On September 16, 2021 Gritstone bio, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing next generation cancer and infectious disease immunotherapies and vaccines, reported a $55.0 million private investment in public equity (PIPE) financing from the sale of 5,000,000 shares of its common stock at a price per share of $11.00 (Press release, Gritstone Oncology, SEP 16, 2021, View Source [SID1234592013]). Gross proceeds from the PIPE financings total $55.0 million, before deducting placement agent fees and offering expenses. The PIPE is being led by Frazier Life Sciences Public Fund, with additional participation from Redmile Group and Gilead Sciences.

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"As long-term backers of Gritstone, we continue to be impressed by the company’s progress and emergence as a leader in development of next generation immunotherapies and vaccines for cancer and infectious diseases," said Jamie Brush, M.D., General Partner and Portfolio Manager of the Frazier Life Sciences Public Fund. "We believe Gritstone’s EDGE platform and integrated vaccine manufacturing capabilities uniquely position the company to rapidly expand into infectious disease vaccine development with a potentially refrigerator stable self-amplifying mRNA vaccine platform. This financing will help ensure Gritstone has the resources to move quickly in this exciting new area, and we are excited to support the company in its next phase of growth."

The closing of the PIPE financing is subject to customary closing conditions and is expected to close by September 17, 2021. Cowen served as the sole placement agent for the PIPE financing.

The securities sold in this private placement have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the U.S. except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Gritstone bio has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the shares of common stock issued in this private placement.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction.

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 16, 2021 NuCana plc (NASDAQ: NCNA), reported the presentation of four posters at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 (Press release, Nucana BioPharmaceuticals, SEP 16, 2021, View Source [SID1234587823]). The Company presented additional data from the ongoing Phase 1b/2 study of NUC-3373 in combination with standard therapies in patients with advanced colorectal cancer (NuTide:302), final data from the Phase 1 study of NUC-3373 in patients with advanced solid tumors (NuTide:301), and additional interim data from the Phase 1 study of NUC-7738 in patients with advanced solid tumors. The Company also presented a trials-in-progress poster describing the ongoing Phase 3 study of Acelarin plus cisplatin in patients with advanced biliary tract cancer.

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"The posters being presented during ESMO (Free ESMO Whitepaper) continue to support the potential of our ProTide platform to transform both existing as well as novel nucleoside analogues into more effective and safer medicines for patients with cancer," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "Looking ahead to the remainder of 2021 and first half of 2022, we have multiple milestones that we plan to announce. These include announcing the outcome of the first interim analysis in the Phase 3 NuTide:121 study of Acelarin plus cisplatin in patients with biliary tract cancer, initiating a registrational study for NUC-3373 in patients with colorectal cancer, and initiating and announcing data from a Phase 2 study of NUC-7738 in patients with advanced solid tumors."

Details of NuCana’s e-poster presentations during the ESMO (Free ESMO Whitepaper) Congress 2021 being held September 16-21, 2021 are as follows:

NUC-3373

NuCana presented two posters on NUC-3373, its ProTide transformation of the active anti-cancer metabolite of 5-fluorouracil (5-FU), one of the most widely used anti-cancer medicines. NUC-3373 has been designed to overcome the main challenges associated with 5-FU, including cancer-resistance mechanisms, the generation of toxic metabolites and unfavorable pharmacokinetics.

Poster Title: A Phase Ib study of NUC-3373, a targeted inhibitor of thymidylate synthase, in combination with standard therapies in patients with advanced colorectal cancer (NuTide:302)

This poster describes encouraging interim data from 38 patients with metastatic colorectal cancer. In this difficult-to-treat group, with patients having received a median of four prior lines of therapy, NUC-3373, with or without leucovorin, demonstrated encouraging signs of efficacy. In addition to several patients achieving a longer progression-free survival on NUC-3373 than they had on their prior therapy, tumor reductions were observed in three patients: one who experienced a 40% reduction in their target lesion and two others with 28% and 15% reductions, respectively, in overall tumor burden. NUC-3373 also demonstrated a favorable safety profile in this patient population with no FBAL or FUTP-associated Grade 3 or 4 toxicities, such as hand-foot syndrome, diarrhea or neutropenia.

Based on these encouraging interim results, NuTide:302 has been expanded to a Phase 1b/2 study and now allows enrollment of less heavily pre-treated patients, including second-line colorectal cancer patients. A registrational study of NUC-3373 in second-line colorectal cancer patients is also planned.

Poster Title: Final results of a first-in-human study of the ProTide thymidylate synthase inhibitor NUC-3373, in patients with advanced solid tumours (NuTide:301)

This poster highlights final results from the NuTide:301 study in patients with advanced solid tumors. NUC-3373 showed a favorable safety profile and encouraging anti-cancer activity, including in patients previously treated with 5-FU. Additionally, three patients achieved stable disease lasting at least 9 months. NUC-3373 demonstrated an attractive pharmacokinetic profile with a long plasma half-life of between 6 and 14 hours compared to 8 to 14 minutes for 5-FU. Furthermore, NUC-3373 generated approximately 300 times higher levels of the active anti-cancer metabolite, FUDR-MP, than 5-FU. The recommended Phase 2 monotherapy dose of NUC-3373 was established at 2,500mg/m2.

NUC-7738

NUC-7738, a ProTide transformation of a novel anti-cancer nucleoside analog, 3’-deoxyadenosine, has multiple potential anti-cancer mechanisms of action and is being evaluated in a Phase 1 study in patients with advanced solid tumors who have exhausted all standard therapies.

Poster Title: A first-in-human study of NUC-7738, a ProTide transformation of 3’-deoxyadenosine, in patients with advanced solid tumors (NuTide:701)

This poster describes interim data from the ongoing Phase 1 study (NuTide:701) and the data demonstrate NUC-7738’s encouraging anti-cancer activity in multiple tumor-types. NUC-7738 has been well tolerated with no Grade 3 or 4 treatment-related adverse events and no dose-limiting toxicities. The ProTide generated high levels of the key anti-cancer metabolite, 3’-dATP, which had a prolonged intracellular half-life and was still detectable after 50 hours.

Three case studies were described detailing two patients with metastatic melanoma and one patient with metastatic lung adenocarcinoma who achieved reductions in the size of target lesions coupled with prolonged stable disease. Following treatment with NUC-7738, one patient with metastatic melanoma became eligible for surgery and their tumor was completely resected.

Recruitment to the NuTide:701 study is ongoing and once the recommended Phase 2 dose has been established, NUC-7738 is expected to advance into the Phase 2 part of the study.

Acelarin

Poster Title: Phase III study of NUC-1031 + cisplatin vs gemcitabine + cisplatin for first-line treatment of patients with advanced biliary tract cancer (NuTide:121)

This trial-in-progress poster highlights the Company’s global multi-center, 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. Enrollment of 418 evaluable patients has been achieved and the first of three interim analyses 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.

Abstracts and full session details can be found at www.esmo.org