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Spectrum Pharmaceuticals to Present Data from Phase 2 Clinical Trial for Poziotinib at American Association for Cancer Research Virtual Annual Meeting 2020

On April 21, 2020 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported the presentation of the results for Cohort 1 from its Phase 2 clinical trial, ZENITH20, evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations (Press release, Spectrum Pharmaceuticals, APR 21, 2020, View Source [SID1234556452]). The abstract titled "Poziotinib activity and durability of responses in previously treated EGFR exon 20 NSCLC patients – a Phase 2 study" will be part of the Lung Cancer Targeted Therapy session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting I, to be held April 27-28, 2020. Full details of the presentation are as follows:

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Abstract Title: Poziotinib activity and durability of responses in previously treated EGFR exon 20 NSCLC patients – a Phase 2 study
Authors: Xiuning Le, M.D., Ph.D., et al.
Session: VCTPL08 – Lung Cancer Targeted Therapy
Date and Time: April 27, 2020, 2:05 p.m. – 2:15 p.m. EDT
Abstract Number: CT081
Location: The first edition of the AACR (Free AACR Whitepaper) Virtual Annual Meeting will be available free to everyone. Attendees will be asked to create an account to access the meeting platform which could be found at: View Source

Conference Call and Webcast

Spectrum’s management will host a webcast and conference call at 8:30 a.m. ET / 5:30 a.m. PT on April 28, 2020 to review the data and program strategy. The live call may be accessed by dialing (877) 837-3910 for domestic callers and (973) 796-5077 for international callers and entering the conference ID#: 5536065. A live webcast of the call will be available from the Investors and Media section of the company’s website at View Source and will be archived there shortly after the live event.

Forma Therapeutics Announces Preclinical Data Demonstrating Antitumor Activity of a Potent and Selective Inhibitor of CBP/p300 for Androgen Receptor Positive Cancers to be Presented at the American Association for Cancer Research

On April 21, 2020 Forma Therapeutics, Inc. ("Forma"), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported that it will be presenting an electronic poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) taking place virtually June 22-24, 2020 (Press release, Forma Therapeutics, APR 21, 2020, View Source [SID1234556451]). The poster will include preclinical data from a potent and selective inhibitor of CBP/p300, a known co-activator of the androgen receptor (AR) and a driver of metastatic castration-resistant prostate cancer (mCRPC). The data demonstrate antitumor activity of a novel CBP/p300 inhibitor, FT-6876, in AR-dependent breast cancer cell lines and highlight the possible role of CBP/p300 in proliferation and survival of AR-dependent tumors.

Specific findings indicate that Forma’s investigational agent, FT-6876:

Inhibits the bromodomain of CBP/p300 and prevents binding to acetylated lysine on histone and non-histone proteins;
Reduces histone acetylation at position H3K27, a modification associated with increased gene transcription;
Reduces AR-dependent transcription and AR protein levels; and
Reduces cell proliferation, including levels of Ki-67 in vitro and in vivo in prostate and AR-positive breast cancer models.
"These important data support the rationale that targeting the CBP/p300 bromodomain may provide a differentiated approach to modulating AR pathway activation in malignancies that are dependent on AR," said Patrick Kelly, M.D., chief medical officer of Forma Therapeutics. "The most prominent potential indication for this investigational agent is mCRPC, since there is a dearth of effective treatment options for this advanced form of prostate cancer. We hope to change that."

Abstracts of presentations accepted by AACR (Free AACR Whitepaper) will be published online on May 15, 2020.

About Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Prostate cancer is the second leading cause of cancer death for men in the U.S., and mCRPC is the most advanced form of this disease. Prostate cancer cell growth is driven by activity of the androgen receptor (AR). Primary treatments of mCRPC include therapies that reduce androgen synthesis or inhibit androgen binding and activation of the AR. Studies have shown that approximately 20% to 40% of mCRPC patients demonstrate primary resistance to enzalutamide and abiraterone acetate, two commonly used therapies, and virtually all patients who demonstrate initial clinical responses eventually acquire resistance. There are currently no approved therapies specifically aimed at mCRPC over-expressing AR variants, including AR-v7; therefore, a novel inhibitor of AR co-activator CBP/p300 may play a role in the suppression of mCRPC driven by AR aberrations.

About FT-7051

Clinical development candidate FT-7051, borne from research compound FT-6876, is a potent and selective in vitro inhibitor of CBP/p300, a co-activator of androgen receptor (AR) signaling and a driver of metastatic castration-resistant prostate cancer (mCRPC). In vitro, both FT-7051 and FT-6876 are antiproliferative in AR-positive prostate cancer cell lines, including resistance variant AR-v7 positive models. Forma Therapeutics is evaluating the investigational agent FT-7051 for potential clinical benefit in mCRPC.

ERYTECH Provides Update on the TRYbeCA-1 Phase 3 Clinical Trial of Eryaspase in Second Line Pancreatic Cancer

On April 20, 2020 ERYTECH Pharma (Nasdaq & Euronext: ERYP), a clinical-stage biopharmaceutical company developing red blood cell-based cancer therapeutics, reported an update on the pivotal Phase 3 clinical trial for advanced metastatic pancreatic cancer (TRYbeCA-1), which is evaluating the efficacy and safety of ERYTECH’s lead product candidate eryaspase in combination with chemotherapy as second-line therapy (Press release, ERYtech Pharma, APR 20, 2020, View Source [SID1234556450]).

"We are pleased that the TRYbeCA-1 trial has continued to progress well despite the challenges caused by the COVID-19 global pandemic," said Gil Beyen, CEO of ERYTECH. "The third independent safety review has once again confirmed the favorable safety profile of our lead product candidate eryaspase, and the trial has now surpassed 75% of the planned target enrollment. While prioritizing the safety of patients, health care providers and our employees, we have successfully deployed measures to safeguard the integrity of the trial by ensuring patients’ continued access to treatment and appropriate follow-up. The enrollment of new patients is also continuing, but at a slower pace than over the past few weeks. We currently anticipate a limited delay in completing patient enrollment of 3 to 4 months from previous plans. In addition, and unrelated to COVID-19, the average time to events appears longer than originally expected. We now expect the interim superiority analysis around the end of this year and final results in the second half of 2021."

The independent data monitoring committee (IDMC) has reviewed the safety data for the first 320 patients enrolled and treated in the TRYbeCA-1 trial. In line with the two earlier safety reviews, no safety issues were identified and the IDMC recommended to continue the trial as planned.

To date, more than 75% of the approximately 500 patients to be enrolled in the trial have been randomized. Various measures have been put in place to facilitate compliance with the study schedule and to preserve study data integrity.

Through March 2020, new patient enrollment continued as planned notwithstanding the increasing difficulties experienced by the hospitals to organize the proper treatment and follow-up. Over the past two weeks, ERYTECH has observed a reduction in enrollment rate due to the COVID-19 pandemic and now believes new patient enrollment will be below plan in the coming months. The Company currently expects a delay of 3 to 4 months in completion of patient enrollment, bringing the time of complete enrollment to the fourth quarter of this year.

With more than 75% of the patients enrolled in the trial, the Company believes that the planned interim superiority analysis, to be conducted by an IDMC when two-thirds of the total death events have been reached, will not be significantly affected by the expected delay in enrollment. However, based on recent tracking of the total death events in the trial, the average time to event appears longer than originally anticipated. As a result, the Company now expects to report the interim analysis around year-end 2020 and the final analysis in the second half of 2021.

About TRYbeCA-1

TRYbeCA-1 is a randomized, controlled Phase 3 clinical trial evaluating eryaspase in second-line metastatic pancreatic cancer. The trial is designed to enroll approximately 500 patients at approximately 100 clinical sites in Europe and the United States. Eligible patients are randomized 1-to-1 to receive eryaspase in combination with standard chemotherapy (gemcitabine/nab-paclitaxel or an irinotecan-based regimen) or chemotherapy alone. The primary endpoint of TRYbeCA-1 is overall survival. An interim superiority analysis will be conducted when approximately two-thirds of the events have occurred.

Roche receives FDA approval for cobas HPV test for use on the cobas 6800/8800 Systems to identify women at risk for cervical cancer

On April 21, 2020 Roche (SIX: RO, ROG; OTCQX:RHHBY) reported US Food and Drug Administration (FDA) approval for the cobas HPV test for use on the fully automated, high-throughput cobas 6800/8800 Systems (Press release, Hoffmann-La Roche, APR 21, 2020, View Source [SID1234556448]). The cobas HPV test identifies women at risk for cervical cancer by detecting the presence of high-risk human papillomavirus (HPV) DNA in cervical samples. Persistent high-risk HPV infections can develop into precancerous lesions and, if left untreated, these lesions can progress to cervical cancer.

"The approval of our HPV test for the cobas 6800 and 8800 Systems enables molecular laboratories to achieve the efficiency and scale they need to meet the demands of high-volume cervical screening programs," said Thomas Schinecker, CEO Roche Diagnostics. "This is critical as most healthcare providers in the US have adopted HPV testing as part of their cervical cancer screening protocol, with the ultimate goal of preventing cervical cancer in all women."

The goal of cervical cancer screening is to find and treat precancer early to help stop the progression of disease. The cobas HPV test helps to protect women from the potential harms of undetected and untreated cervical disease by detecting the virus that causes nearly all cervical cancers.

The cobas HPV test, previously approved for the cobas 4800 System, is now part of the growing menu of clinically validated, FDA approved tests for use on cobas 6800/8800 Systems. Laboratories now have the ability to run HPV DNA tests simultaneously with other previously released cobas tests on these high-throughput systems.

The FDA considered data from the registrational IMPACT (IMproving Primary screening And Colposcopy Triage) trial, which enrolled almost 35,000 women in the US to clinically validate cobas HPV for use on the cobas 6800/8800 Systems. Study data will be broadly shared, pending publication of the key findings.

About cobas HPV test
cobas HPV is indicated for use for routine cervical cancer screening as per professional medical guidelines, including triage of ASC-US cytology, co-testing (or adjunctive screen) with cytology, and HPV primary screening of women to assess the risk for cervical precancer and cancer.

The cobas 4800 HPV Test, originally introduced in 2011 and supported by the ATHENA trial (Addressing the Need for Advanced HPV Diagnostics), helps healthcare providers identify women at risk for cervical cancer by individually identifying the presence of the DNA of HPV genotypes 16 and 18 – the two genotypes responsible for about 70 percent of all cervical cancers – and reporting the 12 other high-risk HPV types as a combined result, all in one test and from one patient sample. Roche received the first FDA approval to use an HPV test for primary cervical cancer screening without accompanying Pap cytology for the cobas HPV 4800 Test in 2014. More information about the cobas HPV tests is available at www.hpv16and18.com

About the Roche Cervical Cancer Portfolio
The Roche Cervical Cancer Portfolio enables healthcare professionals to better screen, triage and diagnose women, based on the confidence and clarity of results across a continuum of patient care. The unique combination of molecular, cellular and tissue-based tests provides healthcare professionals powerful information to make patient care decisions and minimize unnecessary treatment.

The Roche cobas 4800 HPV Test, used in combination with CINtec PLUS Cytology and CINtec Histology, offers clinicians and labs in the US powerful support they have not had before. The dual-stain biomarker technology included in the CINtec PLUS Cytology test, which was FDA approved in March 2020, detects the simultaneous presence within a single cell of the two biomarkers — p16 and Ki-67. This abnormality is associated with HPV infections that are transforming and can, if left untreated, progress to pre-cancer or cancer. A positive result of these two biomarkers in a single cell signals that a woman is more significantly at risk for disease. The ability of CINtec PLUS Cytology to distinguish those women who are at higher risk for cervical disease provides labs, clinicians and women, in conjunction with the physician’s assessment of patient screening history, other risk factors, and professional guidelines information, to guide patient management. This could reduce the number and frequency of follow-up visits, saving worry, time and money.

CINtec Histology is the only FDA-cleared test used as an aid to confirm the presence of cervical disease in women who have had a tissue biopsy. The CINtec Histology test uses the p16 biomarker for a more conclusive diagnosis to provide distinctive visual confirmation of precancerous cervical lesions that may be missed by hematoxylin and eosin (H&E) interpretation alone. Both CINtec assays are fully automated on the VENTANA BenchMark IHC/ISH instruments.

About human papillomavirus and cervical cancer
Persistent infection with high-risk human papillomavirus (HPV) is the principal cause of cervical cancer in women, with HPV implicated in greater than 99 percent of cervical cancers worldwide. It can take 10 to 15 years or longer for cervical cancer to develop, so knowing a woman’s individual risk and finding disease early, before cancer develops, is an important prevention strategy. Globally, the World Health Organization estimates there are more than 570,000 new cases of cervical cancer annually, and 311,000 deaths4.

About cobas 6800/8800 Systems
Since 2014, the cobas 6800 and cobas 8800 Systems have established the new standard for routine molecular testing by delivering fully integrated, automated solutions that serve the areas of viral load monitoring, donor screening, sexual health and microbiology. Like the cobas 4800 System, each system is based on Nobel Prize-winning polymerase chain reaction (PCR) technology. The cobas 6800/8800 Systems deliver proven performance with full automation, increased throughput, fast turnaround time and complete track connectivity validated for molecular testing, providing users with greater flexibility to consolidate their in vitro diagnostic (IVD) and laboratory developed testing (LDT) to a single system while increasing overall workflow efficiencies.

The cobas 6800/8800 Systems menu for sexual health includes Chlamydia trachomatis/ Neisseria gonorrhoeae (CT/NG),Trichomonas vaginalis/ Mycoplasma genitalium (TV/MG), and Herpes simplex virus (HSV-1, HSV-2). Additionally, the broad and expanding menu covers other infectious diseases such as a Mycobacteria assay portfolio, Hepatitis B and C (HBV and HCV), Human immunodeficiency virus (HIV), and Cytomegalovirus (CMV). For more information about the tests and systems, please visit www.diagnostics.roche.com.

Clarity Pharmaceuticals Announces US FDA Grants 67Cu-SARTATE™ Orphan Drug Designation for Neuroblastoma

On April 21, 2020 Clarity Pharmaceuticals, a radiopharmaceutical company focused on the treatment of serious disease, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for 67Cu-SARTATE, a therapy for the clinical management of neuroblastoma (Press release, Clarity Pharmaceuticals, APR 21, 2020, View Source [SID1234556447]).

Neuroblastoma most often occurs in children younger than 5 years of age and presents when the tumour grows and causes symptoms. It is the most common type of cancer to be diagnosed in the first year of life and accounts for around 15% of paediatric cancer mortality. High-risk neuroblastoma accounts for approximately 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40%-50%.1

FDA grants ODDs to facilitate the development of investigational therapies intended to treat, diagnose or prevent rare diseases affecting fewer than 200,000 people in the United States. The designation allows Clarity Pharmaceuticals to qualify for a number of incentives, including: seven years of market exclusivity upon regulatory approval, if received; potential tax credits on US clinical costs; exemptions from certain administrative FDA fees; and eligibility for grants to fund future clinical work.

Dr Alan Taylor, Clarity’s Executive Chairman, commented, "At Clarity, we are especially passionate about the development of SARTATE in neuroblastoma. At present, prognosis of high-risk neuroblastoma patients remains unfavourable, despite intensive, multimodal therapy. Also, the effectiveness of current neuroblastoma treatment strategies, such as chemotherapy, radiation, and surgery, is limited in late-stage disease due to patients’ numerous metastases. It is clear that improvements in current treatment approaches are needed to overcome poor outcomes for the patients."

"ODD status will potentially provide a number of advantages for the development of SARTATE for the treatment of neuroblastoma and allow us to progress more swiftly to our ultimate goal of better treatment of children and adults with cancer."