HiFiBiO Therapeutics Receives FDA Clearance of IND Application for HFB200301

On November 1, 2021 HiFiBiO Therapeutics, a multinational clinical-stage biotherapeutics company reported that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for HFB200301 (Press release, HiFiBiO Therapeutics, NOV 1, 2021, View Source [SID1234594087]). HFB200301 is a first-in-class monoclonal agonist antibody designed to promote an antitumor response by stimulating both innate and adaptive immune systems through TNFR2 in solid tumors identified through HiFiBiO’s Drug Intelligent Science (DISTM) platform.

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"The FDA’s clearance of our IND for HFB200301 is an important milestone for HiFiBiO as it further demonstrates the power of our single cell-powered DIS platform to identify and develop novel therapeutics. This milestone also signifies our transition to a clinical stage company," said co-founder and CEO of HiFiBiO Therapeutics, Liang Schweizer, Ph.D. "The FDA’s clearance brings us one step closer toward achieving our mission of delivering novel therapeutics that improve treatment options for cancer patients"

"We were excited to discover that our TNFR2 clinical candidate not only stimulated effector CD4 and CD8 T cells, but also activated NK cells to drive anti-tumor activity" shared Francisco Adrián, Ph.D., CSO of HiFiBiO Therapeutics. "HFB200301 has shown strong in vivo efficacy alone and combined with anti-PD-1 at doses well tolerated in mice and NHPs."

"The planned Phase 1 clinical study will consist of an initial dose escalation followed by expansion cohorts in selected solid tumors identified through HiFiBiO DISTM platform. The company is also exploring a potential combination with checkpoint inhibitor therapy", said Luigi Manenti, M.D., CMO of HiFiBiO Therapeutics. "We remain committed to further developing novel immune therapies for patients with cancer and autoimmune diseases."

HFB2003 (TNFR2)

HFB200301 is a first-in-class agonistic anti-TNFR2 antibody that binds potently and selectively to TNFR2 and induces the activation of CD4 T cells, CD8 T cells and NK cells. In vivo, HFB200301 demonstrates potent antitumor activity as a single agent and in combination with anti-PD-1. HiFiBiO is applying a biomarker strategy by leveraging its DIS platform to select patients who may benefit the most from HFB200301 treatment.

Exact Sciences to participate in November investor conferences

On November 1, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will participate in the following conferences and invited investors to participate by webcast (Press release, Exact Sciences, NOV 1, 2021, View Source [SID1234594015]).

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Jefferies London Healthcare Conference
Fireside Chat on Tuesday, November 16, 2021 at 10:40 a.m. ET

Stifel Virtual Healthcare Conference
Fireside Chat on Tuesday, November 16, 2021 at 3:20 p.m. ET

Evercore ISI HealthCONx Virtual Conference
Fireside Chat on Tuesday, November 30, 2021 at 11:20 a.m. ET
The webcasts can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

Mustang Bio Awarded NIH Grant For MB-106 CD20-Targeted CAR T Cell Therapy for Treatment of B-cell non-Hodgkin Lymphomas

On November 1, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that the company has been awarded a grant of approximately $2 million from the National Cancer Institute of the National Institutes of Health ("NIH") (Press release, Mustang Bio, NOV 1, 2021, View Source [SID1234594032]). This two-year award will partially fund the Phase 1, Open Label, Multicenter Trial to Assess the Safety, Tolerability and Efficacy of MB-106, a CD20-targeted, autologous CAR T cell therapy for patients with relapsed or refractory B-cell non-Hodgkin lymphomas ("NHL") or chronic lymphocytic leukemia ("CLL").

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In addition, the Office for Human Research Protections has approved Federalwide Assurance ("FWA") for Mustang’s research. FWA is an assurance of compliance with the U.S. federal regulations for the protection of human subjects in research.

Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "The NIH grant and FWA validate our scientific efforts as we continue to advance the development of MB-106. This grant will contribute to Mustang’s evaluation of MB-106 in clinical trials with the hope to bring this therapeutic treatment to patients with relapsed or refractory B-cell non-Hodgkin lymphomas and chronic lymphocytic leukemia."

Research is supported by the National Cancer Institute of the National Institutes of Health under Award Number R44CA265616. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

About MB-106 (CD20-targeted CAR T Cell Therapy)
CD20 is a membrane-embedded surface molecule which plays a role in the differentiation of B-cells into plasma cells. The CAR T was developed by Mustang’s research collaborator, Fred Hutch, in the laboratories of the late Oliver Press, M.D., Ph.D., and Brian Till, M.D., Associate Professor in the Clinical Research Division, and exclusively licensed to Mustang in 2017. MB-106 has been optimized as a third-generation CAR derived from a fully human antibody and is currently in a Phase 1/2 open-label, dose-escalation trial at Fred Hutch in patients with B-NHL and CLL. Additional information on the trial can be found at View Source using the identifier NCT03277729.

BioNTech to Present New Clinical Data from First-in-Class CAR-T Program BNT211 in Late-breaking Session at 36th SITC Annual Meeting

On November 1, 2021 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company"), a next generation immunotherapy company pioneering novel therapies for cancer and infectious diseases, reported that new clinical data from the first-in-human Phase 1/2 trial evaluating the Company’s novel CAR-T cell therapy candidate, BNT211, will be presented in an oral presentation (Press release, BioNTech, NOV 1, 2021, View Source [SID1234594067]). The presentation is scheduled for the late-breaking abstract poster session at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), being held both in person and virtually from November 10 – 14, 2021.

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"Our goal is to leverage our understanding of immunology and tumor biology together with our advanced technologies to provide cancer patients with novel treatments," said Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "Claudin-6 is a new target that we believe is well-suited for CAR-T therapy and presents a differentiated avenue for the treatment of solid tumors. We appreciate the opportunity to present initial data from our first-in-human study of the CAR-T product candidate to leading immuno-oncology experts in this prestigious late-breaking forum, which further underline the potential of our technology."

BNT211 is an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin 6 (CLDN6) and the first CAR-T product candidate in the Company’s clinical development. BNT211 is currently being investigated as a monotherapy and in combination with a CLDN6-encoding mRNA-based vaccine (CARVac) in a first-in-human Phase 1/2 clinical trial (NCT04503278) to evaluate safety and preliminary efficacy in patients with CLDN6-positive relapsed or refractory advanced solid tumors.

Poster Details:

Program: BNT211
Poster Title: A phase I/II trial to evaluate safety and efficacy of CLDN6 CAR-T cells and vaccine-mediated in vivo expansion in patients with CLDN6-positive advanced solid tumors
Abstract Number: 958
Presenter: Prof. Andreas Mackensen, M.D., University Hospital Erlangen, Germany
Date & Time: Friday, November 12, 2021; 12.25 – 12.40 pm ET

Lantern Pharma’s Proprietary A.I. Platform for Precision Oncology Drug Development, RADR®, Surpasses 10 Billion Datapoints – Significantly Enhancing Precision Medicine Capabilities & Expanding Potential for Biopharma Collaborations and Partnerships

On November 1, 2021 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that its proprietary A.I. platform RADR has exceeded 10.4 billion datapoints(Press release, Lantern Pharma, NOV 1, 2021, View Source [SID1234594650]). RADR is Lantern’s proprietary integrated A.I. platform for large-scale biomarker and drug-tumor interaction data analytics that leverages machine-learning. RADR is used to provide mechanistic insights about drug-tumor interactions, predict the potential response of cancer types and subtypes to existing drugs and drug candidates, and uncover patient groups that may respond to potential therapies being developed by Lantern and its collaborators.

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RADR is also being used to: (1) help define and develop combination strategies involving drugs in development by Lantern and existing drugs that are approved for a range of oncology indications; (2) guide the prioritization of potential indications for development; and (3) identify potential new drug candidates to in-license and develop.

The increase to 10.4 billion datapoints was also accompanied by other significant improvements in the functionality, feature set and further automation of RADR, which are intended to help scale the A.I. platform’s drug development capabilities. The significant increase in the number of drug-tumor interaction data sets and cancers sub-types covered by RADR includes new data from collaborations in glioblastoma multiforme (GBM) and pancreatic cancer and data from transcriptome, genome and methylome data-sets in blood, bladder and other rare cancers being considered for future development or have limited therapeutic options.

Panna Sharma, CEO and President of Lantern Pharma, stated, "Our team has been well ahead of schedule in the growth of our platform, and RADR has now surpassed 10.4 billion data points covering more cancer sub-types, which further advances our goal of building the most complete and powerful A.I. platform for precision oncology drug development. Additionally, the new data will drive insights and potential drug-candidate innovations faster and into areas of cancer that have remained untouched or intractable."

Corresponding with this growth in datapoints, the Company has also focused resources and technology development on the growth and improvements to the library of algorithms designed specifically to help solve challenging data and correlation problems for cancer drug development. By using an ensemble-based approach in applying the library of algorithms to statistical, correlative and inferential problems related to drug-tumor interaction, RADR can rapidly analyze large amounts of complex data and predict with high accuracy how both tumors and patients will respond to drugs and drug candidates. RADR’s ability to rapidly sift through large amounts of curated and complex datasets is key in predicting the probability of a tumor or a patient group in responding to a cancer treatment. Additionally, the RADR platform evolves as new datasets are added, which improves and sharpens the insights generated from the algorithms. Lantern plans on continuing further RADR expansion by incorporating and curating additional datasets from proprietary studies and public data sources and further automating the evolution of its library of algorithms. Additionally, the Company will be augmenting the 10.4 billion datapoints with additional data from immuno-oncology related studies and clinical trials, including antigen, immune-response and protein data that it believes will enable a potentially more robust and more powerful multiomic analysis. "In the next phase of growth for RADR our belief is that we can deepen our capabilities in novel ADC development and also predict combination therapy approaches using our drug candidates and existing approved immuno-oncology therapies," stated Mr. Sharma.

"Previously, the task of identifying new cancer therapies has been costly, risky, and inefficient. Specifically, studying how existing compounds and therapeutic combinations can affect different cancer subtypes often took years, whereas our platform can reduce many key aspects of this process to months. As a result, we believe our platform changes the industry paradigm in a meaningful way. We have witnessed first-hand the growing industry interest in solutions that innovate the development of precision therapeutics and combination therapies, which we believe will pave the road to new partnerships. Accordingly, we believe our growing A.I. platform will be pivotal in uncovering potential new therapeutic opportunities and developing insights into the creation of combination-therapy programs, both internally and through third-party party collaborations to drive long-term shareholder value."

RADR’s highly scalable machine-learning methods are designed to guide drug development and yield new biological insights, while also having the potential to increase response rates and improve outcomes in clinical trials. The robustness and growing number of datasets powering RADR is anticipated to continue to improve machine-learning results, accelerate automation of other features and aid oncology drug development for Lantern and its partners with an ultimate focus on benefitting cancer patients.