On June 29, 2020 Nucleix, a liquid biopsy company revolutionizing cancer treatment by detecting the disease earlier, reported the publication of an independent study in the Journal of Clinical Pathology evaluating the company’s urine-based Bladder EpiCheck in patients diagnosed with high-grade non-muscle invasive bladder cancer (NMIBC) (Press release, Nucleix, JUN 29, 2020, View Source [SID1234561540]). The findings support the use of the Bladder EpiCheck methylation biomarkers to detect bladder cancer recurrence in NMIBC patient populations that have undergone instillations.

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The study evaluated 374 patients with a history of high-grade NMIBC who were followed for one year with voided urine cytology and white-light cystoscopy and biopsies, which is standard clinical practice according to European Association of Urology Guidelines. All patients were undergoing treatment with instillations and were selected for cystoscopy based on cytology results. In this study, patients were referred for cystoscopy and biopsies when within cytology categories of high-grade urothelial carcinoma (HGUC), suspicious for high-grade urothelial carcinoma (SHGUC) and atypical urothelial cells (AUC). One hundred and twenty-seven patients in the study (34%) had a pathologically proven recurrence.

"Monitoring for recurrence in patients with high-grade NMIBC undergoing instillations currently requires routine invasive cystoscopies, which are painful procedures for patients and require substantial resources from healthcare providers. Cytology is a routine urine test used in combination with cystoscopy to detect high-grade recurrences; however, it has inherent limitations, such as reader dependency and low sensitivity," said Aharona Shuali, M.D., vice president of medical at Nucleix. "The purpose of this study was to determine if the Bladder EpiCheck test could perform similar to, or better than, cytology in identifying, at a molecular level, which patients have high probability of recurrence and should undergo a cystoscopy and biopsies, and which might be able to avoid these invasive procedures."

The Bladder EpiCheck test was performed together with cytology in all cases and demonstrated a sensitivity of 95%, specificity of 85%, negative predictive value (NPV) of 97% and positive predictive value (PPV) of 76%. Bladder EpiCheck had approximately 90% concordance with HGUC and NHGUC categories, and a high EpiScore (≥90) was strongly correlated with HGUC category (41% vs. 3% in SHGUC, p=0.0001).

The study found that 33% of the negative patients were unnecessarily referred to cystoscopy and biopsy, a finding reflecting cytology’s specificity of 67%. The study demonstrates that if Bladder EpiCheck had been used to select patients for cystoscopy, instead of cytology, this number could have been reduced to 15%, as Bladder EpiCheck specificity was much higher (85%) while detecting 95% of the recurrences.

"These data demonstrate excellent performance of the Bladder EpiCheck test in accurately identifying recurrence vs. non-recurrence in the high-risk NMIBC patient populations without being impacted by the side effects of instillations," said Dr. Francesco Pierconti, associate professor at the Agostino Gemelli University Hospital in Rome, Italy, and lead author of the study. "After two years of experience with Bladder EpiCheck in clinical routine with consistent excellent performance, we are now using it, instead of cytology, to select high-risk NMIBC patients for further workup with cystoscopy and biopsies, allowing us to safely avoid unnecessary procedures," continued Dr. Pierconti, who also serves as professor in the Division of Anatomic Pathology and Histology at the Catholic University of the Sacred Heart in Rome, Italy.

The study titled, "Methylation study of the Paris system for reporting urinary (TPS) categories" has been published online and can be accessed here.

About Bladder EpiCheck

Bladder EpiCheck provides patients and clinicians with a simple, objective urine test to detect recurrence of bladder tumors. The test analyzes subtle disease-specific changes in DNA methylation markers, allowing for the detection of 92% of the high-risk (non Ta-LG) cancers. Bladder EpiCheck demonstrated negative predictive value (NPV) of 99% for high-risk cancer, meaning that when receiving a negative Bladder EpiCheck result, there is 99% chance that no high-risk cancer is present. Bladder EpiCheck is intended for use as a noninvasive method for monitoring of tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer. Bladder EpiCheck is CE-marked and available in Europe. The test is not available for sale in the United States.

On June 29, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported it has enrolled and safely dosed the last patient for stage 2 of Part A (1st line NSCLC) of its TACTI-002 Phase II study, completing recruitment for Part A (Press release, Immutep, JUN 29, 2020, View Source [SID1234561557]).

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TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada) and is evaluating the combination of Immutep’s lead product candidate, eftilagimod alpha ("efti" or "IMP321") with MSD’s KEYTRUDA (pembrolizumab).

Immutep recently reported new data from TACTI-002 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Annual Meeting 2020, including results from stage 1 of Part A which showed an improving Progression Free Survival ("PFS") estimate of more than 9 months in patients with 1st line NSCLC.

The Company expects to report more mature data from TACTI-002 in H2 CY20.

TACTI-002 Recruitment Update

In total 81 patients out of up to 109 (74%) are already enrolled in the trial at 12 clinical sites across Australia, Europe, the UK and US. Recruitment is ongoing for Part B (second line NSCLC) and for stage 2 of Part C (2nd line HNSCC). Current recruitment numbers for each Part are below.

About the TACT-002 Trial

TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of efti with MSD’s KEYTRUDA (pembrolizumab) in up to 109 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.

The trial is a Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in up to 12 study centres across the U.S., Europe, UK and Australia.

Patients participating in three parts:

Part A – First line Non-Small Cell Lung Cancer (NSCLC), PD-X naive

Part B – Second line NSCLC, PD-X refractory

Part C – Second line Head and Neck Squamous Cell Carcinoma (HNSCC), PD-X naive

TACTI-002 is an all comer study in terms of PD-L1 status, a well-known predictive marker for response to pembrolizumab monotherapy especially in NSCLC. PD-L1 expression is typically reported in three groups for NSCLC: < 1%, 1-49% and ³50% (Tumour Proportion Score or TPS). Patients with a high PD-L1 status are typically more responsive to anti-PD-1 monotherapy such as pembrolizumab, whereas those with low PD-L1 status are overall significantly less responsive. Pembrolizumab monotherapy is registered in the US and the EU for first-line NSCLC patients with a TPS score ³1% (US) and ³50% (EU), reflecting 65% and 30% of all first line NSCLC patients, respectively.

On June 29, 2020 CRISPR Therapeutics (Nasdaq:CRSP), a biopharmaceutical company focused on developing transformative gene-based medicines for serious diseases, reported that it is commencing an underwritten public offering of $325,000,000 of common shares (Press release, CRISPR Therapeutics, JUN 29, 2020, View Source [SID1234563988]). In addition, the underwriters will have a 30-day option to purchase up to an additional $48,750,000 of common shares at the public offering price less the underwriting discount.

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Goldman Sachs & Co. LLC, BofA Securities and Jefferies are acting as joint book-running managers for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering.

The common shares will be offered and sold pursuant to the Company’s previously filed automatically effective shelf registration statement on Form S-3 (File No. 333-227427) filed with the U.S. Securities and Exchange Commission (the "SEC") on September 19, 2018. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

The offering will be made only by means of a prospectus. A copy of the prospectus supplement relating to the offering will be filed with the SEC and may be obtained, when available, from Goldman Sachs & Co. LLC by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected]; from BofA Securities by mail at NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or from Jefferies, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 547-6340, or by email at [email protected].

On June 29, 2020 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company"), a clinical-stage biotechnology company focused on patient-specific immunotherapies for the treatment of cancer and infectious diseases, reported a private investment of USD 250 million (EUR 223 million) by Temasek and other accredited investors (Press release, BioNTech, JUN 29, 2020, View Source [SID1234561522]). The private placement includes an investment of approximately USD 139 million in ordinary shares and a USD 112 million investment in 4-year mandatory convertible notes.

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"We are pleased to welcome Temasek onboard as a new shareholder. We believe their long-term investment approach, global presence, and deep experience in the biotechnology field are a good fit with our vision to build a leading global biopharmaceutical company," said Ugur Sahin, CEO and Co-founder of BioNTech.

Upon closing, private placement investors will receive 2,595,996 ordinary shares in BioNTech, which will be subject to a 180-day lock-up agreement. The 4-year mandatory convertible notes will come with a coupon of 4.5% per annum and a conversion premium of 20% above the reference price. The investment is expected to close in early- to mid-August, subject to customary closing conditions.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any security. The securities referenced herein have not been and will not be registered under the Securities Act of 1933, as amended (Securities Act), or applicable state securities laws and may not be offered or sold in the United States or any state thereof absent registration under the Securities Act and applicable state securities laws or an applicable exemption from registration requirements.

On June 29, 2020 Exicure, Inc. (NASDAQ:XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) technology, reported that it has been added to the Russell 2000 index. This addition was effective June 26, 2020 (Press release, Exicure, JUN 29, 2020, View Source [SID1234561541]).

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"We are pleased that Exicure has reached this important milestone," said Dr. David Giljohann, Exicure’s Chief Executive Officer. "We look forward to telling a growing set of investors about our clinical progress in neurology, oncology, and ophthalmology using our genetic medicines," concluded Dr. Giljohann.

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