On December 9, 2021 Exai Bio, a next-generation liquid biopsy company, reported it has raised a $67.5 million Series A financing to accelerate development of its non-invasive, RNA-based liquid biopsy platform for early cancer detection (Press release, Exai Bio, DEC 9, 2021, View Source [SID1234596709]). The financing was led by leading life sciences and tech investors Section 32 and Casdin Capital, with participation from Two Sigma Ventures, who have been integral to advancing cancer diagnostics and artificial intelligence/machine learning technologies.

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Exai Bio’s platform delivers unprecedented clinical insight into cancer biology from non-invasive blood samples enabling early and accurate diagnosis of cancer to inform personalized care treatments. Unlike first generation liquid biopsy tests which measure circulating tumor DNA (ctDNA) mutations and/or epigenetic markers (such as ctDNA methylation or fragmentation patterns), Exai Bio’s proprietary platform measures cell-free RNA profiles, analyzing them using advanced artificial intelligence and machine learning algorithms. Specifically, Exai Bio is focused on orphan non-coding RNA (oncRNA), small RNA sequences not seen in normal tissue but abundant in tumors. In liquid biopsy samples, these tumor-specific oncRNAs translate to higher sensitivity and specificity, ultimately enabling a more accurate diagnosis as compared to ctDNA-based liquid biopsy tests. Exai Bio’s approach is applicable across multiple unmet needs in cancer.

"Exai Bio is the first company founded to explore the important role of oncRNA in early and more accurate cancer detection and its important impact on improved patient outcomes and health economics," said Patrick Arensdorf, chief executive officer, Exai Bio. "Combining oncRNA technology with cutting-edge machine learning and artificial intelligence to decipher tumor signals and understand the active biology of disease, Exai Bio’s next generation liquid biopsy platform provides actionable information to help inform accurate clinical decisions."

Exai Bio’s next generation liquid biopsy platform was developed based on groundbreaking research conducted by Hani Goodarzi, PhD, assistant professor of Biochemistry and Biophysics, a member of the Bakar Computational Health Sciences Institute and the Helen Diller Family Comprehensive Cancer Center at the University of California, San Francisco (UCSF), and co-founder and scientific advisor for Exai Bio. Dr. Goodarzi’s research, published in Nature, 2018, was the first to identify breast cancer-specific oncRNA and its role as a robust promoter of breast cancer metastasis. The paper also identified the opportunity to utilize oncRNA for early cancer detection via liquid biopsy.

Since 2018, Dr. Goodarzi’s research into oncRNA has continued, and today, Exai Bio’s liquid biopsy platform has been utilized in multiple studies, most notably including the I-SPY 2 study collaboration with UCSF. I-SPY 2 is a neoadjuvant, adaptive clinical trial designed to improve outcomes in individuals with high-risk breast cancer.

Dr. Goodarzi will present data from I-SPY 2 at the San Antonio Breast Cancer Symposium in San Antonio, Texas. The poster, "Tumor-released circulating orphan non-coding RNAs reflect treatment response and survival in breast cancer," demonstrates that the changes in tumor-released oncRNA content of the blood are a significant predictor of clinical outcomes. The study results show that oncRNA "fingerprints" are blood-accessible and enable building predictive models of tumor response. These data will be presented on Thursday, December 9th, 2021 at 7:00 AM Central Time.

Dr. Goodarzi commented, "It’s incredibly rewarding that our early research and the discovery of tumor specific-RNA can have such a meaningful impact on early cancer detection and therapy selection, and potentially improve health outcomes for so many people diagnosed with cancer. The data in the neoadjuvant breast cancer setting is significant, as early stage breast cancer has been a difficult target for ctDNA-based liquid biopsy approaches. I look forward to the continued development of our platform and its exploration in a broad range of cancers."

Exai Bio holds the exclusive license for the development and commercialization of its next generation liquid biopsy platform from the UCSF Innovation Ventures’ Office of Technology Management & Advancement, which leads licensing and business development efforts on behalf of the university.

Exai Bio is led by an experienced founding management team and advisors including:

Patrick Arensdorf, founder and chief executive officer, formerly Chan Zuckerberg Biohub, Bluestar Genomics, ImmuMetrix (acquired by CareDx), Intersect ENT (acquired by Medtronic)
Babak Alipanahi, PhD, founder and chief scientific officer, formerly Google Health, 23andMe, Deep Genomics
Nelson Lee, chief administrative officer, formerly Lawrence J. Ellison Institute for Transformative Medicine (USC), Evidation Health, Crescendo Bio (acquired by Myriad)
Kimberly Chau, vice president clinical operations, formerly CELLective Dx, Kyphon (acquired by Medtronic), Scios (acquired by Johnson & Johnson), Corgentech
Hani Goodarzi, PhD, founder and scientific advisor, UCSF, Rockefeller, Princeton, 2021 Vilcek Prize for Creative Promise in Biomedical Sciences
Robert Warren, MD, clinical advisor, UCSF Surgical Oncology Research Lab
Michael Pellini, MD, managing partner at Section 32, commented, "Exai Bio is delivering clinically meaningful advances in liquid biopsy approaches with the potential to significantly improve cancer care. The ability of Exai Bio’s platform to detect and utilize oncRNA as a cancer signal reveals important insights into cancer biology that can lead to earlier and more accurate cancer detection and diagnosis and better inform personalized treatment options."

On December 9, 2021 K36 Therapeutics, Inc. ("K36"), a privately held biotechnology company developing breakthrough therapies for the unmet medical needs of cancer patients, reported its $30 million Series A financing co-led by F-Prime Capital and Atlas Venture with Eight Roads Ventures (Press release, K36 Therapeutics, DEC 9, 2021, View Source [SID1234596739]). The funds will be used to advance the company’s lead candidate, KTX-1001, through its first clinical proof-of-concept studies. KTX-1001 is a first-in-class, selective inhibitor of the histone methyltransferase (HMT) MMSET, which is overexpressed in up to 20% of multiple myeloma patients due to a t(4;14) translocation. The company plans to submit an IND for KTX-1001 in the first half of 2022.

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"We are developing KTX-1001 to provide a targeted therapy that specifically addresses the underlying cause of cancer for these multiple myeloma patients. KTX-1001 will be the first therapeutic agent to enter the clinic that directly targets overexpression of MMSET," said Terry Connolly, Ph.D., President and Chief Executive Officer of K36. "I am excited to be leading an experienced team of drug developers and working with our tremendous group of clinical advisors as we advance this program to rapid human POC studies."

K36 also announced that industry veteran, Lori Kunkel, M.D., has joined the company’s board of directors, bringing with her more than two decades of experience in oncology and immunology drug development, commercialization and corporate strategy.

"Direct inhibition of MMSET as a potential treatment for high-risk t(4;14)-positive multiple myeloma has been eagerly pursued for many years, and I am delighted to be working with the team who is first to take this precision medicine to the clinic," said K36 board member Lori Kunkel, M.D.

"K36 has the potential to address a significant unmet medical need in multiple myeloma patients who are t(4;14)-positive and beyond," said Chong Xu, Ph.D., F-Prime Capital Partner and K36 board member. "This investment reflects our confidence in the K36 team and their ability to rapidly advance the development of KTX-1001. We are proud to support the company on its mission to develop therapies for cancer patients on a global scale."

"K36 has assembled a world-class team of drug developers and clinical advisors and is now well funded to progress KTX-1001 through the clinic," said Jason Rhodes, Atlas Venture Partner and K36 board member. "We look forward to working with the K36 team as the company progresses into its next stage of growth."

On December 9, 2021 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that presentation by Andrew D. Simmons, Ph.D., Clovis’ Senior Vice President, Translational Medicine, at the 3rd Targeted Radiopharmaceuticals Summit being held virtually December 7-9, 2021 (Press release, Clovis Oncology, DEC 9, 2021, View Source [SID1234596657]). Dr. Simmons’ presentation, titled "Innovations in Peptide Targeted Radionuclide Therapies (PTRT) to Target Fibroblast Activation Protein (FAP) in Solid Tumors", reviews the Company’s preclinical data and describes the Phase 1/2 study currently enrolling for its targeted radiotherapy candidate FAP-2286, the first PTRT and imaging agent targeting FAP to enter clinical development and the lead candidate in Clovis Oncology’s targeted radionuclide therapy (TRT) development program.

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"Clinician enthusiasm for the potential of targeted radiopharmaceuticals, and in particular, FAP as a target, continues to increase, and we are committed to becoming a leader in this emerging field," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We look forward to sharing initial data from the ongoing Phase 1 LuMIERE study of our first targeted radiotherapy candidate FAP-2286, anticipated in 2022."

Following Dr. Simmons’ presentation at 9:35am Eastern time, his slide presentation can be found at View Source with other recent Clovis-sponsored presentations, posters and supplemental information. For more information about FAP-2286, targeted radionuclide therapy, or Clovis’ TRT development program, please visit targetedradiotherapy.com.

About FAP-2286

FAP-2286 is a clinical candidate under investigation as a peptide-targeted radionuclide therapy (PTRT) and imaging agent targeting fibroblast activation protein (FAP). FAP-2286 consists of two functional elements; a targeting peptide that binds to FAP and a site that can be used to attach radioactive isotopes for imaging and therapeutic use. High FAP expression has been shown in pancreatic ductal adenocarcinoma, salivary gland, mesothelioma, colon, bladder, sarcoma, squamous non-small cell lung, squamous head and neck cancers, and cancers of unknown primary. High FAP expression was detected in both primary and metastatic tumor samples and was independent of tumor stage or grade. Clovis holds US and global rights for FAP-2286 excluding Europe, Russia, Turkey, and Israel.

FAP-2286 is an unlicensed medical product.

About Targeted Radionuclide Therapy

Targeted radionuclide therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing delivery of radiation to normal tissue. Targeted radionuclides are created by linking radioactive isotopes, also known as radionuclides, to targeting molecules (e.g., peptides, antibodies, small molecules) that can bind specifically to tumor cells or other cells in the tumor environment. Based on the radioactive isotope selected, the resulting agent can be used to image and/or treat certain types of cancer. Agents that can be adapted for both therapeutic and imaging use are known as "theranostics." Clovis, together with licensing partner 3B Pharmaceuticals, is developing a pipeline of novel, targeted radiotherapies for cancer treatment and imaging, including its lead candidate, FAP-2286, an investigational peptide-targeted radionuclide therapeutic (PTRT) and imaging agent, as well as three additional discovery-stage compounds.

About the LuMIERE Clinical Study

LuMIERE is a Phase 1/2 study evaluating FAP-2286 as a peptide-targeted radionuclide therapy (PTRT) targeting fibroblast activation protein, or FAP, in patients with advanced solid tumors (NCT04939610). The Phase 1 portion of the LuMIERE study is evaluating the safety of the investigational therapeutic agent and will identify the recommended Phase 2 dose and schedule of lutetium-177 labeled FAP-2286 (177Lu-FAP-2286). FAP-2286 labeled with gallium-68 (68Ga-FAP-2286) will be utilized as an investigational imaging agent to identify patients with FAP-positive tumors appropriate for treatment with the therapeutic agent. Once the Phase 2 dose is determined, Phase 2 expansion cohorts are planned in multiple tumor types.

On December 9, 2021 Bavarian Nordic A/S (OMX: BAVA) ("Bavarian Nordic" or the "Company") reported that it has in connection with the directed issue and private placement registered with the Danish Business Authority, a capital increase of a nominal value of DKK 63,736,800 (6,373,680 shares of DKK 10 each) (the "New Shares"), representing 9.94% of the registered share capital prior to the capital increase (the "Offering") (Press release, Bavarian Nordic, DEC 9, 2021, View Source [SID1234596688]).

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The New Shares have been issued under a temporary ISIN code and are expected to be admitted to trading and official listing under the permanent ISIN code DK0015998017 on Nasdaq Copenhagen A/S with effect from 10 December 2021. After registration of the share capital increase, the share capital of Bavarian Nordic amounts to nominally DKK 704,683,930 divided into 70,468,393 shares of DKK 10 each. The total number of voting rights in Bavarian Nordic are 70,468,393.

The New Shares rank pari passu with the Company’s existing shares and carry the same dividend and other rights. Each New Share carries one vote at the Company’s general meetings.

Reference is made to company announcements no. 40 and 41 of 6 December 2021.

The amendments to the Company’s articles of association required by the capital increase have been registered today with the Danish Business Authority and an updated version can be found at bavarian-nordic.com.

JOINT GLOBAL COORDINATORS AND JOINT BOOKRUNNERS
Citigroup Global Markets Limited and Nordea Danmark, filial af Nordea Bank Abp, Finland acted as Joint Global Coordinators and Joint Bookrunners in connection with the Offering (jointly the "Joint Global Coordinators and Joint Bookrunners").

Kromann Reumert and Latham & Watkins LLP acted as Danish and U.S. legal advisors respectively to the Company. Plesner acted as Danish legal advisors to the Joint Global Coordinators and Joint Bookrunners.

On December 9, 2021 Immunic, Inc. (Nasdaq: IMUX), a clinical-stage biopharmaceutical company developing a pipeline of selective oral immunology therapies focused on treating chronic inflammatory and autoimmune diseases, reported enrollment of the first patient in its open-label phase 1 trial of IMU-935, a highly potent and selective inverse agonist of the transcription factor RORγt, in metastatic castration-resistant prostate cancer (mCRPC) (Press release, Immunic, DEC 9, 2021, View Source [SID1234596713]).

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The trial’s Principal Investigator is Johann Sebastian de Bono, M.D., Ph.D., Regius Professor of Cancer Research and Professor in Experimental Cancer Medicine, The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust, London. The trial has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA), the Research Ethics Committee (REC) and the Health Research Authority (HRA) in the United Kingdom.

"After receiving available established treatments, many of which are being given soon after diagnosis, few effective treatments remain for men suffering from mCRPC with this disease being invariably fatal. There is therefore an urgent need to find alternative therapeutic options," stated Professor de Bono. "Preclinical data indicate that IMU-935 may suppress the expression of the mutated AR-V7 receptor, which is a hallmark and progression driver of CRPC. In addition, by repressing pro-tumorigenic Th17 cells and IL-17 cytokines, IMU-935 may further impact tumor growth. I look forward to exploring the anticancer activity of this agent against mCRPC."

"As one of world’s leading experts on the subject of castration-resistant prostate cancer, Professor de Bono’s expertise and deep understanding of the unique mechanism of action of IMU-935 provides important corroboration of this key pipeline program within the scientific and clinical communities," noted Daniel Vitt, Ph.D., Chief Executive Officer and President of Immunic. "Based on the compelling preclinical data highlighting the therapeutic potential of IMU-935 to affect mCRPC, which is the second leading cause of cancer-related death among men, we recognize the potential importance of this program. We are pleased to have enrolled the first patient on plan and look forward to continuing to progress the trial."

The phase 1 trial is structured in two portions: a dose-escalation part and an optional expansion part. A total of between 18 and 24 patients are planned to be enrolled in the dose-escalation part at three dose levels of IMU-935 to be given for three cycles of 28 days each. At each of the three dose levels, a safety analysis after 28 days and an interim analysis after three months of treatment will be performed. The main analysis for this trial is planned after the last patient has received six months of study treatment. The primary objective is to evaluate the safety and tolerability of increasing doses of IMU-935 to establish the maximum tolerated dose and the recommended phase 2 dose. The trial will also evaluate the anti-tumor activity of IMU-935 by means of prostate-specific antigen (PSA) levels, circulating tumor cell (CTC) numbers, and radiographic response assessments of tumor progression. Patients who receive a benefit from IMU-935 will have the option to continue treatment until progression. Following completion of all dose-escalation cohorts, an expansion cohort at one or two therapeutically active dose levels with up to 18 additional patients may be performed to support selection of a recommended phase 2 dose. Initial clinical data is expected to be available in the third quarter of 2022.

The company also re-iterates its prior guidance that data from the multiple ascending dose part of the ongoing phase 1 trial of IMU-935 is expected in the fourth quarter of 2021, with initial clinical data in psoriasis expected in the second quarter of 2022, and that regarding vidofludimus calcium (IMU-838), phase 2 top-line data in ulcerative colitis is expected to be available in the second quarter of 2022.

For more information on the phase 1 clinical trial of IMU-935 in mCRPC, please visit: www.clinicaltrials.gov, NCT05124795.

About Castration-Resistant Prostate Cancer
Castration-resistant prostate cancer (CRPC) is a form of advanced prostate cancer. Approximately 200,000 new cases of prostate cancer are diagnosed each year in the United States, with roughly 40,000 cases progressing to CRPC. Because early stages of prostate cancer rely on testosterone to grow, approaches to lower testosterone can be employed therapeutically. With CRPC, the cancer no longer completely responds to treatments that lower testosterone, significantly limiting available treatment options in these patients. Common sites of metastasis are lymph nodes, bones, bladder, rectum, lung, or liver. Although metastatic CRPC may be asymptomatic, typical signs/symptoms include problems urinating, pain while passing urine or blood in the urine, tiredness, weakness, weight loss, shortness of breath, or bone pain. The main goal in treating metastatic CRPC is to control symptoms and slow progression.

About IMU-935
IMU-935 is a highly potent and selective inverse agonist of RORγt (retinoic acid receptor-related orphan nuclear receptor gamma truncated) with additional activity on DHODH (dihydroorotate dehydrogenase). The nuclear receptor RORγt is believed to be the main driver for the differentiation of Th17 cells and the expression of cytokines involved in various inflammatory and autoimmune diseases. This target is believed to be an attractive alternative to approved antibodies for targets such as IL-23, IL-17 receptor and IL-17, itself. IMU-935 shows strong cytokine inhibition targeting both Th17 and Th1 responses in preclinical testing, as well as indications of activity in animal models for psoriasis and inflammatory bowel disease. Preclinical experiments indicate that, while leading to a potent inhibition of Th17 differentiation and cytokine secretion, IMU-935 did not affect thymocyte maturation. IMU-935 is an investigational drug product that has not been approved in any jurisdiction.