On November 1, 2017 Exelixis, Inc. (NASDAQ: EXEL) reported financial results for the third quarter of 2017 and provided an update on progress toward fulfilling its key corporate objectives, as well as commercial and clinical development milestones (Press release, Exelixis, NOV 1, 2017, View Source [SID1234521427]).

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Exelixis is focused on maximizing the opportunity for its two internally discovered compounds, cabozantinib and cobimetinib, to improve care and outcomes for people with cancer around the world. The company’s top priority remains the ongoing commercialization of CABOMETYX (cabozantinib) tablets as a treatment for patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. During the third quarter of 2017, CABOMETYX generated $90.4 million in net product revenue, while COMETRIQ (cabozantinib) capsules for the treatment of patients with progressive, metastatic medullary thyroid cancer generated an additional $6.1 million in net product revenue, for a combined $96.4 million in net product revenue for the cabozantinib franchise.

“In addition to strong financial performance, the third quarter of 2017 was marked by significant clinical and regulatory milestones that continue to drive us forward in our mission to help cancer patients recover stronger and live longer,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “In August, we completed the filing for CABOMETYX in previously untreated advanced RCC, which has been accepted by the FDA and granted Priority Review. With an upcoming FDA action date of February 15, 2018, our commercial team is fully prepared for a potential launch of CABOMETYX in this expanded indication to bring this much needed option to even more patients with advanced RCC as quickly as possible. In addition, based on the positive results from the CELESTIAL pivotal trial, demonstrating that cabozantinib provided a statistically significant and clinically meaningful improvement in overall survival for patients with advanced hepatocellular carcinoma, we are moving rapidly to complete our U.S. regulatory filing in the first quarter of next year.”

Cabozantinib Highlights

Strong Growth in Cabozantinib Franchise Net Revenue. Cabozantinib generated $96.4 million in net product revenue during the third quarter of 2017, an increase of 10 percent from the second quarter of 2017 and an increase of 126 percent year-over-year.

Phase 3 CELESTIAL Trial Meets Primary Endpoint of Overall Survival (OS), with supplemental New Drug Application (sNDA) Filing Planned for Q1 2018. In October, Exelixis announced that the CELESTIAL trial met its primary endpoint of OS, with cabozantinib providing a statistically significant and clinically meaningful improvement in OS compared to placebo in patients with advanced hepatocellular carcinoma (HCC). The independent data monitoring committee for the study recommended that the trial should be stopped for efficacy following review of the second planned interim analysis. CELESTIAL is a randomized, global phase 3 trial of cabozantinib compared to placebo in patients with advanced HCC who have been previously treated with sorafenib. The safety data in the study were consistent with the established profile of cabozantinib. Based on these results, Exelixis plans to submit an sNDA to the U.S. Food and Drug Administration (FDA) in the first quarter of 2018. Detailed results from CELESTIAL will be submitted for presentation at a future medical conference.

Submission and Acceptance of sNDA for CABOMETYX for the Treatment of Previously Untreated Advanced RCC with FDA Priority Review. In August, Exelixis announced it had completed the submission of its sNDA to the FDA for CABOMETYX for the treatment of previously untreated advanced RCC. The sNDA submission is based on results from the CABOSUN randomized phase 2 trial of CABOMETYX compared to sunitinib in patients with previously untreated advanced RCC with intermediate- or poor-risk disease. After the quarter ended, the company announced the FDA had accepted the sNDA and granted Priority Review, assigning a Prescription Drug User Fee Act (PDUFA) action date of February 15, 2018.

Start of Phase 3 Trial of Cabozantinib in Combination with Nivolumab or with Nivolumab and Ipilimumab in Previously Untreated Advanced or Metastatic RCC. In July, Exelixis and Bristol-Myers Squibb (BMS) announced the initiation of CheckMate 9ER, the pivotal phase 3 trial evaluating cabozantinib in combination with two of BMS’ leading immunotherapies, nivolumab and ipilimumab, compared to sunitinib. The trial is planned to enroll 1,014 treatment-naïve patients, with a primary endpoint of progression-free survival.

Cabozantinib and Cobimetinib Data Presentations at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2017 Congress. In September, Exelixis-discovered compounds were the subject of 10 presentations at the ESMO (Free ESMO Whitepaper) 2017 Congress held in Madrid, Spain. Data from CABOSUN, the randomized phase 2 trial of cabozantinib compared to sunitinib in patients with previously untreated advanced RCC with intermediate- or poor-risk disease, were the subject of a poster discussion which showed cabozantinib demonstrated a clinically meaningful and statistically significant reduction in the rate of disease progression or death. Other cabozantinib presentations included an oral presentation of data from the phase 1b trial of cabozantinib, nivolumab, and ipilimumab in advanced genitourinary malignancies, as well as additional analyses of the phase 3 METEOR trial in advanced RCC. Cobimetinib presentations at the Congress included two data sets concerning forms of metastatic melanoma. The company, along with its collaboration partner Ipsen, also hosted an investor and media event in Madrid to discuss the data for cabozantinib presented at the Congress and to take part in a question and answer session with Drs. Toni Choueiri, Sumanta Pal and Thomas Powles.

Cobimetinib Highlights

Settlement of Arbitration between Exelixis and Genentech Regarding Companies’ Collaboration Agreement for Cobimetinib. In July, Exelixis announced a settlement of its arbitration with Genentech concerning claims asserted by Exelixis against Genentech related to the development and commercialization of cobimetinib, the Exelixis-discovered medicine that is marketed as COTELLIC. The revised revenue and cost-sharing arrangement resolves the companies’ dispute pursuant to the arbitration demand filed on June 3, 2016, and aligns both companies’ interests in advancing cobimetinib as a promising therapy for patients with multiple forms of cancer. Moving forward, the revenue applied to the profit and loss statement for the COTELLIC collaboration (Collaboration P&L) will now be calculated using the average of the quarterly net selling prices of COTELLIC and any additional branded Genentech product(s) prescribed with COTELLIC. Exelixis will continue to share U.S. commercialization costs, while Genentech’s portion of these costs will now be allocated to the Collaboration P&L in proportion to the number of Genentech products in any given combination including COTELLIC.

Corporate Highlights

Updates from Partnered Programs with Daiichi Sankyo and BMS. In the third quarter and shortly after the quarter ended, Exelixis announced milestones for compounds from two of its partnered programs.

In September, collaborator Daiichi Sankyo announced positive top-line results from ESAX-HTN, a phase 3 pivotal trial of esaxerenone (formerly CS-3150) in patients with essential hypertension in Japan. As a result, Daiichi Sankyo plans to submit a Japanese regulatory application for esaxerenone for an essential hypertension indication in the first quarter of 2018. Daiichi Sankyo also announced the initiation of a pivotal trial of esaxerenone in patients with diabetic nephropathy. ESAX-DN is a phase 3 study in patients with type-2 diabetes with microalbuminuria who are taking an angiotensin II receptor blocker (ARB) or an angiotensin converting enzyme (ACE) inhibitor in Japan.

In October, Exelixis earned a $10 million milestone from BMS as part of the two companies’ worldwide collaboration for compounds targeting retinoic acid-related orphan receptor (ROR), a family of nuclear hormone receptors implicated in inflammatory conditions. The milestone was triggered by BMS’ filing of a Clinical Trial Authorization in Europe for a first-in-human study of a RORγt inverse agonist.

Debut of New Mission-Driven Corporate Branding and Website. In September, Exelixis introduced new corporate branding aligned with its mission, growth strategy and commitment to bring best-in-class oncology medicines to market. The new branding included a redesigned logo crafted as a wordmark with an extractable symbol that will become emblematic of Exelixis, as well as the revised corporate tagline, Resilience.Results.Remission. The new corporate branding celebrates the company’s unwavering perseverance to deliver results, and its aspirational commitments to the diverse audiences it serves.

Third Quarter 2017 Financial Results

Total revenue for the quarter ended September 30, 2017 was $152.5 million, compared to $62.2 million for the comparable period in 2016. Total revenue includes $96.4 million and $56.1 million of net product revenue and collaboration revenue, respectively, compared to $42.7 million and $19.5 million for the comparable period in 2016. The increase in net product revenues primarily reflects the growth in product sales of CABOMETYX since the product’s launch in late April 2016. Collaboration revenues for the quarter ended September 30, 2017 include two milestones totaling $45.0 million resulting from Ipsen’s receipt of the validation from the European Medicines Agency for the application for variation to the CABOMETYX marketing authorization for the addition of a new indication in first-line treatment of advanced RCC in adults; we also recognized $11.1 million in additional revenue from the company’s collaboration agreements with Ipsen, Takeda and Genentech during the quarter. Collaboration revenues for the comparable period in 2016 include the recognition of a $15.0 million milestone from Daiichi Sankyo and $4.5 million in revenue from the company’s collaboration agreements with Ipsen, Takeda and Genentech.

Research and development expenses for the quarter ended September 30, 2017 were $28.5 million, compared to $20.3 million for the comparable period in 2016. The increase in research and development expenses was primarily a result of increases in personnel expenses, clinical trial costs and consulting and outside services. The increase in personnel-related expenses was primarily a result of an increase in headcount associated with the re-launch of the company’s internal discovery program and the build-out of the company’s medical affairs organization. The increase in clinical trial costs was predominantly due to start-up costs associated with CheckMate 9ER and start-up costs associated with the phase 1b trial of cabozantinib and atezolizumab in locally advanced or metastatic solid tumors; those increases were partially offset by decreases in costs related to METEOR, the company’s completed phase 3 pivotal trial comparing CABOMETYX to everolimus in patients with advanced RCC. The increase in consulting and outside services was primarily in support of the company’s medical affairs organization.

Selling, general and administrative expenses for the quarter ended September 30, 2017 were $38.1 million, compared to $32.5 million for the comparable period in 2016. The increase in selling, general and administrative expenses was primarily a result of increases in consulting and outside services to support the company’s marketing activities and in personnel expenses resulting primarily from an increase in general and administrative headcount to support the company’s commercial and research and development organizations. Those increases were partially offset by a decrease in losses under the collaboration agreement with Genentech driven by Genentech’s change in cost allocation approach in December 2016.

Other income (expense), net for the quarter ended September 30, 2017 was $3.4 million compared to $(18.5) million for the comparable period in 2016. The increase in other income (expense), net, was primarily due to a $13.8 million loss on extinguishment of debt associated with the conversions of the 4.25% Convertible Subordinated Notes due 2019 (2019 Notes) during the third quarter of 2016, and a $7.8 million decrease in interest expense due to the conversions and the redemption of the 2019 Notes during the third and fourth quarters of 2016, the repayment of the Silicon Valley Bank term loan in March 2017 and the repayment of the Deerfield Notes in June 2017.

Net income for the quarter ended September 30, 2017 was $81.4 million, or $0.28 per share, basic and $0.26 per share, diluted, compared to a net loss of $(11.3) million, or $(0.04) per share, basic and diluted, for the comparable period in 2016. The transition to profitability was primarily due to the increase in net product revenues, reflecting the growth in product sales of CABOMETYX since the launch in late April 2016, which was supplemented by the growth in our collaboration revenues and partially offset by the increase in operating expenses.

Cash and cash equivalents, short- and long-term investments and long-term restricted cash and investments totaled $422.3 million at September 30, 2017, as compared to $479.6 million at December 31, 2016.

2017 Financial Guidance

The company is updating its guidance that total costs and operating expenses for the full year will be between $285 million and $295 million. This guidance includes approximately $25 million of non-cash costs and expenses related primarily to stock-based compensation expense.

Basis of Presentation

Exelixis adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31st. For convenience, references in this press release as of and for the fiscal periods ended September 29, 2017, December 30, 2016 and September 30, 2016 are indicated as being as of and for the periods ended September 30, 2017, December 31, 2016 and September 30, 2016, respectively.

Conference Call and Webcast

Exelixis management will discuss the company’s financial results for the third quarter of 2017 and provide a general business update during a conference call beginning at 5:00 p.m. EDT / 2:00 p.m. PDT today, Wednesday, November 1, 2017.

To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 96645455 to join by phone.

A telephone replay will be available until 8:00 p.m. EDT on November 3, 2017. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 96645455. A webcast replay will also be archived on www.exelixis.com for one year.

On November 1, 2017 Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, reported financial results for the quarter and nine months ended September 30, 2017, and provided updates on its development programs (Press release, Conatus Pharmaceuticals, NOV 1, 2017, View Source [SID1234521452]).

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Program Updates
In collaboration with Novartis under terms of the company’s Option, Collaboration and License Agreement with Novartis, which was executed in December 2016, Conatus is conducting four randomized, double-blind, placebo-controlled Phase 2b clinical trials designed to evaluate emricasan treatment in various patient populations, including three EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) clinical trials in patients with fibrosis or cirrhosis caused by nonalcoholic steatohepatitis (NASH), and a fourth clinical trial in POLT-HCV-SVR patients:

POLT-HCV-SVR, initiated in the second quarter of 2014, in approximately 60 post-orthotopic liver transplant (POLT) recipients with liver fibrosis or cirrhosis post-transplant as a result of recurrent hepatitis C virus (HCV) infection who have successfully achieved a sustained viral response (SVR) following HCV antiviral therapy, with top-line results expected in the second quarter of 2018;

ENCORE-PH (for Portal Hypertension), initiated in the fourth quarter of 2016, in approximately 240 patients with compensated or early decompensated NASH cirrhosis and severe portal hypertension, with top-line results expected in the second half of 2018 followed by an integrated treatment extension period for clinical outcomes;

ENCORE-NF (for NASH Fibrosis), initiated in the first quarter of 2016, in approximately 330 patients with NASH fibrosis, with top-line results expected in the first half of 2019; and

ENCORE-LF (for Liver Function), initiated in the second quarter of 2017, in approximately 210 patients with decompensated NASH cirrhosis, with top-line results expected in the second half of 2019.
Results from the four ongoing emricasan clinical trials are expected to support the design of Phase 3 clinical efficacy and safety trials.

Pipeline Expansion Plans

In October 2017, the European Medicines Agency (EMA) granted Orphan Drug Designation in the European Union to the company’s pan-caspase inhibitor IDN-7314 for the treatment of primary sclerosing cholangitis (PSC), a disease affecting bile ducts in the liver, which can lead to cirrhosis and liver failure. In June 2017, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation in the United States to IDN-7314 for the treatment of PSC.

These orphan drug designations were based on previously reported data with IDN-7314 demonstrating reduction of relevant biomarkers in two preclinical models of PSC. New results, showing that IDN-7314 markedly diminished inflammasome activation and reduced liver injury in a preclinical model of PSC, were presented in October 2017 at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases (AASLD). In a separate study, IDN-7314 reduced biochemical markers in a new acute preclinical model of PSC.

Conatus believes the orphan drug designations, along with the growing body of preclinical data, warrant further evaluation of IDN-7314 as a potential product candidate in PSC as a component of its initial pipeline expansion plans. The company’s ongoing pipeline expansion activities also include:

internal development of new preclinical product candidates leveraging its expertise with the caspase inhibition technology platform, and

evaluation for potential in-licensing or acquisition of external clinical-stage product candidates consistent with its product development and regulatory expertise.
Conatus may pursue the development of product candidates in liver disease and in other related disease areas.

Financial Results
The net loss for the third quarter of 2017 was $4.0 million compared with $6.9 million for the third quarter of 2016. The net loss for the first nine months of 2017 was $13.0 million compared with $20.6 million for the first nine months of 2016.

Total revenues were $9.6 million for the third quarter of 2017 and $26.6 million for the first nine months of 2017, compared with $0.0 million for the comparable periods in 2016. Total revenues for both periods in 2017 consisted of collaboration revenue related to the Option, Collaboration and License Agreement with Novartis.

Research and development expenses were $11.2 million for the third quarter of 2017 compared with $4.8 million for the third quarter of 2016. Research and development expenses were $32.3 million for the first nine months of 2017 compared with $13.8 million for the first nine months of 2016. The increases in research and development expenses were primarily due to the ramp up of our ENCORE-NF, ENCORE-PH and ENCORE-LF clinical trials.

General and administrative expenses were $2.4 million for the third quarter of 2017 compared with $2.1 million for the third quarter of 2016. General and administrative expenses were $7.4 million for the first nine months of 2017 compared with $6.9 million for the first nine months of 2016. The increases in general and administrative expenses were primarily due to higher personnel costs and professional fees.

Cash, cash equivalents and marketable securities were $85.2 million at September 30, 2017, compared with $77.0 million at December 31, 2016. Based primarily on lower than expected spending on in-licensing and internal pipeline development, the company is now projecting a year-end 2017 balance of between $70 million and $75 million. The company believes its current and forecasted financial resources are sufficient to maintain operations and ongoing emricasan clinical development activities through the end of 2019, as well as to fund anticipated pipeline expansion activities.

Conference Call and Audio Webcast
Conatus will host a conference call and audio webcast at 4:30 p.m. Eastern Time today to discuss the financial results and provide a corporate update. To access the conference call, please dial 877-312-5857 (domestic) or 970-315-0455 (international) at least five minutes prior to the start time and refer to conference ID 99505370. A live and archived audio webcast of the call will also be available in the Investors section of the Conatus website at www.conatuspharma.com.

On November 1, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX), reported that updated data for TGR-1202 (umbralisib), the Company’s once-daily PI3K delta inhibitor, and TG-1101 (ublituximab), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, have been selected for presentation at the upcoming 59th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, to be held December 9-12, 2017, at the Georgia World Congress Center in Atlanta, Georgia (Press release, TG Therapeutics, NOV 1, 2017, View Source [SID1234521406]). Abstracts are now available online and can be accessed on the ASH (Free ASH Whitepaper) meeting website at www.hematology.org . Clinical abstract highlights as well as the details of clinical and preclinical posters to be presented at ASH (Free ASH Whitepaper) are outlined below.

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Clinical Abstract Highlights:

TGR-1202 Integrated Analysis: 336 patients with relapsed/refractory Lymphoid Malignancies exposed to a TGR-1202 based regimen for upwards of 4+ years, demonstrated a favorable safety profile with infrequent Grade 3/4 adverse events prevalent amongst prior generation PI3K delta inhibitors: transaminitis ( < 3%), colitis ( < 1%), and pneumonitis ( < 0.5%)
Kinase Inhibitor Intolerance Study: In patients with Chronic Lymphocytic Leukemia (CLL) who are intolerant to prior BTK or PI3K delta inhibitor therapy, no patients (n=22) discontinued due to TGR-1202 intolerance with a median follow-up of 6 months
TG-1101 + TGR-1202 + PD-1 Triplet: 60% ORR (3 of 5) observed in BTK refractory CLL patients treated with the triple combination of TGR-1202 plus TG-1101 plus pembrolizumab
Poster presentations at the ASH (Free ASH Whitepaper) 2017 meeting include the following:

Sunday December 10, 2017:

Title: Phase I/II Study of Pembrolizumab in Combination with Ublituximab (TG-1101) and Umbralisib (TGR-1202) in Patients with Relapsed/Refractory CLL
Abstract Number: 3010
Session: 642. CLL: Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 10, 2017; 6:00 PM – 8:00 PM ET
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2
Presenter: Anthony R. Mato, MD, University of Pennsylvania, Philadelphia, PA

Title: Umbralisib/TGR-1202 as a Novel Dual PI3K/CK1 Inhibitor Has a Unique Therapeutic Role in Silencing Oncogenes in Aggressive Lymphomas
Abstract Number: 2809
Session: 625. Lymphoma: Pre-Clinical—Chemotherapy and Biologic Agents: Poster II
Date and Time: Sunday, December 10, 2017; 6:00 PM – 8:00 PM ET
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2
Presenter: Ipsita Pal, PhD, Columbia University Medical Center, New York, NY

Title: Differential Regulation of T Cells By PI3K Delta Inhibitors in a CLL Murine Model
Abstract Number: 3009
Session: 642. CLL: Therapy, excluding Transplantation: Poster II
Date and Time: Sunday, December 10, 2017; 6:00 PM – 8:00 PM ET
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2
Presenter: Kamira K. Maharaj, BS, Moffit Cancer Center, Tampa, FL
Monday, December 11, 2017:

Title: An Integrated Safety Analysis of the Next Generation PI3Kδ Inhibitor Umbralisib (TGR-1202) in Patients with Relapsed/Refractory Lymphoid Malignancies
Abstract Number: 4037
Session: 623. Mantle Cell, Follicular, and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster III
Date and Time: Monday, December 11, 2017; 6:00 PM – 8:00 PM ET
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2
Presenter: Matthew S. Davids, MD, Dana Farber Cancer Institute, Boston, MA

Title: KI Intolerance Study: A Phase 2 Study to Assess the Safety and Efficacy of Umbralisib (TGR-1202) in Patients with Chronic Lymphocytic Leukemia (CLL) Who Are Intolerant to Prior BTK or PI3K-δ Inhibitor Therapy
Abstract Number: 4314
Session: 642. CLL: Therapy, excluding Transplantation: Poster III
Date and Time: Monday, December 11, 2017; 6:00 PM – 8:00 PM ET
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2
Presenter: Anthony R. Mato, MD, University of Pennsylvania, Philadelphia, PA

Title: PI3K-Delta Inhibitors Induce Primary Monocyte Cytotoxicity but Do Not Alter Monocyte Differentiation
Abstract Number: 4284
Session: 641. CLL: Biology and Pathophysiology, excluding Therapy: Poster III
Date and Time: Monday, December 11, 2017; 6:00 PM – 8:00 PM ET
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2
Presenter: Daphne Friedman, MD, Durham VA-Duke University Medical Center, Durham, NC
The above referenced abstracts can be viewed online through the ASH (Free ASH Whitepaper) meeting website at www.hematology.org. Following each presentation, the data presented will be available on the Publications page of the Company’s website at www.tgtherapeutics.com.

TG THERAPEUTICS INVESTOR & ANALYST EVENT

TG Therapeutics will also host a reception on Sunday, December 10, 2017 beginning at 8:00pm ET with featured presentations beginning promptly at 8:15pm ET. The event will take place at the Ritz Carlton Atlanta (Downtown) in the Congress Room. This event will be webcast live and will be available on the Events page, located within the Investors & Media section of the Company’s website at www.tgtherapeutics.com, as well as archived for future review. This event will also be broadcast via conference call. To access the conference line, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), and reference Conference Title: TG Therapeutics December 2017 Investor & Analyst Event.

On November 1, 2017 Unum Therapeutics, a clinical-stage biopharmaceutical company focused on the development of novel immunotherapy products designed to harness the power of a patient’s immune system to cure cancer, reported that initial clinical data from the ATTCK-20-2 Phase I study and pre-clinical data on its Antibody-Coupled T cell Receptor (ACTR) platform will be presented in an oral presentation and a poster presentation, respectively, at the 59th ASH (Free ASH Whitepaper) Annual Meeting, which is being held in Atlanta, GA December 9-12, 2017 View Source The oral presentation will highlight early data from an ongoing Phase I dose escalation study, ATTCK-20-2 (ClinicalTrials.gov No. NCT02776813), of ACTR087 used in combination with rituximab in subjects with relapsed/refractory CD20+ B cell Non-Hodgkin lymphoma. In the first dose level studied (Cohort 1), ACTR087 used in combination with rituximab induced two complete responses (CR) and one partial response (PR) in patients evaluable for response (n=6), with no ACTR087-related serious adverse events (SAEs), no adverse events (AEs) leading to treatment discontinuation, no cytokine-release syndrome (CRS), and no neurotoxicity. The Company is currently enrolling and treating patients in Cohort 2. The poster presentation will provide data from non-clinical studies demonstrating the adaptability of ACTR T Cells to target T cell targets such as CD38 via combination with daratumumab, and bypass the challenges of scFv-based CAR-T cell production to effectively target CD38-expressing tumor cells.

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Presentation Details:

Oral Presentation

Presentation Title: ACTR087, Autologous T Lymphocytes Expressing Antibody Coupled T-cell Receptors (ACTR), Induces Complete Responses in Patients with Relapsed or Refractory CD20-Positive B-cell Lymphoma, in Combination with Rituximab
Authors (affiliation): L. Akard (IBMT), S. Jaglowski (OSU), S. Devine (OSU), M. McKinney (Duke), M. Vasconcelles, H. Huet, S. Ettenberg, A. Ranger, J. Abramson (MGH)
Presenter: L. Akard (IBMT)
Presentation Date: Monday, December 11, 2017
Presentation Time: 7:45 AM
Location: Georgia World Congress Center, Bldg A, Lvl 4, A411-A412
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)—Results from Prospective Clinical Trials: Immune-Based Therapeutic Approaches
Abstract Number: 580

Poster Presentation

Presentation Title: Adaptability of Antibody-Coupled T Cell Receptor (ACTR) Engineered Autologous T Cells in Combination with Daratumumab Over CAR-based Approaches
Authors: Taylor Hickman, Adrianna Graziano, Katie O’Callaghan, Ryan Boomer, Eugene Choi, Allison Nelson, Greg Motz, Jessica Sachs, Birgit Schultes, Seth Ettenberg, and Tooba Cheema
Presenter: Taylor Hickman, Senior Associate Scientist, Unum Therapeutics
Presentation Date: Sunday, December 10, 2017
Presentation Time: 6:00 PM – 8:00 PM
Location: Georgia World Congress Center, Bldg A, Lvl 1, Hall A2
Session: 703. Adoptive Immunotherapy: Poster II
Abstract Number: 3189

The poster will be posted on Unum’s website following the presentations.

About Antibody-Coupled T cell Receptor (ACTR) Technology

Unum’s proprietary ACTR is a chimeric protein that combines components from proteins normally found on two different human immune cell types – natural killer (NK) cells and T cells – to create a novel approach to cancer cell killing. T cells bearing the ACTR receptor protein can be directed to attack a tumor by combining with a monoclonal antibody that binds antigens on the cancer cell surface.

In contrast to other T cell therapy approaches for cancer that are limited to a single cancer cell surface target and, therefore, treat a narrow set of tumors, Unum’s approach is not restricted by a specific tumor cell antigen and, thus, we believe may have applications for treating many different types of cancers when combined with the right antibodies.

Unum is developing ACTR in combination with a range of tumor-targeting antibodies for use in both hematologic and solid tumor indications. ACTR087 used in combination with rituximab, an anti-CD20 antibody, is Unum’s most advanced product candidate, currently in Phase I clinical testing for the treatment of adult patients with relapsed/refractory CD20-positive B cell non-Hodgkin lymphoma. The Company has two additional product candidates on track for imminent clinical testing under Investigational New Drug Applications (INDs) in effect with the FDA: ACTR707 used in combination with rituximab for the treatment of adult patients with relapsed/refractory CD20-positive B cell non-Hodgkin lymphoma, and ACTR087 in combination with a novel anti-BCMA antibody, SEA-BCMA, for the treatment of adult patients with relapsed/refractory multiple myeloma.

vTv Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, vTv Therapeutics, 2017, NOV 1, 2017, View Source [SID1234521415]).

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