PHARMACY MARKET, PHARMA TECH
Jazz Pharmaceuticals plc and Zymeworks Inc. | December 28, 2022
Jazz Pharmaceuticals plc and Zymeworks Inc. recently informed that the former has chosen to keep its exclusive rights to develop and sell Zymeworks' Zanidatamab in key markets, such as the U.S., Europe, and Japan, as part of the license and collaboration agreement made in October 2022.
A pivotal trial in previously treated HER2-amplified biliary tract tumors (BTC) found that 41.3% (95% CI: 30.4, 52.8) of recruited patients with HER2-amplified and expressing (IHC2+ and 3+) illness achieved an objective response as judged by independent central review. The median response length was 12.9 months (95% CI: 5.95 to not attained). In this trial, Zanidatamab's safety profile was similar to what had been found in previous studies of monotherapy, while no new safety signals were found.
Jazz Pharmaceuticals stated that the compelling top-line clinical data from the pivotal study in patients with BTC demonstrated the transformative potential of Zanidatamab. This big win gives the company more confidence that it can make this medicine better for cancer patients who have big unmet needs. Even though its main focus will be on the ongoing clinical trials for BTC and GEA, these data will add to the growing amount of evidence that Zanidatamab is effective against a wide range of HER2-expressing cancers.
Zymeworks expressed that the collaboration with Jazz is going well, which will speed up the global development of Zanidatamab in many types of cancer and may give patients with hard-to-treat cancers and few treatment options access to a basic HER2-targeted drug.
Jazz will pay Zymeworks $325 million to exercise its option to develop and sell Zanidatamab in all countries except Asia-Pacific in the fourth quarter of 2022.
About Jazz Pharmaceuticals
Jazz Pharmaceuticals, founded in 2003 and located in Dublin (Ireland), innovates to improve the lives of patients and their families. The company transforms biopharmaceutical discoveries into innovative medications to reimagine what's possible.
Zymeworks develops next-generation multifunctional biotherapeutics. Zanidatamab is a new Azymetric™ HER2-targeted bispecific antibody being examined in numerous Phase 1, Phase 2, and pivotal clinical trials globally as a targeted therapeutic option for patients with HER2-positive solid tumors. Zanidatamab Zovodotin (ZW49) is a bispecific antibody-drug combination in Phase 1 clinical development. It combines Zanidatamab's unique design and antibody framework with Zymeworks' ZymeLink™ linker-cytotoxin.
BUSINESS INSIGHTS, PHARMA TECH
KSQ Therapeutics | January 30, 2023
KSQ Therapeutics, a leading clinical-stage biotechnology company developing therapies to treat cancer and autoimmune diseases, recently announced that Ono Pharmaceutical (ONO) has acquired multiple research-stage DNA damage response (DDR) programs. The programs were identified using KSQ's CRISPRomics platform technology. All of the programs are new and have the potential to be first-in-class therapies.
ONO's Discovery & Research Executive Director/ Senior Executive Officer Toichi Takino commented, "ONO appreciates the ability of KSQ's CRISPRomics platform technology to discover novel therapeutic targets with high selectivity for cancer cells." He added, "Through this acquisition agreement, we expect that the programs acquired from KSQ will lead to the creation of innovative medicines that will help treat cancer patients."
(Source – Business Wire)
KSQ's Chief Executive Officer Qasim Rizvi commented, "This acquisition of multiple research-stage oncology programs by ONO is further validation of the power of our platform to identify novel oncology targets and develop potential first-in-class programs." He added, "This is an important transaction for KSQ, enabling us to focus on our other programs. We look forward to watching ONO's progress as they advance these programs toward clinical studies."
(Source – Business Wire)
As per the terms of the agreement, ONO will pay KSQ a double-digit million upfront payment, prospective near-term milestone payments with potential long-term value in the triple-digit millions, and net sales-based royalties.
About KSQ Therapeutics
Founded in 2015, KSQ Therapeutics is a clinical-stage firm using its CRISPRomics® discovery platform to systematically decode the genome and identify optimal gene targets for oncology and autoimmune disease. It utilizes the platform for innovative drug development across diverse therapeutic domains and is actively creating a proprietary pipeline of tumor- and immune-focused drug candidates. Headquartered in Cambridge, Massachusetts, KSQ was formed by functional genomics thought leaders and CRISPR screening technology pioneers.
Citius Pharmaceuticals, Inc. | November 22, 2022
Citius Pharmaceuticals, Inc. a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the Company has been selected to participate in New Jersey's Technology Business Tax Certificate Transfer Program, more commonly known as the Net Operating Loss Program, and will receive $3.6 million in non-dilutive capital through the New Jersey Economic Development Authority. Citius expects to receive the funds by late 2022 or early 2023.
"This was the first year that Citius qualified for the program, and we are delighted to have been selected to participate in New Jersey's NOL Program. As a pre-revenue business, this program allows us to convert certain losses from operations into tangible working capital today, supporting our ongoing research and development efforts. We are thankful to the NJ Economic Development Authority for aiding our efforts in our initial year of participation. This non-dilutive funding will provide added cash runway as we advance a late-Phase 3 trial for Mino-Lok®, a Phase 2b trial for Halo-Lido, and a recently submitted biologics license application for I/ONTAK,"
Jaime Bartushak, Chief Financial Officer of Citius
About the Technology Business Tax Certificate Transfer Program
The NOL Program enables participants to sell their New Jersey net operating losses and unused R&D tax credits to unrelated profitable corporations for cash. The NJEDA and the New Jersey Department of Treasury's Division of Taxation jointly administer the NOL Program, which has routinely been hailed as a "lifeline" by entrepreneurs seeking capital for their companies. The average award for companies approved to sell their net operating losses through the program in 2022 was over $3.1 million. Thirty-six percent of program applicants are private businesses, while the remaining 64 percent are publicly traded companies. To date, more than $1.17 billion in funding has been distributed to over 570 technology and life sciences companies since the program's inception in the late 1990s.
About the New Jersey Economic Development Authority
The New Jersey Economic Development Authority serves as the State's principal agency for driving economic growth. The NJEDA is committed to making New Jersey a national model for inclusive and sustainable economic development by focusing on key strategies to help build strong and dynamic communities, create good jobs for New Jersey residents, and provide pathways to a stronger and fairer economy. Through partnerships with a diverse range of stakeholders, the NJEDA creates and implements initiatives to enhance the economic vitality and quality of life in the State and strengthen New Jersey's long-term economic competitiveness.
About Citius Pharmaceuticals, Inc.
Citius is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, with a focus on oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies. The Company's diversified pipeline includes two late-stage product candidates, Mino-Lok®, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections which is currently enrolling patients in a Phase 3 Pivotal superiority trial, and I/ONTAK a novel IL-2R immunotherapy for an initial indication in cutaneous T-cell lymphoma for which a BLA has been submitted. Mino-Lok® was granted Fast Track designation by the U.S. Food and Drug Administration. I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and peripheral T-cell lymphoma. In the first half of 2022, Citius initiated a Phase 2b trial for Halo-Lido, a topical formulation for the relief of hemorrhoids.