On April 11, 2018 Tarveda Therapeutics, Inc., a clinical stage biopharmaceutical company discovering and developing Pentarins as a new class of potent and selective cancer medicines, reported that the company will present preclinical data related to PEN-866 at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, occurring April 14-18, 2018 in Chicago, IL (Press release, Tarveda Therapeutics,APR 11, 2018, View Source [SID1234525272]). PEN-866 is a miniature drug conjugate designed to treat patients with solid tumor types known to be sensitive to topoisomerase 1 inhibitors such as SN-38, the payload of PEN-866. The presentation will address the combination of PEN-866 with PARP inhibitors in models of ovarian cancer, lung cancer and colorectal cancer.

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Details of the poster presentation are as follows:

Title: Combination of the miniature drug conjugate PEN-866 with PARP inhibitors as a rational approach to overcoming limitations of PARP inhibitor monotherapy
Date:

April 18, 2018
Time:

8:00 AM – 12:00 PM CT
Location:

Section 37, McCormick Place North/South, Chicago, IL

About PEN-866
PEN-866 exploits the activation of Heat Shock Protein 90 (HSP90) in tumors to accumulate and release its potent anti-cancer payload, SN-38. PEN-866 is a miniature conjugate that comprises a small molecule, HSP90-targeting ligand linked to SN-38, the active metabolite of irinotecan. The conjugate accumulates and is retained in tumors, and by way of a sustained release of SN-38, causes prolonged DNA damage and tumor regressions in multiple patient-derived and other xenograft tumor models.

About Pentarins
Tarveda is developing Pentarins, potent and selective miniature drug conjugates with high affinity for specific cell surface and intracellular targets. Pentarins are engineered to bind to their tumor cell targets and provide sustained release of their potent therapeutic payloads deep into solid tumor tissue. Comprised of a targeting ligand conjugated to a potent cancer cell killing agent through a tuned chemical linker, Pentarins are designed to overcome the deficits of both larger antibody drug conjugates and small molecules that limit their therapeutic effectiveness against solid tumors. Together, the components of Tarveda’s Pentarins have distinct, yet synergistic, anticancer attributes: the small size of Pentarins allows for rapid and deep penetration into the tumor tissue, the ligand’s targeting ability allows for specific binding and retention in tumor cells, and the chemical linker is tuned to optimize the release of the potent, cell killing payload inside the cancer cells for efficacy.

On April 11, 2018 ADC Therapeutics (ADCT), an oncology drug discovery and development company that specializes in the development of proprietary Antibody Drug Conjugates (ADCs) targeting major cancers, reported its presence at the Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) taking place April 14-18, 2018 in Chicago, USA (Press release, ADC Therapeutics, APR 11, 2018, View Source [SID1234525271]). Two poster presentations will highlight strong preclinical data for its two new investigational programs ADCT-601 targeting AXL and ADCT-701 targeting DLK-1. In addition, Dr. Jaewoong Lee, of The Beckman Institute of the City of Hope will make an oral presentation on novel preclinical data for ADCT-301 targeting CD25.

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"Our two new investigational programs show compelling efficacy and safety in preclinical studies," said Dr. Jay Feingold, Chief Medical Officer and Senior Vice President of Clinical Development at ADCT. "These results provide an important step to advance ADCT-601 and ADCT-701 into the clinic and enlarge our pipeline of PBD-based ADCs in multiple ongoing clinical trials for the treatment of both solid and hematological cancers."

Poster titles and highlights of the data that will be presented are available on the AACR (Free AACR Whitepaper) conference website at www.aacr.org and include the following:

ADCT-701, a novel pyrrolobenzodiazepine (PBD) dimer-based antibody-drug conjugate (ADC) targeting DLK1-expressing tumors Abstract #744, April 15, 1:00 pm – 5:00 pm CT

– ADCT-701 is an ADC composed of a humanized IgG1 antibody against human DLK1, site-specifically conjugated using GlycoConnectTM technology to PL1601, which contains a valine-alanine cleavable linker and the PBD dimer cytotoxin SG3199.

– ADCT-701 demonstrated potent and specific in vitro and in vivo anti-tumor activity in DLK1-expressing cancer-derived models and it was stable and well tolerated in rats.

Preclinical activity of ADCT-601, a novel pyrrolobenzodiazepine (PBD) dimer-based antibody-drug conjugate (ADC) targeting AXL-expressing tumors Abstract #2792A, April 16, 1:00 pm – 5:00 pm CT

– ADCT-601 is an ADC composed of a humanized IgG1 antibody against human AXL, site-specifically conjugated using GlycoConnectTM technology to PL1601, which contains a valine-alanine cleavable linker and the PBD dimer cytotoxin SG3199.

– ADCT-601 demonstrated potent and specific in vitro and in vivo anti-tumor activity in various cancer-derived models with different levels of membranous AXL, and it was stable and well tolerated in rats.

CD25 enables oncogenic BCR- and TCR-signaling and represents a therapeutic target in lymphoblastic malignancies Abstract #2983, April 16, 2018, 4:05 PM – 4:20 PM

– Novel data identifies CD25 as a previously unrecognized feedback regulator of oncogenic B/TCR-signaling supporting CD25 as a therapeutic target in refractory lymphoid malignancies.

– ADCT-301 demonstrated durable remissions in patient-derived Ph+ ALL cells PDX models

On April 11, 2018 Lytix Biopharma Reported that it will present data at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place from 14th – 18th April 2018 at McCormick Place North/South, Chicago, Illinois, US (Press release, Lytix Biopharma, APR 11, 2018, View Source
[SID1234525270]).

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Dr Mikael J. Pittet, Associate Professor at Harvard Medical School, Senior Faculty of the Center for Systems Biology (CSB) at Massachusetts General Hospital (MGH) and Director of the CSB Cancer Immunology Program will present the data in a poster presentation from 8-12 am on Wednesday April 18. Previous experimental studies identified LTX-315’s ability to control cancer in mice grafted with various tumor cell lines triggering tumor-specific T cells. The analyses has now been extended to conditional genetic mouse models of both melanoma (driven by Braf and Pten alterations) and soft tissue sarcoma (driven by Kras and P53 alterations). In these genetic models, cancer cells are derived from somatic cells that are transformed in their normal tissue microenvironment and progress to high-grade tumors that are poorly infiltrated by T cells and typically resist prescribed chemo- and immunotherapeutic treatments.

"We are excited to present this data at AACR (Free AACR Whitepaper) in conjunction with Dr Pittet’s team which shows that LTX-315 not only delays tumor progression substantially in both models, but also profoundly alters the tumor microenvironment, most notably characterized with CD8+ T cell, NK cell and dendritic cell infiltration. A similar transition from a ‘cold’ to a ‘hot’ tumor microenvironment is seen in patients with melanoma, sarcoma and breast cancer after treatment with LTX-315. Furthermore, CD8+ T cell depletion in mice abrogated long-term antitumor efficacy of LTX-315, indicating that these cells are required for drug-induced tumor control. Importantly, the ability to convert non-T-cell-infiltrated tumors into ones that display antitumor T cell immunity opens the possibility to prime and make unresponsive tumors sensitive for systemic immune treatments," commented Dr Edwin Klumper, CEO of Lytix Biopharma.

View Source!/4562/presentation/8122

April 18, 2018, 8:00 AM – 12:00 PM
Section 25 Session PO.CL06.08 – Immunomodulatory Agents and Interventions 3

5549 / 5 – Antitumor efficacy of the oncolytic peptide LTX-315 in genetic mouse models that resist conventional chemo- and immunotherapeutic treatments

M. J. Pittet1, H-W. Liao1, B. Sveinbjørnsson2, Ø. Rekdal2; 1Massachusetts Gen. Hosp., Boston, MA, 2Lytix Biopharma, Tromso, Norway

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.

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.