On April 12, 2018 ImmunoCellular Therapeutics, Ltd. ("ImmunoCellular" or the Company) (NYSE American: IMUC) reported that it has been able to verify successful transfer of the selected T cell receptor genetic material into human hematopoietic stem cells (Press release, ImmunoCellular Therapeutics, APR 12, 2018, View Source [SID1234525479]). This milestone represents the next important step in validating the Stem-to-T-Cell approach, and is a key component of the proof-of-concept work for this technology. This achievement is a key next step to begin preclinical testing. ImmunoCellular’s Stem-to-T-Cell technology is designed to stimulate the patient’s immune system to produce an unlimited supply of killer T cells that specifically target and destroy tumor cells with minimal side effects.

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ImmunoCellular Therapeutics Logo. (PRNewsFoto/ImmunoCellular Therapeutics) (PRNewsFoto/IMMUNOCELLULAR THERAPEUTICS)

At the end of 2017, the research team at ImmunoCellular successfully transfected genetic material into human hematopoietic stem cells. That work was the basis for this most recent achievement. Successful completion of this phase of work enables the Company to begin preclinical testing in animals, which, if successful, could allow ImmunoCellular’s Stem-to-T-Cell technology to advance into human clinical testing.

"We are excited to have achieved this critical next milestone in our Stem-to-T-Cell program, and are excited to begin the preclinical animal testing that can lay the foundation for potentially proceeding toward conducting human clinical trials," said Steven J. Swanson, PhD, Senior Vice President, Research. "We and our collaborators are now working to design and implement the necessary animal studies to complete our proof-of-concept work. Our vision is to develop solutions for intractable cancers, extend the lives of cancer patients, and provide hope for a potential cure. We believe that our Stem-to-T-Cell program is potentially a game-changing treatment for cancer, and could be effective in treating many types of cancers."

Anthony J. Gringeri, PhD, President and Chief Executive Officer commented: "We are pleased with the productivity and achievements to date of our research team and the continued generation of scientific validation of our Stem-to-T-Cell program. Continued testing of our novel immuno-oncology technology may elucidate how it can be applied in a real-world therapeutic setting, and lead the way toward conducting clinical trials, including potential exploration of combination with other approaches. From a corporate perspective, we are pleased with our ability to achieve our research goals while continuing to operate in a cost-efficient manner. We are also continuing to explore potential collaborations for our clinical programs and other strategic alternatives for our Company."

About ImmunoCellular’s Stem-to-T-Cell Program

Based on the technology in-licensed from The California Institute of Technology in 2014 ImmunoCellular’s Stem-to-T-Cell program is designed to harness the power of the immune system in highly directed and specific ways to engineer highly antigen-specific tumor killing. At the core of the Stem-to-T-Cell technology is the harvesting of stem cells from cancer patients and then cloning into them T cell receptors that are specific for cancer cells. These engineered stem cells can then be reintroduced into the patient and are pre-programed to produce daughter cells that are antigen specific killer T cells that are capable of identifying, binding to, and killing cancer cells. Because stem cells are immortal, these reengineered stem cells could provide a natural and perpetual source of T cells that can target and destroy cancer cells in the patient.

The Stem-to-T-Cell platform has the potential to address many types of cancer, including both solid and hematological tumors and has the potential to result in a potentially curative therapy for many different types of cancers. The stem cell platform represents a novel and more direct approach to generating killer T cells by using the patient’s stem cells as starting material. Thus, ImmunoCellular’s Stem-to-T-Cell technology shares some similarities with other immuno-oncology technologies, such as CAR-T, and could potentially be used in combination approaches. Unlike CAR-T therapies which deliver a large bolus of active T cells into the patient’s circulation and have been associated with toxicity in some patients, ImmunoCellular’s approach enables a more gradual and measured release of killer T cells and has the potential for lower toxicity while also yielding a more sustained response.

On April 12, 2018 Jounce Therapeutics, Inc. (NASDAQ:JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers for patient enrichment, reported that its nonclinical translational data will be presented in two posters at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, Illinois from April 14-18, 2018 (Press release, Jounce Therapeutics, APR 12, 2018, View Source;p=RssLanding&cat=news&id=2342263 [SID1234525282]).

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"The data presented at AACR (Free AACR Whitepaper) for gastric cancer and triple negative breast cancer provides an example of the way in which we use the Jounce Translational Science Platform to interrogate the cellular microenvironment within the tumor to explore potential biomarkers. These data, focused on our ICOS agonist antibody program, JTX-2011, help inform our clinical development strategy," said Deborah Law, D. Phil., chief scientific officer of Jounce Therapeutics.

Details on the posters are as follows:

Genomics based studies of gastric tumors identify ICOS as potential target for therapeutic intervention
Session Title: Immune Checkpoints 1
Location: McCormick Place South, Exhibit Hall A, Poster Section 31
Date and Time: Monday Apr 16, 2018 from 8:00 AM – 12:00 PM CT
Poster Board Number: 10; Permanent Abstract Number: 1685

Integrated genomics and histology based studies of triple negative breast cancer identify ICOS as potential target for therapeutic intervention
Session Title: Immune Checkpoints 1
Location: McCormick Place South, Exhibit Hall A, Poster Section 31
Date and Time: Monday Apr 16, 2018 from 8:00 AM – 12:00 PM CT
Poster Board Number: 3; Permanent Abstract Number: 1678

The posters will be available on the "Investors and Media" section of the Jounce Therapeutics website at www.jouncetx.com.

About JTX-2011
Jounce’s lead product candidate, JTX-2011, is a monoclonal antibody that binds to and activates ICOS, a protein on the surface of certain T cells. Preclinical data support that JTX-2011 may have a dual mechanism of action that stimulates anti-tumor T effector cells, and also reduces the immunosuppressive T regulatory cells in the tumor microenvironment. The company is developing JTX-2011 to treat solid tumors as a single agent and in combination with other therapies.

On April 12, 2018 Seattle Genetics, Inc. (Nasdaq: SGEN) reported data highlights from nine presentations showcasing the company’s innovative, proprietary antibody-drug conjugate (ADC) platform technologies as well as its emerging immuno-oncology pipeline (Press release, Seattle Genetics, APR 12, 2018, View Source;p=RssLanding&cat=news&id=2342255 [SID1234525283]). Data include preclinical and clinical advances with ADCETRIS (brentuximab vedotin), ladiratuzumab vedotin, SGN-CD48A and SGN-2FF. Additionally, Seattle Genetics will present the first preclinical data describing the novel empowered antibody SEA-BCMA. These data will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018 being held April 14-18, 2018 in Chicago.

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"We are an emerging multi-product company, advancing a substantial pipeline of targeted therapies for patients with solid tumors and blood cancers," said Dennis Benjamin, Ph.D., Senior Vice President of Research at Seattle Genetics. "New data featured in nine presentations underscore our commitment to scientific innovation and the needs of patients. These data presentations highlight the potential combination of ADCs with checkpoint inhibitors, novel ADC payloads, antibody masking technologies and progress with our immuno-oncology program, SGN-2FF. We are also presenting preclinical data for our new multiple myeloma program, SEA-BCMA, which has a phase 1 study scheduled to start this year."

Abstracts can be found at www.aacr.org and include the following:

An oral presentation and poster presentation on Sunday and Monday, April 15 and 16, 2018, respectively (Abstracts #930, 2803), will showcase preclinical data evaluating proprietary NAMPT inhibitors and auristatins as ADC payloads. The data show NAMPT inhibitors have a unique mechanism of action and encouraging therapeutic window. Preclinical data also describe the development of novel auristatin payloads with potential application across multiple tumor types.
An innovative approach to masking antibodies for tumor specific activation will be featured in a poster presentation on Sunday, April 15, 2018 (Abstract #250). Preclinical data demonstrate that coiled-coil masked antibodies and ADCs show improved tolerability and equivalent antitumor activity compared to unmasked counterparts. The data suggest this technology may be applied to a range of antibodies or ADCs and could enable their development against previously inaccessible cancer targets.
The novel preclinical program SEA-BCMA will be highlighted in a poster presentation on Tuesday, April 17, 2018 (Abstract #3833). The cell surface protein BCMA is expressed on cells of several cancer types, including multiple myeloma and other B cell malignancies. SEA-BCMA is an antibody empowered using Seattle Genetics’ proprietary Sugar Engineered Antibody (SEA) technology designed to enhance antibody effector functions. The preclinical data support initiation of a phase 1 trial for multiple myeloma, which is planned for 2018.
Clinical biomarker data from a phase 1 trial evaluating the novel immuno-oncology agent SGN-2FF in patients with advanced solid tumors will be shown in a poster presentation on Wednesday, April 18, 2018 (Abstract #5551). The preliminary data demonstrate the biological effects of SGN-2FF and support further development of this novel immuno-oncology agent.
Three poster presentations on Monday and Wednesday, April 16 and 18, 2018 (Abstracts #1789, 2742, and 5619) will highlight preclinical data evaluating the ability of ADCETRIS, ladiratuzumab vedotin and SGN-CD48A, each of which are auristatin-based ADCs, to elicit additional mechanisms of action, including immunogenic cell death. These data support clinical evaluation in combination with checkpoint inhibitors. ADCETRIS and ladiratuzumab vedotin are being evaluated in combination with checkpoint inhibitors in multiple ongoing clinical trials.

On April 11, 2018 Exelixis, Inc. (NASDAQ: EXEL) reported that its first quarter 2018 financial results will be released on Wednesday, May 2, 2018 after the markets close (Press release, Exelixis, APR 11, 2018, View Source;p=RssLanding&cat=news&id=2342154 [SID1234525268]). At 5:00 p.m. EDT / 2:00 p.m. PDT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update. Access to the event is available via the Internet from the company’s website.

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 7895176 to join by phone.

A telephone replay will be available until 8:30 p.m. EDT on May 4, 2018. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 7895176. A webcast replay will also be archived on www.exelixis.com for one year.

On April 11, 2018 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, and Medison Pharma Ltd., Israel’s leading commercial partner for innovative pharmaceuticals, reported an exclusive distribution agreement to commercialize ZEJULA (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, in Israel (Press release, TESARO, APR 11, 2018, View Source [SID1234525269]). ZEJULA is currently approved in the United States and Europe as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy, regardless of BRCA mutation or biomarker status.

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Under terms of the agreement, Medison will have the exclusive right to commercialize ZEJULA in all indications, excluding prostate cancer, in Israel. Medison will also be responsible for any potential patient access programs prior to regulatory approval. Further terms of the agreement were not disclosed.

"TESARO is committed to globalizing our mission, bringing transformative therapies to those facing cancer. This is an important step forward for us and the many patients in Israel who may benefit from ZEJULA," said Orlando Oliveira, Senior Vice President and General Manager, TESARO International. "We are proud to enter this agreement with Medison which, alongside a track record of bringing important therapies to patients across a number of oncology indications, offers a tremendous potential for collaboration as a source for innovation."

"We are excited about the opportunity to provide ZEJULA to cancer patients in our region. We plan to expedite access to ZEJULA via an early patient access program and will work closely with regulators to bring ZEJULA to patients here as quickly as possible," said Meir Jakobsohn, Founder and CEO, Medison Pharma. "Through our corporate venture arm with a dedicated research team, Medison partners with innovative biopharmaceutical companies, providing us access to best-in-class assets across a number of disease areas. We are happy to find in TESARO a partner that understands the mutual value which can be achieved through strategic collaboration."

ZEJULA is not currently approved for use in Israel.

About ZEJULA (Niraparib)
Niraparib is marketed in the United States and Europe under trade name ZEJULA. ZEJULA (niraparib) is a poly(ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. In preclinical studies, ZEJULA concentrates in the tumor relative to plasma, delivering greater than 90% durable inhibition of PARP 1/2 and a persistent antitumor effect.

ZEJULA is the most utilized PARP inhibitor among women with ovarian cancer in the U.S., with more than 4,000 patients treated in 2017. Following European Commission approval in November 2017, ZEJULA is the first and only PARP inhibitor in Europe authorized for marketing for the maintenance treatment of patients with recurrent ovarian cancer, regardless of BRCA mutation status. TESARO’s clinical development program for ZEJULA incorporates monotherapy and combination approaches for multiple tumor types including ovarian, breast, and lung cancer.

Janssen Biotech has licensed rights to develop and commercialize ZEJULA specifically for patients with prostate cancer worldwide, except in Japan. Takeda Pharmaceutical Company Limited has licensed rights for all potential indications for ZEJULA in Japan, as well as rights in South Korea, Taiwan, Russia and Australia, excluding prostate cancer. TESARO has an agreement with Zai Lab for the clinical development and co-marketing of ZEJULA in China.

ZEJULA Select Important Safety Information
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML) was reported in patients treated with ZEJULA in some clinical studies. Discontinue ZEJULA if MDS/AML is confirmed. Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia) have been reported in patients treated with ZEJULA. Do not start ZEJULA until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment, and periodically after this time.

Hypertension and hypertensive crisis have been reported in patients treated with ZEJULA. Monitor blood pressure and heart rate monthly for the first year and periodically thereafter during treatment with ZEJULA. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Based on its mechanism of action, ZEJULA can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment and for six months after receiving the final dose. Because of the potential for serious adverse reactions in breastfed infants from ZEJULA, advise a lactating woman not to breastfeed during treatment with ZEJULA and for one month after receiving the final dose.