预约演示
更新于：2026-03-28
Amezalpat
更新于：2026-03-28
概要
基本信息
非在研机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床1/2期 |
特殊审评孤儿药 (美国)、孤儿药 (欧盟)、快速通道 (美国) |
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结构/序列
分子式C34H41N3O4 |
InChIKeyKUPVZYDOHAPPNF-UHFFFAOYSA-N |
CAS号1616372-41-8 |
关联
3
项与 Amezalpat 相关的临床试验NCT06680258
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of TPST-1120 in Combination With Atezolizumab Plus Bevacizumab Compared With Placebo Plus Atezolizumab Plus Bevacizumab in Patients With Unresectable or Metastatic Hepatocellular Carcinoma (HCC) Not Previously Treated With Systemic Therapy
The goal of this clinical trial is to determine if TPST-1120 in combination with atezolizumab and bevacizumab helps patients to live longer compared to atezolizumab and bevacizumab alone (the standard of care treatment) in adult patients with hepatocellular carcinoma that cannot be removed by surgery or has spread outside of the liver (called metastatic). The trial also will study the safety and side effects of the drug combination compared to the standard of care treatment. Other questions the trial aims to answer include:
1. Does TPST-1120 in combination with atezolizumab and bevacizumab improve the time that patients are alive and cancer is not growing (progression free survival) compared to atezolizumab and bevacizumab
2. Does TPST-1120 in combination with atezolizumab and bevacizumab improve the shrinking of cancer (the overall response rate) compared to atezolizumab and bevacizumab
Trial participants will be randomly assigned to take one of the following:
1. TPST-1120 3 tablets (600 mg) by mouth twice a day every day along with atezolizumab 1200 mg intravenously every 3 weeks and bevacizumab 15 mg/kg intravenously every 3 weeks
2. Placebo (look-alike that does not contain study drug) 3 tablets by mouth twice a day every day along with atezolizumab 1200 mg intravenously once every 3 weeks and bevacizumab 15 mg/kg intravenously once every 3 weeks
Trial participants will receive routine and trial-specific cancer care from their study doctor including
* visits to the clinic every 3 weeks for physical examination, labs and questions about health and symptoms
* measurement of their cancer by CT scan every 9 weeks.
Trial participants can stop study treatment at any time they choose and for any reason. They also can continue to receive study treatment for as long as the treatment is controlling cancer growth and they are tolerating the drug effects.
1. Does TPST-1120 in combination with atezolizumab and bevacizumab improve the time that patients are alive and cancer is not growing (progression free survival) compared to atezolizumab and bevacizumab
2. Does TPST-1120 in combination with atezolizumab and bevacizumab improve the shrinking of cancer (the overall response rate) compared to atezolizumab and bevacizumab
Trial participants will be randomly assigned to take one of the following:
1. TPST-1120 3 tablets (600 mg) by mouth twice a day every day along with atezolizumab 1200 mg intravenously every 3 weeks and bevacizumab 15 mg/kg intravenously every 3 weeks
2. Placebo (look-alike that does not contain study drug) 3 tablets by mouth twice a day every day along with atezolizumab 1200 mg intravenously once every 3 weeks and bevacizumab 15 mg/kg intravenously once every 3 weeks
Trial participants will receive routine and trial-specific cancer care from their study doctor including
* visits to the clinic every 3 weeks for physical examination, labs and questions about health and symptoms
* measurement of their cancer by CT scan every 9 weeks.
Trial participants can stop study treatment at any time they choose and for any reason. They also can continue to receive study treatment for as long as the treatment is controlling cancer growth and they are tolerating the drug effects.
开始日期2025-12-01 |
申办/合作机构 |
NCT04524871
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients With Advanced Liver Cancers (Morpheus-Liver)
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with advanced liver cancers. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, modify the participant population, or introduce additional cohorts of participants with other types of advanced primary liver cancer.
Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.
Cohort 1 will enroll participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy for their disease. Eligible participants will initially be randomly assigned to one of several treatment arms (Stage 1). Participants who experience loss of clinical benefit or unacceptable toxicity during Stage 1 may be eligible to receive treatment with a different treatment combination (Stage 2). When a Stage 2 treatment combination is available, this will be introduced by amending the protocol.
开始日期2020-11-01 |
申办/合作机构 |
NCT03829436
A Phase 1/1b Open-label, Dose-escalation and Dose-expansion Study of TPST-1120 as a Single Agent or in Combination With Systemic Anti-Cancer Therapies in Subjects With Advanced Solid Tumors
This is a phase 1/1b open label, multicenter dose escalation and dose expansion study to investigate the safety, tolerability and anti-tumor activity of TPST-1120, a small molecule selective antagonist of PPARα (peroxisome proliferator activated receptor alpha) as monotherapy and in combination with a systemic anticancer agent, nivolumab, an anti-PD1 antibody, in subjects with advanced solid tumors.
开始日期2019-03-20 |
申办/合作机构 |
100 项与 Amezalpat 相关的临床结果
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100 项与 Amezalpat 相关的转化医学
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100 项与 Amezalpat 相关的专利（医药）
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1
项与 Amezalpat 相关的文献（医药）2025-08-01·BIOORGANIC CHEMISTRY
Peroxisome proliferator-activated receptor antagonists as emerging therapeutics in cancer treatment
Review
作者: Ramaa, C S ; Patil, Vijay M ; Lavecchia, Antonio ; Misal, Snehal
Cancer remains one of the leading causes of mortality worldwide, driving the need for novel therapeutic strategies. Peroxisome proliferator-activated receptors (PPARs) are a family of nuclear hormone receptors that regulate lipid metabolism, inflammation, and tumor progression. While PPAR agonists have been widely explored for their anticancer potential, recent evidence highlights PPAR antagonists as promising therapeutic candidates. These antagonists selectively modulate oncogenic pathways by disrupting metabolic and signaling networks that support tumor growth, survival, and metastasis. PPARα antagonists, such as N-(2-bromophenyl)-2-[[(3-chlorophenyl)amino]thioxomethyl]acetamide (GW6471) and TPST-1120, impair tumor metabolism and angiogenesis, reducing cancer progression. Their combination with immunotherapy has shown enhanced antitumor effects in preclinical models. PPARβ/δ antagonists, including 4-[3-(4-Acetyl-3-hydroxy-2-propylphenoxy)propoxy]benzoic acid (GSK0660) and methyl 3-(N-(4-(hexylamino)-2-methoxyphenyl)sulfamoyl)thiophene-2-carboxylate (ST247), suppress β-catenin-driven oncogenic transcription, modulating cell proliferation and invasion. PPARγ antagonists, such as 2-Chloro-5-nitro-N-phenylbenzamide (T0070907) and 2-Chloro-5-nitro-N-phenylbenzamide (GW9662), interfere with cancer cell metabolism, apoptosis, and migration, thereby enhancing their antitumor efficacy. Combination strategies involving chemotherapy, radiotherapy, or targeted therapies have shown synergistic effects, improving treatment response and overcoming resistance. Beyond direct tumor suppression, PPAR antagonists modulate immune responses and reshape the tumor microenvironment, offering a multifaceted therapeutic approach. Despite promising results, clinical translation remains limited and requires further studies to improve selectivity, pharmacokinetics, and drug delivery strategies. This review provides a comprehensive analysis of the medicinal chemistry, molecular mechanisms, and pharmacological development of PPAR antagonists, highlighting their potential clinical applications. Future efforts should refine drug design, develop personalized treatments, and conduct well-designed clinical trials to unlock their role in precision oncology.
103
项与 Amezalpat 相关的新闻（医药）2026-02-11
Tempest outlines a capital-efficient post-transaction strategy to advance a diversified portfolio of next-generation CAR-T and oncology assets
Development approach prioritizes partner-funded and externally supported programs to generate clinical data before deploying significant internal capital
Pipeline expansion includes TPST-4003, an in vivo dual-targeting CD19/BCMA CAR-T, with potential near-term milestones
BRISBANE, Calif., Feb. 11, 2026 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST) (“Tempest”), a clinical-stage biotechnology company with a diversified portfolio of cell therapy and small molecule product candidates, today outlined its post-transaction strategy to advance its newly acquired CAR-T assets while maintaining a capital-efficient operation model.
Following the recent closing of its strategic transaction, Tempest plans to prioritize development of its clinical-stage dual-targeting CD19/BCMA CAR-T program, TPST-2003, while expanding the portfolio into next-generation modalities, including TPST-4003, a newly disclosed in vivo CAR-T program designed to deliver the same dual-targeting CD19/BCMA construct without the need for ex vivo cell manufacturing.
“Our strategy is to leverage partner-funded and externally supported development where possible to generate high-value clinical data before committing significant internal capital,” said Dr. Matt Angel, President and Chief Executive Officer of Tempest. “This approach allows us to advance multiple programs in parallel, expand the long-term optionality of our CAR-T portfolio and preserve flexibility as we evaluate the most compelling path forward.”
Strategic Priorities:
Advance TPST-2003 through upcoming clinical milestones
Tempest plans to continue development of TPST-2003, a dual-targeting CD19/BCMA CAR-T therapy, with near-term clinical data expected from an ongoing Phase 1 clinical trial in China. The company anticipates initiation of a registrational Phase 2b in China by the end of 2026, with interim data expected in 2027. Development activities in China are funded by a strategic partner, providing access to pivotal data while preserving internal capital.
Expand the portfolio with in vivo CAR-T development (TPST-4003)
TPST-4003 represents Tempest’s first in vivo CAR-T program and is designed to extend the TPST-2003 biology into a potentially more scalable and patient-friendly modality. The company expects to advance the program through preclinical development and evaluate potential clinical entry through a strategic partner-funded Investigator Initiated Trial in the near-term.
Position amezalpat for pivotal development through business development
Amezalpat remains Phase 3-ready in first-line hepatocellular carcinoma (“HCC”), supported by global regulatory alignment and positive randomized Phase 2 data. Tempest plans to pursue business development discussions to advance pivotal development.
Advance TPST-1495 through externally funded clinical development
Tempest plans to initiate a Phase 2 study of TPST-1495 in familial adenomatous polyposis (“FAP”), with first patient enrollment expected in Q1 2026. The study is expected to be funded by the National Cancer Institute and conducted through the Cancer Prevention Clinical Trials Network, enabling advancement with limited internal capital deployment.
Advance a diversified next-generation CAR-T pipeline
Tempest plans to progress additional dual-targeting CAR-T programs that broaden the platform across modalities and indications, including:
TPST-3003: an allogeneic dual-targeting CD19/BCMA CAR-T
TPST-2206: a dual-targeting CD70/CD70 CAR-T
TPST-3206: an allogeneic dual-targeting CD70/CD70 CAR-T
About Tempest Therapeutics
Tempest Therapeutics is a clinical-stage biotechnology company with a diverse portfolio of cell therapy and small molecule product candidates that leverage tumor-targeted and/or immune-mediated mechanisms to potentially treat a wide range of cancers. Tempest is headquartered in Brisbane, California. More information about Tempest can be found on the company’s website at
Forward-Looking Statements
This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (the “Securities Act”)) concerning Tempest Therapeutics, Inc. These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Tempest Therapeutics, as well as assumptions made by, and information currently available to, management of Tempest Therapeutics. Forward-looking statements contained in this press release include but are not limited to statements relating to: Tempest Therapeutics’ plan to advance its portfolio in a capital-efficient manner, including through partner-funded and externally supported programs; the design, initiation, progress, timing, scope and results of clinical trials, including the anticipated initiation of a registrational Phase 2b in China for TPST-2003 by the end of 2026, the planned initiation of a Phase 2 study of TPST-1495 in FAP with first patient enrollment expected in Q1 2026 and the funding therefor, and the anticipated Phase 3 study for amezalpat; portfolio expansion with in vivo CAR-T development through a strategic partner-funded Investigator Initiated Trial in the near-term; the planned advancement of a diversified next-generation CAR-T pipeline; anticipated therapeutic benefit and regulatory development of Tempest Therapeutics’ product candidates; and Tempest Therapeutics’ ability to achieve its operational plans. Any forward-looking statements in this press release are based on Tempest Therapeutics’ current expectations, estimates and projections about its industry as well as management’s current beliefs and expectations of future events only as of today and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to Tempest Therapeutics’ need for additional capital to fund its planned programs and operations and to continue to operate as a going concern; unexpected safety or efficacy data observed during preclinical or clinical trials; funding from the National Cancer Institute for the expected Phase 2 study of TPST-1495 may not be available at the levels anticipated, or at all, and external from strategic partners may not be available on the timeline or at the levels anticipated, if at all, in which case Tempest Therapeutics’ decision and ability to continue the development of any such program will be subject to holistic program considerations and capital availability; past results may not be indicative of future results; clinical trial site activation or enrollment rates that are lower than expected; loss of key personnel; changes in expected or existing competition; changes in the regulatory environment; risks relating to volatility and uncertainty in the capital markets for biotechnology companies; and unexpected litigation or other disputes. These and other factors that may cause actual results to differ from those expressed or implied are discussed in greater detail in the “Risk Factors” section of Tempest’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, the “Risk Factors” section under Proposal 5 contained in Tempest’s definitive proxy statement on Schedule 14A, filed with the Securities and Exchange Commission (“SEC”) on December 31, 2025, and in other documents filed by Tempest from time to time with the SEC. Except as required by applicable law, Tempest Therapeutics undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Tempest Therapeutics’ views as of any date subsequent to the date of this press release and should not be relied upon as prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Tempest Therapeutics.
Investor Contacts:
Sylvia Wheeler
Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com
Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com
临床2期细胞疗法免疫疗法
2026-02-04
All-stock transaction brings Tempest a portfolio of next-generation CAR-T assets, including TPST-2003, a clinical-stage dual-targeting CD-19/BCMA CAR-T with strategic partner-funded BLA filing in China planned for 2027 Operational runway extended to mid-2027, supporting multiple potential value-generating milestones Matt Angel, Ph.D., joins Tempest as President and CEO Previously announced transaction closed following stockholder approval of share issuance at the 2025 Annual Meeting on January 27, 2026
BRISBANE, Calif., Feb. 04, 2026 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST) (“Tempest”), a clinical-stage biotechnology company with a pipeline of advanced strategic therapeutic assets, today announced the closing of a previously announced transaction pursuant to which Tempest acquired certain dual-targeting chimeric antigen receptor (CAR)-T programs and obtained financing support from Factor Bioscience Inc. and its affiliates (collectively, “Factor”) in an all-stock transaction resulting in a diverse portfolio including clinical-stage product candidates and an extended runway with multiple potential near-term milestones (the “Transaction”).
“I am excited to join the Tempest team and to have the opportunity to develop this innovative pipeline of potential therapies to treat a range of solid tumors and hematologic malignancies,” said Dr. Matt Angel, President and Chief Executive Officer of Tempest. “I look forward to advancing the company’s vision of bringing important therapies to patients.”
“The Board is pleased to announce the closing of this transaction, which not only provides increased financial stability for Tempest, but also the opportunity for potentially significant milestones over the next 12-18 months from both the legacy small molecule programs and the new cell therapy assets,” said Stephen Brady, Chair of the Board.
“As Tempest moves into this next phase, we would like to thank Geoff Nichol and Mike Raab.” Mr. Brady continued. “We are grateful for Geoff’s support, engagement and inquisitive mind since he joined the Board in 2021, and wish him continued success in his endeavors. Mike Raab has been our Chair since 2018, during which time he provided clear leadership, thoughtful perspectives, and significant contributions to Tempest throughout his tenure. We are thrilled that Mike will continue to serve on the Board, bringing the ongoing benefit of his experience and guidance to the company.”
Key Takeaways:
Amezalpat (TPST-1120) remains Phase 3 ready in first-line liver cancer (“HCC”), supported by global regulatory agreement and positive randomized Phase 2 data. Tempest plans to pursue business development discussions to advance pivotal development. TPST-2003: new dual-targeting CD19/BCMA CAR-T asset Phase 1 complete in patients with relapsed/refractory multiple myeloma (“rrMM”), with data expected in 2026 and a biologics license application (“BLA”) in China planned for 2027 Phase 1 currently enrolling patients with POEMS syndrome, with data expected in 2027 and a BLA in China planned for 2028 Tempest has global rights to TPST-2003 outside of China, India, Turkey and Russia, and plans to pursue a potential registrational study in rrMM in the U.S. starting in 2027 Pivotal data from the Chinese study expected to validate probability of success for the program, and rights include the right to reference data generated in support of the planned China BLA All development activities in China to be funded by strategic partner Tempest expects a Phase 2 study of TPST-1495 in familial adenomatous polyposis (“FAP”) to enroll the first patient in Q1’26 and to be funded by the National Cancer Institute and operationalized by the Cancer Prevention Clinical Trials Network. Plan to continue the development of additional new preclinical and research-stage pipeline programs: TPST-2206: dual-targeting CD70/CD70 CAR-T for renal cell carcinoma TPST-3003: allogeneic dual-targeting CD19/BCMA TPST-3206: allogeneic dual-targeting CD70/CD70 Existing cash and an investment commitment from Factor is expected to provide a runway to mid-2027 and potentially through key data milestones.
Phase 1 complete in patients with relapsed/refractory multiple myeloma (“rrMM”), with data expected in 2026 and a biologics license application (“BLA”) in China planned for 2027 Phase 1 currently enrolling patients with POEMS syndrome, with data expected in 2027 and a BLA in China planned for 2028 Tempest has global rights to TPST-2003 outside of China, India, Turkey and Russia, and plans to pursue a potential registrational study in rrMM in the U.S. starting in 2027 Pivotal data from the Chinese study expected to validate probability of success for the program, and rights include the right to reference data generated in support of the planned China BLA All development activities in China to be funded by strategic partner
TPST-2206: dual-targeting CD70/CD70 CAR-T for renal cell carcinoma TPST-3003: allogeneic dual-targeting CD19/BCMA TPST-3206: allogeneic dual-targeting CD70/CD70
Combined Pipeline
Advisors
MTS Health Partners, L.P. served as financial advisor to Tempest, and Cooley LLP served as legal advisor. In addition, MTS Securities, LLC (an affiliate of MTS Health Partners, L.P.) provided an opinion to the board of directors of Tempest regarding the fairness of the purchase price to be paid by Tempest to Factor in connection with the Transaction, subject to the qualifications and limitations set forth therein. Morse, Barnes-Brown & Pendleton, P.C. served as legal advisor to Factor.
About Tempest Therapeutics
Tempest Therapeutics is a clinical-stage biotechnology company with a diverse portfolio of cell therapy and small molecule product candidates that leverage tumor-targeted and/or immune-mediated mechanisms to potentially treat a wide range of cancers. Tempest is headquartered in Brisbane, California. More information about Tempest can be found on the company’s website at https://www.tempesttx.com.
Forward-Looking Statements
This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (the “Securities Act”)) concerning Tempest Therapeutics, Inc. These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Tempest Therapeutics, as well as assumptions made by, and information currently available to, management of Tempest Therapeutics. Forward-looking statements contained in this press release include but are not limited to statements relating to: the investment commitment and extension of Tempest Therapeutics’ cash runway through mid-2027; the potential benefits of the Transaction, including the combination of the programs and ability to benefit patients; the design, initiation, progress, timing, scope and results of clinical trials, including the anticipated Phase 3 study for amezalpat and the advancement of TPST-2003; the expectation that the pivotal data from the Chinese study will validate the probability of success for TPST-2003; the anticipated China BLA; the expected Phase 2 study for TPST-1405 and the timing for first patient enrollment and the funding therefor; the planned continued development of additional new preclinical and research-stage pipeline programs; anticipated therapeutic benefit and regulatory development of Tempest Therapeutics’ product candidates; and Tempest Therapeutics’ ability to achieve its operational plans. Any forward-looking statements in this press release are based on Tempest Therapeutics’ current expectations, estimates and projections about its industry as well as management’s current beliefs and expectations of future events only as of today and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to Tempest Therapeutics’ need for additional capital to fund its planned programs and operations and to continue to operate as a going concern; unexpected safety or efficacy data observed during preclinical or clinical trials; funding from the National Cancer Institute for the expected Phase 2 study of TPST-1405 may not be available at the levels anticipated, or at all, in which case Tempest Therapeutics’ decision and ability to move forward with this trial will be subject to holistic program considerations and capital availability; past results may not be indicative of future results; clinical trial site activation or enrollment rates that are lower than expected; loss of key personnel; changes in expected or existing competition; changes in the regulatory environment; risks relating to volatility and uncertainty in the capital markets for biotechnology companies; and unexpected litigation or other disputes. These and other factors that may cause actual results to differ from those expressed or implied are discussed in greater detail in the “Risk Factors” section of Tempest’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, the “Risk Factors” section under Proposal 5 contained in Tempest’s definitive proxy statement on Schedule 14A, filed with the Securities and Exchange Commission (“SEC”) on December 31, 2025, and in other documents filed by Tempest from time to time with the SEC. Except as required by applicable law, Tempest Therapeutics undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Tempest Therapeutics’ views as of any date subsequent to the date of this press release and should not be relied upon as prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement in reaching any conclusion or making any investment decision about any securities of Tempest Therapeutics.
Investor Contacts:
Sylvia Wheeler Wheelhouse Life Science Advisors swheeler@wheelhouselsa.com
Aljanae Reynolds Wheelhouse Life Science Advisors areynolds@wheelhouselsa.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/246ed768-1ec8-4ca2-9d36-d3ca777afad9
临床1期临床2期细胞疗法
2025-11-23
最近，资金基本耗竭的Tempest Therapeutics发生了一场奇怪的交易，公司通过股权置换管线的方式获得了新管线。
只是给出的未来计划有点诡异：公司计划在2026年获得在我国开展I期临床的数据，然后第二年计划提交BLA？要说Tempest的处境可不容乐观，竟然会如此异想天开？
Tempest的现状
要说Tempest Therapeutics在交易之前的情况那是真的很不妙，公司核心管线Amezalpat（TPST-1120）快要进入III期了，和FDA也沟通好了，结果公司没钱了。
Amezalpat本身还是很有希望的。
在此前的I/II期临床中，Amezalpat（TPST-1120）联合阿替利珠单抗（Tecentriq）和贝伐单抗（Avastin）治疗不可切除或转移性HCC患者时，ORR达30%，而对照组（仅阿替利珠单抗+贝伐单抗）为13.3%。
虽然说罗氏确实是合作方，但是罗氏并不全权负责临床试验，只是提供T药。钱还得是Tempest自己出。
由于资金耗尽，今年4月的时候，Tempest开启了战略评估模式，顺便裁掉了26名全职员工中的21名，以延长有限的现金储备的使用时间。想给III期临床找个合作伙伴，不过显然事情没那么顺利。
4月一直到Q3财报发布，公司都没找到合作伙伴开启下一阶段。而这时公司账上现金及其等价物只剩下750万美元了，继续维持运营都难。
此外，Tempest Therapeutics本身还有另外一款管线TPST-1495，虽说公司在今年3月表示过着管线是美国国家癌症研究所（NCI）癌症预防部门资助的……不过推测可能是NCI方面的资金审批问题，2025年就说要展开的临床招募，根据最新消息，竟然要到2026年才能招募到第一名患者，估摸着整个2025年这TPST-1495的进展基本是啥也没干。
在这种情况下Tempest看起来是真没辙了。
Factor的诡异交易
Factor Bioscience是这次事件的真正主角，与Tempest交易本身有点复杂。
Tempest Therapeutics通过资产购买协议，收购了Factor Bioscience特定CAR-T项目，而Tempest又以发行新股作为支付方式，向Factor Bioscience发行约827万股普通股。
也就是用股权换了Factor管线。
最后，Factor Bioscience承诺提供资金支持。同时原Factor的首席执行官兼联合创始人会出任现在Tempest CEO。
由于Tempest本身因为之前的裁员已经不剩下几个人了，现在这局面相当于由Factor Bioscience的人马直接掌舵新Tempest的发展。
Factor公司本身拥有多款细胞治疗管线，虽然之前并未上市，公开信息不多，只知道之前主要是通过授权合作和专利费用获得收入的，还有来自美国国防部的资金支持，但现在这家公司似乎有临床推进计划。
这次新Tempest 获得的四款CAR-T管线分别是CD19/BCMA CAR-T TPST-2003，针对肾细胞癌的CD70/CD70双位点 CAR-T TPST-2206，同种异体CD19/BCMA CAR-T TPST-3003，同种异体CD70/CD70双位点 CAR-T TPST-3206。
更有趣的是，新Tempest 的目标是在我国开展临床，其中重点项目是TPST-2003。公司打算在我国开展rrMM（多发性骨髓瘤）的TPST-2003临床，预计2026年获得数据，2027年计划在我国提交BLA。
TPST-2003还有另外一项罕见病适应症，1期临床目前正在招募POEMs综合征患者，数据预计在2027年公布，计划在2028年在中国进行BLA。
不过，这个时间节点设置的是否有点太快了？I期临床，第一年内获得数据，第二年直接推动上市？
其他管线则是“计划开发中”的状态。
有趣的是，或许让Factor Bioscience看上Tempest Therapeutics原因是Tempest Therapeutics本身有在我国开展TPST-1120的临床，之前Tempest找了CRO公司诺为泰上海分公司在我国开展临床。或许相同的路径能更方便推动临床进展。
至于Tempest Therapeutics本身剩下的管线，TPST-1120仍然是处于寻找合作伙伴的状态，看起来短期内找到愿意给出III期临床推进是有点难了。TPST-1495则如上文所述，预计将在2026年招募第一名患者，资金由NCI支持。
总结
看得出来，Factor Bioscience想要通过Tempest推进CAR-T临床，不过总感觉公司是否有些过度吹嘘了？2年内国内提交上市？
参考来源：
https://ir.tempesttx.com/news-releases/news-release-details/tempest-announces-strategic-acquisition-new-dual-car-t-programs
免疫疗法细胞疗法财报并购临床3期
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 转移性肝细胞癌 | 临床3期 | - | 2025-12-01 | |
| 不可切除的肝细胞癌 | 临床3期 | - | 2025-12-01 | |
| 原发性恶性肝肿瘤 | 临床2期 | 美国 | 2020-11-01 | |
| 原发性恶性肝肿瘤 | 临床2期 | 中国 | 2020-11-01 | |
| 原发性恶性肝肿瘤 | 临床2期 | 法国 | 2020-11-01 | |
| 原发性恶性肝肿瘤 | 临床2期 | 以色列 | 2020-11-01 | |
| 原发性恶性肝肿瘤 | 临床2期 | 新西兰 | 2020-11-01 | |
| 原发性恶性肝肿瘤 | 临床2期 | 韩国 | 2020-11-01 | |
| 原发性恶性肝肿瘤 | 临床2期 | 中国台湾 | 2020-11-01 | |
| 晚期癌症 | 临床1期 | 美国 | 2019-03-20 |
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临床结果
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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 |
|---|
临床1/2期 | 肝细胞癌 一线 | - | 遞範淵製艱艱夢選構窪(觸餘窪蓋淵鏇淵窪積艱) = 膚艱鑰膚鹹夢夢憲淵網 衊選繭鹽構網膚範築膚 (鹽糧製糧襯膚繭襯窪選 ) 更多 | 积极 | 2024-06-20 | ||
遞範淵製艱艱夢選構窪(觸餘窪蓋淵鏇淵窪積艱) = 築艱艱鹽築餘齋積製餘 衊選繭鹽構網膚範築膚 (鹽糧製糧襯膚繭襯窪選 ) 更多 | |||||||
临床1期 | 38 | 鬱製廠顧糧壓餘積築鏇(築範鬱鑰築鏇網艱獵壓) = The most common were grade 1-2 nausea, fatigue, and diarrhea. 製廠壓襯顧鏇遞齋襯顧 (夢襯齋選遞艱鬱簾築鹹 ) 更多 | 积极 | 2024-03-29 | |||
临床1/2期 | 70 | 獵鬱窪鏇醖憲獵範膚淵(構艱願獵遞鹹鹹膚觸襯) = 願夢鑰糧遞選壓壓衊構 遞鹹襯鏇觸繭襯築艱鹽 (繭製觸衊襯憲壓窪繭範 ) 更多 | 积极 | 2023-10-11 | |||
獵鬱窪鏇醖憲獵範膚淵(構艱願獵遞鹹鹹膚觸襯) = 築築範獵繭鑰製繭窪衊 遞鹹襯鏇觸繭襯築艱鹽 (繭製觸衊襯憲壓窪繭範 ) 更多 | |||||||
临床2期 | 30 | 齋顧鏇範構窪鬱淵淵壓(鏇遞簾積艱簾製網襯鹹) = 糧膚構觸觸糧廠築顧選 築壓醖鹹觸鹽廠壓艱齋 (願襯艱鑰膚構廠網獵願 ) | 积极 | 2022-11-07 | |||
齋顧鏇範構窪鬱淵淵壓(鏇遞簾積艱簾製網襯鹹) = 糧夢淵鏇壓繭構選獵遞 築壓醖鹹觸鹽廠壓艱齋 (願襯艱鑰膚構廠網獵願 ) | |||||||
临床1期 | 35 | 築憲鑰襯鹹觸遞鏇憲顧(衊獵鏇窪艱繭選餘積窪) = For TPST-1120 monotherapy, the most common treatment related AEs (TRAEs) were nausea (20%), fatigue (15%), and diarrhea (10%), all Grade 1-2. One monotherapy subject (5%) experienced a Grade 3 TRAE (hypertension). In the combination cohort the most common TRAEs related to either drug were fatigue (40%), diarrhea (27%) and nausea (20%), all Grade 1-2. Three combination subjects (19%) experienced Grade 3 TRAEs (one each arthralgia, hepatic enzyme increased, muscle spasms). 簾窪糧襯蓋襯壓壓艱獵 (網膚簾鹹繭製鬱鹹膚醖 ) | 积极 | 2022-06-02 | |||
临床1期 | 晚期癌症 FAO/PPARα gene expression | 338 | 艱築膚壓鏇網衊願餘襯(網艱壓積膚鏇艱繭築獵) = 膚遞獵鏇鹹鬱鏇餘憲選 壓壓構蓋製網繭廠衊鏇 (築簾壓簾製鏇艱簾醖鏇 ) | 积极 | 2019-11-01 |
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