On October 16, 2017 Bristol-Myers Squibb Company (NYSE:BMY) reported data evaluating Opdivo (nivolumab) and Opdivo plus Yervoy (ipilimumab) in previously treated small cell lung cancer (SCLC) patients whose tumors were evaluable for tumor mutation burden (TMB), from the Phase 1/2 CheckMate -032 trial (Press release, Bristol-Myers Squibb, OCT 16, 2017, View Source [SID1234520929]). The primary objective of this trial was objective response rate (ORR) as assessed by a blinded independent central review (BICR), for which results were previously presented; in the pooled intent-to-treat (ITT) population (n=401), the ORR was 11% with Opdivo alone and 22% with the combination. Among the ITT population, 211 (53%) patients had an evaluable TMB result for these analyses and were divided into subgroups of high, medium and low levels of TMB.

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Patients with high TMB who received Opdivo plus Yervoy had an ORR of 46%; the ORR was 16% and 22% in patients with medium and low levels of TMB, respectively. Patients with high TMB who received Opdivo had an ORR of 21%; the ORR was 7% and 5%, in patients with medium and low levels of TMB, respectively. In patients with high TMB who received Opdivo plus Yervoy, 62% were alive at one year; 20% and 23% of patients with medium and low levels of TMB were alive at one year, respectively. In patients with high TMB who received Opdivo, 35% were alive at one year; 26% and 22% of patients with medium and low levels of TMB were alive at one year, respectively. No new safety data were presented in this analysis.

Over time, cancer cells accumulate mutations that are not seen in normal cells of the body. Tumor mutation burden is a measurement of the quantity of mutations carried by tumor cells, and is one type of biomarker that may help predict the likelihood a patient responds to Immuno-Oncology (I-O) therapies.

“These exploratory TMB data from CheckMate -032 are the first to show the potential of using mutation burden to predict response in some patients with the combination of two I-O agents,” said Matthew D. Hellmann, M.D., study investigator, Memorial Sloan Kettering Cancer Center. “Further investigation is warranted to explore the application of this marker across lung cancers, and in the setting of both I-O combination and monotherapy.”

These data will be presented today at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer (WCLC) in Yokohama, Japan during the Biomarker for Lung Cancer oral session from 4:15-4:25 PM JST (Abstract # 11063).

Nick Botwood, M.D., development lead, thoracic cancers, Bristol-Myers Squibb, said, “Assessing the effect of TMB on treatment outcomes has been an important part of our ongoing translational medicine research. Based on these exploratory data from CheckMate -032 in previously treated small cell lung cancer, and the growing scientific evidence for this biomarker, we continue to investigate TMB to understand its relevance as a marker to potentially predict outcomes with immunotherapy. We are committed to our ongoing thoracic cancer development program, focused on identifying patients most likely to benefit from immunotherapy.”

About CheckMate -032

CheckMate -032 is an ongoing Phase 1/2 open-label trial, evaluating the safety and efficacy of Opdivo monotherapy 3 mg/kg every two weeks or Opdivo 1 mg/kg plus Yervoy 3 mg/kg every three weeks for four cycles, in advanced or metastatic solid tumors. All patients were treated until disease progression or unacceptable toxicity. The trial included both PD-L1 expressors and non-expressors. The primary objective was objective response rate (ORR) as assessed by a blinded independent central review (BICR). Secondary objectives included safety, overall survival (OS), progression-free survival (PFS) and duration of response (DOR). Biomarker analysis was an exploratory objective.

Progression-free survival data for the TMB-evaluable patient population were also presented at the WCLC. Patients with high TMB who received Opdivo plus Yervoy had a one-year PFS rate of 30%; the rates were 8% and 6% in patients with medium and low TMB levels, respectively. Patients with high TMB who received Opdivo had a one-year PFS rate of 21%; the rate was 3% in patients with medium TMB level; PFS was not evaluable in patents with low TMB level.

About Small Cell Lung Cancer

Small cell lung cancer (SCLC) is one of two main types of lung cancer, which has been the most common cancer in the world for several decades and accounts for about 10% to 15% of all lung cancers. Survival rates vary depending on the stage of the cancer when it is diagnosed, and five-year survival rates tend to be lower than non-small cell lung cancer, as SCLC is faster growing and symptoms are often not detected until the cancer is at an advanced stage. Globally, the five-year survival rate for Stage I SCLC is between 20% and 40%; for Stage IV SCLC, the five-year survival rate drops to 1%.

Bristol-Myers Squibb & Immuno-Oncology: Advancing Oncology Research

At Bristol-Myers Squibb, patients are at the center of everything we do. Our vision for the future of cancer care is focused on researching and developing transformational Immuno-Oncology (I-O) medicines for hard-to-treat cancers that could potentially improve outcomes for these patients.

We are leading the scientific understanding of I-O through our extensive portfolio of investigational compounds and approved agents. Our differentiated clinical development program is studying broad patient populations across more than 50 types of cancers with 14 clinical-stage molecules designed to target different immune system pathways. Our deep expertise and innovative clinical trial designs position us to advance I-O/I-O, I-O/chemotherapy, I-O/targeted therapies and I-O/radiation therapies across multiple tumors and potentially deliver the next wave of therapies with a sense of urgency. We also continue to pioneer research that will help facilitate a deeper understanding of the role of immune biomarkers and how patients’ tumor biology can be used as a guide for treatment decisions throughout their journey.

We understand making the promise of I-O a reality for the many patients who may benefit from these therapies requires not only innovation on our part but also close collaboration with leading experts in the field. Our partnerships with academia, government, advocacy and biotech companies support our collective goal of providing new treatment options to advance the standards of clinical practice.

On October 16, 2017 Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) (“Actinium” or “the Company”), a biopharmaceutical company developing innovative targeted therapies for cancers lacking effective treatment options, reported that it will present at the BIO Investor Forum being held on October 16-17th at the Westin St. Francis Hotel in San Francisco, California (Press release, Actinium Pharmaceuticals, OCT 16, 2017, View Source [SID1234520933]). Details for Actinium’s presentation are below:

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Date: Tuesday, October 17, 2017
Time: 3:00 PM PT
Room: Elizabethan C

Members of Actinium’s management team will be available for one-on-one meetings with conference attendees. To arrange a meeting with management, please contact Steve O’Loughlin, Actinium’s Principal Financial Officer, at [email protected] or utilize the conference partnering system View Source

About BIO Investor Forum

The BIO Investor Forum is an international biotech investor conference focused on investment trends and opportunities in life sciences, with unbiased emphasis on venture stage growth and emerging public companies as well as those poised to join the growth “watch list” in 2018.

On October 16, 2017 New subgroup analysis from Eli Lilly and Company’s (NYSE: LLY) Phase 3 REVEL trial of CYRAMZA (ramucirumab) in advanced non-small cell lung cancer (NSCLC) was presented at the 18th World Conference on Lung Cancer (WCLC), hosted by the International Association for the Study of Lung Cancer in Yokohama, Japan (Press release, Eli Lilly, OCT 16, 2017, View Source [SID1234520931]). Specifically, these new data are an exploratory, post-hoc analysis focused on patients whose cancer rapidly progressed on first-line therapy. Time-to-progression (TTP) is defined as the time from start of first-line therapy until progressive disease – when the person’s cancer grows, spreads or gets worse. In this analysis, aggressive disease was defined based on rapid TTP on first-line therapy.

“Despite recent advancements, patients with aggressive, rapidly progressing advanced non-small cell lung cancer who progress before or at the time of their first scan – which is typically done between nine and 12 weeks – often have a less favorable response to their second-line therapy. This is a population that has poor prognosis and immediate unmet needs with limited treatment options,” said Martin Reck, M.D., Ph.D., Department of Thoracic Oncology, Lung Clinic Grosshansdorf.

Dr. Reck continued, “This REVEL exploratory analysis demonstrated that efficacy, safety, and quality-of-life outcomes among patients receiving ramucirumab plus docetaxel who have aggressive disease with rapid progression on first-line therapy are consistent with the outcomes of the intent-to-treat population. These results suggest that such patients may derive meaningful benefit from ramucirumab plus docetaxel in the second-line setting.”

The global, randomized, double-blind, placebo-controlled REVEL Phase 3 study evaluated ramucirumab, in combination with docetaxel, in patients with metastatic NSCLC whose cancer had progressed on or after prior platinum-based chemotherapy for locally advanced or metastatic disease. REVEL, which included patients with nonsquamous and squamous forms of NSCLC, demonstrated improved overall survival ﴾OS﴿, progression‐free survival ﴾PFS﴿, and objective response rate ﴾ORR) – independent of histology.1 Please see the ‘About REVEL’ section below for more detailed efficacy and safety results in the trial’s intent-to-treat (ITT) patient population. The REVEL ITT trial results, presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in 2014, supported the U.S. Food and Drug Administration approval of ramucirumab in NSCLC in December 2014.

This new subgroup analysis focused on outcomes from patients according to their TTP on first-line treatment. Of the 1,253 patients enrolled in REVEL, on first-line therapy, 11 percent (n=133) had TTP ≤9 weeks, 17 percent (n=209) had TTP ≤12 weeks, and 28 percent (n=354) had TTP ≤18 weeks. Baseline characteristics of each subgroup were balanced between treatment arms.

The results show that the trend for OS and PFS outcomes favored the ramucirumab-plus-docetaxel treatment arm, with hazard ratios similar to those of the ITT population. In all three subpopulations, ORR also favored the ramucirumab-plus-docetaxel treatment arm.

≤9 Weeks
≤12 Weeks
≤18 Weeks
REVEL ITT Population

Ramucirumab +
Docetaxel
n=71
Placebo +
Docetaxel
n=62
Ramucirumab +
Docetaxel
n=111
Placebo +
Docetaxel
n=98
Ramucirumab +
Docetaxel
n=182
Placebo +
Docetaxel
n=172
Ramucirumab +
Docetaxel
n=628
Placebo +
Docetaxel
n=625
Median OS, months
(95% CI)
8.28
(5.19-10.84)
4.83
(3.09-6.90)
9.10
(6.70-10.84)
5.78
(4.30-7.49)
8.51
(6.97-9.95)
5.95
(4.44-6.97)
10.51
(9.53-11.24)
9.13
(8.44-10.02)
Unstratified HR
(95% CI)
0.69
(0.47-1.01)
0.74
(0.54-1.00)
0.80
(0.63-1.01)
0.86
(0.75-0.98)
Median PFS, months
(95% CI)
3.01
(2.66-4.07)
1.48
(1.41-1.87)
3.61
(2.76-4.21)
1.61
(1.45-2.60)
3.22
(2.79-4.14)
1.61
(1.48-2.60)
4.50
(4.21-5.36)
3.02
(2.79-3.94)
Unstratified HR
(95% CI)
0.69
(0.48-0.98)
0.73
(0.55-0.97)
0.72
(0.58-0.89)
0.78
(0.69-0.87)
ORR, %
(95% CI)
18.3
(10.1-29.3)
3.2
(0.4-11.2)
18.9
(12.1-27.5)
9.2
(4.3-16.7)
19.2
(13.8-25.7)
10.5
(6.3-16.0)
22.9
(19.7-26.4)
13.6
(11.0-16.5)

Safety overview outcomes from patients with TTP on first-line therapy ≤18 weeks are similar to what was observed from patients with TTP on first-line therapy ≤9 weeks and ≤12 weeks, as well as in the ITT population. There were no new safety signals observed in these subpopulations.

“We are encouraged by this REVEL subgroup analysis, as patients with this aggressive type of cancer who experience rapid disease progression on first-line therapy urgently need additional treatment options that can help stop or slow the cancer from growing and spreading,” said Levi Garraway, M.D., Ph.D., senior vice president, global development and medical affairs, Lilly Oncology. “The results of this REVEL analysis add to the growing body of knowledge we have about aggressive lung cancer and demonstrates Lilly’s longstanding commitment to advancing the science in lung cancer treatment and to improving the care of patients with this disease.”

Notes to Editor

About REVEL
REVEL was a global, double-blind, randomized Phase 3 study of CYRAMZA (ramucirumab) plus docetaxel compared to placebo plus docetaxel in people with metastatic non-small cell lung cancer (NSCLC) whose cancer had progressed on or after prior platinum-based chemotherapy for locally advanced or metastatic disease. In total, 1,253 patients – including people with nonsquamous (73%) and squamous (26%) forms of NSCLC – were randomized in 26 countries over six continents.1

In the trial, CYRAMZA plus docetaxel achieved a statistically significant improvement in overall survival (the primary endpoint), progression-free survival and objective response rate (secondary endpoints). CYRAMZA plus docetaxel significantly extended median overall survival compared to placebo plus docetaxel (10.5 months [95% confidence interval (CI): 9.5, 11.2] vs. 9.1 months [95% CI: 8.4, 10.0], respectively; hazard ratio 0.86 [95% CI: 0.75, 0.98]; P=0.024). Furthermore, CYRAMZA plus docetaxel significantly delayed disease progression (progression-free survival of 4.5 months for CYRAMZA plus docetaxel [95% CI: 4.2, 5.4] vs. 3.0 months for placebo plus docetaxel [95% CI: 2.8, 3.9]; hazard ratio 0.76 [95% CI: 0.68, 0.86]; P < 0.001). The percentage of deaths at the time of analysis was 68% (428 patients) and 73% (456 patients) in the CYRAMZA-plus-docetaxel and placebo-plus-docetaxel arms, respectively. The progression-free survival number of events was 558 (89%) and 583 (93%) for CYRAMZA-plus-docetaxel and placebo-plus-docetaxel treatment arms, respectively. Significantly more patients responded to CYRAMZA combined with docetaxel than with placebo plus docetaxel (23% [95% CI: 20, 26] for CYRAMZA plus docetaxel vs. 14% [95% CI: 11, 17] for placebo plus docetaxel; P < 0.001). The labeling for CYRAMZA contains a Boxed Warning for hemorrhage and additional Warnings and Precautions for arterial thromboembolic events, hypertension, infusion-related reactions, gastrointestinal perforations, impaired wound healing, clinical deterioration in patients with Child-Pugh B or C cirrhosis, and reversible posterior leukoencephalopathy syndrome. In the REVEL trial, the most common adverse reactions (all grades) observed in patients treated with CYRAMZA plus docetaxel at a rate of ≥30% and ≥2% higher than placebo were neutropenia (low white blood cell count) (55% vs. 46%), fatigue/asthenia (weakness) (55% vs. 50%) and stomatitis/mucosal inflammation (37% vs. 19%). The most common serious adverse events with CYRAMZA were febrile neutropenia (fever and potentially other infection signs along with low white blood cell count) (14%), pneumonia (6%), and neutropenia (5%); 42% of patients treated with CYRAMZA plus docetaxel received granulocyte colony-stimulating factors (treatment for low white blood cells) vs. 37% of patients who received placebo plus docetaxel. See the Important Safety Information at the end of this press release and the Prescribing Information. About Lung Cancer Lung cancer is the leading cause of cancer death in the U.S. and most other countries, killing nearly 1.6 million people worldwide each year.2 In the U.S., lung cancer is responsible for approximately 27 percent of all cancer deaths, more than those from breast, colon and prostate cancers combined.3 Stage IV non-small cell lung cancer (NSCLC) is a very difficult-to-treat cancer and the prognosis is poor for metastatic NSCLC.4 NSCLC is much more common than other types of lung cancer, and accounts for about 85 percent of all lung cancer cases.5 For those people affected by NSCLC, about 70 percent have nonsquamous cell carcinoma, while about 30 percent have squamous cell carcinoma.5 Approximately half of patients with metastatic NSCLC who begin first-line therapy will move on to second-line treatment.6 Despite currently available therapies, there continues to be a need for new second-line treatment options for patients with NSCLC.1 About CYRAMZA (ramucirumab) In the U.S., CYRAMZA (ramucirumab) is approved for use as a single agent or in combination with paclitaxel as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy. It is also approved in combination with docetaxel as a treatment for people with metastatic non-small cell lung cancer (NSCLC) whose cancer has progressed on or after platinum-based chemotherapy. Additionally, it is approved with FOLFIRI as a treatment for people with metastatic colorectal cancer (mCRC) whose cancer has progressed on or after therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. Ramucirumab is being investigated in a broad global development program that has enrolled more than 10,000 patients across more than 70 trials worldwide. There are several studies underway or planned to investigate ramucirumab as a single agent and in combination with other anti-cancer therapies for the treatment of multiple tumor types. Previously completed Phase 3 studies of ramucirumab have demonstrated benefit in advanced forms of gastric, non-small cell lung and colorectal cancer ¾ three of the world's leading causes of cancer-related deaths. Ramucirumab is an antiangiogenic therapy. It is a vascular endothelial growth factor (VEGF) Receptor 2 antagonist that specifically binds and blocks activation of VEGF Receptor 2 by blocking the binding of VEGF receptor ligands VEGF-A, VEGF-C, and VEGF-D. Ramucirumab inhibited angiogenesis in an in vivo animal model. About Angiogenesis and VEGF Protein Angiogenesis is the process of making new blood vessels. In a person with cancer, angiogenesis creates new blood vessels that give a tumor its own blood supply, allowing it to grow and spread. Some tumors create proteins called VEGF. These proteins attach to the VEGF receptors of blood vessel cells causing new blood vessels to form around the tumors, enabling growth. Blocking the VEGF protein from linking to the blood vessels helps to inhibit tumor growth by slowing angiogenesis and the blood supply that feeds tumors. Of the three known VEGF receptors, VEGF Receptor 2 is linked most closely to VEGF-induced tumor angiogenesis.

On October 16, 2017 AstraZeneca and Medimmune, its global biologics research and development arm, reported it continue to demonstrate their progress in lung cancer research at the IASLC 18th World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer in Yokohama, Japan, 15-18 October 2017 (Press release, AstraZeneca
, OCT 16, 2017, View Source [SID1234520928]). With 43 data presentations, including 16 oral presentations, AstraZeneca is focusing on four key scientific drivers of progress in lung cancer: treating earlier stages of the disease; strategies to overcome tumour resistance; improved testing to match the right treatments to the right patients; and continued exploration of the potential of immuno-oncology combinations.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “The data we are presenting at WCLC 2017 illustrate the science-led strength of our clinical programme focused on tackling multiple mechanisms associated with this complex disease. We are constantly striving to deliver on our ambition of one day eliminating cancer as a cause of death.”

Treating lung cancer at earlier stages of the disease

To date, the majority of research has been focused on metastatic disease, where the medical need is most urgent. But with the potential for clinical benefit becoming clearer in earlier stages of disease, long-term quality of life is an increasingly important component in deciding the right treatment.

At WCLC, patient-reported outcomes from the Phase III Imfinzi PACIFIC trial will be presented during the Presidential Symposium. The PACIFIC trial of Imfinzi (durvalumab) in patients with locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) who have not progressed following platinum-based chemoradiation therapy, is the first to demonstrate superior progression-free survival (PFS) in this setting.

Rina Hui, MD, PhD, clinical associate professor of medicine, Westmead Clinical School at the University of Sydney and Principal Investigator on the trial, said: “As we treat patients with earlier stages of disease and pursue curative intent, quality-of-life considerations definitely affect the choice of treatment. If quality-of-life data support significant clinical benefits, then we may be looking at a new treatment paradigm for these patients.”

Overcoming tumour resistance

More patients taking therapies targeting mutations are experiencing longer periods before their disease worsens; however, tumours often adapt and develop new resistance mechanisms. At WCLC, AstraZeneca is presenting new data on novel combinations that may help overcome a common secondary resistance and established driver of disease progression in patients treated with EGFR TKIs – mesenchymal epithelial transition factor (MET).

Early safety and efficacy results from the multi-arm, Phase Ib TATTON study will be presented, investigating the c-Met receptor tyrosine kinase inhibitor (TKI) savolitinib in combination with EGFR T790M inhibitor Tagrisso (osimertinib) in patients with MET-positive resistance. [Abstract #8985]. These data will be supplemented by the first results of a multi-centre Phase Ib study investigating the combination of savolitinib and Iressa (gefitinib) in a similar patient population. [Abstract #8995].

Myung-Ju Ahn, MD, PhD, Professor, Department of Hematology & Oncology, Samsung Medical Center, Seoul, South Korea, said: “Cancer is stealthy and we must continue to find new ways to combat resistance. The early results for both gefitinib and osimertinib in combination with savolitinib show exciting progress and are an important area of continued focus.”

Testing to identify the most suitable treatment

Biomarker-guided lung cancer research is continuing to improve ways to identify patients who are most likely to benefit from treatment with precision medicines. In NSCLC, this has meant improving the accuracy and availability of blood-based testing to facilitate diagnosis and identification of the most suitable treatments throughout the disease continuum. At WCLC, AstraZeneca is presenting progress in ctDNA testing in EGFRm NSCLC across multiple lines of therapy and technologies.

In the 1st-line setting, new analyses across the Tagrisso FLAURA [Abstract #8978] and Iressa BENEFIT [Abstract #9278] trials reveal good concordance between tissue and plasma ctDNA testing, and support the utility of blood-based testing to determine eligibility for both Tagrisso and Iressa. In addition, concordance studies comparing multiple plasma ctDNA diagnostics in two different studies of Tagrisso [Abstract #8984 and #9811] in the 2nd line setting continue to build understanding of the comparability of different technologies and expand testing across platforms.

Jhanelle Gray, MD, Medical Oncologist and Director of Clinical Research in the Department of Thoracic Oncology at H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida, said: “Testing continues to be a critical part of lung cancer care, but the rapid development and evolution of multiple testing modalities and platforms can be challenging for physician teams to manage. Continued understanding of how assays compare builds confidence in treatment decisions, leading to better patient outcomes”

Combining with IO

As the promise of IO continues to build through the use of monotherapies, the next era in cancer control may involve combinations with a goal of achieving long-term survival for a broader population of patients. At WCLC, AstraZeneca is sharing results from two early trials of checkpoint inhibitor combinations, with and without chemotherapy.

When combined with chemotherapy, Imfinzi with or without tremelimumab could be administered safely and demonstrated encouraging preliminary clinical activity in patients with NSCLC in a study conducted by the Canadian Cancer Trials Group [Abstract #8700].
The Phase II, open-label, NIBIT-MESO-1 study [Abstract #9202] of Imfinzi plus tremelimumab as 1st- or 2nd-line treatment in patients with malignant mesothelioma demonstrated a safety profile consistent with our previous observations/publications in NSCLC, and clinical activity in this difficult-to-treat cancer.
Rosalyn A. Juergens MD., PhD. Assistant Professor, Department of Oncology. McMaster University, Canada said: “As we continue to explore the full benefit of immunotherapies, the promise of combinations is really starting to be seen for patients who may not be expected to benefit from the current monotherapies. We continue to push research boundaries in this area with the hope that we can make a real difference to patients in need.”

On October 16, 2017 Vical Incorporated (Nasdaq:VICL) reported that the company will report financial results for the three months ended September 30, 2017, before the opening of trading on Monday, October 23, and conduct a conference call and webcast to discuss the financial results and provide a company update at noon Eastern Time on Monday, October 23 (Press release, Vical, OCT 16, 2017, View Source [SID1234520969]). The call will be open on a listen-only basis to any interested parties. The company will also provide a business update, including details on independent and partnered development programs in the conference call and webcast.

Conference Call
To listen to the conference call, dial in approximately ten minutes before the scheduled call to (719) 457-2619 (preferred), or (888) 349-9582 (toll-free), and reference confirmation code 3889356. A replay of the call will be available for 48 hours beginning about two hours after the call. To listen to the replay, dial (719) 457-0820 (preferred) or (888) 203-1112 (toll-free) and enter replay passcode 3889356. The call also will be available live and archived through the events page at www.vical.com.

Invited participants may ask questions during the conference call. Others may submit questions before the call by e-mail addressed to [email protected] or by fax to (858) 646-1150. Submitted questions will be screened for appropriateness and general interest. Selected questions received with sufficient notice before the call will be answered as time permits at the end of the call. For further information, contact Vical’s Investor Relations department by phone at (858) 646-1127 or by email at [email protected].