On September 16, 2021 IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company focusing on discovering, developing, and manufacturing innovative medicines, reported the completion of $108 million Series C to advance the global development of novel cell therapies and biologics for oncology and autoimmune diseases (Press release, IASO BioMed, SEP 16, 2021, View Source [SID1234587842]). The Series C round was led by CDH Baifu, and followed by CCB International, with strong participation from Everbright Limited, Co-Stone Capital, CNCB Capital and Plaisance Capital. Current shareholder GL Ventures also participated. Since its founding in 2017, IASO Bio has raised more than $178 million.

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Proceeds from the financing will be used to accelerate the global development and regulatory submissions of multiple novel cell therapies. The company will also use the funds to develop a broader pipeline of universal allogeneic cell therapies and cell products for the treatment of solid tumors, expanding global strategic partnerships on core assets to further diversify the Company’s existing portfolio and platforms.

Wen (Maxwell) Wang, M.D., Ph.D., CEO & CMO of IASO Bio, said, "We are obliged to thank all the shareholders for their trust. I am very proud that our track record in transforming innovation into clinically-validated medicines, and our exponential growth, have been well recognized by prestigious domestic and international investors. We are committed to developing transformative drugs, and after four years of rapid and steady growth, our business is now well driven by both cell therapies and biological drugs. Our first product candidate – fully human BCMA CAR-T (CT103A) – is in the pivotal trial stage and will submit NDA soon. Our second product candidate – the world’s first fully human CD19/CD22 dual targeting CAR-T cell therapy – received clearance of China’s NMPA in July, and the clinical trial has been progressing in an orderly manner. Our third product candidate – the world’s first fully human CD5 targeting CAR-T cell therapy – has finished pre-clinical study and is in pre-IND stage.

"The clinical development of these three innovative products marks the full coverage of our products in plasma cell, B cell, and T cell malignancies. Moreover, we are advancing the clinical development of our core candidate CT103A in frontline therapy, combination regimens, indication expansion, and overseas development. We still have two INDs to file in the second half of this year. The proceeds raised will enable us to advance our innovative pipeline and consolidate our strategic positioning and advantages in immuno-oncology and autoimmune diseases. With an innovative and pioneering spirit and strong execution ability, our team will continue to commit ourselves to bringing life-changing therapies to patients worldwide."

Mr. Wei Ying, Managing Partner of CDH Baifu, said, "As cell and gene therapies are being developed rapidly, transformative treatments are delivered to patients at an unprecedented pace. In an increasingly competitive environment, IASO Bio has established a diversified pipeline including fully human assets, and multiple blockbuster CAR-T candidates have achieved promising clinical outcomes. Biopharma is one of the key areas of focus for CDH. We are very happy to work with the outstanding team at IASO, and we look forward to exploring partnerships with IASO Bio in the field to accelerate delivery of innovative therapies and contribute to the development of the biopharma industry."

On September 16, 2021 TAE Life Sciences (TLS), a biological-targeting radiation therapy company developing next-generation boron neutron capture therapy (BNCT), reported a partnership with BEC GmbH (BEC) to incorporate a customized, robotic patient positioning system as part of its Alphabeam Neutron System for the high-precision radiation treatment of tumors (Press release, TAE Life Sciences, SEP 16, 2021, View Source [SID1234587841]).

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During BNCT, it is essential that the patient is positioned accurately in relation to the radiation beam and that the radiation therapist has the ability to adjust the patient’s position throughout the whole treatment session. BEC will be developing a unique chair setup that will allow for flexible patient treatment in a seated position in addition to the traditional treatment couch configuration. Exclusively designed for TLS’ Alphabeam Neutron System, the chair is optimal for treating specific types of head and neck cancers.

"The exact positioning of the patient and the ability to adjust as necessary during treatment is paramount in BNCT and we are thrilled to partner with BEC to adopt the best positioning system available today," said Bruce Bauer, PhD, CEO of TAE Life Sciences. "BEC is renowned in its field and the coupling of our BNCT therapy with its positioning system provides the best of both worlds in helping to treat invasive, recurrent and difficult to treat cancers."

Installed in the ceiling and equipped with a linear axis, BEC’s exacure system positions patients for treatment in front of the radiation beam in a stable and flexible manner, while allowing for up to 7 levels of movement. The camera system monitors the position of the patient treatment table 500 times per second and applies corrections in real time, if necessary, to ensure optimal treatment results. The requirements for medical devices that are used for BNCT treatment differ substantially from the requirements for systems used in conventional radiotherapy, as material properties become degraded by neutron irradiation. BEC provides the first certified complete system that guarantees safe operation of all components even under the effects of neutron radiation.

"Our robotic patient positioning system was developed specifically for partners like TAE Life Sciences that have created next-generation BNCT as a first line treatment for cancer patients, and we look forward to working together to provide flexible robotic patient positioning for high-end radiation treatment," said Matthias Buck, CEO of BEC GmbH.

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 Xilio Therapeutics, Inc. (Xilio) a biotechnology company developing tumor-selective immuno-oncology therapies for patients with cancer, reported that the first patient has been dosed in the company’s Phase 1/2 clinical trial evaluating XTX101 for the treatment of solid tumors (Press release, Xilio Therapeutics, SEP 16, 2021, View Source [SID1234587839]). XTX101 is a tumor-selective anti-CTLA-4 monoclonal antibody designed to improve upon the therapeutic index of existing anti-CTLA-4 therapies by overcoming their historical potency and tolerability limitations.

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"The initiation of our first clinical trial with XTX101 is an exciting moment for Xilio and for the patients with cancer who we believe would benefit from anti-CTLA-4 therapies, but are limited because of toxicity challenges," said Marty Huber, M.D., chief medical officer of Xilio Therapeutics. "In preclinical studies, XTX101 has shown potential to deliver meaningful responses and favorable tolerability. Our Phase 1/2 clinical trial will evaluate XTX101 as a monotherapy as well as in combination with the checkpoint inhibitor pembrolizumab. We look forward to advancing this trial and exploring the therapeutic potential of XTX101 for patients."

Leveraging its proprietary geographically precise solutions (GPS) platform, Xilio engineered XTX101 to be activated in the tumor microenvironment with the potential to result in localized clinical activity without dose-limiting toxicities. In preclinical studies, XTX101 exhibited tumor-selective biological activity and robust tumor growth inhibition, including complete responses in murine cancer models, with favorable tolerability. These data demonstrate enhanced activity and an improved tolerability profile compared to an analog of ipilimumab, a CTLA-4 blocking antibody approved for the treatment of certain solid tumor cancers. XTX101 has also demonstrated enhanced tumor growth inhibition and tolerability when administered in combination with an anti-PD-1 in vivo.

The Phase 1/2 clinical trial is a first-in-human, multi-center, open-label trial that will evaluate the safety and tolerability of XTX101 as a monotherapy, as well as a combination therapy with pembrolizumab, for the treatment of adult patients with advanced solid tumors. The Phase 1 portion of the trial will consist of three cohorts, beginning with an accelerated and standard 3+3 dose-escalation monotherapy cohort to assess the tolerability of XTX101 at the target dose in patients with advanced solid tumors who have progressed after receiving the standard-of-care treatment for their tumor. Following completion of enrollment in the dose-escalation cohort, XTX101 will be evaluated in a monotherapy cohort designed to evaluate evidence of anti-CTLA-4 pharmacodynamic activity in patients who have progressed on anti-PD-1 or anti-PD-L1 treatment but have not received prior treatment with an anti-CTLA-4 therapy, and XTX101 will be evaluated in combination with pembrolizumab in patients who have not previously been treated with an anti-PD-1 or anti-PD-L1 treatment. The Phase 1 portion of the trial is anticipated to enroll approximately 100 patients across all cohorts at multiple sites in the United States.

On September 16, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported that interim clinical results from a Phase 1/1b clinical study of SBT6050 as a monotherapy and in combination with pembrolizumab in patients with advanced or metastatic HER2-expressing or amplified solid tumors, at the 2021 European Society for Medical Oncology Congress (Press release, Silverback Therapeutics, SEP 16, 2021, View Source [SID1234587838]).

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"Over this past year, we have gathered compelling data with clear signals of SBT6050’s pharmacological activity, marked by the activation of both the innate and adaptive immune response in patients," said Laura Shawver, Ph.D., chief executive officer of Silverback. "We look forward to moving into expansion cohorts and to expanding our clinical development plan to include combination with standard-of-care trastuzumab-containing regimens."

As of August 1, 2021, 40 patients with advanced or metastatic HER2-expressing or amplified solid tumors were enrolled into the SBT6050-101 trial. SBT6050 dose levels ranged from 0.3 to 1.2 mg/kg in the monotherapy dose escalation arm (Part 1), and 0.15 and 0.3 mg/kg in the pembrolizumab combination arm (Part 3). Patients received between 1 and 17 doses of SBT6050.

As a monotherapy and in combination with pembrolizumab, SBT6050 was generally well-tolerated, with an adverse event profile that is consistent with immune system activation and considered on-mechanism. "The adverse event profile thus far has been very manageable and importantly, suggests the potential to combine with other standard of care agents," said Samuel Klempner, MD, Medical Oncologist at the Massachusetts General Hospital. "The signals of anti-tumor activity are encouraging and its complementary mechanism of action with standard-of-care agents makes SBT6050 attractive for combination regimens."

Initial Safety Data

The most frequent treatment-related adverse events were consistent with immune activation, and included injection site reactions, fever and chills, hypotension, nausea, vomiting, and fatigue. These were mostly Grade 1 or 2 in nature, and no Grade 4 or higher related adverse events were reported.
At higher dose levels, dose limiting toxicities (DLTs) were observed and included Grade 3 hypotension, injection site reaction, fever, and hypoxia. These DLTs resolved with supportive care.
Cytokine release syndrome (CRS) > Grade 2 was not observed at any dose level.
Pharmacokinetic and Pharmacodynamic Data

SBT6050 exposures increased with dose and exhibited a linear PK profile at 0.6 mg/kg and higher. Linear exposure is evidence of saturation of receptor mediated clearance.
Conjugate stability was assessed using a highly sensitive assay, and no active levels of SBT6050’s free payload were detected in the blood and any amount of free payload was absent in 98% of all blood samples tested.
SBT6050 induces pharmacologic activity indicative of myeloid and NK/T cell activation at all dose levels, with effects plateauing at 0.6 mg/kg.
Pharmacodynamic activity is maintained with repeat dosing of SBT6050.
Anti-Tumor Activity

Early signals of anti-tumor activity were observed in a heavily pre-treated, heterogeneous population.
Among 18 evaluable patients for tumor types of interest, one patient with HER2 IHC 2+ NSCLC had a confirmed partial response (-55% per RECIST 1.1 criteria), maintained at the most recently available scan obtained at 36 weeks post-enrollment, and 8 weeks after discontinuing study treatment. In addition, stable disease was reported in seven patients.
SBT6050 targets the pertuzumab binding domain of HER2 and is designed to be used in combination with standard of care agents, including trastuzumab-containing regimens. Silverback will be discussing details of its expanded clinical development strategy on the scheduled investor webcast today.

Conference Call and Webcast on Thursday, September 16, 2021, at 6:30 AM ET

Silverback’s management team will host a conference call today at 6:30 AM ET. A live webcast, including slides, can be accessed through the Events section of the Company’s website at View Source An archived replay will be available shortly after the conclusion of the event.

About SBT6050

SBT6050 is the first of a new class of targeted immuno-oncology agents designed to direct a TLR8 agonist linker-payload to activate myeloid cells in tumors expressing moderate to high levels of HER2. TLR8 is expressed in myeloid cell types prevalent in human tumors and TLR8 agonism can activate a broad spectrum of anti-tumor immune mechanisms, including pathways involved in the innate and adaptive immune response. SBT6050 was specifically designed to bind to the HER2 sub-domain II, the pertuzumab epitope, to enable combinations with trastuzumab-containing therapies. SBT6050 is currently being evaluated in a Phase 1/1b trial in patients with advanced or metastatic HER2-expressing or amplified solid tumors.