On July 8, 2020 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported a webcast and conference call highlighting its progress and key accomplishments in the first half of 2020 (Press release, Zymeworks, JUL 8, 2020, View Source [SID1234561766]).

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"I’m proud to say we’ve taken a major step towards achieving our goal of bringing an important new therapeutic to patients with HER2-expressing cancers," said Ali Tehrani, Ph.D., President and CEO of Zymeworks. "ZW25, which we will now refer to as zanidatamab, has started its first registration-enabling trial in HER2+ 2L biliary tract cancer targeting a potential BLA in 2022."

Dr. Tehrani added, "This achievement, supported by the updated zanidatamab clinical data in BTC and GEA as well as the two partnership updates, highlights a productive first half of 2020 and sets the stage for more to come in the second half of the year."

Zanidatamab Clinical Updates

Registration-Enabling Trial in HER2+ Biliary Tract Cancer
Zymeworks initiated a global Phase 2 trial of single agent zanidatamab in patients with previously treated HER2 gene amplified BTC to support accelerated approval based on a primary endpoint of objective response rate, and secondary endpoints of duration of response and safety. This study may enable filing of a BLA as early as 2022.

Updated Single Agent Biliary Tract Cancer Data
In 15 response-evaluable refractory BTC patients, the response rate with single agent zanidatamab was 47% with a disease control rate of 67%. Results compare favorably to the single digit response rates typically seen with chemotherapy in this setting.

Updated Single Agent Gastroesophageal Adenocarcinoma Data
In 34 response evaluable patients with HER2-expressing GEA, zanidatamab continues to demonstrate exciting single agent anti-tumor activity with a 38% response rate, and 62% disease control rate in patients who have received a median of 3 prior lines of treatment, including Herceptin.

Updated Chemotherapy Combination Gastroesophageal Adenocarcinoma Data
Twenty response-evaluable HER2-expressing GEA patients were treated with zanidatamab in combination with either paclitaxel or capecitabine, both of which are used as single agent chemotherapies for patients with progression after first line treatment. The overall response rate was 55%, including a 60% response rate in combination with paclitaxel. As a comparator, the response rate for paclitaxel alone in 2nd line HER2+ GEA is ~ 20%. Responses were observed in patients with FISH+ and FISH- disease.

Business Highlights

New Azymetric Partnership with Merck
Zymeworks signed a new licensing agreement with its long-term partner Merck to develop additional multispecific antibody therapeutic candidates using the Azymetric and EFECT platforms. Zymeworks is eligible to receive up to US$411 million in option exercise fees and clinical development and regulatory approval milestone payments and up to US$480 million in commercial milestone payments, as well as tiered royalties on worldwide sales.

Expanded Partnership with Bristol-Myers Squibb
BMS (formerly Celgene) expanded its Azymetric collaboration with Zymeworks, gaining access to the EFECT platform and extending its research term, with the objective of developing up to 10 therapeutic candidates as per the original agreement. The expanded partnership resulted in a US$12 million upfront payment to Zymeworks. Milestones remain at up to US$1.7 billion plus tiered royalties on global sales.

On July 7, 2020 AbbVie (NYSE: ABBV) reported that it will announce its second-quarter 2020 financial results on Friday, July 31, 2020, before the market opens (Press release, AbbVie, JUL 7, 2020, View Source [SID1234561712]). AbbVie will host a live webcast of the earnings conference call at 8 a.m. Central time. It will be accessible through AbbVie’s Investor Relations website investors.abbvie.com. An archived edition of the session will be available later that day.

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On Juy 7, 2020 Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, along with its collaborators, reported two distinct studies (one oral and one poster presentation) at the recent 2020 virtual ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer that took place July 1-4, 2020 (Press release, Natera, JUL 7, 2020, View Source [SID1234561729]).

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The studies highlight: a) the clinical validity of Signatera, a personalized and tumor-informed circulating tumor DNA (ctDNA) assay for identifying molecular residual disease (MRD) in patients with oligometastatic CRC; and b) a prospective trial, already in progress, that will measure the clinical outcomes of MRD-guided treatment in stage II-III CRC patients.

These presentations build upon a fast-growing set of evidence that Signatera MRD testing is valid and useful for guiding post-surgical treatment decisions in colorectal cancer (escalation or de-escalation of therapy), including for late-stage oligometastatic patients where surgical resection may lead to cure.

"Now that Signatera is being used in prospective interventional trials, we’re seeing confirmation that it can help inform treatment decisions after oligometastatic resection in the 20 percent to 30 percent of patients with metastatic CRC,"1-3 said Alexey Aleshin, M.D., M.B.A., Natera’s Senior Medical Director for Oncology. "This clinical data suggest ctDNA testing is a highly accurate tool in guiding treatment and supports the advancement of our efforts with Signatera to improve cancer management."

Details about the abstracts are as follows:

Assigned ID: SO-34 | Oral Presentation

Presenter: Stacey A. Cohen, M.D.

Clinical Experience of a Personalized and Tumor-Informed Circulating Tumor DNA Assay for Minimal Residual Disease Detection in Oligometastatic Colorectal Cancer Patients

This study is a sub-analysis of the first large, real-world study using personalized MRD in 535 unique patients with Stage I-IV CRC, and is one of the first studies to evaluate ctDNA detection rates in late-stage oligometastatic CRC. The study found that ctDNA detection was significantly associated with stage of disease, demonstrating a detection rate of 100 percent in patients with active metastatic disease in a pre-surgical setting.

Assigned ID: P-120 | Poster Presentation

Presenter: Hiroki Yukami, M.D.

Prospective observational study monitoring circulating tumor DNA in resectable colorectal cancer patients undergoing radical surgery: GALAXY study in CIRCULATE-Japan (Trial in Progress)

The poster presentation highlighted the GALAXY study design, a prospective, observational study, which is part of the CIRCULATE-Japan trial, organized by the National Cancer Center (NCC) Japan. The CIRCULATE-Japan trial is a multicenter, randomized trial that will investigate optimal ctDNA-guided treatment strategies for patients with Stage II-III CRC, particularly adjuvant chemotherapy decisions based on MRD status.

About Signatera

Signatera is a custom-built ctDNA test for treatment monitoring and MRD assessment in patients previously diagnosed with cancer. The test is available for clinical and research use, and it was granted Breakthrough Device Designation by the FDA in 2019. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. This maximizes accuracy for detecting the presence or absence of residual disease in a blood sample, even at levels down to a single tumor molecule in a tube of blood. Unlike a standard liquid biopsy, Signatera is not intended to match patients with any particular therapy. Rather, it is intended to detect and quantify how much cancer is left in the body, to detect recurrence earlier and to help optimize treatment decisions. Signatera’s test performance has been clinically validated in multiple cancer types including colorectal, non-small cell lung, breast, and bladder cancers. Medicare has proposed insurance coverage for the use of Signatera in patients with Stage II or III colorectal cancer, and it is expected to finalize that coverage decision in mid-2020. Signatera has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). Although FDA is exercising enforcement discretion of premarket review and other FDA legal requirements for laboratory-developed tests in the US, certification of the laboratory is required under CLIA to ensure the quality and validity of the tests. CAP accredited, ISO 13485 certified, and CLIA certified. © 2020 Natera, Inc. All Rights Reserved.

On July 7, 2020 Vor Biopharma, an oncology company pioneering engineered hematopoietic stem cells (eHSCs) for the treatment of cancer, reported it has raised $110 million in a Series B financing (Press release, Vor BioPharma, JUL 7, 2020, View Source [SID1234561713]). Proceeds will advance the company’s lead candidate VOR33 into clinical trials, deepen its portfolio, and accelerate the validation of additional targets for its scientific platform, which is designed to remove redundant proteins so that transplanted stem cells become invisible to targeted therapies while leaving diseased cells vulnerable. Vor’s treatment strategy has the potential to bring a revolutionary treatment paradigm for patients with acute myeloid leukemia and other hematologic malignancies.

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"Vor has an elegant approach to engineering hematopoietic stem cells that we believe is amongst the most promising innovations in oncology," said Joshua Resnick, MD, Managing Director at RA Capital Management. "We are proud to support the efforts of their impressive team of experienced leaders and drug developers as they work aggressively to establish a new standard of care in stem cell transplants and forge ahead into first-in-human clinical studies."

RA Capital Management led the Series B financing, along with a diverse group of well-respected new investors including Fidelity Management & Research Company, LLC, Pagliuca Family Office, Alexandria Venture Investments, and other undisclosed investors, including additional institutional crossover investors. Existing investors 5AM Ventures, Johnson & Johnson Innovation — JJDC, Inc. (JJDC), Osage University Partners, and co-founder PureTech Health participated in the financing.

"The high caliber of investors participating in this financing underscores the tremendous potential of our eHSC platform," said Robert Ang, MBBS, MBA, Vor’s President and Chief Executive Officer. "We have ambitious goals for the coming year, and this financing is an important step as we prepare to treat cancer patients in our first clinical trials."

On July 7, 2020 Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company focused on Next Generation DNA Damage Response (DDR) therapeutics for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease (RPD) Designation for its drug Silmitasertib, a Casein Kinase 2 (CK2) inhibitor, being developed as a treatment for recurrent sonic hedgehog (SHH) medulloblastoma (Press release, Senhwa Biosciences, JUL 7, 2020, View Source [SID1234561730]). With the RPD designation, Senhwa Biosciences is eligible for a Priority Review Voucher (PRV) which can be used for a subsequent marketing application, and may be sold or transferred. In August 2015, AbbVie bought a PRV from United Therapeutics Corp for $350 million which allowed AbbVie to accelerate one of its drug’s FDA review process.

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Medulloblastoma is the most common cancerous brain tumor in children. Treatment for medulloblastoma usually includes surgery, followed by radiation or chemotherapy, or both. Currently there is no targeted drug available. Recurrent SHH medulloblastoma is recognized as one of the four major sub-groups of medulloblastoma, with about 80-100 new cases per year. The FDA grants RPD Designation for serious or life-threatening diseases that primarily affect people from birth to 18 years old and which affect fewer than 200,000 people in the U.S.

Senhwa’s clinical partner, the Pediatric Brain Tumor Consortium (PBTC, www.pbtc.org) is currently conducting a Phase I/II and Surgical study of Silmitasertib, in both children and adults with recurrent SHH medulloblastoma, at its participating member academic medical centers and children’s hospitals across the United States. This clinical trial is sponsored by the PBTC and funded through the Consortium grant awarded by the National Institute of Health (NIH) – Cancer Therapy Evaluation Program (CTEP).

Silmitasertib is safe and well-tolerated in humans. To date, three Phase I trials of Silmitasertib in cancer patients have been completed; currently, there are one ongoing Phase I and two ongoing Phase II studies of Silmitasertib.

About Silmitasertib
Silmitasertib is a first-in-class small molecule drug which targets CK2 and acts as a CK2-inhibitor. A Phase I/II study has shown that Silmitasertib achieved clinical benefit, resulting in stable disease and extending the duration of treatment in patients who are unresponsive to standard of care therapy. The combination of Silmitasertib with DNA-damaging agents such as gemcitabine (Gemzar) plus cisplatin (Platinol) has been shown to synergistically improve the efficacy of cholangiocarcinoma (CCA) treatments. In December 2016, Silmitasertib was granted Orphan Drug Designation by the US FDA for the treatment of CCA.