Immunovant Inc IMVT

PALM BEACH, Fl, Oct. 5, 2022 /PRNewswire/ -- FinancialNewsMedia.com News Commentary - Advanced pancreatic ductal adenocarcinoma (PDAC) remains a significant cause of mortality accounting for up to 4% of all cancer-related deaths worldwide. Of concern, despite treatment, the mortality rates remain high and essentially unchanged over the last two decades. Furthermore, even in the setting of adjuvant therapy, 5-year survival rates remain poor at only 25%, while for metastatic disease it is 1%. As a consequence, there is an ongoing need for the development of improved diagnostic techniques, treatment options, and surveillance markers to improve the outcomes for this devastating disease. Researchers are continuing to improve their understanding of how to best treat PDAC.  Pancreatic ductal adenocarcinoma (PDAC) is a highly aggressive form of cancer and the most common type of pancreatic cancer. It makes up more than 90% of pancreatic cancers and leads to nearly half a million deaths per year worldwide. The yearly number of cases is expected to more than double in the next 10 years in Europe and the United States due to our aging society as well as increased rates of obesity and type 2 diabetes.  PDAC survival rates are slowly improving, but the outlook remains poor. PDAC tends to quickly spread to other body spots, and a lack of symptoms in the early stages frequently leads to late diagnosis.  PDAC tends to have a very poor prognosis compared to other cancers, but researchers are continuing to examine the best way to treat it. Survival rates have been improving slowly over time. Currently, only about 10%Trusted Source of people live at least 5 years after their diagnosis.  PDAC has the best outlook when caught in the early stages and can be removed surgically. However, only about 2%Trusted Source of cancers are diagnosed in stage 0 or 1. Researchers have found that people with stage 1 PDAC who receive surgery have a 5-year survival rate of 38.2% compared to 2.9% in people who don't get surgery.  Active biotech and pharma companies in the markets this week include Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), Senti Biosciences, Inc. (NASDAQ: SNTI), Inhibrx, Inc. (NASDAQ: INBX), Immunovant, Inc. (NASDAQ: IMVT), Autolus Therapeutics plc (NASDAQ: AUTL).

A report in the Radiation Oncology Journal said: "PDAC represents a cancer entity of extraordinarily high malignancy, particularly poor prognosis, and constantly increasing patient numbers. Its aggressive biology and the fact that most patients present in advanced or disseminated stages of disease render the development of novel PDAC treatment strategies one of the superordinate challenges in current oncological research. Results of the last 20 years have led to the establishment of a detailed multi-step model of PDAC development and progression. Although this has unquestionably reformed our understanding of PDAC as a disease, none of these findings could be successfully translated into a therapeutic breakthrough so far. It is becoming increasingly evident that the clinical performance of single-agent therapies lags behind the original expectations, and instead intelligent combinations appear to be required.  In order to improve the efficacy and the outcome of clinical PDAC treatment, it will be inevitable to develop novel treatment strategies which combine different therapeutic modalities aiming at achieving synergism."

Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS:  Oncolytics Biotech® Announces Upcoming Presentations at the Society for Immunotherapy of Cancer 37th Annual Meeting - Interim results from the phase 1/2 GOBLET study's pancreatic cancer cohort to be presented in a poster on November 11th and discussed during a key opinion leader webinar on November 14th at 10 a.m. ET - Oncolytics Biotech^® today announced the acceptance of two abstracts for poster presentations at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting, which is taking place both virtually and in-person at the Boston Convention and Exhibition Center in Boston, MA, from November 8 – 12, 2022.

Both abstracts will be published by SITC at 8:00 a.m. ET on November 7, 2022. Additional details on the abstracts and corresponding poster presentations are shown below.

Title: Pelareorep combined with atezolizumab and chemotherapy demonstrates encouraging results as first-line treatment in advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) patients – Interim results from the GOBLET study

Abstract Number: 650

Poster Session Date and Time: November 11, 2022 from 9:00 a.m. – 8:30 p.m. ET

Poster Session Location: Boston Convention and Exhibition Center, Hall C

Title: The oncolytic virus pelareorep in combination with immune checkpoint inhibitor activates T-cell functioning in early breast cancer patients – immunophenotype results from AWARE-1 study

Abstract Number: 548

Poster Session Date and Time: November 11, 2022 from 9:00 a.m. – 8:30 p.m. ET

Poster Session Location: Boston Convention and Exhibition Center, Hall C

Key Opinion Leader Webinar on Pancreatic Cancer and Interim Phase 1/2 GOBLET Study Data

Oncolytics will host a key opinion leader (KOL) webinar to discuss the current treatment landscape and unmet medical need in pancreatic cancer, as well as the interim GOBLET study results that will be presented at the SITC conference on November 14, 2022 at 10 a.m. ET. The webinar will include both formal presentations and a live question and answer session.  To register for the webinar, please click here.  CONTINUED… Read this full press release and more news for ONCY at:  https://www.financialnewsmedia.com/news-oncy/  

Other recent developments in the biotech industry of note include:

Senti Biosciences, Inc. (NASDAQ: SNTI) recently reported financial results for the second quarter ended June 30, 2022, and highlighted recent corporate accomplishments, including the selection of a lead development candidate from its SENTI-202 program with an anticipated Investigational New Drug (IND) application in 2023.

"We continued to invest in our gene circuit technology platform while advancing oncology programs toward the clinic, including two IND filings on track for 2023, the first of which we anticipate will be from our SENTI-202 program for the treatment of acute myeloid leukemia (AML). I am extremely proud of our team for their work that enabled the achievement of one of our most significant milestones to date—the selection of our first development candidate that uses CAR-NK cells engineered with Logic Gating and Multi-Arming gene circuits," said Timothy Lu, MD, PhD, Chief Executive Officer and Co-Founder of Senti Bio. "We believe that our approach to engineering gene circuits has the potential to improve the next-generation of cell and gene therapies by enhancing the specificity and efficacy of treatments for people living with cancer."

Inhibrx, Inc. (NASDAQ: INBX) recently announced that, based on discussions with the U.S. Food and Drug Administration (FDA), there is potential to pursue an accelerated approval in the U.S. for INBRX-101, an optimized recombinant human AAT-Fc fusion protein, in patients with emphysema due to alpha-1 antitrypsin deficiency (AATD) using functional alpha-1 antitrypsin (AAT) serum levels as the surrogate endpoint. Inhibrx also announced the detection of INBRX-101 in the bronchoalveolar lavage fluid (BALF) samples from all AATD patients tested in the Phase 1 study.

Inhibrx plans to initiate in the first quarter of 2023 a potential registration-enabling clinical trial using functional AAT as a surrogate endpoint with the intent to submit for regulatory approval under the FDA's Accelerated Approval Program. The FDA expressed support to collaborate and work with Inhibrx to address the regulatory challenges associated with AATD drug development. The FDA emphasized the importance of being able to demonstrate INBRX-101's ability to maintain a trough level within the normal range of AAT in healthy individuals. Based on data from the completed Phase 1 study of INBRX-101, the dosing of INBRX-101 every three or four weeks in patients with AATD is predicted to maintain patients above the lower threshold of the normal range and achieve an average level of functional AAT that approximates that of healthy non-deficient (MM genotype) adults.

Immunovant, Inc. (NASDAQ: IMVT) recently announced a new anti-FcRn, IMVT-1402, at Roivant's Investor Day at 11:00am on September 28, 2022. The presentation can be accessed at the Investor Relations section of the Company's website, located at www.immunovant.com.

"We are excited to unveil IMVT-1402, which has a combination of features that we believe could make a significant impact in the lives of people with autoimmune diseases," said Pete Salzmann, M.D., Chief Executive Officer at Immunovant. "As with batoclimab, IMVT-1402 may offer deep, potentially best-in-class IgG reduction formulated for the same simple subcutaneous route of administration delivered in a matter of seconds. Additionally, IMVT-1402 has been observed to have minimal or no impact on levels of albumin and LDL in animal studies. With these encouraging preclinical results, we are pursuing an accelerated development plan to bring IMVT-1402 to the clinic, with a Phase 1 study planned to start in early 2023 contingent on IND clearance. Importantly, our cash runway guidance into calendar year 2025 remains unchanged, as expected Phase 1 development costs for IMVT-1402, have been included," Dr. Salzmann added.

Autolus Therapeutics plc (NASDAQ: AUTL) recently announced that it has entered into an agreement with Bristol Myers Squibb (NYSE: BMY). The agreement grants Bristol Myers Squibb access to incorporate Autolus' proprietary RQR8 safety switch into an initial set of selected cell therapy programs on a target-by-target basis for the treatment of cancer, with an option for Bristol Myers Squibb to incorporate the RQR8 safety switch in additional cell therapy programs beyond the initial set of selected programs.

Managing toxicities is a critical step in the successful application of programed cell therapies. Safety switches are designed to allow the use of pharmacological agents to selectively eliminate a cell therapy in the event a patient experiences severe adverse side effects from the treatment. Autolus' proprietary RQR8 switch works by administration with the widely available and approved pharmaceutical antibody, rituximab. Once administered, rituximab binds to the engineered CD20 epitopes on the surface of the cell therapy and triggers selective cell death.

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