On June 9, 2020 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an innovation-driven pharmaceutical company, reported dosing of the first patient in a Phase 1/2 clinical study evaluating oral selinexor in combination with standard of care therapy in patients with newly diagnosed or recurrent glioblastoma (GBM) (Press release, Karyopharm, JUN 9, 2020, View Source [SID1234560922]). This global study is expected to enroll approximately 400 patients at clinical sites in the U.S., Europe, and Israel.

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Selinexor is an oral selective inhibitor of nuclear export (SINE) compound which blocks the cellular protein XPO1, whose function includes playing a key role in regulating the activity of tumor suppressor proteins and other oncoproteins relevant in cancer cell biology. XPO1 may be an important, novel target in the treatment of patients with GBM as it is frequently overexpressed in both GBM and in high-grade gliomas, and the degree of XPO1 over-expression correlates with higher tumor grade and poor overall patient survival. Nonclinical studies indicate that selinexor has potent anti-GBM activity as monotherapy and is synergistic when combining with radiation, temozolomide and lomustine. Additionally, in previous clinical studies (KING study/NCT01986348), selinexor has demonstrated that it crosses the blood-brain barrier with adequate intra-tumoral penetration and single-agent efficacy with durable response and disease stabilization in heavily pretreated GBM patients further supporting the rationale for clinical development of selinexor to treat patients with brain cancers.

The randomized, multi-center, Phase 1/2 study (XPORT-GBM-029/NCT04421378) will be conducted in two phases: a Phase 1 dose finding study followed by a Phase 2 randomized efficacy exploration study, designed to independently evaluate three different combination regimens in three treatment arms in patients with newly diagnosed GBM (Arms A and B) or with recurrent GBM (Arm C). Arms A and B will investigate selinexor in combination with radiation therapy with or without the addition of temozolomide, while Arm C will evaluate the combination of selinexor and lomustine. The primary endpoints in the study are progression-free survival in patients with newly diagnosed GBM and overall survival (OS) in patients with recurrent GBM.

Yazmín Odia, M.D., Chief of Neuro-Oncology at Miami Cancer Institute, Baptist Health South Florida (BHSF), and investigator in the study, stated, "We are very excited about the launch of this innovative clinical trial on behalf of our patients who desperately need new treatment options for what is typically an incurable disease and given the few meaningful therapeutic advances in recent years."

"We are hopeful that this study evaluating the activity of selinexor in combination with currently used standard treatments will help us further identify promising novel approaches for the treatment of patients with both newly diagnosed and recurrent GBM," commented Minesh Mehta, M.D., Chief of Radiation Oncology at Miami Cancer Institute, BHSF, and investigator in the study.

"While selinexor has been most extensively studied in patients with hematologic malignancies, there is increasing evidence that selinexor may also play an important role in the treatment of a variety of solid tumors, including patients with GBM," said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. "We were highly encouraged by the results from our previous Phase 2 KING study, which evaluated selinexor as a single agent in patients with recurrent GBM and demonstrated clear anti-cancer activity. We now look forward to assessing selinexor’s activity in combination with currently used standard of care treatments where we hope it will prove to be synergistic and even more effective."

Selinexor, marketed as XPOVIO, is currently approved by the U.S. Food and Drug Administration (FDA) as a treatment for patients with relapsed or refractory multiple myeloma. Selinexor is currently the only XPO1 inhibitor approved by the FDA and has been extensively tested in clinical trials across numerous cancer indications worldwide since 2012. Karyopharm has also submitted two additional supplemental New Drug Applications for XPOVIO which are currently under review by the FDA; one is for an expansion of XPOVIO’s label to include XPOVIO as a treatment for patients with multiple myeloma after at least one prior line of therapy and the other for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

About GBM

Glioblastoma Multiforme (GBM) is one of the most common and particularly aggressive forms of brain tumors of primarily glial cell origin. GBM is diagnosed in patients at a median age of 64 years but can occur at any age, including in childhood. GBM is an incurable disease and the prognosis for patients is typically poor due in part to its aggressive and extensive infiltration of surrounding central nervous system tissue and its frequent inaccessibility for surgical resection within the brain. In addition, the blood-brain barrier presents an obstacle for many chemotherapeutic agents, with only small, lipophilic molecules able to reach the tumor. Median survival in patients with newly diagnosed GBM is approximately 15 months and approximately five to seven months in patients with recurrent disease.

About XPOVIO (selinexor)

XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. Karyopharm has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor. A supplemental New Drug Application was accepted by the FDA seeking accelerated approval for selinexor as a new treatment for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), and selinexor has received Fast Track and Orphan designation and Priority Review from the FDA with a scheduled PDUFA date of June 23, 2020 for this patient population. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON), for which Karyopharm announced positive top-line results in March 2020. In May 2020, Karyopharm submitted a supplemental New Drug Application based on data from the Phase 3 BOSTON study. Additional, ongoing trials for selinexor include as a potential backbone therapy in combination with approved myeloma therapies (STOMP), in liposarcoma (SEAL) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

For more information about Karyopharm’s products or clinical trials, please contact the Medical Information department at:

Tel: +1 (888) 209-9326
Email: [email protected]

IMPORTANT SAFETY INFORMATION

Thrombocytopenia

XPOVIO can cause thrombocytopenia, leading to potentially fatal hemorrhage. Thrombocytopenia was reported as an adverse reaction in 74% of patients, and severe (Grade 3-4) thrombocytopenia occurred in 61% of patients treated with XPOVIO. The median time to onset of the first event was 22 days. Bleeding occurred in 23% of patients with thrombocytopenia, clinically significant bleeding occurred in 5% of patients with thrombocytopenia and fatal hemorrhage occurred in <1% of patients.

Monitor platelet counts at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment. Institute platelet transfusion and/or other treatments as clinically indicated. Monitor patients for signs and symptoms of bleeding and evaluate promptly. Interrupt and/or reduce dose, or permanently discontinue based on severity of adverse reaction.

Neutropenia

XPOVIO can cause neutropenia, potentially increasing the risk of infection. Neutropenia was reported as an adverse reaction in 34% of patients, and severe (Grade 3-4) neutropenia occurred in 21% of patients treated with XPOVIO. The median time to onset of the first event was 25 days. Febrile neutropenia was reported in 3% of patients.

Obtain neutrophil counts at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment. Monitor patients for signs and symptoms of concomitant infection and evaluate promptly. Consider supportive measures including antimicrobials for signs of infection and use of growth factors (e.g., G-CSF). Interrupt and/or reduce dose, or permanently discontinue based on severity of adverse reaction.

Gastrointestinal Toxicity

Gastrointestinal toxicities occurred in patients treated with XPOVIO.

Nausea/Vomiting

Nausea was reported as an adverse reaction in 72% of patients, and Grade 3 nausea occurred in 9% of patients treated with XPOVIO. The median time to onset of the first nausea event was 3 days.

Vomiting was reported in 41% of patients, and Grade 3 vomiting occurred in 4% of patients treated with XPOVIO. The median time to onset of the first vomiting event was 5 days.

Provide prophylactic 5-HT3 antagonists and/or other anti-nausea agents, prior to and during treatment with XPOVIO. Manage nausea/vomiting by dose interruption, reduction, and/or discontinuation. Administer intravenous fluids and replace electrolytes to prevent dehydration in patients at risk. Use additional anti-nausea medications as clinically indicated.

Diarrhea

Diarrhea was reported as an adverse reaction in 44% of patients, and Grade 3 diarrhea occurred in 6% of patients treated with XPOVIO. The median time to onset of diarrhea was 15 days.

Manage diarrhea by dose modifications and/or standard anti-diarrheal agents; administer intravenous fluids to prevent dehydration in patients at risk.

Anorexia/Weight Loss

Anorexia was reported as an adverse reaction in 53% of patients, and Grade 3 anorexia occurred in 5% of patients treated with XPOVIO. The median time to onset of anorexia was 8 days.

Weight loss was reported as an adverse reaction in 47% of patients, and Grade 3 weight loss occurred in 1% of patients treated with XPOVIO. The median time to onset of weight loss was 15 days.

Monitor patient weight at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment. Manage anorexia and weight loss with dose modifications, appetite stimulants, and nutritional support.

Hyponatremia

XPOVIO can cause hyponatremia; 39% of patients treated with XPOVIO experienced hyponatremia, 22% of patients experienced Grade 3 or 4 hyponatremia. The median time to onset of the first event was 8 days.

Monitor sodium level at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment. Correct sodium levels for concurrent hyperglycemia (serum glucose >150 mg/dL) and high serum paraprotein levels. Treat hyponatremia per clinical guidelines (intravenous saline and/or salt tablets), including dietary review. Interrupt and/or reduce dose, or permanently discontinue based on severity of adverse reaction.

Infections

In patients receiving XPOVIO, 52% of patients experienced any grade of infection. Upper respiratory tract infection of any grade occurred in 21%, pneumonia in 13%, and sepsis in 6% of patients. Grade ≥3 infections were reported in 25% of patients, and deaths resulting from an infection occurred in 4% of patients. The most commonly reported Grade ≥3 infections were pneumonia in 9% of patients, followed by sepsis in 6%. The median time to onset was 54 days for pneumonia and 42 days for sepsis. Most infections were not associated with neutropenia and were caused by non-opportunistic organisms.

Neurological Toxicity

Neurological toxicities occurred in patients treated with XPOVIO.

Neurological adverse reactions including dizziness, syncope, depressed level of consciousness, and mental status changes (including delirium and confusional state) occurred in 30% of patients, and severe events (Grade 3-4) occurred in 9% of patients treated with XPOVIO. Median time to the first event was 15 days.

Optimize hydration status, hemoglobin level, and concomitant medications to avoid exacerbating dizziness or mental status changes.

Embryo-Fetal Toxicity

Based on data from animal studies and its mechanism of action, XPOVIO can cause fetal harm when administered to a pregnant woman. Selinexor administration to pregnant animals during organogenesis resulted in structural abnormalities and alterations to growth at exposures below those occurring clinically at the recommended dose.

Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with a female partner of reproductive potential to use effective contraception during treatment with XPOVIO and for 1 week after the last dose.

ADVERSE REACTIONS
The most common adverse reactions (incidence ≥20%) are thrombocytopenia, fatigue, nausea, anemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatremia, neutropenia, leukopenia, constipation, dyspnea, and upper respiratory tract infection.

The treatment discontinuation rate due to adverse reactions was 27%; 53% of patients had a reduction in the XPOVIO dose, and 65.3% had the dose of XPOVIO interrupted. The most frequent adverse reactions requiring permanent discontinuation in 4% or greater of patients who received XPOVIO included fatigue, nausea, and thrombocytopenia. The rate of fatal adverse reactions was 8.9%.

On June 9, 2020 Provectus (OTCQB: PVCT) reported that the Indian Patent Office (IPO) has granted the Company’s patent application for the combination of investigational autolytic cancer immunotherapy PV-10 and systemic immunomodulatory therapy, such as immune checkpoint blockade (CB) (Press release, Provectus Biopharmaceuticals, JUN 9, 2020, View Source [SID1234560940]). Pfizer, Inc. is a co-assignee on this award. The Company’s cancer combination therapy patent estate provides intellectual property (IP) protection in a number of countries in Asia, Europe, and North America into the 2030s.

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New IPO patent 337563 is associated with a family of US patents, including 9,107,887, which is entitled "Combination of local and systemic immunomodulative therapies for enhanced treatment of cancer" and was awarded by the United States Patent and Trademark Office (USPTO) in 2015, and 9,808,524, 9,839,688, and 10,471,144, which were awarded by the USPTO from 2017 to 2019.

The new 2020 IPO patent award for cancer combination therapy follows the Company’s IPO patent 297453, which was awarded in 2018 and protects Provectus’ proprietary manufacturing process used to produce the active pharmaceutical ingredient (API) in the Company’s current and prospective investigational drug products. IPO patent 297453 is associated with a family of US composition of matter and process patents, including 8,530,675, which is entitled "Process for the Synthesis of 4,5,6,7-tetrachloro-3′,6′-dihydroxy-2′,4′,5′,7′-tetraiodo-3H-spiro[isobenzofuran-1,9-xanthen]-3-one (Rose Bengal) and Related Xanthenes" and was awarded by the USPTO in 2013, and 9,273,022 and 9,422,260, which were awarded by the USPTO in 2016.

The Company is also pleased to announce that it received application number 20200138942 from the USPTO for a fifth cancer combination therapy patent application filing, which is based on the abovementioned patent family and includes the combination of PV-10 and two systemic immunomodulatory therapies, such as an anti-CTLA-4 agent (e.g., Yervoy) and an anti-PD-1 agent (e.g., Opdivo). The Company is the sole assignee for this new cancer combination therapy patent application.

The triplet immunotherapy combination of PV-10, Yervoy, and Opdivo for the treatment of uveal melanoma metastatic to the liver (mUM) in patients naïve to CB and refractory to single-agent and combination therapy CB was the subject of the Company’s poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program, held online May 29-31, 2020, entitled "Percutaneous hepatic injection of rose bengal disodium (PV-10) in metastatic uveal melanoma." This study, led by Sapna Patel, MD, Associate Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine of The University of Texas MD Anderson Cancer Center (MDACC), is enrolling patients into a single-center cohort at MDACC of up to 25 mUM patients.

Small molecule-based PV-10 is administered either by cutaneous intratumoral (IT) injection to superficial melanoma and non-melanoma skin cancer tumors (such as basal cell carcinoma, Merkel cell carcinoma, and squamous cell carcinoma) or by percutaneous IT injection to visceral primary and metastatic tumors of the liver (such as hepatocellular carcinoma, metastatic colorectal cancer, metastatic neuroendocrine tumors, and mUM). By targeting tumor cell lysosomes, PV-10 treatment may yield immunogenic cell death in solid tumor cancers that results in tumor-specific reactivity in circulating T cells and a T cell mediated immune response against treatment refractory and immunologically cold tumors.1-3 Adaptive immunity can be enhanced by combining CB with PV-10.4

About PV-10

PV-10 is an investigational new drug undergoing clinical study for adult solid tumor cancers, such as relapsed and refractory cancers metastatic to the liver and metastatic melanoma. PV-10 is also undergoing preclinical study for relapsed and refractory pediatric solid tumor cancers (e.g., neuroblastoma, Ewing sarcoma, rhabdomyosarcoma, and osteosarcoma)5,6 and relapsed and refractory pediatric blood cancers (such as acute lymphocytic leukemia and acute myelocytic leukemia)7,16.

Tumor Cell Lysosomes as the Seminal Drug Target

Lysosomes are the central organelles for intracellular degradation of biological materials, and nearly all types of eukaryotic cells have them. Discovered by Christian de Duve, MD in 1955, lysosomes are linked to several biological processes, including cell death and immune response. In 1959, de Duve described them as ‘suicide bags’ because their rupture causes cell death and tissue autolysis. He was awarded the Nobel Prize in 1974 for discovering and characterizing lysosomes, which are also linked to each of the three primary cell death pathways: apoptosis, autophagy, and necrosis.

Building on the Discovery, Exploration, and Characterization of Lysosomes

Cancer cells, particularly advanced cancer cells, are very dependent on effective lysosomal functioning.8 Cancer progression and metastasis are associated with lysosomal compartment changes9,10, which are closely correlated with (among other things) invasive growth, angiogenesis, and drug resistance11.

PV-10 selectively accumulates in the lysosomes of cancer cells upon contact, disrupting the lysosomes and causing the cells to die. Provectus1,12, external collaborators6, and other researchers14,15,17 have independently shown that PV-10 (RB) triggers each of the three primary cell death pathways: apoptosis, autophagy, and necrosis.

Cancer Cell Autolytic Death via PV-10: PV-10 induced autolytic cell death, or death by self-digestion, in Hepa1-6 murine HCC cells can be viewed in this Provectus video of the event (ethidium homodimer 1 [ED-1] stains DNA, but is excluded from intact nuclei; lysosensor green [LSG] stains intact lysosomes; the video is provided in 30-second frames; the event has a duration of approximately one hour). Exposure to PV-10 triggers the disruption of lysosomes, followed by nucleus failure and autolytic cell death. Identical responses have been shown by the Company in HTB-133 human breast carcinoma (which can be viewed in this Provectus video; this event has a duration of approximately two hours) and H69Ar human multidrug-resistant small cell lung carcinoma. Cancer cell autolytic cell death was reproduced by research collaborators from POETIC using relapsed and refractory human pediatric neuroblastoma cells to show that lysosomes are disrupted upon exposure to PV-10.5

Immune Signaling Pathways: PV-10 causes acute autolytic destruction of injected tumors (i.e., cell death), mediating several identified immune signaling pathways studied to date, such as the release of danger-associated molecular pattern molecules (DAMPs) and tumor antigens that initiate an immunologic cascade where local response by the innate immune system facilitates systemic anti-tumor immunity by the adaptive immune system. The DAMP release-mediated adaptive immune response activates lymphocytes, including CD8+ T cells, CD4+ T cells, and NKT cells, based on clinical and preclinical experience in multiple tumor types. Other mediated immune signaling pathways that have been identified include PARP cleavage5 and, now, stimulator of interferon genes (STING), which plays an important role in innate immunity16. PV-10 is the first cancer drug that may facilitate multiple, complementary, immune system signaling pathways.17

Orphan Drug Designations (ODDs)

ODD status has been granted to PV-10 by the U.S. Food and Drug Administration for the treatments of metastatic melanoma in 2006, hepatocellular carcinoma in 2011, neuroblastoma in 2018, and ocular melanoma (including uveal melanoma) in 2019.

Drug Product

Rose bengal disodium (RB) (4,5,6,7-tetrachloro-2’,4’,5’,7’-tetraiodofluorescein disodium salt) is a small molecule halogenated xanthene and PV-10’s active pharmaceutical ingredient. The Company manufactures RB using a patented process designed to meet strict modern global quality requirements for pharmaceuticals and pharmaceutical ingredients (Good Manufacturing Practice, or GMP). PV-10 drug product is an injectable formulation of 10% w/v GMP RB in 0.9% saline, supplied in single-use glass vials containing 5 mL (to deliver) of solution, and administered without dilution to solid tumors via IT injection.

Intellectual Property (IP)

Provectus’ IP includes a family of US and international (a number of countries in Asia, Europe, and North America) patents that protect the process by which GMP RB and related halogenated xanthenes are produced, avoiding the formation of previously unknown impurities that exist in commercial grade RB in uncontrolled amounts. The requirement to control these impurities is in accordance with International Council on Harmonisation (ICH) guidelines for the manufacturing of an injectable pharmaceutical. US patent numbers are 8,530,675, 9,273,022, and 9,422,260, with expirations ranging from 2030 to 2031.

The Company’s IP also includes a family of US and international (a number of countries in Asia, Europe, and North America) patents that protect the combination of PV-10 and systemic immunomodulatory therapy (e.g., anti-CTLA-4, anti-PD-1, and anti-PD-L1 agents) for the treatment of a range of solid tumor cancers. US patent numbers are 9,107,887, 9,808,524, 9,839,688, and 10,471,144, with expirations ranging from 2032 to 2035; US patent application numbers include 20200138942.

On June 9, 2020 Voltron Therapeutics, Inc. reported that it has entered into a Sponsored Research Agreement (SRA) with the Vaccine and Immunotherapy Center (VIC) of the Massachusetts General Hospital (MGH). Leveraging VaxCelerate, a self-assembling vaccine (SAV) platform licensed exclusively to Voltron Therapeutics by Partners HealthCare, the goal of the collaboration is to optimize the dosing and development of potent compounds that inhibit tumor growth in mice in the treatment of Human Papilloma Virus (HPV) induced malignancy and Ovarian cancer (Press release, Voltron Therapeutics, JUN 9, 2020, View Source;immunotherapy-center-at-the-massachusetts-general-hospital-to-advance-the-development-of-a-personalized-cancer-vaccine-301073035.html [SID1234560957]).

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In prior research, the SAV, when combined with a checkpoint inhibitor in a model of HPV-induced cancer, demonstrated a significant improvement in survival over either agent alone or combined. Based on these preliminary findings, several aspects of the protein core of the vaccine construct were re-engineered to optimize its ability to bind targets on cancer cells. These new Voltron Therapeutics sponsored preclinical studies set out to underscore the SAV’s safety and efficacy track record and position it for human trials.

Dr. Mark Poznansky, Director, Vaccine and Immunotherapy Center, MGH stated, "The self-assembling vaccine, co-invented with my colleague Dr. Jeffrey Gelfand, has been designed to be highly adaptable, designed for safety and allows for seamless modifications in order to target specific proteins found in tumor cells. Leveraging the protein HSP70, we are able to determine the quantity and timing of vaccination that best induces T-cell responses and explore the maximized benefit from vaccine induced anti-tumor immunity."

The SAV program has intellectual property surrounding composition of matter. The vaccine incorporates a heat shock protein that activates the immune system, bound to targeting peptides. The base core technology relies on synthesizing the heat shock protein with Avidin. Biotinylated immunogenic peptides are then bound to the HSP to customize the vaccine.

"Voltron Therapeutics is excited to continue our groundbreaking work with the VIC by supporting ongoing research dedicated to our Oncology program and the advancement of the VaxCelerate platform to develop vaccines to fight a range of cancers," said Pat Gallagher, Chief Executive Officer, Voltron Therapeutics. "The resources at the VIC and MGH to support vaccine development and innovation are instrumental in helping us advance this important work. We are hopeful that further development, pre-clinical testing and additional proof of concept results could lead to first in human trials in 2021 and ultimately make a significant and lasting difference in the treatment of cancer patients."

Additionally, Voltron Therapeutics has closed on $3.5 million in a Series-A Preferred funding round. The funds raised will be used to accelerate the development of SAV technology and expansion of the Company’s vaccine portfolio.

"This funding for Voltron Therapeutics will allow the company to conclude preclinical work as it moves toward human trials with the self-assembling vaccine," added James Ahern, Founder of Laidlaw Venture Partners, and member of the Voltron Therapeutics Board of Directors. "We at LVP are committed to continuing to support Voltron as it progresses the SAV portfolio into clinical development, with financial sponsorship and leverage of our expert network."

Voltron Therapeutics and MGH have a longstanding relationship for the development of vaccines to fight infectious diseases and cancer. Recently, Voltron Therapeutics announced a separate joint agreement to advance an application of the VaxCelerate platform to develop a vaccine designed to protect patients at risk of Coronavirus (COVID-19) infection. This vaccine will be entering animal testing this quarter. Currently, preclinical data exists in two different infectious disease settings with encouraging results. The COVID-19 vaccine could be in humans by late 2020/early 2021.

On June 9, 2020 Oasmia Pharmaceutical reported that it will publish its Year End Report for the financial year 2019/2020 on June 18, 2020, at 08.00 am CET (Press release, Oasmia, JUN 9, 2020, View Source [SID1234560923]).

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The company will hold a conference call and an online presentation on the same day at 10.00 am (CEST). The call will be hosted by Francois Martelet, CEO, and Michael af Winklerfelt, CFO. The presentation will be in English.

The conference call will be broadcast live on the web via the link: View Source

On June 9, 2020 Oncology Venture A/S (Nasdaq First North Stockholm: OV.ST) ("OV" or the "Company") reported that it has called upon Global Corporate Finance (GCF) to invest SEK 10 million in a directed shared issue in accordance with the Company’s share subscription agreement with GCF (Press release, Oncology Venture, JUN 9, 2020, View Source [SID1234560941]). The draw-down notice was issued to GCF on June 9, and the share subscription price shall be calculated as 95% of the daily volume weighted average price (VWAP) of the Company’s shares for the five consecutive trading days following the date of the draw down notice.

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The investment is the first investment tranche of up to a total of five such tranches Oncology Venture may request from Global Corporate Finance (New York City, NY, U.S.). Each investment tranche can total up to SEK 10 million.