On November 1, 2021 Exact Sciences Corp. (NASDAQ: EXAS) reported that data from the Rx for Positive Node, Endocrine Responsive Breast Cancer, or RxPONDER, trial were published in The New England Journal of Medicine (Press release, Exact Sciences, DEC 1, 2021, View Source [SID1234596335]).i The study, led by the independent SWOG Cancer Research Network and sponsored by the National Cancer Institute (NCI), successfully defined the benefit of chemotherapy in early-stage, node-positive breast cancer patients with Oncotype DX Breast Recurrence Score results of 0 to 25. Initial results from RxPONDER were reported at the 2020 San Antonio Breast Cancer Symposium (SABCS). The findings have now been confirmed in this peer-reviewed publication.

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RxPONDER results show that guiding treatment w/ Oncotype DX test can spare chemo use in majority of postmenopausal women
In the study, postmenopausal women with 1 to 3 positive nodes and Recurrence Score results of 0 to 25 showed no benefit from chemotherapy after a median of five years of follow-up, meaning they can potentially avoid negative side effects of the treatment. Importantly, no chemotherapy benefit was observed regardless of the number of affected nodes, tumor grade or size. In premenopausal women with 1 to 3 positive nodes, a statistically significant chemotherapy benefit was observed.

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 chemotherapyii even though approximately 85% of them have Recurrence Score results of 0 to 25.iii In addition, approximately two out of three early-stage breast cancer patients are postmenopausal.iv

"Our goal with RxPONDER was to better understand when to use adjuvant chemotherapy to enable personalized treatment instead of a one-size-fits-all approach," said study lead author Kevin Kalinsky, M.D., a long-time SWOG investigator and director of the Glenn Family Breast Center at the Winship Cancer Institute of Emory University. "These practice-changing results definitively show that postmenopausal women with this common form of breast cancer can be spared unnecessary chemotherapy and receive only hormone therapy, potentially saving tens of thousands of women the time, expense and harmful side effects that can be associated with chemotherapy. For the women diagnosed with breast cancer prior to menopause who may benefit from chemotherapy, the data help individualize the discussion of risk and benefit of chemotherapy."

Based on the RxPONDER results, the National Comprehensive Cancer Network (NCCN)v updated its guidelines for breast cancer and recognized the Oncotype DX Breast Recurrence Score test as the only test that can be used for prediction of chemotherapy benefit in early-stage breast cancer patients with 1 to 3 positive axillary lymph nodes, including micrometastases.vi The Oncotype DX test is now the only test classified as "preferred" with the highest level of evidence for node-negative and postmenopausal node-positive (1 to 3 positive nodes) patients. In addition, NCCN recommends considering the test to assess prognosis in premenopausal node-positive patients who are candidates for chemotherapy.

"The RxPONDER results, together with the foundational TAILORx resultsvii in node-negative, early-stage breast cancer, further elevate the test to a standard of care, supporting its inclusion in guidelines as well as its reimbursement and adoption on a global scale," said Rick Baehner, M.D., chief medical officer of Precision Oncology at Exact Sciences. "Now with the RxPONDER results, many more women worldwide may be able to receive hormone therapy alone, avoiding the negative side effects of chemotherapy without increasing the risk of cancer returning."

One of the largest clinical trials in node-positive, HR-positive, HER2-negative early breast cancer, RxPONDER enrolled more than 5,000 women with up to three positive nodes. The prospective, randomized Phase III study was conducted at 632 sites in nine countries – the United States, Canada, Mexico, Colombia, Ireland, France, Spain, South Korea and Saudi Arabia. Women with a Recurrence Score result of 0 to 25 were randomized to treatment with hormone therapy alone or chemotherapy followed by hormone therapy. Randomized patients were stratified based on their Recurrence Score result, menopausal status and type of lymph node surgery. Further analyses and additional patient follow up are planned by the SWOG investigators.

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 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 daysviii 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 1, 2021 LintonPharm Co., Ltd., a China-based clinical stage biopharmaceutical company focused on the development of T cell engaging bispecific antibodies for cancer immunotherapy, reported that the first patient has been dosed in the Company’s Phase 1/2 clinical trial program for catumaxomab (clinicaltrials.gov: NCT04799847), a monoclonal bispecific antibody being studied for the treatment of Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG) (Press release, Lintonpharm, DEC 1, 2021, View Source [SID1234596354]).

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"The initiation of our Phase 1 trial of catumaxomab for the treatment of NMIBC is an important step in our clinical program evaluating catumaxomab as targeted therapy in a broad range of cancers", said Robert Li, PH.D., DABT, Co-founder and CEO of LintonPharm. "Patients with NMIBC BCG failure need new therapies due to the limitations of current treatments which bring poor prognosis, such as high rates of tumor recurrence, bladder dysfunction and lifelong intervention. Based on encouraging pre-clinical data and clinical experience with patients who’ve received catumaxomab in the past through the compassionate use program, we are hopeful that catumaxomab will be a very promising immunotherapy candidate for patients with NMIBC BCG failure."

A recent publication indicated clinical benefits of catumaxomab as compassionate use in patients with EpCAM-positive recurrent NMIBC. It is noted that catumaxomab was well tolerated and presented promising performance in tumor control [1]. Based on the data and the developmental potential, catumaxomab could provide a feasible, safe, and efficacious therapy for NMIBC patients, if approved.

Bladder cancer is the 10th most commonly diagnosed cancer worldwide, with approximately 573,000 new cases in 2020 and roughly 75 percent are diagnosed as NMIBC [2][3]. Currently, the mainstay treatments of NMIBC include transurethral resection, chemotherapy and intravesical BCG [3].

About Catumaxomab

Catumaxomab was approved by the European Medicines Agency in 2009 for the treatment of malignant ascites. This bispecific antibody binds to a transmembrane glycoprotein on the tumor cell–the epithelial cell adhesion molecule (EpCAM)–and CD3 on the T cell, and also recruits immune accessory cells through FcγR binding. Catumaxomab destroys tumor cells by engaging T cell and accessory cell mediated cytotoxicity and has the potential to induce long-term vaccinal effects which has been verified in animal models.

Recently, catumaxomab was authorized by regulatory authorities in China, Taiwan (China) and South Korea to conduct a global Phase 3 clinical trial for treating patients with advanced gastric cancer (clinicaltrials.gov: NCT04222114).

On December 1, 2021 Zetagen Therapeutics, a private, clinical-stage, biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, reported it has received Breakthrough Device designation from the Centers for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) for its ZetaMet technology (Press release, Zetagen Therapeutics, DEC 1, 2021, View Source [SID1234596376]). Previously known as ZetaFuse, ZetaMet is a synthetic, small-molecule, inductive biologic technology being developed to target and resolve metastatic bone lesions while inhibiting future tumor growth and regenerating bone.

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"We are pleased to receive this important designation from the Agency and look forward to partnering with them," said Joe C. Loy, CEO of Zetagen Therapeutics. "Our researchers have discovered an entirely new pathway for an established molecule which, if proven successful in human clinical trials, could create a new treatment paradigm for the hundreds of thousands of patients living with cancers that involve metastatic bone lesions."

ZetaMet works through a mechanism of action (MOA) which is a novel and patented molecular pathway. The small molecule, precisely-dosed, delivered to the affected area through a proprietary drug-eluting carrier, stimulates stem cells, activating cells to grow healthy bone known as "osteoblasts", and inhibits cells associated with bone degradation called "osteoclasts". The combination technology has, thus far, in preclinical studies, demonstrated its ability to resolve existing metastatic bone lesions, inhibit pain and stimulate targeted bone regeneration.

Bone metastases are common among cancer patients and occur when cells from the primary cancerous tumor relocate to the bone. When these cancers relocate, they can cause changes to the bone, damaging it in a process called osteolysis. Osteolysis can cause small holes within the bone, weakening it and increasing the risk of breakage. These holes are called "lytic lesions." Among cancers which metastasize to bone, Breast and Prostate are most prevalent, amounting to approximately 70-percent of cases.1

ZetaMet has successfully passed its preclinical trials and is being prepared for its first human clinical trial in early 2022.

On December 1, 2021 BeyondSpring Pharmaceuticals (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a global pharmaceutical company focused on the development of cancer therapeutics, reported it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) seeking approval of plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN) (Press release, BeyondSpring Pharmaceuticals, DEC 1, 2021, View Source;utm_medium=rss&utm_campaign=beyondspring-pharmaceuticals-receives-complete-response-letter-from-the-fda-for-plinabulin-new-drug-application-for-prevention-of-chemotherapy-induced-neutropenia-cin [SID1234596319]). The FDA issued the CRL to indicate that they have completed their review of the application and have determined that it cannot be approved in its present form.

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The FDA’s CRL indicated that the results of the single registrational trial (106 Phase 3) was not sufficiently robust to demonstrate benefit and that a second well controlled trial would be required to satisfy the substantial evidence requirement to support the CIN indication.

"BeyondSpring strongly believes that plinabulin in combination with G-CSF has significant potential to raise the standard of care in CIN, a devastating side effect of chemotherapy," said Dr. Lan Huang, BeyondSpring’s co-founder, chief executive officer and chairwoman. "The Company plans to request a meeting with the FDA and remains committed to its goal of bringing plinabulin to cancer patients in need globally."

BeyondSpring remains confident in the efficacy and safety data for plinabulin in combination with G-CSF for the prevention of CIN. The Company expects to work closely with the FDA to consider the possible future clinical pathway for CIN, which may include a second study.

Plinabulin is the first drug candidate submitted for FDA approval that has the potential to work in the critical first week of chemotherapy treatment before G-CSF is effective, to prevent the onset and improve clinical outcomes of CIN.

About Plinabulin
Plinabulin, BeyondSpring’s lead asset, is a selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer. It is a novel, intravenous infused, patent-protected, NDA-stage asset for CIN prevention and a Phase 3 anti-cancer candidate for non-small cell lung cancer (NSCLC) with recently released positive topline data. Plinabulin triggers the release of the immune defense protein, GEF-H1, which leads to two distinct effects: first is a durable anticancer benefit due to the maturation of dendritic cells resulting in the activation of tumor antigen-specific T-cells to target cancer cells, and the second is early-onset of action in CIN prevention after chemotherapy by boosting the number of hematopoietic stem/progenitor cells (HSPCs). Plinabulin received Breakthrough Therapy designation and priority review from both U.S. and China FDA for the CIN prevention indication. As a "pipeline in a drug," plinabulin is being broadly studied in combination with various immuno-oncology agents that could boost the effects of the PD-1/PD-L1 antibodies and re-sensitize PD-1/PD-L1 antibody-resistant patients.

On December 1, 2021 Melanie Comito, MD, division chief of hematology and oncology at Upstate Golisano Children’s Hospital, reported that it has been awarded a $50,000 infrastructure grant by the St. Baldrick’s Foundation (Press release, SUNY Upstate, DEC 1, 2021, View Source [SID1234596336]).

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These one-year grant provides Upstate the staffing to open, coordinate, and treat more children on clinical trials, making it possible for more children to access these trials close to home.

Upstate was on of 24 institutions to receive an infrastructure grant, totaling more than $1.1 million.

The award supports the work at the Dr William J. Waters Center for Children’s Cancer and Blood Disorders at Upstate Golisano Children’s Hospital, which provides oncology care to children, adolescents, and young adults.

"To be able to offer clinical trials for children with cancers is one of the most important things we can do at our center," Comito said. "As a smaller center, we still see a variety of types of cancer, so we have to be prepared by having as many trials open as possible.

"We currently have 47 open clinical trials available for pediatric cancer patients which allows children in our 17-county area to have access to clinical trials closer to home, Comito added. "St. Baldrick’s infrastructure support is essential for supporting our clinical research staff so that we can meet this goal of curing as many children as possible."

"St. Baldrick’s Infrastructure Grants are designed for one reason, to treat more children on clinical trials, often their best hope for a cure," said Kathleen Ruddy, St. Baldrick’s CEO. "Thanks to donors, volunteers, advocates, and all those who are fighting every day for kids with cancer, from making these $1.1 million in grants possible. These grants are particularly critical because they often help children who are treated at smaller hospitals, or those where resources are scarce, but needs are high."

St. Baldrick’s is a volunteer-driven charity committed to funding the most promising research to find cures for childhood cancers. St. Baldrick’s coordinates its signature head-shaving events worldwide where participants collect pledges to shave their heads in solidarity with kids with cancer, raising money to fund research.