On December 10, 2020 Ambrx Inc., a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code, reported a clinical update on their lead program ARX788, a homogeneous and highly stable, site-specific antibody drug conjugate (ADC) targeting HER2 positive cancers (Press release, Ambrx, DEC 10, 2020, View Source [SID1234572609]).

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"As presented at the 2020 San Antonio Breast Cancer Symposium, ARX788 Phase 1 studies demonstrated promising antitumor activity in heavily pre-treated cancer patients at the recommended Phase 2 dose," said Joy Yan, MD, PhD, Ambrx Chief Medical Officer.

• ORR of 74% (14/19) and DCR of 100% in the 1.5 mg/kg cohort of the Phase 1 HER2-positive breast cancer trial in China
• ORR of 67% (2/3) and DCR of 100% in the 1.5 mg/kg cohort of Phase 1 HER2-positive pan tumor trial in U.S. and Australia
• mDOR or mPFS at the 1.5 mg/kg dose have not been reached.
• ARX788 was well-tolerated, with most adverse events being mild or moderate, and were manageable.

Patients who failed prior Kadcyla (T-DM1) or Enhertu (DS-8201a) achieved clinical responses, as assessed by RECIST v1.1 in the ACE-Pan Tumor-01 (ARX788-1711) trial, which enrolled patients with HER2 expressing cancers including breast cancer, gastric/gastroesophageal junction adenocarcinoma, non-small cell lung cancer, bladder, colorectal, biliary track, and salivary gland cancers in US and Australia.

"The randomized controlled Phase 2/3 HER2-positive breast cancer pivotal trial in China has treated 22 subjects as of December 5th, 2020 and continues to quickly enroll patients," said Dr. Xichun Hu, the leading PI of the ongoing ARX788 Phase 1 and Phase 2/3 trials in China.
"We remain on track to open multiple global ARX788 registrational studies next year, with the first study in HER2-positive breast cancer patients who failed prior T-DM1, T-DXd, or tucatinib-containing regimens starting in early 2021. These global registrational studies are designed to obtain BLA and sBLA in HER2 positive breast cancer, HER2 positive gastric cancer, HER2-low breast cancer, and other HER2-expressing or HER2-mutated solid tumors," said Dr. Yan.

About ARX788
ARX788 is a homogeneous and highly stable antibody drug conjugate (ADC) targeting the HER2 receptor. ARX788 is a Precision Biologic ADC that consists of two cytotoxic payloads site-specifically conjugated to a Herceptin (trastuzumab) based antibody. ARX788 was designed for maximum performance in the preclinical setting by optimizing the number, position and chemical bonds that conjugate the cytotoxic AS269 payload to the antibody. AS269 is a proprietary tubulin inhibitor specifically designed to form a highly stable covalent bond with our synthetic amino acids, a fundamental step in the creation of a Precision ADC. Ambrx is developing and commercializing ARX788 with its partner NovoCodex.

On December 10, 2020 Physicians’ Education Resource, LLC, (PER) is leading the industry this month with two high-impact, reported that continuing medical education–certified interactive annual conferences on cancer management on Saturday, Dec. 12 (Press release, Physicians’ Education Resource, DEC 10, 2020, View Source [SID1234572625]).

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These virtual conferences will deliver value for oncologists across cancer tumor types. Clinicians can kick-start their day hearing expert perspectives on the advantages of currently available liquid-based and tissue-based testing approaches and continue their day discussing new and emerging tumor biomarkers that drive personalized treatment with oncology immunotherapies with world-renowned oncology experts.

"PER is committed to producing specific, impactful programming to help health care professionals stay up to date on the latest data, biomarkers and patient care strategies," said Phil Talamo, CHCP, president of PER. "Throughout these two highly anticipated cutting-edge virtual conferences, our learners will be able to attend specific tumor type sessions and discuss cancer management strategies in real time with expert faculty."

The PER cancer management interactive virtual conferences on Dec. 12 are:

4th Annual Precision Medicine Through Plasma: Using Liquid Biopsies in Contemporary Oncology Care will be a live conference led by returning co-chair Benjamin P. Levy, M.D. In this innovative half-day program, health care professionals will learn about current applications and examine emerging developments, all aimed at individualizing treatment for patients with cancer. To register, click here.

5th Annual International Congress on Immunotherapies in Cancer: Focus on Practice-Changing Application will be a full-day, live conference led by returning co-chairs Naiyer Rizvi, M.D., and Mario Sznol, M.D. Using a mix of brief presentations, panel discussions and case reviews, this meeting will engage participants and provide clinicians with immunotherapeutic strategies based on emerging data. These strategies can be directly applied to day-to-day management of lung cancers, melanoma, genitourinary cancers and hematologic malignancies. To register, click here.

On December 10, 2020 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported the selection of three abstracts for presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, taking place virtually on January 15 – 17, 2021 (Press release, Zymeworks, DEC 10, 2020, View Source [SID1234572610]).

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The presentations highlight updated clinical data for the HER2-targeted bispecific antibody, zanidatamab, in HER2-expressing gastroesophageal adenocarcinoma (both as monotherapy and in combination with chemotherapy) and in HER2-expressing/amplified biliary tract cancer (as monotherapy). Zymeworks is currently recruiting globally in a pivotal clinical trial in patients with HER2-amplified biliary tract cancer for which a "trial in progress" poster will also be presented during the meeting.

Oral Presentation Session

Title: Zanidatamab (ZW25) in HER2-expressing gastroesophageal adenocarcinoma (GEA):

Results from a phase I study

Lead Author: Funda Meric-Bernstam, MD, UT MD Anderson Cancer Center, TX

Abstract: 164

Rapid Abstract Session: Esophageal and Gastric Cancer

Date and Time: January 15, 2021 at 11:30 am – 12:15 pm ET

Poster Presentations

The poster presentations will be available on Friday, January 15 at 8:00 am ET on the conference website as well as the Zymeworks website.

Title: Zanidatamab (ZW25) in HER2-positive biliary tract cancers (BTCs): Results from a phase I study.

Lead Author: Funda Meric-Bernstam, MD, UT MD Anderson Cancer Center, TX

Abstract: 299

Poster Session: Hepatobiliary Cancer

Title: A phase IIb, open-label, single-arm study of zanidatamab (ZW25) monotherapy in subjects with advanced or metastatic HER2-amplified biliary tract cancers (BTCs).

Lead Author: Shubham Pant, MD, UT MD Anderson Cancer Center, TX

Abstract: TPS352

Trials in Progress Poster Session: Hepatobiliary Cancer

About Zanidatamab

Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade,

increased binding, and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and registration-enabling clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. The FDA has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified biliary tract cancer (BTC), and two Fast Track designations to zanidatamab, one as monotherapy for refractory BTC and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA). These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program. Zanidatamab has also received Orphan Drug designations for the treatment of biliary tract, gastric and ovarian cancers, as well as Orphan Drug designation for the treatment of gastric cancer from the European Medicines Agency.

On December 10, 2020 Creatv MicroTech, a privately-held biotechnology company reported that it has pioneered a blood test to predict treatment response in patients with newly diagnosed Stage I-III esophageal cancer (EC) treated with chemoradiation therapy (CRT) (Press release, CREATV MICROTECH, DEC 10, 2020, View Source [SID1234572626]). The results were published in the Journal of Translational Medicine. Creatv’s collaborator MD Anderson Cancer Center recruited patients for the study under standard of care CRT and IRB approved protocol. "We are delighted to present a method to stratify patients with EC who are responding to CRT using a single tube of blood," said Dr. Cha-Mei Tang, CEO of Creatv. "Now, patients who are not responding to CRT can be identified quickly for alternative therapy." Currently, no other blood test predicts treatment response for Stage I-III esophageal cancer therapies.

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In the United States, 18,440 new cases are expected in 2020 for esophageal cancer, a disease that has the sixth highest cancer mortality rate. Even localized disease has a 5-year survival rate of less than 50%, making timely treatment decisions critical to patient outcome. The ability to monitor a patient’s response to therapy throughout treatment will allow for more precise adjustment to therapeutic regimes to optimize the management of the disease. In a completely novel concept, the test analyzes patients’ immune response to the presence of cancer, isolating cells from cancer sites that have migrated into the blood stream. Creatv demonstrated that a particular subtype of cell, Cancer Associated Macrophage-Like cells (CAMLs), tracks the patient’s response to therapy in real time. CAMLs are phagocytic myeloid cells that reveal the patient’s immunological response to active malignancy. CAMLs are not found in the blood of normal, healthy individuals.

Creatv has previously shown that in solid tumors, patients with CAMLs larger than 50 µm in size have a poorer prognosis, with shorter progression free survival (PFS) and overall survival (OS). In this paper, Creatv presents the findings from a two-year single blind prospective study of 32 esophageal cancer patients with Stage I-III treated with standard CRT. A CAML size of ≥50 µm in blood drawn immediately after the completion of CRT indicates a poor prognosis compared to patients with CAMLs < 50 µm, with a Hazard Ratio (HR) =12.0 for progression free survival (PFS) 95% CI 2.7-54.1, p=.004.

The paper is available here.

About LifeTracDx Liquid Biopsy

Creatv’s liquid biopsy assays (LifeTracDx) are commercialized Research Use Only tests designed for analysis of CAMLs and Circulating Tumor Cells (CTCs). LifeTracDx tests are applicable for cancer screening, companion diagnostics, prediction of treatment response (including immunotherapy) and prognosis. LifeTracDx tests also provide unfragmented tumor DNA for sequencing and can predict minimal residual disease (MRD) and early detection of cancer recurrence. LifeTracDx tests are currently used in more than 20 clinical trials, from basic research to drug development. Creatv’s publications have shown that LifeTracDx liquid biopsy can be used for multiple solid tumor cancers as an early predictor of patient response to therapy.

On December 10, 2020 Purple Biotech Ltd. (the "Company") (NASDAQ/TASE: KTOV), a clinical-stage company advancing first-in-class therapies to overcome tumor immune evasion and drug resistance, reported that it has changed its corporate name from Kitov Pharma Ltd. to Purple Biotech Ltd (Press release, Kitov Pharmaceuticals , DEC 10, 2020, View Source [SID1234572643]). The name change will be effective for trading purposes on the Tel Aviv Stock Exchange (TASE) and the NASDAQ Capital Market (NASDAQ) as of market open on December 22, 2020. At that time, the Company’s ordinary shares and American Depositary Shares (ADSs) will begin to trade under the new ticker symbol, "PPBT," on the TASE and NASDAQ, respectively. The Company’s ordinary shares will continue to trade on the TASE and its ADSs will continue to trade on NASDAQ under the ticker symbol "KTOV" through market close on December 21, 2020. The Company’s ADSs were assigned a new CUSIP number (74638P109), effective on December 22, 2020, as described above.

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"Over the past few years, our business has evolved significantly towards an exciting new vision and our new name, Purple Biotech, completes the transformation to our focus on advancing first-in-class oncology therapies," said Isaac Israel, the Company’s Chief Executive Officer.

"2020 has been a year of substantial achievements for our company. We recently initiated Phase 1/2 clinical studies for NT219 and expect to begin our Phase 1/2 studies for CM24 shortly. We also successfully completed over $60 million in financings this year to support our clinical development and strategic plans. As we head into 2021, we look forward to leveraging the compelling opportunities that lie ahead of us and to advancing our objectives to increase the longevity and the quality of life of cancer patients", added Isaac Israel.

The Company will also be relocating its corporate headquarters shortly to the Science Park near the Weizmann Institute in Rehovot, Israel, a key regional biotech hub.

No action is required by shareholders and holders of ADSs in connection with the corporate name change. The number of outstanding ordinary shares and ADSs are not affected by the name change. In connection with the name change, the Company expects to make additional ordinary course filings with the U.S. Securities and Exchange Commission.