On December 19, 2019 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported the presentation of a poster entitled, "Liposomal annamycin inhibition of lung localized breast cancer," at the San Antonio Breast Cancer Symposium held December 14 – 29, 2019 (Press release, Moleculin, DEC 19, 2019, View Source [SID1234552508]).

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"We now have another round of new key findings that we believe support the potential expansion of Annamycin to indications beyond acute leukemia," commented Walter Klemp, Chairman and CEO of Moleculin. "Our ongoing sponsored research at MD Anderson has now resulted in new patented discoveries that clearly demonstrate unusually high activity of Annamycin against lung metastatic cancers in animal models. This activity is a direct result of surprisingly high uptake of Annamycin by the lungs. The findings of experiments comparing organ distribution of Annamycin with doxorubicin are quite astonishing. We are seeing a 5 to 7-fold higher concentration of Annamycin in lungs than in plasma and at least 5-fold higher than that of doxorubicin. Doxorubicin, which is the current standard of care for treatment for frequently occurring lung metastases of such solid tumors as sarcoma, colorectal cancer, breast cancer and bladder cancer, is unfortunately not effective against such metastases, and consequently doxorubicin-based therapies fail the vast majority of such patients. Our research suggests that the surprisingly high activity of Annamycin in animal models of lung metastases may be, in part, due to the high level of accumulation of Annamycin in the lungs. We believe the tumor growth inhibition and even tumor regression observed with Annamycin might offer a new treatment option for patients with lung localized cancers. This notion is also supported by previously observed high activity of Annamycin against multidrug resistant tumors in animal models and its lack of cardiotoxicity thus far supported by both animal studies and clinical studies in humans."

"Importantly, the published poster, which can be found on our web site at View Source, shows substantially increased survival in both triple negative breast cancer and colon cancer lung metastases animal models," Mr. Klemp added. "It should also be noted that treatment with Annamycin resulted in long-term survival of a significant number of animals. We’re not just seeing a reduction in tumor growth, but often a reversal of tumor activity resulting in an almost complete reduction of tumor burden."

Mr. Klemp concluded, "We believe our research continues to support the view that Annamycin has market potential far beyond the treatment of acute leukemia as indicated by our ongoing US and European clinical trials. The absence of cardiotoxicity being demonstrated in those trials alone makes Annamycin a compelling candidate to potentially replace doxorubicin in a number of treatment settings. Furthermore, our new data, showing the ability of Annamycin to accumulate at disproportionately high levels in the lungs, suggests an opportunity to treat patients for whom the standard of care is ineffective. If this capability can be demonstrated in future human clinical trials, we believe Annamycin may be able to fill the existing void of effective chemotherapeutics for lung metastases and bring hope to a large population of patients in the USA and around the world, as the lungs are among the most common sites of cancer metastases."

On December 19, 2019 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that new data from the vopratelimab ICONIC trial, on the association of a predictive RNA signature with the emergence of ICOS hi CD4 T cells and clinical outcomes, will be presented at a poster session at the 2020 ASCO (Free ASCO Whitepaper)-SITC Clinical Immuno-Oncology Symposium Annual Meeting, being held February 6-8, 2020 in Orlando, Florida (Press release, Jounce Therapeutics, DEC 19, 2019, View Source [SID1234552507]).

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"We are pleased to present the new data that led to our selection of a predictive biomarker for our next vopratelimab trial. We believe patient selection strategies to identify patients more likely to respond to immuno-oncology therapies may better address unmet medical needs," said Elizabeth Trehu, M.D., chief medical officer of Jounce Therapeutics. "The potential predictive biomarker that we will present at ASCO (Free ASCO Whitepaper)-SITC is an RNA signature. In 2020, we plan to initiate the new Phase 2 predictive biomarker trial, which will study vopratelimab in combination with our investigational PD-1 inhibitor, JTX-4014, in RNA signature selected patients."

Poster Presentation Details

Title: Association of a predictive RNA signature (RS) with emergence of ICOS hi CD4 T cells and efficacy outcomes for the ICOS agonist vopratelimab (vopra) and nivolumab (nivo) in patients (pts) on the ICONIC trial
Author: Timothy A. Yap, M.B.B.S., Ph.D., M.R.C.P., B.S., The University of Texas MD Anderson Cancer Center
Session Title: Poster Session A
Abstract Number: 14
Session Date and Time: Thursday, February 6, 2020, 11:30 AM-1:00 PM and 6:00 PM-7:00 PM ET

About Vopratelimab
Jounce’s lead product candidate, vopratelimab (formerly JTX-2011), is a clinical-stage monoclonal antibody that binds to and activates ICOS, the Inducible T cell CO-Stimulator, a protein on the surface of certain T cells commonly found in many solid tumors. Vopratelimab is currently being assessed in the Phase 2 EMERGE clinical trial in sequence with ipilimumab in patients with non-small cell lung cancer (NSCLC) or urothelial cancer who were previously treated with PD-1/PD-L1 inhibitor therapies. Jounce is also planning to initiate a new predictive biomarker trial of vopratelimab with its investigational PD-1 inhibitor, JTX-4014, in RNA signature selected patients. Vopratelimab was previously assessed in the Phase 1/2 ICONIC trial and was found to be safe and well-tolerated, alone and in combination with each of the anti-PD-1 antibodies nivolumab and pembrolizumab, as well as with ipilimumab, an antibody that binds to CTLA-4. Jounce has previously presented data demonstrating the emergence of ICOS hi CD4 T cells in the peripheral blood in patients treated with vopratelimab alone or in combination with nivolumab, and has further shown that emergence of these cells, which is related to vopratelimab and not PD-1 inhibitors, is associated with improved response rate, progression free survival, and overall survival.

On December 19, 2019 IntelGenx Technologies Corp. (TSXV: IGX) (OTCQX: IGXT) (the "Company" or "IntelGenx") is reported that it has filed a preliminary short form prospectus (the "Prospectus") with respect to an offering (the "Offering") of units ("Units") for a minimum of Cdn$4,000,000 and a maximum of Cdn$10,000,000 aggregate gross proceeds (Press release, IntelGenx, DEC 19, 2019, View Source [SID1234552506]). Each Unit will consist of one share (an "Offered Share") of the common stock of the Company ("Common Stock") and one half of one common stock purchase warrant (each whole common stock purchase warrant, a "Warrant"). Each Warrant will entitle the holder to purchase one share of Common Stock (a "Warrant Share"). Concurrently with the filing of the Prospectus, the Corporation has filed a registration statement on Form S-1 (the "Registration Statement") with the United States Securities and Exchange Commission (the "SEC") to register the Units and the Warrant Shares.

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The Offering is being conducted on a commercially reasonable best efforts basis by Echelon Wealth Partners Inc. (the "Agent") in the provinces of British Columbia, Alberta, Manitoba and Ontario. Final pricing of the Units (the "Offering Price"), the Warrant exercise price and term, and the determination of the number of Units to be sold pursuant to the Offering will be determined in the context of the market prior to the filing of the final short form prospectus in respect of the Offering.

The Company has granted to the Agent an option to increase the size of the Offering by up to 15%, exercisable in whole or in part at any time for a period of 30 days after and including the closing date of the Offering.

The net proceeds from the Offering will be used for the Company’s Phase 2A Montelukast Study, general working capital requirements, and, depending on the size of the offering, expansion of the Company’s manufacturing facility.

The Company will apply to list the Offered Shares and the Warrant Shares underlying the Units on the TSX Venture Exchange (the "TSXV"). There is no established trading market for the Warrants and IntelGenx does not expect a market to develop. A copy of the Prospectus is available under the Corporation’s profile at www.sedar.com and a copy of the Registration Statement can be obtained from the SEC’s website at www.sec.gov or by request to Echelon Wealth Partners Inc. at [email protected]. The Offering is subject to certain customary conditions including, but not limited to, the receipt of all necessary approvals, including the approval of the TSXV and the SEC declaring the Registration Statement effective.

A registration statement relating to these securities has been filed with the SEC but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. No offer to buy the securities can be accepted and no part of the purchase price can be received until the registration statement has become effective, and any such offer may be withdrawn or revoked, without obligation or commitment of any kind, at any time prior to notice of its acceptance given after the effective date.

On December 19, 2019 Genmab A/S (Nasdaq: GMAB) and CureVac AG reported that they have entered into a research collaboration and license agreement (Press release, Genmab, DEC 19, 2019, View Source [SID1234552505]). This strategic partnership will focus on the research and development of differentiated mRNA-based antibody products by combining CureVac’s mRNA technology and know-how with Genmab’s proprietary antibody technologies and expertise.

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"As part of Genmab’s effort to fundamentally transform cancer treatment we have once again entered into a collaboration that will further provide us with the potential to lead innovation in the antibody space," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "CureVac’s unique mRNA technology, which uses the body’s own ability to produce specific proteins from nucleic acid, combined with Genmab’s world-class antibody expertise and robust proprietary technology platforms could create multiple novel options for the treatment of patients with cancer."

"We are delighted to partner with Genmab. Through our agreement focused on mRNA encoding antibodies, we will continue to demonstrate the robustness of our mRNA technology," said Daniel L. Menichella, Chief Executive Officer of CureVac. "We believe that the collaboration with Genmab represents the first antibody deal in the field of mRNA. It is our hope that the collaboration will be successful for patients, the two companies and their shareholders."

Under the terms of the agreement Genmab will provide CureVac with a USD 10 million upfront payment. Genmab will also make a 20 million euro equity investment in CureVac. The companies will collaborate on research to identify an initial product candidate and CureVac will contribute a portion of the overall costs for the development of this product candidate, up to the time of an Investigational New Drug Application. Genmab would thereafter be fully responsible for the development and commercialization of the potential product, in exchange for undisclosed milestones and tiered royalties to CureVac. The agreement also includes three additional options for Genmab to obtain commercial licenses to CureVac’s mRNA technology at pre-defined terms, exercisable within a five-year period. If Genmab exercises any of these options, it would fund all research and would develop and commercialize any resulting product candidates with CureVac eligible to receive between USD 275 million and USD 368 million in development, regulatory and commercial milestone payments for each product, dependent on the specific product concept. In addition, CureVac is eligible to receive tiered royalties in the range from mid-single digits up to low double digits per product. CureVac would retain an option to participate in development and/or commercialization of one of the potential additional programs under pre-defined terms and conditions.

On December 19, 2019 FORMA Therapeutics, Inc., a clinical stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported the closing of $100 million Series D financing (Press release, Forma Therapeutics, DEC 19, 2019, View Source [SID1234552504]). The financing was led by RA Capital Management, with participation from Cormorant Asset Management, Wellington Management, Samsara BioCapital and funds managed by Janus Henderson Investors, as well as an undisclosed healthcare investment fund.

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"This financing reflects our sharpened focus on serving patients with rare hematologic diseases and cancers," said Frank Lee, chief executive officer of FORMA Therapeutics. "In the last month, we have presented important proof of mechanism and differentiating clinical data for our programs in sickle cell disease, glioma, AML and NASH. We are energized by the commitment from this group of leading industry investors as we move into 2020, another critical year with multiple clinical data readouts and a new program entering the clinic."

"We are impressed with FORMA’s seamless transformation over the past year, moving from an early discovery engine to a clinical-stage, asset-focused company," said Peter Kolchinsky, Ph.D., managing partner of RA Capital Management and new FORMA board member. "We feel fortunate to be able to come together with our peers to capitalize FORMA’s development of what we believe are several best-in-class molecules. While there are already many programs in development to help patients with sickle cell disease and the cancers we are targeting, FORMA’s candidates represent a unique and likely complementary contribution to the future armamentarium, which is important both for patients and strategically for FORMA."

Financing proceeds will support the ongoing clinical development of FT-4202, FORMA’s pyruvate kinase-R (PKR) activator in clinical development as a potential disease-modifying therapy for sickle cell disease (SCD). Data presented at the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting confirm that FT-4202 activates PKR with a simultaneous effect on hemoglobin oxygen affinity and adenosine triphosphate (ATP) levels, and it was safe and well-tolerated in healthy subjects. A Phase 1/2 study is currently enrolling patients with sickle cell disease.

The funding will also support FORMA’s deep pipeline, including FT-7051, a novel and potent selective inhibitor of CBP/p300 binding to DNA for androgen receptor-driven cancers, also being investigated for its potential in AR-v7 mCRPC; olutasidenib, a next generation inhibitor of mutated isocitrate dehydrogenase 1 (IDH1m) in development to treat gliomas, relapsed/refractory acute myeloid leukemia (R/R AML), myelodysplastic syndrome (MDS) and other IDH1m solid tumors; and progress on a variety of preclinical programs.