On December 6, 2021 BostonGene Corporation, a biomedical software company committed to defining optimal precision medicine-based therapies for cancer patients, reported that seven abstracts were selected for presentations at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, BostonGene, DEC 6, 2021, View Source [SID1234596513]). The event will be held from December 11 – 14, 2021 at the Georgia World Congress Center. BostonGene will exhibit in booth #3765.

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"We’re honored to have multiple presentations accepted by the ASH (Free ASH Whitepaper) Program Committee. Our presentations underscore the power of integrated analysis to discover distinct characteristics of the tumor microenvironment associated with clinical outcome to diverse therapeutic regimens in lymphoma," said Nathan Fowler, MD, Chief Medical Officer at BostonGene.

Details of the oral and poster presentations are below:

Oral presentations:

Title: High Rates of Remission with the Initial Treatment of Oral Azacitidine Plus CHOP for Peripheral T-Cell Lymphoma (PTCL): Clinical Outcomes and Biomarker Analysis of a Multi-Center Phase II Study
Abstract Number: 138
Session: 624. Hodgkin Lymphomas and T/NK cell Lymphomas
Time and Location: Saturday, December 11, 2021: 1:15 PM, Thomas Murphy Ballroom 3-4
Presenter: Jia Ruan, MD, PhD, Weill Cornell Medicine and New York Presbyterian Hospital

Research conducted by Weill Cornell Medicine, Memorial Sloan Kettering Cancer Center, Washington University School of Medicine, Moffitt Cancer Center and BostonGene.

Title: Phase 2 Study of Acalabrutinib Window Prior to Frontline Therapy in Untreated Aggressive B-Cell Lymphoma: Preliminary Results and Correlatives of Response to Acalabrutinib
Abstract Number: 524
Session: 626. Aggressive Lymphomas Prospective Therapeutic Trials
Time and Location: Sunday, December 12, 2021: 4:45 PM, Thomas Murphy Ballroom 1-2
Presenter: Mark Roschewski, MD, National Cancer Institute, National Institutes of Health

Research conducted by the National Cancer Institute (NCI), the National Institute of Allergy and Infectious Diseases (NIAID), both part of the National Institutes of Health (NIH), Stanford University and BostonGene.

Title: The Combination of Duvelisib and Romidepsin (DR) Is Highly Active Against Relapsed/Refractory Peripheral T-Cell Lymphoma with Low Rates of Transaminitis: Final Results and Biomarker Analysis
Abstract Number: 619
Session: 624. Hodgkin Lymphomas and T/NK cell Lymphomas
Time and Location: Monday, December 13, 2021: 10:30 AM, Hall A1
Presenter: Steven Horwitz, MD, Memorial Sloan Kettering Cancer Center

Research conducted by Memorial Sloan Kettering Cancer Center, Dana Farber Cancer Institute, Harvard Medical School, Washington University in St. Louis, Stanford University and BostonGene.

Poster presentations:

Title: HHV-6 in the Lymphoma Microenvironment: Both Chicken and Egg?
Abstract Number: 1377
Session: 624. Hodgkin Lymphomas and T/NK cell Lymphomas
Time and Location: Saturday, December 11, 2021: 5:30 PM – 7:30 PM
Presenter: Genevieve Crane, MD, PhD, Cleveland Clinic

Research conducted by Weill Cornell Medicine, Cleveland Clinic, Memorial Sloan Kettering Cancer Center, Columbia University and BostonGene.

Title: Immune-Depleted Tumor Microenvironment Signature Is Associated with BTK Inhibitor Resistance in Mantle Cell Lymphoma
Abstract Number: 1321
Session: 621. Lymphomas: Translational—Molecular and Genetic
Time and Location: Saturday, December 11, 2021: 5:30 PM – 7:30 PM, Hall B5
Presenter: Preetesh Jain, MBBS, MD, DM, PhD, The University of Texas MD Anderson Cancer Center

Research conducted by MD Anderson and BostonGene.

Title: A Prospective Study of Clonal Evolution in Follicular Lymphoma: Circulating Tumor DNA Correlates with Overall Tumor Burden and Fluctuates over Time without Therapy
Abstract Number: 524
Session: 621. Lymphomas
Time and Location: Saturday, December 11, 2021, 5:30 PM – 7:30 PM, Hall B5
Presenter: Allison Distler, National Cancer Institute, National Institutes of Health and George Washington University

Research conducted by the National Cancer Institute (NCI), National Institutes of Health (NIH), George Washington University, Adaptive Biotechnologies and BostonGene.

Title: Topographic Analysis of Low-Grade Myeloid Neoplasms By Multiparametric in Situ Imaging of Human Bone Marrow Core Biopsy Tissues
Abstract Number: 2593
Session: 636. Myelodysplastic Syndromes—Basic and Translational
Time and Location: Sunday, December 12, 2021: 6:00 PM – 8:00 PM, Hall B5
Presenter: Sanjay Patel, MD, MPH, MSc, Weill Cornell Medicine

Research conducted by Weill Cornell Medicine and BostonGene.

In addition to the oral and poster presentations, the abstracts have been published online in the November supplemental issue of "Blood".

On 6 December 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, DEC 6, 2021, View Source [SID1234596534]). This programme is part of the overall share repurchase programme of up to DKK 20 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 5 November 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.7 billion in the period from 11 November 2021 to 1 February 2022.

Since the announcement 29 November 2021, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 29,908,560 B shares of DKK 0.20 as treasury shares, corresponding to 1.3% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 20 billion during a 12- month period beginning 3 February 2021. As of 3 December 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 31,155,009 B shares at an average share price of DKK 563.25 per B share equal to a transaction value of DKK 17,547,995,580.

On December 06, 2021 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that new data from the ongoing Phase 1 study of SRF617, an antibody targeting CD39, will be presented in a scientific poster at the European Society for Medical Oncology Immuno-Oncology Congress (ESMO-IO), to be held virtually from December 8-11, 2021 (Press release, Surface Oncology, DEC 6, 2021, View Source [SID1234596482]).

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"Results from this first-in-human dose-escalation study of SRF617 show promising signs of activity, both as a monotherapy and in combination with chemotherapy and pembrolizumab in both immune checkpoint naïve and experienced patients," said Alison O’Neill, M.D., chief medical officer. "We are currently enrolling Phase 2 cohorts for patients with PD-1 naïve gastric cancer and patients with PD-1 relapsed/refractory gastric or non-small-cell lung cancer (NSCLC) and look forward to opening first-line pancreatic cancer cohorts soon."

Safety Overview

The recommended Phase 2 dose for SRF617 monotherapy has been determined to be 1400 mg Q2W based on aggregate review of safety, clinical PK/PD and preclinical data.
No instances of dose-limiting toxicity were observed through dose escalation to the 1400 mg dose level.
Monotherapy Highlights

PK are linear and correlate strongly with PD target occupancy. SRF617 is well-tolerated at doses that sustain full target occupancy throughout the dosing interval and demonstrate dose-dependent loss of CD39 on B cells. Early data from a patient undergoing paired tumor biopsy show marked decrease of CD39 expression in the tumor microenvironment following SRF617 treatment.
Ten of 32 evaluable patients (31%) receiving SRF617 as a monotherapy had disease stabilization at eight weeks, with four (12%) persisting beyond 16 weeks.
One patient with NSCLC whose disease previously progressed on chemotherapy and PD-1 blockade had prolonged disease stabilization beyond 24 weeks.
Combination Highlights

The recommended Phase 2 dose for SRF617 in combination with pembrolizumab has also been determined to be 1400 mg Q2W.
Of patients treated with SRF617 in combination with pembrolizumab (KEYTRUDA), four of eight evaluable patients (50%) had disease stabilization at six weeks, with three of the eight exhibiting disease control at 12 weeks and one beyond 20 weeks.
Of patients treated with SRF617 in combination with gemcitabine/albumin-bound paclitaxel (Abraxane), there was one confirmed partial response in a patient with pancreatic cancer whose disease had progressed on prior chemotherapy. The SRF617 1400mg dose cohort is currently enrolling.
About the SRF617-101 Clinical Trial:

The trial is a Phase 1, open-label, multicenter, first-in-human dose-escalation trial of SRF617, a monoclonal antibody that binds and inhibits CD39 activity, in patients with advanced solid tumors. The monotherapy dose escalation portion of the study evaluates the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of SRF617 as a monotherapy in patients with advanced solid tumors. The combination therapy dose escalation portion of the study evaluates the safety, tolerability, PK and preliminary efficacy of SRF617 in combination with gemcitabine + albumin-bound paclitaxel, or SRF617 in combination with pembrolizumab, in patients with locally advanced or metastatic solid tumors.

About SRF617:

SRF617 is a fully human antibody designed to inhibit the enzymatic activity of CD39 in the tumor microenvironment, allowing for a dual mechanism of action to promote anti-tumor immunity via reduction of immunosuppressive adenosine in addition to increasing levels of immunostimulatory ATP. A substantial body of research supports a role for CD39 in allowing cancer to evade immune responses. For example, pancreatic cancer stromal cells within the tumor micro-environment express high levels of CD39, which may inhibit anti-cancer immune responses. In preclinical studies, SRF617 has exhibited strong affinity for and inhibition of CD39, the ability to reduce adenosine and increase ATP levels and anti-tumor activity both as a single agent and in combination with multiple therapeutic agents. SRF617 has been granted Orphan Drug designation for the treatment of advanced pancreatic cancer by the FDA.

On December 6, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that it has submitted its New Drug Application (NDA) for poziotinib to the U.S. Food and Drug Administration (FDA) for use in patients with previously treated locally advanced or metastatic non-small cell lung cancer (NSCLC) with HER2 exon 20 insertion mutations (Press release, Spectrum Pharmaceuticals, DEC 6, 2021, View Source [SID1234596498]). The NDA submission is based on the positive results of Cohort 2 from the ZENITH20 clinical trial, which assessed the safety and efficacy of poziotinib. The product has received Fast Track designation and there is currently no treatment specifically approved by the FDA for this indication.

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"The NDA submission for poziotinib marks an important step in achieving a first treatment for patients with HER2 exon 20 insertion mutations in lung cancer," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals. "I want to thank the patients, investigators and our internal staff who have passionately worked to achieve this important milestone in an area of high unmet medical need."

ZENITH20 Cohort 2 Clinical Results Summary

Results for Cohort 2 of the ZENITH20 clinical trial have been published in the Journal of Clinical Oncology (November 29, 2021), and can be accessed by clicking here.

Cohort 2 enrolled 90 patients who received an oral once daily dose of 16 mg of poziotinib. The intent-to-treat analysis demonstrated a confirmed objective response rate (ORR) of 27.8% (95% Confidence Interval (CI), 18.9%-38.2%). The observed lower bound of 18.9% exceeded the pre-specified lower bound of 17%. The median duration of response was 5.1 months and the median progression free survival was 5.5 months. In this cohort, 87% of patients had drug interruptions with 11 patients (12%) permanently discontinuing due to adverse events. 13 patients (14%) had treatment-related serious adverse events. As previously announced, the company had a successful pre-NDA meeting with the FDA which resulted in an agreement to submit an NDA for poziotinib. During the meeting, Spectrum confirmed with the FDA that Cohort 2 data could serve as the basis of an NDA submission. The company will continue to work with the FDA as appropriate, while the agency conducts its review.

About the ZENITH20 Clinical Trial

The ZENITH20 study consists of seven cohorts of NSCLC patients. Cohorts 1 (EGFR) and 2 (HER2) in previously treated NSCLC patients with exon 20 mutations and Cohort 3 (EGFR) in first-line patients have completed enrollment. Cohort 4 (HER2) in first-line NSCLC patients with exon 20 mutations is still enrolling patients. Cohorts 1- 4 are each independently powered for a pre-specified statistical hypothesis and the primary endpoint is objective response rate (ORR). Cohort 5 includes previously treated or treatment-naïve NSCLC patients with EGFR or HER2 exon 20 insertion mutations. Cohort 6 includes NSCLC patients with classical EGFR mutations who progressed while on treatment with first-line osimertinib and developed an additional EGFR mutation. Cohort 7 includes NSCLC patients with a variety of less common mutations in EGFR or HER2 exons 18-21 or the extracellular or transmembrane domains.

December 6, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported it will present new data demonstrating the benefits of using the Guardant360 liquid biopsy test to help guide targeted therapy options for patients with advanced breast cancer at the 2021 San Antonio Breast Cancer Symposium (SABCS) on December 7-11 (Press release, Guardant Health, DEC 6, 2021, View Source [SID1234596514]). These studies were based on data from the GuardantINFORM real-world clinical genomic platform, which features extensive de-identified genomic data and aggregated commercial payer claims from advanced cancer patients who received the Guardant360 liquid biopsy assay.

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Data from one study (Abstract P5-13-29) confirmed that patients with BRCA1/2 reversion mutations, thought to cause acquired therapeutic resistance, experienced worse survival outcomes when treated with a PARP inhibitor as compared to patients without reversion mutations. The study also validates recent advancements in homologous recombination deficiency (HRD) assessment in the Guardant360 lab developed test (LDT), detecting additional inactivating alterations in BRCA1/2, including copy number loss and large genomic rearrangements. These data further demonstrate the Guardant360 test’s ability to reliably identify patients with advanced breast cancer who are most likely to benefit from PARP inhibitor treatment.

Another study (Abstract P1-18-07) using the GuardantINFORM platform demonstrated that, for advanced breast cancer patients with PIK3CA mutations identified using the Guardant360 liquid biopsy and subsequently treated with alpelisib, there was no significant difference in treatment outcomes regardless of whether they had clonal or subclonal PIK3CA mutations. This suggests patients with these mutations may benefit from alpelisib targeted therapy irrespective of mutation clonality.

"These studies further support the tremendous value that our Guardant360 liquid biopsy test and GuardantINFORM real-world clinical genomic platform bring to physicians, and most importantly the patients they treat," said Helmy Eltoukhy, Guardant Health Co-CEO. "Guardant360 identifies mutations driving the cancer, which enables the physician to match a patient with the right precision therapy without the need for a tissue biopsy, which can be difficult and time-consuming, potentially delaying treatment for patients with advanced breast cancer."

Full List of Guardant Health Presentations:

Analytical and clinical validation of a ctDNA assay for detecting copy number loss and structural rearrangement variants contributing to homologous recombination and repair (HRR) deficiency (Abstract Number: P5-13-29)
Impact of PIK3CA mutation (PIK3CA-mt) clonality on alpelisib (ALP) activity based on real-world evidence (RWE) following liquid biopsy testing (Abstract Number: P1-18-07)
SOLTI-1903 HOPE: Real-world clinical practice study to assess the impact of using genomic data on the next treatment decision making-choice in patients with locally advanced or metastatic breast cancer in Spain (Abstract Number: OT2-06-01)
Early changes in circulating tumor DNA and its effect on clinical outcomes in patients with advanced breast cancer receiving the CDK4/6 inhibitor palbociclib: Genotyping results from POLARIS (Abstract Number: P1-18-05)
The full abstracts can be found at the official SABCS website here.

About the Guardant360 Liquid Biopsy Test

The Guardant360 liquid biopsy test is part of the market leading Guardant360 portfolio that offers oncologists end-to-end testing solutions from treatment selection to treatment response monitoring. Since it was first introduced, the Guardant360 liquid biopsy test has become widely accepted for blood-based comprehensive genomic profiling (CGP) with more than 250 peer-reviewed publications including over 60 clinical outcomes studies. It has been trusted by more than 9,000 oncologists with more than 200,000 tests performed to date.

About GuardantINFORM

The GuardantINFORM clinical-genomic platform is intended to help accelerate research and development of the next generation of cancer therapeutics by offering biopharma partners an in-silico platform that combines de-identified longitudinal clinical information and genomic data collected from the Guardant360 liquid biopsy test. With data from more than 160,000 patients diagnosed with locally advanced and metastatic cancers, this robust dataset offers real-world insights into anti-cancer therapy use in the clinic, tumor evolution, and treatment resistance throughout each patient’s treatment journey for many advanced solid tumor cancers, including non-small cell lung, breast, colon, and prostate.