On April 4, 2018 Molecular Partners AG (ticker: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin therapies*, reported that new pre-clinical data from two of its pipeline candidates, MP0310 and its lead proprietary oncology drug MP0250, as well as the DARPin toolbox will be presented at the Annual Meeting 2018 of the American Association of Cancer Research (AACR) (Free AACR Whitepaper) in Chicago (Press release, Molecular Partners, APR 4, 2018, View Source [SID1234525191]).

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MP0310 targets simultaneously 4-1BB and FAP and is the first of a series of tumor-restricted agonists that only activate immune cells in the tumor and not in the rest of the body thereby allowing full activation and potentially opening the therapeutic window for combinations.

MP0250 is a phase 2 multi-DARPin candidate targeting simultaneously VEGF and HGF, two prominent escape pathways, and has the potential to reverse resistance that has built to standard of care cancer therapies.

The four abstracts to be presented include the most recent pre-clinical data of MP0310 as well as the rationale of MP0250 in EGFR mutated NSCLC (Non-small Cell Lung Cancer).

"We are very pleased with the progress of our portfolio showcasing the innovation power of the DARPin technology in the multi-specific biologics space," commented Michael T. Stumpp, Chief Scientific Officer. "With MP0250 and MP0310, we are moving forward with two candidates that have the potential to add significant patient benefit and support existing therapies."

The data will be presented in the following sessions under the following titles:

MP0310:
Tuesday, 17 April 2018, 8.00 am: PO.IM02.07 – Immunomodulatory Agents and Interventions 1: 3752 / 2 – Preclinical pharmacology of MP0310: A 4-1BB/FAP bispecific DARPin drug candidate promoting tumor-restricted T-cell co-stimulation (Link et al.)
Tuesday, 17 April 2018, 8.00 am: PO.TB07.01 – Cancer Imaging: Immunology and Systems Analysis in Vivo: 3029 / 2 – FAP-mediated tumor accumulation of a T-cell agonistic FAP/4-1BB DARPin drug candidate analyzed by SPECT/CT and quantitative biodistribution
(Reichen et al.)
Portfolio:
Tuesday, 17 April 2018, 1.00 pm: PO.CL06.05 – Immune Checkpoints 4: 4552 / 7 – Tumor-restricted immune modulation by multispecific molecules from the DARPin toolbox (Fiedler et al.)
MP0250:
Tuesday, 17 April 2018, 1.00 pm: PO.CT05 – Phase I/II, II, and III Trials in Progress: CT149 / 1 – MP0250, a VEGF- and HGF-blocking multi-DARPin drug candidate, in combination with tyrosine-kinase-inhibitors targeting EGFR-mutated NSCLC: Preclinical rationale and phase Ib/II study outline (Kiemle-Kallee et al.)
Full details on the Molecular Partners’ sessions at AACR (Free AACR Whitepaper) 2018 as well as all presentations can be found here. Following their presentation at the AACR (Free AACR Whitepaper), the posters will also be available one the Molecular Partners website.

About the DARPin Difference
DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin candidates are potent, specific, safe and very versatile. They can engage in more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.

With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin therapies have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin drug candidates in oncology. The most advanced global product candidate is abicipar, a molecule currently in Phase 3, in partnership with Allergan.

Several DARPin molecules for various ophthalmic indications are also in development. The most advanced systemic DARPin molecule, MP0250, is in Phase 1 clinical development for the treatment of solid tumors and in Phase 2 development for hematological tumors. In addition, Molecular Partners intends to further evaluate MP0250 for solid tumors in a phase 1b/2 trial for EGFR-mutated NSCLC. MP0274, the second-most advanced DARPin drug candidate in oncology, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 has moved into Phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin is a registered trademark owned by Molecular Partners AG.

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.

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 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and DarwinHealth reported they have entered into a research agreement providing Daiichi Sankyo with exclusive access to DarwinHealth’s proprietary novel cancer target database in order to identify potential new targets for cancer drug development (Press release, Daiichi Sankyo, APR 4, 2018, View Source [SID1234525189]).

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DarwinHealth’s proprietary database and technology were created to identify critical mechanisms linked to tumor dependencies and maintenance beyond genetic mutations, and include information on Master Regulators of specific tumor subtypes, as well as direct upstream modulators (both necessary for cancer cell maintenance) across more than 35 tumor and 90 tumor subtypes.

"The purpose of this agreement is to identify novel, high-value cancer targets that can subsequently be prioritized and undergo rigorous experimental validation to drive drug development for a new generation of anti-cancer therapies that would be designed, developed, and owned by Daiichi Sankyo," said Gideon Bosker, MD, Chief Executive Officer, DarwinHealth.

DarwinHealth will receive an upfront payment and has the potential to receive development and commercialization milestone payments should specified events occur relating to DarwinHealth’s novel cancer targets. Daiichi Sankyo will receive exclusive access to DarwinHealth’s novel cancer target database for a predetermined amount of time with an option to extend. Financial terms of the agreement were not disclosed.

We believe that the combination of both molecular and computational techniques used by DarwinHealth coupled with the expertise of our scientists in designing small molecules and antibodies may offer a disruptive approach to accelerating the discovery of precision-medicine cancer compounds," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "This new agreement is a natural next step in expanding our current ongoing translational research collaboration and we look forward to working with DarwinHealth to further science to create meaningful treatments for patients with cancer."

"The novel cancer targets will be selected and prioritized based on their role as either Master Regulators (MRs) or their most specific Master Regulator Upstream Modulators (MRUMs) within a tumor-specific checkpoint module," said Professor Andrea Califano, Co-Founder and Chairman of Scientific and Medical Advisory Board, DarwinHealth. "Therefore, they are expected to represent highly valuable targets for anti-tumor therapy, cancer drug design, and preclinical development."

On April 4, 2018 Boehringer Ingelheim and OSE Immunotherapeutics, a biotechnology company focused on the development of innovative immunotherapies, reported a collaboration and exclusive worldwide collaboration and license agreement to jointly develop OSE-172, a SIRP-alpha antagonist targeting myeloid lineage cells (Press release, Boehringer Ingelheim, APR 4, 2018, View Source [SID1234525184]).

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SIRP-alpha is a receptor expressed by myeloid lineage cells such as Dendritic Cells (DCs), tumor-associated macrophages (TAMs) and Myeloid-Derived Suppressor Cells (MDSCs). In targeting SIRP- alpha, OSE-172 prevents the ligand CD47 from binding to and triggering the cellular inhibitory effects of SIRP-alpha. OSE-172 has the potential to enhance anti-tumor immunity by improving T cell activity through enhancement of DC antigen presentation functionality, potentiating the phagocytic and inflammatory properties of macrophages in the tumor microenvironment and enabling differentiation of MDSCs to an effector state.

"This partnership with Boehringer Ingelheim is a real recognition of the value of our innovative approach to treating cancer and will create an exciting new alliance to fuel the phase 1 development of OSE-172," said Dr. Dominique Costantini, CEO of OSE Immunotherapeutics. "Boehringer Ingelheim’s expertise and insights will be invaluable as we step up the clinical development and work to commercialize this new treatment paradigm."

"We are excited to partner with OSE Immunotherapeutics to develop this promising, novel cancer immunotherapy," said Jonathon Sedgwick, Ph.D., Global Head Cancer Immunology & Immune Modulation Research at Boehringer Ingelheim. "A key area of focus is the identification of drugs that target myeloid cell immune regulatory receptors of which SIRP-alpha is a leading example. We are dedicated to developing ground-breaking, first-in-class therapies that can transform the lives of patients and help win the fight against cancer."

Boehringer Ingelheim has acquired the global rights to develop, register and commercialize OSE-172, a monoclonal antibody targeting SIRP-alpha which is expressed in myeloid lineage cells, as part of their continued commitment to research and innovation in immuno-oncology. Under the terms of the agreement, OSE Immunotherapeutics will receive a €15 million upfront payment from Boehringer Ingelheim, and potential additional short-term milestones of up to €15 million upon initiation of a phase 1 clinical study. OSE Immunotherapeutics stands to receive more than €1.1 billion upon reaching pre-specified development, commercialization and sales milestones, plus royalties on worldwide net sales