On June 2, 2022 Caris Life Sciences(Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, the Prostate Cancer Clinical Trial Consortium (PCCTC) and Sorrento Therapeutics, Inc. (NASDAQ: SRNE), a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19, reported a strategic collaboration to guide more precise treatment decisions for patients with advanced prostate cancer (Press release, Caris Life Sciences, JUN 2, 2022, View Source [SID1234615480]).

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"The vast majority of men with prostate cancer do not have their tumors molecularly profiled, in part because of the limited targeted therapy options available for this disease," said Brian Lamon, Ph.D., Chief Business Officer at Caris Life Sciences. "We are very pleased to partner with the PCCTC to leverage our industry-leading precision medicine technologies and maximize the potential of molecular learnings from Sorrento’s Maverick trial to positively impact the future of cancer treatments and drive better outcomes for patients with prostate cancer."

The PCCTC was formed to address critically unmet needs in prostate cancer, with a mission to design, implement and complete early-phase process driven clinical trials and translate scientific discoveries to improved standards of care. The Phase 2 Maverick trial

(ClinicalTrials.gov Identifier: NCT05361915) is sponsored by Sorrento and managed by the PCCTC. Utilizing Caris’ unique MI Profile, PCCTC investigators will profile whole exome DNA, whole transcriptome RNA, and proteins from samples collected from participants enrolled in the trial, creating a molecular blueprint to better understand mechanisms of response and resistance following therapy.

Maverick investigator Rana R. McKay, M.D. of the University of California San Diego (UCSD) noted, "This study is the first biomarker clinical trial for patients with the HSD3B1 adrenal-permissive genotype in men with metastatic castration resistant prostate. A growing wave of data demonstrates that such patients exhibit resistance to hormonal treatment. This study tests the efficacy and safety of avibertinib plus abiraterone in this vulnerable patient population." UCSD is one of 67 member sites of the Caris Precision Oncology Alliance, a growing network of leading cancer centers across the globe that collaborate to advance precision oncology and biomarker-driven research.

"We are excited to partner with Caris and utilize their next generation sequencing platform and data analytics capabilities to evaluate treatment response and resistance patterns in this study," added Jake Vinson, Chief Executive Officer at the PCCTC. "Through this collaboration, we hope to gain knowledge to better guide treatment options for future clinical trial participants, and ultimately all patients with prostate cancer."

Since the launch of its molecular profiling service in 2009, Caris has amassed molecular data on more than 378,000 patients and real-world clinical outcomes on more than 275,000 patients. Caris has the most advanced sequencing laboratories in the world, which allows the company to perform whole exome DNA sequencing and whole transcriptome RNA sequencing on every patient. Caris’ data-driven, molecular insights are changing the landscape of precision medicine with actionable insights from retrospective, epidemiologic and real-time molecular data to enhance research and commercial activities.

On June 2, 2022 Sihuan Pharma and CTTQ-Akeso (Shanghai) Biomed reported that it will cooperate to test Sihuan’s AXL inhibitor paired with CTTQ-Akeso’s anti-PD-1 in patients with solid tumors (Press release, Sihuan Pharmaceutical, JUN 2, 2022, View Source [SID1234615498]). Xuanzhu Biopharm, the novel drug subsidiary of Sihuan, has already been approved to start China trials of its AXL inhibitor in advanced solid tumors and hematological malignancies. CTTQ-Akeso was approved to launch its PD-1 (penpulimab), a product co-developed by Sino Bio and Akeso, as a third-line therapy for Hodgkin’s lymphoma. The companies plan to test the combination in patients with non-small cell lung cancer

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On June 1, 2022 Ipsen (Euronext: IPN; ADR: IPSEY) reported that it has appointed an investment-services provider to purchase 125,000 Ipsen S.A. shares, or about 0.15% of the share capital, over a maximum period of three months (Press release, Ipsen, JUN 1, 2022, View Source [SID1234615290]). The shares purchased under this agreement will be allocated mainly to cover its employee free share-allocation plan.

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This program is made pursuant to the authorization granted by the Combined Shareholders’ meeting, held on May 24th, 2022.

On June 1, 2022 Sichuan Kelun-Biotech Biopharmaceutical Co, Ltd. ("Kelun-Biotech") and Levena Biopharma ("Levena"), a subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), reported the planned presentation of A166 data (Abstract #1037 and Poster #415) in patients with HER2-expressing locally advanced or metastatic solid tumors at the 2022 Annual Meeting of ASCO (Free ASCO Whitepaper), the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), to be held on June 3-7 in Chicago, IL (Press release, Sorrento Therapeutics, JUN 1, 2022, View Source [SID1234615311]). A166 is a HER2 antibody-drug conjugate (ADC) developed by Kelun-Biotech in a partnership with Levena Biopharma, which provided the patent-protected technologies for the generation and production of A166 in relation to (1) Duostatin-5, a proprietary tubulin inhibitor, (2) K-Lock, a site-specific conjugation technology, and (3) an enzymatically cleavable linker.

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As previously reported, in Phase 1 of the study, A166 demonstrated a safety profile that compared favorably to its commercial competitors and potentially superior efficacy as shown by the overall response rate (ORR) of 59.1% and 71.4% in the 4.8 mg/kg cohort and 6.0 mg/kg cohort, respectively, in heavily pretreated patients with HER2-positive breast cancer (data presented at the 2021 ASCO (Free ASCO Whitepaper) meeting [NCT05311397; J Clin Oncol 39, 2021 (suppl 15; abstr 1024)].

At the upcoming 2022 ASCO (Free ASCO Whitepaper) meeting, Kelun-Biotech will report updated data from this Phase 1 trial (Abstract #1037 and Poster #415). The Phase 1 dose expansion of the study was conducted in several sites in China and enrolled a total of 58 female patients (n=23 at 4.8 mg/kg and n=35 at 6.0 mg/kg) treated with A166 in 3-week cycles.

The best ORR was 73.9% (17/23; 95% CI, 51.59 to 89.77) in the 4.8 mg/kg cohort and 68.6% (24/35; 95% CI, 50.71 to 83.15) in the 6.0 mg/kg cohort.
Median progression free survival (PFS) was 12.3 months (95% CI, 6.00-not reached) in the 4.8 mg/kg cohort and 9.4 months (95% CI, 4.00 to 10.40) in the 6.0 mg/kg cohort.
Of 23 patients treated in the 4.8 mg/kg cohort, one had a confirmed and sustained CR lasting 7+ months.
Next generation sequencing was performed on tissue-derived DNA and blood-derived circulating tumor DNA.
The detailed safety data, RECIST 1.1 response rate, and biomarker analyses will be presented in a poster (#415) at the 2022 ASCO (Free ASCO Whitepaper) meeting

On June 1, 2022 Monteris Medical reported that a paper on laser interstitial thermal therapy (LITT) for patients diagnosed with IDH wild–type glioblastoma, the most common and aggressive tumor originating in the brain, has been published in the journal, Neuro- Oncology Advances (Press release, Monteris Medical, JUN 1, 2022, https://www.monteris.com/press-releases/monteris-medical-announces-publication-of-largest-cohort-to-date-of-litt-for-treating-most-aggressive-brain-tumor/ [SID1234615327]). The data on 89 patients collected through the LAANTERN prospective, multi-center registry, showed that LITT offers an effective alternative to traditional surgery for patients with newly diagnosed and recurrent glioblastoma while also delivering the benefits of a minimally invasive surgical procedure, including short recovery time and reduced potential for side effects.

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The publication demonstrated that for newly diagnosed patients treated with LITT followed by standard of care chemotherapy and radiation, overall survival (16.14 months) and progression free survival (11.93 months) are comparable to published outcomes where traditional surgery was used. For patients with recurrent disease, no standard of care is currently established; however, this study showed median post-LITT survival of nearly nine months, compared to the range of 5-13 months observed for traditional surgery. In addition, the functional status of patients stabilized or improved at one month post-LITT.

IDH (isocitrate dehydrogenase – a genetic mutation) wild-type glioblastomas require immediate intervention. With standard of care therapy, median overall survival for glioblastoma is estimated at 15-18 months with fewer than 10% of patients alive at five years. Other molecularly defined gliomas may be less prevalent than IDH wild-type, but they are known to have longer survival rates. Therefore, it is becoming increasingly important to stratify research by sub-type and molecular characteristics to control for the variability in survival rates across all glioma types.

Dr. John de Groot, lead author of the paper and division chief of neuro-oncology at the University of California San Francisco Weill Institute for Neurosciences, said, "For patients with glioblastoma, treatment options are limited, especially for those with recurrent disease. These data clearly demonstrate that LITT remains a critical tool for achieving maximal safe cytoreduction of the tumor and is especially effective when followed by chemotherapy and radiation. The minimally invasive nature of LITT, short recovery, and favorable side effect profile make LITT a safe and effective option."

About 25,000 primary brain tumors are diagnosed in the United States each year. Of these, about 15% are glioblastomas. Those glioblastomas that are moleculary-defined as IDH wild-type tend to grow rapidly and have a worse prognosis than other tumor types.

Martin J. Emerson, president and chief executive officer of Monteris, said, "Congratulations to the LAANTERN physicians and their research teams on the publication of this essential study on LITT and primary brain tumors. We are so grateful to the patients that gave their time and energy to participate in this study. The collective body of evidence that continues to emerge in support of laser ablation has firmly established LITT’s position in the care continuum for appropriate brain tumor and epilepsy patients."

About LAANTERN

LAANTERN is a post-market study designed to evaluate the performance and utilization of the NeuroBlate System in the standard of care, "real-world" setting. This is the first prospective multicenter laser ablation study. All sites operate under an IRB-approved protocol and undergo rigorous data management and monitoring practices to ensure data quality and consistency. The registry will follow up to 3,000 patients for five years evaluating safety, quality of life, health economics and procedural outcomes, including survival and seizure freedom.