Viome Life Sciences Announces Expansion of Collaboration with GSK into new therapeutic interventions for Cancers and Autoimmune Diseases

On October 20, 2021 Viome Life Sciences, a mission-driven systems biology company aiming to help individuals improve their health, reported the expansion of its two-year partnership with GSK, a science-led global healthcare company, to expand clinical research activities1 and potential development of new therapeutic interventions within the fields of chronic diseases including autoimmune diseases and cancers (Press release, GlaxoSmithKline, OCT 20, 2021, View Source [SID1234591621]). This expansion builds on a previously announced collaboration to research the prevention of specific chronic diseases, leveraging Viome’s proprietary microbiome analysis and artificial intelligence platforms and GSK’s expertise in immunology.

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"Most chronic disorders are treated with drugs targeting symptoms and not causes. Viome’s unique mRNA technology and state-of-the-art artificial intelligence platform have the potential to find the root causes of specific chronic disorders and cancers. With that critical information and the unique expertise of GSK, we aspire to one day cure these diseases and not just manage the symptoms," said Viome CEO and Founder, Naveen Jain. "We are excited to expand our collaboration with GSK to develop preventative and therapeutic measures for chronic diseases and cancers."

The gut microbiome is well recognized for its ability to shape immune fitness, with nearly 70-80% of the immune system housed inside the gut microbiome2 [PubMed]. A healthy gut microbiome supports the immune system, which is connected to an individual’s overall well-being, weight, energy, mood, and stress. Imbalances in the gut microbiome have been associated with inflammation and chronic diseases ranging from gastrointestinal inflammatory and metabolic conditions to neurological, cardiovascular, and respiratory illnesses3 [NCBI]. Through this collaboration, Viome and GSK will examine the connection between the gut microbiome and specific chronic disorders by performing a clinical validation trial. The overall objective of the collaboration aims to advance viable health interventions for the many diseases that continue to threaten individuals, families, and communities around the world.

"A better understanding of the interactions between the immune system and microbiome – which have been shown to have a significant impact on human health – has been part of GSK’s innovation strategy," said Rino Rappuoli, Head of R&D Vaccines, GSK. "By combining our robust expertise in immunology with Viome’s unique technology with its proprietary mRNA analysis and artificial intelligence platform, we look forward to uncovering additional key insights into chronic diseases."

Through this partnership, GSK and Viome will continue to examine chronic diseases that are without treatment and will work to develop much-needed new targets for potential interventions. GSK and Viome understand the potential of the gut microbiome to influence an individual’s immune system and determine the effectiveness of health interventions and will tap into Viome’s extensive research and findings as well as GSK’s expertise to accomplish this. Viome is committed to creating a world where chronic diseases could truly be prevented before they cause significant problems.

NeoTX Announces First Patient Enrolled In Phase 2a Clinical Trial Of Naptumomab Estafenatox (NAP), Its Lead Tumor Targeted Superantigen (TTS) Candidate, In Combination With Docetaxel In Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

On October 20, 2021 NeoTX Therapeutics (NeoTX), a clinical-stage immuno-oncology company, reported that the first patient has been enrolled in the company’s phase 2a clinical trial of naptumomab estafenatox (NAP), its lead Tumor Targeted Superantigen (TTS) candidate, in combination with docetaxel in patients with advanced non-small cell lung cancer (NSCLC) (Press release, NeoTX, OCT 20, 2021, View Source [SID1234591620]).

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"Dosing of the first patient in this phase 2 trial represents a crucial step forward for the clinical advancement of NAP" said Asher Nathan, Ph.D., chief executive officer of Neo TX. "This trial is based on promising phase 1 data. NSCLC is one of the deadliest cancers, and we are looking forward to evaluating NAP in this setting".

The phase 2a, open label trial in the US, will assess NAP in combination with docetaxel in patients who had been previously treated with checkpoint inhibitors and have advanced or metastatic NSCLC. The primary endpoint is objective response rate as measured by RECIST 1.1 criteria. The trial will also evaluate safety, duration of response, progression free survival, overall survival, pharmacokinetics, and pharmacodynamics. For more information about the trial, visit View Source

Lightpoint Medical to Present Positive Clinical Trial Data for SENSEI Miniature Gamma Probe in Prostate Cancer Surgery

On October 20, 2021 Lightpoint Medical, a leading medical device company developing and marketing innovative technologies for intra-operative cancer detection, reported that clinical trial results today to support the use of the company’s miniature surgical gamma probe, SENSEI, in prostate sentinel lymph node detection (Press release, lightpoint medical, OCT 20, 2021, View Source [SID1234591619]).

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The interim results from the multi-center clinical trial, which involves cancer centers at Hospital del Mar, Barcelona, Spain; Institut Paoli-Calmettes, Marseille, France; and UZ Leuven, Belgium; demonstrate a 100% detection rate of sentinel lymph nodes using SENSEI in minimally-invasive and robot-assisted prostate cancer surgery.

The results also indicate that SENSEI performed better than standard rigid gamma probes, as SENSEI found additional pelvic sentinel nodes in anatomically restricted areas which could not be detected by the rigid gamma probe. The final study results, expected in Q1 2022, will provide further insights into the performance differences between SENSEI and rigid gamma probes.

The trial results will be presented today at the Annual Congress of the European Association of Nuclear Medicine.

The clinical trial results demonstrate the ease of use and performance of SENSEI in prostate cancer surgery and signal potential application in other surgical procedures across major cancer types.

Principal Investigator, Dr. Lluís Fumadó, Hospital del Mar, Barcelona said "These clinical trial results demonstrate that the use of SENSEI in prostate cancer surgery dramatically enhances our surgical management of prostate cancer patients and is shown to effectively detect sentinel lymph nodes. We look forward to using SENSEI in more procedures and evaluating the probe in combination with the new targeted imaging agent, 99mTc-PSMA, for direct detection of disease metastasis in pelvic lymph nodes."

Lightpoint Medical CEO, Graeme Smith, added "There are active clinical studies at multiple cancer centers evaluating SENSEI in prostate, cervical, and colorectal cancer with studies in lung and endometrial cancer in the pipeline. These positive and highly encouraging results from our multi-center study evaluating SENSEI in prostate cancer surgery demonstrate the ease of use and performance of SENSEI and signal potential application in other major cancer types to detect cancer intra-operatively. All of us at Lightpoint Medical are incredibly grateful to Dr. Lluís Fumadó and the team at Hospital del Mar for leading this study and to all the clinical centers and patients who are working with us."

About SENSEI

Lightpoint Medical has developed SENSEI – a miniaturized surgical gamma probe for minimally-invasive and robot-assisted cancer surgery. The device is approved for sale in the US, EU, UK, and Australia. SENSEI can detect gamma emissions from radiopharmaceuticals. The first application of the device is sentinel lymph node detection in prostate and cervical cancer surgery. It is anticipated that SENSEI will also have application in the direct detection of lymph node metastasis using breakthrough imaging agents such as 99mTc-PSMA in prostate cancer surgery and in radio-guided occult lesion detection in lung cancer surgery.

About sentinel lymph node detection

The intra-operative detection of sentinel lymph nodes is necessary when performing a sentinel lymph node biopsy (SLNB) procedure. The sentinel node is the first lymph node draining from the primary tumor. By identifying and removing the sentinel node during surgery, it is possible to determine whether cancer has spread through the lymphatic system. SLNB is commonly used in multiple cancer types. However, performing SLNB in minimally-invasive and robot-assisted surgery is challenging due to usability limitations when using conventional long rigid gamma probes. SENSEI is a small, flexible gamma probe designed for minimally-invasive and robotic surgery and has the potential to improve SLNB in intra-cavity procedures such as those of the pelvis.

PTC to Announce Fiscal Q4’21 Results on Wednesday, November 3rd, 2021

On October 20, 2021 PTC (Nasdaq: PTC) reported that it will release its fiscal 2021 fourth quarter and full year results on Wednesday, November 3rd after the stock market closes. Senior management will host a live webcast and conference call to review the results on Wednesday, November 3rd at 5pm Eastern Time (Press release, PTC Therapeutics, OCT 20, 2021, View Source [SID1234591617]). The earnings press release, accompanying earnings presentation, and financial data tables will be accessible prior to the conference call and webcast on the Investor Relations section of the Company’s web site at PTC Investor Relations.

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What: PTC Fiscal Q4’21 Conference Call and Webcast

When: Wednesday, November 3rd, 2021 at 5:00pm (ET)

Webcast: View Source

Replay: To access the replay via webcast, please visit View Source.

Please note that statements made on the conference call and webcast are as of the date of the conference call and webcast and PTC does not assume any obligation to update any statements made live or the archived call. Matters discussed may include forward-looking statements about PTC’s anticipated financial results and growth, as well as about the development of products and markets, which are based on current plans and assumptions. Actual results in future periods may differ materially from current expectations due to a number of risks and uncertainties, including those described from time to time in reports filed by PTC with the U.S. Securities and Exchange Commission, including PTC’s most recent reports on Form 10-K and 10-Q.

Ionis to hold third quarter 2021 financial results webcast

On October 20, 2021 Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) reported that it will host a live webcast on Wednesday, November 3rd at 11:30 a.m. Eastern Time to discuss its third quarter 2021 financial results and report on pipeline and business progress (Press release, Ionis Pharmaceuticals, OCT 20, 2021, View Source [SID1234591616]).

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Interested parties may access the webcast at View Source A webcast replay will be available for a limited time at the same address.