On August 10, 2015 Inovio Pharmaceuticals (Nasdaq:INO) reported that it has entered into a license agreement and collaboration with MedImmune, the global biologics research and development arm of AstraZeneca (Press release, Inovio, AUG 10, 2015, View Source [SID:1234507147]).

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Under the agreement, MedImmune will acquire exclusive rights to Inovio’s INO-3112 immunotherapy, which targets cancers caused by human papillomavirus (HPV) types 16 and 18. INO-3112, which is in phase I/II clinical trials for cervical and head and neck cancers, works by generating killer T-cell responses that are able to destroy HPV 16- and 18-driven tumors. These HPV types are responsible for more than 70 percent of cervical pre-cancers and cancers.

MedImmune intends to study INO-3112 in combination with selected immunotherapy molecules within its pipeline in HPV-driven cancers. Emerging evidence suggests that the benefits from immuno-oncology molecules, such as those in MedImmune’s portfolio, can be enhanced when they are used in combination with cancer vaccines that generate tumor-specific T-cells.

Under the terms of the agreement, MedImmune will make an upfront payment of $27.5 million to Inovio as well as potential future payments upon reaching development and commercial milestones totaling up to $700 million. MedImmune will fund all development costs. Inovio is entitled to receive up to double-digit tiered royalties on INO-3112 product sales.

Within the broader collaboration, MedImmune and Inovio will develop up to two additional DNA-based cancer vaccine products not included in Inovio’s current product pipeline, which MedImmune will have the exclusive rights to develop and commercialize. Inovio will receive development, regulatory and commercialization milestone payments and will be eligible to receive royalties on worldwide net sales for these additional cancer vaccine products.

Dr. David Berman, Senior Vice President and Head of the Oncology Innovative Medicines unit, MedImmune, said: "Today’s collaboration with Inovio leverages our deep internal expertise in the use of vaccines to drive antigen-specific T-cell responses. The unique combination of our broad immuno-oncology portfolio with Inovio’s T-cell-activating INO-3112, which enhances cancer specific killer T-cells, has the potential to deliver real clinical benefits for patients."

Dr. J. Joseph Kim, President and CEO, Inovio, said: "Our licensing partnership with MedImmune represents an important step in executing our immuno-oncology combination strategy and advancing Inovio’s cancer vaccine R&D pipeline with a leading cancer immunotherapy company. INO-3112 is progressing, with positive interim data generated in an Inovio-initiated phase I study. We appreciate MedImmune’s recognition of our ability to activate best-in-class killer T-cells in vivo and look forward to working with them on this collaboration."

Today’s agreement builds on the existing partnership between Inovio and MedImmune on two research and development collaborations in the infectious disease area. Both efforts are funded by the Defense Advanced Research Projects Agency (DARPA) and support R&D focused on Ebola, influenza, and bacterial infections. MedImmune has a strong heritage in infectious disease and vaccine innovation, having developed the first monoclonal antibody approved by the US Food & Drug Administration for the prevention of an infectious disease and the technology that led to the creation of an HPV vaccine.

About INO-3112

Inovio’s SynCon DNA-based immunotherapies help the immune system activate disease-specific killer T cells to fight a targeted disease. HPV, the most pervasive sexually transmitted virus, causes numerous pre-cancers and cancers. Inovio’s HPV immunotherapy called INO-3112 targets disease associated with the high-risk HPV types 16 and 18, which are responsible for over 70% of cervical pre-cancers and cancers. INO-3112 combines Inovio’s VGX-3100, its immunotherapy targeting HPV-caused diseases, with its DNA-based immune activator encoded for IL-12. INO-3112 is in three clinical studies for cervical and head and neck cancers.

Earlier this year, Inovio reported preliminary data showing that INO-3112 generated significant antigen-specific CD8+ T cell responses in 3 of 4 patients with head and neck cancer associated with human papillomavirus (HPV) types 16 and 18. These positive results represent the first study and first report of antigen-specific T cell immune responses generated in cancer patients after treatment with a DNA immunotherapy.

Previously in a phase II efficacy trial, treatment with VGX-3100 resulted in histopathological regression of late-stage cervical dysplasia to early stage or no disease, meeting the study’s primary endpoint. In addition, the trial demonstrated clearance of the HPV virus in conjunction with regression of cervical lesions, meeting the secondary endpoint. Robust T-cell activity was observed in subjects who received VGX-3100 compared to those who received placebo.

On August 10, 2015 Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, reported financial results for the second quarter ended June 30, 2015, and also provided an overview of certain corporate accomplishments and plans (Press release, Verastem, AUG 10, 2015, View Source;p=RssLanding&cat=news&id=2078274 [SID:1234507190]).

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"Execution of the ongoing COMMAND trial continues to progress well and we remain on track to report the outcome of the interim analysis during the third quarter of 2015," said Robert Forrester, President and Chief Executive Officer of Verastem. "The independent Data and Safety Monitoring Board (DSMB) will examine pre-specified efficacy and safety data sets to decide whether to recommend continuation in all patients as planned, or to enrich the study population based upon merlin status, or to stop the study early for futility. This will be an important milestone for Verastem."

Q2 2015 and Recent Highlights

VS-6063 (Focal Adhesion Kinase Inhibition)

COMMAND (Control Of Mesothelioma with MAinteNance Defactinib) Study

Registration-directed, randomized, double-blind, placebo-controlled study of VS-6063 as a switch maintenance treatment in patients with malignant pleural mesothelioma benefiting from frontline therapy with pemetrexed (Alimta) and platinum
Co-primary endpoints are Progression Free Survival (PFS) and Overall Survival (OS). The study is designed to provide 90% power to assess the superiority of PFS, with a 1 sided type I error rate of 0.025, assuming a hazard ratio of 0.67
308 patients enrolled at 72 centers in 15 countries as of August 6, 2015
Interim analysis to define the primary patient population anticipated in Q3 2015

Presentations and Publications
Reported encouraging scientific data in support of Verastem’s cancer stem cell inhibitors (VS-6063, VS-4718, and VS-5584) in multiple tumor types, including mesothelioma, small cell lung cancer, breast cancer, and hematologic malignancies, at the 2015 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Copies of the presentations can be accessed at: http://bit.ly/12otlcV

Corporate
Appointed Lou Vaickus, MD, FACP as Interim Chief Medical Officer
Hosted an analyst and investor event at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Guest speakers Professor Dean Fennell, Ph.D., FRCP, and Max Wicha, M.D., gave presentations on mesothelioma and the rationale and importance of targeting cancer stem cells through FAK inhibition

Upcoming Clinical Milestones
Verastem’s anticipated upcoming data milestones include:

VS-6063

COMMAND interim analysis: Q3 2015
Phase 2 results in KRAS-mutated NSCLC at the World Conference of Lung Cancer in Denver, CO on September 6-9th
Updated results from the VS-6063/paclitaxel combination in patients with ovarian cancer: H2 2015
Biomarker "Window of Opportunity" mesothelioma study with preliminary results from the extended treatment cohort: H1 2016

VS-4718
Preliminary Phase 1 results in patients with advanced solid tumors: H2 2015

VS-5584
Preliminary Phase 1 results in patients with advanced solid tumors: H2 2015

Second Quarter 2015 Financial Results
As of June 30, 2015, Verastem had cash, cash equivalents and investments of $132.1 million compared to $92.7 million as of December 31, 2014. Verastem used $12.0 million for operating activities in the second quarter ended June 30, 2015 (the "2015 Quarter").

Net loss for the 2015 Quarter was $15.4 million, or $0.42 per share, as compared to net loss of $13.0 million, or $0.51 per share, for the same period in 2014 (the "2014 Quarter"). Net loss includes stock-based compensation expense of $2.6 million and $3.2 million for the 2015 Quarter and 2014 Quarter, respectively.

Research and development expense for the 2015 Quarter was $11.0 million compared to $8.3 million for the 2014 Quarter. The $2.7 million increase from the 2014 Quarter to the 2015 Quarter was primarily related to an increase of $2.1 million in contract research organization expense for outsourced biology, development and clinical services, which includes Verastem’s clinical trial costs, and an approximate $732,000 increase in personnel costs. These increases were partially offset by a decrease in stock-based compensation expense of approximately $162,000.

General and administrative expense for the 2015 Quarter was $4.4 million compared to $4.8 million for the 2014 Quarter. The $400,000 decrease was primarily due to a decrease in stock-based compensation expense.
There were 36,853,805 common shares outstanding as of June 30, 2015.

Financial Guidance
Based on current operating plans, the Company expects to have sufficient cash, cash equivalents and investments to fund its research and development programs and operations into the first half of 2017.

About VS-6063
VS-6063 (defactinib) is an orally available compound designed to target cancer stem cells through the potent inhibition of focal adhesion kinase (FAK). Cancer stem cells are an underlying cause of tumor resistance to chemotherapy, recurrence and ultimate disease progression. Research has demonstrated that FAK activity is critical for the growth and survival of cancer stem cells. VS-6063 is currently being studied in the registration-directed COMMAND trial in mesothelioma (www.COMMANDmeso.com), a "Window of Opportunity" study in patients with mesothelioma prior to surgery, a Phase 1/1b study in combination with paclitaxel in patients with ovarian cancer, a trial in patients with KRAS-mutated non-small cell lung cancer and a trial evaluating the combination of VS-6063 and VS-5584 in patients with relapsed mesothelioma. VS-6063 has been granted orphan drug designation for use in mesothelioma in the U.S. and EU.

About VS-4718
VS-4718 is an orally available compound designed to target cancer stem cells through the potent inhibition of focal adhesion kinase (FAK). VS-4718 is currently being studied in a Phase 1 dose escalation study in patients with advanced cancers.

About VS-5584
VS-5584 is an orally available compound that has demonstrated potent and highly selective activity against class 1 PI3K enzymes and dual inhibitory actions against mTORC1 and mTORC2. In preclinical studies, VS-5584 has been shown to reduce the percentage of cancer stem cells and induce tumor regression in chemotherapy-resistant models. Verastem is currently conducting a dose escalation trial of VS-5584 in patients with advanced solid tumors as a single agent and a combination trial of VS-5584 and VS-6063 in patients with relapsed mesothelioma. VS-5584 has been granted orphan drug designation for use in mesothelioma in the U.S. and EU.

On August 10, 2015 Inovio Pharmaceuticals, Inc. (NASDAQ:INO) reported financial results for the quarter ended June 30, 2015 (Press release, Inovio, AUG 10, 2015, View Source [SID:1234507149]).

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Total revenue was $5.3 million and $10.5 million for the three and six months ended June 30, 2015, compared to $3.8 million and $6.2 million for the same periods in 2014.

Total operating expenses were $20.4 million and $33.9 million for the three and six months ended June 30, 2015, compared to $14.0 million and $26.3 million for the same periods in 2014.

The net loss attributable to common stockholders for the three and six months ended June 30, 2015, was $6.2 million, or $0.09 per share, and $16.8 million, or $0.26 per share, compared to $10.7 million, or $0.18 per share, and $21.5 million, or $0.37 per share, for the same periods in 2014.

Revenue

The increase in revenue was primarily due to the $3.0 million milestone payment earned in the second quarter 2015 under our partnership agreement with Roche.

Operating Expenses

Research and development expenses for the three and six months ended June 30, 2015, were $16.7 million and $26.1 million, compared to $9.6 million and $17.8 million for the same periods in 2014. The increase for the three and six-month periods was primarily related to increased investment in our product development programs. General and administrative expenses for the three and six months ended June 30, 2015, were $4.7 million and $8.8 million versus $4.3 million and $8.5 million for the same periods in 2014.

Capital Resources

As of June 30, 2015, cash and short-term investments were $154.6 million compared with $93.6 million as of December 31, 2014. At quarter end the company had 71.8 million shares outstanding and 78.9 million fully diluted.

On May 5, 2015, the Company closed an underwritten public offering of 10,925,000 shares of the Company’s common stock, including 1,425,000 shares of common stock issued pursuant to the underwriter’s exercise of its option, at the public offering price of $8.00 per share. The gross proceeds of this offering were $87.4 million. Net proceeds to the Company, after deducting the underwriter’s discounts and commission and other offering expenses, were $81.9 million.

We intend to use the net proceeds received from the sale of our common stock for general corporate purposes, including clinical trial expenses, research and development expenses, general and administrative expenses, manufacturing expenses and potential acquisitions of companies and technologies that complement our business.

Based on management’s projections and analysis, the Company believes that cash and short-term investments meet its planned working capital requirements through the end of 2018.

Inovio’s balance sheet and statement of operations are provided below. Form 10-Q providing the complete 2015 second quarter financial report can be found at: View Source

Corporate Update

Corporate Development

On August 7, 2015, Inovio entered into a strategic cancer vaccine collaboration and license agreement with MedImmune, the global biologics research and development arm of AstraZeneca. Under the agreement, MedImmune acquired exclusive rights to Inovio’s INO-3112 immunotherapy, which targets cancers caused by human papillomavirus (HPV) types 16 and 18. MedImmune intends to study INO-3112 in combination with selected immunotherapy molecules within its pipeline in HPV-driven cancers. Emerging evidence suggests that the benefits from immuno-oncology molecules, such as those in MedImmune’s portfolio, can be enhanced when they are used in combination with cancer vaccines that generate tumor-specific T-cells.

Under the terms of the agreement, MedImmune will make an upfront payment of $27.5 million to Inovio as well as potential future payments upon reaching development and commercial milestones totaling up to $700 million. MedImmune will fund all development costs. Inovio is entitled to receive up to double-digit tiered royalties on INO-3112 product sales.

Within the broader collaboration, Inovio and MedImmune will develop up to two additional DNA-based cancer vaccine products not included in Inovio’s current product pipeline, which MedImmune will have the exclusive rights to develop and commercialize. Inovio will receive development, regulatory and commercialization milestone payments and will be eligible to receive royalties on worldwide net sales for these additional cancer vaccine products.

This is Inovio’s second major partnership with a large pharmaceutical company, adding to its existing license agreement with Roche for Inovio’s INO-1800 hepatitis B immunotherapy. The initiation of a phase I trial for INO-1800 in April triggered a $3 million milestone payment from Roche.

We initiated a partnership with Europe’s largest cancer organization, the European Organization for Research and Treatment of Cancer (EORTC), to evaluate INO-3112 in combination with traditional chemo-radiotherapy for the treatment of patients with locally advanced stage cervical cancer. The primary endpoint of this phase II study is to evaluate progression free survival at 18 months. It is expected to begin in 2016 and will be part of MedImmune’s development plans.

Under an award worth potentially $45 million from the Defense Advanced Research Projects Agency (DARPA), Inovio and collaborators are advancing multiple treatment and prevention approaches against Ebola. These approaches include DNA-based monoclonal antibody technology, protein-based therapeutic monoclonal antibodies, and DNA-based vaccines.

We will advance our DNA vaccine for Middle East Respiratory Syndrome (MERS) into a phase I clinical trial in healthy volunteers in a collaboration with GeneOne Life Science Inc. GeneOne will conduct and fund the clinical study, expected to start by year end, in return for milestone-based co-ownership of this immunotherapy.

Inovio continues its corporate development efforts to secure grants, collaborations, and partnerships to help advance its SynCon immunotherapy and vaccine products.

Clinical Development

Our manuscript detailing the broad study findings of our phase II study of VGX-3100 in patients with high-grade cervical dysplasia (CIN 2/3) has been accepted by a top peer-reviewed medical journal.

We continue preparations to launch our planned phase III registration study of VGX-3100 in early 2016. Necessary steps include scaling from pilot-scale to commercial-level production of our immunotherapy product and delivery devices, significant projects with important quality assurance standards to maintain. We expect our end-of-phase-II meeting with the FDA, which will review our phase II data and proposed phase III clinical trial design, to take place by year end.

As part of our expanding franchise targeting all HPV-associated pre-cancers and cancers, we reported preliminary data from our first cancer study, a head & neck cancer trial, showing that INO-3112 (VGX-3100 plus Inovio’s IL-12 based immune activator) generated strong CD8+ T cell responses in 3 of 4 patients. This study, along with our ongoing cervical cancer phase I study of INO-3112, will now be part of MedImmune’s development plans.

Subsequent to the quarter we launched our phase I study of INO-5150, our SynCon immunotherapy targeting prostate-specific membrane antigen and prostate-specific antigen, in men with biochemically relapsed prostate cancer. This study is evaluating the safety, tolerability, and immunogenicity of INO-5150 alone or in combination with INO-9012, Inovio’s DNA-based IL-12 immune activator.

We initiated with our partner Roche a phase I trial for our hepatitis B immunotherapy, INO-1800. This randomized, open-label, active-controlled, dose escalation study is evaluating the safety, tolerability, and immunogenicity of Inovio’s hepatitis B immunotherapy alone or in combination with Inovio’s IL-12-based immune activator.

The company initiated a phase I trial to evaluate its Ebola immunotherapy and we expect the HIV Vaccine Trials Network to initiate a phase I study of PENNVAX-GP in 2H 2015.

On August 10, 2015 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP) reported financial results for the second quarter ended June 30, 2015, and provided an update on the company’s recent activities (Press release, Ziopharm, AUG 10, 2015, View Source [SID:1234507193]).

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"ZIOPHARM continues to make important headway, both in the lab and clinic, in the development of our novel gene and adoptive cell therapy programs and technologies," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM. "This includes advancement of several chimeric antigen receptor (CAR) and T-cell receptor (TCR) candidates toward the clinic, evolution of the Sleeping Beauty non-viral gene transfer platform, integration of RheoSwitch technology into various adoptive cell therapies and clinical strategies for controlled delivery of IL-12 using adenovirus. Working with Intrexon and our other partners, we look forward to advancing these cancer immunotherapies, and to presenting early data from across these platforms prior to the end of this year."

Recent Highlights

Ad-RTS-hIL-12

Ad-RTS-hIL-12 is a gene therapy candidate for the controlled expression of IL-12, a critical protein for stimulating an anti-cancer T cell immune response, using the RheoSwitch Therapeutic System (RTS) gene switch. In April 2015, ZIOPHARM announced the initiation of a Phase 1b/2 study of Ad-RTS-hIL-12 and veledimex following standard chemotherapy for the treatment of patients with locally advanced or metastatic breast cancer. In May 2015, the Company announced the initiation of a multi-center Phase 1 study of Ad-RTS-hIL-12 and veledimex in patients with recurrent or progressive glioblastoma multiforme, a form of brain cancer.

Both gene therapy trials, which are being conducted at leading centers across the U.S., are currently open and accruing patients. The Company expects that early results from each study will be presented at scientific meetings prior to year end.

ZIOPHARM also announced in July that the U.S. Food and Drug Administration granted Orphan Drug Designation for Ad-RTS-hIL-12 and veledimex in the treatment of patients with malignant glioma. The FDA’s Office of Orphan Products grants orphan drug status to support development of medicines for underserved patient populations or rare disorders affecting fewer than 200,000 people in the U.S. Orphan Drug Designation provides eligibility for a seven-year period of market exclusivity in the United States after product approval, an accelerated review process, accelerated approval where appropriate, grant funding, tax benefits and an exemption from user fees.

Adoptive Cell Therapies

In March 2015, ZIOPHARM and its partner Intrexon (NYSE:XON) announced a global collaboration focused exclusively on novel chimeric antigen receptor T-cell (CAR-T) products with the biopharmaceutical business of Merck KGaA, Darmstadt, Germany. Under terms of the agreement, Intrexon will share the economic provisions of the collaboration, including an upfront payment, milestones and royalties, equally with ZIOPHARM. On July 31, 2015, ZIOPHARM received $57.5 million from Intrexon related to the upfront payment.

The collaboration’s first two CAR-T targets of interest were recently selected, and Intrexon and ZIOPHARM have initiated research and development efforts on these programs. The specific targets were not disclosed. Under the terms of the agreement, ZIOPHARM and Intrexon will also independently conduct research and development on other CAR-T candidates, with the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, having the opportunity to opt-in during clinical development.

ZIOPHARM’s other oncology programs, including those related to TCR and natural killer (NK) cells, continue to advance independently under its Exclusive Channel Collaboration (ECC) with Intrexon.

ZIOPHARM expects that results from its adoptive cell therapy programs, including data highlighting the advancement of the Sleeping Beauty non-viral gene transfer technology, will be presented at medical and scientific meetings prior to year end.

Corporate

In May 2015, ZIOPHARM announced the appointment of Dr. Cooper to the role of Chief Executive Officer. Dr. Cooper brings extensive experience in pioneering the development of adoptive cellular therapies in the field of oncology and translating immunology into clinical practice. Dr. Cooper joined ZIOPHARM from the University of Texas MD Anderson Cancer Center, where his appointments included tenured professor Pediatrics and Immunology; Section Chief Cell Therapy, Children’s Cancer Hospital; and Associate Director, Center for Cancer Immunology Research. Dr. Cooper is now a Visiting Scientist at MD Anderson.

In June 2015, the Company announced that Caesar J. Belbel, Executive Vice President, Chief Legal Officer and Secretary, had been appointed to the added role of Chief Operating Officer. Mr. Belbel joined ZIOPHARM Oncology in September 2011 as Executive Vice President and Chief Legal Officer. Mr. Belbel has over 25 years of experience in senior operational and corporate roles, with expertise in corporate strategy and management, mergers, acquisitions, divestitures and public and private financings.

Second-Quarter 2015 Financial Results

Net loss for the second quarter of 2015 was $14.2 million, or $(0.11) per share, compared to a net loss of $5.6 million, or $(0.06) per share, for the second quarter of 2014. Included in the loss for the second quarter of 2014 was non-cash income of $5.6 million, or $(0.06) per share for the change in fair value of warrants.

Research and development expenses were $7.4 million for the second quarter of 2015 compared to $8.3 million for the second quarter of 2014. The decrease of $0.9 million in research and development expenses is primarily attributable to reduced employee related and clinical study costs.

General and administrative expenses were $7.0 million for the second quarter of 2015 compared to $3.0 million for the second quarter of 2014. The increase of $4.0 million in general and administrative expenses is primarily attributable to non-cash equity compensation and other employee related expenses.

The Company ended the quarter with cash and cash equivalents of approximately $118.6 million. In addition, on July 31, 2015, the Company received $57.5 million from Intrexon related to the Merck Serono agreement. Given current development plans, the Company anticipates that current cash resources, including the recent cash payment received from Intrexon pursuant to the Merck Serono collaboration, will be sufficient to fund our planned operations into the first quarter of 2018.

(Filing, 10-Q, Manhattan Pharmaceuticals, AUG 10, 2015, View Source [SID:1234507160])

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