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.

On June 11, 2018 BridgeBio Pharma reported that it has entered into an agreement with Alexion Pharmaceuticals, Inc. to acquire cyclic pyranopterin monophosphate (cPMP; ALXN1101), a synthetic enzyme co-factor therapy for patients with the ultra-rare disease caused by molybdenum cofactor deficiency (MoCD) Type A (Press release, BridgeBio, JUN 11, 2018, View Source [SID1234576280]). In addition, BridgeBio announced that it was launching a new subsidiary, Origin Biosciences, with sufficient capital to support clinical development of ALXN1101 through potential regulatory approval and commercialization.

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MoCD is an ultra-rare autosomal recessive inborn error of metabolism. The disease is caused by a mutation in the MOCS1 gene and leads to defective production of cPMP. Clinical signs of MoCD present shortly after birth and progress rapidly. Newborns with MoCD experience difficulty feeding and intractable seizures yet have no approved available therapies. Patients have a median survival of three years, and those who survive often have severe and irreversible injury to their central nervous system.

"Historically, replacing missing or defective proteins has proven highly efficacious for treating loss of function monogenic conditions – in the case of MoCD type A, we are replacing the missing or defective cPMP, providing children with much needed MoCD activity," said Michael Henderson, M.D., senior vice president of asset acquisition at BridgeBio. "BridgeBio’s team is committed to continuing the development of ALXN1101 for infants born with MoCD Type A deficiency, their families and caregivers."

ALXN1101 is a synthetic version of cPMP, the missing cofactor causing MoCD Type A. In previous work with a recombinant form of cPMP, 11 patients with MoCD Type A had normalization of biomarkers within two days, eight patients showed some suppression of seizures, and three patients had near-normal development. ALXN1101 has received Breakthrough Therapy designation from the US FDA.

"Patients born with MoCD face a bleak future, and we will do all we can to pursue the development of this exciting compound, which has the potential to replace the missing enzyme," said Neil Kumar, Ph.D., CEO of BridgeBio. "BridgeBio aims to sustainably pursue even the rarest of diseases, such as MoCD, especially where we can support drug programs that target well described genetic diseases at their source."

While specific terms of the deal have not been disclosed, BridgeBio has committed sufficient resources to Origin Biosciences to enable clinical development, regulatory approval and to support commercialization of ALXN1101. Alexion will receive additional payments upon the realization of development and sales milestones.

On June 11, 2018 Nordic Nanovector ASA (OSE: NANO) reported that a poster reporting the ability of Betalutin (177Lu-lilotomab satetraxetan) to reverse resistance to anti-CD20 treatment in non-Hodgkin’s lymphoma (NHL) cell lines will be presented at the inaugural AACR (Free AACR Whitepaper) International Meeting: Advances in Malignant Lymphoma (22-26 June, Boston, MA, USA) (Press release, Nordic Nanovector, JUN 11, 2018, View Source [SID1234553500]).

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The preclinical data, described in an abstract published online (link here), demonstrate that treatment of rituximab-resistant NHL cells with Betalutin significantly elevated the expression of the CD20 receptor on the surface of cells. The increase in CD20 receptors re-sensitizes the cells to the anti-CD20 NHL immunotherapies rituximab (Rituxan) and obinutuzumab (Gazyva/Gazyvaro), causing increased tumour cell death.

These results support previous preclinical studies that highlight the synergistic anti-tumour effects of combining Betalutin with rituximab immunotherapy. Nordic Nanovector is planning to investigate this novel combination therapy in patients with relapsed/refractory follicular lymphoma in the Archer-1 Phase 1b clinical study. This study is targeting dosing of the first patient in the second half of 2018.

Details for the poster presentation are as follows:

Poster Title: 177Lu-lilotomab satetraxetan has the potential to counteract resistance to rituximab and obinutuzumab in non-Hodgkin’s lymphoma Session

Date and Time: Saturday 23 June, 11:45 AM to 1:45 PM (Eastern Daylight Time)

Poster Session A: Basic and Translational Science 1

Location: Salon F, 4th floor, Boston Marriot Copley Plaza Permanent

Abstract Number: A28

The poster will be available on the company’s website at the time of the presentation: www.nordicnanovector.com.

On June 11, 2018 Nkarta Therapeutics, a privately-held cell therapy company developing Natural Killer (NK) immune cells to fight cancer, reported that it has entered into a worldwide exclusive license agreement for proprietary Natural Killer cell engineering technology jointly owned by the National University of Singapore (NUS) and St. Jude Children’s Research Hospital (Press release, Nkarta, JUN 11, 2018, View Source [SID1234530934]). The license, negotiated by the Industry Liaison Office (ILO) of NUS and the St. Jude Office of Technology Licensing (OTL), includes several issued patents and patent applications related to methods to generate large numbers of fully functional NK cells as well as compositions of chimeric receptors for targeting NK cells to tumors and extending their life-span. The licensed technologies are all based on discoveries by Professor Dario Campana, M.D., Ph.D., of NUS and formerly of St. Jude, who is credited with major advances in chimeric antigen receptor (CAR-T) cell therapy in addition to Natural Killer cell therapy.

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"Through this agreement, we have solidified our position as leaders in Natural Killer cell technology," said Paul Hastings, president and chief executive officer of Nkarta. "Natural Killer cells have a unique, innate ability to target and destroy cancer cells, but the amount generated by the body is not sufficient to overcome the disease. With this license we have gained access to exclusive expansion and targeting technologies that will generate an abundant supply of our proprietary engineered and enhanced NK cells that can selectively kill tumor cells."

Dr. Campana added, "As a scientific founder of Nkarta, I am pleased to see the company advance its technology, which enhances the potential of NK cells as a next-generation cell therapy. The company has expertise in key aspects of NK cell engineering, including ways to improve recognition of tumor targets, to support persistence and sustained activity, and to produce genetically-modified NK cells in sufficient quantity to meet clinical requirements."

On JUN 11, 2018 Targovax ASA ("Targovax" or "the Company"; OSE: TRVX), a clinical stage company focused on developing and commercializing immune activating oncology therapies to target, primarily, treatment resistant solid tumors, reported an update to its clinical development strategy (Press release, Targovax, JUN 11, 2018, View Source [SID1234527412]).

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Targovax has previously reported encouraging proof-of-concept data from clinical trials with both of its immune activator platforms technologies; ONCOS, which uses genetically armed oncolytic adenoviruses, and TG, a neo-antigen vaccine that targets mutant RAS cancers. However, based on recent external clinical data and market dynamics, Targovax has decided to prioritize and strengthen the development focus on the ONCOS program.

Over the past 12 months, there has been clinical data released from multiple external studies corroborating the potential of oncolytic viruses as an important class of immune activating agents that can boost the effect of other treatments, such as checkpoint inhibitors. This notion is further strengthened by increased partnering and M&A activity by major global pharmaceutical companies, underscored by the acquisitions earlier this year of Viralytics and Benevir by Merck and Johnson & Johnson, respectively.

Furthermore, data presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting on June 1-5 has fundamentally changed the development preconditions for the TG program. Data from independent trials testing the chemotherapy cocktail Folfirinox in resected pancreas cancer, the lead indication for TG01, has demonstrated an improvement in median overall survival of up to 2 years compared to the current standard of care (gemcitabine and capecitabine). These results are great news for patients suffering from this difficult-to-treat cancer. It is expected that the Folfirinox treatment regimen will be quickly adopted as a new standard of care in resected pancreatic cancer, and it is already clear that that the design of Targovax’s planned randomized phase II trial of TG01 in combination with gemcitabine and capecitabine is inadequate and that the trial will not start. Although we are confident that TG01 will be active in combination with any standard of care therapy, the new Folfirinox median survival benchmark of close to 5 years means that such a combination trial is not practically feasible for Targovax.

Targovax strongly believes in the potential of the TG platform to treat mutant RAS cancers, and is encouraged by the signal of efficacy seen in the recent phase I/II trial in resected pancreas cancer. In addition, the company already has a phase I trial underway in colorectal cancer with TG02, the second-generation product from the TG program, combining with pembrolizumab. This trial is expected to read out in 2019. In light of the new Folfirinox data, the Company will together with its clinical advisors reevaluate and reshape the development plans for TG, and devise a strategy for how to best create value for both patients and shareholders. A revised development strategy for the TG program will be presented during the autumn.

The resources freed up by this decision will be allocated to strengthen and speed up ONCOS development. In particular, Targovax is currently looking into options to expand the ongoing trial in mesothelioma, the target launch indication for ONCOS-102.

Øystein Soug, CEO of Targovax said "It is fortunate for us that the emerging Folfirinox data in resected pancreatic cancer was presented at ASCO (Free ASCO Whitepaper) already this year, as it gave us the opportunity to reassess our trial design before committing to an inadequate combination treatment. We are confident that our TG vaccine has potential to benefit patients with mutant RAS cancers, and will now reassess the TG development plan. ONCOS continues to be our lead program, and we will further sharpen our focus to drive ONCOS-102 forward with full force, and remain in the forefront of oncolytic virus development"