On April 22, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported participation in the Dermatology Nurses’ Association 2021 Annual Convention (Press release, Castle Biosciences, APR 22, 2021, View Source [SID1234578373]). Castle presented posters highlighting each of the company’s three skin cancer gene expression profile (GEP) tests.

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Poster information is as follows:

DecisionDx-Melanoma:

The poster is entitled, "31-gene expression profiling improves risk stratification in patients with T1 cutaneous melanoma."

DecisionDx-Melanoma is Castle’s 31-gene expression profile test that uses an individual patient’s tumor biology to predict risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node (SLN) positivity, independent of traditional staging factors.

Study methods and findings:

Nearly 70% of melanomas are diagnosed with tumor thickness that is less than or equal to 1.0 mm (T1 tumors), and recurrence-free survival (RFS) is generally good among these patients. However, up to 15% of patients with T1 tumors may experience a recurrence. Moreover, due to the large number of patients with T1 tumors, 27-30% of melanoma-related deaths occur in patients originally diagnosed with a T1 tumor, suggesting better identification of T1 patients at high risk of recurrence or metastasis is needed.
DecisionDx-Melanoma is designed to classify a patient’s recurrence risk as low (Class 1: Class 1A lowest) or high (Class 2: Class 2B highest) and has been validated in multiple prospective and retrospective studies.
Univariate analysis of the study data shows DecisionDx-Melanoma to be a stronger predictor of RFS than SLN status.
Multivariable analysis shows DecisionDx-Melanoma to be a strong, independent predictor of RFS.
With Class 2B RFS status similar to SLN positive status, Class 2B patients warrant follow-up strategies similar to SLN positive patients.
DecisionDx-SCC:

The poster is entitled, "Clinical utility of the 40-gene expression profile (40-GEP) for improved patient management decisions and disease related outcomes when combined with current clinicopathological risk factors for cutaneous squamous cell carcinoma (cSCC): Case Series."

DecisionDx-SCC is Castle’s prognostic 40-gene expression profile test for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC) designed to use a patient’s tumor biology to predict individual risk of metastasis for patients with SCC and one or more risk factors.

Study methods and findings:

Two SCC cases were presented that highlight DecisionDx-SCC’s utility in stratifying risk in SCC.
The cases were very similar at diagnosis, both presenting with a history of immunosuppression along with identical staging (T2a per Brigham and Women’s Hospital staging; T1 per American Joint Committee on Cancer staging), but had divergent outcomes:
Case 1 did not recur, despite incomplete resection.
Case 2 developed local recurrence and regional metastasis, and died from SCC, despite clear surgical margins, radiation and chemotherapy treatments.
Subsequent DecisionDx-SCC test results yielded risk level assignments that correlated with the two patients’ outcomes:
Case 1 had a retrospective low-risk (Class 1) DecisionDx-SCC result.
Case 2 had a highest-risk (Class 2B) DecisionDx-SCC result.
The authors concluded that incorporating DecisionDx-SCC as a prognostic factor with traditional clinicopathological risk factors can improve stratification of high-risk SCC patients with at least one risk factor, thereby informing risk-appropriate management strategies.
DecisionDx DiffDx-Melanoma:

The poster is entitled, "Development, validation, and clinical utility of the 35-gene expression profile test for use as an adjunctive melanoma diagnostic tool."

DecisionDx DiffDx-Melanoma is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions.

Study methods and findings:

DecisionDx DiffDx-Melanoma was developed using artificial intelligence methods trained on 200 benign nevi and 216 melanomas to select a panel of 32 discriminant and 3 control genes.
The test’s ability to differentiate accurately between benign and malignant pigmented skin lesions was characterized.
The test provides a high technical success rate at 96.6% with a modest intermediate-risk zone of 3.6%.
The analytical validity data of the DecisionDx DiffDx-Melanoma test demonstrates high precision as an indication of technical success.
Dermatopathologists utilized the DecisionDx DiffDx-Melanoma result to refine their diagnoses and their diagnostic confidence increased by 51%.
Dermatologists utilized the DecisionDx DiffDx-Melanoma result, which in the majority of responses, led to altered treatment plans in agreement with the DecisionDx DiffDx-Melanoma result.
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. To predict likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithm, i31-GEP, to produce an integrated test result. i31-GEP is an artificial intelligence-based neural network algorithm (independently validated in a cohort of 1,674 prospective, consecutively tested patients with T1-T4 cutaneous melanoma) that integrates the DecisionDx-Melanoma test result with the patient’s traditional clinicopathologic features. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through December 31, 2020, DecisionDx-Melanoma has been ordered more than 68,920 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.CastleTestInfo.com.

About DecisionDx DiffDx-Melanoma

DecisionDx DiffDx-Melanoma is designed to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions. Of the approximately 2 million suspicious pigmented lesions biopsied annually in the U.S., Castle estimates that approximately 300,000 of those cannot be confidently classified as either benign or malignant through traditional histopathology methods. DecisionDx DiffDx-Melanoma classifies these lesions as: benign (gene expression profile suggestive of benign neoplasm); intermediate-risk (gene expression profile cannot exclude malignancy); or malignant (gene expression profile suggestive of melanoma). Interpreted in the context of other clinical, laboratory and histopathologic information, DecisionDx DiffDx-Melanoma is designed to add diagnostic clarity and confidence for dermatopathologists while helping dermatologists deliver more informed patient management plans.

More information about the test and disease can be found at www.CastleTestInfo.com.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1, 2A or 2B risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

More information about the test and disease can be found at www.CastleTestInfo.com.

On April 22, 2021 Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) ("Aptorum Group" or "Aptorum"), a clinical-stage biopharmaceutical company, through its affiliate, reported that it has entered into a material transfer and option agreement ("Agreement") with Yale University ("Yale") to evaluate a group of preclinical stage novel immunomodulators (Press release, Aptorum, APR 22, 2021, View Source [SID1234578372]). The novel immunomodulators may potentially target autoimmune and oncology diseases, including but not limited to, rheumatoid arthritis, lupus and sclerosis, as well as a variety of cancers, all subject to further preclinical development and testing. Aptorum also obtained an exclusive option to in-license the novel immunomodulators and its affiliated intellectual property rights including its patent rights and know-how, based on licensing terms pursuant to a binding term sheet incorporated into the Agreement.

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Under the arrangement, Aptorum will be responsible for assessing Yale’s originally developed novel immunomodulators against lupus, arthritis, inflammatory bowel diseases, neurodegenerative diseases or other oncology indications. Upon exercising its option to license, Aptorum will undertake to develop and commercialize one or more of these novel immunomodulators, as supported by Yale.

Mr. Ian Huen, Chief Executive Officer of Aptorum Group, commented: "Aptorum is delighted to partner with Yale to validate and develop its novel class of immunomodulators. Aptorum believes that these immunomodulators have the potential to advance first-in-class drug discovery and development of such drugs for potential autoimmune and oncology diseases in particular. For example, it has been widely reported that COVID-19 infections often trigger a cytokine storm in patients leading to undesirable and often fatal autoiummune reactions1 and we will also explore the potential applications of the immunomodulators for the treatment of these cytokine storms. Through this initiative, we are looking forward to strategically expanding our development footprint in the treatment of those diseases, which have other potential applications such as in oncology and infectious diseases which are already core focuses of our company."

On April 22, 2021 ITM AG reported that the successful close of a convertible loan financing totaling EUR 90 million (USD 109 million) led by Petrichor Healthcare Capital Management with participation of additional undisclosed investors (Press release, ITM Isotopen Technologien Munchen, APR 22, 2021, View Source [SID1234578371]). The proceeds will support the expansion of ITM’s precision oncology pipeline as well as fund late-stage development and market access activities for lead candidate, n.c.a. 177Lu-Edotreotide, currently in a phase III trial in gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Under the terms of the agreement, the loan will convert into shares of ITM in the event of certain future financial or other corporate development transactions. Further details of the financing were not disclosed.

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"This funding represents our commitment to being at the forefront of demonstrating the therapeutic potential of Targeted Radionuclide Therapy and reflects our ambition to translate our leadership as a global radioisotope provider into developing innovative radiopharmaceuticals to meet the needs of patients with difficult-to-treat tumors. The investment from Petrichor and the syndicate recognizes our clinical and corporate achievements to date and enables us to further leverage the full potential of nuclear medicine for cancer patients," commented Steffen Schuster, Chief Executive Officer of ITM.

In conjunction with the financing, Tadd Wessel, Founder and Managing Partner at Petrichor, will join ITM’s supervisory board. He brings more than 20 years of experience in the healthcare financing sector and was formerly a Managing Director at OrbiMed Advisors, where he led the build-out of the healthcare special situations and structured finance business.

Mr. Wessel added: "ITM has established itself as a dominant global provider of therapeutic radioisotopes. We expect the company’s isotope business to benefit from tremendous growth of targeted radiotherapy in the years ahead, while serving as a platform for ITM’s deep pipeline of precision oncology Targeted Radionuclide Therapies and companion diagnostics. Targeted radiotherapy has demonstrated immense success to date, and we expect the drug class to continue to gain recognition as one of the most promising areas within precision oncology. We believe that ITM’s unparalleled expertise and technological capabilities are evidenced by their market leadership, and we look forward to supporting the team in their pursuit of better patient outcomes."

ITM, founded in 2004, is a company built on longstanding experience in the production and supply of high-quality medical radioisotopes for cancer treatment and diagnosis with an established global supply network. The company has forward-integrated to develop Targeted Radionuclide Diagnostics and Therapies designed to provide medical benefit for difficult-to-treat cancer indications.

On April 22, 2021 NeuBase Therapeutics, Inc. (Nasdaq: NBSE) ("NeuBase"), a biotechnology company accelerating the genetic revolution with a new class of precision genetic medicines, reported the pricing of an underwritten public offering of 8,000,000 shares of its common stock, at a price to the public of $5.00 per share (Press release, NeuBase Therapeutics, APR 22, 2021, View Source [SID1234578370]). The gross proceeds to NeuBase from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by NeuBase, are expected to be approximately $40 million, excluding any exercise of the underwriters’ option to purchase additional shares of common stock. In addition, NeuBase has granted the underwriters a 30-day option to purchase up to an additional 1,200,000 shares of its common stock at the public offering price, less underwriting discounts and commissions, to cover over-allotments, if any. All of the shares of common stock in the offering are being sold by NeuBase.

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RBC Capital Markets, Oppenheimer & Co. Inc. and Chardan are acting as the joint book-running managers for the offering, and National Securities Corporation is acting as co-manager.

NeuBase intends to use the net proceeds from the offering for general corporate purposes, working capital and development of its product candidates and pipeline expansion. This offering is expected to close on or about April 26, 2021, subject to the satisfaction of customary closing conditions.

The securities described above were offered by NeuBase pursuant to a shelf registration statement on Form S-3 (File No. 333-254980) previously filed with the Securities and Exchange Commission (the "SEC") on April 1, 2021 and declared effective by the SEC on April 14, 2021. The securities may be offered only by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the offering has been filed with the SEC. Electronic copies of the preliminary prospectus supplement and, when available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained by visiting the SEC’s website at www.sec.gov or by contacting RBC Capital Markets, Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, NY 10281, or by telephone at (877) 822-4089 or by e-mail at [email protected], Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, or by telephone at (212) 667-8055 or by e-mail at [email protected], or Chardan, 17 State Street, 21st floor, New York, New York 10004, by telephone at (646) 465-9032 or by e-mail at [email protected].

This press release does not constitute an offer to sell or the 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 the registration or qualification under the securities laws of any such state or jurisdiction.

On April 22, 2021 Blueprint Medicines Corporation (NASDAQ: BPMC), reported that it will host a live conference call and webcast at 8:30 a.m. ET on Thursday, April 29, 2021 to report its first quarter 2021 financial results and provide a corporate update (Press release, Blueprint Medicines, APR 22, 2021, View Source [SID1234578369]).

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To access the live conference call, please dial (855) 728-4793 (domestic) or (503) 343-6666 (international), and refer to conference ID 9292306. A webcast of the call will also be available under "Events and Presentations" in the Investors & Media section of the Blueprint Medicines website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.