On December 21, 2021 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, and the Menarini Group, ("Menarini"), a privately-held, leading international pharmaceutical company, reported their entry into an exclusive licensing agreement whereby Menarini will commercialize NEXPOVIO, Karyopharm’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound, in Europe and other key global territories (Press release, Karyopharm, DEC 21, 2021, View Source [SID1234597531]).

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Under the terms of the agreement, Menarini received exclusive rights to commercialize NEXPOVIO for the treatment of oncology indications in the European Union and other European countries (including the United Kingdom), Latin America and other key countries. In exchange, Karyopharm will receive an upfront payment of $75 million (USD) in 2021 and is eligible to receive up to an additional $202.5 million in future milestones, plus tiered double-digit royalties on net sales of NEXPOVIO in the licensed territories.

"Menarini is a global pharmaceutical company, with a strong heritage and footprint in Europe and an unwavering commitment to patients, that is dedicated to innovation and bringing new treatment options in oncology. Menarini is an ideal partner to maximize selinexor’s potential to have a positive impact on the treatment of cancer in Europe, Latin America and other key countries and this transaction marks an important step forward toward that goal," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "With a shared vision on the potential of selinexor and Menarini’s commercialization expertise, this agreement aligns our two companies with the common goal of expanding the number of patients who can access NEXPOVIO in these important global territories."

"We are delighted to partner with Karyopharm to provide NEXPOVIO in Europe, Latin America and other key countries in the world," said Elcin Barker Ergun, Chief Executive Officer of the Menarini Group. "Patients suffering from multiple myeloma continuously need different options as resistance develops to first line therapies and the unique mechanism of action of selinexor makes it an ideal partner as a backbone therapy in second line and beyond. The potential further expansion of NEXPOVIO in solid tumors, such as in endometrial cancers, where limited options exist, underline the wide potential of selinexor in playing a role in cancer treatments aligning well with our mission of providing therapies that can prolong patient lives."

NEXPOVIO has received conditional marketing authorization from the European Commission in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for NEXPOVIO in combination with Velcade (bortezomib) and low-dose dexamethasone for the treatment of multiple myeloma following at least one prior therapy. The MAA will be reviewed by the Committee for Medicinal Products for Human Use (CHMP), which will issue an opinion to the European Commission regarding the potential approval for the expanded indication. This review is expected to be completed during the first half of 2022.

About NEXPOVIO (selinexor)

NEXPOVIO, which is marketed as XPOVIO in the U.S., is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. NEXPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). NEXPOVIO 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. NEXPOVIO (selinexor) has been granted conditional marketing authorization by the European Commission in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Therapeutic indication for NEXPOVIO in the EU as well as The EEA Countries of Iceland, Liechtenstein and Norway

NEXPOVIO is indicated in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

IMPORTANT SAFETY INFORMATION

Contraindications: Hypersensitivity to selinexor.

Special warnings and precautions for use:

Recommended concomitant treatments
Patients should be advised to maintain adequate fluid and caloric intake throughout treatment. Intravenous hydration should be considered for patients at risk of dehydration.
Prophylactic concomitant treatment with a 5-HT3 antagonist and/or other anti-nausea agents should be provided prior to and during treatment with NEXPOVIO.

Haematology
Patients should have their complete blood counts (CBC) assessed at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment.

Thrombocytopenia:
Thrombocytopenic events (thrombocytopenia and platelet count decreased) were frequently reported in adult patients receiving selinexor, which can be severe (Grade 3/4). Patients should be monitored for signs and symptoms of bleeding and evaluated promptly.

Neutropenia:
Severe neutropenia (Grade 3/4) has been reported with selinexor.
Patients with neutropenia should be monitored for signs of infection and evaluated promptly.

Gastrointestinal toxicity:
Nausea, vomiting, diarrhoea, which sometimes can be severe and may require the use of anti-emetic and anti-diarrhoeal medicinal products.

Weight loss and anorexia:
Patients should have their body weight, nutritional status and volume checked at baseline, during treatment, and as clinically indicated. Monitoring should be more frequent during the first two months of treatment.

Confusional state and dizziness:
Patients should be instructed to avoid situations where dizziness or confusional state may be a problem and to not take other medicinal products that may cause dizziness or confusional state without adequate medical advice. Patients should be advised not to drive or operate heavy machinery until symptoms resolve.

Hyponatraemia:
Patients should have their sodium levels checked at baseline, during treatment, and as clinically indicated. Monitoring should be more frequent during the first two months of treatment.

Tumour lysis syndrome (TLS):
TLS has been reported in patients receiving therapy with selinexor. patients at a high risk for TLS should be monitored closely. Treat TLS promptly in accordance with institutional guidelines.

Fertility, pregnancy and lactation
Women of childbearing potential/contraception in males and females:
Women of childbearing potential and male adult patients of reproductive potential should be advised to use effective contraceptive measures or abstain from sexual intercourse while being treated with selinexor and for at least 1 week following the last dose of selinexor.

Pregnancy:
There are no data from the use of selinexor in pregnant women. Selinexor is not recommended during pregnancy and in women of childbearing potential not using contraception.

Breast-feeding:
It is unknown whether selinexor or its metabolites are excreted in human milk. A risk to breast-fed children cannot be excluded. Breast-feeding should be discontinued during treatment with selinexor and for 1 week after the last dose.

Undesirable effects
Summary of the safety profile
The most frequent adverse reactions (≥30%) of selinexor in combination with dexamethasone were nausea, thrombocytopenia, fatigue, anaemia, decreased appetite, decreased weight, diarrhoea, vomiting, hyponatraemia, neutropenia and leukopenia.

The most commonly reported serious adverse reactions (≥3%) were pneumonia, sepsis, thrombocytopenia, acute kidney injury, and anaemia.

Description of selected adverse reactions
Infections: Infection was the most common non-haematological toxicity. Upper respiratory tract infection and pneumonia were the most commonly reported infections with 25% of reported infections being serious and fatal infections occurring in 3% of treated adult patients.

Elderly population
Patients 75 years and older had a higher incidence of discontinuation due to an adverse reaction, higher incidence of serious adverse reactions, and higher incidence of fatal adverse reactions.

Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

On December 21, 2021 Heat Biologics, Inc. ("Heat") (NASDAQ: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, reported it has executed a definitive merger agreement to acquire Elusys Therapeutics, a commercial-stage biodefense company and the manufacturer of ANTHIM (obiltoxaximab) Injection, pursuant to which Elusys will merge into a wholly owned subsidiary of Heat (Press release, Heat Biologics, DEC 21, 2021, View Source [SID1234597529]). The acquisition is expected to close during the first quarter of 2022 and is subject to customary closing conditions. ANTHIM is approved for use in the U.S. and Canada, and in Europe and the United Kingdom under the brand name Obiltoxaximab SFL.

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The strategic acquisition of Elusys is intended to enhance Heat’s immunotherapy portfolio and further position Heat to take a lead role in the biodefense space. The addition of ANTHIM, together with Heat’s previously announced RapidVax platform designed to target emerging biological threats, would significantly expand the company’s infectious disease product portfolio. To date, Elusys has been awarded over $350 million in research and development contracts and procurement orders from the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response (ASPR), the National Institute of Allergy and Infectious Disease (NIAID), and the Department of Defense (DOD).

Through ongoing, multi-year partnerships with the U.S. government, Elusys has been supplying ANTHIM to the U.S. Strategic National Stockpile (SNS)—the government’s repository of critical medical supplies for biowarfare preparedness. Following the closing of this acquisition, Elusys will continue to operate as a wholly owned subsidiary of Heat. Under the terms of the merger agreement with Elusys, Heat will acquire all outstanding shares of Elusys. No stock or warrants will be issued in connection with the acquisition, and Elusys has no outstanding debt.

Jeff Wolf, Chief Executive Officer of Heat, commented, "We are excited to announce the signing of a definitive merger agreement for this transformative planned acquisition of Elusys. This is an important step in realizing our vision to develop and commercialize new biopharmaceuticals and vaccines for the global biodefense market. Anthrax represents one of the most significant biological warfare threats facing our country and Elusys has established a successful track record in collaborating with U.S. government agencies including BARDA, NIH, SNS and DOD. Following this acquisition, we look forward to further strengthening the ongoing collaboration with the U.S. government. Our goal is to expand global sales and leverage our capabilities to supply ANTHIM worldwide."

"Additionally, we recently unveiled our RapidVax program, a new cellular vaccine platform targeting known and unknown biological threats. This platform is designed for rapid "plug and play" to deliver new vaccines and to enable the stockpiling of medical countermeasures against emerging infectious agents and biological threats. We plan to leverage our proprietary discovery platform, clinical, regulatory, and manufacturing capabilities to accelerate the development and commercialization of new programs for global biodefense. This transaction will significantly expand our product portfolio and complements our ongoing efforts in the space," concluded Mr. Wolf.

Elizabeth Posillico, CEO of Elusys, stated, "This transaction begins an exciting new chapter for Elusys, and I am grateful to our team for their important contributions to the successful development and commercialization of ANTHIM. Heat brings significant core expertise and resources to accelerate the production and distribution of ANTHIM. I am very pleased that following the closing of the merger certain key members of the Elusys team will continue to manage and support the ANTHIM program. I believe Heat’s Biothreat Advisory Board, which includes leading global experts on biodefense, will facilitate the expansion of the product’s potential worldwide."

David Lasseter, former Deputy Assistant Secretary of Defense for Countering Weapons of Mass Destruction and a member of Heat’s Biothreat Advisory Board, further noted, "Anthrax is the deadliest bioterrorism threat to ever hit American soil, and that threat continues to this day from foreign state actors and others. It has been used as a weapon around the world with significant potential for mass casualties. Inhalation anthrax is the most serious form and can kill quickly if not treated immediately. ANTHIM is a key medical countermeasure for treatment of inhalation Anthrax and is currently stockpiled at strategic locations throughout the US as part of SNS. I and my fellow Biothreat Advisory Board members look forward to working with Elusys to expand the supply of ANTHIM globally to meet this deadly threat."

A special committee of Heat’s Board of Directors negotiated and approved the transaction and Cassel Salpeter & Co. provided a fairness opinion in connection with the transaction. Additional details on the transaction are outlined in Company’s Current Report on Form 8-K, which will be filed with the Securities and Exchange Commission and will be available on the Company’s website.

Elusys was advised by RBC Capital Markets, LLC.

About ANTHIM

Anthrax is a life-threatening infectious disease caused by Bacillus anthracis. Cases of inhalational anthrax in humans can occur through intentional spread of B. anthracis spores as a biowarfare or bioterrorism agent. B. anthracis spores introduced through the lungs lead to inhalational anthrax, which is deadly in humans.

ANTHIM is a monoclonal antibody that binds to the protective antigen (PA) component of anthrax toxin. ANTHIM’s toxin neutralizing activity prevents entry of anthrax toxin into susceptible cells, avoiding further spread of the toxin throughout the body and the ensuing tissue damage that leads to death. ANTHIM is supplied as single-dose vials for IV infusion.

Indications and Usage

ANTHIM is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. ANTHIM should only be used for prophylaxis when its benefit for prevention of inhalational anthrax outweighs the risk of hypersensitivity and anaphylaxis. The effectiveness of ANTHIM is based solely on efficacy studies in animal models of inhalational anthrax. There have been no studies of the safety or pharmacokinetics (PK) of ANTHIM in the pediatric population. Dosing in pediatric patients was derived using a population PK approach. ANTHIM does not have direct antibacterial activity. ANTHIM should be used in combination with appropriate antibacterial drugs. ANTHIM is not expected to cross the blood-brain barrier and does not prevent or treat meningitis.

IMPORTANT SAFETY INFORMATION Including BOXED WARNING

WARNING: HYPERSENSITIVITY and ANAPHYLAXIS
Hypersensitivity reactions, including anaphylaxis, have been reported during ANTHIM infusion. ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs.

WARNINGS AND PRECAUTIONS

Hypersensitivity and anaphylaxis have been reported during the IV infusion of ANTHIM. Due to the risk of hypersensitivity and anaphylaxis, ANTHIM should be administered in monitored settings by personnel trained and equipped to manage anaphylaxis. Monitor individuals who receive ANTHIM closely for signs and symptoms of hypersensitivity reactions throughout the infusion and for a period of time after administration. Stop ANTHIM infusion immediately and treat appropriately if hypersensitivity or anaphylaxis occurs. Pre-medication with diphenhydramine is recommended prior to administration of ANTHIM. Diphenhydramine pre-medication does not prevent anaphylaxis, and may mask or delay onset of symptoms of hypersensitivity.

ADVERSE REACTIONS

The safety of ANTHIM has been studied only in healthy volunteers. It has not been studied in patients with inhalational anthrax. The most frequently reported adverse reactions were headache, pruritus, infections of the upper respiratory tract, cough, vessel puncture site bruise, infusion site swelling, urticaria, nasal congestion, infusion site pain, and pain in extremity.

On December 21, 2021 GeneCentric Therapeutics, a company making precision medicine more precise through RNA-based diagnostics, reported the completion of its Piedmont Study, conducted in collaboration with Atrium Health Levine Cancer Institute (Press release, GeneCentric Therapeutics, DEC 21, 2021, View Source [SID1234597528]).

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Early results suggest that GeneCentric’s Antifolate Predictive Response Signature (AF-PRS), one of the signatures included in the recently announced strategic collaboration with Labcorp, identified a distinct population of patients who clearly benefit from treatment with pemetrexed/platinum doublet chemotherapy. Leveraging this deeper understanding with RNA-based tests such as the AF-PRS may help identify a broader patient population that may benefit from therapy, compared to DNA mutation analysis.

"We founded GeneCentric over a decade ago to study the genomics of lung cancer using the deep insights that can be obtained through gene expression analysis," said Neil Hayes, M.D., GeneCentric co-founder and Director of the University of Tennessee Health Science Center for Cancer Research. "While our work has expanded well beyond the lung, the actionable clinical and genomic datasets we have developed have led to multiple signatures and related prototype tests. As a treating physician, I am excited about the promise of the predictive insights that can be gained from the Piedmont Study as we navigate the existing and emerging treatment options for lung cancer patients."

In this retrospective study of real-world data, clinical response data and existing tumor samples were collected from about 250 patients with non-squamous non-small cell lung cancer (NSCLC) who were treated with either pemetrexed/platinum doublet chemotherapy, pembrolizumab (Keytruda), or the combination of the two. The Piedmont Study paired highly curated real-world clinical and demographic data with bulk tumor RNA transcriptome analysis from patients with NSCLC, which was analyzed using GeneCentric’s RNA-based Tumor and Immune Micro-Environment (rT(I)ME) Explorer platform.

"There has been great progress with the development of new treatment options for patients with locally advanced or metastatic non-small cell lung cancer," said Kathryn Mileham, M.D., Piedmont Study Principal Investigator and Chief of the Section of Thoracic Medical Oncology at Atrium Health Levine Cancer Institute. "With the prevalent use of immune oncology agents alone or in combination with chemotherapy, there needs to be a deeper understanding of how to select the right treatment for the right patient, and the Piedmont Study will aid in this endeavor."

The clinical and genomic data analysis from this study is ongoing. The AF-PRS test and associated lung adenocarcinoma (LUAD) molecular subtype classifier assay explored in the current study will support GeneCentric’s growing pipeline of novel RNA-based predictive response signatures and related tests. In addition, this real-world evidence dataset joins the expanding number of highly curated clinicogenomic datasets across multiple tumor types and therapeutics areas that GeneCentric has developed and deployed, in collaboration with pharmaceutical and biotechnology partners, to explore novel oncology therapeutic options and diagnostic tests.

About the Piedmont Study

Utilizing Atrium Health Levine Cancer Institute’s broad network of 25+ clinical centers that see around 20,000 new cancer cases per year, retrospective baseline clinical, demographic and clinical response data were collected on over 500 patients receiving systemic first-line treatment for locally advanced or metastatic non-squamous NSCLC. The primary focus of the study was a subset of approximately 250 patients with existing tumor samples who received either pemetrexed-containing platinum doublet chemotherapy, pembrolizumab (Keytruda) or the combination of the two. Tumor samples underwent transcriptome RNA sequencing (RNAseq) and were analyzed using GeneCentric’s RNA-based Tumor and Immune Micro-Environment (rT(I)ME) Explorer platform, which is an integrated pipeline used to translate tumor biology insights into actionable genomic signatures predictive of drug response.

On December 21, 2021 Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, reported that it has closed on the second $10 million convertible note pursuant to a financing agreement entered in September, 2021, with Richard E. Uihlein, the Company’s Chairman and largest individual stockholder (Press release, Galectin Therapeutics, DEC 21, 2021, View Source [SID1234597527]). In total, the Company has received $30 million in three convertible notes from Mr. Uihlein in 2021.

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The convertible notes are unsecured and bear interest at a rate of 2% compounded annually. Additional interest of 2.5% per quarter will accrue but will only be paid if the debt and interest are converted into shares of the Company’s common stock, at Mr. Uihlein’s option, on or prior to maturity, which is four years from the date of each loan closing. The conversion price of the debt and interest is fixed at 228% above the price per share of common stock on the day prior to each closing or $5.00 per share, whichever is greater.

Richard E. Uihlein, Chairman of Galectin Therapeutics, commented, "As I have stated many times, I remain deeply committed to the Company’s success and our goal of addressing large, unmet medical needs. I am proud of our progress in 2021 and look forward to achievement of additional significant milestones in 2022 and beyond. I have confidence in our team and our science, and I look forward to furthering our programs."

"I thank Mr. Uihlein for his remarkable commitment to the Company. As I have said previously, the impact of his financial backing and leadership as Chairman cannot be overstated," said Joel Lewis, president and Chief Executive Officer of Galectin Therapeutics. "We expect to continue making significant progress in our NAVIGATE trial for patients with NASH cirrhosis, and we also are exploring how to best move forward in the treatment of advanced head and neck cancer, where we have seen promising early results of belapectin in combination with KEYTRUDA. Earlier this month, following our Annual Stockholders Meeting, I outlined our achievements in 2021 and our goals for 2022, which you may review at View Source We look forward to reporting our progress in 2022."

About Belapectin

Belapectin is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of NASH and fibrosis. Galectin-3 plays a major role in diseases that involve scarring of organs including fibrotic disorders of the liver, lung, kidney, heart and vascular system. Belapectin binds to galectin-3 and disrupts its function. Preclinical data in animals have shown that belapectin has robust treatment effects in reversing liver fibrosis and cirrhosis. A Phase 2 study showed belapectin may prevent the development of esophageal varices in NASH cirrhosis, and these results provide the basis for the conduct of the NAVIGATE trial. The NAVIGATE trial (NAVIGATEnash.com), entitled "A Seamless Adaptive Phase 2b/3, Double-Blind, Randomized, Placebo-controlled Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis" began randomization of patients in August, 2020, and is posted on www.clinicaltrials.gov (NCT04365868). Galectin-3 has a significant role in cancer, and the Company has supported a Phase 1b study in combined immunotherapy of belapectin and KEYTRUDA in advanced melanoma and in head and neck cancer. This trial provided a strong rationale for moving forward into a Phase 2 development program which the company is considering.

About Fatty Liver Disease with Advanced Fibrosis and Cirrhosis

Non-alcoholic steatohepatitis (NASH) has become a common disease of the liver with the rise in obesity and other metabolic diseases. NASH is estimated to affect up to 28 million people in the U.S. It is characterized by the presence of excess fat in the liver along with inflammation and hepatocyte damage (ballooning) in people who consume little or no alcohol. Over time, patients with NASH can develop excessive fibrosis, or scarring of the liver, and ultimately liver cirrhosis. It is estimated that as many as 1 to 2 million individuals in the U.S. will develop cirrhosis as a result of NASH, for which liver transplantation is the only curative treatment available. Approximately 8,890 liver transplants are performed annually in the U.S. There are no drug therapies approved for the treatment of liver fibrosis or cirrhosis.

On December 21, 2021 EXUMA Biotech, Corp., a clinical-stage biotechnology company discovering and developing cell and gene therapies and delivery solutions for liquid and solid tumors, reported the completion of a $41 million Series B2 financing (Press release, EXUMA Biotechnology, DEC 21, 2021, View Source [SID1234597526]). The Series B2 brings the total capital raised since its inception to approximately $130 million.

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Proceeds will be used to support further development of EXUMA’s autologous subcutaneous rPOC CAR-TaNK (T- and NK-like) platform for hematologic and solid tumors and continued clinical investigation of its Tumor Metabolism Regulated (TMR) CAR technology targeting solid tumors. New investors in the Series B2 financing included Americo Life, Inc., in addition to existing investors.

"We are pleased to expand our investor base with support from this strategic group of investors who recognize the potential of our technologies to translate into life-changing therapies for cancer patients," said Gregory Frost, Ph.D., EXUMA Biotech Chairman and Chief Executive Offer.

Additionally, the company announced that Houston Holmes, M.D., MBA, FACP has been appointed to its Board of Directors.

"Dr. Holmes is a renowned cancer specialist who will make an outstanding addition to our board of directors. He has dedicated his life to researching advanced cellular and immunotherapy treatments for hematologic malignancies and to the education of the oncology community about these new modalities," said Frost.

Houston Holmes, M.D., received a BS in medical microbiology from Stanford University School of Medicine, an MD from the University of Texas Southwestern Medical School, and an MBA from the University of Texas at Dallas. He completed an internship and residency in internal medicine at Baylor University Medical Center, and fellowship in medical oncology/hematology at the National Cancer Institute/National Heart, Lung, and Blood Institute. Dr. Holmes has been in practice for over 20 years.

"It’s an exciting time for cell and gene therapies. I’m thrilled to be a part of EXUMA and to join the company in its mission to advance innovative therapies towards the clinic and for cancer patients in urgent need of new treatments," said Houston Holmes, M.D.