Surface Oncology Announces Initiation of Phase I Clinical Trial of SRF373 / NZV930

On June 12, 2018 Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported the initiation of a Phase I trial of SRF373, a fully human antibody targeting CD73. SRF373, also known as NZV930, is the second of Surface’s immunotherapies to advance into the clinic this year (Press release, Surface Oncology, JUN 12, 2018, View Source [SID1234527367]).

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CD73 is an enzyme overexpressed by many tumors that is critical to the production of extracellular adenosine which in turn suppresses immune cell function and the ability of the immune system to recognize and attack tumors. In preclinical studies, NZV930 exhibited potent CD73 enzymatic inhibition, resulting in a reduction of adenosine and increased activity of immune cells.

The first-in-human study is being led by Novartis, which was granted a worldwide exclusive license to develop and commercialize NZV930 as part of its broad strategic collaboration with Surface. Under the collaboration, Surface is eligible to receive development and sales milestone payments for NZV930, as well as tiered royalties.

The Phase I study will evaluate the safety, tolerability, and preliminary anti-tumor activity of NZV930 as a single agent and in combination with other cancer immunotherapies. The initial dose escalation portion of the trial will include patients with triple negative breast cancer, ovarian cancer, microsatellite stable colon cancer, pancreatic cancer, non-small cell lung cancer, and renal cell carcinoma.

"We are very excited that Novartis has advanced our second product program into clinical development" said Rob Ross, M.D., chief medical officer of Surface Oncology. "We believe the profile of NZV930 is compelling and targeting adenosine reduction could play an important role in the treatment of patients suffering with a variety of types of cancer."

ABOUT SRF373 / NZV930

NZV930 is a fully human monoclonal antibody designed to inhibit CD73, an enzyme critical to the production of adenosine—an immunosuppressive metabolite within the tumor microenvironment. CD73 is overexpressed by many tumors making it a potential target with broad applicability. In preclinical studies, NZV930 exhibited potent CD73 enzymatic inhibition, resulting in a reduction of adenosine and increased T cell activity. Novartis holds a worldwide exclusive license to develop and commercialize NZV930.

PharmaMar requests the modification from primary endpoint to OS for the ATLANTIS trial

On June 12, 2018 PharmaMar (MSE:PHM) reported that basedmon recent receipt of OS (overall survival) data from lurbinectedin Phase II small-cellmlung cancer studies, including the monotherapy trial presented at ASCO (Free ASCO Whitepaper) on June 3rd that saw an OS of 11.8 months, a protocol amendment was submitted to FDA and other competent authorities to change the primary endpoint of the ATLANTIS Phase III trial from PFS (progression free survival) to OS (Press release, PharmaMar, JUN 12, 2018, View Source [SID1234527288]). The changes will begin when the competent authorities with responsibility for review and approval of the study approve of the changes, which in the US we expect to happen in the next few weeks. The safety of the patients and the integrity of this study are not compromised by these changes. PharmaMar remains blinded to the data, and
continues to expect completion of recruitment in the third quarter of 2018. This means PharmaMar expects the top line data, which is event driven, to readout in the second half of 2019.

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According to Luis Mora, Managing Director of PharmaMar´s Oncology Business Unit, "we feel that this change in endpoint to OS given what we have seen in the recent data, including those presented at ASCO (Free ASCO Whitepaper), offers us a better chance for success, especially as we know regulators prefer OS data over a surrogate endpoint subject to interpretation in this type of disease setting."

About Zepsyre
Zepsyre (lurbinectedin, PM1183) is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction.

About small-cell lung cancer
SCLC is a very aggressive cancer that usually presents with distant metastases and has already spread at the time of diagnosis, thus limiting the role of traditional approaches and posing a worse prognosis compared to other lung cancer types. The 5-year survival rate is about 5%i About 18% of all the lung cancer cases diagnosed are SCLC, and only in the US more than 34,000 new cases are recorded everyyear. This tumor is strongly associated with tobacco smoking, posing an important public health problemii

After failure to treatment with a platinum-based therapy in first line, the therapeutic alternatives are very limited, and the approval of the last drug for this disease took place 20 years ago.

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).

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.