20 funds with a total size over USD $1.5 billion. Every year, KIP invests in about 50 companies from Korea, China and the U.S. With a portfolio that spans across 30 years, KIP has managed over 20 private equity funds and invested in over 500 companies.

On August 6, 2019 MorphoSys Discloses Biomarker to Stratify Patient Population in B-MIND Study of Tafasitamab plus Bendamustine in r/r DLBCL (Press release, MorphoSys, AUG 6, 2019, View Source [SID1234538248]).

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MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported specifications of the biomarker that was implemented in the currently ongoing phase 3 B-MIND study. B-MIND compares the efficacy of tafasitamab (MOR208) plus bendamustine versus rituximab plus bendamustine in patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL). The biomarker, which is the basis for a co-primary endpoint, is described as a low baseline peripheral blood natural killer (NK) cell count and was implemented in agreement with the FDA as an amendment of B-MIND in the first quarter of this year.

Patients with a low number of NK cells (defined as 100 or fewer NK cells per microliter blood) at study entry represent approximately 50% of the overall study population and are believed to exhibit a less favorable response to anti-CD20-based therapies. Pre-clinical data generated at MorphoSys suggests that tafasitamab’s potential to more efficiently recruit effector cells, predominantly NK cells, may therefore be of particular benefit for this patient population.

The co-primary endpoint allows for efficacy testing in the overall patient population as originally planned, and also in those patients with a low NK cell count at baseline. An event-driven interim analysis is expected to occur in Q4 2019 following a longer than expected duration of response in the overall patient population.

"Patients with r/r DLBCL who are not eligible for high dose chemotherapy and autologous stem cell transplantation have a poor prognosis, which is even worse for patients who are characterized by a low baseline NK cell count. The enhanced NK cell recruitment that tafasitamab is believed to exert through its ENFORCERTM format may activate even minimal NK cell numbers, which could potentially translate into enhanced activity against tumor cells," said Dr. Malte Peters, Chief Development Officer of MorphoSys AG. "The amendment of the B-MIND study allows us to test this hypothesis and potentially to provide a benefit for a distinct patient population that does not have targeted treatment alternatives."

About B-MIND
The phase 3 B-MIND study is designed to investigate the CD19 antibody tafasitamab in combination with bendamustine versus a combination of the CD20 antibody rituximab plus bendamustine in patients with r/r DLBCL who are not eligible for high dose chemotherapy and autologous stem cell transplantation. The biomarker had been implemented in agreement with the FDA in the first quarter of 2019. The pre-planned, event-driven interim analysis of B-MIND is expected to take place in the fourth quarter of 2019. In case the overall study population passes the futility analysis, an event-driven primary analysis of the study is expected in late Q1 2020. In case the overall study population fails, but the biomarker subpopulation passes the futility analysis, the study will continue, but an increase from 330 to 450 patients is required, in which case an event-driven primary analysis of the study is expected in Q1 of 2021. Only if both groups do fail the interim analysis for futility the overall study can be considered futile.

On August 6, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported its intention to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) based on its phase 2 L-MIND study of tafasitamab (MOR208) and lenalidomide in relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL) (Press release, MorphoSys, AUG 6, 2019, View Source [SID1234538247]). A letter of intent was submitted to EMA in early July and MorphoSys plans to complete the MAA submission by mid-2020.

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L-MIND is a single-arm, open-label phase 2 study investigating the antibody tafasitamab in combination with lenalidomide in patients with relapsed or refractory diffuse large B cell lymphoma who are not eligible for high-dose chemotherapy and autologous stem cell transplantation. In July 2019, the company presented positive primary analysis data from L- MIND at the ICML conference in Lugano. These data will form the basis for the planned filing package of the MAA that, if granted, allows for earliest approval in Europe in 2021.

"We are excited about the progress we are making with our plan for a possible regulatory approval for tafasitamab in Europe," said Dr. Malte Peters, Chief Development Officer at MorphoSys. "The preceding constructive interaction with the European regulatory authorities has given us the confidence to pursue an MAA submission for approval in Europe based on L-MIND. This complements our current focus on seeking approval of tafasitamab in the U.S. on the basis of L-MIND, for which we will complete a BLA submission to the FDA by year-end."

On August 6, 2019 Lixte Biotechnology Holdings, Inc. (OTCQB: LIXT) reported that it signed a clinical trial agreement with the Spanish Sarcoma Group (Grupo Español de Investigación en Sarcomas, GEIS) to support a Phase 1b/randomized Phase 2 study of doxorubicin, the global standard for initial treatment of advanced soft tissue sarcomas (ASTS), versus doxorubicin plus LB-100 (Press release, Lixte Biotechnology, AUG 6, 2019, View Source [SID1234538246]).

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Dr. John S. Kovach, CEO of Lixte, said, "We are pleased to support this investigator-initiated trial proposed by GEIS, a leader for many years in seeking improved therapies for ASTS. GEIS has a network of referral centers in Spain and across Europe that has an impressive track record of efficiently conducting innovative studies in ASTS. We believe GEIS and their EU collaborators are an excellent team to evaluate the potential benefit of adding Lixte’s non-cytotoxic inhibitor of DNA damage repair to standard treatment for this challenging disease. The goal is to enter the first patient in the last quarter of this year and to complete enrollment of approximately 170 patients over two years."

Dr. Kovach continued, "Doxorubicin alone has been the mainstay of first line treatment of ASTS for over 40 years with little therapeutic gain from adding cytotoxic compounds to or substituting other cytotoxic compounds for doxorubicin. In animal models, LB-100, an inhibitor of protein phosphatase2A (PP2A), consistently enhances the antitumor activity of doxorubicin without apparent increases in toxicity and, in a Phase 1 clinical trial, LB-100 alone was associated with stabilization of an advanced chondrosarcoma and fibrosarcoma for 6 and 9 months, respectively, without toxicity. LB-100 potentiates the effectiveness of agents like doxorubicin by inhibiting multiple steps required to repair chemotherapy induced DNA damage. We are excited to learn if the combination of LB-100 and doxorubicin will finally advance the effectiveness of ASTS therapy."

Dr. Javier Martin-Broto, Coordinating Investigator of the trial and medical oncologist at Virgen del Rocío University Hospital (Seville) commented, "Although there has been an increase in overall survival in advanced sarcoma in recent years, this gain has not been accompanied by advances in first line therapy. Anthracyclines, and specifically doxorubicin, is still the standard initial treatment. The growing list of negative phase III trials indicates to us that sarcoma therapy is in crisis. It is true that sarcoma encompasses more than 60 different subtypes and, for some of them, substantial advances have emerged. But it is also true that the most frequent sarcoma subtypes desperately need a turning point. One promising topic of research is the combination of doxorubicin with drugs that are able to impair the mechanisms of DNA repair. LB-100 has demonstrated synergistic action in in vivo preclinical mesenchymal tumors. GEIS will lead a European initiative to conduct a phase I/randomized II trial exploring the combination of doxorubicin plus LB-100 in first line of advanced soft tissue sarcomas".

On August 6, 2019 United Therapeutics Corporation (Nasdaq: UTHR) reported that Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics, will provide an overview and update on the company’s business at the 2019 Wedbush PacGrow Healthcare Conference in New York City (Press release, United Therapeutics, AUG 6, 2019, View Source [SID1234538235]).

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The presentation will take place on Tuesday, August 13, 2019, at 10:20 AM Eastern Time, and can be accessed via a live webcast on the United Therapeutics website at View Source under the "Investors" tab in the "Events and Presentations" section. An archived, recorded version of the presentation will be available approximately twenty-four hours after the presentation ends and can be accessed at the same location for 90 days. [uthr-g]