On April 7, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that it will be hosting a key opinion leader (KOL) meeting on bioconjugation and CDK9 inhibitors for the treatment of hematologic and solid tumors on Friday, April 16, 2021 at 12:00 PM ET (Press release, Vincerx Pharma, APR 7, 2021, View Source [SID1234577673]).

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The event will feature presentations by KOLs Brian Druker, M.D., Knight Cancer Institute, and Anthony W. Tolcher, M.D., NEXT Oncology. Dr. Tolcher will discuss tackling normal tissue toxicity from antibody-drug conjugates (ADCs) and Dr. Druker will discuss CDK9 in hematologic malignancies. Drs. Druker and Tolcher will be available to answer questions following the formal presentations.

Vincerx’s management team will discuss its poster titled, "A novel small molecule drug conjugate -αvβ3 integrin antagonist linked to a cytotoxic camptothecin derivative- for the treatment of multiple cancer types," which will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, as well as the Company’s bioconjugation platform. Vincerx’s preclinical bioconjugation platform seeks to address the current limitations of small-molecule and antibody-drug conjugates in oncology and consists of VIP236, a small molecule drug conjugate (SMDC) targeting advanced and metastatic cancer, as well as VIP943 and VIP924, two ADCs targeting hematologic tumors.

KOLs
Brian Druker, M.D., is the director of the Knight Cancer Institute, associate dean for oncology of the OHSU School of Medicine and the JELD-WEN Chair of Leukemia Research. His research is focused on translating the knowledge of the molecular pathogenesis of cancer into specific therapies and investigating the optimal use of these molecularly targeted agents. He performed preclinical studies that led to the development of imatinib (Gleevec) for chronic myeloid leukemia (CML) and then spearheaded the highly successful clinical trials of imatinib, which led to FDA approval of the drug in record time. This work changed the life expectancy of patients with CML from an average of 3 to 5 years to a 95% five-year survival and has resulted in a paradigm-shift in cancer treatment from non-specific chemotherapy to highly targeted therapeutic agents. He is a member of the National Academy of Medicine, the National Academy of Sciences and, among numerous awards, is the recipient of the 2009 Lasker-DeBakey Clinical Medical Research Award, the 2012 Japan Prize in Healthcare and Medical Technology and the 2019 Sjöberg Prize.

Anthony W. Tolcher, M.D. is CEO and Founder of NEXT Oncology, San Antonio and Austin, Texas, Phase I group that seeks to transform early clinical trials. NEXT Oncology’s mission is to accelerate the next breakthrough medicines for cancer and the vision is to be the most successful and respected Phase I program in oncology research. Dr. Tolcher served as President and Co- Founder of START LLC from 2009- 2018, one of the world’s largest Clinical Phase I and early drug development operations in cancer medicine with 5 locations in San Antonio Texas; Grand Rapids, Michigan; Madrid Spain; and Shanghai China.

Dr. Tolcher is a medical oncologist who has over 25 years’ experience in early drug development and clinical trials. He has been involved in many of the initial phase I studies of new agents that subsequently were FDA approved for the treatment of cancer including pembrolizumab (Keytruda), copanlisib (Aliqopa), trastuzumab emtansine (Kadcyla), regorafenib (Stivarga), liposomal vincristine (Marqibo), cabazitaxel (Jevtana), carfilzomib (Kyprolis), gefitinib (Iressa), erlotinib (Tarceva), and eribulin (Halaven). He is currently the principal investigator on 40 phase I clinical studies, is a reviewer for the Journal of Clinical Oncology, Clinical Cancer Research, and Annals of Oncology. He has chaired the Developmental Therapeutics Review Committee for the American Association of Clinical Oncology Annual Scientific Program. Dr. Tolcher has over 100 peer-reviewed publications in scientific journals including Nature, Proceedings of the National Academy of Sciences (USA), Journal of Clinical Oncology, and Clinical Cancer Research, as well as an author of nine book chapters

On April 7, 2021 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs ("Regulus"), reported that Jay Hagan, President and Chief Executive Officer of Regulus, will present at the 20th Annual Needham Healtchare Conference on Thursday, April 15th at 1:30 P.M. ET (Press release, Regulus, APR 7, 2021, View Source [SID1234577690]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live webcast of the presentation will be available on the investor relations section of the Company’s website at www.regulusrx.com. A replay of the webcast will be archived for 30 days following the presentation date.

On April 7, 2021 AVM Biotechnology reported that the first cohort has been fully enrolled in their clinical study (NCT04329728 "The WWRD Study") (Press release, AVM Biotechnology, APR 7, 2021, https://www.prnewswire.com/news-releases/avm-biotechnology-announces-full-enrollment-of-first-cohort-of-relapsedrefractory-non-hodgkins-lymphoma-patients-dosed-with-avm0703-at-major-cancer-centers-in-usa-301263637.html [SID1234577706]). All three patients had failed multiple prior therapies, and one had failed two transplants. These patients are reportedly all doing very well, and one was quoted as saying, "I feel great!" Three major US Cancer Centers are actively enrolling study participants. AVM Biotechnology is excited to advance AVM0703 to the next dose level cohort of no-option lymphoma patients. The drug has been well tolerated, without safety issues, as expected. The study is an adaptive design/expansion cohort trial such that cohort enrollment of relapsed/refractory Non-Hodgkin’s Lymphoma patients for the pivotal trial can immediately follow the dose-escalation phase.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Since originally approving the study, the FDA has approved a reduction in the interval between patients in a cohort, from 7 days to 48-hours and between cohorts, from 21 to 7 days of dosing for the first two cohorts. This reduction was approved in response to drug tolerance data submitted from patients treated under FDA approved compassionate use applications.

AVM0703 targets lymphoma while sparing normal lymphocytes, platelets, red blood cells, and stem cells.

"Considering the delay of many clinical studies due to the pandemic, we are gratified to see enrollment occurring so rapidly," said Janet R. Rea, AVM COO. "We are pleased to see these patients tolerate the drug well after failing multiple other therapies and look forward to seeing continued positive results with dose escalation."

The administration of a single dose of AVM0703 is believed to activate the innate immune system to launch novel gamma/delta Natural Killer T cells (NKT cells), and cytotoxic T cells that possess enhanced activity. Once triggered, these cells provide rapid onset of action and response. AVM0703 targets lymphoma while sparing normal lymphocytes, platelets, red blood cells, and stem cells. AVM believes this treatment could reduce the need for transfusions, lower the costs of cancer care associated with managing treatment side-effects, and improve quality of life for lymphoma patients.

"AVM0703 represents an entirely new approach for cancer and non-cancerous diseases. It has the potential to be a true game-changer. I am encouraged by the pre-clinical data and look forward to seeing results of this pivotal trial," said Dr. William Matsui, MD, Deputy Director of Livestrong Cancer Institute.

AVM0703 is available under Expanded Access or Compassionate Use guidelines.

About Non-Hodgkin’s Lymphoma
Non-Hodgkin’s Lymphoma, a broad heterogeneous constellation of lymphoproliferative disorders, is the seventh most common cancer in both men and women, affecting an estimated 77,240 people in the US each year. The overall five-year survival rate is approximately 72%, and over half of the newly–diagnosed cases are in people over age 65 years. Remission following initial established treatment is common, but the disease typically recurs or relapses in as many as 50% of the patients within two years,1 and in some patients, their disease is "refractory," or resistant to additional treatment. Second-line or so-called salvage therapy in these patients consists of stronger chemotherapy "cocktails" or, more recently, cell therapy or hematopoietic cell transplantation. Both approaches can have significant and serious side effects, and the response rates to salvage chemotherapy range from 26%2 to 45%3, with 50% of patients proceeding to autologous stem cell transplant (ASCT). Four-year survival rates are less than 40% utilizing salvage chemotherapy and 60% for those who then undergo ASCT.3 Treatments and associated side effects, coupled with the medical fragility associated with these patients, leaves many of them no treatment options, i.e., "no-option". AVM Biotechnology is committed to providing an option to these patients.

On April 7, 2021 Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) reported the successful closing of its license agreement with Eli Lilly and Company (Lilly), following the expiration of the waiting period under the Hart-Scott Rodino Antitrust Improvements Act of 1976 (Press release, Rigel, APR 7, 2021, View Source [SID1234577672]). Rigel and Lilly entered a global exclusive license agreement and strategic collaboration to co-develop and commercialize Rigel’s R552, a receptor-interacting serine/threonine-protein kinase 1 (RIPK1) inhibitor, for all indications including autoimmune and inflammatory diseases. Pursuant to the collaboration, Lilly will also lead all clinical development of penetrating RIPK1 inhibitors in central nervous system (CNS) diseases.

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The agreement is effective as of March 27, 2021 and Rigel has received the $125 million upfront cash payment due under the terms of the agreement from Lilly. Additional details about the collaboration can be found in Rigel’s Form 8-K filed with the Securities and Exchange Commission on February 18, 2021.

On April 7, 2021 Seagen Inc. (Nasdaq: SGEN) reported that it will report its first quarter 2021 financial results on Thursday, April 29, 2021 after the close of U.S. financial markets (Press release, Seagen, APR 7, 2021, View Source [SID1234577691]). Following the announcement, Company management will host a conference call and webcast discussion of the results and provide a business update. Access to the event can be obtained as follows:

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Thursday, April 29, 2021
1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

Telephone 844-763-8274 (U.S.) or +1 412-717-9224 (international); conference ID 10153242
Webcast with slides available at www.seagen.com in the Investors section. A webcast replay will be archived on the Company’s website.