On May 20, 2019 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that the International Liver Cancer Association (ILCA) has accepted Can-Fite’s abstract describing the latest data from the Company’s Phase II Liver Cancer study of Namodenoson for an oral presentation at its annual conference (Press release, Can-Fite BioPharma, MAY 20, 2019, View Source [SID1234536467]). The oral presentation titled "The Safety and Efficacy of Namodenoson in the Second Line Treatment of Advanced Hepatocellular Carcinoma (HCC) Patients with Underlying Child-Pugh B (CPB) Liver Cirrhosis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled" will be delivered on September 22, 2019 during the Novel Targets and Prognostic Markers Session from 11:00 am to 12:30 pm. The ILCA’s 13th Annual Conference will take place from September 20 to 22, 2019 in Chicago, Illinois.

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The ILCA is the only international organization devoted exclusively to liver cancer research for experts from all related disciplines. Its mission is to lead a global community of physicians, scientists and allied professionals through education and research with the goal to better prevent and treat liver cancer.

"This is a very prestigious conference that brings together the leading thought leaders, researchers, and physicians in the treatment of liver cancer. Governing members of the ILCA thoroughly research each abstract submission and select those that are most relevant to the advancement of treating liver cancer. We are pleased that the selection committee sees the potential of Namodenoson as a treatment for advanced liver cancer patients with severe liver dysfunction. Based on both safety and efficacy in this Phase II study, Can-Fite is preparing a Phase III trial," stated Can-Fite CEO Pnina Fishman.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated as a second line treatment for hepatocellular carcinoma, with a recently completed Phase II trial and planned Phase III trial in this indication. The drug is currently in an ongoing Phase II trial as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On May 20, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis ("OM"), reported development updates regarding the Company’s lead compound for OM, AG013 (Press release, Oragenics, MAY 20, 2019, View Source [SID1234536484]). These developments include the enrollment of over 80 patients in the Company’s Phase 2 clinical of AG013 and, in addition, the World Health Organization has provided the Company with the generic name of dapatifagene navolactibac for the AG013 compound.

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"We continue to increase the number of clinical sites across the globe with 48 of the 61 identified clinical sites actively enrolling patients for our Phase 2 clinical trial of AG013," stated Alan Joslyn, Ph.D., President and Chief Executive Officer of Oragenics, Inc. "In the meantime, we are pleased to have an agreed upon generic designation for AG013, which will now also be referred to as dapatifagene navolactibac, to allow us a more specific way of referring to the compound moving forward. We anticipate providing further updates as developments warrant."

The ongoing Phase 2 trial is a double-blind, placebo-controlled, two-arm, multi-center trial, in which approximately 200 patients will be randomized in a 1:1 ratio to receive either dapatifagene navolactibac or placebo. The purpose of the study (NCT03234465) is to evaluate the safety, tolerability and efficacy of topically administered dapatifagene navolactibac compared to placebo for reducing the incidence and severity of OM in patients undergoing traditional chemoradiation for the treatment of head and neck cancer. Key measures include duration, time to development, and overall incidence of OM (using a World Health Organization scale) during the active treatment phase, which begins from the start of chemoradiation therapy and ends two weeks following its completion.

Dapatifagene navolactibac, which has been granted Fast Track designation with the U.S. Food and Drug Administration and orphan drug status in Europe, is an Intrexon Actobiotics therapeutic candidate formulated to deliver the therapeutic molecule, human Trefoil Factor 1, to the mucosal tissues in the oral cavity in a convenient oral rinsing solution. Trefoil Factors are a class of peptides involved in the protection of gastrointestinal tissues against mucosal damage and play an important role in these tissues’ subsequent regeneration. The compound was designed by the Company’s strategic partner, Intrexon Actobiotics NV, a wholly-owned subsidiary of Intrexon Corporation (NYSE: XON) whereby Oragenics, Inc. holds an exclusive world-wide license.

On May 20, 2019 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that it has entered into a definitive agreement with certain institutional investors to receive gross proceeds of $6 million (Press release, Can-Fite BioPharma, MAY 20, 2019, View Source [SID1234536504]).

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In connection with the offering, the Company will issue 1,500,000 registered American Depository Shares (ADSs) of Can-Fite at a purchase price of $4.00 per ADS in a registered direct offering. Additionally, for each ADS purchased by investors, the investors will receive an unregistered warrant to purchase one ADS. The warrants will have an exercise price of $4.00 per ADS, will be immediately exercisable and will expire five and one-half years from the issuance date. The closing of the offering is expected to take place on or about May 22, 2019, subject to the satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the exclusive placement agent in connection with this offering.

The ADSs described above (but not the warrants or the ADSs underlying the warrants) are being offered pursuant to a shelf registration statement (File No. 333-220644) which became effective on October 11, 2017. Such ADSs may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

The Company will file a prospectus supplement and the accompanying base prospectus with the SEC relating to such ADSs. When available, copies of the prospectus supplement and the accompanying base prospectus may be obtained at the SEC’s website at View Source, or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, New York 10022, by telephone: (646) 975-6996 or by email at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs issuable upon their exercise, have not been registered under the Act, and may not be offered or sold in the United States absent registration with the SEC or an applicable exemption from such registration requirements.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein. There shall not be any offer, solicitation of an offer to buy, or sale of securities in any state or jurisdiction in which such an offering, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On May 17, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported more mature data relating to Part B of its ongoing phase I TACTI-mel clinical study of the Company’s lead product candidate, eftilagimod alpha ("efti" or "IMP321") in patients with melanoma (Press release, Immutep, MAY 17, 2019, View Source [SID1234536468]). The data will be presented at the World Advanced Therapies & Regenerative Medicine Congress & Expo 2019 in London on May 17, 2019 by Dr Frédéric Triebel, Chief Scientific Officer and Chief Medical Officer of Immutep.

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The ongoing TACTI-mel trial evaluates the combination of efti with anti-PD-1 therapy KEYTRUDA (pembrolizumab) in 24 patients with unresectable or metastatic melanoma. It is a multi-center, open label clinical trial that involves four cohorts of six patients, each cohort testing different dosages of efti, including 1 milligram (mg), 6 mg and 30 mg, in combination with pembrolizumab. Part B of the study includes a cohort of 6 patients at 30 mg of efti in combination with pembrolizumab, starting at cycle 1, day 1 and with a treatment duration of 12 months.

Consistent with previous data reported at 6 months of combination treatment (March 2019), patients in Part B continue to report positive results in terms of tumour reductions after 9 months of treatment. 4 patients are continuing to receive treatment. No new safety data or data from Part A of the study have been reported. The key findings from Part B are:

Part B (starting day 1 cycle 1

of pembro therapy)

N=6

Overall Response Rate (ORR)

50%
Disease Control Rate (DCR)

66%
The full presentation slides from the World Advanced Therapies & Regenerative Medicine Congress & Expo 2019 can be accessed via Immutep’s website at www.immutep.com.

About the TACTI-mel clinical trial

The ongoing TACTI-mel (Two ACTive Immunotherapies in melanoma) Phase I clinical trial is a multicenter, open-label study evaluating the combination of eftilagimod alpha ("efti") with pembrolizumab, in unresectable or metastatic melanoma patients that have had either a suboptimal response or had disease progression with pembrolizumab monotherapy (clinicaltrials.gov identifier NCT 02676869).

On May 17, 2019 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported the Phase 3 INTELLANCE-1 study of depatuxizumab mafodotin (Depatux-M, previously known as ABT-414) in patients with newly diagnosed glioblastoma (GBM), whose tumors have EGFR (epidermal growth factor receptor) amplification, demonstrated no survival benefit for patients receiving Depatux-M at an interim analysis (Press release, AbbVie, MAY 17, 2019, View Source [SID1234536457]). An Independent Data Monitoring Committee (IDMC) recommended the study be stopped due to lack of survival benefit for patients receiving Depatux-M compared with placebo when added to the standard regimen of radiation and temozolomide. No new safety findings were observed. Enrollment in all ongoing Depatux-M studies has been halted.

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"Glioblastoma patients and their caregivers face a devastating disease for which there are few therapeutic options. While we are disappointed that Depatux-M did not demonstrate a survival benefit in the INTELLANCE-1 study, we remain committed to discovering and developing therapies to address some of the most debilitating cancers," said Michael Severino, M.D., vice chairman and president, AbbVie.

The INTELLANCE-1 trial was conducted in collaboration with the RTOG Foundation, an independent, non-profit cancer research organization. Results from INTELLANCE-1 will be submitted for presentation at a medical conference and for publication in a peer-reviewed journal.

"The highly collaborative partnership between RTOG Foundation’s scientific and physician leaders, under the leadership of Andrew Lassman, M.D., the study principal investigator, and the AbbVie team facilitated the early completion of this important international clinical trial. The RTOG Foundation’s outstanding glioblastoma experts will continue to vigorously investigate new approaches to this very challenging malignancy," said Walter J. Curran Jr., M.D., F.A.C.R., F.A.S.C.O., RTOG Foundation Board Chair and Executive Director of the Winship Cancer Institute of Emory University.

About the Phase 3 INTELLANCE-1 Trial and Depatuxizumab Mafodotin (Depatux-M; ABT-414)
The randomized, placebo-controlled Phase 3 study was designed to evaluate the efficacy and safety of Depatux-M versus placebo when administered with concurrent radiation and temozolomide and with adjuvant temozolomide in subjects with newly diagnosed EGFR-amplified GBM.1 The primary endpoint was overall survival, and the interim analysis was based on data from 639 patients. Depatux-M is not approved, and its safety and efficacy have not been evaluated by regulatory authorities.

About AbbVie in Oncology
At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. With the acquisitions of Pharmacyclics in 2015 and Stemcentrx in 2016, our research and development efforts, and through collaborations, AbbVie’s oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 300 clinical trials and more than 20 different tumor types. For more information, please visit View Source