On April 5, 2021 Exelixis, Inc. (Nasdaq: EXEL) reported that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of XB002 in patients with advanced solid tumors (Press release, Exelixis, APR 5, 2021, View Source [SID1234577581]). As a next-generation tissue factor-targeting antibody-drug conjugate (ADC), XB002 has the potential for an improved therapeutic index and may provide a favorable safety profile compared with earlier-generation tissue factor-targeting ADCs.

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"The acceptance of our Investigational New Drug Application for XB002 gets us one step closer to our first biologic entering the clinic and learning more about its potential to help patients with difficult-to-treat cancers," said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. "Considering XB002’s promising preclinical data and potential differentiation from other tissue factor-targeting antibody-drug conjugates, we look forward to initiating our phase 1 trial in patients with advanced solid tumors."

XB002 (formerly ICON-2) is an ADC composed of a human monoclonal antibody against tissue factor that is conjugated to a cytotoxic agent. After binding to tissue factor on tumor cells, XB002 is internalized, and the cytotoxic agent is released, resulting in targeted tumor cell death. XB002 is a rationally designed next-generation ADC that leverages proprietary linker-payload technology.

Preclinical data demonstrated that XB002 binds to tissue factor without affecting the coagulation cascade, in contrast with prior therapies in this class. The data also demonstrated encouraging activity of XB002 in multiple solid tumor cancer models and improved tolerability compared with other tissue factor-targeting ADCs. XB002 has shown significant tumor growth inhibition and, in some cases, complete regression. The rational design and preclinical profile of this novel tissue factor-targeting ADC suggest that, if born out in clinical evaluation, XB002 could have an improved therapeutic index and favorable safety profile compared with earlier tissue factor-targeting ADCs.

On April 5, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported a poster presentation on safety and tolerability of twice daily administered poziotinib in patients with EGFR or HER2 exon 20 mutations (Press release, Spectrum Pharmaceuticals, APR 5, 2021, View Source [SID1234577580]). The company will also present a poster on the evaluation of same-day dosing of ROLONTIS (eflapegrastim) in neutropenic rats and patients with early-stage breast cancer. These poster presentations will be available at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting, taking place from April 10-15, 2021. Details of the presentations are as follows:

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Title: Poziotinib administered twice daily improves safety and tolerability in patients with EGFR or HER2 exon 20 mutations
Speaker: Xiuning Le, M.D., Ph.D.
Session: PO.CT02 – Phase 2 Clinical Trials
Date and Time: April 10, 2021 from 8:30 am – 11:59 pm ET
Presentation Number: CT169

Title: Same-day administration of Eflapegrastim with chemotherapy enhances neutropenic recovery in neutropenic rats and in early-stage breast cancer patients
Speaker: John A. Barrett
Session: PO.CT01 – Phase 1 Clinical Trials
Date and Time: April 10, 2021 from 8:30 am – 11:59 pm ET
Presentation Number: CT116

The poster presentations will be available for viewing by registered participants during the conference via the AACR (Free AACR Whitepaper) website on April 10, 2021.

On April 5, 2021 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported the successful completion of the safety run-in of the Stage 2 of the Phase 2 clinical study of prexigebersen (BP1001), a liposomal Grb2 antisense, for the treatment of acute myeloid leukemia (AML), in combination with frontline therapies, decitabine and venetoclax, in acute myeloid leukemia (AML) patients (Press release, Bio-Path Holdings, APR 5, 2021, View Source [SID1234577578]). The safety run-in of Stage 2 of the Phase 2 clinical trial was comprised of six evaluable patients who were treated with the triple combination of prexigebersen, decitabine and venetoclax.

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"We are particularly pleased with the clean side effect profile and lack of toxicity shown in this segment of the study, as our Phase 2 efficacy segment will include de novo fragile AML patients for whom drug side effect profiles are particularly important. We are also very encouraged by the efficacy signals shown in this dataset, with five of six evaluable relapsed, refractory and newly diagnosed AML patients demonstrating clinical activity. These positive signals give us further confidence in the potential for this program in these late-stage and compromised patients," stated Peter H. Nielsen, Chief Executive Officer of Bio-Path Holdings.

"We look forward to advancing this Phase 2 study, as we believe its unique design provides us with several definable registration pathways. We believe that prexigebersen, with its promising efficacy and safety profile, has the potential to be an ideal combination candidate with frontline therapies," concluded Mr. Nielsen.

In the safety run-in, six evaluable patients were treated with the combination of prexigebersen, decitabine and venetoclax. These patients included four relapsed/refractory AML patients, and two newly diagnosed AML patients. In the preliminary safety data review, five of the patients (83%) responded to treatment, including four (67%) achieving complete response (CR) and one (17%) complete response with incomplete hematologic recovery (CRi). CR rates to combination treatment with decitabine and venetoclax for relapsed/refractory AML patients is 42-52%1,2 and 0-39%1,2 for relapsed/refractory secondary AML patients. Response rates to frontline treatment decitabine and venetoclax for newly diagnosed AML patients is 62-71%3,4. These preliminary data showed the treatment was well-tolerated and there were no dose limiting toxicities attributed to prexigebersen. Three patients remained on treatment for more than one cycle.

Stage 2 of the Phase 2 clinical trial has three treatment cohorts, which the Company believes provides for several potential regulatory pathways. The first two cohorts will treat patients with the triple combination of prexigebersen, decitabine and venetoclax. The first cohort includes newly diagnosed AML patients and the second cohort includes relapsed/refractory AML patients. Finally, the third cohort treats relapsed/refractory AML patients who are venetoclax resistant or intolerant with the two-drug combination of prexigebersen and decitabine.

The Phase 2 clinical trial continues with 21 patients currently enrolled across all three cohorts. Enrollment of 19 patients in each cohort should enable a data review to determine if there is a comparative increase in efficacy versus the decitabine and venetoclax combination therapy sufficient to support petitioning the FDA for approval to switch to breakthrough therapy for accelerated approval. The Phase 2 trial will be conducted at up to ten clinical sites in the U.S. For more information on the Phase 2 study, visit www.clinicaltrials.gov.

On April 5, 2021 Illumina, Inc. (NASDAQ: ILMN) reported preliminary revenue for the first quarter of fiscal year 2021 and updated its fiscal year 2021 revenue guidance (Press release, Illumina, APR 5, 2021, View Source [SID1234577577]). Subject to quarter-end closing adjustments, Illumina expects to report first quarter 2021 revenue of approximately $1,085 million, compared to $859 million in the first quarter of 2020 . This represents year-over-year revenue growth of approximately 26% for the quarter. For fiscal year 2021, Illumina now expects year-over-year revenue growth in the range of 25%-28% compared to fiscal year 2020.

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The company’s record preliminary revenue in the first quarter of 2021 was driven by:

Record orders of approximately $1.4 billion in the quarter and sequencing revenue growth of approximately 28% compared to the prior year period
Sequencing consumables growth of approximately 25% compared to the prior year period demonstrating the solid recovery from the COVID-19 pandemic and the strength of our core business. Most customers are now at or above pre-COVID activity levels. COVID-19 surveillance revenues for sequencing consumables were approximately $20 million in the quarter
Sequencing instrument growth of approximately 120% compared to the prior year period, reflecting strong performance across all instrument categories. The mid-throughput category achieved another record quarter in placements. Some customers built additional capacity for COVID-19 surveillance work and accelerated instrument purchases, which resulted in approximately $35 million of incremental instrument revenue in the quarter
"Our core business is exceptionally strong and growing ahead of our expectations. This is reflected in our outstanding preliminary first quarter revenue and, as a result, we are raising our 2021 revenue guidance," said Francis deSouza, President and CEO. "We are seeing broad-based acceleration across our core clinical and research applications as more patients, physicians and researchers than ever access the benefits of next generation sequencing. In addition, we are experiencing increased demand for COVID surveillance globally due to the critical role that Illumina’s next generation sequencing technology plays in the fight against this pandemic."

The company expects to report its full first quarter 2021 results on its upcoming quarterly conference call following the close of market on Tuesday, April 27, 2021.

Conference call information

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Tuesday, April 27, 2021. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website under the "Company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1-866- 211-4597 or 1-647-689-6853 outside North America, both using conference ID 4359912.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

On April 5, 2021 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported two upcoming presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021, which will be held virtually from April 10-15, 2021 and May 17-21, 2021 (Press release, Arvinas, APR 5, 2021, View Source [SID1234577576]). These presentations will describe the discovery of Arvinas’ two clinical-stage PROTAC degraders, ARV-110 and ARV-471, including the first disclosures of their structures.

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Details for the presentations are as follows:

Title: Discovery of ARV-110, a first in class androgen receptor degrading PROTAC for the treatment of men with metastatic castration resistant prostate cancer
Date and Time: April 11, 2021 from 2:05 PM – 2:15 PM ET
Presenter: Lawrence B. Snyder, Ph.D., Executive Director of Medicinal Chemistry at Arvinas
Session Title: New Therapeutics Targeting Molecular Drivers in Cancer

Title: The discovery of ARV-471, an orally bioavailable estrogen receptor degrading PROTAC for the treatment of patients with breast cancer
Date and Time: April 11, 2021 from 2:20 PM – 2:30 PM ET
Presenter: Lawrence B. Snyder, Ph.D., Executive Director of Medicinal Chemistry at Arvinas
Session Title: New Therapeutics Targeting Molecular Drivers in Cancer

Abstracts will be available for registered attendees on the AACR (Free AACR Whitepaper) website beginning on April 9, 2021.