On May 19, 2021 Exact Sciences Corp. (NASDAQ: EXAS), a global leader in cancer diagnostics, reported new data on its cancer tests and treatment guidance tools will be showcased in seven presentations and one e-abstract at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held virtually June 4-8 (Press release, Exact Sciences, MAY 19, 2021, View Source [SID1234580284]). Data presented will reinforce the value of the Oncotype DX tests in informing personalized treatment decisions and highlight industry research from Thrive, an Exact Sciences company, outlining the need to incorporate a blood-based, multi-cancer screening test into routine clinical care.

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Exact Sciences Strengthens Evidence Supporting Cologuard and Oncotype DX Tests w Multiple Data Presentations @ASCO ’21
"We’re thrilled to participate in ASCO (Free ASCO Whitepaper), alongside our collaborators at leading academic and medical institutions," said Kevin Conroy, chairman and CEO of Exact Sciences. "Exact Sciences is changing the way we detect and treat cancer. The data being presented demonstrate our commitment to providing earlier answers and life-changing treatment guidance to patients and physicians, while strengthening our current tests and accelerating the introduction of new, innovative diagnostics."

Studies supporting Exact Sciences screening and earlier detection efforts consist of a Cologuard (mt-sDNA) modeling study in collaboration with Mayo Clinic to assess the impact of sessile serrated polyps on predicted colorectal cancer outcomes with Cologuard or FIT screening1, and clinical research from Thrive that emphasizes the need for integrating a multi-cancer screening test into the standard of care2.

Data being presented on the Oncotype DX test portfolio include a new analysis, based on first results from the independent RxPONDER study, that reinforce the cost-effectiveness of the Oncotype DX Breast Recurrence Score test in node-positive early-stage breast cancer3; an oral presentation from the West German Study Group (WSG) on the prospective phase III ADAPT study which used the Oncotype DX test to stratify patients with early-stage breast cancer4; and results from a patient-specific meta-analysis of three validation studies of the Oncotype DX Colon Recurrence Score test5.

Also being presented are findings from City of Hope’s Center for Precision Medicine that emphasize a comprehensive sequencing approach to help guide cancer treatment and assess risk for cancer and non-cancer diseases, using Exact Sciences’ GEM ExTra panel6, and early study results from PFS Genomics Inc., a development stage company founded by radiation oncologists, recently acquired by Exact Sciences. PFS Genomics has identified a gene expression signature, named Profile for the Omission of Local Adjuvant. Radiation (POLAR), to predict whether women with early-stage invasive breast cancer, treated with breast conserving surgery, are likely to benefit from radiotherapy7.

Following are the seven abstracts that have been accepted at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting. The on-demand materials, including posters, will be available in the ASCO (Free ASCO Whitepaper) Meeting Library, starting at 9:00AM EDT on June 4, 2021.

Impact of the Sessile Serrated Polyp Pathway on Predicted Colorectal Cancer Outcomes in the CRC-AIM Model
Authors: Kisiel, J., et al.
Session: Prevention, Risk Reduction, and Hereditary Cancer
Abstract Number: 10545

Cancer screening utilization in patients diagnosed with cancer types with and without recommended screening modalities
Authors: Cohain, A., et al.
Session: Prevention, Risk Reduction, and Hereditary Cancer
Abstract Number: 10557

Utilizing commercial health insurance claims data to identify the impact of cancer screening and estimate the added benefit of a multi-cancer liquid biopsy ordered during routine physical exams
Authors: Cohain, A., Hathaway, C., et al.
Session: Publication Only: Prevention, Risk Reduction, and Hereditary Cancer
Abstract Number: e22516

Cost-effectiveness of Oncotype DX Breast Recurrence Score test in postmenopausal women with node-positive early breast cancer based on the RxPONDER trial
Authors: Berdunov, V., et al.
Session: Breast Cancer – Local/Regional/Adjuvant
Abstract Number: 534

Prognostic impact of Recurrence Score, endocrine response and clinical-pathological factors in high-risk luminal breast cancer: Results from the WSG-ADAPT HR+/HER2- chemotherapy trial
Authors: Gluz, O., et. al
Session: Breast Cancer – Local/Regional/Adjuvant
Abstract Number: 504; Oral presentation on June 6, 2021 at 8 AM EDT.

Discovery and validation of a genomic signature to identify women with early-stage invasive breast cancer who may safely omit adjuvant radiotherapy after breast-conserving surgery
Authors: Sjöström, M., et al.
Session: Breast Cancer – Local/Regional/Adjuvant
Abstract Number: 512

Patient-specific meta-analysis of 3 validation studies of the 12-gene Colon Cancer Recurrence Score Assay for recurrence risk assessment after surgery with or without 5FU and oxaliplatin.
Authors: Yothers, G., et al.
Session: Gastrointestinal Cancer – Colorectal and Anal
Abstract Number: 3599

Prospective genomic testing of unselected cancer patients yields insights about cancer susceptibility and non-cancer disease with therapeutic implications
Authors: Gray, S., et al
Session: Prevention, Risk Reduction, and Hereditary Cancer
Abstract Number: 10603

On May 19, 2021 Incyte (Nasdaq: INCY) reported that multiple abstracts highlighting data from its oncology portfolio will be presented during the upcoming 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held virtually from June 4-8, 2021 (Press release, Incyte, MAY 19, 2021, View Source [SID1234580283]).

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"We look forward to presenting data from across Incyte’s oncology portfolio and partner programs at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting," said Steven Stein, M.D., Chief Medical Officer, Incyte. "Data being presented during this congress, including new three-year data from the L-MIND study of tafasitamab in relapsed or refractory diffuse large B-cell lymphoma as well as results of the OPTIC study of ponatinib in chronic phase-chronic myeloid leukemia, underscore our continued focus on advancing science to help meet patients’ needs."

Key abstracts accepted by ASCO (Free ASCO Whitepaper) include:

Oral Presentations

Ponatinib

OPTIC Primary Analysis: A Dose-Optimization Study of 3 Starting Doses of Ponatinib (PON)1(Abstract #7000. Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant.)

Poster Discussions

Tafasitamab

Long-Term Analyses from L-MIND, a Phase 2 Study of Tafasitamab (MOR208) Combined with Lenalidomide (LEN) in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)2 (Abstract #7513. Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia.)

Capmatinib

Capmatinib in MET Exon 14-Mutated, Advanced NSCLC: Updated Results from the GEOMETRY Mono-1 Study3(Abstract #9020. Session: Lung Cancer—Non-Small Cell Metastatic.)

ePosters

Capmatinib

Capmatinib Efficacy in Patients with NSCLC Identified as METex14 Using an NGS-Based Liquid Biopsy Assay: Results from the GEOMETRY Mono-1 Study3(Abstract #9111. Session: Lung Cancer—Non-Small Cell Metastatic.)

Patient-Reported Outcomes in Capmatinib-Treated Patients with METex14-Mutated Advanced NSCLC: Results from the Phase 2 GEOMETRY Mono-1 Study3(Abstract #9056. Session: Lung Cancer—Non-Small Cell Metastatic.)

Phase 1b/2 Study of Capmatinib Plus Gefitinib in Patients with EGFR-Mutated, MET-Dysregulated Non–Small Cell Lung Cancer who Received Prior Therapy: Final Overall Survival and Safety3(Abstract #9048. Session: Lung Cancer—Non-Small Cell Metastatic.)

Pemigatinib

Pemigatinib for Previously Treated Locally Advanced/Metastatic Cholangiocarcinoma (CCA): Update of FIGHT-202 (Abstract #4086. Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary.)

Retifanlimab

Phase 2 Study of Retifanlimab (INCMGA00012) in Patients (Pts) with Selected Solid Tumors (POD1UM-203) (Abstract #2571. Session: Developmental Therapeutics—Immunotherapy.)

Ruxolitinib-Parsaclisib Combination Studies

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Ruxolitinib Plus Parsaclisib in Patients with JAK- and PI3K-Inhibitor Treatment–Naïve Myelofibrosis (Abstract #TPS7058. Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant.)

Tafasitamab

A Phase 3 Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Versus Placebo Plus Lenalidomide and Rituximab in Patients with Relapsed/Refractory (R/R) Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) (Abstract #TPS7568. Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia.)

First-MIND: A Phase 1b, Open-Label, Randomized Study to Assess Safety of Tafasitamab (tafa) or Tafa + Lenalidomide (LEN) in Addition to R‑CHOP in Patients with Newly Diagnosed DLBCL2(Abstract #7540. Session: Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia.)

For full session details and data presentation listings, please see the ASCO (Free ASCO Whitepaper)21 online program at View Source Oral, poster discussion and poster sessions, as well as track-based clinical science symposia, accepted for presentation at ASCO (Free ASCO Whitepaper) will be available on demand beginning Friday, June 4, 2021 at 9:00 a.m. ET.

On May 19, 2021 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported that Alpine will hold an investor event on June 4th, 2021 at 7:00pm ET, to coincide with the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting (Press release, Alpine Immune Sciences, MAY 19, 2021, View Source [SID1234580282]).

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During the investor event, Alpine will present data from the previously announced presentation on NEON-1, the company’s Phase 1 dose escalation clinical trial of ALPN-202 monotherapy, from the ASCO (Free ASCO Whitepaper) Virtual Annual Meeting ("First-in-human dose escalation of ALPN-202, a conditional CD28 costimulator and dual checkpoint inhibitor, in advanced malignancies"). Following the presentation, Alpine will hold a question and answer discussion.

Currently, full abstracts are now live on the ASCO (Free ASCO Whitepaper) meeting website and a copy of Alpine’s presentation will be available on June 4th on the Scientific Publications page of Alpine’s website.

Investor Event – Conference Call and Webcast Details:

To access the investor event by phone, dial (800) 816-3005 (domestic) or (857) 770-0069 (international) and reference conference ID: 3439769.

A live webcast of the investor event will be available online in the investor relations section of the company’s website at View Source A replay will be available on the company website for 90 days following the webcast.

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor with the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. NEON-1 (NCT04186637), a Phase 1 study of ALPN-202 in patients with advanced malignancies, is currently enrolling. Alpine also plans the initiation of NEON-2, a combination study of ALPN-202 and a PD-1 inhibitor, later this year.

On May 19, 2021 Targovax ASA’s ("Targovax" or the "Company") stock exchange reported that Published on 18 May 2021, regarding the board of directors’ resolution to increase the Company’s share capital with NOK 2,129.90 by the issuance of 21,299 new shares, each with a nominal value of NOK 0.10, in order to facilitate an exercise of 21,299 RSUs pursuant to the Company’s RSU program for Board members (Press release, Targovax, MAY 19, 2021, View Source [SID1234580281]).

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Primary insider, Bente-Lill Romøren, member of the board of directors, has exercised

15,250 restrictive stock units ("RSUs") under her RSU agreement and subscribed for 15,250 new shares in the Company following the exercise of RSUs. The exercise price for the options was NOK 0.10 per new share.

Following the RSU exercise and subscription of new shares and the registration of the share capital increase pertaining to the new shares with the Norwegian Register of Business Enterprises (Nw. Foretaksregisteret), Bente-Lilll Romøren holds 35,577 shares, 11,361 RSUs and nil options in Targovax.

On May 19, 2021 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported preliminary safety and anti-tumor activity data from the Company’s ongoing Phase 1 clinical trial of MGC018 (Press release, MacroGenics, MAY 19, 2021, View Source [SID1234580280]). This investigational antibody-drug conjugate (ADC) was designed to deliver a DNA alkylating duocarmycin payload to both dividing and non-dividing cells in a B7-H3-dependent manner. The dataset will be presented in a poster titled "Phase 1 Dose Escalation Study of MGC018, an anti-B7-H3 Antibody-Drug Conjugate (ADC), In Patients with Advanced Solid Tumors" (Abstract #2631) at the upcoming 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held June 4-8, 2021.

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Dose Escalation Results Update

The ASCO (Free ASCO Whitepaper) abstract included data as of January 21, 2021; updated data as of a May 3, 2021 cut-off are included below and will be presented at ASCO (Free ASCO Whitepaper).

A total of 29 patients with advanced solid tumors were enrolled in five dose escalation cohorts with MGC018 at 0.5 to 4.0 mg/kg, administered intravenously every three weeks. This included six patients at the 4.0 mg/kg cohort enrolled subsequent to the 2020 ASCO (Free ASCO Whitepaper) poster presentation. A recommended Phase 2 dose (RP2D) was defined as 3.0 mg/kg every three weeks.

mCRPC. Preliminary evidence of anti-tumor activity by MGC018 has been observed, most notably in patients with advanced metastatic castration-resistant prostate cancer (mCRPC). Reductions in prostate-specific antigen (PSA) levels of ≥ 50% were observed in five of nine mCRPC patients treated in dose escalation, including one with substantial regression of bone disease. Of the nine patients with mCRPC, eight were evaluated for tumor response, all of whom demonstrated a best response of stable disease. Two of these eight patients had measurable disease; both had reductions in target lesions, including a 29% reduction in one patient. The nine mCRPC patients treated in dose escalation received a median of four therapies prior to MGC018, including taxane chemotherapy (eight patients) and next generation hormonal agents (all patients had previously received abiraterone, enzalutamide or both). All nine mCRPC patients in dose escalation are off therapy. Of the five patients who had ≥ 50% PSA reduction, one withdrew consent (without disease progression) at 4 months, one had new bone lesions at 6 months, one initiated subsequent therapy at 6 months, and two had no progression at 7 months.

Melanoma. During dose escalation, three melanoma patients were administered MGC018 at 4.0 mg/kg (the highest dose administered). All had previously received three different checkpoint inhibitor agents. The best responses in target lesion sum reductions for these patients after being treated with MGC018 were 24%, 28% and 36% (confirmed partial response), with this last patient remaining on MGC018 therapy for more than 6 months as of the data cut-off. Based on these data, MacroGenics recently initiated a melanoma expansion cohort (N=approximately 20).

Safety. Adverse events for the dose escalation cohorts of 0.5 mg/kg to 4.0 mg/kg as of the May 3, 2021 data cut-off were generally consistent with those previously reported at ASCO (Free ASCO Whitepaper) 2020. MGC018-related toxicities included hematologic and skin toxicities that have been clinically manageable. In dose escalation overall, at least one treatment-related adverse event was experienced by 27 of 29 patients (93%). At 4.0 mg/kg, one patient developed a dose-limiting toxicity manifested by Grade 3 fatigue that lasted for more than 72 hours and as previously reported, a Grade 4 neutropenia occurred in a patient in the 2.0 mg/kg cohort.

Preliminary Results for mCRPC Cohort Expansion

As of the May 3, 2021 data cut-off, 28 of the 40 patients in the mCRPC cohort expansion had been enrolled, with disease classification available for 20 of these patients: seven had bone only, nine had mixed soft tissue and bone, and four had soft tissue only. Of the 28 mCRPC patients in cohort expansion, 22 had received at least one dose of MGC018 and had a post-baseline PSA. Eleven of these 22 patients (50%) had a PSA reduction of 50% or greater. All but three of these 22 patients were still on therapy as of the data cut-off. Of 13 patients who had measurable disease, six were not yet evaluable and seven had their first 9-week imaging, of which four had reductions in target lesion sums of 13%, 21%, 27% and 35% (unconfirmed partial response). Twelve of these 13 patients were still ongoing on MGC018.

"We continue to be very encouraged by evolving data from our ongoing Phase 1 study of MGC018. To date, we have observed preliminary signals of anti-tumor effects, including PSA reductions of 50% or more in 16 of 31 (52%) patients with late-stage castration-resistant prostate cancer across dose escalation and dose expansion," said Scott Koenig, M.D., Ph.D., President and CEO. "We are very pleased to report decreases in target lesion sums, including an unconfirmed partial response, in mCRPC patients with measurable disease. Finally, we are encouraged to see anti-tumor activity, including a confirmed partial response, in post-checkpoint melanoma patients who have received MGC018. We look forward to sharing the full data at ASCO (Free ASCO Whitepaper) and providing further updates on our ongoing dose expansion cohorts, including patients with mCRPC, non-small cell lung cancer, triple negative breast cancer, melanoma and squamous cell carcinoma of the head and neck, at subsequent scientific conferences."

Conference Call

MacroGenics’ management will host a conference call and webcast with external guest presenters to discuss the preliminary MGC018 results on Friday, June 4, 2021 at 4:30 P.M. ET. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) ten minutes prior to the start of the call and provide the Conference ID: 1583522. The listen-only audio and slide webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days.

ASCO Presentation

The abstract for MacroGenics’ MGC018 poster presentation was submitted to ASCO (Free ASCO Whitepaper) in February 2021 and is available on the ASCO (Free ASCO Whitepaper) website at View Source The poster will be available for on-demand viewing on the ASCO (Free ASCO Whitepaper) website and on the Events & Presentations page on MacroGenics’ website at View Source on or around June 4, 2021.

About MGC018

MGC018 is an ADC comprised of an anti-B7-H3 humanized IgG1/kappa monoclonal antibody conjugated via a cleavable linker to the prodrug seco-DUocarmycin hydroxyBenzamide Azaindole (DUBA; licensed from Byondis, B.V.), with an average drug-to-antibody ratio (DAR) of ~2.7. DUBA is an alkylating agent that can damage DNA in both dividing and non-dividing cells, causing cell death. B7-H3 is a molecule highly expressed on many solid tumors and associated with a poor clinical outcome. MGC018 is being evaluated in a Phase 1 study (NCT03729596). MacroGenics retains worldwide rights to MGC018.