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Oncopeptides will host a webcast on Tuesday, December 10[th] at 13:00 (CET) to provide an update regarding data presented at the ASH annual meeting

On December 6, 2019 Oncopeptides AB (Nasdaq Stockholm: ONCO), reported that the company will host a webcast on Tuesday, December 10th, 2019, at 13:00 (CET) to provide an update regarding the data presented December 7-8 at the American Society Hematology (ASH) (Free ASH Whitepaper) Annual Meeting 2019 (Press release, Oncopeptides, DEC 6, 2019, View Source [SID1234552003]). The webcast will be hosted by CEO Jakob Lindberg.

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Inceptua Medicines Access and Onconova Therapeutics Announce Pre-approval Access Collaboration for Rigosertib in Selected Countries Outside the US

On December 6, 2019 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), and Inceptua Medicines Access (a business unit of the Inceptua Group), a global pharmaceutical company and service partner, reported that they have entered into a collaboration to make available intravenous rigosertib via a Pre-approval Access Program in selected countries around the world (Press release, Onconova, DEC 6, 2019, View Source [SID1234552002]).

Pre-approval Access Programs (also known as expanded access, early access, compassionate use, named patient supply) are regulatory-compliant processes permitting experimental agents in development to be made available upon the request of a physician or a patient for appropriate patients for whom no alternative treatment option exists in their country. Rigosertib is a small molecule that inhibits cellular signaling in cancer cells by acting as a RAS mimetic. Current clinical development of rigosertib is centered upon the therapeutic management of MDS, a heterogeneous group of bone marrow disorders characterized by ineffective hematopoiesis that often develop into acute myeloid leukemia (AML). Rigosertib, in its intravenous formulation, is currently in Phase 3 clinical development for the treatment of higher-risk MDS.

The rigosertib Pre-approval Access Program is expected to launch in first half of 2020 and will allow Inceptua to supply intravenous rigosertib within designated countries, primarily and initially concentrated in selected countries in Europe, in response to physician requests for patients with higher- risk MDS who have exhausted all available treatment options, and are not eligible for or have no access to the INSPIRE study. Under the terms of this agreement, Inceptua will support Onconova through the pre-approval provision of intravenous rigosertib initially into a number of countries including: Australia, Denmark, Finland, France, Ireland, Italy, the Netherlands, Portugal, South Africa, Spain, and the UK.

"Inceptua Medicines Access is delighted to be selected as Onconova’s partner for the Pre-approval Access Program for rigosertib. Higher-risk MDS is a disease with significant unmet need, and we are pleased to be able to support healthcare professionals seeking access to rigosertib, ahead of its commercial launch," said Mark Corbett, EVP, Inceptua Medicines Access.

Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, said, "The rigosertib Pre-approval Access Program is a key strategic initiative for Onconova. We are pleased that intravenous rigosertib will be made compliantly available to suitable patients with higher-risk MDS through their physcians in designated countries. The program will run alongside our ongoing Phase 3 INSPIRE Trial, and is expected to continue until commercial launch in such countries. We are pleased to work with Inceptua, given their strong record of administering such programs successfully."

Navidea Biopharmaceuticals Announces $1.9 Million Private Placement

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.

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.

IntelGenx Announces Issuance of Shares in Payment of Interest on Outstanding Debentures

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]).

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.

Curis Provides First-Ever Demonstration that Targeting IRAK4 in Patients with Relapsed/Refractory Non-Hodgkin’s Lymphoma Results in Anti-Cancer Activity in Ongoing Phase 1 Study

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]).

"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.