On December 6, 2019 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that they have executed agreements with five investors, including an existing investor, John K. Scott, Jr. (collectively, the "Investors"), to purchase approximately 2.1 million shares of the Company’s common stock, par value $0.001 per share, in a private placement for aggregate gross proceeds to Navidea of approximately $1.9 million (Press release, Navidea Biopharmaceuticals, DEC 6, 2019, View Source [SID1234552001]). The securities to be issued to the Investors will represent approximately 9.3% of the Company’s outstanding common stock after such issuance.

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Navidea intends to use the net proceeds from the private placement to fund its research and development programs, including continuing to advance its Phase 2b and Phase 3 clinical trials of Tc99m tilmanocept in patients with rheumatoid arthritis, and for general working capital purposes and other operating expenses.

"This additional investment in Navidea demonstrates our family’s continued commitment to Navidea and our confidence in the long-term vision of its current board and management. It is very encouraging to us as shareholders to have these additional long-term investors co-investing and supporting the Company. This private placement will help Navidea to continue on the path towards obtaining approval for its rheumatoid arthritis diagnostic product," stated John K. Scott, Jr.

"We are very happy that a group of existing long-term shareholders continues to show faith in the potential of Navidea as well as the continued success of its ongoing RA trials," commented Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "The ability to quickly raise $1.9 million without having to pay any fees, give any warrants and at market price was an opportunity that the Company could not pass up. It also gives the Company additional runway to allow for several key milestones that we anticipate in the next few months."

A resale registration statement relating to any future resales of the newly issued shares will be filed with the Securities and Exchange Commission. While the Company expects to close the private placement of approximately 1.2 million shares within the next week, the closing of approximately 900,000 of the private placement shares is conditioned upon and will occur shortly after the U.S. Securities and Exchange Commission informs the Company of its willingness to declare the resale registration statement effective. These securities may not be sold nor may offers to buy be accepted prior to the time that the registration statement becomes effective.

On December 6, 2019 IntelGenx Technologies Corp. (TSXV: IGX) (OTCQX: IGXT) (the "Company" or "IntelGenx") reported that it intends to issue 415,178 common shares of the Corporation (the "Common Shares") at a deemed price of CAD $0.73 per Common Share in payment of an aggregate of $303,080 in interest owing on the Corporation’s 8.00% convertible unsecured subordinated debentures due June 30, 2020 (the "Debentures") (Press release, IntelGenx, DEC 6, 2019, View Source [SID1234552000]).

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Under the terms of the trust indenture governing the Debentures (the "Indenture"), the Corporation has the option to pay the semi-annual interest on the Debentures in either cash or Common Shares, subject to customary conditions set forth in the Indenture. The issuance of the Common Shares in payment of interest on the Debentures is subject to the acceptance by the TSX Venture Exchange Inc. The Common Shares issued in payment of interest on the Debentures will be issued pursuant to exemptions from the prospectus requirements of applicable securities laws.

On December 6, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported updated preliminary data from its ongoing Phase 1 dose escalation study of CA-4948, an IRAK4 kinase inhibitor, for the treatment of patients with relapsed or refractory (R/R) non-Hodgkin’s lymphoma (NHL), including patients with diffuse large B-cell lymphoma (DLBCL), Waldenström’s macroglobulinemia (WM) and oncogenic MYD88 mutations (Press release, Curis, DEC 6, 2019, View Source [SID1234551999]).

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"We are very encouraged by the anti-cancer activity that we have observed to date from CA-4948 during dose escalation in our Phase 1 study," said Robert Martell, MD, PhD, Head of R&D at Curis. "Notably, five of the six patients evaluable for anti-cancer activity at the two highest dose levels of CA-4948 have experienced reduced tumor burden. Additionally, treatment for three of these five patients is ongoing after 33 to 51 weeks. These findings illustrate dose dependent activity compared to earlier dose levels."

Dr. Martell continued: "We believe these results achieve the desired activity outcome for a targeted single agent treating malignancies with complex molecular genetics. Unlike the minority of cancers with a single driver mutation, these genetically complex malignancies have aberrant signaling through multiple signaling pathways. One such pathway is the oncogenic TLR pathway, which depends on IRAK4. Such complex cancers represent the bulk of actual medical need in oncology today, and we believe the most effective therapeutic approaches in these situations is to target multiple such mechanisms. Indeed, synergy was observed preclinically when combining CA-4948 with either BTK inhibitors or a BCL2 inhibitor, and we intend to explore combinations in the clinic."

"We believe these updated clinical data further support the potential of CA-4948 to become a safe, effective therapeutic option for patients with NHL," said James Dentzer, President and Chief Executive Officer of Curis. "CA-4948 is currently the most advanced molecule targeting IRAK4 in clinical development for cancer and given these exciting results, we intend to move aggressively to advance CA-4948 with the goal of bringing this promising new therapy to patients in need. We look forward to expanding the development of CA-4948 with two new clinical trials in 2020 that will study CA-4948 in AML/MDS and in combination therapy in NHL."

The reported data are from Curis’s ongoing Phase 1, open-label, dose escalation 3+3 study designed to evaluate the safety and tolerability of CA-4948, in addition to pharmacokinetics, pharmacodynamics, and anti-cancer activity, in patients with R/R NHL. Patients have been treated in continuous 21-day cycles and at dose levels of 50mg once-daily (QD), 50mg twice-daily (BID), 100mg QD, 100mg BID, 200mg BID and 400mg BID.

Key findings include:

CA-4948 was demonstrated to be generally well-tolerated.
Patients enrolled to date include patients with tumor types of DLBCL, WM, marginal zone lymphoma, follicular lymphoma, and lymphoplasmacytic lymphoma.
Anti-cancer activity, as measured by the reduction of tumor burden, was observed in:
5 out of 6 evaluable patients in the highest dose cohorts of 200mg BID and 400mg BID, with a mean reduction of 29% (ranging from 5% to 47%).
One patient with WM, who dose escalated from 50mg BID to 100mg BID, and then to 200mg BID, experienced dose-corresponding reductions in tumor burden. This patient remains on therapy.
One patient with DLBCL enrolled in the 200mg dose cohort remains on study and has seen tumor reductions of 35%.
One patient treated at 100mg QD had a dose-limiting toxicity (DLT) of maculo-papular rash, which was resolved after steroid treatment. Another patient treated at 400mg BID experienced a DLT of Grade 3 rhabdomyolysis.
Curis is currently evaluating patients at the 400mg BID dose of CA-4948 in its Phase 1 study and plans to continue dose escalation until the maximum tolerated dose and or recommended Phase 2 dose of CA-4948 is determined.

Conference Call Information

Curis management will host a conference call today, December 6, 2019, at 8:00 a.m. ET, to discuss these results. To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 8:00 a.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.

On December 6, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported preliminary tolerability and PK data from its ongoing Phase 1 dose-finding study of fimepinostat, a small molecule dual inhibitor of PI3K/HDAC and suppressor of MYC, in combination with venetoclax, a BCL-2 inhibitor, for the treatment of patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), including patients with double-hit/double-expressor (DH/DE) lymphoma (Press release, Curis, DEC 6, 2019, View Source [SID1234551998]).

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"We are very pleased with the progress in our ongoing Phase 1 study, with the combination of fimepinostat and venetoclax demonstrating a favorable tolerability profile thus far," said James Dentzer, President and Chief Executive Officer of Curis. "We believe demonstrating that this combination is generally well-tolerated for patients is a significant milestone, as both drugs have shown activity as monotherapies in this patient population and we believe activity will be improved by combining the two agents. Based on these data, we plan to initiate an expansion of the current study in 2020."

To date, the study has enrolled 11 patients, 6 patients in the first cohort and 5 patients in the second cohort. Patients in the first cohort received 30mg once-daily (QD) of fimepinostat and 400mg QD of venetoclax, while the patients in the second cohort received 60mg QD of fimepinostat and 400mg QD of venetoclax. To date the combination has been generally well-tolerated by patients.

"There is an urgent need for therapies targeting MYC and BCL-2 alterations, particularly in DH/DE lymphoma, a disease defined by these alterations and one of the deadliest types of lymphoma," said Robert Martell, M.D, Ph.D, Head of R&D at Curis. "We believe fimepinostat is unique in its ability to target MYC through simultaneous inhibition of both PI3K and HDAC. Venetoclax is a rapidly-acting inhibitor of BCL2, the other key abnormality in DH lymphoma. Supported by synergistic anti-cancer effects observed in preclinical models, we believe this is an ideal combination to target DLBCL and we look forward to gaining further insights on the combination from this study.

Dr. Martell continued: "The study was designed with initial patients undergoing a several-week run-in period allowing detailed PK interaction analysis and venetoclax ramp-up to be performed. In preliminary analyses, we found the combination to be generally well tolerated, with no dose-limiting toxicity (DLT) in the first cohort and one DLT of transient grade 3 diarrhea in the second cohort. Importantly, we found no drug-drug PK interaction that required dose modification of either agent. Drug-drug interactions are a major problem for many drugs combining with venetoclax, and we are encouraged that we have not seen such interaction to date with fimepinostat."

Curis’ ongoing Phase 1, open-label, multi-center, dose-finding 3+3 study is designed to evaluate the safety and tolerability, PK and pharmacodynamics, and preliminary activity of the fimepinostat and venetoclax combination in patients with DLBCL, including those with DH/DE lymphoma. Patients are enrolled in two cohorts in the study, with fimepinostat administered on a 5-days-on-2-days-off schedule in combination with venetoclax in 21-day cycles. Curis plans to initiate an expansion of the current study in 2020.

Conference Call Information

Curis management will host a conference call today, December 6, 2019, at 8:00 a.m. ET, to discuss these results. To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412-317-5252 from other locations, shortly before 8:00 a.m. ET. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.

On December 6, 2019 Beijing Hygea Medical Technology reported that it closed a $28 million Series B funding to develop its minimally invasive cryogenic treatment for cancer (Press release, Hygea Medical Technology, DEC 6, 2019, View Source [SID1234551996]). The round was led by Jianxing Medical Fund under the management of CCB International, with participation from Kunying Capital and Shuncheng Capital. Hygea holds 14 patents for its proprietary HYG KB Cryosurgical System and HYG KBD Sterile Cryosurgical Probes. It is also developing cancer diagnostics. An affiliate of the China Academy of Sciences, Division of Physics and Chemistry, Hygea has been supported by China’s 863 program and other China national and Beijing funds.

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