Category: Cancer

BioNTech SE (BNTX) 9/22/21 9:30 AM

BioNTech SE, a biotechnology company, develops and commercializes immunotherapies for cancer and other infectious diseases.

BioNTech SE is a Germany-based clinical-stage biotechnology company. The Company focuses on patient-specific immunotherapies for the treatment of cancer and other serious diseases. It develops a broad product pipeline using different scientific approaches and technology platforms, including individualized mRNA-based product candidates, chimeric antigen receptor T-cells, checkpoint immunomodulators, targeted cancer antibodies and small molecules. In addition, the Company offers diagnostic products and drug discovery services for other therapeutic areas, including infectious diseases, allergies and autoimmune disorders.

Merck & Co. ~ ArQule $2.7 Billion

ArQule shares surge after the cancer drug specialists agreed to a $2.7 billion takeover bid from Merck & Co.

Merck & Co. said Monday that it will acquire oncology specialist ArQule in a $2.7 billion deal that marks the latest in a string of takeovers in the cancer drug sector. Merck said it will pay $20 a share for Woburn, Massachusetts-based ArQule, a premium of more than $10 to the stock’s closing price of $9.66 Friday on the Nasdaq. The group, which focuses on research and development of targeted therapeutics to treat cancers and rare diseases, will be merged into the broader Merck & Co., the companies said.

“We are proud that Merck has recognized the contributions that ArQule, together with its scientific collaborators, has made to the field of precision medicine in oncology with ARQ 531 for the treatment of B-cell malignancies and with the rest of our clinical-stage pipeline,” said ArQuel CEO Paolo Pucci. “With this agreement, ArQule’s pipeline will benefit from Merck’s vast capabilities and determined engagement to benefit the patients who we have always strived to serve.”  

ArQule shares were indicated some 103% higher in early trading following news of the Merck takeover to change hands at $19.64 each. Merck shares, meanwhile, were marked 0.57% lower at $88.34 each.

Merck’s move to buy ArQule follows a $2.5 billion takeover of San Diego, California-based Synthorx by France’s Sanofi SA earlier Monday. Sanofi said it will pay $68 a share for Synthorx, which focuses on cancer and autoimmune disorder treatments, in a deal that will bolster its immuno-oncology pipeline. 

FDA accepts Pfizer’s application for Braftovi doublet for colorectal cancer

Under Priority Review status, the FDA accepts Pfizer’s (PFE -0.5%) supplemental application seeking approval for Braftovi (encorafenib), combined with Eli Lilly’s (LLY +3.2%) Erbitux (cetuximab), for the treatment of BRAFV600E mutation-positive metastatic colorectal cancer in patients who have previously received one or two prior lines of therapy. The agency’s action date is in April 2020. The FDA approved the kinase inhibitor in June 2018 for BRAFV600E- or BRAFV600K-positive melanoma.

As published in The New England Journal of Medicine (NEJM), results from the BEACON CRC trial showed improvements in overall survival (OS) and objective response rates (ORR) for both the BRAFTOVI Doublet and BRAFTOVI Triplet (BRAFTOVI, MEKTOVI and ERBITUX) combination, compared to ERBITUX plus irinotecan-containing regimens (Control).1 In descriptive analyses comparing the Doublet and Triplet arms, the results showed comparable efficacy between the Doublet and Triplet in the overall population. The BRAFTOVI Triplet and Doublet showed no unexpected toxicities.

BioNTech SE

BioNTech SE is a Germany-based clinical-stage biotechnology company. The Company focuses on patient-specific immunotherapies for the treatment of cancer and other serious diseases.

It develops a broad product pipeline using different scientific approaches and technology platforms, including individualized mRNA-based product candidates, chimeric antigen receptor T-cells, checkpoint immunomodulators, targeted cancer antibodies and small molecules. In addition, the Company offers diagnostic products and drug discovery services for other therapeutic areas, including infectious diseases, allergies and autoimmune disorders.

Exelixis, Inc. (EXEL) | NASDAQ

EXEL $19.33 -0.46 (-2.32%)

Exelixis is on a Mission to Help Cancer Patients Recover Stronger and Live Longer

Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model genetic systems, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need.

Our discovery efforts have resulted in four approved products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery — all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poor’s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies.

ZIOPHARM Oncology, Inc. (ZIOP)

ZIOPHARM Oncology, Inc., a biotechnology company, focuses on acquiring, developing, and commercializing a portfolio of immuno-oncology therapies for treating heterogenous solid tumors and unknown antigens. The company develops two immuno-oncology platform technologies, including Sleeping Beauty (SB), which is based on the genetic engineering of immune cells using a non-viral transposon/transposase system to reprogram T-cells outside of the body for infusion; and Controlled IL-12, which delivers interleukin 12 or IL-12, a master regular of the immune system, in a controlled and safe manner to focus the patient’s immune system to attack cancer cells.

Its lead gene therapy product candidate is Ad-RTS-hIL-12 plus veledimex, which is in Phase I clinical trial, to treat patients with recurrent glioblastoma and breast cancer. The company is also developing chimeric antigen receptor (CAR) T-cell and T-cell receptor T-cell therapies. ZIOPHARM Oncology, Inc. has license agreement with Precigen, Inc. and MD Anderson Cancer Center; research and development agreement with the National Cancer Institute, and Ares Trading S.A. The company is headquartered in Boston, Massachusetts.

CEL-SCI Corporation


Multikine Immunotherapy in Head and Neck Cancer

CEL-SCI Corp is a player in the biotechnology sector. It is engaged in the research and development at developing the treatment of cancer and other diseases by using the immune system. The company is focused on activating the immune system to fight cancer and infectious diseases. It is focused on the development of Multikine (Leukocyte Interleukin, Injection), an investigational immunotherapy under development for the treatment of certain head and neck cancers, and anal warts or cervical dysplasia.

Cel-Sci Corporation (CVM) is a small-cap market ($78M) clinical stage cancer biopharmaceutical company.

Cel-Sci: Multikine Immunotherapy & Assessment

Cel-Sci Corporation (CVM) is a small-cap market ($186M) clinical stage cancer biopharmaceutical company. Multikine, a cocktail combination of cytokines and chemokines, is a prospective neoadjuvant treatment and an investigational drug candidate

Cel-Sci stock has appreciated over 30% in the last 3 weeks on IDMC recommendation that the Phase 3 study should continue until the requisite number of events have occurred.

Multikine is an innovative immunotherapeutic approach in clinical development for advanced primary head and neck squamous cell carcinoma, a fatal disease with limited therapeutic options.

As first-line therapy, multikine is designed to boost/enhance the anti-tumor responses of the immune system prior to standard of care treatment.

HNSCC accounts for ~4% of all cancers in the United States. Clinical success with multikine therapy would be a medical breakthrough for patients affected by this disease.

The top-line data readout for Multikine in Phase 3 HNSCC is expected possibly in 2019.