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 9, 2018 Amgen (NASDAQ:AMGN) reported that new pre-clinical data for several of its novel investigational oncology candidates will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, April 14-18, 2018 (Press release, Amgen, APR 9, 2018, View Source;p=RssLanding&cat=news&id=2341642 [SID1234525232]). Data spans Amgen’s early pipeline, including the first presentation of data for its most advanced chimeric antigen receptor (CAR) T cell therapy programs, targeting DLL3 in small cell lung cancer and FLT3 in acute myeloid leukemia (AML). In addition, pre-clinical data for Amgen’s DLL3 CAR T cell therapy and bispecific T cell engager (BiTE) program will be featured in an oral presentation.

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"As part of our overarching research and development strategy, Amgen is committed to advancing multiple modalities to gain biological insights before selecting the optimal treatment approach," said David M. Reese, M.D., senior vice president of Translational Sciences and Oncology at Amgen. "With a variety of tools in our toolkit, we have the ability to comprehensively evaluate these novel approaches to determine how each may perform in different treatment settings. We look forward to seeing how the pre-clinical data ultimately translate in the clinic."

Research presented at the meeting will also include pre-clinical studies examining pharmacodynamic markers for Mcl-1 inhibition, as well as the combination of Amgen’s Mcl-1 inhibitor (AMG 176) with a selective BCL-2 inhibitor in models of AML. AMG 176 is a highly selective and reversible Mcl-1 inhibitor and is being studied in a Phase 1 clinical trial involving patients with relapsed or refractory AML or multiple myeloma. Studies have shown that hematologic malignancies including AML, multiple myeloma and non-Hodgkin lymphoma are particularly sensitive to Mcl-1 inhibition.

In addition, Amgen will present for the first time pre-clinical data evaluating its half-life extended (HLE) anti-BCMA BiTE for the treatment of multiple myeloma. A phase 1 study evaluating Amgen’s anti-BCMA HLE-BiTE (AMG 701) is ongoing.

With the exception of late-breaking research, abstracts are available and can be reviewed on the AACR (Free AACR Whitepaper) website at View Source Identified below are select abstracts of interest on Amgen research:

Immuno-oncology

Targeting DLL3 with BiTE antibody constructs and cell-based therapies for the treatment of SCLC
Abstract #DDT02, Oral Presentation, Sunday, April 15 from 3:24-3:48 p.m. CT at McCormick Place South (Level 1), Room S103
Generation and evaluation of a FLT3 CAR-T cell therapy for the treatment of acute myeloid leukemia
Abstract #2559/18, Poster Session, Monday, April 16 from 1-5 p.m. CT at McCormick Place, Exhibit Hall A, Poster Section 24
Cynomolgus monkey plasma cell gene signature to quantify the in vivo activity of a half-life extended anti-BCMA BiTE for the treatment of multiple myeloma
Abstract #LB-299/21, Poster Presentation, Tuesday, April 17 from 1-5 p.m. CT at McCormick Place, Exhibit Hall A, Poster Section 44
Mcl-1 Inhibition

The utilization of a human MCL-1 knock-in mouse suggests that reductions in B-cells and monocytes may serve as clinically relevant pharmacodynamic markers of MCL-1 inhibition
Abstract #2978, Oral Presentation, Monday, April 16 from 4:35-4:50 p.m. CT at McCormick Place North (Level 4), Room N427
Combined inhibition of MCL-1 and BCL-2 with AMG 176 and venetoclax induces apoptosis and tumor regression in models of acute myeloid leukemia
Abstract #3972/6, Poster Session, Tuesday, April 17 from 8 a.m.-noon CT at McCormick Place, Exhibit Hall A, Poster Section 41
About CAR T Cell Therapy
CAR T cell therapy is an evolving area of personalized medicine in which a patient’s own T cells (a type of white blood cell) are engineered to recognize tumor-specific antigens and incite an immune system attack against the cancer cells. Amgen is exploring the application of CAR T cell therapy across hematologic and solid tumor malignancies. Amgen and Kite Pharma, a subsidiary of Gilead Sciences Inc., are collaborating on engineering and commercializing Car T cell therapies.

About BiTE Technology
Bispecific T cell engager (BiTE) antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the body’s immune system to detect and target malignant cells. The modified antibodies are designed to bridge T cells to tumor cells, using the patient’s own immune system to eradicate cancer. BiTE antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE antibody constructs are currently being investigated for their potential to treat a wide variety of cancers.

About Amgen’s Commitment to Oncology
Amgen Oncology is committed to helping patients take on some of the toughest cancers, such as those that have been resistant to drugs, those that progress rapidly through the body and those where limited treatment options exist. Amgen’s supportive care treatments help patients combat certain side effects of strong chemotherapy, and our targeted medicines and immunotherapies focus on more than a dozen different malignancies, ranging from blood cancers to solid tumors. With decades of experience providing therapies for cancer patients, Amgen continues to grow its portfolio of innovative and biosimilar oncology medicines.

On April 9, 2018 Morphotek, Inc., a subsidiary of Eisai Inc., reported that it licensed its eribulin-linker payload to Bliss Biopharmaceutical Co., Ltd. (BlissBio) of China (Press release, Morphotek, APR 9, 2018, View Source [SID1234527215]). The licensing agreement grants BlissBio the exclusive right to use the eribulin-linker payload to develop a therapeutic ADC against an undisclosed oncology target for the China market. The licensing agreement includes an upfront payment, milestones and sales royalty payments, which are undisclosed. BlissBio has an exclusivity option to expand the territory beyond China to the global market and to develop therapeutic ADCs to two additional undisclosed oncology targets.

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Morphotek’s ADC Services offer third parties the opportunity to license the proprietary eribulin-linker payload to develop investigational ADCs using either Morphotek’s REsidue-SPEcific Conjugation Technology (RESPECT) or an alternative approach to conjugation. The eribulin-linker payload consists of a cytotoxic agent, eribulin, modified by a chemical linker to facilitate optimal conjugation. Eribulin’s anti-tumor activity is mediated by the inhibition of microtubule elongation and mitotic spindle formation, resulting in apoptosis. Eribulin mesylate, marketed as Halaven, is approved in the U.S. for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease, including an anthracycline and a taxane in either the adjuvant or metastatic setting.

Our end-to-end ADC Services provide multiple entry points for clients, starting from development of an antigen site-specific bioconjugate-ready monoclonal antibody and ADC through in vivo safety and efficacy validation. Additional options include manufacture of GMP clinical trial material, GLP toxicology studies and development of immunohistochemistry (IHC) companion diagnostics for patient screening. For more information on Morphotek’s ADC Services business and RESPECT platform, please contact [email protected].

*The ADCs described herein are investigational, as efficacy and safety have not been established. There is no guarantee that the ADCs will be available commercially.

On April 9, 2018 OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, reported that five posters will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting to be held April 14-18, 2018, in Chicago (Press release, OncoMed, APR 9, 2018, View Source [SID1234525233]). Among the presentations will be preclinical data for OncoMed’s novel anti-TIGIT (OMP-313M32) immuno-oncology program, which is currently in a Phase 1a single-agent clinical study. Preclinical data for OncoMed’s differentiated clinical-stage GITRL-Fc (OMP-336B11) program will also be featured. In addition, preclinical immuno-oncology data for OncoMed’s Wnt antagonist vantictumab (anti-FZD, OMP-18R5) in combination with immune checkpoint inhibitors will be presented.

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Details on the poster presentations are provided below:

Poster 20; Abstract 70: Effect of aging on the antitumor activity of GITRL-Fc
Session: Tumor Biology, Dormancy and Aging: The Influential Microenvironment
Date and Time: Sunday Apr 15, 2018 1:00 PM – 5:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 3

Poster 28; Abstract 1733: Wnt antagonists synergize with immune checkpoint inhibitors to enhance anti-tumor responses
Session: Immunology, Immune Responses to Therapies 2
Date and Time: Monday Apr 16, 2018 8:00 AM – 12:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 32

Poster 18; Abstract 2726: In vitro functional activity of OMP-336B11, a GITRL-Fc fusion protein, on primary human immune cells
Session: Immunology, Immune Checkpoints 2
Date and Time: Monday Apr 16, 2018 1:00 PM – 5:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 32

Poster 16; Abstract 3826: GITRL-Fc biomarker and mechanism study: GITRL-Fc reduces Treg frequency in tumors and requires effector function for inhibition of tumor growth
Session: Immunology, Therapeutic Antibodies, Including Engineered Antibodies 3
Date and Time: Tuesday Apr 17, 2018 8:00 AM – 12:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 34

Poster 22; Abstract 5627: Anti-TIGIT biomarker study: Inhibition of TIGIT induces loss of Tregs from tumors and requires effector function for tumor growth inhibition
Session: Clinical Research, Therapeutic Antibodies, Including Engineered Antibodies 4
Date and Time: Wednesday Apr 18, 2018 8:00 AM – 12:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 28

Following the presentations, the posters will be available on the Pipeline section of OncoMed’s website, www.oncomed.com.

Additional information on the meeting can be found on the AACR (Free AACR Whitepaper) website www.aacr.org

On September 9, 2018 Allogene Therapeutics, Inc. (Allogene) reported the completion of the previously announced transaction between Pfizer Inc. (NYSE: PFE) and Allogene for Pfizer’s portfolio of assets related to allogeneic chimeric antigen receptor T cell (CAR T) therapy, an investigational immune cell therapy approach to treating cancer (Press release, Allogene, SEP 9, 2018, View Source [SID1234529314]).

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On April 3, 2018, Allogene and Pfizer announced that the companies had entered into a definitive asset contribution agreement for Pfizer’s allogeneic CAR T portfolio .As a result of the completed agreement, Allogene has received from Pfizer the rights to 16 preclinical CAR T assets licensed from Cellectis and Servier and one clinical asset licensed from Servier,UCART19, an allogeneic CAR T therapy that is being developed for treatment of CD19- expressing hematological malignancies. In partnership with Servier, UCART19 is initially being developed in acute lymphoblastic leukemia (ALL) and is currently in Phase 1.UCART19 utilizesTALEN gene editing technology pioneered and owned by Cellectis.

With the agreement completed, Allogene is well-positioned to rapidly advance the portfolio of CAR T assets contributed by Pfizer into potential innovative new therapies,and ultimately to reach patients in need more quickly."The completion of our agreement with Pfizer represents a bold undertaking by leaders in the field to expedite the development of the next wave of cancer immunotherapies," said David Chang, M.D., Ph.D., President and Chief Executive Officer of Allogene.

Pfizer will continue to participate financially in the CAR T portfolio’s development through a 25 percent ownership stake in Allogene. Prior to the agreement’s completion, Gilead Sciences joined Allogene’s premier Series A investment consortium that already included TPG, Vida Ventures, BellCo Capital, the University of California Office of the Chief Investment Officer, and Pfizer, among others.

Centerview Partners acted as financial advisor to Pfizer, with Ropes & Gray LLP acting as its legal advisor. Coole. LLP served as legal counsel to Allogene, Vida Ventures and TPG. Gibson Dunn & Crutcher LLP also served as legal counsel to TPG.