On May 8, 2018 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the first quarter of 2018. Navidea reported total revenues for the quarter of $276,000. Net loss attributable to common stockholders was $6.7 million (Press release, Navidea Biopharmaceuticals, MAY 8, 2018, View Source [SID1234526226]).

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Michael Goldberg, M.D., President and Chief Executive Officer of Navidea, commented, "We were able to advance our core technology on multiple fronts and we experienced a year free from the severe financial constraints the company labored under for over a decade. Navidea had been pursuing a strategy to become a major player in the development and commercialization of precision medicine diagnostic products and took on too much debt to fund the development of in-licensed products and to develop the commercial infrastructure to market and sell its Lymphoseek product. We continue to also drive the process with the FDA and their agents to seek approval of CD206 as a qualified biomarker, thus advancing the use of Tc99m tilmanocept on a broad front for clinical trials. With our best-in-class activated macrophage targeting system, we have been able to generate significant human imaging data and promising animal data with our therapeutic agents, reinforcing our optimism that this platform holds potential for the diagnosis and treatment of diseases in which macrophages play an important role."

First Quarter 2018 Highlights and Subsequent Events

Entered an Amendment to the Asset Purchase Agreement with Cardinal Health 414, LLC ("Cardinal Health 414") in April 2018, pursuant to which Cardinal Health 414 paid the Company approximately $6.0 million and agreed to pay the Company an amount equal to the unused portion of the letter of credit (not to exceed approximately $7.1 million) promptly after the earlier of (i) the expiration of the letter of credit and (ii) the receipt by Cardinal Health 414 of evidence of the return and cancellation of the letter of credit. In exchange, the obligation of Cardinal Health 414 to make any further contingent payments has been eliminated. Cardinal Health 414 is still obligated to make the milestone payments in accordance with the terms of the earnout provisions of the Purchase Agreement.

Presented strong preclinical results in Navidea’s nonalcoholic steatohepatitis ("NASH") research at the 2nd Annual NASH Summit in April

Signed exclusive license with Meilleur Technologies, Inc. a wholly-owned subsidiary of Cerveau Technologies, Inc. to conduct research using NAV4694, as well as an exclusive license for the development and commercialization of NAV4694 in Australia, Canada, China, and Singapore

Completed two clinical imaging studies of intravenous ("IV")-administered Tc99m tilmanocept in subjects with rheumatoid arthritis and results will be included in a package to be submitted to the U.S. Food and Drug Administration ("FDA") regarding a Phase 3 clinical plan

Continued enrollment in IV-administered Tc99m tilmanocept trial in NASH. Enrollment is anticipated to complete by the end of this year.

Continued enrollment in 27-patient Phase 2 cardiovascular clinical study

Completed a preclinical plan for Kaposi’s Sarcoma to be reviewed by the FDA

Initiated a pilot study for imaging Crohn’s Disease with IV-administered Tc99m tilmanocept and evaluation of archival biopsies of Crohn’s patients for CD206 biomarker analysis

Continued series of regular investor-focused Q&A conference calls to improve Investor Relations strategy

Financial Results

Our consolidated balance sheets and statements of operations have been reclassified, as required by current accounting standards, for all periods presented to reflect the line of business sold to Cardinal Health 414 as a discontinued operation. Accordingly, this discussion focuses on describing results of our operations as if we had not operated the discontinued operation during the periods being disclosed.

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Total revenues for the first quarter of 2018 were $276,000, compared to $580,000 in the first quarter of 2017. These revenues were primarily grant-related in both periods.

●

Research and development expenses for the first quarter of 2018 were $999,000, compared to $705,000 in the first quarter of 2017. The net increase was primarily a result of increased NAV4694 development costs due to the 2017 reversal of previously accrued expenses, offset by decreased Tc99m tilmanocept, Manocept, and therapeutics development costs coupled with decreased net compensation costs.

●

Selling, general and administrative expenses for the first quarter of 2018 were $1.8 million, compared to $3.0 million in the first quarter of 2017. The net decrease was primarily due to decreases in legal and professional services, general office expenses such as insurance, depreciation, rent and travel, and investor relations services.

●

Navidea’s net loss attributable to common stockholders for the quarter ended March 31, 2018 was $6.7 million, or $0.04 per share (basic), compared to net income attributable to common stockholders of $85.6 million, or $0.53 per share, for the same period in 2017.

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Navidea ended the quarter with $2.2 million in cash and investments, not including the accelerated earnout payment of $6.0 million from Cardinal Health 414 which was received after the quarter ended.

Conference Call Details

Investors and the public are invited to access the live audio webcast through the link below. Participants who would like to ask questions during the question and answer session must participate by telephone. Participants are encouraged to log-in and/or dial-in fifteen minutes before the conference call begins.

Event:

Q1 2018 Earnings and Business Update Conference Call

Date:

Wednesday, May 9, 2018

Time:

8:30 am (Eastern Time)

U.S. & Canada Dial-in:

1-929-477-0448

Conference ID:

9493945

Webcast

http://www.audio-webcast.com/cgi-bin/visitors.ssp?fn=visitor&id=5603

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

Michael Goldberg, M.D., President and Chief Executive Officer of Navidea, commented, "We were able to advance our core technology on multiple fronts and we experienced a year free from the severe financial constraints the company labored under for over a decade. Navidea had been pursuing a strategy to become a major player in the development and commercialization of precision medicine diagnostic products and took on too much debt to fund the development of in-licensed products and to develop the commercial infrastructure to market and sell its Lymphoseek product. We continue to also drive the process with the FDA and their agents to seek approval of CD206 as a qualified biomarker, thus advancing the use of Tc99m tilmanocept on a broad front for clinical trials. With our best-in-class activated macrophage targeting system, we have been able to generate significant human imaging data and promising animal data with our therapeutic agents, reinforcing our optimism that this platform holds potential for the diagnosis and treatment of diseases in which macrophages play an important role."

First Quarter 2018 Highlights and Subsequent Events

Entered an Amendment to the Asset Purchase Agreement with Cardinal Health 414, LLC ("Cardinal Health 414") in April 2018, pursuant to which Cardinal Health 414 paid the Company approximately $6.0 million and agreed to pay the Company an amount equal to the unused portion of the letter of credit (not to exceed approximately $7.1 million) promptly after the earlier of (i) the expiration of the letter of credit and (ii) the receipt by Cardinal Health 414 of evidence of the return and cancellation of the letter of credit. In exchange, the obligation of Cardinal Health 414 to make any further contingent payments has been eliminated. Cardinal Health 414 is still obligated to make the milestone payments in accordance with the terms of the earnout provisions of the Purchase Agreement.

Presented strong preclinical results in Navidea’s nonalcoholic steatohepatitis ("NASH") research at the 2nd Annual NASH Summit in April

Signed exclusive license with Meilleur Technologies, Inc. a wholly-owned subsidiary of Cerveau Technologies, Inc. to conduct research using NAV4694, as well as an exclusive license for the development and commercialization of NAV4694 in Australia, Canada, China, and Singapore

Completed two clinical imaging studies of intravenous ("IV")-administered Tc99m tilmanocept in subjects with rheumatoid arthritis and results will be included in a package to be submitted to the U.S. Food and Drug Administration ("FDA") regarding a Phase 3 clinical plan

Continued enrollment in IV-administered Tc99m tilmanocept trial in NASH. Enrollment is anticipated to complete by the end of this year.

Continued enrollment in 27-patient Phase 2 cardiovascular clinical study

Completed a preclinical plan for Kaposi’s Sarcoma to be reviewed by the FDA

Initiated a pilot study for imaging Crohn’s Disease with IV-administered Tc99m tilmanocept and evaluation of archival biopsies of Crohn’s patients for CD206 biomarker analysis

Continued series of regular investor-focused Q&A conference calls to improve Investor Relations strategy

Financial Results

Our consolidated balance sheets and statements of operations have been reclassified, as required by current accounting standards, for all periods presented to reflect the line of business sold to Cardinal Health 414 as a discontinued operation. Accordingly, this discussion focuses on describing results of our operations as if we had not operated the discontinued operation during the periods being disclosed.

Total revenues for the first quarter of 2018 were $276,000, compared to $580,000 in the first quarter of 2017. These revenues were primarily grant-related in both periods.

Research and development expenses for the first quarter of 2018 were $999,000, compared to $705,000 in the first quarter of 2017. The net increase was primarily a result of increased NAV4694 development costs due to the 2017 reversal of previously accrued expenses, offset by decreased Tc99m tilmanocept, Manocept, and therapeutics development costs coupled with decreased net compensation costs.

Selling, general and administrative expenses for the first quarter of 2018 were $1.8 million, compared to $3.0 million in the first quarter of 2017. The net decrease was primarily due to decreases in legal and professional services, general office expenses such as insurance, depreciation, rent and travel, and investor relations services.

Navidea’s net loss attributable to common stockholders for the quarter ended March 31, 2018 was $6.7 million, or $0.04 per share (basic), compared to net income attributable to common stockholders of $85.6 million, or $0.53 per share, for the same period in 2017.

Navidea ended the quarter with $2.2 million in cash and investments, not including the accelerated earnout payment of $6.0 million from Cardinal Health 414 which was received after the quarter ended.

Conference Call Details

Investors and the public are invited to access the live audio webcast through the link below. Participants who would like to ask questions during the question and answer session must participate by telephone. Participants are encouraged to log-in and/or dial-in fifteen minutes before the conference call begins.

Event:

Q1 2018 Earnings and Business Update Conference Call

Date:

Wednesday, May 9, 2018

Time:

8:30 am (Eastern Time)

U.S. & Canada Dial-in:

1-929-477-0448

Conference ID:

9493945

Webcast

http://www.audio-webcast.com/cgi-bin/visitors.ssp?fn=visitor&id=5603

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website

On May 8, 2018 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported financial results for the three months ended March 31, 2018, and provided an operating forecast and program updates (Press release, Ligand, MAY 8, 2018, View Source [SID1234526242]). Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time to discuss this announcement and answer questions.

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"Our financial and business results for the first quarter were excellent, highlighted by significant progress with several of our leading partnered assets. Melinta Therapeutics launched newly-approved intravenous Baxdela in the U.S. and their partners made regulatory filings in new geographies. Sage Therapeutics filed a new drug application for intravenous brexanolone for the treatment of postpartum depression and Retrophin initiated a Phase 3 trial with sparsentan for treating focal segmental glomerulosclerosis. We also out-licensed our GRA program, previously our main internal development program, and initiated a new R&D program to address unmet needs in the diagnostic imaging market," said John Higgins, Chief Executive Officer of Ligand. "Ligand’s Shots-on-Goal business model, with its focus on diversification and expense minimization, is continuing to generate increasing cash flow, and we expect this momentum to build throughout the remainder of 2018."

First Quarter 2018 Financial Results

Total revenues for the first quarter of 2018 were $56.2 million, compared with $29.3 million for the same period in 2017. Royalties were $20.8 million, compared with $24.2 million for the first quarter of 2017 and $14.2 million for the second quarter of 2017. Under the new accounting standard ASC 606, adopted as of the start of 2018, first quarter 2018 royalties should be compared with second quarter 2017 royalties due to the timing of revenue recognition. First quarter 2018 royalties primarily consisted of royalties from Promacta, Kyprolis and EVOMELA. Material sales were $4.4 million, compared with $1.1 million for the same period in 2017 due to the timing of Captisol purchases for use in clinical trials and commercial products. License fees, milestones and other revenues were $30.9 million, compared with $3.9 million for the same period in 2017, primarily due to a $20 million upfront payment received upon the licensing of Ligand’s GRA program and other milestones received.

Cost of goods sold was $0.8 million for the first quarter of 2018, compared with $0.3 million for the same period in 2017. Amortization of intangibles was $3.3 million, compared with $2.7 million for the same period in 2017. Research and development expense was $7.4 million, compared with $8.7 million for the same period of 2017 due primarily to lower spending on the GRA program partnered in the first quarter 2018. General and administrative expense was $7.6 million, compared with $7.3 million for the same period in 2017.

GAAP net income for the first quarter of 2018 was $45.3 million, or $1.83 per diluted share, compared with $5.1 million, or $0.22 per diluted share for the same period in 2017. First quarter of 2018 included a one-time, non-cash gain due to a change in the accounting for our investment in Viking Therapeutics, which resulted in marking the investment to market. Adjusted net income for the first quarter of 2018 was $35.7 million, or $1.55 per diluted share, compared with adjusted net income of $12.6 million, or $0.57 per diluted share, for the same period in 2017.

As of March 31, 2018, Ligand had cash, cash equivalents and short-term investments of $264.4 million in addition to our $27.5 million investment in Viking Therapeutics. Cash generated from operations was $60.8 million for the first quarter of 2018.

2018 Financial Guidance

Ligand affirms previous guidance for 2018 revenue to be approximately $184 million, including royalties of approximately $116 million, material sales of approximately $23 million and license fees and milestones of approximately $45 million, with the potential for up to an additional $20 million in license fees and milestones. Ligand notes that with revenue of $184 million, adjusted earnings per diluted share would be approximately $4.85.

First Quarter 2018 and Recent Business Highlights

Promacta/Revolade

Novartis reported first quarter 2018 net sales of Promacta/Revolade (eltrombopag) of $257 million, an $82 million or 47% increase over the same period in 2017.

Novartis announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to Promacta for use in combination with standard immunosuppressive therapy for the treatment of patients with severe aplastic anemia as a first-line therapy.

Kyprolis (carfilzomib), an Amgen Product Utilizing Captisol

On April 24, 2018, Amgen reported first quarter net sales of Kyprolis of $222 million, a $32 million or 17% increase over the same period in 2017. On May 9, 2018, Ono Pharmaceutical Company is expected to report Kyprolis sales in Japan for the most recent quarter.

On January 17, 2018, Amgen announced that the FDA approved the supplemental New Drug Application to add overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial to the Prescribing Information for Kyprolis.

On January 30, 2018, Amgen announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency (CHMP) adopted a positive opinion recommending a label variation for Kyprolis to include updated OS data from the Phase 3 head-to-head ENDEAVOR trial in patients with relapsed or refractory multiple myeloma.

On April 30, 2018, Amgen announced that the CHMP adopted a positive opinion recommending a label variation for Kyprolis to include the final overall survival (OS) data from the Phase 3 ASPIRE trial.

New Licensing Deals

Ligand announced the signing of a license agreement granting Roivant Sciences exclusive global rights to develop and commercialize LGD-6972 (now named RVT-1502), Ligand’s glucagon receptor antagonist (GRA). Under the terms of the agreement, Ligand received a $20 million upfront license fee, and is eligible to receive up to an additional $528.8 million of milestone payments and tiered royalties ranging from low double digits to the mid-teens, with the top tier applying to annual net sales above $3 billion. Roivant is responsible for all costs related to the program.

Ligand announced worldwide license agreements with venBio Partners, Ferring Pharmaceuticals and Glenmark Pharmaceuticals to use the OmniAb platform technologies to discover fully human antibodies. The agreement with venBio permits the venture capital firm’s portfolio companies to enter into worldwide OmniAb

platform agreements under previously agreed-upon terms. Ligand is eligible to receive annual access payments, milestone payments and royalties on future net sales of any antibodies discovered under these licenses.

Additional Pipeline and Partner Developments

Sage Therapeutics announced the submission of a New Drug Application to the FDA for an intravenous (IV) formulation of brexanolone for the treatment of postpartum depression.

Retrophin announced first patient enrollment in the Phase 3 DUPLEX Study evaluating the long-term nephroprotective potential of sparsentan for the treatment of focal segmental glomerulosclerosis. Topline data from the 36-week interim efficacy endpoint analysis are expected in the second half of 2020.

Retrophin announced that the company received regulatory feedback from both the FDA and European Medicines Agency (EMA) on the development pathway for sparsentan in IgA nephropathy and that a single registration-enabling Phase 3 clinical trial is expected to be initiated in the fourth quarter of 2018

Melinta Therapeutics announced the U.S. launch of the Captisol-enabled IV formulation of Baxdela for the treatment of adult patients with acute bacterial skin and skin structure infections caused by designated susceptible bacteria.

Melinta Therapeutics announced that The Menarini Group and Eurofarma Laboratórios submitted regulatory applications for delafloxacin (Baxdela in the U.S.) in the European Union and Argentina, respectively.

CASI Pharmaceuticals announced a $50 million private placement to prepare for commercialization in China, including potentially for EVOMELA, which has a regulatory application outstanding under priority review with an Expert Advisory Committee review date of April 25-26, 2018.

Aldeyra Therapeutics announced enrollment of the first patient in a Phase 3 clinical trial of topical ocular reproxalap for the treatment of allergic conjunctivitis and also enrollment of the first patient in a Phase 2b clinical trial of reproxalap for the treatment of dry eye disease.

Aldeyra Therapeutics presented the results of a Phase 2a dry eye disease clinical trial of topical ocular reproxalap at the Association for Research in Vision and Ophthalmology 2018 Annual Meeting.

Exelixis announced that its partner Daiichi Sankyo had submitted a regulatory application for esaxerenone (CS-3150) in patients with hypertension to the Japanese Pharmaceutical and Medical Devices Agency.

Takeda Pharmaceuticals highlighted the Phase 3 initiation of pevonedistat and its TAK-020 program during its presentation at the JP Morgan 36th Annual Healthcare Conference.

Merrimack Pharmaceuticals announced it had dosed the first patient in its Phase 2 SHERBOC study of MM-121 (seribantumab) in patients with heregulin-positive, hormone receptor-positive and HER2-negative post-menopausal metastatic breast cancer.

Viking Therapeutics announced the pricing of a $63.3 million public offering of common stock (including over-allotment exercise) with proceeds to fund continued development of VK5211, VK2809 and VK0214.

Opthea announced commencing a Phase 1b/2a trial evaluating the safety and efficacy of OPT-302 in patients with center-involved diabetic macular edema.

Syros Pharmaceuticals announced new preclinical data showing that Captisol-enabled SY-1365, a first-in-class selective cyclin-dependent kinase 7 inhibitor currently in a Phase 1 trial in patients with advanced solid tumors, demonstrated potent anti-tumor activity in multiple models of heavily pretreated ovarian cancer.

Aptevo Therapeutics announced that it had submitted an Investigational New Drug application to the FDA to evaluate APVO436 in a Phase 1 clinical study for the treatment of patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.

Aptevo Therapeutics presented new data for APVO436 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2018 Annual Meeting.

OmniAb partner Ferring Pharmaceuticals announced it is expanding its capabilities in biologics by constructing a new CHF30 million biotech center and manufacturing site.

Arcus Biosciences presented a poster on OmniAb-derived GLS-010 (AB122) at the AACR (Free AACR Whitepaper) 2018 Annual Meeting.

Nucorion Pharmaceuticals presented preclinical data for its novel liver-targeting prodrug technology program, NCO-1010, for the potential treatment of hepatitis B at the European Association for the Study of the Liver’s International Liver Congress.

Internal Research and Development

Ligand announced initiation of an internally funded program to develop through proof-of-concept contrast agents with reduced renal toxicity for diagnostic imaging procedures. This development program will leverage Ligand’s Captisol technology, as well as intellectual property obtained through its acquisition of Verrow Pharmaceuticals for $2 million in cash plus earn outs.

Ligand presented a poster at the National Lipid Association’s 2018 Scientific Sessions showing that Ligand’s LTP Technology significantly improves liver targeting of the statin rosuvastatin (Crestor), and may potentially be an effective strategy to increase the therapeutic index of statins and reduce statin intolerance.

A paper by Ligand scientists entitled "Chickens with humanized immunoglobulin genes generate antibodies with high affinity and broad epitope coverage to conserved targets" was published in the journal MAbs, highlighting the use of OmniChicken in antibody drug discovery.

Adjusted Financial Measures

The Company reports adjusted net income and adjusted net income per diluted share in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company’s financial measures under GAAP include stock-based compensation expense, amortization of debt-related costs, amortization related to acquisitions and intangible assets, changes in contingent liabilities, net losses of Viking Therapeutics, mark-to-market adjustment for amounts owed to licensors, fair value adjustments to Viking Therapeutics convertible note receivable and warrants, unissued shares relating to the Senior Convertible Notes and others that are listed in the itemized reconciliations between GAAP and adjusted financial measures included at the end of this press release. However, other than with respect to total revenue, the Company only provides guidance on an adjusted basis and does not provide reconciliations of such forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in contingent liabilities, net losses of Viking Therapeutics, stock-based compensation expense, mark-to-market adjustments for amounts owed to licensors, effects of any discrete income tax items and fair value adjustments to Viking Therapeutics convertible note receivable. Management has excluded the effects of these items in its adjusted measures to assist investors in analyzing and assessing the Company’s past and future core operating performance. Additionally, adjusted earnings per diluted share is a key component of the financial metrics utilized by the Company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation.

Conference Call

Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (833) 591-4752 from the U.S. or (720) 405-1612 from outside the U.S., using the conference ID 2259939. To participate via live or replay webcast, a link is available at www.ligand.com.

On May 8, 2018 X4 Pharmaceuticals, a clinical stage biotechnology company developing novel CXCR4 inhibitor drugs to improve immune cell trafficking to treat cancer and rare disease, reported that an abstract highlighting X4P-001-IO, the company’s CXCR4 antagonist, has been selected for poster and oral presentation at the 16th Annual Meeting of the Association for Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper), taking place May 15-17 in Mainz, Germany (Press release, X4 Pharmaceuticals, MAY 8, 2018, View Source [SID1234526276]). The presentations will describe clinical results from a pilot study of X4P-001-IO in combination with Opdivo (nivolumab) in patients with clear cell renal cell carcinoma (ccRCC), expanding the range of combination treatment settings in which X4P-001-IO has been studied.

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Details of the presentations on X4P-001 are as follows:

Title: The safety, tolerability, and preliminary clinical activity of the CXCR4 inhibitor X4P-001 and nivolumab in renal cell carcinoma patients that are refractory to nivolumab monotherapy

Author: David F. McDermott, M.D., Beth Israel Deaconess Medical Center, Harvard Medical School

Abstract #: 77

Poster Session: Tumor Biology and Interaction with the Immune System, May 15th, 3:00 – 5:00 PM CET

Oral Presentation Session: Clinical Trials, May 17th, 11:45 AM – 1:00 PM CET

About X4P-001-IO in Cancer

X4P-001-IO is an investigational selective, oral, small molecule antagonist of C-X-C receptor type 4 (CXCR4). CXCR4 is a chemokine receptor present in abundance on certain immune cells and cancer cells and it plays a critical role in immune cell trafficking, infiltration and activation in the tumor microenvironment. CXCR4 signaling is disrupted in a broad range of cancers, facilitating tumor growth by allowing cancer cells to evade immune detection and creating a pro-tumor microenvironment. X4P-001-IO has the ability to help restore immunity within the tumor microenvironment and has the potential to enhance the anti-tumor activity of approved and emerging oncology agents, such as checkpoint inhibitors and targeted therapies. X4P-001-IO is being investigated in several clinical studies in solid tumors.

On May 8, 2018 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 the Company has expanded its collaboration with Memorial Sloan Kettering Cancer Center (MSK) to develop the next generation of genetically engineered chimeric antigen receptor T-cell (CAR T) immunotherapies (Press release, Atara Biotherapeutics, MAY 8, 2018, View Source [SID1234526196]). This agreement is the next step in Atara’s strategy to leverage the potential of the Company’s technology platform to develop genetically modified off-the-shelf, allogeneic T-cell immunotherapies to transform the lives of patients with serious medical conditions.

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Under the agreement, Atara will gain access to several of MSK’s innovative enabling technologies, including a novel CAR T construct that Atara believes has physiologic T-cell activation properties, as well as methods for designing CAR T immunotherapies. Atara is also entering into an exclusive research collaboration for multiple targets with Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering at MSK, to employ next-generation technologies in developing novel CAR T immunotherapies with applications in oncology, autoimmune and infectious diseases.

Dr. Sadelain stated, "We are eager to work with Atara to continue advancing promising allogeneic T-cell immunotherapy technologies that originated at MSK. The new CAR T technologies seek to overcome persistent therapeutic challenges, such as safety and tolerability, durability of treatment response, and activity in areas of significant unmet medical need that are underserved by the current generation of CAR T immunotherapies."

"Our earlier MSK collaboration has been highly productive, highlighted by tab-cel, Atara’s off-the-shelf, allogeneic T-cell immunotherapy currently in Phase 3 development," said Isaac Ciechanover, M.D., Chief Executive Officer and President of Atara Biotherapeutics. "The deepening of our collaboration with MSK allows us to rapidly advance novel gene-edited CAR T development programs leveraging our existing off-the-shelf T-cell immunotherapy technology platform, manufacturing expertise and research and development capabilities. Going forward, we plan to continue to assemble complementary genetic engineering technologies to grow our pipeline and realize the full potential of our platform."

On May 8, 2018 MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number:4875), reported that MediciNova will present a corporate overview at the UBS Global Healthcare Conference on Monday, May 21, 2018 at 9:00 am at the Grand Hyatt New York in New York City (Press release, MediciNova, MAY 8, 2018, View Source;p=RssLanding&cat=news&id=2347957 [SID1234526227]). Yuichi Iwaki, MD, PhD, President and Chief Executive Officer, and Geoffrey O’Brien, JD/MBA, Vice President and Executive Officer, will be available for one-on-one meetings at this conference and investors may request a one-on-one meeting through UBS.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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