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Monopar Announces Projected Timeline of Upcoming Q1 2023 Data Events for Validive, Camsirubicin, and MNPR-101 RIT

On January 26, 2023 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported it is planning to report over the next two months (1) the interim go/no-go analysis for its Validive Phase 2b/3 VOICE trial, (2) clinical data from its camsirubicin Phase 1b trial, and (3) a preclinical progress update on its MNPR-101 RIT program (Press release, Monopar Therapeutics, JAN 26, 2023, View Source [SID1234626584]).

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February 2023:

Camsirubicin Phase 1b Clinical Trial Data Update

In addition to the previously reported improvement in median progression free survival over the prior camsirubicin Phase 2 study, Monopar plans to provide details of the Phase 1b trial’s improved toxicity and safety observed to date compared to doxorubicin.
MNPR-101 Radioimmunotherapeutic (RIT) Preclinical Data Update

Monopar plans to report an update on recently generated preclinical data and anticipated next steps with partner NorthStar Medical Radioisotopes.
March 2023:

Interim Go/no-go Analysis for Validive Phase 2b/3 VOICE Trial

Monopar expects to have the interim analysis completed and to report out the go/no-go decision during March 2023; in the intervening time, patient enrollment and addition of new sites continue in preparation for a potentially positive interim.

Grey Wolf Therapeutics Closes Oversubscribed $49 Million Series B Financing to Advance First-of-its-Kind Neoantigen Creation Approaches

On January 26, 2023 Grey Wolf Therapeutics, a biotechnology company focused on generating entirely novel anti-tumour immune responses through targeted cancer neoantigen creation, reported the closing of an oversubscribed $49 million Series B financing (Press release, Grey Wolf Therapeutics, JAN 26, 2023, View Source [SID1234626583]). The financing was co-led by Pfizer Ventures and Earlybird Venture Capital, and also included investment from new investors Oxford Science Enterprises and British Patient Capital and existing investors Canaan and Andera Partners. Proceeds will support the continued development of the company’s first-of-its-kind immuno-oncology approaches designed to overcome key resistance mechanisms through the creation of novel cancer antigens. This includes the anticipated advancement of the company’s lead asset, GRWD5769, into a Phase 1/2 clinical trial in the first half of 2023.

Grey Wolf Therapeutics’ unique therapeutic strategy is centered on generating entirely novel immune responses against tumours thereby overcoming key resistance mechanisms to current immuno-oncology therapy such as poor tumour recognition by T cells and T cell exhaustion. This is achieved through targeted inhibition of the endoplasmic reticulum aminopeptidases (ERAP1 or ERAP2), which drives the generation and presentation of novel and potent cancer antigens to the surface of tumour cells, in turn eliciting a de novo T cell response against tumours.

The ground-breaking research and development activities conducted by the Grey Wolf team have generated a pipeline of novel ERAP inhibition programs, led by GRWD5769, a potentially first-in-class ERAP1 inhibitor. During the first half of 2023, the company intends to initiate an adaptive Phase 1/2 clinical trial evaluating the safety, tolerability, and efficacy of GRWD5769, including a planned combination with the PD-1 inhibitor Libtayo (cemiplimab), in a range of solid tumour types. Additionally, the company will direct a portion of the Series B proceeds to follow-on programs including efforts focused on ERAP2 inhibition and the identification of entirely novel cancer antigens that can be targeted with MHC Class I directed therapies, such as soluble T cell receptor (TCR) and TCR mimic bispecifics.

"This syndicate of leading life science industry investors brings a wealth of relevant expertise and resources to Grey Wolf at a critical time in our evolution as we prepare to enter the clinic," said Peter Joyce, Ph.D., chief executive officer of Grey Wolf Therapeutics. "The funding these groups have committed to Grey Wolf will not only support our efforts to demonstrate clinical proof-of-concept for ERAP inhibition with our lead program, but it will also drive our continued scientific exploration in this area as we aim to further advance and broaden our pipeline of first-of-their-kind therapeutics."

"The scientific ground being pursued by the Grey Wolf team is fertile with potential solutions for overcoming two of the most significant resistance mechanisms limiting current immune-oncology therapies – poor tumour visibility and T cell exhaustion," said Marie-Claire Peakman, Ph.D., principal with Pfizer Ventures. "We look forward to supporting the company as it enters the clinical setting and works to develop an actionable and completely novel therapeutic approach."

"We believe Grey Wolf is establishing the next essential pillar in oncology treatment, with the potential to overcome treatment resistance and change the game for attacking cancer," said Rabab Nasrallah, Ph.D., principal, Earlybird Venture Capital. "Importantly, preclinical research suggests that the company’s elegant treatment approach holds great promise as a monotherapy, as well as the potential to synergistically improve outcomes when used in rational combination with other anti-cancer agents including immune checkpoint inhibitors. This flexibility further amplifies the potential breadth of impact these investigational therapeutics may have in treating patients."

In conjunction with the financing, Grey Wolf Therapeutics has announced several new appointees to its board of directors including:

Sally Dewhurst, senior associate, Oxford Science Enterprises
Emma Johnson, investment manager, British Patient Capital
Rabab Nasrallah, principal, Earlybird Venture Capital
Marie-Claire Peakman, principal, Pfizer Ventures

CytomX Therapeutics Announces Milestone Achievement in Probody® T-Cell Engaging Bispecific (TCB) Collaboration with Astellas

On January 26, 2023 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, reported that it achieved a clinical candidate milestone under its TCB agreement with Astellas (Press release, CytomX Therapeutics, JAN 26, 2023, View Source [SID1234626581]). The clinical candidate is the first Probody TCB molecule to progress in the collaboration and will trigger a $5 million dollar milestone payment to CytomX. CytomX and Astellas are also collaborating on additional conditionally activated TCB programs with CytomX eligible to receive future preclinical, clinical and commercial milestones. CytomX retains a cost share and co-commercialization option on a select number of targets.

"We are pleased with the achievement of the first Probody TCB clinical candidate in our collaboration with Astellas and that our discovery and research capabilities in this important modality continue to deliver next-generation, localized drug candidates. We look forward to continuing to partner with Astellas in advancing novel TCBs towards the clinic and potentially making a significant contribution in bringing the power of T-cell engaging therapies to a broader set of patients with cancer," said Dr. Marcia P. Belvin, Ph.D., senior vice president and head of research at CytomX.

"The progress with Astellas highlights our strategy to create value through a broad, diversified pipeline of wholly-owned and partnered therapeutic programs as well as expanding our research and development efforts in the field of TCBs. T-cell engaging therapies hold tremendous promise; however, the potency of this modality can lead to widespread activation of the immune system and a narrow therapeutic window. Localizing T-cell activity to the tumor microenvironment could result in important breakthroughs for patients, and the Probody platform has potential to address this challenge," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX Therapeutics.

Centessa Pharmaceuticals Announces FDA Clearance of IND Application for Phase 1/2a Clinical Trial of LB101, First LockBody® Candidate, for Solid Tumors

On January 26, 2023 Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, reported that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2a first-in-human, clinical trial of LB101 for the treatment of solid tumors (Press release, Centessa Pharmaceuticals, JAN 26, 2023, View Source [SID1234626578]). LB101, a conditionally tetravalent PD-L1xCD47 LockBody bispecific monoclonal antibody targeting solid tumors, is the first product candidate developed using the Company’s proprietary LockBody technology which is designed to selectively drive potent effector function activity, such as CD47, in the tumor microenvironment (TME) while avoiding systemic toxicity.

"We are very excited to be bringing our first LockBody candidate to the clinic and to be advancing a potentially transformative technology for patients with solid tumors," said Saurabh Saha MD PhD, Chief Executive Officer of Centessa. "The clearance of our IND for LB101 is an important milestone for our company as we have an ambitious strategy to advance multiple potential LockBody candidates in areas where there is a significant need for new cancer treatment options. We look forward to initiating the Phase 1/2a trial of LB101 as soon as possible."

About LB101

LB101 is a conditionally tetravalent PD-L1xCD47 LockBody bispecific monoclonal antibody which has two anti-CD47 domains blocked by two anti-PD-L1 domains, with proprietary human IgG-derived hinges linking the anti-CD47 and anti-PD-L1 domains. The cell-killing mechanism of action, CD47, is designed to be blocked by the PD-L1 tumor targeting domain until the IgG-derived hinges are naturally degraded in the TME, thus unlocking and activating the CD47 effector function activity in the tumor.

Cardinal Health Teams Up with Palantir to Deliver a Clinically Integrated Supply Chain Solution

On January 26, 2023 Cardinal Health (NYSE: CAH) reported that it has entered into a strategic collaboration with Palantir Technologies Inc. (Palantir) (NYSE: PLTR), a leading builder of operating systems for the modern enterprise, to design a solution that will give health systems and hospitals dynamic purchase decision insights in order to quickly improve their bottom line (Press release, Cardinal Health, JAN 26, 2023, View Source [SID1234626577]).

The Cardinal Health solution, which will be integrated into Foundry, Palantir’s industry-leading operating system, will deploy artificial intelligence (AI) and machine learning (ML) to bring together diagnosis and clinical data with real-time customer purchasing and consumption data for pharmaceutical products with best-in-class data and privacy protections. Future iterations of the tool are expected to help inform purchasing decisions for therapeutic utilization, reimbursement insights and predictive drug inventory needs – to help further improve the connection between health system purchasing and supply chain support.

"We are taking a proactive role in pharmaceutical decision support to provide support to our customers as they continue to manage rising drug expenses, supply chain volatility and continued drug shortages," said Peter J. Siavelis, senior vice president and general manager of Health System and Provider Distribution & Services at Cardinal Health. "By utilizing Palantir’s platform, we are working to reshape the pharmaceutical supply chain with innovative processes, products and solutions to improve access to critical medications and streamline pharmacy inventory management."

As hospitals balance increases in drug expenses due to the growth of specialty therapies and biosimilars, health systems are struggling to right-size pharmacy inventory together with constantly evolving payer formulary updates. Cardinal Health’s data-driven solution will mitigate some of these challenges by analyzing real-time clinical and purchasing data to effectively create a clinically-integrated supply chain for pharmaceuticals.

"Our partnership with Cardinal Health further shows our commitment to improve patient outcomes across the full healthcare value chain and Palantir’s ability to create resilience within the complex challenges of supply chain uncertainty," said Palantir chief operating officer Shyam Sankar. "We’re excited to work with Cardinal Health to achieve their mission-critical objective of expanding access to the medications patients need, by utilizing the software built to handle the toughest problems."

A leader in the data and analytics industry, Palantir launched its Health & Life Sciences division in 2020. Since then, the company has continued to support federal, public and private organizations and is a proven leader in delivering mission-critical software across the public health supply chain.