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Phoenix Molecular Designs Initiates its Phase 1/1b Program to Evaluate PMD-026 in Patients with Resistant Forms of Advanced Breast Cancer

On November 20, 2019 Phoenix Molecular Designs (PhoenixMD), a clinical stage biotechnology company developing precise cancer therapeutics targeting essential kinases, reported that it has dosed the first patient in its Phase 1/1b study of PMD-026, the company’s lead product candidate (Press release, PhoenixMD, NOV 20, 2019, View Source [SID1234551545]). PMD-026 is a proprietary first-in-class orally-available RSK (kinase) inhibitor for the potential treatment of patients with metastatic breast cancer and, more specifically, triple-negative breast cancer (TNBC).

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"Dosing the first patient in this newly initiated clinical trial is a paramount milestone for PhoenixMD," said Andrew Dorr, M.D., chief medical officer of Phoenix Molecular Designs. "We believe PMD-026 to be a promising new approach to treat advanced breast cancer and we look forward to building upon this momentum in the pursuit of a potential treatment option for individuals living with advanced forms of breast cancer."

The company’s Phase 1/1b clinical trial will be conducted at leading medical centers across United States and it will evaluate safety, tolerability, pharmacokinetics and anti-tumor activity of PMD-026 in patients with metastatic breast cancer in the dose escalation as well as in women with TNBC in Phase 1b. Importantly, this trial will include a CAP/CLIA (College of American Pathologists/Clinical Laboratory Improvement Amendments) certified companion diagnostic (CDx) designed to detect RSK2 activation in breast tumors and to then correlate it with response to PMD-026. Activated RSK2 is prevalent in breast cancer as it is highly expressed in 89 percent of primary tumors and is found in metastatic disease. In TNBC, early data indicates that approximately 42 percent of patients have extremely high levels of RSK2 activation. Targeting of RSK2, which drives breast cancer proliferation, by PMD-026 creates a distinct precision medicine approach to treating breast cancer.

"Metastatic breast cancer, including TNBC, is a devastating disease with poor prognosis and few impactful treatment options," said Murali Beeram, M.D., lead investigator of South Texas Accelerated Research Therapeutics (START). "Our team is eager to evaluate RSK2 inhibition in advanced breast cancers and play an integral role, alongside PhoenixMD, in the exploration of new medicines for patients."

About PMD-026
PhoenixMD’s lead candidate, PMD-026, is the first RSK inhibitor being developed for the treatment of TNBC. PMD-026 was precisely designed for TNBC because RSK2 was specifically identified as the key kinase, out of 519 kinases, that drives the growth of this breast cancer subtype. Preclinical data shows the potential for PMD-026 to be effective alone or in combination with conventional chemotherapies. It has the potential to be a platform technology for chemotherapy, hormone therapy and/or immunotherapy sensitization for a wide range of refractory cancers in the future. PMD-026 is currently in Phase 1/1b testing.

IOTA and MassGen Hospital Establish PHOENIX, an Open-access Preclinical Glioblastoma Drug Screening Pipeline

On November 20, 2019 IOTA Pharmaceuticals Ltd (Cambridge, UK) and the Experimental Therapeutic Unit of the Neurology Department of Massachusetts General Hospital (Neurology, MGH, Boston, USA) reported the creation of a new Glioblastoma drug screening pipeline, PHOENIX (Press release, IOTA Pharmaceuticals, NOV 20, 2019, View Source [SID1234551544]).

Based on IOTA’s GBM Drug Bank1 and MGH’s Glioblastoma patient-derived cell screening platforms2, PHOENIX will translate IOTA’s preclinical work on drug-induced gene expression in established GBM cell lines into a clinic-facing pipeline of effective drug combinations that could form the basis for personalised glioblastoma treatments.

The establishment of PHOENIX and the initial findings which have informed the platform will be reported at the American Society for Neuro Oncology meeting being held later this week in Phoenix, Arizona.

PHOENIX has been created with funds received from The Brain Tumour Charity (UK).

1 GBM Drug Bank-a new resource for glioblastoma drug discovery and informatics research.
2 Patient-Derived Glioma Models: From Patients to Dish to Animals.

Information on the PHOENIX pipeline, and how you can participate, can be obtained from Prof Bakhos Tannous at MGH ([email protected]) and Dr David Bailey at IOTA ([email protected]).

Illumina to Webcast Upcoming Investor Conference Presentations

On November 20, 2019 Illumina, Inc. (NASDAQ:ILMN) reported that its executives will be speaking at the following investor conferences and invited investors to participate via webcast (Press release, Illumina, NOV 20, 2019, View Source [SID1234551542]).

Evercore ISI HealthCONx Conference in Boston, MA
Wednesday, December 4, 2019 at 8:45am Eastern Time

Piper Jaffray Annual Healthcare Conference in New York, NY
Thursday, December 5, 2019 at 10:30am Eastern Time

The live webcasts can be accessed in the Investor Relations section of Illumina’s web site under the "company" tab at www.illumina.com. A replay of the presentations will be posted on Illumina’s website after the event and will be available for at least 30 days following.

Massive Bio and The American Sexual Health Association Partner to Increase Patient Access to Cervical Cancer Clinical Trials

On November 20, 2019 Massive Bio, a leader in Artificial Intelligence (AI) based oncology clinical trial enrollment, and The American Sexual Health Association (ASHA), a leader in advancing the health of communities by improving awareness in sexual health, formed an exciting partnership to promote targeted clinical trials to cervical cancer patients – especially for those patients treated at community practices that have limited access to research opportunities (Press release, Massive Bio, NOV 20, 2019, View Source [SID1234551541]).

The National Cervical Cancer Coalition (NCCC), one of ASH (Free ASH Whitepaper)A’s cornerstone women’s health programs, is an important resource for its thousands of members across the country. Through its online resources and network of chapters across the U.S., NCCC offers women, family members and caregivers information and support on issues related to cervical cancer and human papillomavirus (HPV), a virus that can lead to cervical cancer. There is a tremendous need to develop new treatment options for cervical cancer, especially for patients that do not yield optimal results from conventional surgery and radiation.

ASHA and NCCC’s goal to educate cancer patients perfectly aligns with Massive Bio’s mission to connect patients with cutting edge medical research appropriate for their case. Many cancer patients are unaware of the opportunity that clinical trials can offer. Massive Bio provides an innovative platform that will benefit NCCC and other patient stakeholders. This is achieved by connecting patients to specific, tailored clinical trial treatment options that are not widely available or known. When the public comes to ASH (Free ASH Whitepaper)A and NCCC, the expectation is to find trusted solutions that work. Massive Bio will uphold these standards by offering transparent and effective solutions presented by our team of patient advocates and nurses.

"Through our cherished NCCC initiative we are pleased to collaborate with Massive Bio to help meet this important women’s health need through promoting cervical cancer research opportunities in our channels and on our platforms. Our desire is to make a broad, diverse group of patients and stakeholders aware of the clinical trials process along with studies in which they may have interest in taking part. We look forward to working with Massive Bio to help patients find clinical trials for cervical cancer therapies for which they are a good match. As part of this, we also place a premium on providing patients and caregivers a broad array of advocacy and support services as they navigate their cancer journey," said Lynn Barclay, President and CEO of ASH (Free ASH Whitepaper)A.

"Through this partnership, ASH (Free ASH Whitepaper)A and NCCC will be able to give cervical cancer patients the opportunity to utilize Massive Bio’s cutting-edge AI powered end-to-end clinical trial matching platform and SYNERGY-AI Registry. In addition, we support patients throughout their journey for successful enrollment. Massive Bio is always looking for new ways to help cancer patients gain access to the best treatment options available and we are very excited for the opportunity to partner with ASH (Free ASH Whitepaper)A and NCCC," said Selin Kurnaz, PhD., Co-founder and CEO of Massive Bio.

About ASH (Free ASH Whitepaper)A (American Sexual Health Association)

The American Sexual Health Association promotes the sexual health of individuals, families and communities by advocating sound policies and practices and educating the public, professionals and policy makers in order to foster healthy sexual behaviors and relationships and prevent adverse health outcomes. Cervical cancer patients and survivors, an important part of the ASH (Free ASH Whitepaper)A community served by the National Cervical Cancer Coalition, rely on their activities to find local and national resources that can benefit them.

Novocure Announces 43 Presentations on Tumor Treating Fields at 24th Annual Meeting of the Society for Neuro-Oncology

On November 20, 2019 Novocure (NASDAQ: NVCR) reported 43 presentations on Tumor Treating Fields, including three oral presentations, will be featured at the 24th Annual Meeting of the Society for Neuro-Oncology (SNO) on Nov. 20 through Nov. 24 in Phoenix (Press release, NovoCure, NOV 20, 2019, View Source [SID1234551540]). Presentations on Tumor Treating Fields cover a broad and growing range of topics. External authors prepared 34 of the 43 presentations.

The oral presentations on Tumor Treating Fields include an EF-14 post hoc subgroup analysis on tumor growth rates, and the pilot study results of Tumor Treating Fields combined with radiotherapy and temozolomide for the treatment of newly diagnosed glioblastoma.

Highlights among poster presentations include the combinations of Tumor Treating Fields with other therapies such as radiation and immunotherapies, simulations, health economics and outcomes research, patient advocacy, and research on the mechanism of action.

"Year after year, it is amazing to see the continued focus on Tumor Treating Fields at the SNO Annual Meeting," said Novocure CEO Asaf Danziger. "From our first presentation at SNO in 2008 to today, more than 250 abstracts on Tumor Treating Fields have been included at one of the most important conferences in neuro-oncology worldwide. I am proud of our team for their relentless focus on innovative research and for their consistent drive in raising awareness of our therapy among the scientific community. We look forward to another productive year at SNO."

Oral Presentations

(Abstract #: ACTR-46) Tumor Treating Fields combined with radiotherapy and temozolomide for the treatment of newly diagnosed glioblastoma: Final results from a pilot study. R. Grossman. 2:45 to 2:50 p.m. MST Nov. 22.

(Abstract #: RTHP-28) TTFields treatment affects tumor growth rates: A post-hoc analysis of the pivotal phase 3 EF-14 trial. Z. Bomzon. 4:05 to 4:10 p.m. MST Nov. 22.

(Abstract #: QOLP-24) Patients’/parents’ experiences of receiving Optune delivered tumor treatment fields: A Pediatric Brain Tumor Consortium Study: PBTC-048. J. Lai. 7:50 to 7:54 p.m. MST Nov. 22.

Poster Presentations

(Abstract #: RDNA-10) TTFields treatment planning for targeting multiple lesions spread throughout the brain. Z. Bomzon. 7:30 to 9:30 p.m. MST Nov. 22. (Radiation Biology and DNA Repair/Basic Science)

(Abstract #: NIMG-20) Evaluation of head segmentation quality for treatment planning of tumor treating fields in brain tumors. Z. Bomzon. 7:30 to 9:30 p.m. MST Nov. 22. (Neuro-Imaging/Clinical Research)

(Abstract #: HOUT-24) Challenges and successes in the global reimbursement of a breakthrough medical technology for treatment of glioblastoma multiforme. C. Proescholdt. 7:30 to 9:30 p.m. MST Nov. 22. (Health Outcome Measures/Clinical Research)

(Abstract #: EXTH-02) The blood brain barrier (BBB) permeability is altered by Tumor Treating Fields (TTFields) in vivo. E. Schulz. 7:30 to 9:30 p.m. MST Nov. 22. (Experimental Therapeutics/Basic Science)

(Abstract #: IMMU-06) TTFields induces immunogenic cell death and STING pathway activation through cytoplasmic double-stranded DNA in glioblastoma cells. D. Chen. 7:30 to 9:30 p.m. MST Nov. 22. (Immunology/Basic Science)

(Abstract #: DRES-06) Prostaglandin E Receptor 3 mediates resistance to Tumor Treating Fields in glioblastoma cells. D. Chen. 7:30 to 9:30 p.m. MST Nov. 22. (Drug Resistance/Basic Science)

(Abstract #: EXTH-34) In vitro tumor treating fields (TTFields) applied prior to radiation enhances the response to radiation in patient-derived glioblastoma cell lines. S. Mittal. 7:30 to 9:30 p.m. MST Nov. 22. (Experimental Therapeutics/Basic Science)

(Abstract #: CSIG-20) Effect of tumor-treating fıelds (TTFields) on EGFR phosphorylation in GBM cell lines. M. Reinert. 7:30 to 9:30 p.m. MST Nov. 22. (Cell Signaling and Signaling Pathways/Basic Science)

(Abstract #: CBMT-14) The dielectric properties of brain tumor tissue. M. Proescholdt. 7:30 to 9:30 p.m. MST Nov. 22. (Cell Biology and Metabolism/Basic Science)

(Abstract #: CSIG-26) Is intrinsic apoptosis the signaling pathway activated by tumor-treating fields for glioblastoma. K. Carlson. 7:30 to 9:30 p.m. MST Nov. 22. (Cell Signaling and Signaling Pathways/Basic Science)

(Abstract #: ATIM-08) Trial in Progress: CA209-9Y8 phase 2 trial of tumor treating fields (TTFs), nivolumab plus/minus ipilimumab for bevacizumab-naïve, recurrent glioblastoma. Y. Odia. 7:30 to 9:30 p.m. MST Nov. 22. (Adult Clinical Trials – Immunologic/Clinical Research)

(Abstract #: ACTR-60) A phase 2, historically controlled study testing the efficacy of TTFields with adjuvant temozolomide in high-risk WHO grade II and III astrocytomas (FORWARD). A. Allen. 7:30 to 9:30 p.m. MST Nov. 22. (Adult Clinical Trials – Non-Immunologic/Clinical Research)

(Abstract #: TMIC-54) Comparison of cellular features at autopsy in glioblastoma patients with standard treatment of care and tumor treatment fields. A. Lowman. 7:30 to 9:30 p.m. MST Nov. 22. (Tumor Microenvironment/Basic Science)

(Abstract #: ACTR-26) Safety and efficacy of bevacizumab plus Tumor Treating Fields (TTFields) in patients with recurrent glioblastoma (GBM): data from a phase II clinical trial. J. Fallah. 7:30 to 9:30 p.m. MST Nov. 22. (Adult Clinical Trials – Non-immunologic/Clinical Research)

(Abstract #: RBTT-02) Radiosurgery followed by Tumor Treating Fields for brain metastases (1-10) from NSCLC in the phase 3 METIS trial. V. Gondi. 7:30 to 9:30 p.m. MST Nov. 22. (Randomized Brain Tumor Trials in Development/Clinical Research)

(Abstract #: INNV-16) Complete response of thalamic IDH wildtype glioblastoma after proton therapy followed by chemotherapy together with Tumor Treating Fields. M. Stein. 7:30 to 9:30 p.m. MST Nov. 22. (Innovations in Patient Care/Clinical Research)

(Abstract #: INNV-20) A systematic review of tumor treating fields therapy for primary for recurrent and glioblastoma. P. Shah. 7:30 to 9:30 p.m. MST Nov. 22. (Innovations in Patient Care/Clinical Research)

(Abstract #: STEM-16) Dual Inhibition of Protein Arginine Methyltransferase 5 and Protein Phosphatase 2a Enhances the Anti-tumor Efficacy in Primary Glioblastoma Neurospheres. H. Sur. 7:30 to 9:30 p.m. MST Nov. 22. (Stem Cells/Basic Science)

(Abstract #: CBMT-13) 3DEP system to test the electrical properties of different cell lines as predictive markers of optimal tumor treating fields (TTFields) frequency and sensitivity. M. Giladi. 5 to 7 p.m. MST Nov. 23. (Cell Biology and Metabolism/Basic Science)

(Abstract #: EXTH-37) A novel transducer array layout for delivering Tumor Treating Fields to the spine. Z. Bomzon. 5 to 7 p.m. MST Nov. 23. (Experimental Therapeutics/Basic Science)

(Abstract #: NIMG-41) Rapid and accurate creation of patient-specific computational models for GBM patients receiving Optune therapy with conventional imaging (T1w/PD). Z. Bomzon. 5 to 7 p.m. MST Nov. 23. (Neuro-Imaging/Clinical Research)

(Abstract #: HOUT-17) Utilities of rare cancers like malignant pleural mesothelioma and glioblastoma multiforme – do they compare? C. Proescholdt. 5 to 7 p.m. MST Nov. 23. (Health Outcome Measures/Clinical Research)

(Abstract #: INNV-17) Innovative educational approaches to enhance patient and caregiver understanding of Optune for glioblastoma. M. Shackelford. 5 to 7 p.m. MST Nov. 23. (Innovations in Patient Care/Clinical Research)

(Abstract #: EXTH-05) Therapeutic implications of TTFields induced DNA damage and replication stress in novel combinations for cancer treatment. N. Karanam. 5 to 7 p.m. MST Nov. 23. (Experimental Therapeutics/Basic Science)

(Abstract #: EXTH-31) Combination of tumor treating fields (TTFields) and paclitaxel produces additive reductions in proliferation and clonogenicity in patient-derived metastatic non-small cell lung cancer (NSCLC) cells. S. Michelhaugh. 5 to 7 p.m. MST Nov. 23 (Experimental Therapeutics/Basic Science)

(Abstract #: EXTH-53) Tumor Treating Fields leads to changes in membrane permeability and increased penetration by anti-glioma drugs. E. Chang. 5 to 7 p.m. MST Nov. 23. (Experimental Therapeutics/Basic Science)

(Abstract #: RDNA-01) Tubulin and microtubules as molecular targets for TTField therapy. J. Tuszynski. 5 to 7 p.m. MST Nov. 23. (Radiation Biology and DNA Repair/Basic Science)

(Abstract #: SURG-01) OptimalTTF-1: Final results of a phase 1 study: First glioblastoma recurrence examining targeted skull remodeling surgery to enhance Tumor Treating Fields strength. A. Korshoej. 5 to 7 p.m. MST Nov. 23. (Surgical Therapy/Clinical Research)

(Abstract #: ATIM-39) Phase 2 open-labeled study of adjuvant temozolomide plus Tumor Treating Fields plus Pembrolizumab in patients with newly diagnosed glioblastoma (2-THE-TOP). D. Tran. 5 to 7 p.m. MST Nov. 23. (Adult Clinical Trials – Immunologic/Clinical Research)

(Abstract #: ACTR-49) Initial experience with scalp preservation and radiation plus concurrent alternating electric tumor-treating fields (SPARE) for glioblastoma patients. A. Song. 5 to 7 p.m. MST Nov. 23. (Adult Clinical Trials – Non-Immunologic/Clinical Research)

(Abstract #: RTHP-25) TTFields dose distribution alters tumor growth patterns: An imaging-based analysis of the randomized phase 3 EF-14 trial. M. Ballo. 5 to 7 p.m. MST Nov. 23. (Radiation Therapy/Clinical Research)

(Abstract #: ACTR-19) Report on the combination of Axitinib and Tumor Treating Fields (TTFields) in three patients with recurrent glioblastoma. E. Schulz. 5 to 7 p.m. MST Nov. 23. (Adult Clinical Trials – Non-Immunologic/Clinical Research)

(Abstract #: PATH-47) TTF may apply selective pressure to glioblastoma clones with aneuploidy: a case report. M. Ruff. 5 to 7 p.m. MST Nov. 23. (Molecular Pathology and Classification – Adult and Pediatric/Clinical Research)

(Abstract #: RARE-39) Combination of Tumor Treating Fields (TTFields) with lomustine (CCNU) and temozolomide (TMZ) in newly diagnosed glioblastoma (GBM) patients – a bi-centric analysis. L. Lazaridis. 5 to 7 p.m. MST Nov. 23. (Rare Tumors/Clinical Research)

(Abstract #: ACTR-31) The use of TTFields for newly diagnosed GBM patients in Germany in routine clinical care (TIGER: TTFields in Germany in routine clinical care). O. Bahr. 5 to 7 p.m. MST Nov. 23. (Adult Clinical Trials – Non-Immunologic/Clinical Research)

(Abstract #: INNV-09) Clinical efficacy of tumor treating fields for newly diagnosed glioblastoma. Y. Liu. 5 to 7 p.m. MST Nov. 23. (Innovations in Patient Care/Clinical Research)

(Abstract #: EXTH-61) Celecoxib Improves Outcome of Patients Treated with Tumor Treating Fields. K. Swanson. 5 to 7 p.m. MST Nov. 23. (Experimental Therapeutics/Basic Science)

(Abstract #: INNV-23) Glioblastoma and Facebook: An Analysis Of Perceived Etiologies and Treatments. N. Reddy. 5 to 7 p.m. MST Nov. 23. (Innovations in Patient Care/Clinical Research)

(Abstract #: INNV-12) Outcomes in a Real-world Practice For Patients With Primary Glioblastoma: Impact of a Specialized Neuro-oncology Cancer Care Program. N. Banerji. 5 to 7 p.m. MST Nov. 23. (Innovations in Patient Care/Clinical Research)

(Abstract #: RBTT-11): NRG Oncology NRG-BN006: A Phase II/III Randomized, Open-label Study of Toca 511 and Toca FC With Standard of Care Compared to Standard of Care in Patients With Newly Diagnosed Glioblastoma. M. Ahluwalia. 5 to 7 p.m. MST Nov. 23. (Randomized Brain Tumor Trials Development/Clinical Research)