On September 6, 2023 Nimbus Therapeutics, LLC ("Nimbus Therapeutics" or "Nimbus"), a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, reported the closing of a $210 million private financing to advance its next wave of tech-enabled small molecule medicines (Press release, Nimbus Therapeutics, SEP 6, 2023, View Source [SID1234634967]). The round was co-led by new investor GV (Google Ventures) and existing investors SR One and Atlas Venture, with participation from another new investor that is a U.S.-based life sciences-focused fund as well as existing investors Bain Capital Life Sciences, BVF Partners L.P., Gates Frontier, Lightstone Ventures, Pfizer Ventures, RA Capital Management, and SV Health Investors.

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"We’re proud to have built an R&D organization that is a paradigm of excellence in small molecule drug discovery and development. We embark on this next chapter of our history with the backing of a first-rate investor base, a strong pipeline and an unmatched team, which sets us up for lasting success," said Jeb Keiper, M.S., MBA, Chief Executive Officer of Nimbus.

Nimbus will continue the ongoing clinical development of NDI-101150, a hematopoietic progenitor kinase 1 (HPK1) inhibitor, in patients with solid tumors. The new capital will enable the advancement of multiple preclinical programs into and through early clinical development, including programs targeting Werner syndrome helicase (WRN) and an undisclosed autoimmune disease target. Nimbus is also pursuing the development of novel targeted therapies that activate AMPK to treat a potentially broad range of metabolic disorders via a collaboration with Eli Lilly and Company.

"Nimbus is a leader in integrating cutting-edge computational chemistry, high-tech structural biology tools and other industry-shaping technologies and approaches. We’re thrilled to support Jeb Keiper and the team as they bring difficult-to-drug, high-impact targets within reach across a wide range of therapeutic areas," said Krishna Yeshwant, M.D., MBA, General Partner at GV.

"Nimbus has demonstrated its ability to advance early science through to successful product development multiple times. We eagerly anticipate what lies ahead, and we look forward to being part of the company’s next chapter," said Rajeev Dadoo, Ph.D., Managing Partner at SR One.

"Nimbus’ ability to reproducibly design and develop differentiated, clinically proven small molecules is a testament to the strength of its expert team and its unmatched structure-based drug design platform. We’re gratified to see that sentiment reflected in the strong investor interest we received for this financing, the proceeds of which will advance the next breakthrough medicines from Nimbus’ portfolio," said Bruce Booth, D.Phil., Partner at Atlas Venture, Chairman and co-founder of Nimbus.

On September 6, 2023 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, reported the initial closing of a $23 million financing round led by the company’s significant existing investors (Press release, Imvax, SEP 6, 2023, View Source [SID1234634966]). The proceeds from the initial closing will be used to support the company’s ongoing randomized, multicenter, double-blind, placebo-controlled Phase 2b clinical trial of IGV-001 in patients with newly diagnosed glioblastoma (GBM). The trial is enrolling as expected, and the company will continue additional fundraising over the next several months.

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The company also announced the appointment of Stephen Webster to the Imvax Board of Directors. In connection with Mr. Webster’s appointment, David W. Andrews, M.D., has stepped down from the Board but remains as the company’s Chief Medical Officer.

"The support of our existing investors in this fundraising reflects their belief in the promise of IGV-001 and their commitment to patients facing a GBM diagnosis," said John P. Furey, Chief Executive Officer. "We are making tremendous progress in the Phase 2b trial, and our expectation is that the study will be fully enrolled in the first half of 2024."

"I am also pleased to welcome Stephen Webster to the Imvax Board of Directors," Mr. Furey continued. "Stephen brings over 30 years of biotechnology industry experience in raising capital, business development transactions and operations and will be instrumental as we move forward the development of IGV-001 and our pipeline. I want to thank Dr. Andrews, a co-founder of Imvax, for his service on the Board over many years and am grateful for his continued leadership as our Chief Medical Officer."

Mr. Webster served as the Chief Financial Officer of Spark Therapeutics, a publicly traded gene therapy biotechnology company, from July 2014 until its acquisition by Roche for $4.3 billion in December 2019. He was previously Senior Vice President (SVP) and Chief Financial Officer of Optimer Pharmaceuticals, a publicly traded biotechnology company, from July 2012 until its acquisition by Cubist Pharmaceuticals in October 2013. Prior to joining Optimer, Mr. Webster served as SVP and Chief Financial Officer of Adolor Corporation, a biopharmaceutical company, from 2008 until its acquisition by Cubist Pharmaceuticals in 2011. Mr. Webster also served in leadership positions in the investment banking healthcare groups of Broadpoint Capital and PaineWebber Incorporated. Mr. Webster currently serves as a director of two publicly traded biopharmaceutical companies: Cullinan Oncology, Inc., and NextCure, Inc. Mr. Webster received an A.B. in Economics from Dartmouth College and an M.B.A. in Finance from The Wharton School of the University of Pennsylvania.

"I am excited to join the Imvax Board of Directors at a time of tremendous opportunity for the company," said Mr. Webster. "IGV-001 for GBM and the Goldspire platform reflect a unique and potentially transformative approach to personalized, whole tumor-derived immunotherapy. I look forward to working with the Imvax management team and Board to help realize the company’s mission to deliver transformative therapies for patients."

On September 6, 2023 Anova Enterprises, Inc. (Anova), an organization dedicated to accelerating promising treatments to market with its transformative AnovaOS technology platform, and the industry’s first collaborative ‘learning system’, reported a partnership with Dizal Pharmaceuticals (Dizal) to accelerate the development of DZD9008 for patients with EGFR Exon20ins mutant NSCLC (Press release, Dizal Pharma, SEP 6, 2023, View Source [SID1234634965]).

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Dizal is a commercial-stage biopharmaceutical company focused on the discovery and development of differentiated therapeutics for the treatment of cancer and immunological diseases. Dizal are evaluating DZD9008 in a Phase III study in a first-line setting and a Phase II study in a recurrent setting.

EGFR Exon20ins occur in about 2% patients with NSCLC. No target therapy has gained full approval for the treatment. Chemotherapy is the most commonly used in the first-line setting, but the treatment’s efficacy is not optimal. Therefore, there is an unmet medical need to develop more effective therapy.

"Advances in precision medicine have clearly helped patients with EGFR mutations survive longer. Anova and Dizal are committed to building upon recent success with DZD9008 following NDA approval of Sunvozernitib for the treatment of adult patients with locally advanced or metastatic NSCLC patients with EGFR Exon20ins by the National Medical Products Administration (NMPA) of China. We are identifying the underserved group of NSCLC cases that have EGFR Exon20ins mutations and giving them an opportunity to participate in research designed to benefit them.

"It is not enough to identify patients with rare tumor mutations and hope they can access a promising clinical trial," said Martin Walsh, President at Anova. "AnovaOS provides a network that allows any patient to participate in research where they choose to receive care. Being able to deliver study opportunities in real time transforms the way research has been historically conducted."

Research sites and physicians interested in participating in this study should register their profile at www.anovaevidence.com. NSCLC patients with EGFR Exon20ins mutations can e-mail [email protected] to find out more about the study and consider participation. To find out more contact Victor Sirippi, Project Lead at [email protected]

On September 6, 2023 Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, reported it has closed a $55 million Series C financing round led by 83North (Press release, Ibex Medical Analytics, SEP 6, 2023, View Source [SID1234634964]). Additional participants in the round were Sienna Venture Capital and existing investors in the company, Octopus Ventures, aMoon, Planven Entrepreneur Ventures and Dell Technologies Capital. The financing brings total funding to over $100 million since Ibex’s inception in 2016.

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Ibex is transforming cancer diagnostics with AI-powered solutions that help pathologists improve the quality of diagnosis and support laboratories with enhanced efficiency and better turnaround times. Cancer incidence is rising around the world while its diagnosis becomes more complex and nuanced, causing heavy workloads for pathologists and laboratories. The increasing demand is compounded by a global shortage of pathologists who still rely heavily on manual work and solely on visual analysis of biopsies. Ibex’s Galen platform helps overcome these challenges with AI-powered workflows and decision support tools that pathologists use in their everyday practice.

"Ibex is leading the market in live customer deployments as we remain steadfast in our mission of providing every patient with a timely, accurate and personalized cancer diagnosis," said Joseph Mossel, Co-Founder and CEO of Ibex. "This latest financing round will enable us to take major steps toward reaching our goal. We will be using the funds to expand our footprint in the United States to meet the increasing demand for AI-powered diagnostic solutions, and to accelerate the growth of our product portfolio to create more tools for pathologists and labs as they digitally transform their practices. This financing round highlights our strong commercial momentum and our tenacity in pursuing the opportunities that lie ahead."

Ibex’s Galen platform is the most widely deployed AI technology in pathology and has been deployed in laboratories and pathology departments around the world. Ibex achieved several significant milestones recently, including live deployment of Galen at University of Pittsburgh Medical Center (UPMC), the completion of national roll out throughout Wales, and collaboration with AstraZeneca and Daiichi Sankyo for the development of an AI-powered biomarker scoring product for breast cancer. Galen provides health systems and diagnostic laboratories with an integrated solution for cancer diagnosis and biomarker scoring, capable of detecting more the 100 different cancer and non-cancer pathologies while offering enhanced interoperability with scanning systems, image management solutions and lab information systems. Ibex was recently showcased in a KLAS Research report which provided consistently favorable feedback from global customers.

"Our continued investment in Ibex is a testament to the company’s progress in recent years, bringing its unparalleled technology to laboratories, hospitals and digital pathology networks worldwide, catapulting the industry into an AI-powered era," added Gil Goren, Partner at 83North and Board Director of Ibex. "Ibex’s successful deployments demonstrate its responsiveness to market and customer needs, while its product portfolio continues to grow and meet new market demands. We are eager to see Ibex forge the way with new uses of AI in cancer diagnosis, supporting providers as they work to improve patient care and outcomes."

On September 6, 2023 Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing innovative and highly efficacious cell therapies for the treatment of cancer and autoimmune disease, reported that it will present updated, longer-term results from the ongoing investigator-initiated Phase 1 trial in China evaluating FasTCAR-enabled GC012F in transplant-eligible, high-risk patients with newly diagnosed multiple myeloma (NDMM) (Press release, Gracell Biotechnologies, SEP 6, 2023, View Source [SID1234634963]). The findings will be presented in a poster presentation at the 20th International Myeloma Society (IMS) Annual Meeting, taking place September 27-30, 2023, in Athens, Greece and virtually.

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"We look forward to presenting the latest findings from our clinical study evaluating GC012F for patients with newly diagnosed multiple myeloma at this year’s IMS Annual Meeting," said Dr. Wendy Li, Gracell’s Chief Medical Officer. "There remain significant opportunities to improve outcome for front-line high-risk multiple myeloma patients. With a demonstrably impressive safety profile, differentiated BCMA/CD19 dual-targeting design and FasTCAR next-day manufacturing, we believe GC012F is a compelling, innovative candidate to address the unmet needs for this patient population."

Poster presentation details are as follows:

Abstract title: Phase I open-label single-arm study of dual targeting BCMA and CD19 FasTCAR-T cells (GC012F) as first-line therapy for transplant-eligible newly diagnosed high-risk multiple myeloma
Abstract number: P-136
Abstract category: Treatment of Newly Diagnosed Myeloma – Transplant Eligible
Presentation time: 1:30-2:30PM EEST, Wednesday, September 27, 2023
Additional information about the poster and the IMS Annual Meeting is available on the IMS website.

About GC012F

GC012F is Gracell’s FasTCAR-enabled BCMA/CD19 dual-targeting autologous CAR-T cell therapy, which aims to transform cancer and autoimmune disease treatment by driving fast, deep and durable responses with improved safety profile. GC012F is currently being evaluated in clinical studies in multiple hematological cancers as well as autoimmune diseases, and has demonstrated a consistently strong efficacy and safety profile. Gracell has initiated a Phase 1b/2 trial evaluating GC012F for the treatment of relapsed/refractory multiple myeloma in the United States and a Phase 1/2 clinical trial in China is to be commenced imminently. Gracell has also launched an investigator-initiated trial (IIT) evaluating GC012F for the treatment of refractory systemic lupus erythematosus (rSLE).