On November 4, 2019 PhoreMost Limited, the UK-based biopharmaceutical company dedicated to drugging ‘undruggable’ disease targets, and Sentinel Oncology, reported an expansion of their collaboration to accelerate the progression of SOL686, a novel allosteric Polo-like kinase 1 (PLK1) inhibitor through preclinical development and IND enabling studies for the treatment of Glioma (Press release, PhoreMost, NOV 4, 2019, View Source [SID1234550261]).

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Mitotic PLKs are widely recognised as playing crucial roles in disease causing pathways, including K-Ras mutant cancers. Traditional approaches to drugging PLK enzymes have focused on targeting their active site; however this tactic has been hindered by toxicity-associated adverse events. Sentinel Oncology’s allosteric PLK1 inhibitor takes the novel approach of targeting the Polo-box domain (PBD) of the PLKs, thereby aiming to mitigate adverse events seen by active site inhibitors.

The programme has demonstrated a promising combination of specific drug-like properties, mode of action and target validation data obtained so far. Originating from the laboratory of Prof Ashok Venkitaraman at the University of Cambridge, PhoreMost subsequently developed the lead chemical series. Sentinel Oncology then optimised drug-like properties for the series and guided therapeutic positioning. Both PhoreMost and Sentinel Oncology received funding from Innovate UK for the drug discovery programme.

Dr Chris Torrance, CEO of PhoreMost, said: "We are delighted to deepen our long-standing association with Sentinel Oncology, and excited to be progressing this drug discovery programme towards the clinic. This lead compound exemplifies the value of PhoreMost’s strategy to use functional protein-protein interactions to drive the development of novel therapies, and to capitalise on its SITESEEKER platform to change the model of drug discovery through innovation, strategic partnerships and collaboration."

Robert Boyle, CEO of Sentinel Oncology, commented: "We are very excited about the prospects for this programme, and to be collaborating with PhoreMost to advance our allosteric PLK1 inhibitor. The programme adds to our NeuroOncology pipeline, has started formal preclinical studies and is well positioned to enter clinical development as a glioma treatment by 2021."

On November 4, 2019 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for translational research and molecular diagnostic products, reported the availability of its new GeoMx Cancer Transcriptome Atlas through the Technology Access Program (TAP) for the GeoMx Digital Spatial Profiler (DSP) (Press release, NanoString Technologies, NOV 4, 2019, View Source [SID1234550260]).

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This new high-plex RNA expression profiling panel provides the most informed view of the cancer transcriptome based on evidence from the Cancer Genome Atlas Program as well as important immuno-oncology biology. The assay is compatible with both fresh frozen (FF) and Formalin-Fixed Paraffin-Embedded tissue (FFPE) enabling researchers to access more samples to power their studies. NanoString’s GeoMx DSP is used to prepare the sample for spatial analysis using a read-out chemistry designed to be compatible with Illumina’s next-generation sequencing instruments.

"Over the last year we’ve generated strong demand for our GeoMx Digital Spatial Profiler in the translational medicine market," said Brad Gray, president and CEO of NanoString. "The launch of this high-plex RNA assay marks the next phase of our market development activities in which we plan to expand into the large market for discovery applications by leveraging next-generation sequencing read-out to achieve an unprecedented level of multiplex profiling with spatial context."

The GeoMx Cancer Transcriptome Atlas expands on the nCounter PanCancer series of gene expression panels by combining the content from the PanCancer Pathways, PanCancer Immune Profiling and the IO 360 panels with additional gene content. Under the program, a TAP partner can submit FFPE tissue sections to NanoString and NanoString will run the GeoMx Cancer Transcriptome Atlas and provide the analysis report back to the partner.

Researchers interested in participating in NanoString’s technology access program should contact us at [email protected].

On November 4, 2019 RhoVac AB ("RhoVac") reported that the first patient has been screened for the company’s clinical phase IIb study in prostate cancer, a study entitled RhoVac-002 ("BRaVac") (Press release, RhoVac, NOV 4, 2019, View Source [SID1234550259]). The screening took place at the Odense University Hospital.

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BRaVac is a randomized, placebo-controlled and double-blinded study in prostate cancer, with the primary end-point of evaluating if and to what extent treatment with the drug candidate RV001 can prevent or limit the development of cancer measured as a more limited development of PSA (prostate specific antigen) in treated patients compared to the control group (placebo group). The clinical phase IIb study is an international, multicenter study, which is expected to recruit over 175 patients in six European countries (Denmark, Finland, Sweden, United Kingdom, Belgium and Germany), as well as the United States. The first patient is now screened for the study and the ambition is that all patients will be recruited in Q3 2020. The study results on the primary end-points are expected to be reported in 2021.

Anders Ljungqvist, COO: "It has been a challenge to start this large clinical phase IIb study in the summer holiday period, and it is therefore particularly gratifying that the first patient is now screened at Odense University Hospital. Other clinical sites in Denmark are ready to screen patients and Finland is the next country to open up for screening."

Anders Månsson, CEO: "The last few months have been very intense at RhoVac – we have received approval from the Danish authorities to start the clinical phase IIb study, and FDA has also stated, in a pre-IND, a positive opinion on starting the clinical phase IIb trial in the United States. We have also received approval to start the study in Finland. In addition, only a few months ago we completed a new rights issue that will fund the current clinical study, and we applied for and also received a grant of EUR 2.5 million from the EU Research and Innovation Fund Horizon2020. In July 2019, we presented the 12-month follow-up study from the clinical phase I/II-study showing good and stable results over time. The fact that we now have screened our first patient for the clinical phase IIb trial is an extremely important milestone for RhoVac! I would also like to extend my gratitude to all employees and consultants who have worked tirelessly to take the project to the point where it is today. Phase IIb is extremely well prepared, and with this, RhoVac is entering its last development phase, and as a result of this the partnering discussions will advance further."

On November 4, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported strategic actions to reposition the Company with a focus solely on its ENHANZE drug delivery technology (Press release, Halozyme, NOV 4, 2019, View Source [SID1234550258]).

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In order to implement this strategic shift, Halozyme will immediately initiate an organizational restructuring to halt development activities for PEGPH20 and close its oncology operations. As a result, Halozyme expects the following:

Headcount will be reduced by approximately 55%, or approximately 160 positions, with over 80% of the reduction completed in early January 2020.
Restructuring and other cost saving efforts will result in savings of $130 to $140 million in 2020 compared with the Company’s most recent guidance for 2019 operating expenses excluding cost of goods sold.
Upon completion of the restructuring and after booking all related one-time charges, Halozyme anticipates becoming a sustainably profitable company beginning in the second quarter of 2020.
Projected annualized operating expenses excluding cost of goods sold of between $65 million and $75 million will be achieved by the fourth quarter of 2020.
The Company expects to book separation and contract termination fees in the fourth quarter of 2019 and will provide further details during its third quarter 2019 financial results webcast and conference call on Tuesday, November 12.

The go-forward organization will comprise approximately 120 employees focused on driving the continued growth of ENHANZE, specifically in areas that are critical to supporting partners such as manufacturing, quality, regulatory and product development. An additional 12 employees will continue promoting the Company’s commercial drug Hylenex.

The Company’s ENHANZE business continues to grow with three commercial products and 11 products currently in clinical trials. Halozyme will provide a more detailed update for its ENHANZE business during its third quarter financial results webcast and conference call.

Halozyme’s Board of Directors has also authorized the initiation of a capital return program to repurchase up to $350 million of the Company’s outstanding common stock over the next three years. The timing of share repurchases and the number of shares of common stock that are repurchased will depend on market conditions and other factors. Repurchases may be commenced or suspended at any time or from time-to-time at the Company’s discretion without prior notice. Repurchases may be made through both public market and private transactions. The Board will regularly review this capital return policy in connection with a balanced capital allocation strategy.

"Our mission now is to transition our strategy to focus on our high-growth, high-margin ENHANZE drug delivery technology platform," said Dr. Helen Torley, president and CEO of Halozyme. "Our ENHANZE business is well positioned for this growth, supported by strong partnerships with leading brands and a promising development pipeline. As a result, Halozyme now has a clear path to near-term, sustainable profitability with strong cash flows and high growth prospects. In addition, our share repurchase program reflects our continued commitment to creating value for our shareholders and to implementing a capital return philosophy aligned with our new company profile."

Dr. Torley continued, "The results of the well-designed and well-executed HALO-301 study were not what we wanted or expected. I wish to extend my deep appreciation for all who supported this study and made it possible, in particular the patients, their families, our investigators and their staff, our investors and the Halozyme team."

The actions taken by the Company follow the results of its HALO-301 Phase 3 clinical study, which were disclosed in a separate press release issued today.

Conference Call and Webcast Information
Halozyme will webcast a conference call today at 8:30 a.m. ET / 5:30 a.m. PT to discuss its plans to focus strategy on its ENHANZE drug delivery technology. Dr. Helen Torley, president and chief executive officer, will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website and a replay will be available following the close of the call. To access the webcast, please visit www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The call may also be accessed by dialing (877) 824-0907 (domestic callers) or (647) 689-5655 (international callers) using passcode 3069304. A telephone replay will be available after the call by dialing (800) 585-8367 (domestic callers) or (416) 621-4642 (international callers) using replay ID number 3069304.

On November 4, 2019 Alkermes plc (Nasdaq: ALKS) reported that it will present new data from its ARTISTRY clinical development program related to ALKS 4230, an investigational engineered fusion protein designed to selectively expand cancer-fighting immune cells, at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting being held Nov. 6-10, 2019 in National Harbor, MD (Press release, Alkermes, NOV 4, 2019, View Source [SID1234550257]). The company will present preliminary clinical data from the ARTISTRY-1 phase 1/2 study investigating ALKS 4230 as monotherapy and in combination with pembrolizumab in adults with advanced solid tumors, and study design details and preliminary safety data from the ARTISTRY-2 phase 1/2 study evaluating subcutaneous administration of ALKS 4230 as monotherapy and in combination with pembrolizumab. The SITC (Free SITC Whitepaper) posters and a corporate presentation related to the ALKS 4230 program will be posted on the Investors section of the company’s website, available at www.alkermes.com, on Friday, Nov. 8.

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Alkermes’ planned presentations at SITC (Free SITC Whitepaper) will include:

Poster #447: "ALKS 4230, an Engineered IL-2 Fusion Protein, in Monotherapy Dose-Escalation and Combination Therapy With Pembrolizumab in Patients With Solid Tumors: ARTISTRY-1 Trial," will be presented by Ulka N. Vaishampayan, M.D., Karmanos Cancer Institute at Wayne State University
Poster #441: "ARTISTRY-2: A Phase 1/2 Study of Subcutaneously Administrated ALKS 4230 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors," will be presented by John Powderly, M.D., President and CEO of Carolina BioOncology Institute
The poster sessions will take place in Prince George’s Exhibition Hall (A and B) on Friday, Nov. 8 from 12:30 – 2:00 p.m. ET and 6:30 – 8:00 p.m. ET. For more information, including a complete list of abstracts, please visit the SITC (Free SITC Whitepaper) website at View Source

About ALKS 4230
ALKS 4230 is a novel, engineered fusion protein comprised of modified interleukin-2 (IL-2) and the high affinity IL-2 alpha receptor chain, designed to selectively expand tumor-killing immune cells while avoiding the activation of immunosuppressive cells by preferentially binding to the intermediate-affinity IL-2 receptor complex. The selectivity of ALKS 4230 is designed to leverage the proven anti-tumor effects of existing IL-2 therapy while mitigating certain limitations.

About the ARTISTRY Clinical Development Program
ARTISTRY is an Alkermes-sponsored clinical development program evaluating ALKS 4230 in patients with advanced solid tumors. ARTISTRY-1 is an ongoing phase 1/2 study in which ALKS 4230 is administered as an intravenous infusion daily for five consecutive days. ARTISTRY-1 has three distinct stages: an ongoing monotherapy dose-escalation stage, a recently initiated monotherapy expansion stage, and an ongoing combination therapy stage with the PD-1 inhibitor KEYTRUDA (pembrolizumab) in patients with select advanced solid tumors.

ARTISTRY-2 is an ongoing phase 1/2 study of ALKS 4230 administered subcutaneously as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. ARTISTRY-2 is designed to explore the safety, tolerability and efficacy of ALKS 4230 administered subcutaneously and assess once-weekly and once-every-three-week dosing schedules.