On December 3, 2019 Intec Pharma Ltd. (NASDAQ: NTEC) ("Intec" or "the Company") reported that the Company has entered into an Ordinary Shares Purchase Agreement for $10.0 million with Aspire Capital Fund, LLC ("Aspire Capital"), a Chicago-based institutional investor (Press release, Intech Pharmaceuticals, DEC 3, 2019, View Source [SID1234551902]). Under the terms of the Agreement, Aspire Capital is committed to purchase up to $10.0 million of Intec Pharma’s ordinary shares over a 30-month period extending into 2022, subject to certain terms and conditions. There are no warrants, derivatives, or other share classes associated with this agreement. Proceeds from the Agreement will be used to fund the Company’s research and development activites, for working capital and for general corporate purposes.

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"We are delighted to partner with Aspire Capital under this Agreement. Aspire Capital has been a long-term institutional shareholder in Intec Pharma and this Agreement gives us the flexibility to access capital when and if we need it. Moreover, we believe this commitment strengthens our negotiating position with any potential partners for our Parkinson’s disease program and/or for new research collaborations," stated Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma. "Controlling the timing and amount of ordinary shares being sold is key, as we can use this Agreement to opportunistically strengthen our balance sheet without unnecessary dilution as we seek to advance our AP platform programs to key inflection points in 2020. We appreciate Aspire Capital’s continued support."

"To us, the AP represents a major advance in drug delivery especially considering the significant number of approved and development-stage drugs that possess great therapeutic promise but remain hamstrung by either poor bioavailability or a PK profile that promotes adverse outcomes. Backed by a highly experienced management team, robust manufacturing capabilities and strong, supportive evidence from multiple clinical and non-clinical studies, the AP platform has proven to be an elegant solution for addressing these widespread drug delivery challenges. The available data, including those from the recent ACCORDANCE study, clearly demonstrate the APs ability to enhance the PK profile of drugs that have notoriously challenging absorption rates and short upper gastrointestinal residence times without sacrificing tolerability and ultimately, patient quality of life," said Steven G. Martin, Managing Member of Aspire Capital.

"The company’s collaborations with leading pharma companies such as Merck and Novartis further enhance our confidence in the AP platform’s broad applicability beyond Parkinson’s disease, where the company has already demonstrated proof-of-concept and gives us optimism about additional potential partnerships. As a result, we are thrilled to be expanding our longstanding interest and investment in Intec with this transaction," added Mr. Martin.

Under the terms of the Agreement with Aspire Capital, Intec Pharma retains full control over the timing of any stock sales made under the Agreement and the amount of stock sold to Aspire Capital. The agreement contains no restrictions on the use of proceeds, financial covenants or restrictions on future financings and no rights of first refusal, participation rights, penalties or liquidated damages. Intec Pharma maintains the right to terminate the agreement at any time, at its discretion, without any additional cost or penalty.

As consideration for Aspire Capital’s obligations under the Agreement, Intec Pharma also agreed to issue 612,520 ordinary shares to Aspire Capital as a commitment fee. Intec Pharma also entered into a Registration Rights Agreement with Aspire Capital in connection with its entry into the purchase agreement that requires Intec Pharma to file a registration statement regarding the shares sold to Aspire Capital.

For more information on the Agreement, please refer to Intec Pharma’s report on From 8-K filed today with the U.S. Securities and Exchange Commission, which can be found on the Company’s website at View Source

Intec Pharma has filed a prospectus supplement to its Form S-3 shelf registration statement (File No. 333-230016), which was declared effective on March 28, 2019 by the U.S. Securities and Exchange Commission, qualifying the offer and sale of ordinary shares to Aspire Capital. A copy of the Prospectus Supplement is available on EDGAR at www.sec.gov or may be obtained upon request to Intec Pharma.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor will 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 registration or qualification under the securities laws of any such state or other jurisdiction.

On December 3, 2019 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported the presentation of new data in acute myeloid leukemia (AML) at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place Dec. 7-10 in Orlando, Fla (Press release, Astellas, DEC 3, 2019, View Source [SID1234551828]).

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Seven abstracts sponsored by Astellas focus on patients with relapsed (disease that has returned) or refractory (resistant to treatment) AML with a FLT3 mutation (FLT3mut+). The abstracts include new findings from the Phase 3 ADMIRAL trial – an oral presentation on emerging mutations in patients who develop resistance after an initial response to XOSPATA and two poster presentations focused on patient-reported outcomes – as well as data on cost-effectiveness, FLT3 testing and treatment patterns, and venetoclax combination therapy.

"Astellas is committed to elevating care in hard-to-treat cancers, and since the approval of XOSPATA one year ago, we have continued expanding our research program to better understand and address unmet medical needs of patients with FLT3 mutation-positive AML," said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head, Astellas.

Oral Presentation:

Title: Emerging Mutations at Relapse in Patients with FLT3-Mutated Relapsed/ Refractory Acute Myeloid Leukemia Who Received Gilteritinib Therapy in the Phase 3 ADMIRAL Trial (Abstract 14)

Presenter: Catherine C. Smith, M.D., Division of Hematology and Blood and Marrow Transplantation, University of California San Francisco

Session Date/Time: Saturday, Dec. 7, 7:45 a.m. EST
Location: Orange County Convention Center, W304 Level 3

Key Abstracts Presented During Poster Sessions or Available Online:

Title: The Relationship between Hospitalization and Patient-Reported Outcomes (PROs) in Patients with FLT3-Mutated (FLT3mut+) Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML): Results from the Phase 3 ADMIRAL Study (Abstract 1332)

Lead Author: Ellen K. Ritchie, M.D., Weill Cornell Medicine, New York

Session Date/Time: Saturday, Dec. 7, 5:30-7:30 p.m. EST
Location: Orange County Convention Center, Hall B, Level 2
Title: The Relationship between Transplant Status and Patient-Reported Outcomes in Patients with FLT3-Mutated Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML): Results from the Phase 3 ADMIRAL Study (Abstract 3850)

Lead Author: David Cella, Ph.D., Northwestern University, Feinberg School of Medicine, Chicago

Session Date/Time: Monday, Dec. 9, 6-8 p.m. EST
Location: Orange County Convention Center, Hall B, Level 2
Title: Cost-Effectiveness Analysis of Gilteritinib Versus Salvage Chemotherapy (SC) for the Treatment of Relapsed or Refractory (R/R) FLT3-Mutated (FLT3mut+) Acute Myeloid Leukemia (AML) (Abstract 3859)

Lead Author: Amer M. Zeidan, MBBS, MHS, Department of Internal Medicine, Section of Hematology, Yale University School of Medicine and Yale Cancer Center, New Haven, Conn.

Session Date/Time: Monday, Dec. 9, 6-8 p.m. EST
Location: Orange County Convention Center, Hall B, Level 2
Title: Venetoclax in Combination with Gilteritinib in Patients with Relapsed/Refractory Acute Myeloid Leukemia: A Phase 1b Study (Abstract 3910) (Supported by AbbVie, Astellas and Genentech)

Lead Author: Alexander E. Perl, M.D., Abramson Cancer Center of the University of Pennsylvania, Philadelphia.

Session Date/Time: Monday, Dec. 9, 6-8 p.m. EST
Location: Orange County Convention Center, Hall B, Level 2
Title: STREAMLINE – Study of Relapse or Refractory (R/R) FLT3-Mutated Acute Myeloid Leukemia (AML) Using Electronic Medical Records (EMR): First Analysis from a Multicenter, Retrospective Cohort Study (Abstract 5082)

Lead Author: Amer M. Zeidan, MBBS, MHS, Department of Internal Medicine, Section of Hematology, Yale University School of Medicine and Yale Cancer Center, New Haven, Conn.

Title: Cost-Effectiveness Analysis of Gilteritinib Versus Best Supportive Care (BSC) for the Treatment of Relapsed or Refractory (R/R) FLT3 Mutation-Positive (FLT3mut+) Acute Myeloid Leukemia (AML) (Abstract 5085)

Lead Author: Amer M. Zeidan, MBBS, MHS, Department of Internal Medicine, Section of Hematology, Yale University School of Medicine and Yale Cancer Center, New Haven, Conn.

Astellas-Supported Satellite Symposia
Astellas will support the following pre-meeting Friday Satellite Symposia

Title: Data + Perspectives: Exploring the Role of Novel Agents and Emerging Strategies in the Management of Acute Myeloid Leukemia

Session Date/Time: Friday, Dec. 6, 7-11 a.m. EST
Location: Hilton Orlando, Orange Ballroom (Lower Level)
Title: Treating Acute Myeloid Leukemia: Case Challenges and Emerging Therapies

Session Date/Time: Friday, Dec. 6, 6-10 p.m. EST
Location: Hyatt Regency Orlando, Plaza International D-F

On December 3, 2019 Bristol-Myers Squibb Company (NYSE: BMY) and Acceleron Pharma Inc. (NASDAQ: XLRN) reported the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee will hold a review of Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) for the use of Reblozyl (luspatercept-aamt) in patients with myelodysplastic syndromes (MDS) at its meeting on December 18, 2019 (Press release, Bristol-Myers Squibb, DEC 3, 2019, View Source [SID1234551869]). Bristol-Myers Squibb is seeking approval of Reblozyl, an erythroid maturation agent representing a new class of therapy, for the treatment of adult patients with very low- to intermediate-risk MDS-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions.

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Reblozyl is currently being reviewed by the FDA for an indication in patients with MDS, and the agency has set a Prescription Drug User Fee Act (PDUFA), or target action, date of April 4, 2020 for completion of the review. The agency recently granted approval of Reblozyl for the treatment of anemia in adult patients with beta thalassemia who require regular RBC transfusions. Reblozyl is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

Reblozyl is not approved for the treatment of MDS in any country.

About Anemia in Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are a group of closely related, but diverse blood cancers in which mutations prevent the bone marrow stem cells from making healthy blood cells. Most patients experience severe chronic anemia due to the lack of mature RBCs. Anemia associated with MDS remains a significant area of unmet need for these patients, as current treatment options are limited, consisting primarily of medicines that stimulate the production of erythropoietin, and regular RBC transfusions. Regular RBC transfusions can disrupt and diminish a patient’s quality of life and are associated with an increased risk of iron overload, transfusion reactions and infections.

Bristol-Myers Squibb: Advancing Cancer Research

At Bristol-Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase quality, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational chimeric antigen receptor (CAR) T-cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.

About Reblozyl (luspatercept-aamt)

Reblozyl is a first-in-class erythroid maturation agent that promotes late-stage RBC maturation in animal models. Bristol-Myers Squibb and Acceleron are jointly developing Reblozyl as part of a global collaboration. It is currently approved in the U.S. for the treatment of anemia in adult patients with beta thalassemia who require regular RBC transfusions. Reblozyl is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia. A Phase 3 trial (COMMANDS) in erythroid stimulating agent-naïve, lower-risk MDS patients, the BEYOND Phase 2 trial in adult patients with non-transfusion-dependent beta thalassemia, and a Phase 2 trial in myelofibrosis patients are ongoing. For more information, please visit www.clinicaltrials.gov.

U.S. FDA-APPROVED INDICATIONS FOR REBLOZYL

REBLOZYL is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.

REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

Important Safety Information

WARNINGS AND PRECAUTIONS

Thrombosis/Thromboembolism

Thromboembolic events (TEE) were reported in 8/223 (3.6%) REBLOZYL-treated patients. TEEs included deep vein thrombosis, pulmonary embolus, portal vein thrombosis, and ischemic stroke. Patients with known risk factors for thromboembolism (splenectomy or concomitant use of hormone replacement therapy) may be at further increased risk of thromboembolic conditions. Consider thromboprophylaxis in patients at increased risk of TEE. Monitor patients for signs and symptoms of thromboembolic events and institute treatment promptly.

Hypertension

Hypertension was reported in 10.7% (61/571) of REBLOZYL-treated patients. Across clinical studies, the incidence of Grade 3 to 4 hypertension ranged from 1.8% to 8.6%. In patients with beta thalassemia with normal baseline blood pressure, 13 (6.2%) patients developed systolic blood pressure (SBP) >130 mm Hg and 33 (16.6%) patients developed diastolic blood pressure (DBP) >80 mm Hg. Monitor blood pressure prior to each administration. Manage new or exacerbations of preexisting hypertension using anti-hypertensive agents.

Embryo-Fetal Toxicity

REBLOZYL may cause fetal harm when administered to a pregnant woman. REBLOZYL caused increased post-implantation loss, decreased litter size, and an increased incidence of skeletal variations in pregnant rat and rabbit studies. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose.

ADVERSE REACTIONS

Serious adverse reactions occurring in 1% of patients included cerebrovascular accident and deep vein thrombosis. A fatal adverse reaction occurred in 1 patient treated with REBLOZYL who died due to an unconfirmed case of acute myeloid leukemia (AML).

Most common adverse reactions (at least 10% for REBLOZYL and 1% more than placebo) were headache (26% vs 24%), bone pain (20% vs 8%), arthralgia (19% vs 12%), fatigue (14% vs 13%), cough (14% vs 11%), abdominal pain (14% vs 12%), diarrhea (12% vs 10%) and dizziness (11% vs 5%).

LACTATION

It is not known whether REBLOZYL is excreted into human milk or absorbed systemically after ingestion by a nursing infant. REBLOZYL was detected in milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because many drugs are excreted in human milk, and because of the unknown effects of REBLOZYL in infants, a decision should be made whether to discontinue nursing or to discontinue treatment. Because of the potential for serious adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for 3 months after the last dose.

On December 3, 2019 KSQ Therapeutics, a biotechnology company using its proprietary CRISPRomics discovery platform to achieve higher probabilities of success in drug development, reported that KSQ CEO David Meeker, M.D., will present at the Piper Jaffray 31st Annual Healthcare Conference on Tuesday, December 3, 2019 at 8:30 a.m. ET in New York (Press release, KSQ Therapeutics, DEC 3, 2019, View Source [SID1234551886]). Dr. Meeker will provide a corporate overview and update on the company’s research and development programs in immuno-oncology and adoptive cell therapies.

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The company has declared its lead program, a first-in-class biomarker-enabled monotherapy inhibitor of TO-4, an undisclosed target in the DNA Damage Repair (DDR) pathway, which the company plans to develop for ovarian cancer and triple negative breast cancer. The small molecule candidate has shown activity in certain BRCA-mutant and homologous recombination deficient (HRD) cancer models. The company’s second program is KSQ-001, part of KSQ’s engineered tumor-infiltrating lymphocyte (eTIL) adoptive cell therapy program, which will be developed for the treatment of PD-1 refractory solid tumors.

"Over the past year, we have made significant progress in driving the translational process for the lead programs identified from our proprietary CRISPRomics discovery engine and advancing them toward development-stage programs," said Dr. Meeker. "Our focus for the year ahead will be on preparing the clinical program for our lead immuno-oncology candidate and initiating IND-enabling studies for our first adoptive cell therapy candidate. We have a high degree of confidence in the potential of both of these programs because of the insights that we generated that led to their discovery and the significant medical need in the therapeutic areas that we are pursuing."

On December 3, 2019 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported it has completed patient enrollment in its Phase 3 "Fluorescent Light Activated Synthetic Hypericin" (FLASH) study for SGX301 (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) (Press release, Soligenix, DEC 3, 2019, View Source [SID1234551903]). The study successfully enrolled 169 subjects, following positive interim analysis, which included a prospectively defined, unblinded assessment of the study’s primary efficacy endpoint by an independent Data Monitoring Committee (DMC). With enrollment completed, top-line results are expected in the first quarter of 2020.

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SGX301 is a novel, first-in-class, photodynamic therapy that combines synthetic hypericin, a potent photosensitizer that is applied as an ointment to the cancerous skin lesions and activated using a brief, safe, fluorescent light treatment. This treatment approach is expected to minimize the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on exposure to ultraviolet A and B light.

"We are pleased to have completed enrollment and look forward to the top-line results in the first quarter of next year, particularly in light of the DMC recommendation at the interim analysis which observed a beneficial drug effect," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We have invested a significant amount of the Company’s resources into the CTCL development program and continue to positively position this fast-tracked program for approval. We believe SGX301 has the potential to be a valuable therapy in the front-line treatment of early stage CTCL, which is an orphan disease and area of unmet medical need."

"SGX301 has the potential to have a significant impact on the lives of CTCL patients while minimizing their exposure to potential secondary cancers," stated Richard Straube, MD, Senior Vice President and Chief Medical Officer of Soligenix. "We would like to thank the DMC members, our esteemed medical advisory board and our dedicated clinical investigators for their ongoing efforts in the design and conduct of this important clinical trial, as well as all the subjects that are participating in the trial. Our focus is now to complete the treatments for all subjects and to lock the study database, facilitating top-line results in the first quarter of 2020."

Based on the positive results demonstrated in the Phase 2 study of SGX301, the Phase 3 trial is a highly powered, double-blind, randomized, placebo-controlled, multicenter trial. The primary efficacy endpoint is assessed as the percent of patients in each of the two treatment groups (i.e., SGX301 and placebo) achieving a successful response of the treated lesions at the end of Cycle 1 (Week 8) compared to baseline. A successful treatment response is defined as a 50% or greater reduction of the three index lesions treated as determined by the cumulative Composite Assessment of Index Lesion Severity (CAILS) scoring system. Other secondary measures, including treatment response (including duration), degree of improvement, time to relapse and safety, are further determined by data collected throughout the follow-on open-label portions of the trial in Cycle 2 (index lesions treated in all patients) and Cycle 3 (all lesions treated in all patients), as well as the six-month follow-up period.

A prospectively defined interim analysis was conducted in October 2018 by an independent DMC and was used to verify the underlying assumptions defining the required sample size of the study to maintain its rigorous 90% statistical power. The DMC identified a beneficial SGX301 effect and accordingly adjusted the study sample size to approximately 160. The DMC did not identify any safety concerns. The interim recommendation is described in the October 2018 press release here.

About SGX301

SGX301 is a novel first-in-class photodynamic therapy utilizing safe visible light for activation. The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions, is taken up by the malignant T-cells, and then activated by fluorescent light 16 to 24 hours later. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging chemotherapeutic drugs and other photodynamic therapies that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p ≤ 0.04) improvement with topical hypericin treatment whereas the placebo was ineffective: 58.3% compared to 8.3%, respectively. SGX301 has received orphan drug and fast track designations from the US Food and Drug Administration (FDA), as well as orphan designation from the European Medicines Agency (EMA).

The Phase 3 study is referred to as the FLASH (Fluorescent Light Activated Synthetic Hypericin) trial. The trial consists of three treatment cycles, each of 8 weeks duration. Treatments are administered twice weekly for the first 6 weeks and treatment response is determined at the end of Week 8. In the first treatment cycle, approximately 107 subjects receive SGX301 treatment (0.25% synthetic hypericin) and 53 receive placebo treatment of their index lesions. In the second cycle, all subjects receive SGX301 treatment of their index lesions and in the third (optional) cycle all subjects receive SGX301 treatment of all their lesions. Subjects are followed for an additional 6 months after the completion of treatment. The majority of patients enrolled have elected to continue with the optional, open-label component of the study.

The Phase 3 CTCL clinical study is partially funded with this NCI Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc.

About Cutaneous T-Cell Lymphoma (CTCL)

CTCL is a class of non-Hodgkin’s lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin where they form various lesions, typically beginning as a rash and eventually forming raised plaques and tumors as the disease progresses. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL. Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.

CTCL constitutes a rare group of NHLs, occurring in about 4% of the approximate 700,000 individuals living with the disease. It is estimated, based upon review of historic published studies and reports and an interpolation of data on the incidence of CTCL that it affects over 25,000 individuals in the US, with approximately 3,000 new cases seen annually.