On November 11, 2019 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of uro-oncology, reported that it has entered into an exclusive worldwide1 license agreement with Agenus Inc (Nasdaq:AGEN) to develop and commercialize zalifrelimab (AGEN1884, anti-CTLA-4 antibody) via intravesical delivery in combination with UGN-201 for the treatment of urinary tract cancers (Press release, UroGen Pharma, NOV 11, 2019, View Source [SID1234550877]). This combination is based on encouraging preclinical data utilizing UroGen’s proprietary sustained release technology, which is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option while minimizing systemic exposure and potential side effects. UroGen’s initial indication for development will be high-grade non-muscle invasive bladder cancer (HG NMIBC).

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Zalifrelimab (AGEN1884, anti-CTLA-4 antibody) is currently being evaluated by Agenus in combination with Agenus’ anti-PD-1 antibody balstilimab (AGEN2034) in second line cervical cancer with anticipated BLA filing in 2020. UGN-201 is a TLR-7/8 agonist that is in early stage development at UroGen for HG NMIBC.

"Patients with high-grade forms of non-muscle invasive bladder cancer are at a high risk of progression and we are committed to rapidly advancing our development efforts on their behalf," said Liz Barrett, President and Chief Executive Officer of UroGen. "Together with our pipeline medicines, UGN-101 and UGN-102, that target low-grade upper tract urothelial cancer and low-grade bladder cancer, respectively, the addition of this new medicine targeting high grade urothelial diseases provides UroGen with a complementary pipeline that advances our vision to be a leader in uro-oncology."

Under the terms of the agreement and in exchange for the worldwide1 exclusive license to AGEN1884 for the treatment of cancers of the urinary tract via intravesical delivery, Agenus will receive an upfront payment of $10 million, in addition to up to $115 million for achieving certain clinical development and regulatory milestones, up to $85 million upon achieving certain commercial milestones, as well as royalties on net sales of licensed products in the 14-20% range.

UroGen will be responsible for all development and commercialization activities.

UroGen’s lead investigational candidates, UGN-101 (mitomycin gel) for instillation, and UGN-102 (mitomycin gel) for intravesical instillation, are designed to potentially ablate tumors by non-surgical means and to treat several forms of non-muscle invasive urothelial cancer, including low-grade upper tract urothelial cancer (LG UTUC) and low-grade non-muscle invasive bladder cancer (LG NMIBC), respectively. UGN-101 has been granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations by the U.S. Food and Drug Administration for the treatment of LG UTUC.

1 Worldwide license does not include Argentina, Brazil, Chile, Colombia, Peru, Venezuela and their respective territories and possessions.

On November 11, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis, reported the company’s Senior Vice President of Discovery Research, Martin Handfield, MS, Ph.D., will be a featured speaker at the inaugural International Conference on Microbial Research and Applications (MicroBiome 2019) (Press release, Oragenics, NOV 11, 2019, View Source [SID1234550876]).

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Dr. Handfield will be speaking on November 13, 2019 at 12:20PM ET. The International Conference on Microbial Research and Applications will be held November 13-14, 2019 at the Radisson Hotel, Downton-Inner Harbor in Baltimore, Md. Dr. Handfield’s talk will be titled, "Lantibiotics: a large untapped pipeline of attractive scaffolds for the development of novel antibiotics." Those interested in attending the talk may register for the conference via its website, View Source

About Lantibiotics

Lantibiotics are a class of antibiotic compounds with novel mechanism of action, prized for their ability to overcome antibiotic-resistant infections. With resistant strains on the rise, particularly healthcare-acquired infections (HAI), the need for these potent lantibiotic agents is critical. Oragenics is pursuing the commercial-scale production of a lantibiotic for use as an antimicrobial.

On November 11, 2019 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that it will host a conference call and webcast on Tuesday, November 12, 2019 at 5:00 p.m. Eastern Time to review its third quarter 2019 financial and operating results and provide a corporate update (Press release, Marker Therapeutics, NOV 11, 2019, View Source;utm_medium=email&utm_campaign=investor_alerts&utm_content=%5B%5Brssitem_title%5D%5D [SID1234550875]). The webcast will be accessible in the Investors section of the Company’s website at www.markertherapeutics.com. Individuals can participate in the conference call by dialing 877-407-8913 (domestic) or 201-689-8201 (international) and referring to the "Marker Therapeutics Third Quarter 2019 Earnings Call." The archived webcast will be available for replay on the Marker website following the event. About Marker Therapeutics, Inc. Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Marker’s cell therapy technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. This population of T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patient’s immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cell therapies, we believe that our product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies. Marker is also advancing a number of innovative peptide- and gene-based immuno-therapeutics for the treatment of metastatic solid tumors, including the Folate Receptor Alpha program (TPIV200) for breast and ovarian cancers and the HER2/neu program (TPIV100/110) for breast cancer, currently in Phase 2 clinical trials. To receive future press releases via email, please visit: www.markertherapeutics.com/email-alerts/ Forward-Looking Statement Disclaimer This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company’s expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are "forward-looking statements." Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies; our TPIV200 and TPIV100/110 programs; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and, the timing and success of our clinical trials, as well as clinical trials conducted by our collaborators. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company’s most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at www.sec.gov. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Contacts Investor Solebury Trout Chiara Russo (617) 221-9197 [email protected] Media Solebury Trout Amy Bonanno (914) 450-0349 [email protected]

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On November 11, 2019 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported data from the Company’s preclinical pipeline this weekend (Press release, Celldex Therapeutics, NOV 11, 2019, View Source [SID1234550874]). A review of the CDX-0159 early development program was presented at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting on November 9, 2019 in the Distinguished Industry Oral Abstract Session. Preclinical data supporting the continued development of the Company’s CDX-527 bispecific candidate were also presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting (SITC 2019), including both a poster presentation on November 9, 2019 and a talk during the preconference program session "Novel Multi-Targeted Therapeutic Platforms" on Wednesday, November 6, 2019.

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"Our preclinical development efforts have yielded two very exciting candidates for continued advancement," said Tibor Keler, PhD, Executive Vice President and Chief Scientific Officer. "Our KIT inhibitor, CDX-0159, is poised to enter the clinic before year end—first in healthy volunteers and then in patients with chronic idiopathic urticaria, an indication we believe could offer an opportunity for a rapid development pathway. CDX-527, the first candidate from our bispecific platform, builds on our prior clinical experience combining CD27 activation and PD-1 blockade. CDX-527 showed greater activity than the combination of individual antibodies, adding to our optimism that this next-generation checkpoint inhibitor will be an important addition to the Celldex pipeline. We look forward to filing an IND for CDX-527 in the first half of 2020."

CDX-0159 Presentation Highlights:

CDX-0159 is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT and potently inhibits its activity. KIT is expressed in a variety of cells, including mast cells, and its activation by its ligand SCF regulates mast cell functions including activation and survival. In certain inflammatory diseases, such as chronic idiopathic urticaria (CIU), mast cell activation plays a central role in the onset and progression of the disease.

In a Phase 1 clinical study with Celldex’s KIT antagonist monoclonal antibody, CDX-0158, robust inhibition of mast cell activity was observed supporting the concept that targeting KIT can modulate mast cell activity and potentially provide clinical benefit in mast cell related diseases. CDX-0158 was re-engineered and replaced with CDX-0159, a New Molecular Entity (NME), to ablate Fc receptor interactions and effector function and improve its safety profile, while preserving full KIT inhibitory activity. In addition, CDX-0159 was modified to provide extended half-life following administration.

Celldex’s Investigational New Drug (IND) Application for CDX-0159 has been accepted by the Food and Drug Administration and the Company plans to initiate a Phase 1a study of CDX-0159 by year-end 2019. The study is designed to evaluate the safety profile, pharmacokinetics and pharmacodynamics of single ascending doses of CDX-0159 in healthy subjects. Following completion of this study, Celldex plans to further study CDX-0159 in CIU, a mast cell-related disease. CIU presents as itchy hives, angioedema or both for at least six weeks without a specific trigger; multiple episodes can play out over years or even decades. The prevalence of CIU is estimated to be 0.5% to 1% of the total population or up to 3.2 million cases in the United States. About 50% of patients with CIU achieve symptomatic control with antihistamines or leukotriene receptor antagonists. Omalizumab, an IgE inhibitor, provides relief for roughly half of the remaining antihistamine/leukotriene refractory patients. Consequently, there is a need for more effective later line therapies.

CDX-527 Presentation Highlights:

Bispecific antibodies that engage two independent pathways involved in controlling immune responses to tumors are a rapidly growing area for the development of next generation PD-1 inhibitors. CDX-527 is the first candidate from Celldex’s bispecific platform and uses Celldex’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway. Celldex’s prior clinical experience with combining CD27 activation and PD-1 blockade provide the rationale for linking these two pathways into one molecule. The data presented at SITC (Free SITC Whitepaper) demonstrate that CDX-527 is more potent at T cell activation and anti-tumor immunity than the combination of parental monoclonal antibodies. Celldex is currently completing CDX-527 GMP manufacturing activities and IND-enabling studies and plans to file an IND in the first half of 2020. The Company believes that CDX-527 supports development of combination studies across the Celldex pipeline without needing to access competitor checkpoint inhibitors, allowing for quicker and more cost-effective studies.

On November 11, 2019 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that James Breitmeyer, M.D., Ph.D., President and Chief Executive Officer, will present a company overview at the Stifel 2019 Healthcare Conference in New York City on Tuesday, November 19, 2019 at 10:20 a.m. ET / 7:20 a.m. PT (Press release, Oncternal Therapeutics, NOV 11, 2019, View Source [SID1234550873]).

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A live webcast of the presentation will be available online via a link from the investor relations page of the Company’s website at www.oncternal.com, and the webcast will be archived there for at least 30 days following the event.