On February 14, 2022 Adcentrx Therapeutics ("Adcentrx"), a biotechnology company focused on accelerating breakthroughs in antibody drug conjugate ("ADC") therapeutic development, and AvantGen, a leader in the use of yeast display technology for human antibody discovery and optimization, reported a three-year, multi-target partnership for the discovery of antibodies to be developed into novel ADC therapeutic candidates (Press release, Adcentrx Therapeutics, FEB 14, 2022, https://www.prnewswire.com/news-releases/adcentrx-and-avantgen-enter-a-new-partnership-with-a-three-year-multi-target-collaboration-to-discover-antibodies-for-novel-antibody-drug-conjugates-301482030.html [SID1234608092]).

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Under the terms of the collaboration, Adcentrx will specify targets against which AvantGen will screen for novel antibodies using its yeast display system. Adcentrx will be responsible for engineering the antibodies into ADC therapeutic candidates and has worldwide development and commercialization rights. AvantGen will be eligible to receive milestone payments for achievement of certain development milestones.

"We are excited to enter this new partnership with AvantGen to accelerate our ADC development efforts," said Hui Li, Ph.D., President and CEO of Adcentrx. "What attracted us to AvantGen initially is how their yeast display technology and human antibody libraries mimic human diversity to yield high affinity and very specific antibodies. Through our ongoing collaboration, AvantGen has demonstrated its capabilities in rapidly discovering a diverse antibody repertoire with high developability against defined targets. A key objective at Adcentrx, through this collaboration and opportunistic licensing activities, is to identify the best antibodies which we can leverage to assemble a pipeline of next generation ADC therapeutics."

"We are proud to partner with Adcentrx to help accelerate its ADC pipeline build with our robust human antibody discovery platform," said Xiaomin Fan, Ph.D., President and CEO of AvantGen. "The speed that Adcentrx is able to take lead antibody candidates to development stage with its ADC technology is truly remarkable. We believe that this new partnership will enable Adcentrx to develop the most promising next generation ADC therapeutics with our high-quality antibodies."

On February 14, 2022 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported the presentation of preclinical data for its first VDC product candidate, AU-011, which is being developed for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC) (Press release, Aura Biosciences, FEB 14, 2022, View Source [SID1234608091]). The results will be presented as part of the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (GU) Cancer Symposium being held February 17-19 in San Francisco, CA and online.

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"Non-muscle invasive bladder cancer remains an area of high unmet need with high levels of recurrence and progression and no approved targeted therapies. We believe that AU-011’s mechanism of action supports its potential use as a front-line treatment following initial diagnosis and/or for Bacillus Calmette-Guerin (BCG) refractory disease," said Dr. Cadmus Rich, Chief Medical Officer and Head of R&D of Aura Biosciences. "These preclinical data further support AU-011’s potential in treating urothelial cancer, including NMIBC. We look forward to initiating our planned Phase 1 clinical trial in the second half of this year.

Demonstration of AU-011 Applicability in Urothelial Cancer

Using a panel of human bladder cancer cell lines that represent different stages of the disease, AU-011 demonstrated consistent tumor cell binding and cytotoxicity in vitro. These data support that AU-011’s targeting of bladder cancer cells through HSPGs is tumor grade agnostic. Tumor binding and distribution of AU-011 was evident in both ex vivo human bladder cancer tissues and in an in vivo murine bladder cancer model. Collectively, these results support further investigation of the use of AU-011 in patients with urothelial neoplasia.

Details for the poster presentation are as follows:

Title: Targeting Urothelial Neoplasia Using an Investigational Virus-Like Drug Conjugate
Presenter: Rhonda C. Kines, Aura Biosciences
Poster Session: Urothelial Carcinoma, poster #514
Date and time: Friday, February 18 at 3:30 PM PT
Location: On Demand

The poster can be accessed by visiting the "Scientific Presentations" section of "VDC Platform" page of the Aura Biosciences website.

On February 14, 2022 Stablix, Inc., a biopharmaceutical company pioneering targeted protein stabilization (TPS) as a novel therapeutic modality, reported the appointment of Tony Kingsley as Chief Executive Officer (Press release, Stablix Therapeutics, FEB 14, 2022, View Source [SID1234608089]). Mr. Kingsley replaces interim CEO Dr. Carlo Rizzuto, partner at founding investor Versant Ventures, who remains on Stablix’s board of directors.

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Mr. Kingsley is an experienced biotech CEO with a track record leading and building organizations across multiple scientific disciplines, therapeutic areas and stages of drug development. He most recently was president and CEO of Scholar Rock. Prior to that, he was president and CEO of TarisBio, president and COO of The Medicines Company, and the head of global commercial at Biogen.

Earlier in his career, Mr. Kingsley held leadership roles in the medical device and diagnostics industries and was a partner at McKinsey & Company. He received his undergraduate degree from Dartmouth College and an MBA from Harvard Business School.

"I am incredibly excited by the opportunities I see in Stablix’s proprietary scientific approach," said Mr. Kingsley. "Targeted protein stabilization represents a whole new therapeutic platform technology with applications across a wide range of important diseases with high unmet need. I look forward to working with the remarkable scientific team, the board, and our investors to build a leading company."

"We are thrilled that Tony is joining the company at this pivotal time," said Dr. Rizzuto. "His breadth of experience in drug development, strategy, partnering and company building will help us accelerate our efforts to create a powerful scientific platform and world-class organization."

On February 14, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a leader in transforming disease management and improving patient outcomes through innovative diagnostics, reported that it will release its financial results for the fourth quarter and year-ended Dec. 31, 2021, after the close of market on Monday, Feb. 28, 2022 (Press release, Castle Biosciences, FEB 14, 2022, View Source [SID1234608088]).

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Company management will host a conference call and webcast to discuss its financial results at 4:30 p.m. Eastern time on the same day.

Conference Call and Webcast Details

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website, View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until March 31, 2022.

To access the live conference call via phone, please dial 1 844 200 6205 from the United States, or +1 929 526 1599 internationally, at least 10 minutes prior to the start of the call, using the conference ID 223262.

There will be a brief Question & Answer session following management commentary.

On February 14, 2022 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended December 31, 2021, as well as key clinical and corporate developments (Press release, Cel-Sci, FEB 14, 2022, View Source [SID1234608087]).

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Clinical and Corporate Developments include:

During the first fiscal quarter, CEL-SCI completed the commercial scale build out of its dedicated current Good Manufacturing Practice (cGMP) facility in which it manufactures its investigational immunotherapy Multikine (Leukocyte Interleukin, Injection)*. The construction is designed to ensure the facility will be compliant with all U.S. Food and Drug Administration’s (FDA) and European cGMP regulations. Production capacity has been doubled to meet anticipated market demand for Multikine once it receives regulatory approval.
Based on the results of its pivotal Phase 3 study, CEL-SCI intends to file a Biologic License Application (BLA) with the FDA for approval of the Multikine treatment regimen in locally advanced primary squamous cell carcinoma of the head and neck in patients scheduled to receive surgery and radiation as their primary treatments.
CEL-SCI’s trial was conducted in over 20 countries in which marketing clearance applications may also be filed subsequent to FDA filing and/or approval.
The head and neck cancer patients who are scheduled to receive surgery and radiation as their first treatments have not seen a marked improvement in their treatment outcome in decades. This is clearly an unmet medical need. The study showed great improvement in survival with no noted safety issues for these patients. The number of patients who could benefit from this treatment annually is large, estimated at about 211,000 globally.
As of December 31, 2021, CEL-SCI had $37.1 million in cash and cash equivalents.
"Our current focus is in three primary areas, all of which are essential steps towards drug approval. First, we are assembling the clinical documentation required to obtain FDA approval of a Biologic Product License which will allow commercial marketing of Multikine, second, we are preparing and submitting our compelling data to peer review publications and third, on the production side, we are preparing the facility for FDA inspection as part of the Biologic Establishment License Application process. We look forward to providing updates on these essential steps as we reach milestones," stated CEL-SCI CEO, Geert Kersten.

CEL-SCI reported a net loss available to common shareholders of approximately $8.8 million for the quarter ended December 31, 2021 versus a net loss of approximately $8.0 million for the quarter ended December 31, 2020.

During the quarter ended December 31, 2021, CEL-SCI completed a major upgrade of its leased manufacturing facility to prepare for the potential commercial production of Multikine. Total costs of this upgrade were approximately $11.1 million, of which the landlord of the property agreed to finance $2.4 million. The landlord financing is being repaid through increased lease payments over the remaining term of the lease.