On May 24, 2022 Incyte (Nasdaq:INCY) reported that it will present at the 43rd Annual Goldman Sachs Global Healthcare Conference on Tuesday, June 14, 2022 at 8:00 a.m. (PDT) /11 a.m. (EDT) in Rancho Palos Verdes (Press release, Incyte, MAY 24, 2022, View Source [SID1234614991]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

The presentation will be webcast live and can be accessed at Investor.Incyte.com and will be available for replay for 30 days.

On May 24, 2022 Prelude Corporation (PreludeDx), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, reported that its study in 926 DCIS patients demonstrating the clinical utility of DCISionRT was selected for an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Prelude Therapeutics, MAY 24, 2022, View Source [SID1234615008]). The results evaluating the association of DCISionRT, a predictive DCIS Biosignature to assess the impact of Endocrine Therapy (ET) on 10-year ipsilateral breast recurrence (IBR) risk after breast conserving surgery alone or with radiation therapy (RT), will be presented on June 7, 2022 at McCormick Place, Chicago, IL.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

"We continue to expand the clinical evidence and utility of DCISionRT and are excited to have been selected for oral presentation at the prestigious ASCO (Free ASCO Whitepaper) Annual Meeting," said Dan Forche, President and CEO of PreludeDx. "These results amplify the extensive body of clinical evidence empowering physicians and patients to make personalized early-stage breast cancer treatment decisions and enhance patient outcomes."

Oral Abstract Presentation
Title: Assessing the benefit of adjuvant endocrine therapy in patients following breast conserving surgery with or without radiation stratified by a 7-gene predictive DCIS biosignature
Presenter: Pat Whitworth, MD, FACS, FSSO, Nashville Breast Center, and Associate Professor, University of Tennessee
Location: Hall D1
Date: Tuesday, June 7, 9:57 am CDT

About DCISionRT for Breast DCIS
DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. Patients with DCIS have cancerous cells lining the milk ducts of the breast, but they have not spread into surrounding breast tissue. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from the University of California San Francisco, and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. DCISionRT combines the latest innovations in molecular biology with risk-based assessment scores to assess a woman’s individual tumor biology along with other pathologic risk factors and provide a personalized recurrence risk. The test provides a Decision Score that identifies a woman’s risk as low or elevated. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, using a non-linear algorithm to account for multiple interactions between individual factors in order to better interpret complex biological information. DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.

On May 24, 2022 Chinook Therapeutics, Inc. (Nasdaq: KDNY) reported the pricing of its underwritten public offering of 6,428,572 shares of its common stock at a price to the public of $14.00 per share (Press release, Aduro Biotech, MAY 24, 2022, View Source [SID1234615025]). In addition, and in lieu of common stock, Chinook is offering to certain investors pre-funded warrants to purchase up to an aggregate of 1,071,428 shares of common stock at a purchase price of $13.9999 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.0001 per share exercise price for each such pre-funded warrant. The gross proceeds to Chinook from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Chinook, are expected to be $105 million. Chinook has granted the underwriters a 30-day option to purchase up to an additional 1,125,000 shares of common stock in connection with the public offering. The offering is expected to close on or about May 27, 2022, subject to the satisfaction of customary closing conditions. All of the securities are being offered by Chinook.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

SVB Securities, Cantor and William Blair are acting as joint book-running managers for the offering. Wedbush PacGrow is acting as lead manager for the offering.

Chinook intends to use the net proceeds from this offering to continue its phase 3 ALIGN and phase 2 AFFINITY trials of atrasentan, fund a phase 3 clinical trial of BION-1301, continue development of CHK-336 and prepare for the potential commercial launch of atrasentan. The remainder of the net proceeds, if any, will be used for general corporate purposes.

The public offering is being made pursuant to a shelf registration statement (File No. 333-265168) on Form S-3ASR that was filed by Chinook with the Securities and Exchange Commission ("SEC") on May 24, 2022, which became automatically effective upon filing with the SEC. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. A copy of the final prospectus supplement relating to the offering, when available, may be obtained from: SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 4th Floor, New York, NY 10022, by email at [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities of Chinook, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On May 24, 2022 LUMICKS, a leading life science tools company that develops instruments for dynamic single-molecule and cell avidity analysis, reported the publication in Cancer Cell of preclinical research identifying "Avidity Enhancement" as a new strategy to improve therapeutic outcome of Chimeric Antigen Receptor (CAR) T cell immunotherapy in Acute Myeloid Leukemia (AML) (Press release, LUMICKS, MAY 24, 2022, View Source;utm_medium=rss&utm_campaign=avidity-enhancement-new-strategy-for-improving-car-t-therapy [SID1234614972]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

AML poses significant clinical challenges due to its resistance to therapies and its bleak prognosis. Approximately 20,000 people in the US and 300,000 worldwide die from AML every year, making it the most common form of acute leukemia in adults and a major public health issue.

The Cancer Cell paper (May 9, 2022), entitled "Non-cleavable hinge enhances avidity and expansion of CAR-T cells for acute myeloid leukemia," was authored by a team of CAR T cell researchers led by Dr. Marcela V. Maus, Associate Professor of Medicine at Harvard Medical School and Director of the Cellular Immunotherapy program at Massachusetts General Hospital.

The study details a novel strategy for better cancer treatment with CAR T cells for AML. "Avidity Enhancement", increasing cell-cell binding from both the tumor and CAR T cell side, led to a more effective eradication of tumors in mouse models of AML. In this paper, data generated using the LUMICKS z-Movi Cell Avidity Analyzer provided superior correlation with CAR T cell activity in vivo compared to the standard in vitro assays in assessing the potency of CAR variants.

Building upon previous research from the Maus Lab indicating ‘avidity escape’ as an evasion mechanism when CAR T cell therapies are deployed against solid tumors, "avidity enhancement" is a promising strategy for improving clinical success of CAR T therapies.

"We continue to be excited about the pivotal research emerging from The Maus Lab and other leading laboratories that demonstrates how researchers can leverage the technological and scientific power of measuring cell avidity with the z-Movi Cell Avidity Analyzer," said Andrea Candelli, PhD, Chief Scientific Officer of LUMICKS. "This work further solidifies the idea that cell avidity can be a unique biomarker to improve the selection of CAR T therapies for superior therapeutic outcomes in hematological malignancies as well as in solid tumors. We are delighted to collaborate with researchers worldwide in uncovering meaningful new insights, such as the new treatment approaches suggested for AML contained in this new paper in Cancer Cell."

The z-Movi Cell Avidity Analyzer measures cell avidity, or level of binding, between immune cells and their targets, enabling researchers to identify the most potent immunotherapeutic effector cells. This unique technology provides predictive, reproducible, and fast results at single-cell resolution. LUMICKS’ cell avidity solutions use acoustics to measure forces and interactions between cells, with the goal of shortening the drug development cycle of immunotherapies and reducing failure rates in clinical trials. First introduced in 2020, the z-Movi is being rapidly adopted by academic and biopharma laboratories around the world.

About the Study Findings

Unlike other forms of leukemia, AML has been notoriously difficult to successfully target using CAR T cells. Researchers believe this is due to both low expression of the antigenic targeted protein on the cancer cells and unstable expression of activating receptors on the T cells.

In this publication, the researchers have shown that increasing avidity of the CAR T cells to their target cells leads to enhanced tumor killing in vitro as in mouse models. Target protein expression on the cancer cells was chemically enhanced using available therapeutics and/or changing the design of the CAR to stabilize its expression on the T cells. Through this method, the researchers show that enhancing cell avidity for therapeutic efficacy can be achieved by modulating the tumor cell or modulating the surface of the T cell. Either strategy increased the sensitivity of the tumor to CAR T mediated clearance, confirming cell avidity as a crucial biomarker in immune oncology.

On May 24, 2022 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported acceptance of its abstract titled, "TAM Targeted Imaging Agents Binding CD206 and Selective Blocking of Off Target Liver Localization" for presentation at this year’s Society of Nuclear Medicine and Molecular Imaging ("SNMMI") Annual Meeting (Press release, Navidea Biopharmaceuticals, MAY 24, 2022, View Source [SID1234614992]). This work was performed as part of an ongoing research collaboration with the University of Alabama at Birmingham ("UAB"), in the laboratory of Dr. Suzanne Lapi, Professor and Vice Chair of Research in the UAB Department of Radiology. The poster will be presented by Dr. Jennifer Bartels of UAB.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

This year’s annual SNMMI meeting will be held June 11-14 in Vancouver, British Columbia, Canada. The presentation will take place Saturday, June 11, from 6 pm – 8 pm PDT (abstract ID 197; program ID 2862). The abstract will be accessible on the SNMMI’s Annual Meeting website prior to the meeting (View Source).

The objectives of this preclinical study were to evaluate tumor localization of two new CD206 targeted mannosylated dextran (Navidea’s Manocept platform) imaging agents as well as an approach to reduce uptake of these imaging agents by the liver. The new imaging agents were labeled with gallium-68 ("68Ga") to enable positron emission tomography ("PET") imaging. The ultimate goals are to develop next generation Manocept imaging agents that offer improved on-target localization and reduced off-target localization. CD206 is a receptor expressed primarily on activated macrophages, including tumor associated macrophages ("TAMs"), as well as the Kupffer cells of the liver. TAM-targeted Manocept imaging enables imaging of tumors. The information gained from these experiments also suggests strategies to improve targeted delivery of therapeutic payloads to TAMs and other clinically significant targets, while simultaneously reducing off-target liver toxicity.

The experiments described in the poster evaluated the biodistribution in mice with and without tumors of the new 68Ga-labeled Manocept imaging agents that differed in their molecular weights. Also evaluated were the effects on their biodistributions of prior administration of unlabeled constructs or a construct designed to specifically block off-target liver localization. Results showed that the amount of the two imaging agents that localized to tumors differed significantly. Also, pretreatment with the construct designed to selectively block liver localization did significantly reduced liver localization of the 68Ga-labeled imaging agents without reducing their localizations to tumors.

Dr. Suzanne Lapi said, "My research group and I are pleased to present this collaborative work with Navidea at SNMMI and to continue to further advance this project with possible far reaching medical imaging and commercial potentials."

Dr. Michael Rosol, Chief Medical Officer for Navidea, said, "We are delighted by the opportunity to present these results at this internationally recognized meeting." Dr. Rosol continued, "This is another example in a line of research collaborations we have had with the highest level of researchers at top tier institutions that is resulting in work advancing our platform technology. These new technologies suggest exciting new applications in medical imaging and possibly also new therapeutic strategies."