Bexion Pharmaceuticals, Inc. Announces Data at 2018 ASCO Annual Meeting from Ongoing Phase I BXQ-350 Clinical Trial

On June 12, 2018 Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company focused on rare brain and solid tumors, reported data from 17 patients enrolled in the Phase Ia portion of its ongoing Phase I Safety Trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting Poster Session, held in Chicago June 1-5, 2018 (Press release, Bexion, JUN 12, 2018, View Source [SID1234527440]).

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In the poster presentation entitled, "First-in-class Phase Ia Study of BXQ-350 for Solid Tumors and Gliomas", the preliminary data showed:

9 patients with Glioblastoma Multiforme (GBM); 8 patients with other solid tumors
Patients had a median 7 prior systemic therapies
No Dose Limiting Toxicities (DLTs)
No treatment –related serious adverse events (SAEs)
Most common treatment-related moderate AEs were transient fatigue
Best response in 7 patients completing to day 113:
1 Partial Response (appendiceal carcinoma)
6 Stable Disease (improved day 113 RANO/RECIST
1 High Grade Glioma Stable Disease >19+ months
"Bexion’s team was excited to share our Phase Ia data at the ASCO (Free ASCO Whitepaper) conference," stated Dr. Ray Takigiku, Founder and CEO. "With this promising data indicating the potential for a tumor agnostic approach, Bexion is now enrolling patients with solid tumors and gliomas in Phase 1b, and we are initiating efforts to towards a Phase 1 trial in pediatrics and combination Phase 2 studies in adults".

About BXQ-350

BXQ-350 is a unique formulation of a synthetically produced, human lysosomal protein, Saposin C (sphingolipid activator protein, or SapC), and the phospholipid dioleoylphosphatidylserine (DOPS).

Galectin Therapeutics Inc. Announces New CEO

On June 12, 2018 Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, reported that Harold H. Shlevin, Ph.D., currently the Company’s Chief Operating Officer (COO), has been appointed Chief Executive Officer (CEO) and President to succeed Peter G. Traber, M.D., who has tendered his resignation as President, CEO and Chief Medical Officer (Press release, Galectin Therapeutics, JUN 12, 2018, View Source [SID1234527278]). The transition will be effective July 6, 2018.

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Board Chairman, Richard Uihlein commented "As the Company enters this next strategic phase, we are extremely pleased that Dr. Harold Shlevin, who has been Galectin’s COO since 2012, and who has extensive healthcare leadership experience, has agreed to take on the broader role of CEO at this critical juncture. Harold has significant business development experience as an executive and will be responsible for directing and overseeing the potential partnering of our NASH Phase 3 compound. Dr. Shlevin will also oversee future NASH cirrhosis trials and is responsible for the Company’s clinical trials in cancer immunotherapy and any other potential new clinical trials in other indications."

"In conjunction with this transition, the Company has also engaged Back Bay Life Science Advisors, a Boston-based, internationally focused integrated strategy and transaction advisory organization to support the Company, and the management team in its exploration of strategic alternatives. After meeting Dr. Jonathan Gertler and his team, I look forward to my continued involvement in this process. Back Bay, management and the Board have earned and deserve my personal attention and full confidence.", added Mr. Uihlein.

Regarding Dr. Traber, Board Chair Richard Uihlein stated, "Peter has been tireless in his efforts in guiding Galectin over the past seven years. As a distinguished scientist and hepatologist, Peter has a keen interest in conquering NASH cirrhosis, and we believe our compound, GR-MD-02, has shown tremendous potential in this regard. Peter’s clinical and scientific vision was critical to the company in reaching its current Phase 3 ready development trajectory. His recent leadership in meeting with the FDA and being allowed to proceed to clinical phase 3 has been indispensable and positions the Company for its next stage of growth and development. We thank him for his many contributions to the Company."

Dr. Shlevin said, "I am extremely grateful for the Board’s confidence in our experienced team, many of whom I recruited to Galectin Therapeutics and worked with for many years prior to joining Galectin. It has been a personal and professional pleasure to work with Peter over the last six years, and the Company and I wish him well in his future endeavors."

"We believe our NASH-CX Phase 2 trial was the first large, randomized clinical trial of any drug to demonstrate a clinically meaningful improvement in HVPG in NASH cirrhosis patients. With our management team and other core team members and the Board leadership under Dick Uihlein, I am confident in our ability to build value for our shareholders and advance GR-MD-02 to provide patients a treatment option for dealing with their NASH cirrhosis," concluded Dr. Shlevin.

About Dr. Shlevin:

Dr. Shlevin is a 25-year bioscience-industry executive with broad senior management experience in development and commercialization of medical devices, pharmaceuticals, diagnostics and vaccines. As COO of Galectin Therapeutics, he was responsible for all operational aspects of the company, including regulatory affairs & quality assurance, manufacturing, clinical development, business development and commercial development.

Prior to his work at Galectin, Dr. Shlevin served Georgia Institute of Technology’s Advanced Technology Development Center (ATDC) as manager of bioscience partnering and commercialization efforts. He was also previously President and CEO of Solvay Pharmaceuticals US and a member of Solvay’s global pharmaceutical management team. He has also held senior executive positions at Bausch & Lomb Pharmaceuticals, CIBA Vision Ophthalmics (which he co-founded), and CIBA-Geigy Pharmaceuticals, amongst others. Dr. Shlevin earned a B.A. degree from Boston University and M.S. and Ph.D. degrees in physiology from the University of Rochester Medical School and postdoctoral fellowship at Mayo Foundation and Mayo Medical School.

About NASH Cirrhosis

NASH cirrhosis is the final stage in the progression of non-alcoholic steatohepatitis (NASH), a disease of the liver that affects millions of people in the U.S. and worldwide. The liver cell death and inflammation seen in NASH eventually causes progressive scarring of the liver, which eventually can result in liver cirrhosis. While the early stages of NASH can be treated by changes in lifestyle, such as losing weight and exercising, once the disease progresses to NASH cirrhosis there is no treatment available short of a liver transplant. Of the total number of individuals in the world believed to presently have NASH, it is predicted that NASH cirrhosis will eventually kill 20 million of those people.

One of the results of NASH cirrhosis is an increase in blood pressure in the portal vein that brings blood and nutrients from the digestive tract through the liver and then out to the rest of the body. As the scarring effect of cirrhosis on the liver progresses, blood flow through the liver becomes more difficult, increasing the blood pressure in the portal vein, creating varying degrees of portal hypertension. Eventually, this increase in blood pressure causes the veins connected to the liver to dilate and form esophageal varices, which are dilated veins that divert blood through the esophagus, bypassing flow through the liver. These dilated veins in the esophagus are prone to bleeding, which is a major cause of morbidity and mortality in patients with NASH cirrhosis. About half of the patients with well compensated NASH cirrhosis do not have varices, and identification of these patients is determined by endoscopy, which is included in the standard of care for all patients with cirrhosis.

About GR-MD-02

GR-MD-02 is a complex carbohydrate drug that targets galectin-3, a critical protein in the pathogenesis of fatty liver disease 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. The drug binds to galectin-3 proteins and disrupts its function. Preclinical data in animals have shown that GR-MD-02 has robust treatment effects in reversing liver fibrosis and cirrhosis.

Agilent Companion Diagnostic Gains Expanded FDA Approval in Cervical Cancer

On June 12, 2018 Agilent Technologies Inc. (NYSE: A) reported that the U.S. Food and Drug Administration (FDA) has approved its Dako PD-L1 IHC 22C3 pharmDx assay for expanded use (Press release, Agilent, JUN 12, 2018, http://www.agilent.com/about/newsroom/presrel/2018/12jun-ca18057.html [SID1234527279]).

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Physicians in the United States can now gain valuable information to help them identify cervical cancer patients who are most likely to benefit from treatment with KEYTRUDA, an anti-PD1 immunotherapy manufactured by Merck (known as MSD outside the United States and Canada).

PD-L1 IHC 22C3 pharmDx is now the first FDA-approved IHC test for determining PD-L1 expression in cervical cancer and is the first FDA-approved companion diagnostic to identify patients with cervical cancer for treatment with KEYTRUDA. This follows an initial FDA approval for PD-L1 IHC 22C3 pharmDx in non-small cell lung cancer and a subsequent expanded approval to include gastric or gastroesophageal junction adenocarcinoma.

"PD-L1 is a critical biomarker for identifying patients who are likely to derive benefit from anti-PD-1 immunotherapy, and with an increasingly complex marketplace, pathologists look to Agilent as the clear leader to provide accurate and reliable PD-L1 testing," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. "This expansion of use for the Dako PD-L1 IHC 22C3 pharmDx assay gives patients with cervical cancer the possibility of having their tumor sample tested for PD-L1 expression, and determining eligibility for treatment with KEYTRUDA."

Cervical cancer is the third most common gynecologic cancer in the United States, with 13,000 cases expected to be diagnosed this year alone. The overall survival rate has not improved in the past 40 years, despite advancements in prevention and early detection. Cervical cancer patients previously had few treatment options other than highly toxic chemotherapy.

KEYTRUDA is a humanized monoclonal antibody that increases the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells. KEYTRUDA and other targeted immunotherapies are revolutionizing cancer treatment, with their therapeutic value being demonstrated across a growing list of cancer types.

Agilent is a worldwide leader in partnering with pharmaceutical companies to develop immunohistochemical-based diagnostics for cancer therapy. Agilent developed PD-L1 IHC 22C3 pharmDx in partnership with Merck & Co.

Nordic Nanovector Announces Betalutin® has been granted Fast Track designation in the US for Follicular Lymphoma

On June 12, 2018 Nordic Nanovector ASA (OSE: NANO) reported that the US Food & Drug Administration (FDA) has granted Fast Track designation to Betalutin (177Lu-lilotomab satetraxetan) for the treatment of patients with relapsed or refractory follicular lymphoma (FL) after at least 2 prior systemic therapies (Press release, Nordic Nanovector, JUN 12, 2018, View Source [SID1234553499]).

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Lisa Rojkjaer MD, Nordic Nanovector CMO, commented: "We are pleased to have been granted Fast Track designation for Betalutin. This designation is based on the promising safety and preliminary efficacy data in patients with relapsed/refractory indolent non-Hodgkin’s lymphoma from the first part of the LYMRIT 37-01 study, and highlights the potential of Betalutin to be a new therapeutic option for these patients. We are now focusing the PARADIGME trial on 3L CD20-refractory FL patients, a population in urgent need of new therapies, and look forward to working with the FDA to advance the development of Betalutin".

PARADIGME is a global randomised Phase 2b clinical trial comparing two Betalutin dosing regimens (15MBq/kg Betalutin following 40mg lilotomab pre-dosing; 20MBq/kg Betalutin following 100mg/m2 lilotomab pre-dosing) in 3L FL patients. PARADIGME aims to enrol 130 patients across 80-85 sites in approximately 20 countries.

The primary endpoint for the study is overall response rate (ORR) and secondary endpoints include duration of response (DoR), progression free survival (PFS), overall survival (OS), safety and quality of life. An initial efficacy and safety data read-out for PARADIGME is targeted for the first half of 2020.

About Fast Track designation

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. The designation provides the opportunity for more frequent meetings with the FDA over the course of drug development. In addition, the Fast Track programme allows for Rolling Review, which enables a company to submit individual sections of its Biologic License Application (BLA) for review as they are ready, rather than waiting until all sections of the BLA are complete, as well as for eligibility for Accelerated Approval and Priority Review if relevant criteria are met.

-End-

For further information, please contact:

IR enquiries Malene Brondberg, VP Investor Relations and Corporate Communications

Cell: +44 7561 431 762

Email: [email protected]

International Media Enquiries Mark Swallow/David Dible/Isabelle Andrews (Citigate Dewe Rogerson)

Tel: +44 207 638 9571

Email: [email protected]

About Betalutin

Betalutin is a tumour-seeking anti-CD37 antibody (lilotomab) conjugated to a low-intensity radionuclide (lutetium-177). CD37 is highly expressed in B-cell non-Hodgkin’s lymphoma (NHL), representing a novel therapeutic target. Betalutin is internalised in tumour cells and prolonged exposure of the nucleus to radiation destroys DNA leading to tumour cell death. Betalutin also has a crossfire effect limited to a radius of 40 cells, which destroys surrounding tumour cells. Betalutin has shown promising efficacy and tolerability in the Phase 1/2a LYMRIT 37-01 clinical study in relapsed/refractory follicular lymphoma (R/R FL) and is currently in a pivotal Phase 2b trial, PARADIGME, in third line (3L) FL patients who are refractory to standard-of-care anti-CD20-based therapy (including rituximab).

Arcus Biosciences Announces FDA Clearance of INDs for AB928 and AB122 and Initiation of Phase 1/1b Program to Evaluate AB928 Combinations

On June 11, 2018 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported that the U.S. Food and Drug Administration (FDA) has cleared Investigational New Drug (IND) applications for the Company’s two most advanced product candidates, AB928 and AB122 (Press release, Arcus Biosciences, JUN 11, 2018, View Source [SID1234527262]). Clearance of the first IND for AB928 allows the Company to proceed with its planned Phase 1/1b trial to evaluate the safety, tolerability and preliminary efficacy of AB928 in combination with other agents, including AB122 (the Company’s anti-PD-1 antibody) and chemotherapy, in patients with breast and gynecologic malignancies. Two additional IND applications will be submitted this month which, if cleared, will enable the Company to proceed with trials of AB928 combinations in gastrointestinal malignancies, non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC). In parallel, the Company has been completing the regulatory process to evaluate the combination of AB928 and AB122 in patients in Australia and expects to dose its first patient with this combination shortly.

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"We are thrilled to receive our first IND clearances to permit dosing in patients for AB928, our dual adenosine receptor antagonist, in combination with other anti-cancer agents," said Terry Rosen, Ph.D., Chief Executive Officer at Arcus. "For our initial Phase 1/1b combination trials for AB928, we have selected tumor types that we believe will be most responsive to adenosine 2 receptor antagonism and combination partners that we expect to be synergistic with this mechanism, specifically immunogenic cell death (ICD) inducing chemotherapy and anti-PD-1 therapy. We have designed our Phase 1/1b program for AB928 to provide us with significant flexibility to open new arms to evaluate promising combinations and to expand or close existing arms based on the emerging data. We are extremely pleased to begin testing in patients the first adenosine 2 receptor antagonist that was specifically designed to be a therapeutic for cancer."

The Phase 1/1b program for AB928 will initially evaluate AB928 in combination with AB122 and with chemotherapy in three tumor-specific trials. The Phase 1/1b program will begin with a dose-escalation phase to identify the optimal dose of AB928 to be combined with fixed doses of AB122 and with each of the three different ICD-inducing chemotherapy regimens. Once the recommended dose of AB928 for each combination has been selected, the tumor-specific trials will enroll expansion cohorts to evaluate AB928 in combination with AB122 or chemotherapy in the following selected tumor types:

Breast and Gynecologic Malignancies. This trial will initially evaluate AB928 in combination with AB122 and with DOXIL in triple negative breast cancer and ovarian cancer. The FDA has cleared the IND application for this trial.
Gastrointestinal Malignancies. This trial will initially evaluate AB928 in combination with AB122 and with mFOLFOX in gastroesophageal and colorectal cancers. The IND application for this trial will be submitted this month.
Lung Cancer and Renal Cell Carcinoma. This trial will initially evaluate AB928 in combination with AB122 in NSCLC and RCC as well as AB928 in combination with a platinum-based chemotherapy regimen in NSCLC. The trial design will also allow for the exploration of additional AB928 combinations, including triple combinations, and AB928 in combination with other anti-PD-1 antibodies. The IND application for this trial will be submitted this month.
Each trial was designed to allow for the addition of new AB928 combination arms in the future. In the dose-escalation portion of the trials, the Company will assess evidence of immune engagement to enable a mechanistic understanding of early clinical responses and will evaluate the suitability of several potential biomarkers for patient enrichment in the dose-expansion cohorts and in future trials.

Data from the dose-escalation portion of the Phase 1/1b program are expected to be available in the first half of 2019.

About AB928

AB928 is an orally bioavailable, highly potent antagonist of the adenosine 2a and 2b receptors. The activation of these receptors by adenosine interferes with the activity of key populations of immune cells and inhibits an optimal anti-tumor immune response. By blocking these receptors, AB928 has the potential to reverse adenosine-induced immune suppression within the tumor microenvironment. AB928 was designed specifically for the oncology setting, with a profile that includes potent activity in the presence of high concentrations of adenosine and a minimal shift in potency due to non-specific protein binding, both essential properties to be efficacious in the tumor microenvironment. AB928 has other attractive features, including high penetration of tumor tissue and low penetration through the healthy blood-brain barrier. In a Phase 1 trial in healthy volunteers, AB928 has been shown to be safe and well tolerated and to have pharmacokinetic and pharmacodynamic profiles consistent with a once-daily dosing regimen.