On July 27, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that data from the cervical cancer cohort of SUMMIT, an ongoing Phase II basket trial examining the safety and efficacy of neratinib in HER2-mutated cancers, were published in the journal Gynecologic Oncology (Press release, Puma Biotechnology, JUL 27, 2020, View Source [SID1234562413]). The paper, "Neratinib in patients with HER2-mutant, metastatic cervical cancer: Findings from the phase 2 SUMMIT basket trial," appears in the July 25, 2020 online issue at View Source(20)33660-X/pdf and will be published in a future print issue of the journal.

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The Phase II SUMMIT ‘basket’ trial is an open-label, international multi-histology study to evaluate the safety and efficacy of neratinib, administered daily to patients, across a broad spectrum of cancer types in patients whose tumors harbor activating HER2 somatic mutations. The primary endpoint was confirmed objective response rate. Secondary endpoints included response duration, clinical benefit rate, progression-free survival, overall survival, and safety.

Sixteen patients with HER2-mutant, persistent, metastatic or recurrent cervical cancer with disease progression after platinum-based treatment for advanced or recurrent disease were enrolled in the cohort and received oral neratinib daily with mandatory loperamide prophylaxis during the first cycle.

Three of 12 RECIST-measurable patients had confirmed partial responses (overall response rate of 25%; 95% CI 5.5–57.2%); three had stable disease more than 16 weeks (clinical benefit rate of 50%; 95% CI 21.1–78.9%). Response duration for responders were 5.6, 5.9, and 12.3 months. Median progression-free survival was 7.0 months (95% CI 1.0–18.3 months) and the median overall survival was 16.8 months (95% CI 4.1–months not evaluable).

The safety profile observed in neratinib-treated cervical cancer patients in SUMMIT was consistent with that reported for HER2-positive metastatic breast cancer. Diarrhea (75%), nausea (44%), and decreased appetite (38%) were the most common of all grade adverse events. One patient (6%) reported grade 3 diarrhea. The rate of grade 3 diarrhea was considerably lower than reported for metastatic breast cancer patients. While this is a limited dataset, more remains to be revealed as more patients are enrolled. There were no grade 4 events, and no diarrhea-related treatment discontinuations.

Dr. Bradley J. Monk, Professor in the Division of Gynecologic Oncology, University of Arizona College of Medicine and Medical Director of the US Oncology Research Network Gynecological Program, said, "Neratinib demonstrates encouraging clinical activity in metastatic cervical cancer patients with tumors harboring an activating HER2 mutation. Given the limited options for the treatment of cervical cancer after platinum-based therapy failure, neratinib warrants further investigation in this molecular-defined patient population."

The data was initially presented by Anishka D’Souza, M.D., Assistant Professor of Clinical Medicine, Keck School of Medicine of University of Southern California (USC), during the scientific plenary session at the Society of Gynecologic Oncology (SGO) 2019 Annual Meeting in March 2019.

Alan H. Auerbach, Chief Executive Officer and President of Puma, added, "We are very pleased with the activity seen with neratinib in this cohort of patients with HER2-mutated cervical cancer. We look forward to the further development of neratinib in this patient population."

On July 27, 2020 NeoImmuneTech, Inc., a clinical-stage T cell-focused biopharmaceutical company, reported receipt of IND clearance from the US Federal Drug Administration (FDA) to evaluate NT-I7 (efineptakin alfa), the only clinical-stage long-acting human IL-7, in a Window-of-Opportunity trial for patients with locally recurrent squamous cell carcinoma of head and neck (SCCHN) undergoing salvage surgery (Press release, NeoImmuneTech, JUL 27, 2020, View Source [SID1234562412]). The investigator-initiated trial is being conducted by Hyunseok Kang, M.D., Associate Professor of Clinical Medicine at the University of California, San Francisco.

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Over half a million people worldwide are diagnosed with SCCHN every year, making it the sixth most common cancer in the world. Even with intense treatment, about 20-40% of patients experience disease progression or recurrence and would receive salvage surgery as standard of care for locally recurrent disease. Since the majority of these patients had received prior chemoradiotherapy, these patients typically suffer critical shortage of lymphocytes, known as lymphopenia, which is associated with poor prognosis. NT-I7 has demonstrated clinically to help overcome lymphopenia in cancer patients by expanding lymphocyte counts in the peripheral blood as well as in the tumor microenvironment.

"SCCHN has a high rate of recurrence, and salvage surgeries attempted for locally recurrent disease have not been very successful," said Dr. Kang. "Since the majority of these patients received prior chemoradiation, many suffer from treatment-related lymphopenia, which likely results in poor response to systemic anticancer therapy. We hypothesize that by expanding lymphocytes and reverting lymphopenia with NT-I7, we can enhance the efficacy of immune checkpoint inhibitors which are already approved in SCCHN."

"NT-I7’s promising ability to overcome lymphopenia and its excellent safety profile make it especially well-suited as a combination partner with other cancer therapeutics," said NgocDiep Le, M.D., Ph.D., Executive Vice President and Chief Medical Officer of NeoImmuneTech. "The data generated from this study can be used as a proof of concept for how NT-I7 can augment immune checkpoint inhibitors and help to develop interventional studies using NT-I7 based combinations. We believe that our immune enhancer, NT-I7, has the potential to provide new and improved treatment options for patients with this devastating disease."

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T-cell amplification and increased functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T-cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). NT-I7 exhibits favorable PK/PD and safety profiles, making it an ideal combination partner. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

On July 27, 2020 Checkmate Pharmaceuticals, Inc. (Checkmate), a clinical-stage biotechnology company focused on developing proprietary technology to harness the power of the immune system to combat cancer, reported that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its product candidate, CMP-001, a differentiated Toll-like receptor 9 (TLR9) agonist, in combination with a programmed death receptor 1 (PD-1) blocking antibody (nivolumab or pembrolizumab) for two development programs, including (Press release, Checkmate Pharmaceuticals, JUL 27, 2020, View Source [SID1234562411]):

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initial treatment of patients with unresectable Stage III or Stage IV melanoma to prolong the time to disease progression; and
treatment of patients with unresectable or metastatic melanoma refractory to prior anti-PD-1 blockade to improve the overall tumor response rate.
The FDA previously granted Orphan Drug designation to CMP-001 for Stages IIb-IV melanoma.

Fast Track is a designation granted by the FDA to facilitate the development and review of a drug intended to treat a serious condition and for which available nonclinical or clinical data demonstrate the potential to address an unmet medical need. A product candidate granted Fast Track designation may be eligible for several benefits, including more frequent meetings and communications with the FDA review teams and, if relevant criteria are met, the potential for Priority Review or Rolling Review of a Biologics License Application (BLA) or a New Drug Application (NDA).

"These FDA designations for CMP-001 are testaments to the critical need for new drugs designed to treat patients with melanoma," said Barry Labinger, CEO of Checkmate. "We look forward to continued engagement with the FDA in advancing the development of CMP-001 in combination with PD-1 blockade in melanoma and head and neck squamous cell carcinoma."

About CMP-001

CMP-001 comprises a virus-like particle utilizing a CpG-A oligonucleotide. It is designed to trigger the body’s innate immune system via TLR9 and infiltrate the tumor microenvironment by the subsequent induction of both innate and adaptive anti-tumor immune responses. Checkmate believes CMP-001 is the only compound utilizing a CpG-A class TLR9 agonist in clinical development. For information on CMP-001 trials that are currently recruiting patients, please visit www.clinicaltrials.gov.

About Melanoma

Melanoma is a serious form of skin cancer that arises from a particular skin cell type called a melanocyte. Melanoma is a particularly dangerous form of cancer because of its ability to spread to other organs rapidly if not surgically removed at an early stage, as well as low response rates and limited durability of response when treated with commonly used chemotherapeutics. In 2020, melanoma of the skin is estimated to be the fifth most diagnosed cancer, and accounts for approximately 1% of all skin cancers in the U.S. According to the American Cancer Society, there will be an estimated 100,350 new diagnoses and approximately 6,850 patients will die as a result of melanoma in the United States in 2020 alone.

On July 27, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that it will release its financial results for the second quarter ended June 30, 2020, after the close of market on Monday, August 10, 2020 (Press release, Castle Biosciences, JUL 27, 2020, View Source [SID1234562410]).

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Company management will host a conference call and webcast to discuss its financial results and provide a corporate update at 4:30 p.m. Eastern time on the same day.

Conference Call and Webcast Details

A live webcast of the conference call can be accessed at View Source or via the webcast link on the Investor Relations page of the Company’s website (www.castlebiosciences.com). Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until August 31, 2020.

To access the live conference call via phone, please dial 877-282-2581 from the United States and Canada, or +1 470-495-9479 internationally, at least 10 minutes prior to the start of the call, using the conference ID 7388802.

There will be a brief Question & Answer session following the corporate update.

On July 27, 2020 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has granted priority review status to the New Drug Application (NDA) of pamiparib, BeiGene’s investigational inhibitor of PARP1 and PARP2, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy (Press release, BeiGene, JUL 27, 2020, View Source [SID1234562409]).

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"Pamiparib is our third internally developed drug candidate that has been granted priority review in China, following tislelizumab and BRUKINSA. It received priority review within a week of the acceptance of the application, reflecting the unmet need for patients with this advanced disease," commented Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "We look forward to presenting the clinical data that support this NDA at an upcoming medical conference and the next milestones in the pamiparib program."

The NDA of pamiparib as a potential treatment for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer was accepted in July 2020. It is supported by clinical results from the pivotal Phase 2 portion of the Phase 1/2 trial (NCT03333915), which enrolled 113 patients in China with high-grade epithelial ovarian cancer (including fallopian tube or primary peritoneal cancer) or high-grade endometrioid epithelial cancer, harboring germline BRCA1/2 mutation, following at least two prior lines of standard chemotherapy. BeiGene is developing pamiparib as a monotherapy and in combination with other therapies for the treatment of a broad array of solid tumors.

Priority review and approval was established in China to facilitate drug registration management and accelerate the development of innovative drugs with significant clinical advantages and for which there is an urgent clinical need. According to the Drug Registration Regulation (Bureau Order 27) implemented on July 1, 2020, the regulatory authority will prioritize the review process and evaluation resources for applications under priority review. These applications are expected to have reduced review and approval timelines.

About Ovarian Cancer

In China, ovarian cancer is the tenth most common form of cancer among women, with over 50,000 new cases and more than 30,000 deaths in 2018.1 More than 60 percent of patients are diagnosed with advanced disease.2 The standard therapy for ovarian cancer consists of surgery followed by postoperative platinum-based chemotherapy. An estimated 70 percent of patients with epithelial ovarian cancer, which accounts for more than 90 percent of all ovarian cancer,3 who achieve a full remission following first-line therapy will develop recurrent disease.4

About Pamiparib

Pamiparib (BGB-290) is an investigational inhibitor of PARP1 and PARP2 which has demonstrated pharmacological properties such as brain penetration and PARP-DNA complex trapping in preclinical models. Discovered by BeiGene scientists, pamiparib is currently in global clinical development as a monotherapy or in combination with other agents for a variety of solid tumor malignancies. To date, more than 1,200 patients have been enrolled in clinical trials of pamiparib.

A New Drug Applications (NDA) for pamiparib for patients with ovarian cancer has been accepted and granted priority review by the Center for Drug Evaluation (CDE) of the NMPA.

About the Pamiparib Clinical Program

Clinical trials of pamiparib include:

Phase 3 trial in China of pamiparib as maintenance versus placebo in patients with platinum-sensitive recurrent ovarian cancer (NCT03519230);

Phase 2 trial of pamiparib in patients with metastatic castration-resistant prostate cancer with homologous recombination deficiency (NCT03712930);

Phase 2 trial in China of pamiparib in patients with metastatic HER2-negative breast cancer with BRCA mutation (NCT03575065);

Phase 2 trial of pamiparib in patients with advanced or inoperable gastric cancer (NCT03427814);

Phase 1/2 trial in China of pamiparib in patients with advanced ovarian cancer, fallopian cancer, and primary peritoneal cancer or advanced triple negative breast cancer (NCT03333915);

Phase 1b/2 trial of pamiparib in combination with radiation therapy and/or temozolomide in patients with first-line or recurrent/refractory glioblastoma (NCT03150862);

Phase 1b trial of pamiparib in combination with temozolomide in patients with locally advanced or metastatic solid tumors (NCT03150810); and

Phase 1b trial of pamiparib in combination with tislelizumab for a variety of solid tumor malignancies (NCT02660034).