On November 14, 2019 ALX Oncology, a clinical-stage immuno-oncology company developing therapies to block the CD47 checkpoint mechanism, reported that ALX148 clinical results have been selected for presentation at the 61st ASH (Free ASH Whitepaper) Annual Meeting & Exposition, December 7 – 10, 2019, Orange County Convention Center, Orlando, FL (Press release, ALX Oncology, NOV 14, 2019, View Source [SID1234551314]).

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"This year’s ASH (Free ASH Whitepaper) meeting will be an opportunity to provide important clinical updates on our CD47 program in hematologic malignancies," said Sophia Randolph M.D., Ph.D., Chief Medical Officer of ALX Oncology. "We are excited to share the first clinical efficacy data from the combination of ALX148 with rituximab, showing that ALX148 maximizes clinical activity with a best-in-class safety profile. We are committed to further development of this agent with the potential to transform standards-of-care for patients with cancer."

Abstract Details
The presentation will include updated clinical data from the ongoing phase 1b study of ALX148, administered up to 15 mg/kg once weekly (molar equivalent to 30 mg/kg once weekly of an antibody), in combination with rituximab in patients with relapsed/refractory non-Hodgkin lymphoma.

Title: A Phase 1 Study of ALX148, a CD47 Blocker, in Combination with Rituximab in Patients with Non-Hodgkin Lymphoma
Session Name: 704. Immunotherapies: Poster I
Session Date: Saturday, December 7, 2019
Presentation Time: 5:30pm – 7:30pm
Location: Orange County Convention Center, Hall B
Publication Number: 1953

On November 14, 2019 The international medical imaging IT and cybersecurity company Sectra (STO: SECT B)reported that it will publish its interim report for the period May to October 2019 on November 29, 2019 (Press release, Sectra, NOV 14, 2019, View Source [SID1234551334]). Sectra invites analysts, investors, and the media to attend a teleconference/audiocast in conjunction with the publication of the report.

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Publication of the interim report: 8:15 a.m. (CET) November 29, 2019

Presentation and audiocast: 10:00 a.m. (CET) November 29, 2019

To participate, follow online at investor.sectra.com/q2report2019 or call one of the following numbers five to ten minutes before the conference begins:

SE: +46850558356
UK: +443333009261
US: +18338230586

Sectra management will present the interim report and answer any questions. The presentation will be held in English and a recorded version will be available via investor.sectra.com/q2report2019 after the conference.

Approximately 30 minutes before the start, a PDF version of the presentation will be available for download.

Sectra’s financial report calendar

March 4, 2020 at 08:15 a.m.: Nine-month interim report
June 3, 2020 at 8:15 a.m.: Year-end report 2019/2020
Further information about Sectra’s financial events and interim reports: investor.sectra.com/events-and-presentations/

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To subscribe to financial reports, invitations, and information from Sectra via email, please fill in your contact information at investor.sectra.com/subscribe

On November 14, 2019 Trovagene, Inc. (Nasdaq: TROV), a clinical-stage, Precision Cancer Medicine oncology therapeutics company developing drugs that target cell division (mitosis), for the treatment of various cancers including prostate, colorectal and leukemia, reported new positive data from its Phase 2 trial evaluating onvansertib in combination with Zytiga (abiraterone acetate – Johnson & Johnson)/prednisone in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) (Press release, Trovagene, NOV 14, 2019, View Source [SID1234551282]). The data are being presented today at the European Multidisciplinary Congress on Urological Cancers (EMUC) in Vienna, Austria.

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"The new data shared today builds upon the encouraging clinical response seen to date when onvansertib is added to treatment in patients who have developed resistance to androgen receptor signaling inhibitor (ARSi), Zytiga," said Dr. Mark Erlander, Chief Scientific Officer of Trovagene. "Of particular significance are the positive results we are observing in patients who harbor the highly aggressive, resistant variant of the androgen receptor (AR-V7). These patients are resistant to ARS inhibitors including Zytiga and Xtandi (enzalutamide – Pfizer) and their therapeutic options are not only limited, but often ineffective. We believe the addition of onvansertib has the potential to deliver transformative benefit to patients with mCRPC by extending the duration of response to treatment with ARS inhibitors."

Data Summary

The newly reported data include efficacy and safety assessments as of the October 28, 2019 data cut-off date for 15 patients that completed 3 months of treatment and were eligible for evaluation of the primary efficacy endpoint of disease control. Response to treatment was evaluated based on a decrease or stabilization in prostate specific antigen (PSA) values (primary endpoint) and confirmed by radiographic scans.

Efficacy
Overall, across both arms (A and B), a 60% response (SD + PR) was observed in patients who were evaluable for efficacy (completed 3 months of treatment); 72% of patients had a decrease in PSA following one cycle of treatment with onvansertib; 6 patients remain on treatment for ≥4 months.

Trovagene Inc. | 11055 Flintkote Avenue | San Diego | CA 92121 | Tel.: USA [+1] 888-391-7992

All 5 patients who tested positive for the highly-aggressive, resistant AR-V7 variant had decreases in PSA following one cycle of treatment with onvansertib; the primary efficacy endpoint (SD + PR) was achieved in 3 out of 4 evaluable patients (completing 12 weeks of treatment).
Safety
In both arms (A and B) onvansertib in combination with abiraterone was safe and well-tolerated. The most frequent adverse events (AEs) were expected, on-target (based on mechanism of action of onvansertib) hematologic (anemia, neutropenia, thrombocytopenia and white blood cell (WBC) decrease). All hematologic AEs were easily and effectively managed and resolved by delaying or reducing the dose and/or adding growth factor support. No unexpected or off-target AEs have been reported to-date.

About the Phase 2 Trial of Onvansertib in mCRPC
The trial is a Phase 2 open-label multi-center study of onvansertib in combination with Zytiga (abiraterone acetate)/prednisone in patients with mCRPC, showing signs of disease progression and resistance to Zytiga demonstrated by two rising PSA values separated by at least one week, while on Zytiga(NCT03414034). The primary efficacy endpoint is the proportion of patients achieving disease control after 12 weeks of study treatment, as defined by lack of prostate specific antigen (PSA) progression. The trial is being conducted by Beth Israel Deaconess Medical Center (BIDMC), Dana-Farber Cancer Institute (Dana-Farber), and Massachusetts General Hospital Cancer Center (MGH). David Einstein, MD, Genitourinary Oncology Program at BIDMC, is the principal investigator for the trial.
About Onvansertib
Onvansertib is a first-in-class, third-generation, oral and highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK1) enzyme, which is over-expressed in multiple cancers including leukemias, lymphomas and solid tumors. Onvansertib targets the PLK1 isoform only (not PLK2 or PLK3), is orally administered and has a 24-hour half-life with only mild-to-moderate side effects reported. Trovagene believes that targeting only PLK1 and having a favorable safety and tolerability profile, along with an improved dose/scheduling regimen will significantly improve on the outcome observed in previous studies with a former panPLK inhibitor in AML.
Onvansertib has demonstrated synergy in preclinical studies with numerous chemotherapies and targeted therapeutics used to treat leukemias, lymphomas and solid tumor cancers, including irinotecan, FLT3 and HDAC inhibitors, taxanes and cytotoxins. Trovagene believes the combination of onvansertib with other compounds has the potential to improve clinical efficacy in acute myeloid leukemia (AML), metastatic castration-resistant prostate cancer (mCRPC), non-Hodgkin lymphoma (NHL), colorectal cancer and triple-negative breast cancer (TNBC), as well as other types of cancer.
Trovagene has three ongoing clinical trials of onvansertib: A Phase 2 trial of onvansertib in combination with Zytiga (abiraterone acetate)/prednisone in patients with mCRPC who are showing signs of early progressive disease (rise in PSA but minimally symptomatic or

asymptomatic) while currently receiving Zytiga (NCT03414034); a Phase 1b/2 Study of onvansertib in combination with FOLFIRI and Avastin for second-line treatment in patients with mCRC with a KRAS mutation (NCT03829410); and a Phase 1b/2 clinical trial of onvansertib in combination with low-dose cytarabine or decitabine in patients with relapsed or refractory AML (NCT03303339). Onvansertib has been granted orphan drug designation by the FDA in the U.S. and by the EC in the European Union for the treatment of patients with AML.
Trovagene licensed onvansertib (also known as NMS-1286937 and PCM-075) from Nerviano Medical Sciences (NMS), the largest oncology-focused research and development company in Italy, and a leader in protein kinase drug development. NMS has an excellent track record of licensing innovative drugs to pharma/biotech companies, including Array (recently acquired by Pfizer), Ignyta (acquired by Roche) and Genentech.

On November 14, 2019 AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted priority review for the MEK 1/2 inhibitor selumetinib as a potential new medicine for pediatric patients aged three years and older with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs) (Press release, Merck & Co, NOV 14, 2019, View Source [SID1234551299]).

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This is the first acceptance of a regulatory submission for an oral MEK 1/2 monotherapy for patients with NF1, a rare and incurable genetic condition. A Prescription Drug User Fee Act (PDUFA) date is set for the second quarter of 2020.

This regulatory submission was based on positive results from the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP)-sponsored SPRINT Phase 2 Stratum 1 trial. An objective response rate (ORR) was achieved in 66% of pediatric patients with NF1 and symptomatic, inoperable PNs (n=33/50 patients) when treated with selumetinib as a twice-daily oral monotherapy. ORR was defined as the percentage of patients with a confirmed complete or partial response of ≥ 20% tumor volume reduction.

Selumetinib was granted U.S. FDA Breakthrough Therapy Designation for this population in April of 2019, U.S. FDA Orphan Drug Designation in February of 2018, EU Orphan Drug Designation by the European Medicines Agency in August 2018, and Swissmedic Orphan Drug Status in December 2018. AstraZeneca and Merck have a strategic collaboration agreement to co-develop and co-commercialize selumetinib globally.

About SPRINT
The SPRINT trial is a U.S. NCI CTEP-sponsored Phase 1/2 trial. The Phase 1 trial was designed to identify the optimal Phase 2 dosing regimen, and the results were published in the New England Journal of Medicine.

About Selumetinib
Selumetinib is an investigational MEK 1/2 inhibitor. It is designed to inhibit the MEK enzyme in the RAS/MAPK pathway, a cell-signaling pathway, associated with cancer cell growth and proliferation in a number of different tumor types.

About Neurofibromatosis Type 1 (NF1)
NF1 is an incurable genetic condition that affects one in every 3,000 to 4,000 individuals. It is caused by a spontaneous or inherited mutation in the NF1 gene and is associated with many symptoms, including soft lumps on and under the skin (cutaneous neurofibromas), skin pigmentation (so-called ‘cafe au lait’ spots) and, in 30-50% of patients, tumors develop on the nerve sheaths (plexiform neurofibromas). These plexiform neurofibromas can cause clinical issues such as pain, motor dysfunction, airway dysfunction, bowel/bladder dysfunction and disfigurement as well as having the potential to transform into malignant peripheral nerve sheath tumors (MPNST).

People with NF1 may experience a number of complications such as learning difficulties, visual impairment, twisting and curvature of the spine, high blood pressure, and epilepsy. NF1 also increases a person’s risk of developing other cancers, including malignant brain tumors, MPNST and leukemia. Symptoms begin during early childhood, with varying degrees of severity, and can reduce life expectancy by up to 15 years.

About the AstraZeneca and Merck Strategic Oncology Collaboration
In July 2017, AstraZeneca and Merck, known as MSD outside the United States and Canada, announced a global strategic oncology collaboration to co-develop and co- commercialize certain oncology products, including investigational selumetinib, a MEK inhibitor. Working together, the companies will develop selumetinib in combination with other potential new medicines and as monotherapy. Independently, the companies will develop selumetinib in combination with their respective PD-L1 and PD-1 medicines.

Merck’s Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

On November 14, 2019 Bicycle Therapeutics plc (NASDAQ: BCYC), a clinical-stage biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that management will present at the Jefferies 2019 London Healthcare Conference on Wednesday, November 20, 2019 at 2:40 p.m. GMT (9:40 a.m. ET) in London, England (Press release, Bicycle Therapeutics, NOV 14, 2019, View Source [SID1234551315]).

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A live webcast of the presentation can be accessed in the Investors & Media section of Bicycle’s website at www.bicycletherapeutics.com. An archived replay of the webcast will be available for 90 days following the presentation date.