On May 10, 2022 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), a leading global pharmaceutical company providing medicines to nearly 200 million people daily, reported that published its 2021 ESG Progress Report (Press release, Teva, MAY 10, 2022, View Source [SID1234614141]). The report details how Teva further integrated ESG into its business strategy—implementing a strengthened ESG governance structure and setting 13 ambitious targets related to access to medicines, ethics, environment and responsible supply chain, some of which are now linked to the company’s financing strategy and executive compensation.

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"As one of the world’s largest manufacturers of generic medicines, ESG is integral to the long-term strategy of our company and is part of everything we do," said Kåre Schultz, President & CEO of Teva. "Our ESG Progress Report details our actions in 2021, which include issuing a $5 billion sustainability-linked bond, tying our financing strategy to access to medicines and environmental targets. We are in a unique position to help create a healthier future, bringing our essential medicines within reach for more people and reinforcing business integrity through our compliance and ethics policies and trainings."

This year’s ESG Progress Report offers a comprehensive view of ESG at Teva, with new disclosures related to scope 3 emissions, pay equity and the company’s responsible supply chain, and continues to align with leading reporting standards—the Global Reporting Initiative (GRI), Sustainability Accounting Standards Board (SASB) and Task Force on Climate-Related Financial Disclosures (TCFD).

The ESG Progress Report shares Teva’s progress, including:

Integrating ESG further into the business with a $5 billion sustainability-linked bond (SLB): Upon issuance, Teva’s SLB was the largest in the world, the first in the pharmaceutical industry linked to both social and environmental targets and the first from a generic medicines company. The SLB holds Teva accountable to reducing scope 1 and 2 GHG emissions by 25% and increasing access to essential medicines for patients in low- and middle-income countries (LMICs) by 150% by the end of 2025.
Making medicines available and accessible to those who need them: Teva has launched four access to medicines programs to-date, 50% of its 2025 target, including an expanded partnership with Direct Relief and Global HOPE to provide critical treatments for children with cancer and blood disorders across sub-Saharan Africa and new programs in France, Israel and Ghana. Last year, the company also had 585 marketing authorizations approved in LMICs and donated more than $487 million worth of medicines.
Minimizing environmental impact across Teva’s business and value chain: Since 2019, Teva has reduced its scope 1 and 2 GHG emissions by 13%, more than half of its 2025 target. Since 2020, the company also reduced its scope 3 GHG emissions by 5% (20% of 2030 target), increased its total proportion of energy from renewable sources by 4% (to 33%) and improved energy efficiency by 6%. In this same timeframe, it achieved an 8% reduction in both waste from operations and water withdrawal in areas projected to be in water stress.
Fostering an inclusive workplace: Last year, the representation of women in executive and senior management positions at Teva increased by 1.8%. The company also trained nearly 90% of employees on how to foster an inclusive culture.
Promoting ethics and operating with integrity: Teva trained more than 20,000 employees (99.6% of those assigned) on ethics. The company published three new position statements outlining its stance on patient safety, responsible supply chain and risk management. Teva was also ranked in the top 1% in the EcoVadis sustainable procurement assessment as a result of its efforts to make more responsible decisions regarding supply chain partners.
Teva’s ESG performance continues to improve across key rating indices—including S&P Global, ISS ESG, EcoVadis and FTSE4Good—which listed Teva among the top 10-20% of companies in its industry in 2021.

On May 10, 2022 BostonGene reported a strategic agreement with the National Comprehensive Cancer Network (NCCN) to integrate its Clinical Practice Guidelines into the BostonGene Tumor Portrait Test reports (Press release, BostonGene, MAY 10, 2022, View Source [SID1234614140]).

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The NCCN Guidelines are comprehensive, evidence-based recommendations for the prevention, diagnosis, and management of cancer. Applicable to over 97% of malignancies affecting patients in the United States, the NCCN Guidelines assist physicians, nurses, payers, patients, and families in cancer care decision-making.

The BostonGene Tumor Portrait Test uses DNA whole exome (WES) and RNA transcriptome (RNAseq) sequencing to analyze the tumor and its surrounding stroma, revealing critical drivers of each tumor, including immune microenvironment properties, actionable mutations, and biomarkers of response, and link findings to recommended management. By integrating genomic and transcriptomic analysis, in concert with the patient’s clinical history, the BostonGene Tumor Portrait Test provides information regarding biomarkers associated with response/resistance to therapies or therapeutic combinations, NCCN Guidelines treatment recommendations, and ongoing clinical trials.

"Combining BostonGene’s genomic and transcriptomic analysis with the NCCN Guidelines creates a significant opportunity to provide evidence-based care for cancer patients," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "We are pleased to be working with NCCN to further strengthen the BostonGene Tumor Portrait Test report and provide additional decision-making information to physicians."

"NCCN is committed to maintaining clinical practice guidelines that include actionable biomarkers and recommendations for cancer treatment options based upon biomarker results. We are pleased that BostonGene will be utilizing the NCCN Guidelines to generate reports linking biomarker results with evidence-based treatment recommendations," said Robert W. Carlson, MD, Chief Executive Officer at NCCN.

On May 10, 2022 Boston Pharmaceuticals, a clinical stage biopharmaceutical company, reported the appointment of Dr. Sophie Kornowski as Chair of its Board of Directors and Acting Chief Executive Officer, effective immediately (Press release, Boston Pharmaceuticals, MAY 10, 2022, View Source [SID1234614139]). Dr. Kornowski succeeds interim Co-CEOs Dr. Joanne T. Beck and Dr. Craig T. Basson, who will continue in their positions as Chief Operations Officer and Chief Medical Officer, respectively. Since 2018, Sophie Kornowski has been a partner at Gurnet Point Capital, a private investment firm focused on the healthcare sector. In this role, she has worked closely with the Boston Pharmaceuticals team for several years, as a member of the Board of Directors and, at the request of the Board, has recently supported Corporate Development efforts.

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"We are very pleased that Sophie has accepted our invitation to lead Boston Pharmaceuticals into the next phase of its growth trajectory, which includes continued expansion and progress of the pipeline, and the development of a strategy for long-term evolution," said Stefan Meister, the current Chairman of Boston Pharmaceuticals and Vice Chairman of the B-Flexion investment group, which owns the company. "Boston Pharmaceuticals, greatly inspired by our legacy in innovative pharma and biotech, is an important investment for B-Flexion and we look forward to Sophie leading the company into its next phase of growth."

Sophie Kornowski said: "I have worked closely with the Boston Pharmaceuticals team for several years, and it is a great honor to expand my role at this exciting time for the company. Along with the rest of the board and management team, my focus will be upon building the company’s successful history of in-licensing differentiated molecules and developing them in a focused and nimble fashion. I am looking forward to leveraging the firm’s strong organizational capability, diverse pipeline and existing and future financial backing to build a sustainable, best-in-class growth biotech that will provide medicines for many patients in need of new options."

In her position at Gurnet Point Capital, Dr. Kornowski has been a successful investor in several innovative start-ups and high growth businesses that have products in the clinic or commercializing, in diseases such as Attention Deficit Disorder Hyperactivity, Cancer and Food Allergy.

Prior to joining Gurnet Point Capital, she was Executive Vice-President of Roche Partnering and member of the Extended Corporate Executive Committee of F. Hoffmann-La Roche AG, one of the world’s largest healthcare companies, and board member of Chugai Pharmaceuticals. In that role, working closely with R&D and Commercial teams at Roche and Genentech, she was responsible for the Partnering and the M&A strategy with Biotechs, Pharma, HealthTech and Research Institutions worldwide for Roche. Previously, Dr. Kornowski had led the largest affiliate of F. Hoffmann-La Roche outside of the US, based in France for many years. Earlier in her career, she held several leadership commercial roles across geographies in leading innovative pharmaceutical and diagnostic companies in France, Israel and the US. Dr. Kornowski holds an MBA from the University of Chicago Booth and a Doctorate in Pharmacy from Paris Descartes University.

On May 10, 2022 Agilent Technologies Inc. (NYSE: A) reported that its PD-L1 IHC 22C3 pharmDx, Code SK006, is now EU CE-IVD–marked for use in cervical cancer. PD-L1 IHC 22C3 pharmDx can be used as an aid in identifying cervical cancer patients for whom treatment with KEYTRUDA (pembrolizumab) may be appropriate (Press release, Agilent Technologies, MAY 10, 2022, View Source [SID1234614137]).1 KEYTRUDA is an anti-PD-1 therapy developed by Merck (known as MSD outside the U.S. and Canada). In Europe, KEYTRUDA, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumors express PD-L1 [Combined Positive Score (CPS) ≥ 1].2

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PD-L1 expression is a critical biomarker for response to anti-PD-1 therapies such as KEYTRUDA whose therapeutic value is being demonstrated across a growing list of cancer types. Globally, cervical cancer is the fourth most common cancer among women,3 with approximately 30,447 new cases diagnosed in Europe in 2020.4

Sam Raha, president of Agilent’s Diagnostics and Genomics Group, discussed the impact of the updated labeling. "PD-1/PD-L1-targeted immunotherapies such as KEYTRUDA have become important cancer treatment options for a growing number of patients. With this European indication expansion of PD-L1 IHC 22C3 pharmDx into cervical cancer, pathologists have access to reliable diagnostic results, supporting even more cancer patients who could benefit from targeted therapies."

Currently, PD-L1 IHC 22C3 pharmDx is the only CE-IVD marked companion diagnostic indicated as an aid in identifying cervical cancer patients with PD-L1 CPS ≥ 1 for treatment with KEYTRUDA. This indication expansion extends the scope of patients who can be tested to determine eligibility for KEYTRUDA, and further strengthens Agilent’s leadership position as a partner in the development of IHC-based diagnostics for targeted cancer therapies.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

1. PD-L1 IHC 22C3 pharmDx [Instructions for Use]. Santa Clara, CA: Agilent Technologies, Inc. (2022).
2. Keytruda [Summary of Product Characteristics]. European Medicines Agency (2022).
3. WHO. Cervical cancer, Key facts. www.who.int/news-room/fact-sheets/detail/cervical-cancer (accessed May 09, 2022).
4. European Cancer Information System (ECIS), European Commission. Cervical cancer burden in EU-27. View Source (accessed May 09, 2022).

On May 10, 2022 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported financial results for the first quarter ended March 31, 2022 and provided a business update (Press release, Janux Therapeutics, MAY 10, 2022, View Source [SID1234614136]).

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"Janux continues to make meaningful progress towards our goal of developing next-generation immunotherapies that are uniquely designed to overcome the clinical limitations of existing TCE approaches," said David Campbell, Ph.D., President and CEO of Janux. "Recently, we were pleased to have presented compelling preclinical data supporting the planned clinical development of both our lead TRACTr programs at PEGS Boston, and we are excited about our progress in advancing IND application submissions for JANX007 and JANX008 in 2022. In tandem, we continue to advance our TROP2-TRACTr and our PD-L1xCD28 costimulatory TRACIr programs, with the goal of submitting an IND for both in 2023. We look forward to driving our pipeline of next-generation immunotherapies into the clinic and executing on our near-term milestones."

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

TRACTr candidates advancing as planned.
Janux recently submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for its PSMA-TRACTr (JANX007). cGMP manufacturing of drug substance and drug product has been completed to support the IND and supply first-in-human (FIH) clinical studies.
Janux expects to submit an IND application to the FDA for its EGFR-TRACTr (JANX008) in the second half of 2022. cGMP manufacturing of drug substance has been completed to support the IND and supply FIH clinical studies.
Janux expects to submit an IND application to the FDA for its TROP2-TRACTr in 2023.
Merck nominates second target as part of strategic collaboration and license agreement. In May 2022, Merck nominated a second target under the 2020 Research Collaboration and Exclusive License Agreement between Merck and Janux.
Presented preclinical data for JANX007 and JANX008 from the Company’s TRACTr platform at the 18th Annual Protein & Antibody Engineering Summit (PEGS) Boston. In May 2022, Janux presented preclinical data for the Company’s two lead TRACTr programs at PEGS Boston. JANX007 is a novel TRACTr therapeutic targeting prostate-specific membrane antigen (PSMA) for the treatment of metastatic castration-resistant prostate cancer, and JANX008 is a novel TRACTr therapeutic targeting epidermal growth factor receptor (EGFR) for the treatment of multiple solid cancers including colorectal cancer, squamous cell carcinoma of the head and neck, and non-small cell lung cancer.
Data presented showed that JANX007 and JANX008 exhibited enhanced safety and pharmacokinetic properties relative to unmasked T cell engagers (TCE). Both candidates were well tolerated in non-human primate safety studies with limited healthy tissue toxicities and cytokine release syndrome. These data demonstrate key characteristics of JANX007 and JANX008 which support their planned clinical development.
IND-enabling studies ongoing for first TRACIr development candidate, a PD-L1xCD28 costimulatory bispecific for the treatment of solid tumors.
Janux expects to submit an IND application to the FDA for its PD-L1xCD28 TRACIr in 2023. Janux has initiated cGMP manufacturing activities to support production and release of drug substance and drug product.
FIRST QUARTER 2022 FINANCIAL HIGHLIGHTS:

Cash and cash equivalents and short-term investments: As of March 31, 2022, Janux reported cash and cash equivalents and short-term investments of $361.2 million, compared to $375.0 million at December 31, 2021.
Research and development expenses: Research and development expenses for the quarter ended March 31, 2022 were $10.2 million, compared to $1.9 million for the comparable period in 2021.
General and administrative expenses: General and administrative expenses for the quarter ended March 31, 2022 were $4.9 million, compared to $0.7 million for the comparable period in 2021.
Net loss: For the quarter ended March 31, 2022, Janux reported a net loss of $13.4 million, compared to a net loss of $2.3 million for the comparable period in 2021.