On December 8, 2021 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-422, a cyclin-dependent kinase (CDK) 2/4/6 inhibitor, for the treatment of advanced breast cancer (Press release, Nuvation Bio, DEC 8, 2021, View Source [SID1234596628]). The FDA accepted the Company’s first IND application for NUV-422 in October 2020 for the treatment of patients with high-grade gliomas, including glioblastoma multiforme (GBM). The Company began a monotherapy Phase 1/2 study in December 2020 in high grade gliomas and later amended the protocol in the second quarter of 2021 to include HR+/HER2- advanced breast cancer (with and without brain metastases) and metastatic castration resistant prostate cancer (mCRPC). The Company is continuing to enroll patients in the Phase 1 dose escalation portion of the study.

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"FDA clearance of our second IND application for NUV-422 is an important milestone for our lead investigational CDK 2/4/6 inhibitor program as we develop our deep pipeline of innovative new cancer therapeutics," said David Hung, M.D., founder, president, and chief executive officer of Nuvation Bio. "We are encouraged by the differentiated and broad potential of NUV-422 to address multiple tumor types. We look forward to sharing data from the Phase 1 dose escalation portion in the second half of 2022."

With the clearance of this IND in advanced breast cancer, Nuvation Bio will be initiating a Phase 1/2 study in patients with HR+/HER2- advanced breast cancer who have received prior hormonal therapy combined with an approved CDK 4/6 inhibitor. This study (Protocol NUV-422-03) will begin with a Phase 1b dose escalation portion designed to evaluate safety and tolerability of the NUV-422 plus fulvestrant combination and to determine a recommended Phase 2 combination dose of NUV-422. The Phase 2 portion is a randomized, non-comparative study designed to evaluate the safety and efficacy of NUV-422 in combination with fulvestrant relative to NUV-422 monotherapy and fulvestrant monotherapy.

On December 8, 2021 Exact Sciences Corp. (NASDAQ: EXAS), a global leader in cancer diagnostics, reported the presentation of new data at the 2021 San Antonio Breast Cancer Symposium (SABCS) supporting the clinical value of the Oncotype DX Breast Recurrence Score test (Press release, Exact Sciences, DEC 8, 2021, View Source [SID1234596592]). New analyses presented at the meeting include an oral presentation of updated data from the RxPONDER study led by the independent SWOG Cancer Research Network, and sponsored by the National Cancer Institute (NCI).

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Exact Sciences announced new data at the 2021 SABCS, supporting the clinical value of the Oncotype DX test.
"New findings presented at SABCS 2021 add to the wealth of data highlighting the role of the Oncotype DX test in providing critical information to personalize and improve the quality of breast cancer treatment decisions," said Rick Baehner, M.D., chief medical officer of Precision Oncology at Exact Sciences. "Additionally, we are encouraged by results from a study validating our new 16-gene genomic radiation therapy signature in development, showing promise in identifying women with early-stage breast cancer who may be able to forgo irradiation following breast conserving surgery. Like the critical chemotherapy answer we are providing women with the Oncotype DX test, being able to offer clear guidance to radiotherapy benefit enables patients to avoid over- or under-treatment and further personalize their treatment plans."

New data from RxPONDER confirm and strengthen previous findings
Following the recent publication of initial study results in The New England Journal of Medicine[i], updated data were presented in an oral session[ii] at SABCS by Dr. Kevin Kalinsky, study lead investigator. In an analysis with longer follow-up (median 6.1 years), the investigators reported that postmenopausal women with 1-3 positive nodes and Recurrence Score results 0-25 continue to not benefit from adjuvant chemotherapy. In addition, a new analysis of distant recurrence-free interval (defined as time to distant recurrence or death from breast cancer) showed that premenopausal women with Recurrence Score results 0-13 received a modest 2.3% absolute benefit at five years. For those with Recurrence Score results 14-25 the benefit was 2.8%.

Approximately one-third of patients diagnosed with hormone receptor (HR)-positive, HER2-negative early breast cancer have a tumor that has spread to their lymph nodes. The vast majority of these patients currently receive chemotherapy[iii] even though approximately 85% of them have Recurrence Score results 0 to 25.[iv] In addition, approximately two out of three early-stage breast cancer patients are postmenopausal.[v]

Use of a 16-gene radiation therapy signature to identify patients with HR-positive, HER2-negative early-stage breast cancer who may skip radiotherapy
The study, presented at SABCS in a poster session[vi], applied the 16-gene radiation therapy signature to 132 patients enrolled in the Princess Margaret Trial, which randomized patients ages 50 or older to radiotherapy and tamoxifen or tamoxifen alone after breast conserving surgery. The results, in a treatment cohort in line with the current standard of care, support previous validation study data[vii] suggesting that the 16-gene radiation therapy signature may be used to identify patients with a low risk of locoregional recurrence who will not experience significant benefit from adjuvant radiotherapy. The 16-gene radiation therapy signature was developed by PFS Genomics, a company acquired by Exact Sciences earlier this year.

Additional Oncotype DX data presented at SABCS 2021
Other data featured in Poster Sessions and Spotlight Poster Discussions at SABCS 2021 include the following:

Poster #P1-08-28: Real world use of Oncotype DX testing in the management of breast cancer. The North East England experience
Authors: Gault, A., et al.
Date/Time: Wednesday, December 8, 7:00-9:30 a.m. CT

Poster #P2-15-02: Using Oncotype DX Breast Recurrence Score (RS) assay to define the role of neoadjuvant endocrine therapy (NET) in early-stage hormone receptor positive (HR+) breast cancer (BC)
Authors: Taylor, C., et al.
Date/Time: Wednesday, December 8, 5:00-6:30 p.m. CT

Spotlight Poster #PD9-01: Expanding downstaging criteria in AJCC pathologic prognostic staging using Oncotype DX Recurrence Score assay in T1-2N0 hormone-receptor positive patients enrolled in the TAILORx Trial
Authors: Kantor, O., et al.
Date/Time: Thursday, December 9, 7:00-8:30 a.m. CT

Spotlight Poster #PD15-05: Assessment of estrogen receptor (ESR1) mRNA expression for prediction of extended aromatase inhibitor benefit in HR-positive breast cancer using NRG Oncology/NSABP B-42
Authors: Mamounas, E., et al.
Date/Time: Friday, December 10, 7:00-8:30 a.m. CT

About the Oncotype DX and Oncotype MAP Portfolio of Tests
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as risk of distant recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. For patients with advanced and metastatic cancer, the company offers the Oncotype MAP Pan-Cancer Tissue test, a rapid, comprehensive tumor profiling panel, which provides results in three to five business days[viii] and allows physicians to understand a patient’s tumor profile and recommend actionable targeted therapies or clinical trials. With more than 1 million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about the Oncotype DX and Oncotype MAP tests, visit www.OncotypeIQ.com/

On December 8, 2021 PharmaCyte Biotech, Inc. (NASDAQ: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported the results of an additional, more detailed, analysis of the integration site of the cytochrome P450 2B1 gene from the augmented HEK293 cell clone that PharmaCyte uses in its CypCap product (Press release, PharmaCyte Biotech, DEC 8, 2021, View Source [SID1234596612]). This assay is one of the assays required by the U.S. Food and Drug Administration (FDA) in order to have the FDA’s clinical hold lifted on PharmaCyte’s Investigational New Drug Application (IND) for the treatment of locally advanced, inoperable pancreatic cancer (LAPC).

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "We are elated to have completed this sequencing assay given its importance to the FDA, and how incredibly difficult it was to arrive at this successful conclusion. We can report that the DNA sequence analysis of the cytochrome P450 2B1 augmented cells is now complete, and it is a great challenge that is now behind us. This kind of analysis is technically demanding, and we spent a great deal of time getting this right. In addition to extending our characterization of the augmented cells, the data also verifies our previous studies on the cells that are the active component of our novel LAPC therapy."

In previous studies, PharmaCyte showed that the cytochrome P450 2B1 gene in the augmented HEK293 cell clone was located on human chromosome 9 and the flanking sequence had already been determined. The FDA requested that the exact sequence of the cytochrome P450 2B1 gene inserted at that location should also be determined. This is technologically challenging because the introduced DNA is large and concatenated, causing the Company to turn to nanopore sequencing technology for this analysis. Nanopore sequencing is a cutting edge, unique and scalable technology that enables direct, real-time analysis of long DNA fragments. The technology was successfully used to determine the sequence of the introduced DNA, and the analysis of the sequence data shows that it is both intact and complete.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced, inoperable pancreatic cancer, we encourage you to watch the company’s documentary video complete with medical animations at: View Source

On December 8, 2021 IsoPlexis (NASDAQ: ISO), the leader in functional single cell proteomics, reported that new data generated on its IsoLight platform will be presented at the 63rd annual American Society of Hematology (ASH) (Free ASH Whitepaper) conference, taking place December 11-13 at the Georgia World Congress Center in Atlanta, Georgia (Press release, IsoPlexis, DEC 8, 2021, View Source [SID1234596629]).

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At ASH (Free ASH Whitepaper), IsoPlexis’ presented data will outline how to leverage unique powerful single-cell subsets of highly functional "superhero" cells, critical to driving longer term response in cell and immune therapies via functional proteins. The presentation will highlight how to fully leverage these superhero cells for optimization of CAR-T manufacturing, as well as clinical combination immunotherapies for hematologic malignancies and functional biomarkers of potency, durability, and survival.

The presentation, titled "Single-Cell Functional Biomarkers of Potency, Durability, and Survival in Cell Therapy Optimization and Combination Immunotherapies for Hematologic Diseases," will be given on Saturday, December 11 from 1:30 p.m. – 1:45 p.m. eastern time. The presentation will be located in Theater 5 of Exhibit Hall – Building B at the Georgia World Congress Center.

Additionally, the following poster presentations from Stanford University, Medical College of Wisconsin, and Atara Biotherapeutics will also highlight novel applications in acute graft-versus-host disease (aGvHD), bispecific CAR-T cells, and off-the-shelf allogenic T-cell therapies, respectively:

P#1684: Combinatorial Cytokine Secretion Signature of Donor-Derived T Cells Infused with the Graft: A New Potential Biomarker of Acute Graft-Versus-Host Disease in Aβt-Cell/CD19 B-Cell Depleted Hematopoietic Stem Cell Transplant Recipients
P#1728: Bispecific LV20.19 CAR T-Cells Expanded in IL-7 and IL-15 Have Greater Polyfunctionality and Polyfunctional Strength Than CAR T-Cells Expanded in IL-2
P#2809: Comprehensive Activation Profiling of the Tabelecleucel Library, and Off-the-Shelf, Allogeneic EBV-Specific T-Cell Therapy

On December 7, 2021 ISA’s very own Chief Scientific Officer, Cornelis "Kees" Melief, M.D., Ph.D., reported that it will be presenting key learnings in cancer vaccine development in an educational session at the ESMO (Free ESMO Whitepaper) Immune-Oncology Congress 2021, taking place on 8th – 11th December 2021 in Geneva, Switzerland and online (Press release, ISA Pharmaceuticals, DEC 7, 2021, View Source [SID1234596554]).

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Key learnings include:

Direct correlation between strength of cancer vaccine-induced immune response and clinical response
Combination therapy of cancer vaccine with standard of care and/or checkpoint blockers necessary for improved outcomes in treatment of late stage cancers
Session: New indications in head and neck (H&N) cancer (incl anaplastic thyroid) (ID 8)
Presentation title: HPV vaccination for H&N cancer therapy (ID 39)
Authors: Cornelis J. Melief
Date & Time: Thursday, 9th December, 15:30pm – 15:50pm CET
Locations: Room C

Kees Melief comments: "Our findings consistently highlight the direct correlation between the strength of the vaccine-induced immune response and the subsequent clinical response in patients with metastatic (HPV16+) cancers, including oropharyngeal cancer (OPC). Moreover, we argue that to overcome the hostile tumour microenvironment in late-stage cancer, combination of SLP-based therapies with platin-based standard of care and/or checkpoint blocking (anti-PD1 in particular) is necessary for improved treatment outcomes."

Gerben Moolhuizen, Chief Executive Officer, said: " We recently announced that we received FDA Fast Track designation for our lead product ISA101b, for treatment of recurrent and metastatic HPV16+ OPC. We are proud to be presenting our compelling findings in cancer vaccine combination therapy development at this influential medical conference, following the start of a next phase 2 clinical trial investigating the combination of ISA101b and Libtayo in advanced HPV16 positive OPC."