On August 24, 2023 Agilent Technologies Inc. (NYSE: A) reported the issuing of a companion diagnostic (CDx) Class C IVDR certification for PD-L1 IHC 22C3 pharmDx, Code SK006 (Press release, Agilent Technologies, AUG 24, 2023, View Source [SID1234634691]). This CDx assay has previously been CE-IVD–marked for sales in the European Union and is now certified in accordance with the new EU Regulation for in vitro diagnostic medical devices (IVDR).

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PD-L1 IHC 22C3 pharmDx, Code SK006, is indicated as an aid in identifying certain cancer patients for treatment with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, and Regeneron’s anti-PD-1 therapy LIBTAYO (cemiplimab). The IVDR certification covers five CDx cancer indications for KEYTRUDA: non-small cell lung cancer (NSCLC), urothelial carcinoma, head and neck squamous cell carcinoma, esophageal cancer, and triple-negative breast cancer (TNBC). Furthermore, the IVDR certification covers NSCLC for LIBTAYO.

Substantial technological and scientific progress in the medical device sector over the last 20 years has highlighted an important need for updated regulations to help ensure the continued safety and performance of a wide range of medical devices. IVDR compliance certification enhances the confidence of healthcare professionals and patients in the EU by showing that these medical devices can be safely relied upon in diagnostic workflows.

PD-L1 is a critical biomarker for response to anti-PD-1 therapy, and Agilent’s PD-L1 IHC 22C3 pharmDx is widely used by pathology laboratories to identify cancer patients eligible for treatment. At the same time, oncologists are increasingly selecting patients for treatment with anti PD-1 therapies in indications across a growing range of cancer types. This IVDR certification allows healthcare professionals and patients to continue to benefit from the assay without disruption to critical diagnostic capabilities in established indications.

Sam Raha, president of Agilent’s Diagnostics and Genomics Group, commented on the importance of this announcement: "CDx assays are critical diagnostic products for pathology laboratories as they support cancer patients who could benefit from targeted therapies."

Jenipher Dalton, senior vice president of Agilent’s Global Quality and Regulatory Affairs, added: "With this IVDR certification of a Class C-CDx device, Agilent remains committed to continuously supporting laboratories in Europe with high-quality solutions for the benefit of healthcare professionals and patients."

As an innovative industry leader with more than 50 years’ experience, Agilent launched the first FDA-approved companion diagnostic and continues to deliver world-class CDx products in close collaboration with pharma partners.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
LIBTAYO is a registered trademark of Regeneron Pharmaceuticals, Inc.

On August 24, 2023 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that the Compensation Committee of its Board of Directors granted, between the dates of May 15, 2023 and August 15, 2023, non-qualified stock options to purchase an aggregate of 43,000 shares of its common stock and restricted stock units (RSUs) covering an aggregate of 24,500 shares of its common stock to sixteen new employees under Personalis’ 2020 Inducement Plan (Press release, Personalis, AUG 24, 2023, View Source [SID1234634690]).

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The 2020 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee, or non-employee director, of Personalis, as an inducement material to such individual’s entering into employment with Personalis, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. Personalis is making this announcement as required by Nasdaq rules.

All of the inducement stock options were granted on August 15, 2023 and have an exercise price of $1.81 per share, which is equal to the closing price of Personalis’ common stock on the grant date. The inducement stock options vest over four years, with 25% of the shares vesting on the first anniversary of the grant date and 1/36th of the remaining shares vesting monthly thereafter, subject to continued service through each applicable vesting date. The inducement RSUs vest over four years, with 25% of the shares vesting on the first anniversary of the vesting commencement date (which is typically the grant date) and an additional 25% of the shares vesting annually thereafter, subject to continued service through each applicable vesting date. The foregoing inducement awards are subject to the terms and conditions of Personalis’ 2020 Inducement Plan, and the terms and conditions of the applicable award agreement covering each grant.

On August 24, 2023 XNK Therapeutics AB ("XNK") reported that the company has entered into a research collaboration with the Karolinska University Hospital, Sweden, to evaluate the suitability of the company’s autologous natural killer (NK) cell therapy candidate XNK02 as a novel therapy for treatment of acute myeloid leukemia (AML) (Press release, XNK Therapeutics, AUG 24, 2023, View Source [SID1234634689]).

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In collaboration with Karolinska University Hospital, XNK will perform a large-scale bioreactor culture study of AML patients’ immune cells. These cells will be activated and expanded using XNK’s proprietary technology. The study aims to further investigate the expansion procedure (NK cell growth) and to study the properties of the expanded NK cells with respect to their ability to kill the patient’s own tumor cells ex vivo.

"We look forward to conducting this important study together with the group of Dr Martin Jädersten, Medical lead for AML at the Karolinska University Hospital. The study will evaluate our product candidate XNK02 as a novel therapy for patients with AML, for which new treatment modalities are desperately needed," said Dr Tim D’Alessandri, senior scientist and project leader at XNK.

The research collaboration complements the current collaboration with the University of Texas MD Anderson Cancer Center to study XNK02 in AML patient material from various stages of the disease.

Acute Myeloid Leukemia (AML)

AML is the most common form of acute leukemia in adults. Globally, close to 200,000 new patients are diagnosed and about 150,000 will die from AML each year. In AML, the bone marrow produces a large number of abnormal immature blood cells, so called blasts, that can overcrowd the bone marrow and interfere with the production of healthy mature blood cells. This results in, for example, infections and anemia. The blasts can also spread to other parts of the body, including the central nervous system.

Current treatments include chemotherapy, radiation therapy, stem cell transplantation and targeted therapy such as kinase inhibitors and monoclonal antibodies. The overall outcome for patients remains poor, relapse is common and 5-year survival rates are around 30%.

For more information, please contact:

Johan Liwing, CEO, XNK Therapeutics
Tel: +46 706 70 36 75
E-mail: [email protected]

On August 24, 2023 Carisma Therapeutics Inc. (Nasdaq: CARM) ("Carisma" or the "Company"), a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, reported that the Company will present at two healthcare industry conferences in September 2023 (Press release, Carisma Therapeutics, AUG 24, 2023, View Source [SID1234634688]). These conferences include:

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8th Annual CAR-TCR Summit

Michael Klichinsky, PharmD, PhD, Co-Founder and Chief Scientific Officer, will give a presentation during the summit.
"CAR-M: Pioneering a Novel Approach for Solid Tumor Immunotherapy"
Friday, September 1, 2023 at 9:20 am ET
Boston, Massachusetts

CAR-T Consortia Seminar

Michael Klichinsky, PharmD, PhD, Co-Founder and Chief Scientific Officer, will give a presentation during the meeting.
"CAR Macrophages"
Tuesday, September 19, 2023 at 12:00 pm ET
Virtual
A replay of webcasts, when available, will be posted and archived at Carisma’s Investor Events webpage for a limited time following the event.

On August 24, 2023 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that the Company will participate in the Citi Annual BioPharma Conference in Boston (Press release, Jazz Pharmaceuticals, AUG 24, 2023, View Source [SID1234634687]). Company management will participate in a fireside chat on Thursday, September 7, 2023, at 8:20 a.m. PT / 11:20 a.m. ET / 4:20 p.m. IST.

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An audio webcast of the presentation will be available via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. A replay of the webcast will be archived on the website for 30 days.