On May 2, 2022 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported the Company’s CEO Dr. Pnina Fishman has been invited as an expert speaker to deliver a presentation titled "Targeting the A3 Adenosine Receptor for the Treatment of Advanced Liver Cancer" at the Adenosine Pathway Targeted Cancer Immunotherapy Summit in Boston on May 12, 2022 (Press release, Can-Fite BioPharma, MAY 2, 2022, View Source [SID1234613316]).

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Namodenoson, a small orally bioavailable drug that specifically binds to the A3 adenosine receptor (A3AR), over-expressed in liver cancer but not normal cells, is headed into a Phase III liver cancer pivotal trial. The trial has received a green light from both the U.S. FDA and the European Medicines Agency (EMA) and is now open for the recruitment of approximately 450 patients diagnosed with hepatocellular carcinoma (HCC) and underlying Child Pugh B7 (CPB7) who have not responded to other approved therapies. A prior Phase II HCC study patient who continues to be treated with Namodenoson has survived more than five years and cleared all cancer lesions.

"Adenosine pathway targets have become one of the most clinically validated oncology pathways, further validating our A3AR target for the treatment of liver and other cancers. I’m pleased to be invited to speak and share Can-Fite’s experience with adenosine pathway drug development and clinical trials, and radiological data showing the disappearance of tumor lesions from a patient treated with Namodenoson who had advanced disease and fully recovered," stated Can-Fite CEO Dr. Pnina Fishman.

The inaugural Adenosine Pathway Targeted Cancer Immunotherapy Summit is dedicated to optimizing the efficacy of adenosine pathway targeted drugs, overcoming challenges of resistance and immunosuppression, and supercharging therapeutics into the clinic. The conference aims to maximize the clinical and commercial opportunity of the adenosine pathway as a second-generation immuno-oncology target.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On May 2, 2022 CERo Therapeutics, Inc., a biopharmaceutical company pioneering the development of novel autologous engineered immune cell therapies, reported new preclinical data to be presented at the 25th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) demonstrating significant anti-tumor effects of chimeric engulfment receptor (CER) T cells when combined with small molecule therapies in both hematologic and solid tumor models (Press release, Cero Therapeutics, MAY 2, 2022, View Source [SID1234613332]).

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CER T cells are multifunctional, genetically engineered T cells that elicit dual cytotoxic and myeloid-like anti-tumor function. CER T-cells, which target a phagocytic ligand that can be induced by small molecules, offer the potential for broad anti-tumor synergisms through a differentiated mechanism of tumor clearance. The data indicate the potential for the unique CER T-cell reprogramming technology to restore immune dysfunction in advanced tumor microenvironments when used in combination with small molecule inhibitors. The differentiated and combined approach offers the potential for more complete and durable responses than targeted agents alone.

"Our technology platform reprograms cytotoxic T cells to build in innate immune functions, creating multifunctional CER T cell products that intersect conventional T-cell and myeloid cell-like functions to attack tumors," said Daniel Corey, MD, founder and Chief Scientific Officer of CERo. "These data show that CER T cells synergize with current standard-of-care targeted therapies and result in improved tumor clearance and immune activation than either therapy alone in lymphoma and ovarian cancer models. We now have evidence in clinically relevant disease models supporting our approach and look forward to advancing our lead candidate toward IND-enabling studies."

In the ovarian cancer model, CER T cells synergized with sub-clinical doses of the poly (ADP-ribose) polymerase (PARP) inhibitors olaparib and niraparib to eliminate tumor cells in vitro. In these studies, the addition of PARP inhibitors drove CER T-cell cytokine and proliferation responses against ovarian cancer cell targets compared to untreated samples. By comparison, CER T cells or PARP inhibitors alone demonstrated minimal anti-tumor function. Synergisms were also observed in mantle cell lymphoma (MCL) models with the Bruton’s tyrosine kinase inhibitor ibrutinib. The combinatorial approach cleared 90% of tumor cells at sub-therapeutic concentrations of ibrutinib. CER T cells also proliferated and produced T-cell activation cytokines upon target engagement.

Notably, CER T cells exhibited a differentiated mechanism of tumor clearance via enhanced endo/phagocytosis. In co-cultures with MCL tumor cells, CER T cells showed a 15-fold increase in engulfment activity compared to unmodified T cells. Further, in a model system, CER T cells demonstrated the ability to capture, process, and present tumor antigen, and trigger antigen-specific T-cell responses. Finally, in vivo MCL xenograft studies showed that CERs reduced tumor volume relative to controls, with no overt morbidity.

An oral presentation of the abstract entitled "Tim-4-Chimeric Engulfment Receptor (CER) T Cell Therapy Elicits Phosphatidylserine-Dependent Cytotoxic and Antigen-Presenting Cell-Like Function and Synergizes with Approved BTK Inhibitors for the Treatment of Hematologic Malignancies" (abstract 89) will take place on Monday, May 16, 2022 at 4:45-5:00 p.m. ET during the "CAR T-cells and Beyond" session in Room 102 A/B.

Data from the poster entitled "Tim-4-Chimeric Engulfment Receptor (CER) T Cells Elicit Phosphatidylserine-Dependent Cytotoxic and Innate-Like Function and Synergize with Approved PARP Inhibitors in an Ovarian Cancer Model" (abstract 314) will be presented on Monday, May 16.

About CERo’s Platform Technology
CERo’s technology aims to expand the therapeutic potential of engineered T cell-based therapies by introducing distinct and complementary tumor cell clearance pathways into a single T cell. By engineering T cells to express CERs, CERo’s platform technology enables T cells to target tumors, induce cellular damage, engulf tumor fragments, and clear tumors, effectively harnessing the anti-tumor attributes of both innate and adaptive immune responses. CER T-cell products are designed to generate a more complete and durable anti-tumor response. This novel biology amends itself to combinations with classic CAR T-cell or small molecule therapy and has potential applications in hematologic malignancies and solid tumors.

On May 2, 2022 Sema4 (Nasdaq: SMFR), an AI-driven genomic and clinical data intelligence platform company, reported it has completed the acquisition of GeneDx, LLC ("GeneDx"), a leader in genomic testing and analysis for rare disorders, from OPKO Health, Inc. (Nasdaq: OPK) ("OPKO") (Press release, Opko Health, MAY 2, 2022, View Source [SID1234613353]). The transaction establishes Sema4 as one of the largest and most advanced providers of genomic testing in the U.S. and further strengthens its health information database to transform patient care and improve therapeutic development. The acquisition accelerates Sema4’s ability to deliver precision medicine while driving efficiency in its platform.

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Sema4 has streamlined its management team to enable focused execution across its top business priorities, including expanded molecular testing and data-driven health system and biopharma partnerships. Katherine Stueland, former President and CEO of GeneDx and former Chief Commercial Officer of Invitae, will serve as Sema4’s CEO and will serve on Sema4’s Board of Directors. Ms. Stueland brings more than 25 years of experience in the healthcare industry, having overseen multiple commercial organizations and corporate brand transformations.

"I am delighted to have the opportunity to lead Sema4 as we embark on this next chapter for the combined company, with a focus on growth, operating efficiency, scaling toward profitability, and transformational partnerships," said Ms. Stueland. "Our vision is to accelerate the use of genomics and leverage large-scale clinical data to enhance the standard of care through extensive precision medicine solutions. I look forward to realizing that vision with Sema4’s unmatched health intelligence platform, enabling comprehensive family health, from planning a pregnancy through every stage of life."

"The combined company has excellent momentum heading into the remainder of this year," continued Ms. Stueland. "We look forward to providing a comprehensive financial update and forward looking guidance during our first quarter earnings conference call on May 12th."

Eric Schadt, PhD, Sema4’s Founder, will serve as President and Chief Research & Development Officer, reporting to Ms. Stueland, and will continue to serve on the Board of Directors.

"We are very excited to add GeneDx’s complementary capabilities and are equally thrilled to welcome Katherine as our new CEO, given her extensive leadership, commercial, and operational experience," said Dr. Schadt. "This transformative evolution in the scale of our business positions Sema4 to further revolutionize patient care and to provide more holistic support to health system and biopharma partners. I am excited by the opportunity to redouble my efforts to drive our data platform forward and transform not only clinical practice but the way biopharma companies use data to drive innovation."

Summary of Transaction Details
Under the terms of the agreement, Sema4 has acquired GeneDx for an upfront payment of $150 million in cash, subject to adjustment, plus 80.0 million shares of Sema4’s Class A common stock, with up to an additional $150 million revenue-based milestones over the next two years (which will be payable in cash or shares of Sema4 Class A common stock at Sema4’s discretion). Based on the closing stock price of Sema4’s Class A common stock as of April 29, 2022, the trading date on the closing of the transaction, the total upfront consideration represents approximately $322 million, and the total aggregate consideration including potential milestones is approximately $472 million.

The transaction was announced on January 18, 2022 and received approval from Sema4 stockholders on April 27, 2022.

In connection with the transaction, Sema4 has also closed a private placement financing in which it sold $200 million of Sema4’s Class A common stock at a price of $4.00 per share with a syndicate of institutional investors, including Pfizer.

On May 2, 2022 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported the presentation of three novel cell programming approaches at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) being held May 16-19, 2022 (Press release, Autolus, MAY 2, 2022, View Source [SID1234613414]).

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"The data we are presenting showcases our industry leading T cell programming technologies," said Dr. Martin Pule, Autolus’ Chief Scientific Officer. "As we seek to broaden the use of T cell therapy, we understand the CAR itself is not the sole component – instead it’s a combination of targeting, control and activity enhancements, and by improving each element we hope to ultimately improve patient outcomes in a much broader set of indications."

Posters to be presented:

1.Title: Enhancing CAR T Cell Therapy Using Fab Based Constitutively Heterodimeric Cytokine Receptors
Authors: Righi M., Srivastava S., Grothier T., Robson M., Kokalaki E., Isaac G., McKenzie C., Sillibourne J., Thomas S., Cordoba S., Pule M.
Poster Board Number: W-222
Session Date/Time: Wednesday May 18, 2022 5:30 PM – 6:30 PM
Abstract number: 1096
Summary: One of the challenges of targeting some solid tumors effectively with CAR T therapies is the harsh, immunosuppressive microenvironment of the tumor which can lead to poor persistence and a weak anti-tumor activity. Co-administration with cytokines is known to boost T cell activity and persistence, but its systemic or local administration can be toxic. We have therefore developed a versatile constitutive cytokine receptor (CCR) system which recapitulates cytokine signaling by heterodimerization of cytokine receptors, whist avoiding the potential for toxicities. These FabCCR modules signal exclusively to the CAR T cells with the potential to improve T cell therapies (TILs, TCR T cells and CAR T cells) and avoid systemic toxicity, whilst the versatility of the technology allows a broader application in cellular engineering.

2.Title: CAR T cells engineered to express a Fas-CD40 chimera display superior persistence and tumor cytotoxicity
Authors: McKenzie C., El-Kholy M., Parekh F., Lamb K., Allen C., Sillibourne J., Robson M., Thomas S., Cordoba S., Pule M.
Poster Board Number: W-231
Session Date/Time: Wednesday May 18, 2022 5:30 PM – 6:30 PM
Abstract number: 1105
Summary: Engineered T cells have shown remarkable efficacy against hematological cancers, but their effectiveness in solid tumors has been limited by inhibitory receptors expressed by the tumor or its microenvironment. One such inhibitory receptor is FasL, which binds to the Fas/CD95 receptor on the surface of an activated T cell and triggers the T cell to die by apoptosis. We have identified a Fas-CD40 chimeric protein that is able to not only rescue FasL-mediated T-cell apoptosis, but also elicit superior proliferation and anti-tumor cytotoxicity in the presence of FasL. Our data support the potential of this Fas-CD40 chimera to render T cell therapies resistant to FasL-mediated cell death and improve their effectiveness against solid tumors.

3.Title: Development of a minocycline mediated protein-protein displacement platform using an anti-minocycline single domain antibody and a dedicated displaceable peptide
Authors: Jha R., Kinna A., Ferrari M., Bughda R., Ilca T., Cordorba S., Onuoha S., Thomas S., Pule M.
Poster Board Number: M-192
Session Date/Time: Monday May 16, 2022 5:30 PM – 6:30 PM
Abstract number: 311
Summary: CAR T therapies carry the inherent risks of toxicities mediated by the rapid activation of the CAR T cells in the presence of high levels of tumor. The ability to selectively control and tune down CAR T cells activation is highly desirable in order to control potential toxicity whilst maintaining anti-tumor activity. We have developed a novel, minimally immunogenic, small-molecule control system, controllable with the well-tolerated, and widely available antibiotic minocycline. Control systems such as this permit increased safety and control of engineered cell therapies: it makes the therapy tunable, dose dependent and reversible, and thus has applicability in a range of cell therapy approaches.

On May 2, 2022 Herantis Pharma Plc ("Herantis"), developing disease modifying therapies for Parkinson’s disease, reported that members of the Herantis management team will be attending and holding 1×1 meetings with investors and pharmaceutical companies at the following conferences (Press release, Herantis Pharma, MAY 2, 2022, View Source,c3557941 [SID1234613285]):

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Nordic Health Summit Japan (Virtual)

Herantis will participate in the Nordic Pitch Showcase session.

1×1 meetings will be scheduled during May 11-13, 2022

Inderes Investment Day May 23, 2022

The presentation will be available on May 23, 2022 in the service of Inderes (www.inderes.fi)

Bio€quity Europe 2022 (Virtual)

The presentation will be live on the Bio€quity Europe platform.

1×1 meetings will be scheduled during May 23-24, 2022

The presentations will be available via digital libraries, which are accessible to event participants only.

Please contact the conference organizers, or send an email to [email protected], if you wish to schedule a meeting with Herantis.