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Evergreen Theragnostics Completes $15M Series B, Launches Discovery Unit, and Prepares Ga-68 DOTATOC Supply Chain

On March 13, 2023 Evergreen Theragnostics, a clinical stage contract development and manufacturing organization (CDMO) developing radiopharmaceuticals for cancer therapy, reported the completion of a $15M Series B capital raise. The round was primarily subscribed by existing shareholders exercising their rights of first refusal (Press release, Evergreen Theragnostics, MAR 13, 2023, View Source [SID1234628611]).

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Leveraging the capital raise, Evergreen is launching a new business unit, Evergreen Discovery, which is focused on developing novel radiopharmaceuticals for cancer therapy. To support its new business unit, Evergreen has recruited Dr. Thomas Reiner as their Chief Scientific Officer. Prior to this, Dr. Reiner served as Head of Radioligand Therapy Drug Discovery on the Executive Leadership Team of AAA (Advanced Accelerator Applications, a Novartis Company). He is a former Laboratory Head, Associate Professor and Member of the Chemical Biology Program at Memorial Sloan Kettering Cancer Center.

"I am very excited for the opportunity to join Evergreen Theragnostics and to lead their new R&D business unit, Evergreen Discovery. Over the last few years, Evergreen has established itself as a leader in the radiopharmaceutical space, and joining their growing team was an easy choice to make", said Thomas Reiner. "Radioligand Therapy is a new and exciting therapeutic modality, uniquely positioned to treat some of the most devastating types of cancer. Our team will innovate the way we treat these cancers, focusing on unprecedented and first-in-class radiopharmaceuticals."

"Launching Evergreen Discovery represented the next logical step for us, and we are excited to have recruited Thomas as a leader of this new team", said James Cook, President and CEO of Evergreen Theragnostics. "With Evergreen Discovery, we will develop novel radiopharmaceuticals to address some of the most urgent unmet clinical needs."

Evergreen Discovery will be based in a new research facility near Princeton, NJ, opening in Q3’2023.

The company will also use funds from the recent capital raise to prepare for the launch of Ga-68 DOTATOC, if approved. Activities will include building our commercial capabilities and staffing, as well as inventory build. The product is planned to be available through Evergreen’s radiopharmacy partners around the country.

"Evergreen is focused on improving the available options for cancer patients through radiopharmaceuticals. We do so by ensuring product availability for clinical trials through our core CDMO business, and in new ways such as the development of Ga-68 DOTATOC and the establishment of Evergreen Discovery," said Mr. Cook. "We are glad to have secured this important funding to enable our continued pursuit of these goals."

MAIA Biotechnology Announces No Exposure to Silicon Valley Bank

On March 13, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA) reported the Company has no exposure to Silicon Valley Bank ("SVB"). The Company is aware that the Federal Deposit Insurance Corp. has taken control of SVB due to liquidity concerns (Press release, MAIA Biotechnology, MAR 13, 2023, View Source [SID1234628610]). The Company confirms it does not hold any deposits or investments at SVB, as well as at Silvergate Bank, or Signature Bank. MAIA’s cash is managed across a top-tier financial institution.

Paige and Leica Biosystems Announce Expanded Partnership to Enhance Use of Image Management and Artificial Intelligence Technology in Global Digital Pathology Workflows

On March 13, 2023 Paige, a global leader in end-to-end digital pathology solutions and clinical AI applications, and Leica Biosystems, a cancer diagnostics company and global leader in workflow solutions, reported an expanded partnership to enhance the use of digital pathology workflows at hospitals and laboratories around the world (Press release, Paige AI, MAR 13, 2023, View Source [SID1234628609]). Building upon its existing partnership, Leica Biosystems has selected Paige as the preferred provider of software-as-a-service (SaaS) digital pathology image management and viewing software along with diverse embedded AI solutions for their line of Aperio GT 450 digital pathology slide scanners.

Leica Biosystems Aperio instrumentation is used in hospitals and laboratories around the world. Under the partnership, a co-branded version of Paige’s Platform will be introduced as the core interface between pathologists and Leica Biosystems hardware. Users of Aperio GT 450 scanners will have access to Paige’s full suite of digital pathology software, including the FullFocus viewer; the AI-powered worklist FullFolio; Paige Prostate Suite, which includes Paige Prostate Detect; Paige Breast Suite; Paige’s suite of biomarker algorithms; and all third-party AI software solutions deployed through Paige*.

"Our expanded partnership with Leica Biosystems reflects our unwavering commitment to deliver powerful AI applications to pathologists everywhere," said Andy Moye, Ph.D., Chief Executive Officer at Paige. "With the widespread reach of Leica Biosystems scanners, we look forward to providing a seamless end-to-end solution that makes the transition to digital pathology easier for hospitals and laboratories around the world. The goal of our partnership is to help accelerate the ease of adoption of digital pathology and the efficiency with which pathologists can evaluate patient cases and to provide them with the insights needed to take decisive medical action."

With a heritage of innovation spanning more than 150 years, Leica Biosystems has offered nine generations of continually improving digital slide scanning technology, realized in compact, user-friendly image capture devices that integrate with pathology workflows and laboratory information systems. Paige’s offerings include novel AI applications together with a powerful platform to easily view and manage whole slide images, putting the power of digital pathology into the hands of pathologists.

"As two global leaders in digital pathology, we have a shared goal of advancing the practice of pathology to improve patient care through innovative hardware and AI-driven software," said Gustavo Perez, President of Leica Biosystems. "We believe that Paige’s differentiated platform and transformative portfolio of AI technologies will provide a streamlined user experience and help pathologists rapidly transition to digital workflows, enabling them to continue the fight against cancer."

*In European Union & United Kingdom, various Paige products are CE-IVD & UKCA Marked for clinical use with scanners such as Aperio GT 450, and in the United States are limited to Research Use Only and not for use in diagnostic procedures.

About Paige

AnHeart Therapeutics Announces Oral Presentation at the European Lung Cancer Congress (ELCC) 2023

On March 13, 2023 AnHeart Therapeutics ("AnHeart"), a clinical-stage global biopharmaceutical company committed to developing novel precision oncology therapeutics, reported acceptance of an oral presentation at the European Lung Cancer Congress (ELCC) 2023, held in Copenhagen, Denmark and virtually, March 29 – April 1 (Press release, AnHeart Therapeutics, MAR 13, 2023, View Source [SID1234628608]).

This oral presentation at ELCC 2023 will provide updated efficacy and safety data of taletrectinib regional Phase 2 study (TRUST-I, NCT04395677) with about 1.5-year follow-up in patients. Taletrectinib is a potent, next-generation, CNS-active, ROS1 tyrosine kinase inhibitor (TKI). In previous reports from the TRUST-I study, taletrectinib showed meaningful clinical efficacy and favorable safety profiles in patients with ROS1+ NSCLC (n=109) regardless of crizotinib pretreatment status.

Separately, a global taletrectinib Phase 2 clinical trial (TRUST-II, NCT04919811) is ongoing and actively enrolling patients in North America, Europe and Asia.

The details of the oral presentation are as follows:

Title: Updated Efficacy and Safety of Taletrectinib in Patients with ROS1+ Non-Small Cell Lung Cancer (NSCLC)

Presentation Session Number: 14MO

Presenter: Dr. Wei Li, Shanghai Pulmonary Hospital and Thoracic Cancer Institute, Tongji University School of Medicine, Shanghai, China

Date: Friday March 31, 2023

Location: Auditorium 1, Bella Center Copenhagen, Copenhagen, Denmark

The ELCC 2023 Program can be accessed online at: View Source

Kezar Life Sciences to Change Virtual R&D Day Date to March 15, 2023

On March 13, 2023 Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders, reported that the Company will pull forward its virtual Research and Development (R&D) Day to Wednesday, March 15, 2023 at 4:30 pm ET/1:30 pm PT (Press release, Kezar Life Sciences, MAR 13, 2023, View Source [SID1234628607]).

"The goal of Kezar’s R&D Day is to set expectations for 2023, provide updates on our two clinical assets, and highlight the productivity from our Discovery team. We are progressing more quickly than planned with initiating PALIZADE, our next study of zetomipzomib for the treatment of lupus nephritis, and look forward to sharing the details," said John Fowler, Kezar’s Co-founder and Chief Executive Officer.

In addition, Craig S. Lammert, M.D., Assistant Professor of Medicine at Indiana University School of Medicine and Executive Director of the Autoimmune Hepatitis Association, will present on autoimmune hepatitis (AIH), the unmet need, and the treatment landscape. PORTOLA, a signal seeking study of zetomipzomib in AIH, initiated in the first quarter 2023.

The presentation will be followed by a Q&A session.

Presenters:

John Fowler, Chief Executive Officer, Co-Founder
Noreen Roth Henig, M.D., Chief Medical Officer
Craig S. Lammert, M.D., Assistant Professor of Medicine at Indiana University School of Medicine, and Executive Director of the Autoimmune Hepatitis Association
Neel Anand, D. Phil. (Ph.D.), Senior Vice President, Research and Drug Discovery
To register for this event, please visit the Events & Presentations page of Kezar’s website. On the day of the event, a live webcast and conference call will be accessible from the Events & Presentations page of Kezar’s website. Additionally, a replay of the event will be available for 90 days following the presentation.

About Zetomipzomib

Zetomipzomib (KZR-616) is a novel, first-in-class, selective immunoproteasome inhibitor with broad therapeutic potential across multiple autoimmune diseases. Preclinical research demonstrates that selective immunoproteasome inhibition results in a broad anti-inflammatory response in animal models of several autoimmune diseases, while avoiding immunosuppression. Data generated from Phase 1 and Phase 2 clinical trials provide evidence that zetomipzomib exhibits a favorable safety and tolerability profile for development in severe, chronic autoimmune diseases.

About Lupus Nephritis

Lupus nephritis (LN) is one of the most serious complications of systemic lupus erythematosus (SLE). LN is a disease comprising a spectrum of vascular, glomerular and tubulointerstitial lesions and develops in approximately 50% of SLE patients within 10 years of their initial diagnosis. LN is associated with considerable morbidity, including an increased risk of end-stage renal disease requiring dialysis or renal transplantation and an increased risk of death. There are limited approved therapies for the treatment of LN. Management typically consists of induction therapy to achieve remission and long-term maintenance therapy to prevent relapse.

About Autoimmune Hepatitis

Autoimmune hepatitis (AIH) is a rare chronic disease in which the immune system attacks the liver and causes inflammation and tissue damage, severely impacting patients’ physical health and quality of life. Lifelong maintenance therapy is required to avoid relapse and burdensome adverse effects. If left untreated, AIH can lead to cirrhosis, liver failure and hepatocellular carcinoma. In the United States, AIH affects approximately 140,000 individuals, with incidence rates increasing. The cause of this condition remains unclear, with females affected four times as often as males. Currently, standard of care treatment for AIH is chronic, immunosuppressive treatment with corticosteroids that frequently cause life-altering side effects, including diabetes, osteoporotic fractures and cataracts. There is a significant need for treatment regimens that reduce or remove the need for chronic immunosuppression from using corticosteroids.

About KZR-261 and the Inhibition of Protein Secretion

KZR-261 is a first-in-class small molecule compound, derived from Kezar’s research and discovery platform of protein secretion pathway inhibitors. This broad-spectrum anti-tumor agent directly targets the Sec61 translocon and inhibits multiple cancer drivers both within tumor cells and the tumor microenvironment. A Phase 1 clinical trial is underway for the treatment of solid tumor malignancies.

Kezar’s drug discovery platform of protein secretion pathway inhibitors is a novel approach with broad application. The protein secretion pathway is a highly conserved and ubiquitously functioning pathway in all cells in the body and involves a conserved protein complex called the Sec61 translocon, the target of Kezar’s compounds. In preclinical models, Kezar’s library of protein secretion inhibitors have demonstrated broad activity with far-reaching potential in oncology, immune-oncology, and autoimmunity.