On January 29, 2019 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that the US Food and Drug Administration (FDA) has granted Fast Track designation to IPH4102 for the treatment of adult patients with relapsed or refractory Sézary syndrome (SS) who have received at least two prior systemic therapies (Press release, Innate Pharma, JAN 29, 2019, View Source [SID1234532938]). IPH4102 is Innate Pharma’s wholly-owned first-in-class anti-KIR3DL2 antibody, developed for the treatment of T-cell lymphoma.

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Fast Track is a process designed to facilitate the development and expedite the regulatory review of investigational drugs to treat serious conditions and fill an unmet medical need.

"We are pleased that the FDA has granted Fast Track designation to IPH4102 as there remains a high need for treatment options with strong efficacy and adequate safety profile to allow for treatment of Sézarysyndrome, the most aggressive form of cutaneous T-cell lymphoma (CTCL)," said Pierre Dodion, Chief Medical Officer of Innate Pharma. "IPH4102 is a key element of our strategy to build a commercial franchise of treatments focused on rare cancers in the field of hemato-oncology. We intend to initiate a global multi-cohort Phase II study (TELLOMAK) in the first half of 2019 to confirm the clinical activity of IPH4102 in Sézary syndrome and evaluate the potential in other subtypes of T-cell lymphomas, including Mycosis fungoides (MF) and peripheral T-cell lymphoma (PTCL). We look forward to working with the FDA to advance this promising program through clinical development."

Sézary syndrome is the leukemic variant of cutaneous T-cell lymphoma (CTCL), a heterogeneous group of non-Hodgkin’s lymphomas which arise primarily in the skin. Patients often experience very poor quality of life with severe and debilitating pruritus (chronic itchy skin). Despite recent advancements, Sézary syndrome is associated with a high relapse rate with currently available therapies.

Fast track designation is based on preliminary results of the Phase I dose-escalation and expansion study of IPH4102 in advanced CTCL (n=44). As of October 15, 2018, data from the subgroup of 35 SS patients revealed strong clinical activity, demonstrated by an overall response rate (ORR) of 42.9%, median duration of response (DoR) of 13.8 months and median progression-free survival (PFS) of 11.7 months. The ORR appeared to be higher (n=28, 53.6%) in patients with no histologic evidence of large cell transformation (LCT)*. Importantly, clinical activity was associated with a substantial improvement in quality of life as assessed by the SkinDex29 and Pruritus Visual Analog Scale (VAS) scores. IPH4102 displayed a favorable safety profile, consistent with previous observations.

On January 29, 2019 Genetic Immunity, a clinical stage biotechnology company, is reported that it is expanding its collaboration with JSC Pharmadis by granting licenses to twenty cancer indications of its trans-dermally delivered pDNA-based vaccine technology (Press release, Genetic Immunity, JAN 29, 2019, View Source [SID1234554012]).

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The new indications cover twenty different cancer types including vaccines for the treatment of: prostate cancer, glioblastoma, colon & rectal cancer, Non-Hodgkin lymphoma, endometrial cancer, stomach cancer, bladder cancer, cervical cancer, lung cancer, thyroid cancer, leukemia, breast cancer, kidney cancer, ovarian cancer, liver cancer, myeloma, lip-oral cavity cancer, oesophagus cancer, brain cancer and gallbladder cancer.

"We are gratified to have expanded our collaboration with Pharmadis with the license of a tremendous portfolio of potential cancer immunotherapies. Closely following our HIV vaccine deal, the management of Pharmadis felt it would be a tremendous opportunity for them to have access to a broad range of possible treatment breakthroughs. Once they understood the basis of our platform technology, it was an easy next step for us to expand our collaboration and work with a single pharma player in Russia," stated Viktor Rozsnyay, CEO of Genetic Immunity.

"I think this is a singular collaboration, as to my knowledge, no-one has ever licensed such a broad range of product candidates based on a single product platform. We are excited for this opportunity and bring to market a revolutionary array of cancer treatments that can affect the lives of millions of people," added Rozsnyay.

Under terms of the new agreement, Pharmadis received rights to market all twenty cancer vaccines in Russia and the Commonwealth of Independent States. Genetic Immunity and Pharmadis will jointly develop all vaccines and seek Russian marketing approval. Clinical trials will be conducted beginning with prostate cancer and glioblastoma. Upon approval Genetic Immunity will receive double-digit royalties on sales.

The DermaVir immunotherapy vaccine platform contains a novel plasmid DNA that encodes disease specific antigens. The first product to demonstrate this technology is Genetic Immunity’s HIV vaccine that Pharmadis licensed in 2018. For cancer vaccines based on the technology platform the disease specific pDNA will be used with appropriate antigens coded. The vaccine is topically administered using the DermaPrep medical device.

"Upon completing our HIV vaccine license with Genetic Immunity, we continued discussion to see how we may use other products in Russia. As we became familiar with the Company’s pDNA platform technology we felt it would make sense to propose an extension to our licensing agreement to cover as many cancer types as possible. Genetic Immunity’s management agreed with our proposal and we are happy to further our collaboration. The next two to three years will be of paramount importance as we hope to bring to market a number of revolutionary cancer vaccines to combat the disease," stated Nikolai Kovalev, Managing Director of Pharmadis.

The design of pDNA needed for prostate cancer and glioblastoma is already underway. Once completed, an investigator sponsored trial will be conducted in Moscow, Russia, at the European Medical Center. The first indication will cover glioblastoma, an aggressive brain cancer, with principal investigator Professor Alexey Krivoshapkin, a world-renowned neurosurgeon.

Plasmid DNA based vaccines have been proven safe, but poorly immunogenic in human subjects. Genetic Immunity has developed several technologies to improve the immunogenicity of DNA-encoded antigens, including:

Antigeneering of plasmid DNA to safely and authentically express most of the antigens of HIV or other pathogens, including cancer.
The formulation of plasmid DNA to a pathogen-like nanoparticle called NanoComp. These nanoparticles target professional antigen-presenting cells, such as Langerhans cells and dendritic cells.
A targeted transdermal delivery device called DermaPrep. It has been shown that topical DermaPrep administration results in antigen expression in the lymph nodes by dendritic cells.

On January 29, 2019 Actinium Pharmaceuticals, Inc. (NYSE American: ATNM) ("Actinium" or "the Company") reported that it will host a key opinion leader (KOL) breakfast on targeted conditioning for bone marrow transplant (BMT) and CAR-T from 8:00 AM to 9:30 AM EST on Thursday, February 7th, in New York City (Press release, Actinium Pharmaceuticals, JAN 29, 2019, View Source [SID1234532940]).

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The event will feature a presentation by KOL Sergio Giralt, MD, Chief of Adult BMT, Memorial Sloan Kettering Cancer Center, who will discuss the potential of targeted conditioning with ARCs or Antibody Radiation-Conjugates in conjunction with BMT or Bone Marrow Transplant for patients ineligible or underserved by current conditioning regimens. Dr. Giralt’s presentation will highlight an initial safety and feasibility analysis of data from Actinium’s pivotal Iomab-B Phase 3 SIERRA trial, which were presented in an oral presentation at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2018. Dr. Giralt will be available at the conclusion of the event to answer any questions from the audience.

In addition, members of the Actinium management team will discuss how the Company is applying its ARCs for targeted conditioning in patients prior to CAR-T with the goal of eliminating the need for chemotherapy conditioning regimens like Flu/Cy (Fludarabine and Cyclophosphamide). Finally, management will introduce their AWE or Antibody Warhead Enabling technology platform that has enabled combination trials with Venetoclax, a bio-better of J&J’s darzalex, and a research collaboration with Astellas Pharma, Inc.

This event is intended for institutional investors, sell-side analysts, and business development professionals only and they are requested to RSVP Click Here. For those who are unable to attend in person, a live webcast and replay will be accessible via the link Click Here.

About Dr. Sergio Giralt
Dr. Giralt, MD, Chief of Adult BMT, Memorial Sloan Kettering Cancer Center; Chair, Myeloma Service; and a board-certified hematologist/oncologist whose clinical practice and research focus on stem cell transplantation for patients with blood disorders. Previously, Dr. Giralt was Deputy Chair of the Department of Stem Cell Transplantation and Cellular Therapies at the University of Texas MD Anderson Cancer Center.

Dr. Giralt and his colleagues pioneered the use of reduced-intensity conditioning regimens for older or more debilitated patients with blood cancers, and are currently using and studying T cell depletion techniques to dramatically reduce the risk of graft-versus-host disease, a serious complication of donor stem cell transplantation. Dr. Giralt’s clinical and research activities include stem cell transplantation for patients with blood disorders and improving treatments for older patients who have acute and chronic leukemia. He has published and presented extensively on these topics. Additionally, Dr. Giralt has served as the principal investigator for a number of clinical trials that examine new treatment approaches for multiple myeloma and other blood cancers that aim to reduce symptom burden and improve treatment tolerability.

Dr. Giralt received his medical degree from Universidad Central de Venezuela. He completed his residency at Good Samaritan Hospital and his fellowship at The University of Texas MD Anderson Cancer Center. Dr. Giralt is Professor of Medicine at Weill Cornell Medical College and the Chief Attending Physician of the Adult Bone Marrow Transplant Service in the Department of Medicine at Memorial Sloan Kettering Cancer Center in New York City. In addition, he is the Melvin Berlin Family Chair in Myeloma Research.

On January 28, 2019 Physicians’ Education Resource (PER), a leading resource for continuing medical education (CME), reported that it will host its 23rd annual International Congress on Hematologic Malignancies: Focus on Leukemias, Lymphomas, and Myeloma from Thursday, Feb. 28 to Sunday, March 3 at the Eden Roc Miami Beach in Florida (Press release, Physicians’ Education Resource, JAN 28, 2019, View Source [SID1234532924]).

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This dynamic Winter Hematology congress will be co-chaired by Andre Goy, M.D., M.S., the chairman and executive director of the lymphoma division and chief of the John Theurer Cancer Center at Hackensack University Medical Center, chief science officer and director of research and innovation of the Regional Cancer Care Associates; Sagar Lonial M.D., FACP, a professor and executive vice chair in the department of hematology and medical oncology at Emory School of Medicine, and chief medical officer of Winship Cancer Institute of Emory University; and Jorge Eduardo Cortes, M.D., the D.B. Lane Cancer Research Distinguished Professor for Leukemia Research, deputy chair and professor of medicine, and an internist in the department of leukemia, division of cancer medicine at The University of Texas MD Anderson Cancer Center.

"Our winter hematology congress continually offers the latest updates and insights in the evolving field of hematologic oncology," said Phil Talamo, president of PER. "With all the recent advancements this past year, this conference will discuss new data and challenge participants to apply new information they have learned, reflect on new practices they can bring back to their clinics to share with their peers, and ultimately improve patient outcomes."

The 23rd annual congress is a three-and-a-half-day engaging and highly interactive meeting that provides community-based hematologists and medical oncologists interested in the treatment of hematologic malignancies with the opportunity to interact with internationally renowned experts in the management of leukemias, lymphomas, myeloma, myelodysplastic syndromes, myeloproliferative neoplasms, and benign hematologic malignancies. During the congress, faculty experts will review latest information on pressing topics for 2019, including the expanding role of new immunologic approaches, including CAR T cells and checkpoint inhibitors, the emergence of molecular-based therapies and new cytotoxic formulations in patients with acute leukemias, new approaches for treatment and duration of therapy among patients with myeloproliferative neoplasms and more. The meeting will also feature several engaging Medical Crossfire discussion panels interspersed throughout the meeting to allow attendees to explore some of the most challenging clinical situations in the management of hematologic malignancies.

On January 28, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, reported the closing of its previously announced public offering of 4,207,317 ordinary shares, including 548,780 shares sold pursuant to the full exercise of the underwriters’ option to purchase additional shares (Press release, UroGen Pharma, JAN 28, 2019, View Source [SID1234532925]). All of the ordinary shares were sold at a price to the public of $41.00 per share. The net proceeds of the public offering are approximately $162.1 million, after deducting the underwriting discounts and commissions but before payment of other offering expenses. All ordinary shares sold in the offering were offered by the Company.

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Goldman Sachs & Co. LLC, J.P. Morgan and Jefferies acted as joint book-running managers for the offering. Oppenheimer & Co. acted as lead manager for the offering.

A shelf registration statement relating to the ordinary shares was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on October 26, 2018. A final prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and is available on the SEC’s website at View Source Copies of the final prospectus supplement and accompanying prospectus may be obtained by contacting:

Goldman Sachs & Co. LLC, c/o: Prospectus Department, 200 West Street, New York, New York 10282, or via telephone at 866-471-2526, or via email: [email protected]; or
J.P. Morgan Securities LLC, c/o: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717 or via telephone at 866-803-9204, or via email: [email protected]; or
Jefferies LLC, c/o: Equity Syndicate Prospectus Departments, 520 Madison Avenue, 2nd Floor, New York, New York 10022, or via telephone at 877-821-7388, or via email: [email protected].
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall 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.