On November 19, 2018 Blue Earth Diagnostics, a molecular imaging diagnostics company, reported results from an investigational Phase 3 blinded image evaluation (BIE) study of the diagnostic efficacy of 18F-fluciclovine positron emission tomography (PET) imaging, as an adjunct to magnetic resonance imaging (MRI), in adults with glioma (Press release, Blue Earth Diagnostics, NOV 19, 2018, View Source [SID1234531528]). The primary aim was to determine the diagnostic performance of 18F-fluciclovine PET when combined with MRI (CE-T1W MRI), compared to that of MRI (CE-T1W MRI) alone. Results demonstrated that the overall ability of the readers to assess the diagnostic performance of 18F-fluciclovine with MRI had a Positive Predictive Value (PPV) of more than 90%. 18F-fluciclovine is a synthetic amino acid labeled with the radioisotope F 18, enabling PET imaging to visualize the increased amino acid transport that occurs in malignant tumors such as glioma. Glioma is a serious and life-threatening condition accounting for about 80% of all malignant brain tumors.

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18F-fluciclovine under the tradename Axumin (fluciclovine F 18 injection) is an FDA-approved molecular imaging agent indicated for PET imaging in men with suspected prostate cancer recurrence based on elevated blood levels of prostate specific antigen (PSA) following prior treatment. 18F-fluciclovine PET imaging is being investigated for the detection and continuing assessment of glioma. (For additional product information please see the end of this news release.)

Results of the study were presented in a Poster Session, "A blinded image evaluation study to determine the diagnostic efficacy of 18F-fluciclovine PET, as an adjunct to MRI imaging, in adults with glioma," by Matthew P. Miller, PhD, Blue Earth Diagnostics, Oxford, UK at the 23rd Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology, in New Orleans, La., from November 15 – 18, 2018.

"It is a great pleasure to share results from the 18F-fluciclovine PET blinded image evaluation study in glioma with the prestigious clinical community at the Society of Neuro-Oncology," said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. "18F-fluciclovine PET is designated as an Orphan Drug by the FDA and EMA for the diagnosis of glioma, and Blue Earth Diagnostics is investigating its potential use in adults with glioma as part of our mission to develop and commercialize innovative PET imaging agents to address unmet medical needs in cancer. We look forward to publishing the full results of this study in an upcoming peer-reviewed medical journal."

"Glioma is a serious and potentially life-threatening disease, and the ability to identify the location and extent of a tumor is important in planning appropriate treatment for patients, in both initial diagnosis and subsequent monitoring for recurrence," said Peter Gardiner, MB ChB, MRCP, FFPM, CMO of Blue Earth Diagnostics. "PET imaging provides additional insight beyond MRI into the biology and treatment response of gliomas1."

"Guidelines from the Response Assessment in Neuro-Oncology (RANO) working group and the European Association for Neuro-Oncology (EANO) emphasize the clinical value of PET imaging with superiority of amino acid PET over glucose PET and provides a framework for the use of PET to assist in the management of patients with glioma1," said Matthew P. Miller, PhD, Head of Imaging at Blue Earth Diagnostics and lead author on the BED006 study. "18F-fluciclovine is a synthetic amino acid taken up by certain cancer cells. This blinded image evaluation study examined the diagnostic performance of 18F-fluciclovine PET imaging, in conjunction with various types of MRI, for imaging of suspected glioma when interpreted by readers unfamiliar with 18F-fluciclovine PET. Results indicated a Positive Predictive Value (PPV) of more than 90% for each of the three blinded readers and consistent image interpretation across these readers. Additionally, 18F-fluciclovine PET with MRI (CE-T1W MRI) identified additional regions suspicious for glioma that MRI alone was unable to identify, which subsequent biopsies confirmed as malignant."

About the Phase 3 Blinded Image Evaluation (BIE) Study in Glioma (BED006)

Study BED006 was a prospective, Phase 3, Blinded Image Evaluation (BIE) study of 18F-fluciclovine PET data sets derived from a previous prospective Phase 2 study, designed to evaluate the efficacy of 18F-fluciclovine PET combined with MRI imaging, as compared to MRI alone, in adults with glioma. The primary objective of the study was to determine the positive predictive value (PPV) of 18F-fluciclovine PET when combined with MRI (CE-T1W MRI), compared to MRI (CE-T1W MRI) alone. Secondary objectives included determining the diagnostic performance of 18F-fluciclovine PET and MRI compared with various types of MRI: CE-T1W MRI alone; fluid-attenuated inversion recovery ("FLAIR") (or T2-weighted MRI) alone; and FLAIR (or T2W) MRI and CE-T1W MRI in combination. The study also assessed the reproducibility of interpretation of 18F-fluciclovine PET with MRI (CE-T1W MRI) image evaluation when interpreted by naïve readers.

Thirty-five 18F-fluciclovine PET and MRI (CE-T1W and FLAIR [or T2W]) image datasets with corresponding histopathological standard-of-truth data collected from patients who received 18F-fluciclovine for the imaging of suspected glioma in a previously conducted, prospective Phase 2 clinical trial (JapicCTI-132289) were evaluated. Three independent, blinded readers assessed images captured by cranial PET scan, a mean of 13.1 minutes after the injection of 18F-fluciclovine. Reader reproducibility was assessed by determining agreement in diagnostic performance parameters.

Results demonstrated the diagnostic performance of 18F-fluciclovine PET imaging, in conjunction with MRI, with a PPV of more than 90% for each of the three readers, regardless of whether images were positive or negative on MRI. The sensitivity of 18F-fluciclovine with MRI (CE-T1W MRI) (range 65.8 – 71.1%) was shown to be higher than that of MRI alone (CE-T1W MRI) (42.1%) but not as high as FLAIR (or T2W) MRI alone (86.8%). The 88.9% specificity of 18F-fluciclovine with MRI (CE-T1W MRI) was equal to that of MRI (CE-T1W MRI) alone and higher than FLAIR (or T2W) MRI alone (33.3%). Agreement across readers indicated high concordance, with 89.4% of PET scans in agreement.

Blue Earth Diagnostics is pursuing regulatory filings for the use of 18F-fluciclovine PET imaging in adults for the detection and continuing assessment of the disease. The compound has been granted Orphan Drug status by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for the diagnosis of glioma.

About 18F-fluciclovine PET in Glioma

18F-fluciclovine PET is a diagnostic imaging radiopharmaceutical for PET imaging that consists of a synthetic amino acid labeled with the radioisotope F 18, enabling the visualization of the increased amino acid transport that occurs in malignant tumors. 18F-fluciclovine, under the trade name Axumin, is approved by the U.S. Food and Drug Administration (FDA) for PET imaging in men with biochemically recurrent prostate cancer. It is also under investigation by Blue Earth Diagnostics for use in adults for the detection and continuing assessment of glioma. 18F-fluciclovine has been granted Orphan Drug status by both the FDA and the European Medicines Agency for the diagnosis of glioma. The compound was invented at Emory University in Atlanta, Ga., with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences.

About Glioma
Glioma, the most commonly occurring type of primary brain tumor, is a serious and life-threatening condition. Cancer of the brain and central nervous system (CNS) is the twelfth most common cause of cancer death worldwide. Glioma accounts for about 25% of all brain tumors, and 80% of all malignant brain tumors. The most aggressive form of glioma, glioblastoma multiforme, is associated with significant morbidity and mortality with relatively low 5-year survival estimates after diagnosis. Current treatment options for patients with glioma include surgery, radiation and chemotherapy. Accurate evaluation of the location and extent of a glioma tumor is essential before or during surgery and radiotherapy and in assessing the continuing status of the disease. The detection and assessment of gliomas typically involves magnetic resonance imaging (MRI), which may be complemented by metabolic imaging using an appropriate amino acid-based PET radiopharmaceutical, as recommended in the Response Assessment in Neuro-Oncology (RANO) working group and European Association for Neuro-Oncology (EANO) guidelines.1

U.S. Indication and Important Safety Information About Axumin*

INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

NOTE: Axumin (fluciclovine F 18) injection is not currently approved in the United States for treatment planning in men with biochemically recurrent prostate cancer.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full U.S. Axumin prescribing information is available at www.axumin.com.

*This press release is intended to provide information about Blue Earth Diagnostics’ business in the United States. Please be aware that the approval status and product label for Axumin varies by country worldwide. Refer to the individual country product label for complete information or contact Blue Earth Diagnostics.

On November 19, 2018 FLX Bio, Inc., a clinical-stage, biopharmaceutical company focused on the development of oral small-molecule drugs that target immune drivers of cancer and other immune-related disorders, reported that Brian Wong, M.D., Ph.D., CEO and Rekha Hemrajani, COO will participate in an analyst-led fireside chat at the Evercore ISI HealthCONx on Tuesday, November 27 at 12:30 p.m. EST, in Boston, MA (Press release, FLX Bio, NOV 19, 2018, View Source [SID1234531444]).

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A live webcast and audio archive of the presentation may be accessed here or on the FLX Bio website at View Source Please connect to the website 10 minutes prior to the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast.

On November 16, 2018 Seattle Genetics, Inc. (Nasdaq:SGEN) reported a new approval for ADCETRIS (brentuximab vedotin) in combination with CHP chemotherapy (cyclophosphamide, doxorubicin, prednisone) from the U.S. Food and Drug Administration (FDA) for adults with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified (Press release, Seattle Genetics, NOV 16, 2018, View Source [SID1234531400]). The approval is based on the successful outcome of the phase 3 ECHELON-2 clinical trial that compared ADCETRIS plus CHP to CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). The FDA granted Breakthrough Therapy designation and Priority Review to this supplemental Biologics License Application (BLA) and reviewed it under the Real-Time Oncology Review Pilot Program leading to approval less than two weeks after submission of the complete application.

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"The current standard of care for initial treatment of peripheral T-cell lymphoma is multi-agent chemotherapy. That treatment has not significantly changed in decades and is too often unsuccessful in leading to long-term remissions, underscoring the need for new treatments," said Steven Horwitz, M.D., Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center, New York. "The ECHELON-2 clinical trial demonstrated ADCETRIS plus CHP was superior to the current standard of care, CHOP, for both progression-free survival and all other key secondary endpoints, including, most importantly, overall survival. With this approval, clinicians have the opportunity to transform the way newly diagnosed CD30-expressing PTCL patients are treated."

This is the sixth FDA-approved indication for ADCETRIS, which also has approval for adult patients with: (1) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine (AVD), (2) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (3) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (4) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (5) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

"By participating in the FDA’s Real-Time Oncology Review process and working closely with the FDA, we are now able to make the ADCETRIS regimen available to previously untreated patients with CD30-expressing PTCL in an unprecedented less than two weeks after submission of our supplemental BLA," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "The ECHELON-2 clinical trial demonstrated ADCETRIS plus CHP results in a superior outcome for patients when compared to current standard of care, CHOP. We want to thank the patients, physicians and their staff who participated in the ECHELON-2 trial, which supported this FDA approval."

The ECHELON-2 data will be presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2018 Annual Meeting, on Monday, December 3, 2018, at 6:15 pm PT at the San Diego Convention Center in Room 6F in San Diego, Calif. Patients in ECHELON-2 were randomized to receive either a combination of ADCETRIS plus CHP or CHOP, a recognized standard of care for frontline PTCL. Results from the trial demonstrated that combination treatment with ADCETRIS plus CHP was superior to CHOP for progression free survival (PFS) as assessed by a Blinded Independent Central Review facility (BICR; hazard ratio=0.71; 95% CI, 0.54–0.93; p-value=0.011). This corresponds to a 29 percent reduction in the risk of progression, death, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease. The ADCETRIS plus CHP arm also demonstrated superior overall survival (OS), a key secondary endpoint, compared to CHOP (hazard ratio=0.66; 95% CI, 0.46-0.95; p-value=0.024). All other key secondary endpoints, including PFS in patients with sALCL (hazard ratio=0.59; 95% CI, 0.42-0.84; p-value=0.003), complete remission rate (68% vs 56%; p-value=0.007) and objective response rate (83% vs 72%; p-value=0.003) were statistically significant in favor of the ADCETRIS plus CHP arm.

The safety profile of ADCETRIS plus CHP in the ECHELON-2 trial was comparable to CHOP and consistent with the established safety profile of ADCETRIS in combination with AVD. The most common adverse events of any grade that occurred in at least 20 percent of patients in the ADCETRIS plus CHP arm were peripheral neuropathy, nausea, diarrhea, neutropenia, lymphopenia, fatigue, mucositis, constipation, alopecia, pyrexia, vomiting and anemia. Serious adverse reactions occurring in at least two percent of ADCETRIS plus CHP-treated patients included febrile neutropenia, pneumonia, pyrexia and sepsis. Based on ECHELON-2 clinical trial results, prophylactic growth factors (G-CSF) should be administered starting at cycle one for patients receiving ADCETRIS plus CHP for previously untreated PTCL.

ECHELON-2 Phase 3 Clinical Trial Design

The multi-center, randomized, double-blind, placebo-controlled phase 3 trial is investigating ADCETRIS plus CHP (cyclophosphamide, doxorubicin, prednisone) versus CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) as frontline therapy in patients with CD30-expressing peripheral T-cell lymphoma, also known as mature T-cell lymphoma. The primary endpoint is progression-free survival (PFS) per BICR facility assessment, with events defined as progression, death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease. Secondary endpoints include PFS in patients with systemic anaplastic large cell lymphoma (sALCL), complete remission rate, overall survival and objective response rate, in addition to safety. The trial was conducted at sites across North America, Europe and Asia and was designed to enroll 450 patients, approximately 75 percent of whom were to be diagnosed with sALCL. The ECHELON-2 trial was conducted under a Special Protocol Assessment (SPA) agreement from the U.S. Food and Drug Administration (FDA) and the trial also received European Medicines Agency (EMA) scientific advice.

Please see Important Safety Information, including Boxed Warning, at the end of this press release.

About T-Cell Lymphomas

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. There are more than 60 subtypes of non-Hodgkin lymphomas which are broadly divided into two major groups: B-cell lymphomas, which develop from abnormal B-lymphocytes, and T-cell lymphomas, which develop from abnormal T-lymphocytes. There are many different forms of T-cell lymphomas, some of which are extremely rare. T-cell lymphomas can be aggressive (fast-growing) or indolent (slow-growing). PTCL accounts for approximately 10 percent of the estimated 74,680 people diagnosed with non-Hodgkin lymphoma in the U.S. in 2018.1

About ADCETRIS (brentuximab vedotin)

ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include the recently completed phase 3 ECHELON-2 trial in frontline peripheral T-cell lymphomas (also known as mature T-cell lymphoma), the completed phase 3 ECHELON-1 trial in previously untreated Hodgkin lymphoma, the completed phase 3 ALCANZA trial in cutaneous T-cell lymphoma, and the ongoing CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval for six indications in adult patients with: (1) previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone, (2) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine, (3) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (4) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (5) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (6) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplantation (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, and (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

ADCETRIS has received marketing authorization by regulatory authorities in 72 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

On November 16, 2018 ArQule, Inc. (Nasdaq: ARQL) reported the presentation of clinical and preclinical data on ARQ 751 in three poster presentations at the 30th EORTC/AACR/NCI Symposium held from November 13 to 16, 2018 in Dublin, Ireland (Press release, ArQule, NOV 16, 2018, View Source [SID1234531401]). The data presented highlight clinical data from ARQ 751-101, a Phase 1 study in adult patients with refractory and/or metastatic tumors that harbor AKT, PI3K or PTEN genetic alterations, and preclinical data on ARQ 751 in combination with other agents.

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Clinical data highlights and key conclusions include:

1. A Phase 1 Dose Escalation Study of ARQ 751 in Adult Patients with Advanced Solid Tumors with AKT1, 2, 3 Genetic Alterations, Activating PI3K Mutations, PTEN-null, or Other Known Actionable PTEN Mutations

ARQ 751 demonstrated manageable toxicity at doses from 5 mg QD to 75 mg QD, and the recommended Phase 2 dose was determined to be 75 mg QD
Evidence of clinical activity was observed with two partial responses in ER+/PR+/HER2- stage IV breast cancer patients, one with PTEN C296fs*2 mutation, one with PIK3CA H1047R mutation, 11 patients had stable disease
The data support continued development of ARQ 751 as a monotherapy or in combination with other anti-cancer agents due to its manageable safety profile and preliminary evidence of biological activity
"ARQ 751, as a highly specific allosteric AKT inhibitor, holds great potential in treating patients with solid tumors harboring mutations in the AKT/PI3K/PTEN pathways," said Brian Schwartz, M.D., Chief Medical Officer of ArQule. "The presented data are very encouraging and demonstrate both preliminary signs of clinical activity and a favorable safety profile while also determining the recommended Phase 2 dose. At ArQule, we are committed to developing genetically targeted cancer treatments to provide effective new treatment options for patients, particularly those with advanced or relapsed disease, and look forward to advancing the ARQ 751 clinical program."

Preclinical data highlights include:

2. Combination of the AKT inhibitor ARQ 751 with Immune Checkpoint Inhibitor and Other Therapeutic Agents

In preclinical cellular models, ARQ 751 exerted greater anti-proliferative and biochemical effects when in combination with multiple therapeutic agents including an ER antagonist, aromatase inhibitor, androgen receptor antagonist and a BTK inhibitor
In an in vivo colon cancer animal model, ARQ 751 in combination with an anti-PD-1 antibody exhibited superior anti-tumor activity compared to single agents
3. Miransertib and ARQ 751 exhibit superior cell-death-inducing properties compared to other AKT inhibitors and can overcome resistance to other allosteric AKT inhibitors

ArQule’s AKT inhibitors, miransertib and ARQ 751 showed superior activity in comparison to other allosteric and ATP-competitive AKT inhibitors currently in clinical development
Miransertib and ARQ 751 have the potential to overcome some mechanisms of resistance to AKT inhibitors
Miransertib and ARQ 751 in combination with ATM inhibition demonstrated synergistic effects
Dr. Shubham Pant, MD, Associate Professor in the Department of Investigational Cancer Therapeutics at MD Anderson Cancer Center, said "AKT inhibitors have significant potential to treat a broad range of solid tumors in molecularly defined patient populations. The presented data show that ARQ 751 exhibits unique properties that differentiate it from other AKT inhibitors. It is our hope that by combining ARQ 751 with a broad spectrum of therapeutic agents, including hormonal agents, we could provide new opportunities for combinatorial interventions in oncology."

All posters presented by ArQule at the EORTC/AACR/NCI Symposium are available on the company’s website at View Source

About ARQ 751
ARQ 751 is an orally bioavailable, selective small molecule inhibitor of the AKT serine/threonine kinase. The AKT pathway when abnormally activated is implicated in multiple oncogenic processes such as cell proliferation and apoptosis. This pathway has emerged as a target of potential therapeutic relevance for compounds that inhibit its activity, which has been linked to a variety of cancers as well as to select non-oncology indications. ARQ 751 is currently in a Phase 1 study in adult patients with refractory and/or metastatic tumors that harbor genetic alterations along the AKT pathway.

About Miransertib
Miransertib (ARQ 092) is an orally bioavailable, selective, pan-AKT (protein kinase B) inhibitor that potently inhibits AKT1, 2 and 3 isoforms. Dysregulation of AKT has been implicated in a variety of rare overgrowth diseases and cancers; however, there are currently no approved inhibitors of AKT. AKT inhibitors, either as single agent or combination therapy, show significant promise in molecularly defined patient populations. Miransertib is currently in a Phase 1/2 company-sponsored study for PIK3CA-Related Overgrowth Spectrum (PROS), a Phase 1 study for ultra-rare Proteus syndrome conducted by the National Institutes of Health (NIH/NHGRI), and a Phase 1b study in combination with the hormonal therapy, anastrozole, in patients with advanced endometrial cancer with AKT and PI3K mutations. Miransertib has been granted Rare Pediatric Disease Designation and Fast Track Designation by the U.S. Food and Drug Administration (FDA), as well as Orphan Designation by the FDA and European Medicines Agency in the rare overgrowth disease, Proteus syndrome.

On November 16, 2018 apceth Biopharma GmbH, an established contract manufacturing organization in the field of gene and cell therapy, reported it has started supplying clinical batches of DCprime’s cell-based cancer vaccine DCP-001 to a phase II clinical study for the treatment of Acute Myeloid Leukemia (AML) (Press release, apceth, NOV 16, 2018, View Source [SID1234531454]). AML is a haematological cancer characterized by high risk of relapse, even after initial response to chemotherapy. Cancer vaccination with dendritic cells could be a successful strategy to boost the patient’s immune system and result in lasting disease control. DCprime announced yesterday that the first patient has been treated with the product DCP-001 at the Amsterdam University Medical Center (UMC).

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"We are proud to be the manufacturing partner of DCprime for DCP-001, the first off-the shelf dendritic cell vaccine in a cancer indication with high unmet medical need", explained Dr Christine Günther, CEO of apceth Biopharma. "Our long-term collaboration with DCprime has always been constructive and cooperative, from technology transfer to the large-scale manufacturing process."

Dr Erik Manting, CEO of DCprime, commented: "Based on the recently published encouraging results of the phase I trial with our lead product DCP-001, we aim to confirm these results in the phase II ADVANCE-II trial and we are happy with the enrollment of the first patient. We would like to thank the apceth Biopharma team for their important contribution to the manufacturing of our product."