On May 31, 2022 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s investigational new drug (IND) application for its lead product candidate, JANX007, a PSMA-TRACTr in development for the treatment of metastatic castration-resistant prostate cancer (mCRPC) (Press release, Janux Therapeutics, MAY 31, 2022, View Source [SID1234615280]). JANX007 is the Company’s lead novel T cell engager (TCE) therapeutic from its TRACTr platform. Janux plans to initiate a Phase 1 clinical trial for JANX007 in the second half of 2022.

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"We are proud to announce today the clearance of Janux’s first IND – a critical milestone for our TRACTr platform and for the Company as we advance a broad pipeline of next generation immunotherapies to address unmet needs and improve the treatment of cancer," said David Campbell, Ph.D., President and CEO of Janux. "JANX007 is uniquely designed to overcome the clinical limitations of existing TCE approaches, potentially providing mCRPC patients a safer therapeutic option, while also generating potent anti-tumor activity by enabling the delivery of a higher concentration of active drug. With this IND acceptance, we are on track to advance JANX007 into the clinic in the second half of this year."

Unlike existing TCE approaches to prostate cancer that have been limited to-date by dose-limiting toxicities, poor pharmacokinetic (PK) profiles and attenuated efficacy, JANX007 is designed as a safer, highly potent anti-tumor approach to mCRPC. In preclinical studies, JANX007 was well tolerated in non-human primates with limited healthy tissue toxicities and cytokine release syndrome and exhibited enhanced safety and PK properties relative to unmasked TCEs. These data along with the superior manufacturability properties of JANX007 support its further development as an attractive mCRPC therapeutic.

On May 31, 2022 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported the launch of the Twist Human Methylome Panel, a product now available to customers that can advance applications in cancer metastasis, human development and functional genetics (Press release, Twist Bioscience, MAY 31, 2022, View Source [SID1234615279]). The panel can be used to identify a robust, collated set of CpG sites, methylated cytosine and guanine nucleic bases, across the human genome to identify biologically relevant methylation markers. Compared to traditional array based or whole genome bisulfite sequencing approaches, this panel provides overall cost savings while also covering previously unknown methylation markers. The Twist Human Methylome Panel can also be used as a first pass discovery tool to identify methylation biomarkers that can then be used in a variety of applications, such as more targeted liquid biopsy panels.

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The DNA methylome is the comprehensive set of nucleotides within the genome that have a methyl group attached. DNA methylation plays a key role in many biological processes, including cancer. When present on a single nucleotide, a methyl group can alter genetic behavior without changing the DNA sequence. Analyzing the pattern in which methylation occurs within a specific genetic sequence as well as the fraction of the genome that has a methyl group attached (methylated) provides a unique understanding of disease pathology. CpG sites, which often repeat to create CpG islands, turn a gene "on" or "off" and are associated with neurodegeneration, cancer and multiple rare diseases. Detection of CpG islands therefore can inform diagnoses or development stage of multiple diseases.

The Twist Human Methylome Panel is highly targeted to capture and detect the most recently identified and relevant CpG methylation regions in the genome. Twist uses hybrid capture panels to explore the methylome and the content that can be investigated to include 84.2% of CpG islands as well as other CpG sites.

"With the customizable Twist Human Methylome Panel, we are able to cover four times the amount of CpG sites compared to average microarrays. Using our NGS-based panel provides a higher dynamic range, allowing more accurate identification of differentially methylated regions, which we believe will enhance research-based assays and diagnostic tests that incorporate this dynamic tool," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "Previously, when identifying methylation markers, researchers had to choose between a low-cost, static option or a very expensive panel that covers a significant portion of the methylome, but often more than needed. As technology progresses, the compromise that researchers need to make between cost and coverage becomes less and less."

"We look forward to expanding our work with Twist as well as extending our epigenomics expertise and offerings to customers by incorporating the Twist Human Methylome Panel into our Epigenomics Profiling Services. This aligns with our efforts to continue offering new solutions to link methylation research with a wide range of disease indications and progression," said Didier Allaer, CEO of Diagenode, a leading epigenomics company and early access customer for the Twist Human Methylome Panel. "The new panel will enable us to offer a solution with broad coverage of the human methylome and to bring epigenetics research to new frontiers of biomarker discovery on clinical samples."

About Twist Human Methylome Panel

The Twist Human Methylome Panel enables the identification and study of methylation biomarkers spanning a wide range of targets and applications. The 123 megabase panel covers 84.2% of CpG island sites contained within the human genome and is optimized with the Twist Methylation workflow for robust end-to-end performance. The high capture efficiency increases the sensitivity of detection and internal data show that the Twist Human Methylome Panel achieves a depth of coverage of 90% of bases at 30x coverage with high probe specificities of 95% on-target rates, as well as high uniformity across the target region.

On May 31, 2022 Shasqi, a clinical-stage biotechnology company developing precision activated oncology therapeutics with its proprietary Click Activated Protodrugs Against Cancer (CAPAC) platform, reported that it will present interim data from its Phase 1 clinical study of SQ3370 in advanced solid tumors, at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held at McCormick Place in Chicago, IL, on June 3-7, 2022 (Press release, Shasqi, MAY 31, 2022, View Source [SID1234615278]).

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Presentation details:

Abstract Title: Interim Phase 1 results for SQ3370 in advanced solid tumors
Abstract Number: 3085
Poster Number: 77
Poster Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date and Time: Sunday, June 5, 2022, 8:00 AM-11:00 AM CDT
Key highlights include:

26 patients received treatment with SQ3370 and as of the data cutoff date, 21 patients were evaluable
77% of patients had metastases with a median number of 2 metastatic sites (1-5); most frequently lung (50%) and more than 50% being previously treated with doxorubicin
Escalating doses of SQP33 protodrug ranging from 0.38x to 12x the molar equivalent of conventional doxorubicin per cycle along with a dose of 10 or 20 mL of SQL70 were administered
SQ3370 was well tolerated with 62% of patients receiving more than 500 mg/m2 cumulative doxorubicin equivalents given as SQP33
The most common treatment emergent adverse events reported were nausea, fatigue, anemia, and constipation
At a median follow-up of 9.2 weeks, of the 21 evaluable patients, 71% had stable disease, with a median duration of 80 days
Dose escalation continues as the maximum tolerable dose has not yet been reached
SQ3370 demonstrates proof of concept for the CAPAC platform
About CAPAC and SQ3370

SQ3370 is the first click chemistry-based treatment to be tested in humans. It utilizes Shasqi’s proprietary CAPAC platform, an approach that activates cancer drugs at a tumor with decreased systemic toxicity. Shasqi is validating its platform with SQ3370, which is designed to activate a powerful chemotherapeutic, doxorubicin, at the tumor site. The investigational product is based on the chemical reaction between a drug protected through a trans-cyclooctene modification (a protodrug) and a tetrazine-modified biopolymer. The biopolymer is injected into the target tumor lesion, where it precisely activates an intravenously infused protodrug. Shasqi believes its click-chemistry approach can improve the efficacy and safety of many existing therapeutics across various modalities with a limited therapeutic window.

On May 31, 2022 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, reported that Markus Renschler, MD, President and Chief Executive Officer will participate in a presentation at the 2022 Jefferies Healthcare Conference (Press release, Cyteir Therapeutics, MAY 31, 2022, View Source [SID1234615277]). The meeting is being held in person in New York City on Friday, June 10, 2022 at 11:00 a.m. ET.

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A live webcast of the presentation will be available in the Investors & Media section of the Cyteir website at www.cyteir.com. A webcast replay will also be available on the website shortly after conclusion of the event for 30 days.

On May 31, 2022 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate the immune response to cancers and infections, reported that it has entered into 3 new clinical collaborations with Targovax, Oxford BioTherapeutics, and Immunogenesis, doubling its current number of clinical collaborations (Press release, Agenus, MAY 31, 2022, View Source [SID1234615276]). These 6 collaborations span a range of Agenus’ clinical assets, including botensilimab (Fc-enhanced anti-CTLA-4), balstilimab (anti-PD-1), zalifrelimab (anti-CTLA-4), and QS-21 STIMULON.

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Agenus is pursuing partnerships with companies developing agents with complementary mechanisms, paving the way for promising immunotherapy combinations to address immunosuppression in the tumor microenvironment. The combination studies are being sponsored and executed by our collaborators, with drug supply and scientific support provided by Agenus. This strategy, enabled by in-house integrated manufacturing and scientific capabilities, positions Agenus to achieve the insights and advances needed to drive development on accelerated timelines.

"These new collaborations with Targovax, Oxford BioTherapeutics, and Immunogenesis are exciting next steps in our partnership strategy to broaden combinations and indications under evaluation with our immunomodulatory antibodies," said Dr. Steven O’Day, Chief Medical Officer at Agenus. "We believe these combinations may unlock the power of immunotherapy more broadly, potentially offering new and promising benefit to patients with treatment-resistant solid tumors."

Agenus’ new and ongoing clinical collaborations are supporting and enabling:

Targovax to conduct a clinical trial combining botensilimab and balstilimab with ONCOS-102 (oncolytic virus) in patients with PD-1 relapsed/refractory melanoma. ONCOS-102 is designed to induce immune activation and immunogenic cell death to improve response to immunotherapy.

Oxford BioTherapeutics to conduct a clinical trial combining balstilimab with OBT076 (CD205-targeting antibody-drug conjugate) in patients with solid tumors, including lung, gastric, and ovarian cancer. OBT076 is expected to deplete CD205+ cancer cells, and immuno-suppressive cells within the tumor microenvironment, leading to T cell activation and increased response to immunotherapy.

Immunogenesis to conduct a clinical trial combining balstilimab and zalifrelimab with evofosfamide (hypoxia-reversal agent) in patients with advanced solid tumors, including prostate, pancreatic, HPV-negative head and neck cancer. Evofosfamide is anticipated to reduce tumor hypoxia and restore T cell infiltration and activity within the tumor microenvironment, increasing responsiveness to checkpoint therapy.

Targovax to conduct a clinical trial combining QS-21 STIMULON with TG01 (KRAS vaccine) in up to 3 cancer indications, including multiple myeloma. TG01 is designed to induce T cells that recognize and destroy mut-RAS cancer cells; QS-21 STIMULON is expected to improve immune cell recognition, activation, and TCR diversity of the immune response.

Rottapharm Biotech is conducting a clinical trial combining balstilimab with CR6086 (EP4 antagonist) in patients with pMMR-MSS colorectal cancer. CR6086 is expected to inhibit the immune suppressive role of prostaglandins in the tumor microenvironment, improving immunogenicity and responsiveness to immunotherapy. The Phase 1/2 study commenced in 2021.

Nelum is conducting a clinical trial combining zalifrelimab with NLM-001 (hedgehog inhibitor) and chemotherapy in patients with advanced pancreatic cancer. NLM-001 in combination with chemotherapy is anticipated to condition the tumor microenvironment to improve T cell infiltration, activation, and responsiveness to immunotherapy. The Phase 1/2 study commenced in 2021.