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Sandoz receives US FDA approval for long-acting oncology supportive care biosimilar Ziextenzo™ (pegfilgrastim-bmez)

On November 5, 2019 Sandoz, a Novartis division and a global leader in biosimilars, reported that the US Food and Drug Administration (FDA) approved its biosimilar ZiextenzoTM (pegfilgrastim-bmez) (Press release, Sandoz, NOV 5, 2019, View Source [SID1234550446]). Sandoz biosimilar pegfilgrastim has been approved and marketed in Europe as Ziextenzo (pegfilgrastim) since 2018. Sandoz now intends to launch Ziextenzo in the US as soon as possible this year.

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Ziextenzo is indicated to decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

"When a cancer patient with febrile neutropenia gets an infection, it can have serious consequences such as delays or dose reductions of chemotherapy," said Carol Lynch, President of Sandoz Inc. "The approval of Ziextenzo expands our oncology portfolio, providing physicians with a long-acting supportive oncology biosimilar option. It builds on the foundation of trust and experience we developed with our short-acting filgrastim Zarxio – the leading filgrastim by market share in the US – including consistent product supply and reliable patient services."

A study has shown that each year in the US, more than 60,000 cancer patients are hospitalized with evidence of neutropenia, including fever or infection, with more than 4,000 deaths as a result.1 Sandoz is now the first and only company to offer physicians in the US the choice between a long- and short-acting biosimilar filgrastim treatment to best suit the individual needs of tens of thousands of patients undergoing chemotherapy.

The FDA approval of Ziextenzo was based on analytical, preclinical and clinical research, including data from a pivotal three-way pharmacokinetics (PK) and pharmacodynamics (PD) study (LA-EP06-104).2 This study compared Sandoz pegfilgrastim with US-sourced reference pegfilgrastim, Sandoz pegfilgrastim with EU-sourced reference pegfilgrastim, and US-sourced with EU-sourced reference pegfilgrastim. PK and PD similarity were demonstrated in all three comparisons, and no clinically meaningful differences were observed regarding safety and immunogenicity among the treatment groups.

Sandoz has proven biosimilars create early and expanded patient access to life-changing biologics while increasing healthcare savings. Its four approved biosimilars in the US are part of a leading global portfolio with eight marketed biosimilars. Building on this success, Ziextenzo can help increase positive treatment outcomes for patients undergoing chemotherapy and drive significant savings for the healthcare system.2,3

Sandoz is a global biosimilar leader and will continue to help millions of patients in oncology, immunology, endocrinology and other underserved therapy areas access biologic medicines sustainably and affordably.

About Ziextenzo (pegfilgrastim-bmez)
Pegfilgrastim is a long-acting form of filgrastim. Filgrastim is very similar to a natural protein (granulocyte-colony stimulating factor) – also known as G-CSF – produced by a person’s own body. Ziextenzo is indicated in the US to decrease the incidence of infection, as manifested by febrile neutropenia (low white blood cell count with a fever), in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.4 Febrile neutropenia is caused by cytotoxic chemotherapy (medicines that destroy rapidly growing cells); white blood cells are important as they help your body fight infection.5

Cumberland Pharmaceuticals To Announce Third Quarter 2019 Financial Results

On November 5, 2019 Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) reported that it will release third quarter 2019 financial results after the market closes on Tuesday, November 12, 2019 (Press release, Cumberland Pharmaceuticals, NOV 5, 2019, View Source [SID1234550387]). A conference call and live Internet webcast will be held on Tuesday, November 12, at 4:30 p.m. Eastern Time to discuss the results.

To participate in the call, please dial 877-303-1298 (for U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international callers). The Conference ID for the rebroadcast is 9865969. The live webcast and rebroadcast can be accessed via Cumberland’s website at View Source

Ryvu Therapeutics to Present at BIO-Europe 2019

On November 5, 2019 Ryvu Therapeutics (WSE: RVU) reported that Pawel Przewiezlikowski, Chief Executive Officer, will present a corporate overview at the following conference in Hamburg, Germany (Press release, Ryvu Therapeutics, NOV 5, 2019, View Source [SID1234550386]):

Event: BIO-Europe 2019, Nov. 11-13, 2019
Location: Congress Center Hamburg
Date/Time: Tuesday, Nov. 12, at 4:15 p.m. CET

Compugen Presents Preclinical Data for COM902 Anti-TIGIT Program at SITC 2019

On November 5, 2019 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported preclinical results from its COM902 anti-TIGIT program supporting its potential clinical use in various combinations with PD-1 inhibitors and COM701, a first-in-class PVRIG inhibitor (Press release, Compugen, NOV 5, 2019, View Source [SID1234550385]). The findings will be presented in a poster titled "COM902, a Novel Therapeutic Antibody Targeting TIGIT Augments T Cell Function and the Activity of PVRIG Pathway Blockade In Vitro and In Vivo" at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2019) in National Harbor, Maryland, on Saturday, November 9, 2019.

"These new preclinical data further substantiate our theory that TIGIT and PVRIG are part of a foundational immuno-oncology axis, the DNAM axis," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We believe that a combined treatment of COM902 with COM701, our first-in-class PVRIG antibody, has the potential to enhance the clinical impact of cancer immunotherapy in patients unresponsive to approved treatments. We look forward to advancing COM902 to the clinic early next year."

Key findings in the poster include:

Broad expression of TIGIT and PVRIG ligands, PVR and PVRL2 in solid tumors.
Superior binding affinity of COM902 to T cells with similar and or greater in vitro function compared to several clinical anti-TIGIT antibodies.
Increased T cell activation by COM902 on tumor infiltrating lymphocytes (TILs), which was further enhanced by combination with COM701.
Reduced mouse melanoma tumor growth in TIGIT and PVRIG knockout mice with further tumor growth reduction in TIGIT/PVRIG double knockouts.
COM902 inhibited tumor growth and increased survival when combined with anti-PVRIG or anti-PD-L1 antibodies in a mouse model of colon cancer.
The poster will be available on Compugen’s website following the poster presentation.

About COM902

COM902, a high affinity, fully human antibody targeting TIGIT, was developed for combination treatment with COM701. Preclinical data demonstrate that TIGIT inhibition, either alone or in combination with other checkpoint inhibitors, can enhance T cell activation and increase anti-tumor immune responses. Parallel inhibition of TIGIT and PVRIG, the two coinhibitory arms of the DNAM-1 axis, results in synergistic effects on effector T cell function and tumor growth inhibition in various model systems that can be further increased with the addition of PD-1 blockade. Based on preclinical data these combinations may be clinically important for enhancing anti-tumor immune response and expanding the patient population responsive to checkpoint inhibition. The Company plans to initiate Phase 1 studies in patients with advanced malignancies in early 2020 pursuant to the FDA’s clearance of an investigational new drug application in October 2019.

Compugen discovered TIGIT in 2009 leveraging its immune checkpoint computational discovery platform through which PVRIG was also discovered. The TIGT discovery was published by Compugen in October 2009 in the Proceedings of the National Academy of Sciences (PNAS).

Compugen Presents Initial Clinical Data from Ongoing Phase 1 Trial of COM701 in Patients with Advanced Solid Tumors at SITC 2019

On November 5, 2019 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported preliminary results from its ongoing Phase 1 dose escalation study of COM701, a first-in-class anti-PVRIG antibody, in patients with advanced solid tumors (Press release, Compugen, NOV 5, 2019, View Source [SID1234550384]). COM701 was well-tolerated with no dose-limiting toxicities observed. Furthermore, COM701 demonstrated initial signals of anti-tumor activity in the heavily pretreated patient population enrolled on the study. The clinical data will be presented in a poster titled "Phase 1 Study of the Safety, Tolerability and Preliminary Anti-Tumor Activity of COM701 Monotherapy in Patients with Advanced Solid Tumors" at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2019) on Friday, November 8, 2019.

"We are encouraged by the emerging safety profile and initial signals of anti-tumor activity of COM701. While the primary objective of this portion of the trial was to test the safety and tolerability of COM701, we were excited to observe early signals of anti-tumor activity in the all-comer, extensively pretreated patient population enrolled, including patients with microsatellite stable colorectal cancer (MSS-CRC), which we may choose to further evaluate in future studies," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We believe COM701 has the potential to broaden the checkpoint inhibitor landscape with a biology driven prioritization rationale that addresses indications most relevant to the PVRIG pathway. We look forward to initiating our biomarker driven COM701 monotherapy expansion cohorts in these four prioritized indications – ovarian, endometrial, breast and lung cancers."

Ecaterina Ileana Dumbrava, M.D., Assistant Professor, Department of Investigational Cancer Therapeutics, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center and presenting author, said "Expanding the reach of cancer immunotherapy drugs to broader patient populations is an urgent need given the number of patients with advanced cancer who are non-responsive or refractory to currently available therapies. The initial signals of anti-tumor activity of COM701 are encouraging, particularly given the heavily pretreated all-comer patient population, with the majority of patients refractory to previous therapy. We observed a trend in dose-response relationship in this hard-to-treat patient population and furthermore, encouraging signals of anti-tumor activity in five out of six treated patients with MSS colorectal, a challenging indication, typically not responsive to current immune checkpoint blockers."

The reported data are from the monotherapy arm of the ongoing, Phase 1, open-label, dose escalation study and include the first seven (7) cohorts (n=13) at dose levels of 0.01, 0.03, 0.1, 0.3, 1, 3, and 10 mg/kg IV every three (3) weeks.

Key findings presented at the poster in SITC (Free SITC Whitepaper) include data updated as of October 15, 2019:

COM701 was well-tolerated through 10 mg/kg with no dose-limiting toxicities observed.
The best timepoint response of stable disease (SD)/disease control rate reported in 9 of 13 patients (69%) with a median of seven prior anticancer therapies (range of 2-15).
All the patients with CRC (N=6) had microsatellite stable status, and 5 of 6 patients (83%) had best timepoint response of stable disease.
Pharmacokinetic profile supports IV Q3 weekly dosing.
Peripheral PVRIG receptor occupancy greater than or equal to 90% was demonstrated at COM701 ≥1 mg/kg.
There are two patients remaining on study treatment with COM701 monotherapy.
Enrollment to COM701 monotherapy dose at 20 mg/kg Q4 weekly is on-going.

The poster will be available on Compugen’s website following the poster presentation.

About the COM701 Phase 1 Study

The Phase 1 open-label clinical trial of COM701 (anti-PVRIG antibody) is designed to assess the safety and tolerability of administering escalating doses of COM701 monotherapy as well as of combination administration with Bristol-Myers Squibb’s Opdivo (nivolumab) in patients with advanced solid tumors. Additionally, secondary endpoints include preliminary anti-tumor activity, pharmacokinetics and pharmacodynamics of COM701 monotherapy as well as COM701 in combination with Opdivo in patients with selected tumor types, including non-small cell lung cancer, ovarian cancer, breast cancer and endometrial cancer. The Phase 1 study, which is expected to enroll approximately 140 patients, is currently recruiting in the United States. Additional information is available at www.clinicaltrials.gov (NTC03667716).