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10-Q – Quarterly report [Sections 13 or 15(d)]

Eli Lilly has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Veeva and Merck Form Long-Term Strategic Partnership

On November 1, 2022 Veeva Systems (NYSE: VEEV) reported a ten-year strategic partnership agreement with Merck (NYSE: MRK), known as MSD outside of the United States and Canada, that builds on the existing 12-year partnership between the companies (Press release, Merck & Co, NOV 1, 2022, View Source [SID1234622752]). Under the terms of the agreement, Merck will take a Veeva-first approach to new industry-specific software and data, selecting Veeva products when they are fit for purpose to maximize the value of Veeva’s integrated, cloud-based platform and products. Veeva will provide Merck with a strategic pricing approach and Merck will have input into Veeva’s product roadmap. The partnership helps accelerate Merck’s digital strategy and makes it more efficient for Merck to evaluate, purchase, operate, and create value from Veeva products and services.

"Transforming our digital, data, and analytics capabilities is integral to enabling our global colleagues to deliver on our purpose of using the power of leading-edge science to save and improve lives around the world," said Robert M. Davis, chief executive officer and president, Merck. "Our strategic partnership with Veeva expands our capacity to leverage innovative technology and enhances our ability to deliver value to patients and all our stakeholders – this is key to how we measure success."

"I am excited to see our partnership with Merck evolve to this strategic level," said Veeva CEO Peter Gassner. "Our teams share a common passion for the industry and an understanding of strategic partnership. I look forward to seeing what we create together over the coming years."

Additional Information Connect with Veeva on LinkedIn: linkedin.com/company/veeva-systems Follow @veeva_eu on Twitter: twitter.com/veeva_eu

Dragonfly Therapeutics Announces First Patient Dosed in Clinical Trial Evaluating Solid Tumor Targeting TriNKET® Conducted by Merck

On November 1, 2022 Dragonfly Therapeutics, Inc. ("Dragonfly"), reported that the first patient has been dosed in a clinical trial being conducted by Merck, known as MSD outside the United States and Canada, to evaluate a solid tumor targeting TriNKET developed by Dragonfly (Press release, Dragonfly Therapeutics, NOV 1, 2022, https://www.prnewswire.com/news-releases/dragonfly-therapeutics-announces-first-patient-dosed-in-clinical-trial-evaluating-solid-tumor-targeting-trinket-conducted-by-merck-301663741.html [SID1234622751]). Dragonfly will receive an undisclosed milestone payment triggered by this event.

"Across both our 1.0 and 2.0 collaborations, Merck has been an extraordinary partner in oncology, immune disorders and other fields," said Bill Haney, co-founder and CEO of Dragonfly Therapeutics. "We are delighted that the first immunotherapy candidate from our initial collaboration has advanced into the clinic, and equally enthusiastic by the progress we are making together on bringing Dragonfly’s TriNKET technology to targets that address other indications."

The companies’ collaboration, initially focused on a number of solid tumor targets, began in October 2018. The collaboration was subsequently expanded in 2020 with a multi-target agreement to develop and commercialize additional natural killer ("NK") cell engager immunotherapies in oncology, infectious disease and immune disorders. Merck licensed this first TriNKET immunotherapy candidate from Dragonfly in November 2020.

Intensity Therapeutics’ Data on Lead Asset, INT230-6, Accepted for Three Presentations at Key Upcoming Clinical Oncology Conferences in November

On November 1, 2022 Intensity Therapeutics, Inc. ("Intensity"), a clinical-stage biotechnology company focused on the discovery and development of proprietary, first-in-class immune-based cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported that three abstracts have been selected for presentation at key upcoming clinical oncology conferences: the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting and the Connective Tissue Oncology Society (CTOS) 2022 Annual Meeting in November (Press release, Intensity Therapeutics, NOV 1, 2022, View Source [SID1234622750]).

November 10-12: Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting being held at the Boston Convention and Exhibition Center, Boston, MA. Two poster presentations have been selected.

Presentation 1
Abstract Number: 545
Title: A Phase II Randomized Window of Opportunity Trial Evaluating Cytotoxic and Immunomodulatory effects of Intratumoral INT230-6 (Cisplatin, Vinblastine) in Early Stage Breast Cancer: the INVINCIBLE Trial
First Author: Angel Arnaout, M.D., FACS
Session Date and Time: Thursday, November 10, 2022, 9:00 am – 9:00 pm EST
Location: Hall C; In-Person & On Demand

Presentation 2
Abstract Number: 710
Title: Safety and Survival Results From a Phase 1/2 Trial of Intratumoral Agent INT230-6 (cisplatin vinblastine) Induces Immunological Cancer Cell Death Alone or With Pembrolizumab in Patients with Refractory, Metastatic Cancers
First Author: Jacob Stephen Thomas, M.D.
Session Date and Time: Friday, November 11, 2022, 9:00 am – 9:00 pm EST
Location: Hall C; In-Person & On Demand

November 16-19: Connective Tissue Oncology Society (CTOS) 2022 Annual Meeting being held at the Vancouver Convention Center, Vancouver BC, Canada. An oral podium presentation will be made by Matthew Ingham, M.D., Assistant Professor of Medicine in the Division of Hematology and Oncology at New York Presbyterian Hospital/Columbia University Medical Center.

Oral presentation
Abstract ID: 1301741
Title: Intratumoral INT230-6 (Cisplatin, Vinblastine, Shao) Alone or with Ipilimumab Prolonged Survival with Favorable Safety in Adults with Refractory Sarcomas (NCT03058289)
Session: Session 9: Immunology & Immunotherapy
Session Date Friday, November 18, 2022
Time: 3:30 PM – 5:00 PM PST
First Author: Matthew Ingham, M.D.

Each of the above presentations will be accessible on the "Publications, Papers and Posters" page of Intensity’s website at: View Source

About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, discovered using Intensity’s proprietary DfuseRx℠ technology platform, is designed to cause tumor necrosis following direct intratumoral injection. INT230-6 contains two proven, potent anti-cancer agents, cisplatin and vinblastine, with a penetration enhancer molecule, SHAO, that helps disperse the potent cytotoxic drugs throughout tumors and enable diffusion into cancer cells. Importantly, each of the active drug agents remain in the tumor causing local disease control and tumor necrosis, leading to a favorable safety profile and the induction of an anti-cancer systemic immune response, resulting in shrinkage of uninjected tumors. Immunosuppression, often seen when dosing intravenous chemotherapy, is absent when treating with INT230-6.

Study IT-01 consists of a dose escalation and several Phase 2 expansion cohorts (NCT03058289) to evaluate INT230-6 in patients with various advanced solid tumors. In 2019, the Company signed a clinical collaboration agreement with Merck Sharpe & Dohme (Merck) to evaluate the combination of INT230-6 and KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with advanced pancreatic, colon, squamous cell and bile duct malignancies, as part of study IT-01. In 2020, the Company executed a clinical collaboration agreement with Bristol-Myers Squibb Company to evaluate the combination of INT230-6 with Bristol-Myers Squibb’s anti-CTLA-4 antibody, Yervoy (ipilimumab), in patients with advanced liver, breast and sarcoma cancers, as a separate cohort in study IT-01. In 2021, the Company executed agreements with the Ottawa Hospital Research Institute and the Ontario Institute of Cancer Research to study INT230-6 in a randomized controlled neoadjuvant phase 2 study in women with early stage breast cancer (the INVINCIBLE study) (NCT04781725). Over 200 patients have been enrolled in Intensity’s studies to date.

Avidity Biosciences to Participate in Upcoming Investor Conferences

On November 1, 2022 Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs), reported that the Avidity management team will be participating at the following upcoming conferences (Press release, Avidity Biosciences, NOV 1, 2022, View Source [SID1234622748]):

31st Annual Credit Suisse Healthcare Conference on November 8 at 11:00 a.m. PT/2:00 p.m. ET
5th Annual Evercore ISI HealthCONx Conference on November 29 at 7:30 a.m. PT/10:30 a.m. ET
Live webcasts of each event, up-to-date event details and an archived replay of the webcasts following each event, will be available on the "Events and Presentations" page in the "Investors" section of Avidity’s website at View Source