On April 4, 2018 Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a late-stage clinical company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer, reported key pipeline progress and operating results for the quarter and year ended December 31, 2017 (Press release, Eleven Biotherapeutics, APR 4, 2018, View Source [SID1234525175]).

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"2017 was a year of significant developments for our company, and as we look ahead, I am highly encouraged by what we have already achieved in 2018. Vicinium, our lead product candidate, holds significant potential in treating a range of cancers, and is well underway in a registration trial for people with non-muscle invasive bladder cancer," said Stephen Hurly, president and chief executive officer of Eleven Biotherapeutics. "We recently completed enrollment in our Phase 3 VISTA trial, and we are pleased that initial data from the first patients in the VISTA trial were selected for an oral presentation at the American Urological Association Annual Meeting. 2018 is set to be a transformative year, and with the completion of our recent equity financing, we are capitalized to continue advancing Vicinium. We look forward to assessing its efficacy and safety in NMIBC, and exploring opportunities to expand its utility in other indications and in combination regimens."

Recent Pipeline and Corporate Highlights

On March 23, 2018, Eleven Biotherapeutics closed a $10.0 million equity financing priced at-the-market. This financing, coupled with the proceeds from the company’s $8.0 million public offering completed in November 2017, extends the company’s cash runway into the first quarter of 2019 based on its current operating plan.
In March 2018, Eleven Biotherapeutics announced that enrollment was completed in the company’s Phase 3 VISTA trial evaluating its lead product candidate, Vicinium, for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) who have been previously treated with bacillus Calmette-Guérin (BCG).
In December 2017, a trial at the US National Cancer Institute (NCI) of Vicinium in combination with AstraZeneca’s immune checkpoint inhibitor, Imfinzi (durvalumab), for the treatment of NMIBC opened.
In September 2017, Eleven Biotherapeutics completed the manufacturing of all Vicinium necessary for its ongoing trials.
Upcoming Data Presentations

Present Preclinical Data at AACR (Free AACR Whitepaper):Eleven Biotherapeutics will present preclinical data from its deBouganin program at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting during two poster sessions. The company’s systemically administered product candidates are designed using its proprietary de-immunized variant of the plant-derived cytotoxin bouganin, deBouganin. Details of the presentations are as following:
Poster Title: VB6-845d Tumor Cell Killing Elicits Biologic Features of Immunogenic Cell Death
Date and Time:April 16, 2018 from 1:00 to 5:00 p.m. CT
Poster Title: Engineering and Characterization of Anti-PSMA Humabody-DeBouganin Fusion Proteins
Date and Time: April 18, 2018 from 8:00 a.m. to 12:00 p.m. CT
Present Data from Phase 3 VISTA Trial at AUA Annual Meeting:Eleven Biotherapeutics will present the first, topline data from its Phase 3 VISTA trial of Vicinium in patients with NMIBC who have been previously treated with BCG during a plenary session at this year’s American Urological Association Annual Meeting being held in San Francisco. The data being presented are three-month data from an initial 75 patients in the trial. Details of the presentation are as follows:
Presentation Title: Phase 3 Study of Vicinium in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer: Initial Results
Date and Time:Monday, May 21, 2018 at 11:00 a.m. PT
Fourth Quarter and Full-Year 2017 Financial Results

Cash Position: Cash and cash equivalents were $14.7 million as of December 31, 2017, compared to $25.3 million as of December 31, 2016, a decrease of $10.6 million, which was primarily driven by $17.6 million in cash used by operating activities plus, $0.1 million in capital expenditures, partially offset by $7.1 million in cash provided through the November 2017 underwritten public offering.
Revenue: No revenue was recognized during the three months ended December 31, 2017, compared to $0.8 million for the same three-month period in 2016. Revenue was $0.4 million for the twelve months ended December 31, 2017, compared to $30.0 million for the same period in 2016. The decrease was primarily due to a decrease in license revenue as we recognized the upfront license fee and development milestone payment under the license agreement with Roche, relating to the execution of the license agreement and the successful submission of the IND application for EBI-031 during 2016, as well as a decrease in collaboration revenue from a terminated collaboration.
R&D Expenses: Research and development expenses were $3.1 million for the three months ended December 31, 2017, compared to $2.8 million for the same period in 2016. For the twelve months ended December 31, 2017 research and development expenses were $12.5 million compared to $13.5 million for the 2016 fiscal year. The decrease of $1.0 million was primarily due to a decrease in EBI-031 related development expenses of $3.0 million due to the license agreement with Roche in which Roche is responsible for all on-going development expenses, as well as a decrease of $1.7 million of isunakinra-related development expenses, which development activities are no longer ongoing. These decreases were partially offset by increases in Vicinium-related development expenses of $5.4 million, since the company’s acquisition of Viventia Bio Inc. (Viventia) in September 2016.
G&A Expenses: General and administrative expenses were $2.0 million for the three months ended December 31, 2017, compared to $2.8 million for the same period in 2016. For the twelve months ended December 31, 2017 general and administrative expenses were $8.1 million compared to $14.7 million for fiscal 2016. The decrease of $6.7 million was primarily due to a reduction of professional fees as well as salaries and related costs for personnel, including stock-based compensation. For the year ended December 31, 2016, the company had higher professional fees related to the license agreement with Roche, the company’s 2016 review of strategic alternatives and the acquisition of Viventia. In addition, for the year ended December 31, 2016, the company recorded higher severance costs related to the acquisition of Viventia.
Net Income (Loss): Net loss was $6.6 million, or $0.22 per share, for the three months ended December 31, 2017, compared to net loss of $3.5 million, or $0.15 per share, for the same period in 2016. Net loss was $29.0 million, or $1.11 per share, for the twelve months ended December 31, 2017, compared to net income of $1.9 million, or $0.09 per share, for the same period in 2016. Fiscal 2016 was benefited by approximately $30.0 million in revenue under the company’s license agreement with Roche while no comparable revenue was recognized during fiscal 2017.
Financial Guidance: Following Eleven Biotherapeutics’ recent $10.0 million equity financing in March 2018, the company expects to have capital to fund its current operating plans into the first quarter of 2019; however, we have based this estimate on assumptions that may prove to be wrong, and our capital resources may be utilized faster than we currently expect.
About Vicinium

Vicinium, Eleven Biotherapeutics’ lead product candidate, is a next-generation antibody-drug conjugate (ADC) developed using the company’s proprietary Targeted Protein Therapeutics platform. Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A (ETA). Vicinium is constructed with a stable, genetically engineered peptide linker to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical studies conducted by Eleven Biotherapeutics, EpCAM has been shown to be overexpressed in non-muscle invasive bladder cancer (NMIBC) cells with minimal to no EpCAM expression observed on normal bladder cells. Eleven Biotherapeutics is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicinium for the treatment of NMIBC in patients who have previously received two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Topline, three-month data from the trial are expected in mid-2018. Additionally, Eleven Biotherapeutics believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On April 4, 2018 Eleven Biotherapeutics, Inc. (NASDAQ: EBIO), a late-stage clinical company developing next-generation antibody-drug conjugate (ADC) therapies for the treatment of cancer, reported key pipeline progress and operating results for the quarter and year ended December 31, 2017 (Press release, Eleven Biotherapeutics, APR 4, 2018, View Source [SID1234525196]).

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"2017 was a year of significant developments for our company, and as we look ahead, I am highly encouraged by what we have already achieved in 2018. Vicinium, our lead product candidate, holds significant potential in treating a range of cancers, and is well underway in a registration trial for people with non-muscle invasive bladder cancer," said Stephen Hurly, president and chief executive officer of Eleven Biotherapeutics. "We recently completed enrollment in our Phase 3 VISTA trial, and we are pleased that initial data from the first patients in the VISTA trial were selected for an oral presentation at the American Urological Association Annual Meeting. 2018 is set to be a transformative year, and with the completion of our recent equity financing, we are capitalized to continue advancing Vicinium. We look forward to assessing its efficacy and safety in NMIBC, and exploring opportunities to expand its utility in other indications and in combination regimens."
Recent Pipeline and Corporate Highlights

On March 23, 2018, Eleven Biotherapeutics closed a $10.0 million equity financing priced at-the-market. This financing, coupled with the proceeds from the company’s $8.0 million public offering completed in November 2017, extends the company’s cash runway into the first quarter of 2019 based on its current operating plan.

In March 2018, Eleven Biotherapeutics announced that enrollment was completed in the company’s Phase 3 VISTA trial evaluating its lead product candidate, Vicinium, for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) who have been previously treated with bacillus Calmette-Guérin (BCG).

In December 2017, a trial at the US National Cancer Institute (NCI) of Vicinium in combination with AstraZeneca’s immune checkpoint inhibitor, Imfinzi (durvalumab), for the treatment of NMIBC opened.

In September 2017, Eleven Biotherapeutics completed the manufacturing of all Vicinium necessary for its ongoing trials.
Upcoming Data Presentations

Present Preclinical Data at AACR (Free AACR Whitepaper): Eleven Biotherapeutics will present preclinical data from its deBouganin program at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting during two poster sessions. The company’s systemically administered product candidates are designed using its proprietary de-immunized variant of the plant-derived cytotoxin bouganin, deBouganin. Details of the presentations are as following:

Poster Title: VB6-845d Tumor Cell Killing Elicits Biologic Features of Immunogenic Cell Death

Date and Time: April 16, 2018 from 1:00 to 5:00 p.m. CT

Poster Title: Engineering and Characterization of Anti-PSMA Humabody-DeBouganin Fusion Proteins

Date and Time: April 18, 2018 from 8:00 a.m. to 12:00 p.m. CT

Present Data from Phase 3 VISTA Trial at AUA Annual Meeting: Eleven Biotherapeutics will present the first, topline data from its Phase 3 VISTA trial of Vicinium in patients with NMIBC who have been previously treated with BCG during a plenary session at this year’s American Urological Association Annual Meeting being held in San Francisco. The data being presented are three-month data from an initial 75 patients in the trial. Details of the presentation are as follows:

Presentation Title: Phase 3 Study of Vicinium in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer: Initial Results

Date and Time: Monday, May 21, 2018 at 11:00 a.m. PT
Fourth Quarter and Full-Year 2017 Financial Results

Cash Position: Cash and cash equivalents were $14.7 million as of December 31, 2017, compared to $25.3 million as of December 31, 2016, a decrease of $10.6 million, which was primarily driven by $17.6 million in cash used by operating activities plus, $0.1 million in capital expenditures, partially offset by $7.1 million in cash provided through the November 2017 underwritten public offering.

Revenue: No revenue was recognized during the three months ended December 31, 2017, compared to $0.8 million for the same three-month period in 2016. Revenue was $0.4 million for the twelve months ended December 31, 2017, compared to $30.0 million for the same period in 2016. The decrease was primarily due to a decrease in license revenue as we recognized the upfront license fee and development milestone payment under the license agreement with Roche, relating to the execution of the license agreement and the successful submission of the IND application for EBI-031 during 2016, as well as a decrease in collaboration revenue from a terminated collaboration.

R&D Expenses: Research and development expenses were $3.1 million for the three months ended December 31, 2017, compared to $2.8 million for the same period in 2016. For the twelve months ended December 31, 2017 research and development expenses were $12.5 million compared to $13.5 million for the 2016 fiscal year. The decrease of $1.0 million was primarily due to a decrease in EBI-031 related development expenses of $3.0 million due to the license agreement with Roche in which Roche is responsible for all on-going development expenses, as well as a decrease of $1.7 million of isunakinra-related development expenses, which development activities are no longer ongoing. These decreases were partially offset by increases in Vicinium-related development

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expenses of $5.4 million, since the company’s acquisition of Viventia Bio Inc. (Viventia) in September 2016.

G&A Expenses: General and administrative expenses were $2.0 million for the three months ended December 31, 2017, compared to $2.8 million for the same period in 2016. For the twelve months ended December 31, 2017 general and administrative expenses were $8.1 million compared to $14.7 million for fiscal 2016. The decrease of $6.7 million was primarily due to a reduction of professional fees as well as salaries and related costs for personnel, including stock-based compensation. For the year ended December 31, 2016, the company had higher professional fees related to the license agreement with Roche, the company’s 2016 review of strategic alternatives and the acquisition of Viventia. In addition, for the year ended December 31, 2016, the company recorded higher severance costs related to the acquisition of Viventia.

Net Income (Loss): Net loss was $6.6 million, or $0.22 per share, for the three months ended December 31, 2017, compared to net loss of $3.5 million, or $0.15 per share, for the same period in 2016. Net loss was $29.0 million, or $1.11 per share, for the twelve months ended December 31, 2017, compared to net income of $1.9 million, or $0.09 per share, for the same period in 2016. Fiscal 2016 was benefited by approximately $30.0 million in revenue under the company’s license agreement with Roche while no comparable revenue was recognized during fiscal 2017.

Financial Guidance: Following Eleven Biotherapeutics’ recent $10.0 million equity financing in March 2018, the company expects to have capital to fund its current operating plans into the first quarter of 2019; however, we have based this estimate on assumptions that may prove to be wrong, and our capital resources may be utilized faster than we currently expect.
About Vicinium
Vicinium, Eleven Biotherapeutics’ lead product candidate, is a next-generation antibody-drug conjugate (ADC) developed using the company’s proprietary Targeted Protein Therapeutics platform. Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A (ETA). Vicinium is constructed with a stable, genetically engineered peptide linker to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical studies conducted by Eleven Biotherapeutics, EpCAM has been shown to be overexpressed in non-muscle invasive bladder cancer (NMIBC) cells with minimal to no EpCAM expression observed on normal bladder cells. Eleven Biotherapeutics is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicinium for the treatment of NMIBC in patients who have previously received two courses of bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Topline, three-month data from the trial are expected in mid-2018. Additionally, Eleven Biotherapeutics believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On April 4, 2018 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that interim clinical data from the ongoing Phase 1 clinical trial for LOXO-292, the company’s highly selective RET inhibitor, will be presented in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held June 1 – 5, 2018 in Chicago, Illinois (Press release, Loxo Oncology, APR 4, 2018, View Source [SID1234525176]). The presentation is entitled "A Phase 1 Study of LOXO-292, A Potent and Highly Selective RET Inhibitor, in Patients with RET-Altered Cancers."

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The Company will be hosting a conference call and webcast to discuss the data after they are presented at ASCO (Free ASCO Whitepaper). Details regarding the date and time of the presentation and webcast will be announced closer to the ASCO (Free ASCO Whitepaper) conference.

On April 4, 2018 Arvinas LLC, a private biotechnology company creating a new class of drugs based on protein degradation, reported the closing of a $55 million Series C financing (Press release, Arvinas, APR 4, 2018, View Source [SID1234529237]). The financing was led by new investor Nextech Invest, with participation from additional new investors Deerfield Management, Hillhouse Capital, and Sirona Capital. All existing investors also participated in this financing round, including Canaan Partners, 5AM Ventures, RA Capital Management, OrbiMed, and New Leaf Venture Partners.

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Proceeds from the financing will support the advancement of the Company’s two lead programs toward clinical investigation. The two programs, which target the androgen receptor for castration resistant prostate cancer and the estrogen receptor for ER+ positive breast cancer, both nominated orally available clinical candidates in the fourth quarter of 2017. These proceeds will also advance the Company’s early stage oncology pipeline, CNS pipeline, and efforts on undruggable targets.

"This past year has been exciting for us with two clinical candidate nominations, the expansion of our collaboration with Genentech and the announcement of a new collaboration with Pfizer," said John Houston, Ph.D., President and Chief Executive Officer of Arvinas. "With this additional financial support from existing and new investors who believe in our innovative protein degradation platform, we will continue executing on our strategy of progressing our lead programs to the clinic, expanding the use of the platform outside of oncology, and tackling undruggable targets."

In connection with the financing, Jakob Loven, Ph.D., partner with Nextech Invest, will join the Arvinas board of directors.

"The Arvinas PROTAC platform is an elegant, novel therapeutic modality that circumvents delivery challenges associated with existing therapeutic approaches to eliminate protein function, and Arvinas has proven to be the clear leader in developing a new era of targeted medicines using its protein degradation technology," said Dr. Loven.

The Company’s PROTAC Platform offers potential improvements over traditional small molecule inhibitors by using the cell’s natural and selective ubiquitin proteasome system to degrade disease-causing proteins. By removing target proteins directly rather than simply inhibiting them, PROTACs can provide multiple advantages over small molecule inhibitors which can require high systemic exposure to achieve sufficient inhibition, often resulting in toxic side effects and eventual drug resistance. With multiple protein targets, Arvinas’ PROTAC platform has demonstrated that a transient binding event at a range of binding sites and affinities can translate into very potent degradation of the target protein.

On April 4, 2018 Compugen Ltd. (NASDAQ: CGEN), a leader in predictive discovery and development of first-in-class therapeutics for cancer immunotherapy, reported it entered into an exclusive license agreement with MedImmune, the global biologics research and development arm of AstraZeneca, to enable the development of bi-specific and multi-specific immuno-oncology antibody products (Press release, Compugen, APR 4, 2018, View Source [SID1234525602]).

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Under the terms of the agreement, Compugen will provide an exclusive license to MedImmune for the development of bi-specific and multi-specific antibody products derived from a Compugen pipeline program. MedImmune has the right to create multiple products under this license and will be solely responsible for all research, development and commercial activities under the agreement. Compugen will receive a $10 million upfront payment and is eligible to receive up to $200 million in development, regulatory and commercial milestones for the first product as well as tiered royalties on future product sales. If additional products are developed, additional milestones and royalties would be due to Compugen. Compugen will retain all other rights to its entire pipeline of programs as monotherapies and in combination with other products.

"We are excited to announce our agreement with MedImmune, a global leader in the development of antibody-based oncology therapeutics," said Anat Cohen-Dayag, PhD, President and CEO of Compugen. "This licensing deal allows us to monetize specific scientific advances in our programs, while we continue to advance our lead programs into clinical trials." Dr. Cohen-Dayag added, "We are committed to our strategy of selectively collaborating with biopharmaceutical companies for the development of first-in-class products against our diverse, computationally-derived portfolio of targets."

"This agreement with Compugen will support our abilities to generate novel immunotherapy targets which, coupled with MedImmune’s expertise in antibody engineering, can advance our goal of delivering treatments to meaningfully improve the lives of cancer patients," said Ronald Herbst, Vice President, Oncology Research & Development, MedImmune.

Conference Call and Webcast Information

Compugen management will host a conference call today, April 2, 2018, at 8:30 a.m. ET to discuss the license agreement. To access the live conference call by telephone, please dial 1-800-994-4498 from the U.S. or +972-3-918-0608 internationally. The conference call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

About Bi-Specific and Multi-Specific Products

Antibodies are naturally occurring components of the immune system that bind specifically to a target protein via two identical arms. Through genetic engineering, antibodies can be modified to bind to different proteins through the two separate arms by exchanging one arm with that of another antibody with a different target specificity (bi-specific antibodies). Alternatively, additional features can be engineered into an antibody to allow binding to three or more target proteins simultaneously (multi-specific antibodies). These engineered forms of antibodies are increasingly being developed as therapeutics, as they enable multiple mechanisms of action for treating disease within a single molecule.