Savara to Present at Jefferies Healthcare Conference

On June 1, 2022 Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported that its management team will present at the Jefferies Healthcare Conference on June 8, 2022 at 1:00 pm ET in New York City (Press release, Savara, JUN 1, 2022, View Source [SID1234615446]). A live webcast of the presentation will be available on Savara’s website at www.savarapharma.com/investors/events-presentations/ and will be archived for 90 days.

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Ipsen Initiates a Share Buy-Back Program to Cover Its Employee Free Share-Allocation Plan

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.

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. and Levena Biopharma, a Sorrento Company, are to Present Positive Clinical Progress of A166, an Anti-HER2 ADC, in Treating Locally Advanced or Metastatic HER2-Positive Breast Cancer Patients at the ASCO 20

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

Monteris Medical Announces Publication of Largest Cohort to Date of LITT for Treating Most Aggressive Brain Tumor

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.

Cambrex Acquires Leading EU Stability Storage Company Q1 Scientific

On June 1, 2022 Cambrex, a leading global contract development and manufacturing organization (CDMO) providing drug substance, drug product, and analytical services across the entire drug lifecycle, reported the acquisition of Q1 Scientific – a leading provider of environmentally-controlled cGMP stability storage services for the pharmaceutical, medical device and life science industries, strategically located in Waterford, Ireland (Press release, Cambrex, JUN 1, 2022, View Source [SID1234615344]).

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"Stability storage and testing is a critical component of drug development and commercialization of new therapies. Q1 Scientific brings world-class capabilities to our ever-expanding portfolio of outsourced pharmaceutical services." said Tom Loewald, CEO, Cambrex. "This acquisition is a natural extension of our current offerings that will broaden and increase our expertise in this critical area, as well as our footprint in the European market."

Q1 Scientific’s state-of-the-art cGMP facility is ICH validated to meet the specific storage requirements of any pharmaceutical project, with options from -80 C storage up to +50 C, with a full range of humidity control. The 20,000 sq. ft. Waterford facility boasts nearly 40 walk-in stability storage chambers, reach-in freezers and stability units, and ultra-low temperature freezers for biologic therapies. The company also provides sample management and transport services.

"We’re pleased to join Cambrex as we continue to provide leading stability storage services to our current customers," said Stephen Delaney, CEO, Q1 Scientific. "With Cambrex’s scientific expertise and scale, we’ll be able to accelerate our growth and offer an integrated suite of analytical services, providing a full range of market-leading solutions for our customers."

Cambrex offers a variety of storage and testing capabilities with walk-in and reach-in chambers that meet the ICH Q1A requirements. The acquisition will expand Cambrex’s capabilities into the European market.

As pharmaceutical and biopharmaceutical companies continue to seek outsourcing options for non-core capabilities to reduce their footprint, Q1 Scientific’s stability storage services, combined with Cambrex’s industry-leading analytical services portfolio, provide specialized capabilities of high value to the industry.