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 Pfizer Inc. reported that the independent Data Monitoring Committee for the Phase 3 ATLAS trial evaluating INLYTA (axitinib) as adjuvant therapy for patients at high risk of recurrent renal cell carcinoma (RCC) after nephrectomy recommended stopping the trial at a planned interim analysis due to futility (Press release, Pfizer, APR 10, 2018, View Source [SID1234525250]). The recommendation was based on the study failing to demonstrate a clear improvement in the primary endpoint of extending disease-free survival (DFS) for patients treated with INLYTA compared with patients treated with placebo. No new safety signals were observed, and the safety profile was consistent with the known profile of INLYTA in advanced RCC.

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"We are disappointed by the outcome of this study as we had hoped the efficacy that INLYTA has demonstrated as a second-line treatment in patients with advanced renal cell carcinoma would carry over to patients with earlier stage disease, where it would delay or prevent disease relapse. That goal was not achieved. We will conduct additional analyses on the data that may provide insight into this result. Studies evaluating INLYTA in combination with immune checkpoint inhibitors for patients with a variety of advanced stage cancers, including RCC, will continue," said Mace Rothenberg, M.D., Chief Development Officer, Oncology, Pfizer Global Product Development.

Detailed efficacy and safety data from ATLAS will be submitted for presentation at a future medical meeting.

INLYTA has had a significant impact on the treatment of patients with advanced RCC worldwide in its currently approved indications, supported by an extensive body of evidence in scientific literature including more than 50 publications. More than 66,000 patients have been treated with INLYTA to date.1 For more information on INLYTA, please visit www.INLYTA.com.

About RCC

Each year, approximately 338,000 new cases of kidney cancer are diagnosed worldwide, representing approximately 2-3 percent of all cancers.2,3,4 Renal cell carcinoma (RCC) is the most common type of kidney cancer, accounting for around 90 percent of cases.5 Approximately 75 percent of patients with clear cell RCC are non-metastatic, and 70-80 percent will have a nephrectomy with curative intent, or surgical removal of the tumor.6 However, a subset will relapse after surgery and once their disease becomes metastatic, their long-term prognosis is poor in advanced RCC with a 5-year survival rate as low as 12%.7

About ATLAS

ATLAS (A Randomized Double-Blind Phase 3 Study of Adjuvant Axitinib Versus Placebo in Subjects at High Risk of Recurrent RCC)(NCT01599754) is a global, multicenter, randomized double-blind Phase 3 trial that investigated the clinical efficacy and safety of adjuvant INLYTA (5 mg twice daily) versus placebo in patients (n=724) at high risk of recurrent RCC following nephrectomy. Patients were dosed up to 3 years (for a minimum of 1 year) in the study and the primary endpoint was disease-free survival (DFS). The study was conducted in collaboration with SFJ Pharmaceuticals, who provided the funding and clinical development supervision to generate the clinical data.

About INLYTA (axitinib)

INLYTA is an oral therapy that is designed to inhibit tyrosine kinases, including vascular endothelial growth factor (VEGF) receptors 1, 2 and 3; these receptors can influence tumor growth, vascular angiogenesis and progression of cancer (the spread of tumors). In the U.S., INLYTA is approved for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. INLYTA is also approved by the European Medicines Agency (EMA) for use in the EU in adult patients with advanced RCC after failure of prior treatment with sunitinib or a cytokine.

INLYTA Important Safety Information

Hypertension including hypertensive crisis has been observed. Blood pressure should be well controlled prior to initiating INLYTA. Monitor for hypertension and treat as needed. For persistent hypertension, despite use of antihypertensive medications, reduce the dose. Discontinue INLYTA if hypertension is severe and persistent despite use of antihypertensive therapy and dose reduction of INLYTA, and discontinuation should be considered if there is evidence of hypertensive crisis.

Arterial and venous thrombotic events have been observed and can be fatal. Use with caution in patients who are at increased risk or who have a history of these events.

Hemorrhagic events, including fatal events, have been reported. INLYTA has not been studied in patients with evidence of untreated brain metastasis or recent active gastrointestinal bleeding and should not be used in those patients. If any bleeding requires medical intervention, temporarily interrupt the INLYTA dose.

Cardiac failure has been observed and can be fatal. Monitor for signs or symptoms of cardiac failure throughout treatment with INLYTA. Management of cardiac failure may require permanent discontinuation of INLYTA.

Gastrointestinal perforation and fistula, including death, have occurred. Use with caution in patients at risk for gastrointestinal perforation or fistula. Monitor for symptoms of gastrointestinal perforation or fistula periodically throughout treatment.

Hypothyroidism requiring thyroid hormone replacement has been reported. Monitor thyroid function before initiation of, and periodically throughout, treatment.

No formal studies of the effect of INLYTA on wound healing have been conducted. Stop INLYTA at least 24 hours prior to scheduled surgery. Reversible Posterior Leukoencephalopathy Syndrome (RPLS) has been observed. If signs or symptoms occur, permanently discontinue treatment.

Monitor for proteinuria before initiation of, and periodically throughout, treatment. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment.

Liver enzyme elevation has been observed during treatment with INLYTA. Monitor ALT, AST, and bilirubin before initiation of, and periodically throughout, treatment.

For patients with moderate hepatic impairment, the starting dose should be decreased. INLYTA has not been studied in patients with severe hepatic impairment.

Women of childbearing potential should be advised of potential hazard to the fetus and to avoid becoming pregnant while receiving INLYTA.

Avoid strong CYP3A4/5 inhibitors. If unavoidable, reduce the dose. Grapefruit or grapefruit juice may also increase INLYTA plasma concentrations and should be avoided.

Avoid strong CYP3A4/5 inducers and, if possible, avoid moderate CYP3A4/5 inducers.

The most common (≥20%) adverse events (AEs) occurring in patients receiving INLYTA (all grades, vs sorafenib) were diarrhea (55% vs 53%), hypertension (40% vs 29%), fatigue (39% vs 32%), decreased appetite (34% vs 29%), nausea (32% vs 22%), dysphonia (31% vs 14%), hand-foot syndrome (27% vs 51%), weight decreased (25% vs 21%), vomiting (24% vs 17%), asthenia (21% vs 14%), and constipation (20% vs 20%).

The most common (≥10%) grade 3/4 AEs occurring in patients receiving INLYTA (vs sorafenib) were hypertension (16% vs 11%), diarrhea (11% vs 7%), and fatigue (11% vs 5%).

The most common (≥20%) lab abnormalities occurring in patients receiving INLYTA (all grades, vs sorafenib) included increased creatinine (55% vs 41%), decreased bicarbonate (44% vs 43%), hypocalcemia (39% vs 59%), decreased hemoglobin (35% vs 52%), decreased lymphocytes (absolute) (33% vs 36%), increased ALP (30% vs 34%), hyperglycemia (28% vs 23%), increased lipase (27% vs 46%), increased amylase (25% vs 33%), increased ALT (22% vs 22%), and increased AST (20% vs 25%).

For more information and full Prescribing Information, visit www.INLYTA.com.

About the SFJ Pharmaceuticals Group

SFJ is a global drug development company, which provides a unique and highly customized co-development partnering model for the world’s top pharmaceutical and biotechnology companies. SFJ provides at-risk funding and the global clinical development management and oversight, necessary for regulatory submission for some of the most promising drug development programs of Pharmaceutical and Biotechnology companies. SFJ’s mission is to leverage its financial strength and global team of pharmaceutical development experts to accelerate the development of life-saving and life enhancing drugs for the benefit of physicians and the patients they serve.

On April 10, 2018 H3 Biomedicine Inc., a clinical stage biopharmaceutical company specializing in the discovery and development of next-generation cancer medicines using its data science and precision chemistry product engine, reported that two presentations at the upcoming 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, being held April 14–18, 2018 in Chicago (Press release, H3 Biomedicine, APR 10, 2018, View Source [SID1234525249]). Both presentations underscore the Company’s scientific leadership in RNA splicing, including the identification of somatic mutations in cancer for the discovery and development of novel therapies.

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Oral Presentation / Education Session – Saturday, April 14; 2:00 – 2:25 p.m. (CDT)
Discovery of H3B-8800: A novel, orally bioavailable, small molecule SF3b modulator
Location: Room S103 – McCormick Place South (Level 1)
Presenter: Dominic Reynolds, Ph.D., Vice President of Chemistry, H3 Biomedicine Inc.

Poster Presentation – Tuesday, April 17; 8:00 a.m. to 12:00 p.m. (CDT)
Comprehensive genomic profiling of hematologic malignancies identifies recurrent somatic splicing factor mutations in non-Hodgkin’s lymphoma (NHL) and multiple myeloma (MM)
Abstract 3406, Location: Main Exhibit Hall, Section 17, Poster Board 18

This poster presentation is related to a multi-year, ongoing collaboration between H3 Biomedicine and Foundation Medicine, Inc. (NASDAQ:FMI) for the discovery and development of precision medicines in oncology.

About H3B-8800
Splicing modulation is one of several research focus areas of H3 Biomedicine. A Phase 1 trial is underway in patients with hematologic malignancies for H3B-8800, the company’s first spliceosome pathway-targeting cancer therapeutic. H3B-8800 is a potent, selective and orally bioavailable small molecule modulator of wild-type and mutant SF3b complex, a splicing factor gene. The study is evaluating the safety and preliminary efficacy of H3B-8800 in patients with myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and chronic myelomonocytic leukemia (CMML) who carry mutations in splicing factor genes. In February 2018, H3 published preclinical data in Nature Medicine demonstrating that H3B-8800 modulates RNA splicing and shows preferential antitumor activity in a range of spliceosome-mutant cancer models.

On April 10, 2018 VBL Therapeutics (Nasdaq:VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported that the Company will present new data on MOSPD2, a novel target for Bi-specific Ab mediated killing of tumor cells, at the 2018 Annual American Association for Cancer Research (AACR) (Free AACR Whitepaper) Meeting, to be held April 14-18, 2018 at McCormick Place North/South in Chicago, Illinois (Press release, VBL Therapeutics, APR 10, 2018, View Source [SID1234525248]).

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Poster Presentation Details:

Late-Breaking Research: Immunology 1
Date: Monday, April 16, 2018
Time: 8:00 am – 12:00 noon
Session Location: Poster Section 45

On April 10, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s lead, oral Selective Inhibitor of Nuclear Export (SINE) compound selinexor for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy (Press release, Karyopharm, APR 10, 2018, View Source [SID1234525246]). The FDA’s statement, consistent with the design of Karyopharm’s Phase 2b STORM study, noted that the three prior lines of therapy include regimens comprised of an alkylating agent, a glucocorticoid, Velcade (bortezomib), Kyprolis (carfilzomib), Revlimid (lenalidomide), Pomalyst (pomalidomide) and Darzalex (daratumumab). In addition, the patient’s disease must be refractory to at least one proteasome inhibitor (Velcade or Kyprolis), one immunomodulatory agent (Revlimid or Pomalyst), glucocorticoids and to Darzalex, as well as to the most recent therapy. The Company expects to report top-line data from the STORM study at the end of April 2018.

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The FDA’s Fast Track program facilitates the development of drugs intended to treat serious conditions and that have the potential to address unmet medical needs. A drug program with Fast Track status is afforded greater access to the FDA for the purpose of expediting the drug’s development, review and potential approval. In addition, the Fast Track program allows for eligibility for Accelerated Approval and Priority Review, if relevant criteria are met, as well as for Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be submitted for review.

"The designation of Fast Track for selinexor represents important recognition by the FDA of the potential of this anti-cancer agent to address the significant unmet need in the treatment of patients with penta-refractory myeloma that has continued to progress despite available therapies," said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. "We are fully committed to working closely with the FDA as we continue development of this potential new, orally-administered treatment for patients who currently have no other treatment options of proven benefit."

About the Phase 2b STORM Study

In the multi-center, single-arm Phase 2b STORM (Selinexor Treatment of Refractory Myeloma) study, approximately 122 patients with heavily pretreated, penta-refractory myeloma receive 80mg oral selinexor twice weekly in combination with 20mg low-dose dexamethasone, also dosed orally twice weekly. Patients with penta-refractory disease are those who have previously received an alkylating agent, a glucocorticoid, two immunomodulatory drugs (IMiDs) (Revlimid (lenalidomide) and Pomalyst (pomalidomide)), two proteasome inhibitors (PIs) (Velcade (bortezomib) and Kyprolis (carfilzomib)), and the anti-CD38 monoclonal antibody Darzalex (daratumumab), and their disease is refractory to at least one PI, at least one IMiD, Darzalex, glucocorticoids and their most recent anti-myeloma therapy. Overall response rate is the primary endpoint of the study, with duration of response and clinical benefit rate being secondary endpoints. All responses will be adjudicated by an Independent Review Committee (IRC).

About Selinexor

Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus. This reinitiates and amplifies their tumor suppressor function and is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 2,300 patients have been treated with selinexor, and it is currently being evaluated in several mid- and later-phase clinical trials across multiple cancer indications, including in multiple myeloma in a pivotal, randomized Phase 3 study in combination with Velcade (bortezomib) and low-dose dexamethasone (BOSTON), in combination with low-dose dexamethasone (STORM) and as a potential backbone therapy in combination with approved therapies (STOMP), and in diffuse large B-cell lymphoma (SADAL), and liposarcoma (SEAL), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with one or more approved therapies in a variety of tumor types to further inform Karyopharm’s clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.