On January 3, 2019 Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company developing a new approach to treating cancer based upon a novel proprietary technology platform, reported that it will present at Biotech Showcase 2019, to be held January 7–9, during the most important week in healthcare finance at the Hilton San Francisco Union Square (Press release, Genprex, JAN 3, 2019, View Source [SID1234532421]).

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Genprex will present at Biotech Showcase as follows:

Date: Monday, January 7, 2019

Time: 3:30pm (PST)

Room: Franciscan A (Ballroom Level)

Venue: Hilton San Francisco Union Square Hotel, 333 O’Farrell Street, San Francisco, CA

Genprex is pioneering a new approach to treating cancer–based upon a novel proprietary technology platform–that includes the company’s initial product candidate, Oncoprex immunogene therapy. The company holds a portfolio of 30 issued patents, and two pending patents covering its proprietary platform technologies–and it has seen tremendous promise from pre-clinical research and clinical trials of those technologies at the University of Texas MD Anderson Cancer Center.

The Clinical and pre-clinical research conducted to date indicates that Genprex’s lead candidate, Oncoprex, is synergistic with and may enhance the efficacy of commercially approved and highly successful epidermal growth factor receptor (EGFR) inhibitors and immune checkpoint inhibitors. To date, multiple clinical trials have demonstrated potential for the intravenous, systemic delivery of Oncoprex, which is comprised of the tumor suppressor gene TUSC2 (also known as FUS1) encapsulated in a lipid nanovesicle.

"Genprex stands at the forefront of the new age in the fight against cancer, and I am immensely proud to be with a company operating in that position," said Rodney Varner, CEO of Genprex. "In my three decades of professional experience, I’ve never worked with another company that has the innovative, dedicated, and multi-faceted talent we have at Genprex. It is inspiring to work with such a tireless group in such a revolutionary sector of the biomedical field."

Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and executives in one place during the course of one of the industry’s largest annual healthcare investor conferences, J.P. Morgan Annual Healthcare Conference.

"We are delighted that Genprex will be presenting at Biotech Showcase this year," said Sara Demy, CEO of Demy-Colton. "Biotech Showcase is the perfect platform for life science companies to showcase their innovation and seek out their next deal. We are thrilled to, once again, be hosting what we believe will be the great strategic networking opportunity of 2019."

On January 3, 2019 Adlai Nortye Ltd. ("Adlai Nortye"), a global clinical-stage biopharmaceutical company reported that it has entered into a clinical collaboration with Merck (known as MSD outside the US and Canada) to evaluate the combination of Adlai Nortye’s AN0025 (EP4 Antagonist) and Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with solid tumors (Press release, Merck & Co, JAN 3, 2019, View Source [SID1234553811]).

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Under the terms of the agreement, Adlai Nortye and Merck will collaborate in a clinical trial to evaluate the safety and preliminary efficacy of the combination of AN0025 (EP4 Antagonist) and KEYTRUDA in patients with solid tumors.

"We are excited to announce this collaboration with Merck, to help bring innovative cancer treatments to patients with unmet medical needs. AN0025 is an investigational, oral EP4 antagonist – potentially first-in-class – with high activity and high selectivity," said Carsten Lu, CEO of Adlai Nortye. "Based on preliminary results, it is well tolerated in patients with solid tumors. This collaboration is supported by our recent preclinical data demonstrating the potential ability of AN0025 (EP4 Antagonist) to rescue patients who do not initially respond to anti-PD-1 therapy alone or who are resistant to PD-1 inhibitors with solid tumors."

"With its proposed mechanism of action and observed preclinical results, we believe that AN0025 (EP4 Antagonist) will become a key component in furthering the development of our oncology pipeline," said Dr. Lars Birgerson, CDO and CEO of Adlai Nortye USA. "In preclinical studies, AN0025 (EP4 Antagonist) combined with radiotherapy, chemoradiotherapy and with immune checkpoint inhibitors demonstrated antitumor activity in different malignancies, we are optimistic that the combination of AN0025 (EP4 Antagonist) with KEYTRUDA may provide meaningful clinical benefit in patients with solid tumors."

On January 3, 2019 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that it has exclusively licensed worldwide rights to a mesothelin-targeted chimeric antigen receptor T-cell (CAR T) immunotherapy for solid tumors from Memorial Sloan Kettering Cancer Center (MSK) (Press release, Atara Biotherapeutics, JAN 3, 2019, View Source [SID1234532388]). The most advanced program in Atara’s CAR T collaboration with MSK will focus on development of a next-generation, mesothelin-targeted CAR T using novel 1XX CAR signaling domain and PD-1 dominant negative receptor (DNR) checkpoint inhibition technologies for patients with mesothelin-associated solid tumors.

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"We are excited by the promising initial clinical results of the mesothelin-directed CAR T approach and believe mesothelin, an antigen well recognized as associated with aggressive solid tumors, is a promising target for developing a next-generation CAR T incorporating our PD-1 DNR technology," said Prasad S. Adusumilli, M.D., FACS, Deputy Chief of Thoracic Service, Director of Mesothelioma Program and Head of Solid Tumors Cell Therapy at the Cellular Therapeutics Center at MSK.

PD-1 DNRs are modified PD-1 receptors that lack inhibitory function and are designed to enhance CAR T efficacy in solid tumors without the need for development of a CAR T in combination with a PD-1 checkpoint inhibitor. Animal models have demonstrated that CAR T immunotherapies with a PD-1 DNR result in enhanced activity against solid tumors1.

"We look forward to collaborating with Atara to develop a next-generation mesothelin-targeted CAR T immunotherapy," said Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering, and Head, Gene Expression and Gene Transfer Laboratory at MSK. "Our novel mesothelin 1XX CAR is designed to extend functional CAR T cell persistence by sustaining T cell effector functions without precipitating exhaustion, provides a complementary technology to tackle challenging tumor microenvironments."

Mesothelin is a solid tumor-associated antigen that is expressed at high levels on the surface of cells in aggressive solid tumors including mesothelioma, triple-negative breast cancer, esophageal cancer, pancreatic cancer and non-small cell lung cancer. Initial results from an ongoing MSK investigator-sponsored Phase 1 study (NCT02414269) of a mesothelin-targeted CAR T immunotherapy for patients with malignant pleural cancers were presented at the 2018 American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting and support activity and safety in patients with advanced mesothelioma2,3. This ongoing Phase 1 dose-escalation study continues to accrue patients and enhanced response rates were observed when patients were subsequently treated with pembrolizumab, a PD‑1 checkpoint inhibitor. MSK is also investigating mesothelin-targeted CAR T cells for patients with advanced breast and lung cancer (NCT02792114). Additional results from these ongoing studies are expected to be presented at upcoming scientific congresses.

"Our CAR T strategy includes collaboration with investigators on cutting-edge technologies to advance programs with near-term clinical potential," said Dietmar Berger, M.D., Ph.D., Global Head of Research and Development of Atara Biotherapeutics. "Based on the encouraging MSK Phase 1 clinical experience, we are progressing a next‑generation, mesothelin‑targeted CAR T that leverages MSK technologies designed to further enhance responses in patients with mesothelioma and other advanced solid tumors. We are also developing three additional next-generation and off-the-shelf, allogeneic CAR T immunotherapies in oncology for patients with acute myelogenous leukemia (AML) and B-cell malignancies, leveraging Atara’s world-class T cell manufacturing capabilities and research expertise."

In the MSK investigator-sponsored Phase 1 study presented at the 2018 ASGCT (Free ASGCT Whitepaper) Annual Meeting, patients with malignant pleural cancers were administered a mesothelin-targeted autologous CAR T immunotherapy regionally into the chest cavity following cyclophosphamide pre-conditioning (NCT02414269). Of the six patients treated with CAR T cells following preconditioning cyclophosphamide who subsequently received checkpoint inhibitors, one showed a complete metabolic response (CMR), two had a partial response (PR) and one exhibited stable disease (SD). Mesothelin-targeted CAR T immunotherapy and PD-1 checkpoint inhibition was well-tolerated with no adverse events greater than Grade 2 and no on-target, off-tumor toxicity.

Financial terms of the agreement were not disclosed.

References
1Cherkassky L, et al. Human CAR T cells with cell-intrinsic PD-1 checkpoint blockade resist tumor-mediated inhibition. J Clin Invest. 2016 Aug 1;126(8):3130-44. doi: 10.1172/JCI83092. Epub 2016 Jul 25.
2Adusumilli PS, et al. A phase I clinical trial of malignant pleural disease treated with regionally delivered autologous mesothelin-targeted CART cells: safety and efficacy – a preliminary report. Abstract 342; 2018 ASGCT (Free ASGCT Whitepaper) Annual Meeting; Chicago, IL; May 16-19, 2018.
3Adusumilli PS, et al. Regional delivery of mesothelin-targeted CAR T cell therapy generates potent and long-lasting CD4-dependent tumor immunity. Sci Transl Med. 2014 Nov 5;6(261):261ra151. doi: 10.1126/scitranslmed.3010162.

On January 3, 2019 Allergan plc (NYSE: AGN) reported it intends to release fourth quarter and full year 2018 financial results on Tuesday, January 29, 2019, prior to the open of U.S. Financial Markets (Press release, Allergan, JAN 3, 2019, View Source(3) [SID1234532406]).

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Allergan will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, January 29, 2019 to discuss its financial results. The dial-in number to access the call is U.S./Canada (877) 251-7980, International (706) 643-1573, and the conference ID is 8599848.

A replay of the conference call will also be available beginning approximately two hours after the call’s conclusion and will remain available through 11:30 p.m. Eastern Time on February 28, 2019. The replay may be accessed by dialing (855) 859-2056 or (404) 537-3406 and entering the conference ID 8599848.

To access the webcast, please visit Allergan’s Investor Relations website at View Source;. A replay of the webcast will also be available on Allergan’s Investor Relations website.

On January 3, 2019 GeneCentric Therapeutics, Inc. reported the appointment of Michael V. Milburn, PhD, as Chief Executive Officer and President, and he will join GeneCentric’s Board of Directors (Press release, GeneCentric Therapeutics, JAN 3, 2019, View Source [SID1234532422]). Dr. Myla Lai-Goldman, founder, current CEO and President, will assume the newly-created role of Executive Chairperson of the Board of Directors, succeeding Clay Thorp, Founder and General Partner at Hatteras Venture Partners, as Board Chair.

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"We founded GeneCentric, with UNC researchers Chuck Perou and Neil Hayes, with a vision to develop cancer tests to match a drug to an individual patient in order to maximize the efficacy of cancer treatments and reduce adverse events," said Dr. Lai-Goldman. "We have made great progress in establishing a subtyping platform built around an expanding array of pan-cancer tests, applying the platform to lung, head and neck, bladder, and pancreatic cancer, and entering initial partnerships with pharmaceutical companies to enable precision drug development in oncology. Michael is well positioned to build on the scientific base we have established and drive our commercial efforts with pharmaceutical companies."

In addition to GeneCentric, Dr. Lai Goldman serves on the Board of Directors at West Pharmaceutical Services and Qvella Corporation as well as a Venture Partner with Hatteras Venture Partners.

"GeneCentric is at the forefront of developing RNA-based informatics and data science which will be key to developing the next generation cancer immunotherapies and chemotherapies," said Milburn. "Myla and the scientific founders and team have been instrumental in building a technology that is highly valued by our pharmaceutical partners to get the right cancer treatment to the right patient. This is a very exciting time for GeneCentric as we begin to deploy our cancer tests alongside cancer drugs."

Dr. Milburn joined GeneCentric in September of 2018 as Chief Scientific Officer and leads the development of its RNA-based technology platform for developing new cancer tests focused on pharmaceutical drug development. Previously, Dr. Milburn was CSO at Metabolon and led the R&D efforts that established the company as a premier metabolomics technology. Prior to Metabolon, he served as Senior Vice President of Research and Corporate Development at Sirtris Pharmaceuticals and Senior Vice President of Research at Plexxikon. He also held senior research positions at Structural Genomix and GlaxoWellcome.

Dr. Milburn received his PhD in Biophysical Chemistry from the University of California at Berkeley and was a post-doctoral research fellow at Harvard Medical School. Dr. Milburn has published over 100 peer-reviewed scientific articles and is an Adjunct Professor in the Department of Molecular and Structural Biochemistry at NCSU.

"Michael brings a broad range of expertise that spans drug development, biomarker discovery and diagnostic development and commercialization, along with a strong track record commercial execution that built significant value," said Clay Thorp, Founder and General Partner at Hatteras Venture Partners. "We look forward to his new leadership role at GeneCentric as they expand their cancer technology and expertise with pharmaceutical partners."