On April 26, 2017 GlaxoSmithKline reported another quarter of continued progress (Press release, GlaxoSmithKline, APR 26, 2017, View Source [SID1234518697]).

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

                  Schedule Your 30 min Free Demo!

Q1 sales of £7.4 billion, +19% AER, + 5% CER
Total EPS of 21.4p >100% AER, >100% CER; Adjusted EPS of 25.0p, +31% AER, +9% CER

View full Q1 2017 results (PDF): View Source

Summary:

Financial highlights

Sales growth across all three businesses: Pharmaceuticals £4.2 billion, +17% AER, +4% CER; Vaccines £1.2 billion, +31% AER, +16% CER; Consumer Healthcare £2.0 billion, +16% AER, +2% CER
Improved Group operating margin reflecting leverage from sales growth, focus on costs and benefits of restructuring. Pharmaceuticals 34.4%; Vaccines 29.6%; Consumer Healthcare 17.2%
Net cash flow from operations of £1.1 billion (Q1 2016: £0.5 billion). Free cash flow of £0.7 billion
(Q1 2016: £0.2 billion outflow), primarily reflecting improved operating performance and the net benefit of exchange rate movements
19p dividend declared for Q1 2017. Continue to expect 80p for FY 2017
2017 Adjusted CER earnings per share guidance maintained
Product and pipeline highlights

New product sales of £1.4 billion +72% AER, +52% CER. On track to deliver £6 billion (CER) sales in 2018
Results from MUSCA study demonstrate Nucala significantly improves quality of life and lung function in patients with severe asthma
Positive SWORD study presented for two-drug regimen of dolutegravir and rilpivirine for treatment of HIV
Positive results reported in-house from ZOSTER-048 study of Shingrix in individuals previously vaccinated with Zostavax*
Flonase Sensimist launched in US; second Rx to OTC switch in 3 years
Outlook assumptions and cautionary statements

Assumptions related to 2017 guidance and 2016-2020 outlook

In outlining the expectations for 2017 and the five-year period 2016-2020, the Group has made certain assumptions about the healthcare sector, the different markets in which the Group operates and the delivery of revenues and financial benefits from its current portfolio, pipeline and restructuring programmes.

For the Group specifically, over the period to 2020 GSK expects further declines in sales of Seretide/Advair. The introduction of a generic alternative to Advair in the US has been factored into the Group’s assessment of its future performance. The Group assumes no premature loss of exclusivity for other key products over the period. The Group’s expectation of at least £6 billion of revenues per annum on a CER basis in 2018 from products launched since 2013 includes contributions from the current pipeline asset Shingrix. The Group also expects volume demand for its products
to increase, particularly in Emerging Markets.

The assumptions for the Group’s revenue and earnings expectations assume no material interruptions to supply of the Group’s products and no material mergers, acquisitions, disposals, litigation costs or share repurchases for the Company; and no change in the Group’s shareholdings in ViiV Healthcare or Consumer Healthcare. They also assume no material changes in the macro-economic and healthcare environment.

The Group’s expectations assume successful delivery of the Group’s integration and restructuring plans over the period 2016-2020. Material costs for investment in new product launches and R&D have been factored into the expectations given. The expectations are given on a constant currency basis and assume no material change to the Group’s effective tax rate.

Assumptions and cautionary statement regarding forward-looking statements

The Group’s management believes that the assumptions outlined above are reasonable, and that the aspirational targets described in this report are achievable based on those assumptions. However, given the longer term nature of these expectations and targets, they are subject to greater uncertainty, including potential material impacts if the above assumptions are not realised, and other material impacts related to foreign exchange fluctuations, macroeconomic activity, changes in regulation, government actions or intellectual property protection, actions by our competitors, and other risks inherent to the industries in which we operate.

This document contains statements that are, or may be deemed to be, “forward-looking statements”. Forward-looking statements give the Group’s current expectations or forecasts of future events. An investor can identify these statements by the fact that they do not relate strictly to historical or current facts. They use words such as ‘anticipate’, ‘estimate’, ‘expect’, ‘intend’, ‘will’, ‘project’, ‘plan’, ‘believe’, ‘target’ and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results. Other than in accordance with its legal or regulatory obligations (including under the UK Listing Rules and the Disclosure and Transparency Rules of the Financial Conduct Authority), the Group undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The reader should, however, consult any additional disclosures that the Group may make in any documents which it publishes and/or files with the SEC. All readers, wherever located, should take note of these disclosures. Accordingly, no assurance can be given that any particular expectation will be met and investors are cautioned not to place undue reliance on the forward-looking statements.

On April, 27 2017 Roche reported a good start in 2017 (Press release, Hoffmann-La Roche, APR 27, 2017, View Source [SID1234518708]).

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

                  Schedule Your 30 min Free Demo!

Group sales increase 4%1 at constant exchange rates and in Swiss francs
Pharmaceuticals Division sales up 3%, driven mainly by Tecentriq and Perjeta
Diagnostics Division sales grow 6%, primarily due to immunodiagnostic solutions
US FDA approves Ocrevus to treat two forms of multiple sclerosis
EU approves Alecensa for the treatment of a specific form of lung cancer
Successful phase III Aphinity study of Perjeta treatment regimen in early breast cancer
Outlook for 2017 confirmed

Commenting on the Group’s results, Roche CEO Severin Schwan said: «We have started the year with good growth in both our Pharmaceuticals and Diagnostics Divisions and with important positive clinical study results. A highlight of the first quarter was the US approval of our medicine Ocrevus for the treatment of multiple sclerosis (MS). Ocrevus is the first and only FDA approved medicine for both relapsing and primary progressive forms of MS and represents a new era for the treatment of this disease. We are well on track to meet our full-year targets.»

Group results
Good sales growth in both divisions
Group sales rose 4% to CHF 12.9 billion. Sales in the Pharmaceuticals Division increased 3% to CHF 10.2 billion, driven by very good early uptake of Tecentriq and continued strong growth of Perjeta and partially offset by lower sales of Tamiflu. In the US, sales advanced 6%, led by the recently launched medicines Tecentriq and Alecensa, as well as Xolair and MabThera/Rituxan. Sales of Tamiflu declined due to competition from generics. In Europe (+1%), Perjeta, Actemra/RoActemra and Herceptin were the main contributors to sales growth. In the International region, sales advanced 1%, led by the Latin America and Asia–Pacific subregions. In Japan (-2%), sales were impacted by government price reductions in April 2016.

Diagnostics Division sales increased 6% to CHF 2.8 billion. Centralised and Point of Care Solutions2 was the main contributor, led by the growth of its immunodiagnostics business (+13%). In regional terms, growth was driven in particular by Asia–Pacific (+13%) and Latin America (+21%). In EMEA3 (+2%) and Japan (+4%), sales increases were led by Centralised and Point of Care Solutions, and in North America (+4%) by Tissue Diagnostics.

Important new product approvals in Pharmaceuticals
The US Food and Drug Administration (FDA) approved Ocrevus for the treatment of two forms of multiple sclerosis (MS); relapsing MS (RMS) and primary progressive MS (PPMS). Ocrevus is an important new treatment option for people with RMS, and due to the favourable benefit-risk profile has the potential to change disease course. It is also the first and only medicine approved to treat PPMS, a particularly disabling form of MS. Multiple sclerosis, for which there is currently no cure,4 is a chronic disease that affects an estimated 2.3 million people around the world. The European Commission granted Alecensa a conditional marketing authorisation as monotherapy for adult patients with ALK5-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib.

Clinical trial results support key new indications for Roche medicines
Roche communicated important clinical results in the first quarter of 2017. The phase III Aphinity study with Roche’s Perjeta regimen met its primary endpoint. It showed that adjuvant (after surgery) treatment with the combination of Perjeta, Herceptin and chemotherapy achieved a statistically significant reduction in the risk of recurrence of invasive disease or death in people with HER2-positive early breast cancer compared with Herceptin and chemotherapy alone. Encouraging results from the Tecentriq phase II study IMmotion 150 were presented: the study compared Tecentriq plus Avastin as well as Tecentriq monotherapy to the treatment with sunitinib in people with previously untreated, locally advanced or metastatic renal cell carcinoma.

The phase III Alur study met its primary endpoint, showing that Alecensa significantly improved progression-free survival (PFS) in people with ALK-positive advanced NSCLC who had progressed following treatment with platinum-based chemotherapy and crizotinib, compared with chemotherapy. In addition, in early April Roche announced that the phase III Alex study met its primary endpoint, showing that Alecensa as initial (first-line) treatment significantly improved PFS compared with crizotinib in people with ALK-positive NSCLC.

The US FDA accepted Roche’s supplemental Biologics License Application and granted priority review for Actemra/RoActemra for giant cell arteritis (GCA), a form of vasculitis. The FDA also granted breakthrough therapy designation for MabThera/Rituxan, in pemphigus vulgaris, a rare skin disease.

New generation of diagnostics products
The cobas HPV DNA test for cobas 6800/8800 systems was launched in the EU and other markets accepting the CE-mark, and the US FDA cleared the CINtec Histology test to aid in the diagnosis of cervical pre-cancer. These tests are a key part of Roche’s cervical cancer prevention portfolio. Human papillomavirus (HPV) is the cause of almost all cases of cervical cancer, a leading cause of death in women.

The cobas Liat PCR system was launched in markets accepting the CE-mark. This real-time PCR system covers four assays, including a test for the rapid detection of Clostridium difficile. Timely and accurate diagnosis of this infection is important because it can quickly become life-threatening. In the US, the FDA approved Roche’s cobas e 801 module for high-volume immunology testing. The Accu-Chek Instant system for effortless, reliable and affordable blood glucose monitoring was introduced in various markets in the EU.a

On April 27, 2017 The Bayer Group reported a very successful start to 2017 and generated strong sales and earnings growth in the first quarter (Press release, Bayer, APR 26, 2017, View Source [SID1234518711]).


"At Pharmaceuticals, we once again benefited from the very good performance of our key growth products," CEO Werner Baumann said when he presented the interim report for the first quarter on Thursday. Consumer Health, Crop Science and Animal Health also registered increases in sales and EBITDA before special items. Covestro posted substantial growth in sales and earnings. Driven by Covestro’s performance, Bayer has raised its Group outlook for 2017.

Sales of the Bayer Group increased by 11.7 percent to EUR 13,244 million (Q1 2016: EUR 11,854 million) in the first quarter. Adjusted for currency and portfolio effects (Fx & portfolio adj.), sales advanced by 9.4 percent. Sales of the Life Science businesses amounted to EUR 9,680 million, up by 4.9 percent (Fx & portfolio adj.) year on year. Group EBITDA before special items improved by 14.9 percent to EUR 3,893 million (Q1 2016: EUR 3,387 million). EBIT climbed by a substantial 34.3 percent to EUR 3,116 million (Q1 2016: EUR 2,320 million) after special charges of EUR 85 million (Q1 2016: EUR 272 million). These mainly resulted from expenses related to efficiency improvement programs, impairment losses on intangible assets, and costs in connection with the agreed acquisition of Monsanto. EBIT before special items moved ahead by 23.5 percent to EUR 3,201 million (Q1 2016: EUR 2,592 million). Net income climbed by 37.9 percent to EUR 2,083 million (Q1 2016: EUR 1,511 million), and core earnings per share from continuing operations by 11.5 percent to EUR 2.62 (Q1 2016: EUR 2.35).

Cash flow provided by operating activities from continuing operations climbed by a substantial 49.6 percent to EUR 826 million (Q1 2016: 552 million) due to the improvement in EBITDA. Net financial debt of the Bayer Group declined by EUR 1.4 billion to EUR 10.4 billion between December 31, 2016, and March 31, 2017, due mainly to cash inflows from the sale of Covestro shares.

Strong gains at Pharmaceuticals

Sales of prescription medicines (Pharmaceuticals) rose in the first quarter by an encouraging 7.4 percent (Fx & portfolio adj.) to EUR 4,263 million (Q1 2016: EUR 3,889 million). "Our key growth products were once again especially successful, registering combined growth of 20 percent on a currency-adjusted basis," Baumann said. The oral anticoagulant Xarelto, the eye medicine Eylea, the cancer drugs Xofigo and Stivarga, and the pulmonary hypertension treatment Adempas posted total combined sales of EUR 1,445 million (Q1 2016: EUR 1,187 million). Sales of Xarelto climbed by 19.6 percent on a currency-adjusted basis (Fx adj.), due primarily to higher volumes in Europe and Japan. In addition, Bayer once again significantly expanded its business with the eye medicine Eylea (Fx adj.: plus 19.3 percent), with performance driven by higher sales volumes in Europe. Encouraging sales were also achieved in Canada and Japan.

Sales of the hormone-releasing intrauterine devices of the Mirena product family increased by a substantial 22.7 percent (Fx adj.), primarily due to the performance of the U.S. business, which also benefited from the successful market launch of the new Kyleena intrauterine device. Bayer also recorded substantial sales increases for its diabetes treatment Glucobay (Fx adj.: plus 14.6 percent), its Aspirin Cardio product for the secondary prevention of heart attacks (Fx adj.: plus 13.8 percent) and its X-ray contrast agent Ultravist (Fx adj.: plus 18.0 percent), primarily as a result of the positive development of business in China. On the other hand, business with the Kogenate/ Kovaltry blood-clotting medicines was down overall (Fx adj.: minus 8.5 percent), largely due to fluctuations in the order volumes placed by Bayer’s distribution partner for these products. As expected, sales of the multiple sclerosis product Betaferon/Betaseron were also lower than in the prior-year quarter due to reduced demand in Europe and the United States (Fx adj.: minus 12.1 percent). Overall, the Pharmaceuticals business grew in all regions on a currency-adjusted basis.

EBITDA before special items of Pharmaceuticals increased by a substantial 19.1 percent to EUR 1,502 million (Q1 2016: EUR 1,261 million). While sales rose, selling expenses and research and development expenditures were at around the same level as the prior-year quarter.

Growth in sales and earnings at Consumer Health

Adjusted for currency and portfolio effects, sales of self-care products advanced by 2.6 percent to EUR 1,601 million (Q1 2016: EUR 1,520 million) in the first quarter. "We achieved double-digit percentage sales gains for several products at Consumer Health as well," Baumann noted. The division registered encouraging growth in Europe/Middle East/Africa and in Asia/Pacific. Sales in North America were level year on year on a currency-adjusted basis, while business declined substantially in Latin America.

The sunscreen product Coppertone delivered positive performance (Fx adj.: plus 21.3 percent), primarily in the United States and China where Bayer built inventories in the distribution channel ahead of the summer season. Encouraging sales gains were also recorded for Canesten skin and intimate health products (Fx adj.: plus 11.5 percent), in part due to the expansion of the product portfolio last year. Sales of the Alka-Seltzer family of products to treat gastric complaints and cold symptoms advanced significantly (Fx adj.: plus 19.6 percent), especially in the United States due to a strong cold season and as a result of a product line extension. The One A Day vitamin product achieved double-digit growth (Fx adj.: plus 19.1 percent), as did the Elevit prenatal vitamin (Fx adj.: plus 13.4 percent). By contrast, sales of Dr. Scholl’s foot care products declined substantially (Fx adj.: minus 33.6 percent), primarily due to the reduction of inventories in distribution channels ahead of a change in product lines and a weak market environment in the United States. Business with the antihistamine Claritin was down slightly (Fx adj.: minus 2.4 percent), mainly because of a slow start to the allergy season in the United States. Gains in Europe and China only partially offset this effect.

EBITDA before special items of Consumer Health advanced by 2.3 percent to EUR 392 million (Q1 2016: EUR 383 million). This increase resulted from the positive development of sales as well as from one-time gains of around EUR 20 million, primarily from the sale of brands. A higher cost of goods sold, in part due to write-downs on inventories, had an opposing effect.

Crop Science: business expanded in North America

Sales of the agriculture business increased by 3.2 percent (Fx & portfolio adj.) to EUR 3,120 million (Q1 2016: EUR 2,936 million). "Crop Science benefited primarily from encouraging performance in North America," Baumann said. Sales in that region grew by 8.9 percent (Fx adj.). Business development was also positive in Europe/Middle East/ Africa (Fx adj.: plus 2.0 percent) and in Asia/Pacific (Fx adj.: plus 2.9 percent), while sales in Latin America declined by 9.8 percent (Fx adj.).

Sales at Seeds (which also includes the traits business) rose by 8.0 percent (Fx and portfolio adj.). At Crop Protection, gains were primarily recorded at SeedGrowth (seed treatment products) and Herbicides, which posted increases of 7.1 percent and 5.3 percent (both Fx and portfolio adj.), respectively. Business at Insecticides expanded by 3.9 percent (Fx and portfolio adj.), while sales at Fungicides were 6.2 percent lower (Fx and portfolio adj.) than in the prior-year quarter. Sales growth of 20.5 percent (Fx and portfolio adj.) at Environmental Science was based on the delivery of products to the company that acquired the consumer business in October 2016.

EBITDA before special items of Crop Science increased by 2.4 percent to EUR 1,115 million (Q1 2016: EUR 1,089 million). Positive earnings effects resulted primarily from higher volumes. These stood against an increase in the cost of goods sold and in research and development expenses.

Substantial earnings growth at Animal Health

Sales of the Animal Health business rose by 2.9 percent (Fx and portfolio adj.) to EUR 440 million (Q1 2016: EUR 408 million). The development of business in the Asia/Pacific region in particular was encouraging. Business in North America benefited from the sales generated by the Cydectin product portfolio that Bayer acquired from Boehringer Ingelheim Vetmedica, Inc. in the United States. Bayer once again significantly expanded business with its Seresto flea and tick collar (Fx adj.: plus 38.2 percent), primarily as the result of higher volumes in the United States and Europe. By contrast, sales of the Advantage family of flea, tick and worm control products were considerably lower than in the prior-year quarter (Fx adj.: minus 10.0 percent), partly due to intensified competitive pressure and shifts in demand patterns. EBITDA before special items increased by 10.7 percent to EUR 135 million (Q1 2016: EUR 122 million). Positive earnings contributions resulted from both price increases as well as the Cydectin business that Bayer acquired. These stood against an increase in selling expenses and research and development expenditures.

Covestro records substantial expansion in volumes and prices

Sales of Covestro advanced by 23.6 percent (Fx & portfolio adj.) in the first quarter compared with the prior-year period, to EUR 3,564 million (Q1 2016: EUR 2,850 million). Selling prices were much higher overall, especially at Polyurethanes, while volumes increased substantially in all business units. EBITDA before special items improved by 66.5 percent to EUR 839 million (Q1 2016: EUR 504 million). Substantially higher selling prices more than offset the effect of a slight increase in raw material prices. In addition, higher volumes had a positive effect on earnings.

Group outlook for 2017 raised

For 2017, Covestro is now budgeting a substantial sales increase (previously: increase) and a significant improvement in EBITDA after adjustment for special items (previously: on or above the prior-year level).

This development leads to the following changes for the Bayer Group. Sales are now expected to increase to around EUR 51 billion (previously: more than EUR 49 billion). This now corresponds to a mid- to high-single-digit (previously: low- to mid-single-digit) percentage increase on a currency- and portfolio-adjusted basis. EBITDA before special items is now expected to improve by a low-teens percentage (previously: mid-single-digit percentage). Bayer now aims to grow core earnings per share from continuing operations by a mid- to high-single-digit percentage (previously: mid-single-digit percentage). Bayer’s interest in Covestro amounts to only 53 percent as of March 2017 (previously: 64 percent for the full year). Excluding capital and portfolio measures, net financial debt is targeted to be around EUR 8 billion at the end of 2017 (previously: around EUR 10 billion).

Taking into account the potential opportunities and risks, at this point in time Bayer is not adjusting the forecasts issued for its Life Science businesses in February 2017 and refers to its Annual Report 2016 for further information. This forecast is based on the exchange rates as of March 31, 2017. There were no significant changes in this regard compared with December 31, 2016.

On April 26, 2017 Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company focused on the emerging field of regenerative medicine, reported that the results from its completed Phase 2 clinical trial of AST-VAC1 are now available online in Cancer, a leading peer-reviewed journal of the American Cancer Society (Press release, BioTime, APR 26, 2017, View Source [SID1234518695]). The study publication is available at View Source

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

                  Schedule Your 30 min Free Demo!

"This important publication in the journal Cancer shows why AST-VAC1 has the potential to become an important new therapy for AML patients by safely prolonging the duration of remission in patients with high-risk AML," said Steve Cartt, President and Chief Executive Officer of Asterias. "We believe these Phase 2 results also demonstrate the potential of our AST-VAC2 allogeneic (non-patient specific) dendritic cell cancer vaccine to achieve promising results in its upcoming Phase 1/2a study in non-small cell lung cancer and to potentially be developed for the treatment of other types of cancer, as well."

The publication, titled "Immune Responses and Long-Term Disease Recurrence Status After Telomerase-Based Dendritic Cell Immunotherapy in Patients With Acute Myeloid Leukemia," describes the previously reported results of the Phase 2 study of AST-VAC1, Asterias’ patient-specific dendritic cell cancer vaccine, in which 57% of patients who received AST-VAC1 had prolonged relapse-free survival, including high-risk patients over 60 years old or in second remission.

The Phase 2 multicenter, open label trial was designed to evaluate the safety and tolerability of the AST-VAC1 vaccination regimen in patients with intermediate or high risk AML who were in complete clinical remission. Additional objectives of the study were to evaluate the immune responses to AST-VAC1 and to explore the effects of vaccination on relapse in this patient population. Long-term follow-up results showed that 11 out of 19 patients (58 percent) receiving AST-VAC1 during complete remission were relapse-free with a median follow-up of 52 months. In addition, four out of seven patients (57 percent) over the age of 60 remained in remission after a median 54 months of follow-up. Such prolonged relapse-free survival was favorable compared to that previously reported for these patient groups (20-40% overall group and 10-20% for subjects over 60 years old). AST-VAC1 was found to be safe and well-tolerated in this study over multiple vaccinations.

About Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow. AML is the most common type of acute leukemia and has the potential for rapid progression, if untreated. In AML, the bone marrow produces an excess number of immature cells known as blasts. In AML, these blasts fail to mature into normal red and white blood cells. Instead, the blasts proliferate and accumulate in the bone marrow and peripheral blood, leading to deficiencies in normal mature cells. These deficiencies, often referred to as cytopenias, can induce several adverse effects including anemias and susceptibility to infections. Current treatment strategies for AML are associated with significant morbidities and in most instances, AML leads to death.

Approximately 20,500 new cases of AML are diagnosed in the U.S. annually. AML remains a high unmet clinical need, particularly in patients over the age of 60 years who face poor outcomes and have limited therapeutic options. Treatment and prognosis in AML is strongly influenced by a patient’s age and tumor profile. Successful treatment and survival of advanced age patients or those with a high risk profile is very poor, with a four year relapse-free survival of 10% – 20% (Rolig et al, 2011). Detailed characterizations of genetic abnormalities associated with AML have elucidated their high number and relative complexity, making development of targeted therapeutics to these mutations very challenging. For this reason, broad immunotherapy approaches such as autologous cell vaccines are particularly promising.

About AST-VAC1

AST-VAC1 is a cancer immunotherapy, consisting of autologous mature antigen-presenting dendritic cells pulsed with a messenger RNA for the protein component of human telomerase (hTERT) and a portion of a lysosomal targeting signal (LAMP). hTERT is a common protein in tumor cells and is responsible for the increased proliferative lifespan of cancer cells. In AST-VAC1, the dendritic cells present telomerase to the immune system to induce T cells to target and kill hTERT-expressing tumor cells. The LAMP signal allows AST-VAC1 to stimulate both cytotoxic and helper T cell responses to telomerase, critical elements to induce and maintain immune responses that kill tumor cells. Because of the widespread expression of telomerase in the majority of cancers, AST-VAC1 is a platform immunotherapeutic that could be used alone or in conjunction with other therapeutics such as immune checkpoint inhibitors to target immune-based destruction of tumors.