On September 16, 2021 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that it has entered into a definitive agreement on September 15, 2021 to sell an aggregate of 3.5 million shares of common stock at a purchase price of $14.50 per share (Press release, Vincerx Pharma, SEP 16, 2021, View Source [SID1234587807]). The private placement was led by new and existing investors, including Deerfield Management Company, Rock Springs Capital, Point72 Asset Management, and Sphera Healthcare, among others.

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The Company intends to use the net proceeds from the financing for working capital and general corporate purposes, including to support the clinical evaluation of VIP152, the Company’s potent and selective inhibitor of CDK9, in additional indications and combination regimens, as well as to advance its bioconjugation platform. Vincerx had $85.6 million in cash and cash equivalents as of June 30, 2021.

"The Vincerx team remains focused on our mission of developing innovative and urgently needed oncology therapies. We look forward to the planned initiation of our Phase 1 dose escalation study in CLL relapsed or refractory to venetoclax and BTK inhibitors in the second half of this year. In addition to our monotherapy approach, we are also excited to initiate our combination studies in the early part of next year, which would expand our addressable patient population and allow us to move to earlier lines of therapy," said Ahmed Hamdy M.D., Chief Executive Officer of Vincerx.

The financing is expected to close on September 20, 2021, subject to satisfaction of customary closing conditions. SVB Leerink acted as the lead placement agent. LifeSci Capital and Cantor Fitzgerald acted as co-placement agents.

The securities to be sold in the private placement have not been registered under the Securities Act of 1933 or applicable state securities laws and may not be offered or sold in the United States absent registration under the Securities Act or an applicable exemption from such registration requirements. The Company has agreed to file a resale registration statement with the U.S. Securities and Exchange Commission covering the resale of the shares of common stock sold in the private placement. This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

On September 16, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to improve treatment decisions, reported that it has received approval from the New York State Department of Health for its proprietary DecisionDx DiffDx-Melanoma gene expression profile (GEP) test (Press release, Castle Biosciences, SEP 16, 2021, View Source [SID1234587840]). DecisionDx DiffDx-Melanoma is designed to provide an objective and comprehensive diagnostic offering to aid dermatopathologists in characterizing difficult-to-diagnose melanocytic lesions.

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"We are proud of the expansion of our New York Clinical Laboratory Permit to include the DecisionDx DiffDx-Melanoma test, as it exemplifies our ongoing commitment to providing high-quality, dermatologic genomic tests that can transform care and improve patients’ lives," said Kristen Oelschlager, chief operating officer of Castle Biosciences. "For patients in New York with ambiguous melanocytic lesions, we believe access to our DecisionDx DiffDx-Melanoma test can provide clarity in the management of their disease for improved overall outcomes."

In May of 2021, Castle acquired myPath Melanoma, a clinically validated GEP test designed to be used as an adjunct to histopathology when the distinction between a benign nevus and a malignant melanoma cannot be made confidently by histopathology alone. Together, myPath Melanoma and DecisionDx DiffDx-Melanoma comprise Castle’s comprehensive diagnostic offering for difficult-to-diagnose melanocytic lesions. Both GEP tests, myPath Melanoma and DiffDx-Melanoma, are designed to provide a comprehensive diagnostic workflow that leverages the strengths of both tests for better patient care.

Castle previously received approvals in the state of New York for its other GEP tests, including DecisionDx-Melanoma, DecisionDx-SCC, DecisionDx-UM and DecisionDx-PRAME, as well as its next generation sequencing panels, DecisionDx-CMSeq and DecisionDx-UMSeq.

In 2020, Castle doubled the footprint of its College of American Pathologists (CAP) accredited, Clinical Laboratory Improvement Amendments (CLIA)-certified primary laboratory facility located in Phoenix. The Company expanded the space to approximately 23,500 square feet by adding a new laboratory facility in close proximity to its primary facility to support growth and provide certain operational redundancy. Earlier this year, Castle further expanded this facility to include approximately 3,600 additional square feet.

About Castle Biosciences’ Comprehensive Diagnostic Offering for Difficult-to-Diagnose Melanocytic Lesions

Castle Biosciences’ comprehensive diagnostic offering leverages the strengths of myPath Melanoma and DecisionDx DiffDx-Melanoma. These gene expression profile tests are designed to provide a highly accurate, objective result to aid dermatopathologists and dermatologists 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. For these cases, the treatment plan can also be uncertain. Obtaining highly accurate, objective ancillary testing can mean the difference between a path of overtreatment or the risk of undertreatment. Interpreted in the context of other clinical, laboratory and histopathologic information, myPath Melanoma and DecisionDx DiffDx-Melanoma are designed to reduce uncertainty and provide confidence for dermatopathologists and help dermatologists deliver more informed patient management plans.

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

On September 16, 2021 Second Genome, a biotechnology company that leverages its proprietary platform sg-4sight to discover and develop precision therapies and biomarkers from public and proprietary microbiome data, reported preclinical data demonstrating that the Company’s novel microbiome-derived peptide, SG-3-00802, can reverse resistance to anti-programmed death protein-1 (PD-1) therapy, illustrating that the microbiome directly interacts with the immune system to impact antitumor immunity (Press release, Second Genome, SEP 16, 2021, View Source [SID1234587855]). The data (E-Poster #1023P) were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021, held virtually September 16-21.

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"Despite the clinical success of immune checkpoint inhibitors (ICI) in many cancers, there is still significant unmet need in ICI-resistant patients, but there is encouraging promise for microbiome-derived approaches to turn anti-PD-1 non-responders into responders and ultimately provide innovative new therapies for people living with cancer," said Helena Kiefel, Ph.D., Head of Immuno-Oncology at Second Genome. "We were pleased to share preclinical data at ESMO (Free ESMO Whitepaper) demonstrating that the combination of SG-3-00802 with anti-PD-1 antibody was able to achieve complete tumor regression and significant prolongation of survival in an ICI-resistant model. We believe SG-3-00802 has potential to improve responses in immune checkpoint inhibitor-resistant cancer patients. Importantly, based on the mechanism of action, SG-3-00802 has potential for broad clinical development in combination with immunogenic chemotherapies and radiation in earlier lines of therapy. We look forward to advancing SG-3-00802 into the clinic, with an IND submission on track for 2022."

Using Second Genome’s proprietary algorithms, an ICI responder-specific microbial signature was identified, and biologically active molecules were derived from the ICI-responder microbiome. SG-3-00802’s unique pathway and its use to treat tumors markedly increased CXCL10 and CD8 T cell levels and reduced tumor volumes, increasing overall survival in mouse models. Furthermore, treatment in combination with anti-PD-1 significantly improved overall survival in anti-PD-1-insensitive RENCA mouse model, with many mice showing complete tumor regression, versus anti-PD-1 antibody alone. Surviving mice with fully regressed tumors also rejected newly implanted tumors when rechallenged with RENCA cells, demonstrating long-lasting antitumor memory responses generated by the combination of SG-3-00802 plus anti-PD-1.

The mechanism of action by which SG-3-00802 exerted its anti-tumor effects demonstrated to be CXCR3 dependent. Receptor activation and immune cell recruitment assays demonstrated that SG-3-00802 enhanced the activity of CXCR3 in the presence of its endogenous ligands, resulting in increased lymphocyte migration, validating CXCR3 as the functional target. These observations were confirmed in vivo, as CXCR3 inhibition decreased the anti-tumor activity of SG-3-00802 alone and in combination with anti-PD1.

The poster presentation will be available for on-demand viewing on the ESMO (Free ESMO Whitepaper) website and will also be made available on the Company’s website at View Source

On September 15, 2021 Today Patrys reported that new data from a successful preclinical study highlighting the potential for using our deoxymab antibodies as targeting agents in antibody drug conjugates (ADCs) (Press release, Patrys, SEP 15, 2021, View Source [SID1234587728]).

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ADCs harness the targeting attributes of antibodies to deliver payloads specifically to the sites of disease, and are one of the most active areas of drug development

The study data confirms that it is possible to conjugate the anticancer drug monomethyl auristatin E (MMAE) to Patrys’ full-sized IgG deoxymab, PAT-DX3. MMAE conjugated to PAT-DX3 was shown to inhibit tumour growth by 99.7% in mice implanted with human breast cancer cells, showing that deoxymabs can be used to effectively target delivery to tumours in animals.

According to Patrys CEO and Managing Director, Dr James Campbell:

"We are very excited by the potential of using our deoxymabs as the basis for new ADCs. This work has shown that deoxymabs can be used to target cancers and, by using a potent and validated ADC payload, deliver a drug. As with the therapeutic applications we are working on, the ability of our deoxymab antibodies to target multiple types of cancer, enter the cell and cell nucleus, and transit the blood brain barrier provides some really novel ways for using them as targeting agents for ADCs.

"This study has clearly demonstrated the proof of concept and is expected to open up a range of potential development or partnering opportunities for the Company."

On September 15, 2021 NuCana plc (NASDAQ: NCNA) reported it has completed enrollment of the number of patients in the ongoing Phase III NuTide:121 study required to conduct the first interim analysis (Press release, Nucana BioPharmaceuticals, SEP 15, 2021, View Source [SID1234587744]). The study, which is comparing Acelarin combined with cisplatin to the global standard of care, gemcitabine plus cisplatin, as a first-line treatment for patients with advanced biliary tract cancer, has enrolled 418 patients with measurable disease. The first interim analysis will be conducted after the 418th patient has completed 28 weeks of follow-up, which is expected to occur in the first half of 2022. NuCana believes that a statistically significant improvement in the Objective Response Rate (ORR) at the first interim analysis, accompanied by positive trends in other endpoints, has the potential to allow for accelerated approval of a new drug application (NDA) for Acelarin in the United States. Recruitment in the NuTide:121 study, which is intended to enroll up to 828 patients, is ongoing and NuCana believes subsequent analyses could provide the confirmatory data to support full (regular) approval.

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"We are very pleased to achieve this important enrollment milestone which brings us closer to our goal of developing more effective and safer medicines for patients with cancer," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "Biliary tract cancer is a devastating disease and there is a significant need for more effective medicines. We are especially grateful to all of the patients, their families, the investigators and other health care professionals involved in the NuTide:121 study."

Mr. Griffith continued: "The primary objective of the first interim analysis is to demonstrate at least a 14% improvement in the ORR in the Acelarin plus cisplatin arm compared to the gemcitabine plus cisplatin arm. In the ABC-08 study of Acelarin plus cisplatin as a first-line treatment for patients with biliary tract cancer, an ORR of 44% was achieved among the evaluable population. This compared favorably to the ORR of 26% achieved among evaluable patients treated with gemcitabine plus cisplatin in the ABC-02 study, which established this regimen as the global standard of care. We look forward to announcing the outcome of this first interim analysis in the first half of 2022."

About NuTide:121

NuTide:121 is a global, multi-center, 1:1 randomized Phase 3 study comparing Acelarin, a ProTide transformation of gemcitabine, in combination with cisplatin, to gemcitabine in combination with cisplatin in up to 828 patients with advanced biliary tract cancer who have not previously received treatment for advanced disease. The primary endpoints of NuTide:121 are Overall Survival (OS) and Objective Response Rate (ORR) and the FDA-approved protocol includes three interim analyses. Based on the statistical analysis plan, and subject to any further regulatory guidance, the Company believes that a statistically significant improvement in ORR at either of the first two interim analyses, accompanied by positive trends in other endpoints, has the potential to allow for an accelerated approval of a new drug application (NDA) for Acelarin in the United States. Under this scenario, the NuTide:121 study would continue and the Company believes it could use the data from subsequent analyses as the confirmatory data required to support full (regular) approval. There are currently no agents approved for the first-line treatment of patients with biliary tract cancer.

About Biliary Tract Cancer

Biliary tract cancer, including cholangiocarcinoma, gallbladder and ampullary carcinoma, are a group of cancers originating in the biliary tract. The biliary tract is comprised of the gallbladder and interconnecting ducts responsible for the transport of bile from the liver to the gallbladder and small intestine. Approximately 178,000 new cases of biliary tract cancer are diagnosed each year worldwide, with more than 18,000 of those diagnoses in the United States. There are currently no agents approved for the first-line treatment of patients with advanced biliary tract cancer; however, the worldwide standard of care in these patients is the combination of gemcitabine and cisplatin. Patients receiving this regimen have a median overall survival of 11.7 months.