On February 3, 2020 Calibr, the drug discovery and development division of Scripps Research, reported that the U.S. Food and Drug Administration has given clearance to the Investigational New Drug (IND) application for Calibr’s "switchable" CAR-T cell therapy, which is being evaluated for the treatment of certain cancers, including relapsed/refractory B-cell malignancies such as non-Hodgkin lymphoma and chronic lymphocytic leukemia (Press release, The Scripps Research Institute, FEB 3, 2020, View Source [SID1234553776]).

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Having achieved this regulatory milestone, Calibr can begin clinical trials for its novel cell therapy candidate, CLBR001 + SWI019. The therapy leverages a patient’s own immune cells to treat cancer, putting them under the control of a novel molecular "switch" that seeks to eliminate life-threatening side effects that have hampered the use of cell therapies to date.

"CLBR001 + SWI019 is a first-in-class switchable CAR-T cell platform designed to confer the efficacy associated with engineered T cell therapies, while potentially affording greater safety and versatility through the incorporation of a control switch," says Travis Young, PhD, Calibr’s vice president of biologics and leader of its CAR-T development program. "If successful, this approach holds promise to be universally applied to other types of cancer, including solid tumor cancers that have yet to reap the benefits of CAR-T therapies."

CAR-T, short for chimeric antigen receptor T-cell, is a relatively new form of cancer therapy that has achieved remarkable responses in patients with blood- or bone marrow-based diseases such as leukemias and lymphomas. It works by genetically engineering a patient’s own T cells—which play a key role in immune response—to seek and destroy cancer within the body. However, some patients who receive T-cell therapies experience an adverse effect, which can be severe, called cytokine release syndrome, which occurs when the immune system reacts too strongly and causes dangerous inflammation.

Calibr’s switchable CAR-T cell platform incorporates an antibody known as SWI019 that acts as a switch, activating the engineered cell and directing it to engage the cancer target. This may allow doctors to more precisely regulate the potency of the therapy and is expected to provide a significant safety advantage. In preclinical studies, the approach proved highly effective at eliminating tumors while controlling the level of cytokines produced in response to treatment.

"AbbVie continues to be impressed by Calibr’s progress on advancing this innovative switchable cell therapy technology," says Mohit Trikha, Ph.D., vice president, head of Oncology Early Development and Bay Area site head at AbbVie. "This milestone is an important step forward for this potential CAR-T therapy and our recently expanded collaboration with Scripps Research, which holds promise to rapidly advance additional treatment options for patients."

The launch of the clinical study—the third being run independently by the institute and the fifth study to originate from Calibr’s research—is another major landmark for Scripps Research’s pioneering nonprofit drug development model. News of the FDA’s decision comes on heels of another recent IND acceptance for Calibr’s first-in-class bispecific antibody for prostate cancer; that drug candidate, CCW702, is now being tested in a phase I trial for patients with metastatic, castrate resistant prostate cancer.

The switchable CAR-T cell platform was invented at Scripps Research and progressed to the Investigational New Drug stage with support from the Wellcome Trust. Calibr recently partnered its platform with biopharmaceutical company AbbVie, which holds certain rights to commercialization.

"AbbVie has been an outstanding partner for Scripps Research on this CAR-T cell program," says Scripps Research President and CEO Peter Schultz, PhD. "We look forward to continuing to bring novel therapies to the clinic through this collaboration."

Clinical development of CLBR001 + SWI019 will be led by Calibr’s Chief Medical Officer Pamela D. Garzone, PhD. Calibr expects to begin enrolling patients for the phase 1 clinical trial in the first half of 2020, with the potential to expand the platform to solid tumors in coming years.

On February 3, 2020 The University of Texas MD Anderson Cancer Center reported that circulating tumor cells (CTCs), a form of liquid biopsy, was independently associated with melanoma relapse, suggesting CTC assessment may be useful in identifying patients at risk for relapse who could benefit from more aggressive therapy following primary treatment (Press release, MD Anderson, FEB 3, 2020, View Source [SID1234553774]).

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Results from the study were published in Clinical Cancer Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). Although CTCs can be detected in melanoma patients, there is limited data regarding their significance in stage III (node-positive) disease. This prospective study was based on earlier research that found CTCs in a significant number of breast cancer patients, which was associated with relapse, independent of other existing methods for determining prognosis.

"Our findings are significant, given that there is a need for blood-based biomarkers to guide clinical decision making for stage III melanoma patients," said Anthony Lucci, M.D., professor of Breast Surgical Oncology and Surgical Oncology, and study lead. "There currently are no blood tests available to help doctors accurately tell which patients are likely to relapse, and should be given therapy, and which are low risk, and could be observed."

The researchers assessed CTCs during the patient’s first clinic visit, and relapse-free survival was compared between patients with one or more CTCs, versus those with no CTCs. CTCs were observed in 90 out of 243 patients enrolled in the study.

"Our analysis demonstrated that CTC detection was significantly associated with a decrease in relapse-free survival at six months, and persisted at a 54-month longer-term follow-up," said Lucci. "The data from this study provides support for the future pursuit of liquid biopsy techniques to help identify patients most likely to benefit from adjuvant systemic therapy."

Lucci added that this is vital given that there currently is no clear consensus on when to recommend immunotherapy for node-positive melanoma patients. Despite the development of new targeted and immune therapies to treat melanoma, many patients either do not respond to these therapies or develop resistance to therapy within six to eight months. Because such therapies also can have side effects, avoiding treatment in patients at low risk for relapse may prevent overtreatment.

The study was funded by Sheila Prenowitz, Debbie and Craig Kiefer, the Simon and Linda Eyles Foundation, the Sam and Janna Moore family, and the Wintermann Foundation. Lucci reported no disclosures.

On February 3, 2020 CytomX Therapeutics, Inc. (NASDAQ: CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported the appointment of Alison L. Hannah, M.D., as senior vice president and chief medical officer (Press release, CytomX Therapeutics, FEB 3, 2020, View Source [SID1234553772]).

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"Alison brings to CytomX broad and deep experience in guiding clinical stage therapies to registration," said Amy Peterson, M.D., chief development officer of CytomX Therapeutics. "She will be a tremendous asset to our company given her extensive and successful track record in clinical drug development."

Dr. Hannah brings 30 years of experience in the development of investigational cancer therapies having most recently served as a consultant to nearly 30 pharmaceutical and biotechnology companies. In this capacity, Dr. Hannah has successfully filed over 40 regulatory applications for First-in-Human clinical testing and has played significant roles in the broad marketing approval of 8 therapeutics (talazoparib, enzalutamide, defibrotide, carfilzomib, sunitinib, toceranib, irinotecan and filgrastim) including extensive experience interacting with global health and regulatory authorities. Earlier in her career, Dr. Hannah held the role of Senior Medical Director at SUGEN, Inc. (acquired by Pharmacia & Upjohn, now Pfizer) where she had oversight of clinical development, clinical operations, and pharmacovigilance. At SUGEN, she specialized in the development of tyrosine kinase inhibitors, including sunitinib (SUTENT) for kidney cancer. Dr. Hannah began her career at Quintiles, a global contract research organization, where she specialized in overseeing early to registrational-stage oncology clinical trials. Dr. Hannah currently serves on the board of NeoGenomics, a publicly traded cancer diagnostic company. Dr. Hannah received her B.A in biochemistry and immunology from Harvard University and her M.D. from the University of Saint Andrews.

"CytomX’s Probody technology represents a truly innovative approach to cancer drug development," said Alison Hannah, M.D., chief medical officer of CytomX Therapeutics. "I am pleased to be joining at a time where the advancement to Phase 2 with both of our wholly owned assets, CX-072 and CX-2009, and continued progress within our partnered programs, marks our dedication to helping oncology patients with serious unmet needs."

On February 3, 2020 Bio-Thera Solutions, a commercial-stage biopharmaceutical company, reported that the Phase III clinical trial comparing the safety and efficacy of BAT1706 versus Avastin1 (bevacizumab) met its primary endpoint (Press release, BioThera Solutions, FEB 3, 2020, View Source [SID1234553770]). BAT1706 is being developed by Bio-Thera Solutions as a proposed biosimilar to Avastin. The trial demonstrated equivalence in overall response rate (ORR) for the first-line treatment of patients with non-squamous non-small cell lung cancer.

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"We are pleased to report on our second proposed biosimilar with positive study results. These results demonstrate the potential of our proposed bevacizumab biosimilar to be a safe and effective treatment option for cancer patients," said Shengfeng Li, Ph.D., CEO of Bio-Thera Solutions. "Bio-Thera is committed to increasing patient access to innovative medicines through the development of high-quality biosimilars."

The BAT1706 Phase III clinical study is a multicenter, randomized, double blind, study evaluating the efficacy, safety, pharmacokinetics and immunogenicity of BAT1706 versus EU Avastin plus chemotherapy in patients with advanced non squamous non-small cell lung cancer. The primary endpoint measures ORR. Results of the study will be presented in full at a future medical meeting or summarized in publication.

More information regarding the BAT1706 Phase III clinical trial, including inclusion and exclusion criteria and primary and secondary outcome measures, can be found here: View Source

BAT1706 is Bio-Thera Solutions’ second proposed biosimilar with positive Phase III study results. The company’s first biosimilar product, QLETLI (格乐立), a biosimilar to Humira (adalimumab), has received marketing authorization and is available in China. Bio-Thera Solutions is developing several additional proposed biosimilars, including ustekinumab, secukinumab and golimumab, among others.

About BAT1706

BAT1706 is a monoclonal antibody (mAb) that is in development as a potential biosimilar to Avastin. BAT1706 works by binding the vascular endothelial growth factor (VEGF) protein. In the U.S., Avastin is indicated for the treatment of patients with metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, persistent, recurrent, or metastatic cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. BAT1706 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not yet been established by regulatory authorities.

On February 3, 2020 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported, that it has filed a registration statement on Form F-1 with the United States Securities and Exchange Commission (the "SEC") to offer 6,000,000 American Depositary Shares ("ADSs") representing its ordinary shares (Press release, BioNTech, FEB 3, 2020, View Source [SID1234553769]). In addition, BioNTech intends to grant the underwriters a 30-day option to purchase up to an additional 900,000 of ADSs in connection with the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. BioNTech is a clinical-stage biopharmaceutical company focused on patient-specific immunotherapies for the treatment of cancer and other serious diseases.

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J.P. Morgan, BofA Securities, Berenberg and SVB Leerink are acting as lead joint book-running managers for the offering.

The proposed offering will be made only by means of a prospectus. Copies of the preliminary prospectus relating to the offering may be obtained, when available, for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, copies of the preliminary prospectus, when available, may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by telephone at +1 (866) 803-9204, or by e-mail at [email protected]; BofA Securities, Inc., NC1-004-03-43; 200 North College Street, 3rd Floor, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, or by e-mail at [email protected]; Berenberg Capital Markets LLC, Attention: Investment Banking, 1251 Avenue of the Americas, 53rd Floor, New York, New York 10020, or by telephone at +1 (646) 949-9000, or by e-mail at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, or by telephone at +1 (800) 808-7525, ext. 6132, or by e-mail at [email protected].

A registration statement relating to these securities has been filed with the SEC but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.