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 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 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 10, 2018 THERADIAG (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and theranostics, reported its consolidated annual results for the year ended December 31, 2017, approved by its Board of Directors on April 10, 2018, and its revenue to March 31, 2018 (Press release, Theradiag, APR 10, 2018, View Source;utm_medium=rss&utm_campaign=theradiag-reports-its-2017-annual-results-and-sales-for-first-quarter-2018 [SID1234525251]).

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"Having refocused our development efforts on our high value-added products, especially Lisa Tracker, we discontinued the Prestizia activity and reorganized our teams. Combined with the risks arising from our dispute with HOB Biotech and the termination of our agreements, this generated an exceptional loss in 2017", said Michel Finance, Theradiag’s CEO. "However, the results of our reorganization, the confirmation of first-quarter growth in our strategic activities, especially theranostics, and a solid financial position mean that we can look forward to 2018 with confidence and envisage a rapid return to breakeven while continuing to develop new partnerships."

As previously reported, Theradiag generated consolidated revenue of €9,058 K in the year to December 31, 2017, compared with €8,978 K in 2016. The sales of Lisa Tracker kits for routine use continue to grow strongly, rising by 20% in 2017, boosted by the partnerships concluded with pharmaceutical companies.

As in 2016, products developed in-house accounted for 75% of the company’s total sales.

Exports continued to grow as a proportion of sales, accounting for 51% of the total in 2017 as opposed to 46% in 2016.

The non-launch of BioCLIA, co-developed with HOB Biotech, impacted revenue growth in 2017.

Bottom line heavily impacted by non-recurring items
Before exceptional charges, Theradiag’s net loss in 2017 was close to that in 2016, excluding BioCLIA development costs. On the basis of the 2018 perimeter (i.e. without Prestizia and with the beneficial effects of the restructuring plan), the net loss excluding exceptional charges in 2017 would have been €850 K. Assuming moderate sales growth, the company’s new business structure and organization will bring it back to breakeven.

The net loss in 2017 was compounded by the company’s restructuring plan, which generated a charge of €423 K. As reported in December, the Board of Directors decided to discontinue the Prestizia research activity due to the absence of medium-term revenue prospects at the subsidiary and in order not to hamper the development of the rest of Theradiag’s activities. This had an impact of €1,655 K on the bottom line. In addition, as discussions on the renegotiation of agreements with the Chinese partner HOB Biotech are unfruitful, and following the termination of those agreements, Theradiag establishes a contingency provision of €1,637 K.

This generated an exceptional loss of €3,728 K (€2,224 K in exceptional charges and €1,504 K in amortization of goodwill for Prestizia) and a net loss of €5,959 K. The impact of these non-recurring items on the cash position was less than 30% of their total amount.

Excluding exceptional charges and with equivalent revenue, the net loss in 2017 would have been €2,236 K compared with a net loss of €2,112 K in 2016. The additional €124 K consisted mainly of costs associated with the development of BioCLIA.

Solid cash position
At December 31, 2017, Theradiag had available net cash of €5.16 million as opposed to €3.74 million at December 31, 2016, following the successful completion of a €4-million capital increase in May 2017.

2017 highlights: continuing development of theranostics

Launch on the US market of three new tests in the Lisa Tracker range
Further progress was made in bringing Lisa Tracker monitoring tests to the US market as part of the licensing agreement with Inform Diagnostics (formerly Miraca Life Sciences).

The Simponi (golimumab), Inflectra (infliximab-dyyb) and Renflexis (infliximab-abda) monitoring kits supplemented the InformTxTM range.

The only company in the US to supply the Cimzia (certolizumab pegol) and Stelara (ustekinumab) monitoring kits, Inform Diagnostics now offers the most extensive range of monitoring kits on the US market. Inform Diagnostics also continues to offer the Remicade (infliximab), Humira (adalimumab) and Entyvio (vedolizumab) monitoring kits.

Conclusion of agreements with pharmaceutical companies
Partnership agreement with Biogen
Theradiag has entered into a partnership agreement with Biogen to provide its Lisa Tracker kits for monitoring Flixabi (an infliximab biosimilar).

As a result, Biogen now supplies Lisa Tracker monitoring kits in the competitive tenders in which it participates in France and other European countries to optimize the treatment of patients receiving Flixabi.

Under this agreement, Theradiag is Biogen’s preferred supplier of infliximab monitoring kits. Theradiag will also handle implementation, provide training to laboratories in how to use kits and follow up clinicians’ requests concerning monitoring. Biogen has previously validated the use of Lisa Tracker kits for monitoring Flixabi.

Partnership agreement with MSD
Theradiag has signed a partnership with MSD France (Merck Sharp & Dohme) to supply its Lisa Tracker kits for the monitoring of Remicade.

Under this agreement, MSD France has referenced the Lisa Tracker monitoring kits to accompany the supply of Remicade. Kits are supplied under the conditions set out in the contracts won by MSD France to supply Remicade.

Theradiag will also handle implementation, provide training to laboratories in how to use kits and follow up clinicians’ requests concerning monitoring.

Highlights since year-end

Partnership agreement with Biogaran
Theradiag has entered into a partnership agreement with the pharma group Biogaran to supply its Lisa Tracker kits for monitoring Biogaran’s biosimilar drugs.

Under the agreement, Biogaran has referenced the Lisa Tracker monitoring kits in France to support the biosimilar drugs it supplies. Theradiag will handle implementation, provide training to laboratories in how to use kits and follow up clinicians’ requests concerning monitoring.

"Theradiag positions itself as pharmaceutical companies’ preferred supplier of monitoring kits with all infliximab biosimilars on the market. These partnership initiatives continued in 2018 with recently announced agreements. The interest shown by these leading pharma companies validates our expertise and our theranostic approach and is instrumental in leveraging our growth and enhancing our reputation", said Gérard Tobelem, Chairman of the Board of Directors.

Termination of agreements with HOB Biotech
Since the last press release dated February 20th, 2018, discussions between Theradiag and HOB Biotech continued but no agreement was reached. In this context, Theradiag has given notice to HOB Biotech that all agreements between the two companies are terminated, on the grounds of contractual breaches identified but not remedied by HOB Biotech. Consequently, these agreements are now terminated. Theradiag will take all legal means to be indemnified by HOB Biotech, because of its losses.

Theradiag generated consolidated revenue of €2.3 million in the first quarter of 2018, the same level as in the first quarter of 2017.

The theranostics business unit generated revenue of €1 million in the first quarter of 2018, compared with €1.1 million in the first quarter of 2017. Theranostics sales over the period consisted entirely of kits for routine use and were 8% higher than in both the first and the last quarters of 2017. There were no non-recurring theranostics sales to pharmaceutical partners, whereas substantial revenue was generated in the first quarter of 2017 as a result of an agreement with a pharmaceutical company.

Sales of kits for routine use have been boosted by the agreements concluded in 2016 and 2017.

IVD sales got off to a great start in the first quarter with growth of 13%.

On April 10, 2018 Illumina, Inc. (NASDAQ:ILMN) reported that it will issue results for first quarter 2018 following the close of market on Tuesday, April 24, 2018 (Press release, Illumina, APR 10, 2018, View Source [SID1234525252]).

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On the same day, at 2:00 pm Pacific Time (5:00 pm Eastern Time), Francis deSouza, President and Chief Executive Officer, and Sam Samad, Senior Vice President and Chief Financial Officer, will host a conference call with analysts, investors, and other interested parties to discuss financial and operating results.

Conference Call Details

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Tuesday, April 24, 2018. Interested parties may access the live teleconference through the Investor Relations section of Illumina’s web site under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 800-708-4539, or 1-847-619-6396 outside North America, both with passcode 46755682.

A replay of the conference call will be available from 4:30 pm Pacific Time (7:30 pm Eastern Time) on April 24, 2018 through May 1, 2018 by dialing 888-843-7419, or 1-630-652-3042 outside North America, both with passcode 46755682.