Link Cell Therapies Announces Foundational Publication in Nature Unveiling Novel CAR T Cell Technology Designed to Kill Cancers without Off-Tumor Toxicity

On March 20, 2023 Link Cell Therapies, a biotechnology company expanding the universe of solid and hematologic cancer antigens that can be safely and effectively targeted with T cell therapies, reported a milestone publication in the journal Nature (Press release, Link Cell Therapies, MAR 20, 2023, View Source [SID1234629046]). The paper, titled "Co-opting signaling molecules enables logic-gated control of CAR T cells,"details the company’s LINK CAR technology, a logic-gated system engineered to bypass traditional T cell signaling machinery to optimize and customize CAR T cell responses, killing solid tumors without on-target, off-tumor toxicity.

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Link Cell Therapies was launched in May of 2022 with $12M in seed funding by Samsara BioCapital and Sheatree Capital. The company is also developing two additional platform technologies beyond LINK, including ZAP and BOOST, to overcome some of the most significant hurdles facing CAR T therapies. ZAP is geared to reduce T cell exhaustion by engaging the ZAP-70 signaling pathway. BOOST amplifies CAR and TCR signaling to avoid T cell evasion associated with low target antigen expression.

"While CAR-T cells have revolutionized the treatment of hematologic cancers, they have not achieved the same success in solid tumor cancers. One reason is that in solid tumors, it is difficult to find targets that are expressed on cancer cells and not also found on healthy cells," said Robbie Majzner, MD,co-founder of Link Cell Therapies and Assistant Professor of Pediatrics in Hematology/Oncology at Stanford University. "Drawing insights from native T cell signaling networks, we have successfully engineered a logic-gating system that requires two antigens expressed on the same tumor cell to selectively control CAR T cell activity."

Pre-clinical findings published in the March 15th issue of Nature show that the downstream signaling molecules LAT and SLP-76 can be repurposed into surface receptors that enhance the function and specificity of CARs through Boolean logic AND-gating. When paired together, LAT and SLP-76 enabled AND-gating and further mediated robust CAR activity in mouse models of cancer.

"Logic-gates are an increasingly important focus in oncology drug discovery," said Crystal Mackall, MD, co-founder of Link Cell Therapies and Founding Director of the Stanford Center for Cancer Cell Therapy. "Link Cell Therapies’ LINK CAR is the first true and reversible Boolean logic AND-gate system in which recognition of two antigens expressed on the same cell is required to achieve killing of tumor cells while sparing normal cells."

Conventional logic CAR systems have shortcomings in either specificity or efficacy in vivo. Using an in vitro toxicity model, the study authors confirmed that competing logic-gate systems mediated unwanted bystander killing of single antigen positive cells, whereas LINK CAR T cells eradicated double-positive tumor cells and avoided single-antigen-positive cells. When tested in an in vivo setting, only LINK CARs showed tumor regression without any signs of on-target, off-tumor toxicity.

Link Cell Therapies plans to investigate its LINK CAR platform further using patient samples and single-cell technologies to identify and validate safe and effective targets.

"Samsara prides itself on partnering with founders to launch companies that are advancing truly innovative technologies in difficult therapeutic areas where treatment options for patients are limited," said Abe Bassan, Interim President of Link Cell Therapies and Principal at Samsara BioCapital. "These advances could have a broad impact, not only in the field of cancer immunotherapy but also as researchers demonstrate the impact of CAR T cells in additional therapeutic areas."

Transactions in connection with share buy-back program

On March 20, 2023 Genmab reported the initiation of a share buy-back program to honor our commitments under our Restricted Stock Units program (Press release, Genmab, MAR 20, 2023, View Source [SID1234629045]).

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The share buy-back program is expected to be completed no later than March 31, 2023 and comprises up to 220,000 shares.

The following transactions were executed under the program from March 13, 2023, to March 17, 2023:

No. of shares Average price (DKK) Total value (DKK)
Accumulated through last announcement 133,000 342,851,540
March 13, 2023 8,000 2,447.52 19,580,160
March 14, 2023 8,000 2,507.62 20,060,960
March 15,2023 6,000 2,511.67 15,070,020
March 16, 2023 6,000 2,494.93 14,969,580
March 17, 2023 6,000 2,516.56 15,099,360

Total 34,000 84,780,080
Accumulated under the program 167,000 427,631,620
Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 710,416 shares as treasury shares, corresponding to 1.08% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 06 dated February 22, 2023.

Exelixis Announces $550 Million Share Repurchase Program

On March 20, 2023 Exelixis, Inc. (Nasdaq: EXEL) reported that the company’s Board of Directors has authorized the repurchase of up to $550 million of the company’s common stock before the end of 2023 (Press release, Exelixis, MAR 20, 2023, View Source [SID1234629044]).

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The timing and amount of any share repurchases under the share repurchase program will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of Exelixis’ common stock and general market conditions. Share repurchases under the program may be made from time to time through a variety of methods, which may include open market purchases, in block trades, accelerated share repurchase transactions, exchange transactions, or any combination of such methods. The program does not obligate Exelixis to acquire any particular amount of its common stock, and the share repurchase program may be modified, suspended or discontinued at any time without prior notice.

Enlivex Receives Positive DSMB Recommendation and IMOH Clearance to Continue Phase I/II Trial of Allocetra combined with chemotherapy in patients with peritoneal metastases arising from solid cancers

On March 20, 2023 Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the "Company"), a clinical-stage macrophage reprogramming immunotherapy company, reported that an independent Data and Safety Monitoring Board (DSMB) has completed an interim data review for the first cohort of patients in the Company’s ongoing Phase I/II clinical trial of Allocetra in patients with advanced-stage peritoneal metastasis arising from solid tumors as an add-on to the standard of care (SoC) chemotherapy administered via Pressurized Intraperitoneal Aerosol Chemotherapy (clinicaltrials.gov Identifier: NCT05431907) (Press release, Enlivex Therapeutics, MAR 20, 2023, View Source [SID1234629043]). The Israeli Ministry of Health (IMOH) also reviewed the interim data and provided regulatory clearance to continue the study and open the study’s next cohort. In addition, the safety profile supported a protocol amendment to start new patients in the second cohort with higher initial doses of Allocetra. This IMOH clearance follows a previously-reported IMOH clearance to the Company’s second Phase I/II clinical trial, which is evaluating Allocetra as monotherapy and in combination with anti-PD1 checkpoint inhibitors in patients with advanced-stage solid tumors

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The DSMB based its review on available safety data for the three enrolled patients in the first cohort, in which two patients received three escalating doses of Allocetra, and one received two escalating doses of Allocetra, once every six weeks as an add-on to SoC chemotherapy delivered to the peritoneum. The primary purpose of the dosing regimen for the first cohort was to establish a safety profile that may enable an increase in the Allocetra dosing level administered to additional patients in the study and potentially associate dose levels with indications of effect

There were no mortalities nor DSMB-identified safety signals in the first cohort, and the DSMB recommended that the study continue to further dose escalation and additionally agreed to increase the starting dose of Allocetra in the next cohort. Following the DSMB recommendation, the IMOH reviewed the available safety data for the first cohort and provided regulatory clearance to initiate the recruitment of patients into the second cohort

Einat Galamidi, MD, Medical Vice President of Enlivex, commented, "We are delighted with the safety profile of Allocetra when administered directly into the peritoneal cavity, as demonstrated in the first three patients in this trial. This is the first time Allocetra has been injected locally into the peritoneum cavity, a route of administration that may be relevant to various alternatives of local administration of Allocetra in different oncological indications

ABOUT THE PHASE I/II TRIAL

The Phase I/II trial is a Company-sponsored, open-label, dose escalation and expansion trial that is expected to enroll a total of approximately 12 patients across four cohorts. It is designed to evaluate the safety and potential preliminary efficacy of Allocetra combined with SoC chemotherapy in patients with peritoneal metastases arising from solid cancer. The study begins with two cohorts of intra-patient and intra-cohort dose escalation to determine the maximum feasible dose (MFD) of Allocetra in this population, followed by two additional cohorts comparing administration of Allocetra at the selected dose either before or after administration of SoC via a pressurized intraperitoneal aerosol chemotherapy procedure (PIPAC; a technique applied when patients are not eligible to receive the standard treatment due to a considerable tumor load, large quantities of persistent ascites, or other circumstances).

Intraperitoneally delivered Allocetra and SoC chemotherapy administered via PIPAC will be given to patients every six weeks. Systemic chemotherapy will also be administered per the treating oncologist’s plan. The primary endpoint is the number and severity of Allocetra-related adverse events and serious adverse events during the 16-week assessment period, starting from the first administration of study treatment. Secondary endpoints include efficacy assessments, such as best overall response rate, progression-free survival, and overall survival. Changes from baseline in macrophage and immune cell characteristics in peritoneal fluid and tissues will also be assessed as an exploratory endpoint

ABOUT ALLOCETRA

Allocetra is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as "unmet medical needs", as a stand-alone therapy or in combination with leading therapeutic agents.

Corporate presentation

On March 20, 2023 Century Therapeutics presented its corporate presentation (Press release, Century Therapeutics, MAR 20, 2023, View Source [SID1234629042]).

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