On September 9, 2021 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported that Selecta’s Chief Executive Officer, Carsten Brunn, Ph.D., will provide a corporate update and participate in one-on-one investor meetings at the H.C. Wainwright 23rd Annual Global Investment Conference to be held September 13-15, 2021 (Press release, Selecta Biosciences, SEP 9, 2021, View Source [SID1234587536]).

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The presentation will be available on-demand through the H.C. Wainwright conference portal, starting at 7:00 a.m. ET on Monday, September 13, 2021.

An archived webcast of the presentation will be accessible in the Investors & Media section of the company’s website at www.selectabio.com.

On September 9, 2021 Novocure (NASDAQ: NVCR) reported the United States Food and Drug Administration (FDA) has granted breakthrough designation to the NovoTTF-200T System, a Tumor Treating Fields (TTFields) delivery system intended for use together with atezolizumab and bevacizumab for the first-line treatment of patients with unresectable or metastatic liver cancer (Press release, NovoCure, SEP 9, 2021, View Source [SID1234587552]). The designation offers Novocure an opportunity to interact with FDA experts through several different program options to address regulatory topics efficiently as they arise during the premarket review phase and allows for prioritized review of regulatory submissions.

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The FDA granted breakthrough device designation in part based on clinical data from Novocure’s phase 2 pilot HEPANOVA trial testing the safety and efficacy of TTFields together with sorafenib for the treatment of advanced liver cancer. In granting the designation, the FDA determined that the TTFields delivery system for advanced liver cancer is a breakthrough technology that has the potential to be a more effective treatment for this life-threatening condition, and therefore meets the FDA’s stringent requirements for breakthrough device designation.

"We are very pleased that the FDA has granted breakthrough designation for Tumor Treating Fields together with atezolizumab and bevacizumab to treat advanced liver cancer," said Asaf Danziger, Novocure’s CEO. "Our data suggest that TTFields have the potential to extend survival in this particularly aggressive disease. We are working closely with trial investigators and intend to initiate a randomized controlled trial studying TTFields in combination with atezolizumab and bevacizumab as soon as possible."

TTFields are electric fields that disrupt cancer cell division. TTFields are intended principally for use together with other standard-of-care cancer treatments. There is a growing body of evidence that supports TTFields’ broad applicability with certain other cancer therapies, including radiation therapy, certain chemotherapies and certain immunotherapies. In clinical research and commercial experience to date, TTFields have exhibited no systemic toxicity, with mild to moderate skin irritation being the most common side effect.

Fundamental scientific research extends across two decades and, in all preclinical research to date, TTFields have demonstrated a consistent anti-mitotic effect. The TTFields global development program includes a network of preclinical collaborators and a broad range of clinical trials across all phases, included four phase 3 pivotal trials in a variety of tumor types. To date, more than 20,000 patients have been treated with TTFields.

Use of Tumor Treating Fields for the treatment of liver cancer is investigational only.

About Liver Cancer

Liver cancer is a leading cause of cancer deaths worldwide and is the sixth leading cause of cancer deaths annually in the U.S. The incidence of liver cancer is approximately 42,000 new cases annually in the U.S. The five-year survival rate with existing standards of care is less than 20%.

Hepatocellular carcinoma is the most widespread type of cancer that originates from the liver. Advanced liver cancer has spread either to the lymph nodes or to other organs and because these cancers are widespread, they cannot be treated with surgery. The current common standard treatment for patients with advanced disease and those who progressed on loco-regional therapy is systemic therapy with sorafenib, lenvatinib, or atezolizumab plus bevacizumab.

On September 9, 2021 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported its financial outlook for full year 2021 (Press release, Quest Diagnostics, SEP 9, 2021, View Source [SID1234587568]).

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Since the company reported its financial performance for the second quarter of 2021 on July 22, 2021, COVID-19 molecular testing volumes were stronger than anticipated through the end of August and are expected to continue to be stronger than anticipated because of the surge of the Delta variant. The low end of the company’s outlook now assumes average COVID-19 volumes of at least 40,000 molecular tests per day for the second half of the year. Organic testing volumes in the company’s base business (excluding COVID-19 molecular and antibody testing and the impact of recent acquisitions) remain consistent with its previous outlook.

Updated Outlook for Full Year 2021

The company revised its full year 2021 outlook as follows:

The company is scheduled to participate in the Morgan Stanley 19th Annual Global Healthcare Conference today at 9:30 a.m. Eastern Time. The presentation will be webcast live during the conference and will be available on the company’s investor relations page which can be accessed at ir.QuestDiagnostics.com. During the discussion, the company’s management plans to discuss the company’s vision, goals and two-point strategy to accelerate growth and drive operational excellence, as well as the company’s current perspective on the impact of the COVID-19 pandemic.

Management continues to believe that the COVID-19 pandemic’s impact on its future operating results, cash flows and/or financial condition will be primarily driven by a number of factors beyond the company’s knowledge and control, including: the pandemic’s severity and duration; healthcare insurer, government, and client payer reimbursement rates for COVID-19 molecular tests; the pandemic’s impact on the U.S. healthcare system and the U.S. economy; and the timing, scope and effectiveness of federal, state and local governmental responses to the pandemic including the impact of vaccination efforts.

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, certain financial impacts resulting from the COVID-19 pandemic, amortization expense, excess tax benefits ("ETB") associated with stock-based compensation, costs associated with donations, contributions and other financial support through Quest for Health Equity, the company’s initiative with the Quest Diagnostics Foundation to reduce health disparities in underserved communities, a gain on the sale of an ownership interest in a joint venture and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts; and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional table attached below includes a reconciliation of non-GAAP adjusted measures to GAAP measures.

On September 8, 2021 Sprint Bioscience AB (publ) reported that the company is broadening its pipeline with an additional drug program for the treatment of solid tumors (Press release, Sprint Bioscience, SEP 8, 2021, View Source [SID1234587375]). The program goes by the program name NIMA and aims to develop drugs to inhibit a naturally occurring protein that is associated with poor survival in several different forms of cancer.

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"We have once again been able to identify a target protein that constitutes a very attractive starting point for a new drug program. The ambition is to influence the microenvironment of the tumors so that the growth of cancer cells is inhibited and the body’s immune system can more easily fight them. We will in a time- and resource-efficient way drive the project to a point where it can dock into an international pharmaceutical company’s portfolio and be taken further to clinic development towards the market and cancer patients who need new treatment option"
Erik Kinnman, CEO, Sprint Bioscience

An important aspect of the development of a tumor is that the cancer cells can affect their environment to facilitate the growth of the tumor. This environment is called the tumor microenvironment and differs from the environment around the healthy cells in the body. The ability of cancer cells to reprogram the healthy cells present in the tumor facilitates tumor growth and can inhibit the body’s immune system.

The NIMA program focuses on a target protein that produces metabolites that are important for this reprogramming of the tumor’s microenvironment. Sprint Bioscience develops inhibitors of this target protein to restore balance and thereby prevent the growth of cancer cells while increasing the immune system’s ability to attack them. High levels of the current target protein have been found in tumors from, amongst others, ovarian cancer, breast cancer, and colorectal cancer. Patients with high levels of this protein have a poorer prognosis.

"We have once again been able to identify a target protein that constitutes a very attractive starting point for a new drug program. The ambition is to influence the microenvironment of the tumors so that the growth of cancer cells is inhibited and the body’s immune system can more easily fight them. We will in a time- and resource-efficient way drive the project to a point where it can dock into an international pharmaceutical company’s portfolio and be taken further to clinic development towards the market and cancer patients who need new treatment option,", says Erik Kinnman, CEO, Sprint Bioscience.

The initiation of the NIMA program is part of the company’s accelerating strategy to broaden its project portfolio in the cancer area and thereby create opportunities for further licensing deals that can generate additional multiple revenue streams.

On September 8, 2021 ISA reported the start of patient dosing in a pivotal clinical trial investigating the combination of ISA101b and Libtayo (cemiplimab) in advanced HPV16 positive oropharyngeal cancer (Press release, ISA Pharmaceuticals, SEP 8, 2021, View Source [SID1234587393]). This new study is the third with active recruitment under ISA Pharmaceuticals’ strategic immuno-oncology collaboration with Regeneron.

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The oropharyngeal cancer phase 2 study (NCT04398524) will include 86 patients with recurrent/metastatic HPV16 positive oropharyngeal cancer that progressed with prior anti-PD-1 therapy, a cancer with a high unmet medical need. The primary efficacy outcome parameter is Overall Response Rate (ORR) and the study expects top line data in the second half of 2023.

The other studies testing the combination of ISA101b and Libtayo are:
A cervical cancer phase 2 study (NCT04646005) that is being conducted by Regeneron. It will enrol 103 adult patients with recurrent/metastatic HPV16 positive cervical cancer who have experienced disease progression after first line chemotherapy. Primary endpoint of this study will be ORR.
A randomised, placebo controlled phase 2 study in first and second line HPV16 positive head-and-neck cancer (NCT03669718) that will include 194 patients also with ORR as primary endpoint. ISA Pharmaceuticals runs this study. Top line results for this study are expected in the second half of 2022.

ISA101b immunotherapy targets HPV16 positive cancers. It induces strong and specific immune responses to the HPV16 virus, and (re-)establishes a powerful and targeted T-cell immune response against infected and/or cancerous cells and tissues. ISA101b is using ISA’s proprietary Synthetic Long Peptide (SLP) technology. Libtayo is an anti-PD-1 antibody that is being jointly developed by Regeneron and Sanofi.

Gerben Moolhuizen, Chief Executive Officer of ISA Pharmaceuticals, said: "We are pleased to announce that the first patient has been treated in this new study. It highlights the productive collaboration we have with Regeneron, with active operational involvement from both companies. This additional trial offers a potentially shortened path to first approval in a HPV16 positive cancer indication."

Head-and-neck and cervical cancers can be severe and life-threatening, often diagnosed in young to middle aged adults, with low overall survival rates once these cancers progress to advanced stages. HPV16 is a major cause of head & neck cancer with over 25,000 new cases and 11,000 deaths in Europe(1) and 46,000 new cases and 9,000 deaths in the US(2).