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Myriad’s BRACAnalysis CDx® Test Identifies Patients with Ovarian Cancer Who Would Benefit from Second-Line Maintenance Treatment with Olaparib

On October 26, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that its BRACAnalysis CDx test accurately identified patients who may benefit from treatment with olaparib (Press release, Myriad Genetics, OCT 26, 2016, View Source [SID1234516013]). The BRACAnalysis CDx test was included in the SOLO2 study (NCT01874353) as a diagnostic with olaparib, an oral PARP inhibitor being developed by AstraZeneca (Nasdaq:AZN).

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SOLO2 compared maintenance olaparib against placebo in patients with platinum-sensitive relapsed ovarian cancer. In this study, patients were tested for germline BRCA (gBRAC+) mutations as determined by Myriad’s BRACAnalysis CDx test. The primary endpoint for SOLO2 was progression-free survival (PFS). The aim was to determine whether patients carrying gBRAC mutations treated with olaparib as a second-line maintenance therapy experienced longer progression-free survival, compared to those patients receiving placebo. The results showed that the olaparib-treated patients achieved the primary endpoint of prolonged PFS.

"These outstanding findings represent another meaningful advancement for ovarian cancer patients," said Johnathan Lancaster, M.D., Ph.D., gynecologic oncologist and chief medical officer of Myriad Genetic Laboratories. "Importantly, the results demonstrated that BRCA status as determined by BRACAnalysis CDx can identify patients likely to benefit from PARP inhibition therapy."

The collaboration between Myriad and AstraZeneca on olaparib began in 2007. In Dec. 2014, Myriad received FDA approval for BRACAnalysis CDx to identify patients with advanced ovarian cancer who are eligible for fourth-line treatment with olaparib. BRACAnalysis CDx is Myriad’s first FDA-approved companion diagnostic and was the first-ever laboratory developed test reviewed and approved by the FDA.

About BRACAnalysis CDx
BRACAnalysis CDx is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR. Results of the test are used as an aid in identifying ovarian cancer patients with deleterious or suspected deleterious germline BRCA variants eligible for treatment with Lynparza (olaparib). This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108.

Evotec AG announces its intent to acquire Cyprotex PLC

On October 26, 2016 Evotec AG (Frankfurt Stock Exchange, Prime Standard, ISIN: DE 000 566480 9, WKN 566480) reported that it has made an offer to acquire Cyprotex PLC (AIM Listing: CRX-GB), a specialist pre-clinical contract research organisation in ADME-Tox and DMPK headquartered in UK (Press release, Evotec, OCT 26, 2016, View Source [SID1234516093]). The proposed acquisition, which has been unanimously recommended by the board of Cyprotex, is expected to close before year-end 2016.

Evotec will pay approximately £ 55.36 m (EUR 62.00 m; £/EUR exchange rate of 1.12) in cash for the acquisition of all 26.1 million issued and to be issued Cyprotex shares and the funding of all existing company debt. The offer of 1.60 £ per Cyprotex share reflects a 9.4% premium to the VWAP of the past 30 trading days at AIM. The offer is intended to be implemented by a scheme of arrangement regulated by the UK takeover code, with already >50% shares secured irrevocable.

Nordic Nanovector and Heidelberg Pharma enter collaboration to develop novel antibody-drug conjugates (ADCs) targeting leukaemias

On October 26, 2016 Nordic Nanovector ASA (OSE: NANO), reported has entered into a collaboration with Heidelberg Pharma GmbH, a subsidiary of biopharmaceutical company WILEX AG (FSE: WL6) specializing in the development of antibody-drug conjugates (ADCs), to develop novel ADCs for treating leukaemias (Press release, Nordic Nanovector, OCT 26, 2016, View Source [SID1234516028]). Leukaemias are orphan diseases with a significant unmet medical need, applicable indications representing a growing market worth over USD 5 billion by 2020.

This collaboration is part of Nordic Nanovector’s strategy to develop its pipeline of targeted therapies to include antibody products conjugated to anti-cancer compounds that are not radionuclides. Such conjugates are commonly referred to as ADCs.

Jostein Dahle, Nordic Nanovector’s Chief Scientific Officer, commented: "We are pleased to further expand our R&D activities into the ADC area with Heidelberg Pharma in this second strategic collaboration, following closely the collaboration announced recently with LegoChem. During the past year, we have made important steps to execute our strategy designed to build a pipeline of innovative antibody-radionuclide conjugates (ARCs) and ADCs that combine our expertise and platform with complementary technologies from expert partners. This strategy is aimed at creating multiple new targeted treatment options for patients who suffer a range of leukaemias and lymphomas."

Professor Dr Andreas Pahl, Head of Research & Development and member of the Management Board of WILEX and Heidelberg Pharma, commented: "This project extends our portfolio of ADCs to further haematological cancers. Nordic Nanovector has an established chemistry, manufacturing, and controls (CMC) process for their antibody which will speed up processes and reduce the development costs of an ADC."

Moleculin Announces Advancement of Preclinical Testing for Brain Tumor Drug WP1122

On October 26, 2016 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical and clinical-stage pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported promising initial results of the preclinical toxicology work that has begun for WP1122, a unique inhibitor of glucose metabolism, which is an important driver of glycolytic brain tumor progression and survival (Press release, Moleculin, OCT 26, 2016, View Source [SID1234516024]).

The Company indicated that preliminary escalating single dose toxicity testing in mice (oral administration) was successfully completed and even at the highest possible dose, no toxic death was observed. In multiple therapeutic doses, WP1122 was well tolerated during intense twice-daily oral dosing. The Company plans to move forward with completing the preclinical toxicology package in order to generate proof of concept in humans.

Moleculin’s Chairman and CEO, Walter Klemp, commented, "As the newest of our technologies, we are pleased to see development work move to the next level. WP1122 has received significant attention from the scientific community as a promising new approach to treating brain tumors. Part of the excitement relates to the unusual nature of WP1122 and its design allowing for high brain uptake and retention. The design uses an alteration similar to that which turns morphine into heroine and enables rapid brain uptake. A similar alteration to our drug allows it to successfully enter the brain in high quantities and increases its circulation time."

Prior to this announcement, the Company had previously announced the presentation of promising preclinical data in July of this year (Moleculin Announces Data on WP1122 Presented at the 28th Annual International Carbohydrate Symposium), supporting the potential for using WP1122 as a treatment for glioblastoma.

No curative therapy exists for patients with high-grade brain tumors and new approaches to the treatment of this disease are urgently needed. One new approach to tackling this problem has been to focus on shutting down the metabolism of tumor cells, which can be highly dependent on glucose for continued survival and proliferation. WP1122 has been shown both in vitro and in vivo to induce a destruction of glioma cells, the most aggressive form of brain tumor, by essentially "starving" them. Its translational potential as a drug for brain tumors in general and glioma in particular is promising due to its improved circulation time as well as its increased brain uptake.

Encouraging initial results for IPH4102 presented at the Third World Congress of Cutaneous Lymphomas

On October 26, 2016 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH), reported encouraging preliminary safety and clinical activity results from the dose-escalation part of the Phase I study testing IPH4102 in patients with relapsed/refractory cutaneous T-cell lymphomas ("CTCL"), an orphan disease (Press release, Innate Pharma, OCT 26, 2016, View Source [SID1234516012]). IPH4102 is Innate Pharma’s wholly-owned, first-in-class anti-KIR3DL2 humanized therapeutic antibody, designed to trigger immune cell-mediated killing of CTCL cancer cells.

These data are presented in a poster at the Third World Congress of Cutaneous Lymphomas (October 26-28, 2016, New-York, USA) and will be discussed by the Principal Investigator, Professor Martine Bagot, Head of the Department of Dermatology at Saint-Louis Hospital (Paris) in the Scientific Session "Endpoints & Clinical Trials" on October 28, 2016, 1:30 – 2:45 p.m. EST.

The Phase I study is currently ongoing. Data are reported for the first seven dose levels (0.0001 to 1.5 mg/kg, 16 patients) of the dose-escalation part. In this population, IPH4102 was well-tolerated with no dose-limiting toxicity reported. The majority of adverse events is typical for CTCL or reflects low grade infusion-related reactions. As of September 10, 2016, the best global response rate was 38% across all dosage levels. Complete responses appeared with increasing doses and/or duration of exposure in skin and blood (respectively 2 and 3, seen in 4 patients)[1]. All responses are ongoing at the time of the analysis, which occurred after a median duration of treatment of 126+ days (range of 41+ to 298+).

Three additional dose levels (3, 6 and 10 mg/kg) remain to be evaluated and the dose escalation part of the trial is now expected to be completed by Q2 2017 (previously expected at the end of 2017).

"These preliminary results are very encouraging and fully support the continuation of the development of the antibody candidate. By targeting KIR3DL2 on CTCL cells and triggering their killing by immune effector cells, IPH4102 has the potential to deliver a new treatment option for patients in high medical need at advanced stages of the disease," said Pierre Dodion, Chief Medical Officer of Innate Pharma. "The development of IPH4102 benefits from long lasting collaborations with Saint Louis Hospital in Paris and reference centers, such as Stanford (US). Together we look forward to the complete safety data of the dose-escalation part of the trial and commencing cohort expansion of this new drug candidate, which is wholly-owned by Innate Pharma."

Martine Bagot, Principal Investigator and Head of the Dermatology Department at the Saint-Louis Hospital, Paris, added: "This study offers preliminary safety and efficacy results that are promising for IPH4102, in patients with CTCL subtypes that historically have been shown to be particularly difficult to treat. We are delighted with the progress that has been made with this candidate through translational research and an exceptional academic-industrial partnership."

The study started enrolling patients in November 2015. So far, 16 patients with KIR3DL2-positive CTCL have been enrolled in seven dose-cohorts, including 13 patients with Sézary syndrome, 2 patients with mycosis fungoides and 1 patient with CD4+ CTCL. Median age was 71 years and patients had received 2 to 8 lines of prior systemic therapy for their disease.

All of the 16 patients treated with IPH4102 were evaluable for safety and clinical activity assessments.

As of September 10, 2016, patients had received up to 18 administrations of IPH4102. Treatment is ongoing in 12 patients. Preliminary results of exploratory endpoints such as pharmacodynamics in skin and blood are in line with clinical activity results (see poster #O-11), and show depletion of KIR3DL2-expressing tumor cells in skin and blood of patients after IPH4102 administrations.

Presentation/ Poster Details

The oral presentation, entitled "First-in-Human, open label, multicenter phase I study of IPH4102, first-in-class humanized anti-KIR3DL2 mAb, in relapsed/refractory CTCL: preliminary safety and clinical activity results" will take place on October 28, 2016, 1:30 – 2:45 p.m. EST. It will be available on the Company’s website, in the Product Pipeline – IPH4102 section following the session. The associated poster is displayed during the entire congress and is available on Innate Pharma’s website.

Simultaneously, poster #O-11 entitled "First-in-Human, open label, multicenter phase I study of IPH4102, first-in-class humanized anti-KIR3DL2 mAb, in relapsed/refractory CTCL: preliminary results of exploratory biomarkers" has been presented by Hélène Sicard, Anne Marie-Cardine and Maxime Battistella and is available on Innate Pharma’s website under Product Pipeline – IPH4102.