On August 24, 2023 Circio reported its first half year results 2023 (Presentation, Circio, AUG 24, 2023, View Source [SID1234634930]).

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On August 24, 2023 Laekna, Inc. (2105.HK), a science-driven, clinical-stage biotechnology company dedicated to bringing novel therapies to cancer and liver fibrosis patients worldwide, reported the interim results for the six months ended June 30, 2023, and provided the latest updates on the clinical and preclinical development of its drug candidates (Press release, Laekna Therapeutics, AUG 24, 2023, View Source [SID1234634703]).

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Dr. Chris LU, the Chairman and CEO of Laekna, Inc. said, "The first half of 2023 has been extraordinary for us. Laekna has become a publicly listed company, and our innovative product pipeline has gained recognition from investors and the capital market.

In the second half of 2023, we expect to achieve more milestones and present read-outs of several key clinical trials in major international conferences.

We truly believe that, with our innovation and persistent drive, we can bring hope to patients and create value for the market."

BUSINESS HIGHLIGHTS

– Advancing clinical trials

Afuresertib (LAE002) +Paclitaxel for PROC (PROFECTOR-II), Phase II pivotal

The patients have been fully enrolled and the topline data is expected to be available in the late fourth quarter of 2023. We will discuss with FDA and NMPA for NDA submission in the U.S. and in China, respectively, should the topline data meet the NDA criteria.

Afuresertib +Fulvestrant in HR+/HER2-breast cancer, Phase Ib/III

The patient enrollment has been completed for Phase Ib trial in April 2023. The study has showed promising early results and the results will be presented in the fourth quarter of 2023 in an academic cancer conference. We are currently in discussion with the regulatory agencies to initiate a Phase III pivotal trial.

Afuresertib +LAE001/prednisone in mCRPC, Phase II

We have completed the patient enrollment in the U.S. and in South Korea in March 2023. The study demonstrated promising treatment benefit for mCRPC patients. The study readouts will be presented in the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023. A following pivotal trial design will be discussed with the regulatory agencies.

Afuresertib +LAE005+nab-paclitaxel in TNBC, Phase I

We have completed the dose escalation phase and determined RP2D. The study demonstrated promising treatment benefit for TNBC patients, and the detailed results will be orally presented in the Chinese Society of Clinical Oncology (CSCO) 2023.

Afuresertib +Sintilimab+paclitaxel in CC and EC, Phase I

We have completed three out of four cohorts of the dose escalation study and have observed high response rate in cervical cancer (CC) and endometrial cancer (EC) patients who have been treated up to 3 lines of SOCs including PD-1 drugs and/or chemotherpy.

– Discovery of preclinical candidates

LAE102 IND approval

LAE102 is our first internally discovered antibody. We have obtained the IND approval from FDA in May 2023. We will first investigate LAE102 in cancer indications, and will explore LAE102 late on in other disease indications, such as obesity and metabolic diseases, pulmonary arterial hypertension, etc.

Pre-clinical candidates (PCC) declaration

We have advanced three PCC drug candidates from our internal discovery platform: LAE111, a LILRB1 and LILRB2 bispecific antibody; LAE113, a TIGIT-PVRIG bispecific antibody; and LAE112, a FGFR2b monoclonal antibody.

EXPECTED UPCOMING MILESTONES

Presenting Afuresertib+LAE005+nab-paclitaxel Phase I clinical study results as an oral presentation at the CSCO 2023 in Xiamen, China in September 2023.
Presenting Afuresertib+LAE001 Phase I/II clinical study results as a poster presentation at the ESMO (Free ESMO Whitepaper) 2023 in Madrid, Spain in October 2023.
Presenting LAE111/LILRB1-2 bispecific antibody as a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 38th annual meeting in San Diego, California, U.S., in November 2023.
Presenting LAE113/TIGIT/PVRIG bispecific antibody as a poster presentation at the SITC (Free SITC Whitepaper) 38th annual meeting in San Diego, California, U.S., in November 2023.
Presenting Afuresertib+fulvestrant Phase Ib clinical study results in the fourth quarter of 2023.
FINANCIAL HIGHLIGHTS

As of June 30, 2023, the Company’s cash and cash equivalents amounted to RMB837million and total assets amounted to RMB1,063million. We remained committed to investing in research and development, with research and development expenses totaling RMB102million for the six months ended June 30, 2023.

On August 24, 2023 Xcell Biosciences Inc. (Xcellbio), an instrumentation company focused on cell and gene therapy applications, reported that it has achieved key milestones in its R&D collaboration with Labcorp, a global leader of innovative and comprehensive laboratory services, aimed at driving innovation in the development and validation of cell and gene therapies (Press release, Xcell Biosciences, AUG 24, 2023, View Source [SID1234634692]). Those milestones include jointly generated results that have supported new intellectual property filings and data presented at scientific meetings.

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The collaboration between Xcellbio and Labcorp, announced last year, was established to facilitate joint projects focused on improving the safety and efficacy of cell and gene therapies. The projects included in the collaboration use Xcellbio’s proprietary AVATAR platform to metabolically reprogram tumor-targeting CAR T cells to enhance their potency and persistence in the suppressive solid tumor microenvironment (TME). The function of these cells is being tested on Xcellbio’s TME-reprogrammed tumor cell lines, which serve as a more physiologically representative platform for tumor-killing assays compared to standard tumor cell lines.

The collaboration has yielded data readouts that have been jointly submitted in intellectual property filings and publicly presented through two posters at the 2023 annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). These data include demonstrations of enhanced CAR T cell expansion, viral transduction, and potency as a result of utilizing the AVATAR platform. The observations were initially made in vitro and are now being validated through in vivo mouse studies to confirm the efficacy and translatability of the findings.

"Our work with Labcorp has demonstrated a significant leap in understanding how metabolic conditioning can dramatically affect cell therapy behavior, particularly within the solid tumor microenvironment," said James Lim, Ph.D., Co-Founder and Chief Scientific Officer at Xcellbio, who is leading the study. "These preclinical studies are designed to assess the safety and efficacy of cell and gene therapies to support future programs that would develop or validate therapies for use in patients."

Recently, the collaboration has expanded to include the exploration of cell types beyond CAR T cells to accelerate the discovery and development of novel therapies. Labcorp will use Xcellbio’s AVATAR platform to support the development of cell-based potency assays that incorporate critical TME factors, as well as the clinical manufacture of therapeutic cells that are metabolically reprogrammed for enhanced in vivo potency.

"We are thrilled with the outcomes achieved so far through our collaboration with Xcellbio and the significant strides we have made together in advancing cell and gene therapy research," said Maryland Franklin, Ph.D., Vice President and Enterprise Head of Cell and Gene Therapy at Labcorp. "The expansion of our partnership to include other cell types further showcases our shared commitment to driving innovation in therapeutic development."

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.