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.

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.

On June 1, 2022 aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines from its proprietary tRNA synthetase biology platform, reported that Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer, will present a corporate overview at the 2022 Jefferies Healthcare Conference, which is scheduled to take place June 8 – 10, 2022, in New York, NY (Press release, aTyr Pharma, JUN 1, 2022, View Source [SID1234615364]).

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Dr. Shukla will present on Wednesday, June 8, 2022, at 10:00am EDT.

In addition to the presentation, company management will be available to participate in one-on-one meetings with investors who are registered attendees of the conference. A webcast of the event will be available on the Investor’s section of the company’s website at www.atyrpharma.com. Following the event, a replay of the presentation will be available on the aTyr website for at least 30 days.

On June 1, 2022 Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, reported the presentation of preclinical data supporting further investigation of a rationally designed microbial consortium candidate (DE486) to prevent or treat gastrointestinal (GI) mucositis – a common and often painful complication of radiation and chemotherapy involving the breakdown of the rapidly-dividing epithelial cells lining the GI tract (Press release, Seres Therapeutics, JUN 1, 2022, businesswire.com/news/home/20220601005127/en/Seres-Therapeutics-Presents-Microbiome-Therapeutic-Research-at-the-2022-American-Society-of-Clinical-Oncology-ASCO-Annual-Meeting [SID1234615380]). These results are available online as part of the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

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"Microbiome-based therapeutics may offer a potentially novel approach to mitigate debilitating side-effects that can lead to delays or dose reductions of life-saving cancer treatments," said Matthew Henn, Ph.D., Chief Scientific Officer at Seres. "This microbial consortium builds on our scientific and clinical data, and we are encouraged by these preclinical results that suggest potential areas of investigation and future development opportunities for this new area of medicine."

In laboratory experiments, chemotherapy caused mice to develop mucositis of the small intestine and rapidly lose weight. Treatment with a defined consortium of microbes from Seres’ proprietary strain library was shown to reduce inflammation and restore the mice to their normal weight after about a week. In contrast, treating mice with a different microbial cocktail that was intentionally selected to include pro-inflammatory bacteria that may be found in cancer patients with a disrupted microbiome was observed to have the opposite effect, resulting in continued weight loss.

These data support the potential of specifically designed combinations of microbes to minimize damage done to the lining of the GI tract by cancer treatment as a strategy to prevent or manage GI mucositis.

Seres will also present a poster on June 4 at 8:00-11:00 AM CDT detailing the design of an early Phase 1b trial evaluating the efficacy, safety and pharmacokinetics of SER-155 in adults undergoing allogeneic hematopoietic stem cell transplantation (HSCT). SER-155 is a cultivated investigational microbiome therapeutic rationally designed to improve clinical outcomes in patients undergoing HSCT by restoring colonization resistance to pathobionts, promoting epithelial barrier integrity, and reducing colonic inflammation. In addition to SER-109, SER-155 represents Seres’ second active development program in its Infection Protection franchise.

Another poster presentation on June 4 at 1:15-4:15 PM CDT will reprise Phase III trial results of SER-109, an investigational microbiome therapeutic for recurrent C. difficile infection (rCDI). The data showed SER-109 was associated with lower recurrence rate vs. placebo regardless of baseline comorbidity score category. This suggests SER-109 has a side effect profile comparable to placebo and may significantly reduce rCDI rates, which disproportionately affect cancer patients.

Phase 1b Study of SER-155 in Stem Cell Transplant

Hematopoietic stem cell transplant (HSCT) is frequently used to treat lymphoma, leukemia and multiple myeloma or for people who received high doses of chemotherapy or radiation that damaged their bone marrow. While it can be curative, stem cell transplant also carries the risk of life-threatening complications.

A Phase 1b clinical trial (NCT04995653) is now enrolling adults undergoing allogeneic HSCT to test whether the investigational microbiome therapeutic SER-155 is safe and effective at preventing graft-versus-host disease, blood infections and other serious complications.

The trial is designed to enroll 10 participants in an initial open-label cohort to gauge safety. Then, an additional 60 adults will be enrolled into a double-blind, randomized, placebo-controlled arm to assess efficacy. Participants in the second cohort will receive either vancomycin followed by SER-155 or placebo. Adverse events and microbiome samples will be logged for the first year following stem cell transplantation.

Phase 3 ECOSPOR III Study of SER-109 Data Encore

Cancer patients are at greater risk of developing rCDI and tend to have worse outcomes, due to their weakened immune system and frequent antibiotics exposure.i

Encore data from the completed double-blind, randomized, placebo-controlled Phase 3 ECOSPOR III trial (NCT03183128) show that the investigational microbiome therapeutic SER-109 significantly reduced rCDI rates. SER-109 was also observed to be well tolerated, with a safety profile comparable to placebo and no serious drug-related adverse events observed. From 4 weeks post-treatment through 24 weeks, adults with a history of rCDI had fewer recurrences after taking SER-109 compared with those who received placebo.

Seres expects to finalize a Biologics License Application (BLA) submission for SER-109 with the U.S. Food and Drug Administration (FDA) in mid-2022, with an anticipated launch in the first half of 2023, if approved. SER-109 has obtained FDA Breakthrough Therapy and Orphan Drug Designations, supporting the expectation of an expedited review timeline.

About SER-155
SER-155, an oral consortium of cultivated bacteria, is a microbiome therapeutic candidate in clinical development. SER-155 is designed using microbiome biomarker data from human clinical data, human cell-based assays, and in vivo disease models, with the aim to decrease infection and translocation of antibiotic-resistant bacteria in the gastrointestinal tract and modulate host immune responses to decrease GvHD. The rationale for this program is based in part on published clinical evidence from Seres’ collaborators at Memorial Sloan Kettering Cancer Center showing that allogeneic HSCT patients with decreased diversity of commensal microbes are significantly more likely to die due to infection and/or lethal GvHD. SER-155 was developed using Seres’ reverse translational discovery platform to potentially reduce incidences of gastrointestinal infections, bloodstream infections and GvHD in immunocompromised patients, including in patients receiving allogeneic HSCT or solid organ transplants.

About SER-109
SER-109 is an oral microbiome therapeutic candidate consisting of a consortium of highly purified Firmicutes spores, which normally live in a healthy microbiome. SER-109 is designed to prevent the recurrence of CDI by restructuring the microbiome to a state that resists C. difficile colonization and growth. The SER-109 manufacturing purification process is designed to remove unwanted microbes, thereby reducing the risk of pathogen transmission beyond donor screening alone. The FDA has granted SER-109 Breakthrough Therapy designation and Orphan Drug designation for the prevention of rCDI.