An Open-Label, Multi-Center Phase 2 Clinical Trial Evaluating SNS-301 in Patients With ASPH+ High Risk Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia

To evaluate safety, immunogenicity and anti-tumor responses of intradermally delivered SNS-301 in patients with ASPH+ high risk MDS and CMML.

开始日期2020-04-01

申办/合作机构

Sensei Biotherapeutics, Inc.

NCT04034225 / Terminated临床1/2期

An Open-Label, Multi-Center Trial of SNS-301 Added to Pembrolizumab in Patients With Locally Advanced Unresectable or Metastatic/Recurrent Squamous Cell Carcinoma of the Head and Neck

To evaluate safety, immunogenicity and anti-tumor responses of intradermally delivered SNS-301 added to checkpoint inhibitor therapy in locally advanced unresectable or metastatic/recurrent squamous cell carcinoma of the head and neck (SCCHN) patients.

开始日期2019-11-11

申办/合作机构

Sensei Biotherapeutics, Inc.

NCT03120832 / Completed临床1期

Phase 1, Open Label Trial to Evaluate the Safety and Immunogenicity of PAN-301-1 in Cancer Patients

This is a Phase I, open-label, parallel design study of PAN-301-1 (SNS-301), a HAAH directed nanoparticle vaccine, given intradermally in cohorts of patients with biochemically relapsed prostate cancer, using a fixed dose escalation schema every 21 days.

开始日期2016-12-01

申办/合作机构

Sensei Biotherapeutics, Inc.

[+1]

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项与 PAN-301-1 相关的文献（医药）

2015-01-01·Iranian journal of pharmaceutical research : IJPR4区 · 医学

Evaluation of Anti-inflammatory and Analgesic Activity of the Extract and Fractions of Astragalus hamosus in Animal Models.

4区 · 医学

Article

作者: Sima Norouzi ; Majid Motaghinejad ; Manijeh Motevalian ; Asie Shojaii

The objective of this study was to evaluate the anti-inflammatory and analgesic activities of the hydro-alcoholic extract of the pods of Astragalus hamosus (HAAH), a plant used in Iranian traditional medicine, and antinociceptive effects of different fractions in animal models. The anti-inflammatory effect was evaluated by the rat paw edema induced by formalin. Also the analgesic effect was examined by the acetic-acid-induced writhing response and hot plate test. The analgesic effects of chloroform, hexane, ethyl acetate and aqueous fractions were evaluated by the hot-plate method. The hydroalcoholic extract of Astragalus hamosus could reduce the edema in a dose-dependent manner (P<0.05). In the acute phase, the result of 1000 mg/Kg and in the chronic phase, the result of 100 and 300 mg/Kg of the extract were more significant and comparable with the effect of sodium salicylate. Also application of different doses of HAAH had significant anti-nociceptive effects on both animal models. The findings showed that HAAH at doses of 700 and 1000 mg/Kg produced analgesic effects comparable to sodium salicylate. The hexane and ethyl acetate (but not the other fractions) showed significant analgesic activity in hot plate test, when compared to morphine. The results of this study demonstrated the anti-inflammatory and analgesic effects of HAAH extract and hexane and ethyl acetate fractions of the extract in animal models and justify traditional use of this plant in the treatment of pain and inflammatory conditions. More studies to clarify the active components are necessary.

2010-05-01·Xi bao yu fen zi mian yi xue za zhi = Chinese journal of cellular and molecular immunology

[Cloning of the variable region genes from hybridoma against HAAH and then construction and expression of anti-HAAH scFv].

Article

作者: Song, Kai ; Hu, Yan-ting ; Yang, Hui ; Wang, Hua ; Wang, Wei ; Xue, Xiao-ping ; Lei, Ying-feng

AIM:

Construction and expression of anti-HAAH single chain variable fragment (scFv) by cloning of the variable region genes from anti-HAAH hybridoma cells G3/F11.

METHODS:

Total RNA was extracted from hybridoma cells G3/F11. By RT-PCR, murine V(H) and V(L) genes of mAb were amplified respectively. Then, They were assembled into V(H)-linker-V(L) scFv template by SOE-PCR and anti-HAAH scFv was express in E.coli by constructed pHEN 1-anti-HAAH vector. The expression of anti-HAAH scFv were detected by SDS-PAGE and Western blotting and the binding activity were demonstrated by ELISA.

RESULTS:

The analysis of DNA sequencing shown that the full-length of constructed scFv gene was 744 bp, encoding 248 amino acids. Moreover, the V(H) and V(L) genes were functional antibody variable region genes, as there were four FRs and three CDRs in both of them. By SDS-PAGE and Western blotting, the expression level of anti-HAAH scFv were detected. The expression level of pHEN 1-anti-HAAH scFv, which was expressed in E.coli HB2151, was 7.8% in total E.coli protein and were existed in soluble protein mainly. By indirect ELISA detection with HAAH protein, the binding activity of soluble anti-HAAH scFv was very well.

CONCLUSION:

The murine V(H) and V(L) genes of mAb against HAAH have been cloned successfully and anti-HAAH scFv have been constructed and expressed. Besides, the scFv could be further studied about their biological activity and application, due to their high affinity shown in preliminary detection.

2004-01-01·Journal of biomedicine & biotechnology

Cancer Diagnostics Integrated With Therapeutics: A Comprehensive Approach to Managing the Disease

Article

作者: Ghanbari, Hossein A.

A promotional poster by the US Public Health Service in cooperation with the American Society for Control of Cancer dated 1938 hangs in our conference room and shows a rooster crowing at sunrise. The poster reads: “Early is the Watch Word for Cancer Control; early diagnosis/early treatment will save many lives; early cancer can be cured.” It is obvious that the prerequisite for early treatment is early diagnosis. Currently, it is soundly projected that early diagnosis increases the survival of cancer patients by five years, making it the best “treatment” alternative yet. Currently, there are a number of in vitro (laboratory) as well as in vivo (imaging) cancer diagnostics procedures available. However, the specificity and sensitivity of many of these tests are barely acceptable, and the diagnosis of cancer is usually made with the aid of other parameters—biopsy being the most definitive. More important, and more relevant to this editorial, the diagnostic markers in many of these cancer tests may not have anything to do with cancer biology or etiology; they just happen to be there. The best and well-known example is the prostate-specific antigen (PSA) test for prostate cancer that measures PSA production (and hence its serum level) which is elevated in individuals with large prostate, enlarged prostate, or enlarging or inflamed prostate (by injury, infection, cancer, etc). Although patients with prostate cancer usually have elevated PSA levels, a majority of people with abnormally high serum PSA levels do not have prostate cancer. Figure 1 A promotional poster by the US Public Health Service in cooperation with the American Society for Control of Cancer dated 1938. On the treatment side, physicians generally consider cancers that affect each organ or group of organs as “distinct” diseases (eg, brain tumor, prostate cancer, lung cancer, colon cancer, breast cancer, ovarian cancer, etc). For physicians, particularly surgeons, caring for cancer patients, this perspective makes a lot of sense because each tumor presents itself differently and has different implications and ramifications for individual patients. These differences have a considerable impact on the strategy for patient management. However, in drug discovery process, one needs to be more open-minded and treat cancer as a biological phenomenon with a mechanism of action spanning over various “cancers.” Drug discovery scientists need not be restrictive toward any particular cancer, and physicians need not be skeptical toward a pan approach to cancer diagnosis and treatment. Scientists and physicians alike need to actively consider prevention in their approach for patient management. Ideally, the goal of cancer patient management is to tie the diagnosis with the treatment. We are working toward this goal by continuing research and development in which the diagnostic marker and therapeutic target is the very same molecule. It is certainly possible to measure serum and tissue levels of this molecule for diagnosis, to target it for treatment, to examine it for prognosis, and subsequently use it for surveillance, and even use it to predict the aggressiveness of cancer and choose the treatment option. The diagnostic marker and therapeutic target in our cancer discovery program is human aspartyl (asparaginyl) β-hydroxylase (HAAH). This enzyme is an α-ketoglutarate-dependent deoxygenase that catalyzes post-translational hydroxylation of β carbons of aspartyl and asparaginyl residues present in epidermal-growth-factor (EGF)-like domains of certain proteins, including notch and notch homologues, which have known roles in oncogenesis and cellular functions that propagate the malignant phenotype. Experimental overexpression of HAAH causes malignant transformation, and inhibition of over-expression or inactivation of HAAH results in normalization of malignant phenotypes. HAAH over-expression correlates with motility of malignant neoplastic cells; as such, it has a functional role in cell migration or invasiveness—properties required for infiltrative and metastatic tumor growth. As a diagnostic marker, HAAH is found to be overexpressed in virtually every tissue of every cancer specimen and absent in noncancer tissues (with the exception of placental trophoblast cells) tested by immunohistochemical (IHC) methods. Moreover, preliminary studies using sandwich ELISA for analysis of serum samples have resulted in an assay specificity of 97% and sensitivity of 95%–100% (depending on the sample set). Gene expression analysis (RT-PCR or qRT-PCR) also has demonstrated the overexpression of HAAH in virtually every cancer tissue type tested and in none of the noncancer specimens. Beyond just a simple diagnostic marker, HAAH levels could be used to predict the aggressiveness of cancer in the patient and guide the physician in choosing an appropriate treatment option. In a recent study by Takashi Maeda, MD, et al, “Clinicopathological Correlates of Aspartyl (Asparaginyl) β-Hydroxylase Over-Expression in Cholangiocarcinoma Cancer Detection and Prevention,” it was demonstrated that HAAH expression in surgically resected intrahepatic cholangiocarcinoma significantly correlated with tumor size, growth types, differentiation, vascular invasion, and poor prognosis after surgery. Further, HAAH has been proven, in principle, to be a valid target for cancer therapeutic development. Its relevance to cancer is well established by its biological role and its presence in most cancer cells. Upon over-expression, HAAH migrates to the cell surface and is primarily present in the infiltrating periphery of the tumor, making it an accessible target. Moreover, anti-HAAH antibodies (both naked and bound to toxins) internalize subsequent to binding to HAAH on the cell surface. Also, anti-HAAH antibodies and antisense inhibit proliferation, motility, and invasion in vitro and in vivo. Finally, in preliminary animal efficacy studies, injection of an anti-HAAH antibody has shown inhibition of growth and metastasis of established human colon cancer in a mouse xenograft model of human colon cancer metastasized to the liver. Aside from HAAH's diagnostic and therapeutic value, based on the biological role of HAAH and the molecule, per se, it can be readily speculated that HAAH may be used as a target for the prevention of cancer. Obvious examples of preventive measures would be passive and active immunization for individuals at high risk. Again, the preventative approach can be keyed to HAAH levels, particularly for the period of post-treatment or post-surgery and other “at-risk” patients. Many breakthroughs have been reported in the area of cancer diagnostics, therapeutics, and even prevention. Moreover, there has been a widespread tendency to combine these approaches. However, true integration of these approaches requires a common thread, and the discoverers and practitioners in oncology need to actively seek that common thread. Here, I have highlighted HAAH as a common thread to demonstrate that true integration of diagnostics and therapeutics is a possibility and its pursuit should stand at the forefront of efforts to manage and eventually tame cancer.

项与 PAN-301-1 相关的新闻（医药）

2022-11-03

·Endpoints

'Do the right thing': Billionaire pushes struggling biotech to return cash to investors

With a record number of biotechs now trading below cash amid a brutal public market downturn, many have sought ways to extend the cash runway — shuttering programs, laying off employees, or even raising money by selling shares at a discounted price — and stay afloat. In the case of Sensei Biotherapeutics, though, an investor believes the right thing to do would be to reduce the cash runway. Christian Angermayer, a German billionaire who holds an 11% stake in Sensei through his family office Apeiron Investment Group, is unequivocal in an open letter: STAT first reported on the letter, which Sensei posted in an SEC filing . He began backing Sensei (formerly Panacea), Angermayer writes, in its earliest stages, drawn to an immunophage platform that promises to generate one-of-a-kind I/O therapies, eventually becoming one of its largest shareholders. But the stock has been on a steady decline since the IPO in February 2021 , and plunged further after Sensei’s sole clinical program, SNS-301, disappointed in early-stage trials, leading to its eventual discontinuation. While the shares debuted at $19 per piece, they now trade below $1.50. Execs have since shifted focus to a range of preclinical programs, but Angermayer describes them as “fundamentally unrelated to the promising technology underpinning SNS-301.” He continues: In his letter, Angermayer notes that he’s attempted to discuss the matter privately with the board, but it hasn’t been receptive to his suggestions. By going public with his concerns and argument, he hopes to get more shareholders to voice their concerns and pressure the board to take action. “We appreciate that reducing cash runway is always uncomfortable and the natural resistance for a Board to having to put its investment thesis to the test of a shareholder vote of confidence. However, we are convinced that reconsolidating shareholder support for Sensei will be critical for its long-term success and survival,” he writes. “We want to emphasize that we do see value in the preclinical work Sensei is doing, however, we believe it can be done with significantly less cash than the Company has on hand at the moment.”

IPO

2021-08-04

·GlobeNewswire

Sensei Biotherapeutics Reports Second Quarter 2021 Results

- Company announced first set of pH-sensitive anti-VISTA antibodies showing significant in vivo anti-tumor activity in combination with PD-1 blockade in a human VISTA knock-in mouse model – - Company plans to select a lead SNS-VISTA candidate and initiate IND-enabling studies by year-end 2021 - SNS-401-NG on track to start IND-enabling studies in second half of 2022 – -Strong cash position of $162.5 million to support platform innovation and next generation program development - BOSTON, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (NASDAQ: SNSE), an immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, today reported financial results for the second quarter ended June 30, 2021 and provided recent corporate updates, including new in vivo data from the company’s SNS-VISTA program. “The second quarter of 2021 was an important one for Sensei as we advanced our next-generation ImmunoPhage platform technology based on critical learnings from our first generation ImmunoPhage and expanded our R&D footprint and capabilities. We also continue to make important strides toward the clinic with our SNS-VISTA program,” said John Celebi, president and chief executive officer of Sensei Biotherapeutics. “As we enter the third quarter of 2021, we are in a strong cash position to progress our development programs. By leveraging the synergies of these programs, our goal is to generate tumor-specific T-cells through our ImmunoPhage platform and to unleash the full potential of tumor-specific T-cells through our TMAb platform. We are looking forward to sharing additional data and to announcing new programs.” Sensei also announced today early in vivo data from its SNS-VISTA program. VISTA is recognized as an important immune checkpoint regulator. Disrupting the interaction of VISTA and its receptor on T-cells, known as PSGL1, has been shown to enhance T-cell activation and tumor cell killing. The VISTA-PSGL1 T-cell checkpoint is activated under low pH conditions such as the tumor microenvironment. Sensei’s research team has identified a set of fully-human, highly selective, pH-dependent anti-VISTA antibodies. In a human VISTA knock-in mouse model, these parental antibodies significantly enhanced anti-tumor responses in combination with PD-1 blockade compared to treatment with PD-1 blockade alone. Based on these nonclinical data, the company plans to initiate IND-enabling studies with a lead candidate and present data at a scientific conference by the end of 2021. “Since the inception of our SNS-VISTA program, we have believed the key to unlocking the power of this immune checkpoint is to design an antibody that selectively binds and blocks VISTA at low pH levels in the tumor microenvironment,” said Robert Pierce, MD, chief scientific officer of Sensei Biotherapeutics. “This pH-driven, tumor-selective approach is an important feature of our VISTA platform due to high levels of expression on blood cells at physiologic pH. Thus, blood represents a significant pharmacokinetic sink, which can hinder distribution into the tumor microenvironment. Additionally, we believe that by engineering pH-sensitivity into our VISTA antibody, the safety profile may be improved by limiting on-target and off-tumor binding and activity. We believe these nonclinical data are an important proof point for our platform. We look forward to selecting a lead candidate and moving into IND-enabling studies.” Recent Updates and Second Quarter Highlights: Strengthened Board of Directors and Immuno-Oncology Advisory Board – In August, Sensei announced that it appointed Kristian Humer as an independent director to its Board. Additionally, in the second quarter, Sensei announced the addition of Jessie English, Ph.D. to its Board of Directors and Maura Gillison, M.D. and Richard Ulevitch, Ph.D. to its Immuno-Oncology Advisory Board. Prioritized pipeline toward next-generation platform programs – In June, Sensei announced its decision to reprioritize its resources toward its pipeline of next generation product candidates, including: its multi-antigenic next generation ImmunoPhage candidate SNS-401-NG, which uses an optimized antigen linkage technology developed at Sensei; its monoclonal antibody SNS-VISTA (V-set Immunoglobulin Domain Suppressor of T cell Activation) candidate; and complete discovery work for its VSIG4 (V-Set And Immunoglobulin Domain Containing 4) TMAb program. As part of the company’s prioritization, it discontinued development of SNS-301, a first-generation, single-antigen ImmunoPhage that expressed a fragment of the tumor-associated antigen, human aspartate β-hydroxylase (ASPH). Strengthened TMAb (Tumor Microenvironment Antibody Biologics) platform – In July, Sensei expanded the scope of its collaboration with AdiMab, LLC to include additional antibody campaigns focused on the generation of human monoclonal antibodies for its next generation pH sensitive antibody programs. Selected Contract manufacturer (CDMO) for SNS-VISTA – In July, Sensei selected a CDMO for the manufacture of GMP-grade material to advance its SNS-VISTA program toward clinical studies. Expanded Operational Footprint – In June, Sensei expanded its research footprint by adding an additional 5,000 square feet of laboratory space at its 451D Street Boston headquarters. The additional lab space will support the advancement of Sensei technologies used for the discovery of nanobodies used in its ImmunoPhage platform or as standalone therapeutics. Upcoming Program Milestones: Sensei is focused on progressing novel product candidates generated from both its ImmunoPhage platform and Phortress Library™, and TMAb platform. Sensei’s Phortress Library of Immunophages, derived from antigens found across multiple patient populations and tumor types, enables a personalized, yet off-the-shelf therapeutic option to patients. TMAb (Tumor Microenvironment Antibody Biologics) Platform VISTA (V-domain Ig suppressor of T cell activation) is an immune checkpoint that inhibits anti-tumor immune responses. VISTA may play a role in both intrinsic and acquired PD-1/PD-L1 resistance. VSIG4 (V-Set and Immunoglobulin Domain Containing 4) is a B7-family related protein and a potent inhibitor of T-cell activity, often overexpressed on macrophages within the tumor microenvironment. VSIG4 may play a role in enforcing the immunosuppressive program in macrophage-rich tumors. Inhibition of VSIG4 activity could also enhance T-cell-mediated anti-tumor immune responses. ImmunoPhage™ Platform SNS-401-NG is a potential first-in-class, multi-antigenic personalized ImmunoPhage candidate being developed in collaboration with the University of Washington. The first clinical application is directed to the treatment of Merkel Cell Carcinoma (MCC), an aggressive form of skin cancer commonly driven by the Merkel Cell Polyoma Virus. Once clinical proof of concept is achieved, Sensei plans to evaluate a broader basket study in patients with head and neck cancer, lung cancer, melanoma, and triple negative breast cancer based on the prevalence of Phortress antigens. Second Quarter 2021 Financial Results Cash Position – Cash, cash equivalents and marketable securities were $162.5 million as of June 30, 2021, as compared to $16.6 million as of December 31, 2020. Sensei expects the current cash balance to fund operations at least into the first half of 2024. Research and Development (R&D) Expenses – R&D expenses were $5.9 million for the quarter ended June 30, 2021, compared to $2.9 million for the quarter ended June 30, 2020. The increase in R&D expenses was primarily attributable to increased headcount to support Sensei’s research, development, and manufacturing activities. General and Administrative (G&A) Expenses – G&A expenses were $3.9 million for the quarter ended June 30, 2021, compared to $1.3 million for the quarter ended June 30, 2020. The increase in G&A expenses was primarily attributable to higher personnel costs, including stock-based compensation expense, and costs associated with operating as a public company. Net Loss – Net loss was $9.8 million, for the quarter ended June 30, 2021, compared to $4.9 million for the quarter ended June 30, 2020. About Sensei BiotherapeuticsSensei Biotherapeutics is a biopharmaceutical company engaged in discovery, development, and delivery of next generation immunotherapies with an initial focus on treatments for cancer. Sensei has developed two unique approaches – its ImmunoPhage platform that leverages bacteriophage to fully engage the immune system, and its TMAb (Tumor Microenvironment Antibody Biologics) platform, comprising unique human monoclonal antibodies and alpaca derived nanobodies that are selectively active in the tumor microenvironment. Using the ImmunoPhage platform, Sensei is developing a library of ImmunoPhage, called Phortress™, to target multiple tumor-associated antigens to create a personalized, yet off-the-shelf cocktail approach for treating cancer patients. The platform is designed to enable efficient, scalable and cost-effective manufacturing to support all of Sensei’s clinical programs. SNS-401-NG is an ImmunoPhage cocktail in preclinical development for the treatment of Merkel Cell Carcinoma. Using its TMAb platform, the company has developed SNS-VISTA, an antibody-based therapeutic in lead generation targeting an immune checkpoint gene that inhibits anti-tumor immune responses called V-domain Ig suppressor of T cell activation (VISTA). For more information, please visit , and follow the company on Twitter @SenseiBio and LinkedIn. Cautionary Note Regarding Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Sensei’s current beliefs and expectations. These forward-looking statements include expectations regarding the development of Sensei’s product candidates and platforms, the availability of data from Sensei’s preclinical studies, and its belief that its existing cash and cash equivalents will be sufficient to fund its operations at least into the first half of 2024. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the development of therapeutic product candidates, such as preclinical discovery and development, conduct of clinical trials and related regulatory requirements, Sensei’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Sensei’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 30, 2021 and Sensei’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Sensei as of the date of this release, and Sensei assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contact:Lora PikeVP, Investor Relations and CommunicationsSensei Biotherapeuticslpike@senseibio.com Media Contact:Mike BeyerSam Brown Inc. Healthcare Communications312-961-2502mikebeyer@sambrown.com

财报抗体First in Class免疫疗法

2021-06-28

·BioSpace

Sensei Biotherapeutics Announces Prioritization of Next-Generation Multi-Antigenic ImmunoPhage Platform, Monoclonal Antibody and Nanobody Programs

- Company to focus on development of next-generation phage product candidates from ImmunoPhage platform and monoclonal antibody and nanobody programs - - Discontinuation of first-generation, single-antigen phage SNS-301 program upon analysis of clinical activity and antigen specific T-cell data - - Cash runway extended into first half of 2024 - - Conference call scheduled for today at 4:30 p.m. ET - BOSTON, June 28, 2021 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, an immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, today announced that it is reprioritizing its pipeline programs to focus on its product candidates, including its multi-antigenic next generation ImmunoPhage candidate, now referred to as SNS-401-NG, and its monoclonal antibody SNS-VISTA (V-set Immunoglobulin Domain Suppressor of T cell Activation) candidate. With this reallocation of resources, Sensei expects its cash and cash equivalents will be sufficient to fund its operations into the first half of 2024. “Sensei’s approach to drug development is deeply rooted in targeting key mechanisms of checkpoint resistance to induce a robust, focused and coordinated immune response to cancer. We believe our next generation, multi-antigenic ImmunoPhage product candidates have the potential to drive robust antigen-specific T cell responses that will translate into clinical benefit,” said John Celebi, president and chief executive officer of Sensei Biotherapeutics. “Given the totality of data generated to-date from the Phase 1/2 combination trial of first-generation SNS-301, we believe we have captured important insights into the power of our ImmunoPhage platform that will further advance development of our pipeline product candidates. Through SNS-301, we have gained important information on key product attributes that we believe contribute to the safety and immunogenicity of our ImmunoPhage platform as well as how to manufacture and scale our product candidates. Specifically, we have learned that the use of gpD fusion as an antigen display technology is suboptimal for use in an active cancer vaccine. We believe the incorporation of new antigen attachment technologies will ensure optimal immunogenicity. We are excited by our next generation programs, and we look forward to further advancing our two ongoing programs SNS-401-NG and SNS-VISTA into the clinic and completing discovery work for our VSIG4 antibody program.” “I would like to express my gratitude to all of the patients and their families, investigators and collaborators who participated in the SNS-301 study,” said, Marie-Louise Fjaellskog, M.D., Ph.D. chief medical officer of Sensei Biotherapeutics. “Our data-driven decision-making process is at the forefront of our work, and we are well positioned and capitalized to further progress our next-generation pipeline programs, SNS-401-NG and SNS-VISTA, by utilizing our two unique drug discovery approaches – our ImmunoPhage platform and our monoclonal antibody and nanobody platform. We look forward to initiating IND-enabling studies for SNS-VISTA by the end of 2021 and for SNS-401-NG in second half of 2022.” SNS-301 was developed as a first-generation, bio-engineered, inactivated bacteriophage virus expressing a fragment of the tumor-associated antigen, human aspartate β-hydroxylase (ASPH), as a fusion protein to the bacteriophage lambda capsid decoration protein, gpD, for patients with locally advanced unresectable or metastatic squamous cell head and neck cancer (SCCHN). To date, 25 patients were enrolled in the Phase 1/2 clinical study and received at least one dose of SNS-301 in combination with pembrolizumab; one patient had a deep and durable partial response (PR) and 8 patients had stable diseases. While encouraged by the safety pro the SNS-301 single antigen approach, based upon the recent analysis of antigen specific T-cell activation which did not show a significant increase in ASPH-specific T cells, including the one patient who experienced a long-standing and deep PR, and an updated analysis of clinical data, Sensei has decided to reprioritize its pipeline and refocus resources. Sensei anticipates sharing full SNS-301 clinical data and the results of specific B and T cell response data at a future scientific conference. Next-Generation Pipeline Highlights and Upcoming Milestones Sensei is focused on progressing novel product candidates generated from both its ImmunoPhage platform and Phortress Library™, coupled with its human monoclonal antibody and nanobody platform. Sensei’s Phortress Library of immunophages, derived from antigens found across multiple patient populations and tumor types, enables a personalized, yet off-the-shelf therapeutic option to patients. SNS-401-NG is a first-in-class, multi-antigenic personalized ImmunoPhage candidate being developed in collaboration with the University of Washington. Sensei has designed SNS-401-NG as a personalized product candidate composed of premanufactured Immunophage from Sensei’s Phortress library on an improved and proprietary bacteriophage construct. Sensei intends to initiate IND-enabling studies for this product candidate in the second half of 2022. The first clinical application is directed to the treatment of Merkel Cell Carcinoma (MCC), an aggressive form of skin cancer commonly driven by the Merkel Cell Polyoma Virus. If clinical proof of concept is achieved, Sensei plans to evaluate a broader basket study in patients with head and neck cancer, lung cancer, melanoma, and triple negative breast cancer based on the prevalence of Phortress antigens. VISTA (V-domain Ig suppressor of T cell activation) is an immune checkpoint that inhibits anti-tumor immune responses. VISTA is implicated in PD-1/PD-L1 resistance and therapeutic intervention. VISTA has the potential to be effective as a monotherapy and synergistic with PD-1/PD-L1 inhibition. Sensei has generated potent pH-dependent parental antibodies that block the interaction of VISTA with its receptor, PSGL1, expected to result in a favorable pharmacokinetic (PK) pro selective activity in the acidic tumor microenvironment – a critical feature of this product candidate, and an important differentiator to other compounds in development targeting VISTA. Sensei plans to present preclinical data from the SNS-VISTA program at a scientific conference in 2021 and to initiate IND-enabling studies by the end of 2021. VSIG4 (V-Set And Immunoglobulin Domain Containing 4) is a potent inhibitor of T cell activity, often overexpressed on macrophages within the tumor microenvironment. Sensei believes that a tumor-selective blocking monoclonal antibody will have potent anti-tumor immune effects. Sensei is extending its approach to developing antibodies with enhanced tumor selective activity to other candidate immune checkpoint targets, and anticipates selecting a product candidate from this program in 2023. Conference Call and Webcast Information Sensei will host a live conference and webcast today, June 28, 2021, at 4:30 p.m. ET, to discuss these company updates. To access the conference call, please dial 833-362-0204 (domestic) or 914-987-7673 (international) and refer to conference ID number 7464477. The live webcast can be accessed under the “Events & Presentations” section of Sensei’s website at . The webcast will be archived and made available for replay on Sensei’s website approximately two hours after the call and will be available for 30 days. About Sensei Biotherapeutics Sensei Biotherapeutics is a biopharmaceutical company engaged in discovery, development, and delivery of next generation immunotherapies with an initial focus on treatments for cancer. Sensei has developed two unique approaches – its ImmunoPhage platform that leverages bacteriophage to fully engage the immune system, and its monoclonal antibody (mAb) and nanobody platform, comprising unique human monoclonal antibodies and alpaca derived nanobodies that are selectively active in the tumor microenvironment. Using the ImmunoPhage platform, Sensei is developing a library of ImmunoPhage, called Phortress™, to target multiple tumor-associated antigens to create a personalized, yet off-the-shelf cocktail approach for treating cancer patients. The platform is designed to enable efficient, scalable and cost-effective manufacturing to support all of Sensei’s clinical programs. SNS-401-NG is an ImmunoPhage cocktail in preclinical development for the treatment of Merkel Cell Carcinoma. Using its mAb platform, the company has developed SNS-VISTA, an antibody-based therapeutic in lead generation targeting an immune checkpoint gene that inhibits anti-tumor immune responses called V-domain Ig suppressor of T cell activation (VISTA). For more information, please visit , and follow the company on Twitter @SenseiBio and LinkedIn. Cautionary Note Regarding Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Sensei’s current beliefs and expectations. These forward-looking statements include expectations regarding the preclinical and clinical development of Sensei’s product candidates and platforms, the availability of data from Sensei’s clinical trials, and its belief that its existing cash and cash equivalents will be sufficient to fund its operations into the first half of 2024. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the development of therapeutic product candidates, such as preclinical discovery and development, conduct of clinical trials and related regulatory requirements, Sensei’s reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in Sensei’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 30, 2021 and Sensei’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Sensei as of the date of this release, and Sensei assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contact: Lora Pike VP, Investor Relations and Communications Sensei Biotherapeutics lpike@senseibio.com Media Contact: Mike Beyer Sam Brown Inc. Healthcare Communications 312-961-2502 mikebeyer@sambrown.com

合作抗体First in Class疫苗免疫疗法

100 项与 PAN-301-1 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
慢性粒单核细胞白血病	临床2期	-	Sensei Biotherapeutics, Inc.	2020-04-01
骨髓增生异常综合征	临床2期	-	Sensei Biotherapeutics, Inc.	2020-04-01
具有隐匿性原发灶的复发性转移性颈部鳞癌	临床2期	美国	Sensei Biotherapeutics, Inc.	2019-11-11
复发性头颈部鳞状细胞癌	临床2期	美国	Sensei Biotherapeutics, Inc.	2019-11-11
前列腺癌	临床1期	美国	Sensei Biotherapeutics, Inc.	2016-12-01

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04034225 (ASCO2023) 人工标引	临床1/2期	晚期头颈部鳞状细胞癌	25	SNS-301+Pembrolizumab (patients (pts) not achieving tumor reductions on PD-1 blockade alone)	壓觸網鹹壓鑰築窪糧鹹(廠願衊憲鹹鬱夢糧獵憲) = Grade 3 TRAEs included pruritus, rash, dehydration and QT prolongation. 製衊顧窪夢醖襯衊製製 (遞鑰廠鹹憲艱壓鏇範鹹 )	不佳	2023-05-26
				SNS-301+Pembrolizumab (PD-1 blockade naïve patients)
NCT03120832 (CTgov)	临床1期	前列腺癌	12	PAN-301-1 vaccine (Cohort 1)	膚膚繭繭願築獵鹹願構(願鏇願鏇鹽襯製顧廠襯) = 廠鹽鑰鹹廠窪願艱廠鏇糧簾襯憲醖糧蓋網遞醖 (鏇範積選獵顧餘繭鑰襯, 艱鑰襯網衊夢醖衊鑰襯 ~ 夢餘餘構夢範範遞觸構) 更多	-	2021-11-12
				PAN-301-1 vaccine (Cohort 2)	膚膚繭繭願築獵鹹願構(願鏇願鏇鹽襯製顧廠襯) = 膚夢網齋遞鹹構選窪艱糧簾襯憲醖糧蓋網遞醖 (鏇範積選獵顧餘繭鑰襯, 衊積築衊鬱衊觸製鏇鏇 ~ 夢鑰觸觸膚鏇鑰網築網) 更多
NCT04034225 (ASCO2021) 人工标引	临床1/2期	晚期头颈部鳞状细胞癌	13	pembrolizumab+SNS-301	顧簾積獵淵繭簾夢壓壓(遞構願簾顧鹽積餘網獵) = rash & dehydration (also a serious adverse event) 製網壓艱鹹齋顧積鹽襯 (艱鏇醖願夢構簾網積顧 )	积极	2021-05-28
NCT03120832 (ESMO2018) 人工标引	临床1期	非转移性前列腺癌 ASPH Overexpression	12	PAN-301-1	齋鏇衊遞鏇觸鹹壓壓衊(衊構窪壓夢壓糧膚夢鹽) = 3X10^11 particles 蓋範憲繭鑰鹹齋壓憲襯 (網窪遞壓積憲艱齋鹽廠 ) 更多	积极	2018-10-20