Advanced cervical cancer patients treated with standard of care (SOC) chemoradiation plus glutaminase inhibition with telaglenastat (CB-839) will have increased progression-free survival (PFS) compared to historical rates for patients receiving SOC chemoradiation alone.

Start Date31 Jan 2025

Sponsor / Collaborator

Washington University School of Medicine

[+2]

NCT04824937 / Unknown statusPhase 2IIT

A Phase II Study of the Glutaminase Inhibitor Telaglenastat (CB-839) in Combination With the PARP Inhibitor Talazoparib in Participants With Metastatic Castration-Resistant Prostate Cancer

The purpose of this research is to test the effectiveness of an experimental drug combination for people with metastatic castration-resistant prostate cancer (mCRPC).
The names of the study drugs involved in this study are:
Telaglenastat (CB-839)
Talazoparib

Start Date01 Jul 2021

Sponsor / Collaborator

The General Hospital Corp.

[+3]

NCT04250545 / Active, not recruitingPhase 1IIT

A Phase 1 Trial of MLN0128 (Sapanisertib) and CB-839 HCl (Telaglenastat) in Advanced NSCLC Patients

This phase I/Ib trial studies the side effects and best dose of CB-839 HCl when given together with sapanisertib in treating patients with non-small cell lung cancer that has spread to other places in the body (advanced). CB-839 HCl and sapanisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Start Date26 Oct 2020

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Telaglenastat

100 Translational Medicine associated with Telaglenastat

100 Patents (Medical) associated with Telaglenastat

181

Literatures (Medical) associated with Telaglenastat

01 Feb 2025·ENVIRONMENTAL POLLUTION

Ambient PM2.5 orchestrates M1 polarization of alveolar macrophages via activating glutaminase 1-mediated glutaminolysis in acute lung injury

Article

Author: Zhang, Fang ; Cao, Xue ; Su, Jingran ; Tu, Yikun ; Chen, Mo ; Ding, Wenjun ; Wang, Yuanli ; Shao, Mengyao ; Hu, Xiaoqi

The temporary explosive growth events of atmospheric fine particulate matter (PM_2.5) pollution during late autumn and winter seasons still frequently occur in China. High-concentration exposure to PM_2.5 aggravates lung inflammation, leading to acute lung injury (ALI). Alveolar macrophages (AMs) participate in PM_2.5-induced pulmonary inflammation and injury. The polarization of AMs is dependent on metabolic reprogramming. However, the mechanism underlying the PM_2.5-induced glutaminase-mediated glutaminolysis in AM polarization is still largely obscure. In this study, we found that PM_2.5-treated mice exhibited pulmonary dysfunction and inflammation. The concentrations of glutamate and succinate were increased in PM_2.5-treated lungs and AMs compared with the controls, whereas glutamine and α-ketoglutarate (α-KG) levels were decreased, indicating that glutaminolysis in AMs was aberrantly activated as evidenced by increased mRNA and protein levels of GLS1 after PM_2.5 exposure. Moreover, we determined that the GLS1/nuclear factor kappa-B (NF-κB)/hypoxia-inducible factor-1α (HIF-1α) pathway regulated M1 polarization of AMs upon PM_2.5 exposure. Inhibition of glutaminolysis by GLS1 specific inhibitor CB-839 and GLS1 siRNA significantly decreased PM_2.5-induced M1 macrophage polarization and attenuated pulmonary damage. Taken together, our findings reveal a novel mechanism by which a metabolic program regulates M1 polarization of AMs and suggest that GLS1-mediated glutaminolysis is a potential therapeutic target for treating PM_2.5-induced ALI.

01 Jan 2025·COLLOIDS AND SURFACES B-BIOINTERFACES

Photothermal nanocomposite reactivate “immune-hot” for triple-negative breast cancer treatment via glutamine metabolism reprograming

Article

Author: Li, Shize ; Qiu, Chenyu ; Lin, Yinhao ; Zhang, Youting ; Kou, Longfa ; Hou, Yanxian ; Jiang, Zewei ; Li, Lele ; Cheng, Yingfeng ; Chen, Nuo ; Yao, Yinsha ; Zhu, Wanling ; Wu, Fugen ; Chen, Ruijie ; Ye, Zhanzheng

Herein, a photothermal nanocomposite PAI@CB839 nanoparticles (NPs) was constructed to perform a heat-immune therapy for triple-negative breast cancer (TNBC). Firstly, a photothermal agent animated IR780 was modified on a mPEG-NH₂ using 4,4'-dicarboxylazobenzene as a linker. The synthesized PAI exhibited superior photothermal efficiency of the IR780 even after assembling in water. As a functional carrier, PAI was used to load and deliver the glutaminase inhibitor CB839 to tumor tissue. In the hypoxic environment of tumor cells, the azo bond would break, triggering the release of cargo. Upon irradiation, the outstanding photothermal properties of IR780 resulted in tumor cell damage. This process could promote immunogenic cell death and program tumor to "immune-hot" condition. Concurrently, CB839 strengthened the antitumor immune response by remodulating the immunosuppressive TME through disturbing Glu abnormal metabolism, which further inhibited TNBC growth and metastasis. In conclusion, PAI@CB839 NPs exhibited great antitumor efficiency, which pave a new way for TNBC therapeutic regimen development.

01 Dec 2024·CANCER LETTERS

Telaglenastat as an alternative to cisplatin as a radiosensitizer in the treatment of head and neck squamous cell carcinoma

Article

Author: Lehn, Maria ; Korns, Julianna ; Thompson, Samuel ; Waltz, Susan E. ; Wicker, Christina A. ; Wicker, Christina A ; Wise-Draper, Trisha M ; Shyamsunder, Shreya ; Waltz, Susan E ; Lester, Carissa ; Wise-Draper, Trisha M. ; Takiar, Vinita

The efficacy of radiation treatment (RT) of head and neck squamous cell carcinoma (HNSCC) is limited by radioresistance and the toxicity of FDA approved radiosensitizers. In extension to our previous research where we demonstrated that telaglenastat (CB839) increased efficacy of RT in in vitro and in vivo HNSCC models, here, we examine the radiosensitizing effects of telaglenastat in comparison to cisplatin's, as cisplatin is currently the standard of care for concurrent therapy. Combination of telaglenastat with RT reduced tumor volume in a HNSCC patient derived xenograft mouse model. The efficacy of telaglenastat with RT in reducing cell survival and increasing apoptosis was similar if not greater than that of cisplatin with RT in Cal27 and HN5 HNSCC cells. The addition of telaglenastat increased reactive oxygen species and reduced the antioxidant glutathione in both Cal27 and HN5 cells. Reverse Phase Protein Array analyses revealed alterations in cell death and DNA damage response proteins. This study provides the scientific underpinnings for the use of telaglenastat as a radiosensitizer in the treatment of HNSCC either as an alternative to cisplatin or in cisplatin-ineligible patients.

News (Medical) associated with Telaglenastat

10 Jan 2023

·www.fiercebiotech.com

Cash-strapped Calithera closes down in shadow of enrollment delays to cancer trials

"We truly wish the outcome was different today,” Calithera Biosciences CEO Susan Molineaux, Ph.D., said in a release. Calithera Biosciences has kept its head down since a phase 2 fail in 2021 caused layoffs for a third of its workforce. But in the wake of enrollment delays for two lead cancer therapies, the cash-strapped biotech has given up the fight and announced it’s liquidating the business. “The board of directors and management devoted substantial time and effort in identifying and pursuing various opportunities, but we were unable to complete a transaction that would allow us to continue the development of our clinical programs and enhance shareholder value,” CEO Susan Molineaux, Ph.D., said in a release Monday. As a result, all clinical programs will be shut down, with “most” of the company’s employees terminated by the end of this quarter. “Importantly, I would like to sincerely thank our employees and others who have supported Calithera over the years,” Molineaux added in her statement yesterday. “We appreciate your partnership and participation, and we truly wish the outcome was different today.” Money had been tight at the biotech for a while. Calithera had cash and equivalents of $34.1 million at the end of September, which was only expected to last into the second quarter of this year. In November, the company revealed it was “evaluating all options for its programs, including strategic collaboration or licensing agreements and actively considering the sale of certain programs, in order to extend its cash runway.” It can’t have helped that things weren’t quite going to plan for its lead programs, either. Calithera also used its November financial report to reveal that “site activation delays” meant that enrollment for trials of sapanisertib and mivavotinib had been “slower than anticipated.” Still, the company said at the time that initial data from these studies were expected in mid-2023, with sapanisertib having secured an FDA fast-track tag for non-small cell lung cancer in October. The biotech licensed both drugs from Takeda in 2021 after the failure of its own drug telaglenastat in a midstage kidney cancer test prompted Calithera to wield the ax on 35% of staff. Calithera's announcement is just the latest in a string of recent closures for struggling biotechs, with Otonomy winding down in December, followed by Nabriva Therapeutics last week.

Fast TrackFinancial Statement

14 Nov 2022

·www.globenewswire.com

Calithera Biosciences Reports Third Quarter 2022 Financial Results and Business Update

-- Conference Call and Webcast Scheduled for 5:00 p.m. ET on Monday, November 14, 2022 --SOUTH SAN FRANCISCO, Calif., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision-oncology biopharmaceutical company, today announced its financial results for the third quarter ended September 30, 2022. “Earlier in the fourth quarter, we were very pleased to announce that we received FDA Fast Track designation for sapanisertib. This designation facilitates more frequent communication with the Agency, as well as a number of other benefits that could support our efforts to bring sapanisertib to patients in this area of high unmet need more quickly,” said Susan Molineaux, PhD, president and chief executive officer of Calithera. “Today we also share that we have experienced site activation delays on both our sapanisertib and mivavotinib trials, leading to slower than anticipated enrollment for both these programs. We expect initial data from these studies will not be available until mid-2023.” Third Quarter 2022 and Other Recent Highlights Received FDA Fast Track designation for sapanisertib (dual mTORC 1/2 inhibitor). In October, Calithera announced that sapanisertib has been granted Fast Track designation by the FDA for the treatment of adult patients with unresectable or metastatic squamous non-small cell lung cancer (sqNSCLC) whose tumors harbor the NRF2 mutation. Fast Track designation, which is designed to facilitate the development and expedite the review of therapeutic candidates with the potential to treat a serious or life-threatening condition where there is a major unmet medical need, provides a number of potential benefits including increased communication with the FDA, the ability to submit a marketing application on a rolling basis and the possibility of priority review. Began enrolling patients in Phase 2 trial evaluating sapanisertib in sqNSCLC. In July 2022, the Company began enrolling patients in its phase 2 clinical trial (NCT05275673) of the dual mTORC 1/2 inhibitor sapanisertib (CB-228) in patients with relapsed/refractory NRF2 (NFE2L2)-mutated sqNSCLC. The study is designed to confirm the selective activity of sapanisertib in NRF2-mutated tumors compared to wild-type tumors, and to refine dose in this biomarker-defined population. The primary endpoints of the study are investigator-assessed overall response rate (ORR) per RECIST v1.1, and safety. Calithera presented a trial-in-progress poster detailing the study design at the North American Conference on Lung Cancer in September 2022. Continued patient enrollment activities in Phase 2 trial evaluating mivavotinib (SYK inhibitor) in r/r non-GCB DLBCL. In June 2022, the Company began enrolling patients in its multicenter Phase 2 clinical trial (NCT05319028) evaluating mivavotinib (CB-659) in patients with relapsed/refractory non-germinal center B-cell like (non-GCB) diffuse large B-cell lymphoma (DLBCL). The main objectives of the study are to confirm previously observed single-agent activity in non-GCB DLBCL patients, evaluate activity according to MYD88/CD79b mutation status and refine dose/schedule in this patient population. The primary endpoints of the study are overall response rate (as assessed by an independent radiology review committee) and safety. Details of the Phase 2 study design were presented in a trial-in-progress poster at the Pan Pacific Lymphoma Conference in July. Continued to advance VPS4 program through lead optimization. Calithera continued to advance multiple vacuolar protein sorting-associated protein 4A (VPS4A) and VPS4B inhibitors through lead optimization and plans to share updates on this program by the end of 2022. Selected Third Quarter 2022 Financial Results Cash and cash equivalents totaled $34.1 million at September 30, 2022. Based on its current operating plan, the Company expects it has sufficient cash to fund its operations into the second quarter of 2023. The Company is currently evaluating all options for its programs, including strategic collaboration or licensing agreements and actively considering the sale of certain programs, in order to extend its cash runway. Research and development expenses for the third quarter 2022 were $6.5 million, compared to $11.6 million in the same period prior year. The decrease of $5.1 million was primarily due to decreases in the telaglenastat and CB-280 programs and investments in early stage research, partially offset by increases in the sapanisertib and mivavotinib programs. General and administrative expenses for the third quarter 2022 were $3.0 million, compared to $6.3 million in the same period prior year. The decrease of $3.3 million was primarily due to decreased personnel-related costs and legal expenses. Net loss was $9.8 million for the three months ended September 30, 2022. Conference Call Information Calithera will host an update conference call today, Monday, November 14, at 2:00 p.m. Pacific Time/5:00 p.m. Eastern Time. To register for dial-in access to the call, please use this link. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days. About Calithera Calithera Biosciences is a clinical-stage, precision oncology biopharmaceutical company developing targeted therapies to redefine treatment for biomarker-specific patient populations. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer, Calithera is advancing a robust pipeline of investigational, small-molecule oncology compounds with a biomarker-driven approach that targets genetic vulnerabilities in cancer cells to deliver new therapies for patients suffering from aggressive hematologic and solid tumor cancers for which there are currently limited treatment options. Calithera is headquartered in South San Francisco, California. For more information about Calithera, please visit www.calithera.com. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," "poised" and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to the safety, tolerability and efficacy of Calithera’s product candidates, the overall advancement of Calithera’s product candidates in preclinical development and clinical trials, including the availability of initial data for the mivavotinib and sapanisertib trials by mid-2023, Calithera’s ability to potentially initiate registrational studies in biomarker-specific populations in DLBC and relapsed or refractory squamous NSCLC, the expectation that VPS4 inhibitors will be well-tolerated and have strong single-agent activity in tumors with certain mutations, Calithera’s plan to advance multiple VPS4 series through lead optimization and plan to share updates on this program by the end of the year, the unmet need in the treatment of patients with advanced disease, Calithera’s expectation that cash and cash equivalents will be sufficient to meet its current operating plan into the second quarter of 2023 and whether Calithera will be able to enter into strategic collaborations or licensing agreements or sell certain programs and sufficiently extend its cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The potential product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or be successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera's stock price. Additional information concerning these and other risk factors affecting Calithera's business can be found in Calithera's periodic filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances. Calithera Biosciences, Inc. Selected Consolidated Statements of Operations Financial Data(in thousands) (unaudited) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2022 2021 2022 2021Revenue: License revenue $— $6,750 $— $9,750 Total revenue — 6,750 — 9,750 Operating expenses: Research and development 6,447 11,556 23,771 39,715 General and administrative 3,079 6,344 10,957 16,259 Total operating expenses 9,526 17,900 34,728 55,974 Loss from operations (9,526) (11,150) (34,728) (46,224)Other income (expense): Transaction costs allocable to warrant liabilities — — (475) — Change in fair value of warrants liabilities (453) — 2,253 — Interest and other income (expense), net 177 (22) 236 346 Other income (expense), net (276) (22) 2,014 346 Net loss $(9,802) $(11,172) $(32,714) $(45,878) Calithera Biosciences, Inc. Selected Consolidated Balance Sheet Financial Data (in thousands) (unaudited) September 30, December 31, 2022 2021Balance Sheet Data: Cash and cash equivalents$34,068 $59,537 Working capital 25,465 47,446 Total assets 37,083 64,756 Total liabilities 10,695 15,672 Convertible preferred stock 22,342 40,702 Accumulated deficit (505,680) (491,326)Total stockholders’ equity 26,388 8,382 CONTACTS:Stephanie Wong ir@Calithera.com 650.870.1063 INVESTORS:Burns McClellanLee Roth212.213.0006lroth@burnsmc.com MEDIA:Sam Brown, Inc.Hannah Hurdle805.338.4752hannahhurdle@sambrown.com

Phase 2Financial StatementFast TrackPhase 1

15 Aug 2022

·www.globenewswire.com

Calithera Biosciences Reports Second Quarter 2022 Financial Results and Recent Highlights

-- Conference Call and Webcast Scheduled for 5:00 p.m. ET on Monday, August 15, 2022 --SOUTH SAN FRANCISCO, Calif., Aug. 15, 2022 (GLOBE NEWSWIRE) -- Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage, precision-oncology biopharmaceutical company, today announced its financial results for the second quarter ended June 30, 2022. “We continue to deliver on our commitment to efficiently advance our clinical programs, successfully initiating two new clinical trials and sharing program updates at two important medical conferences,” said Susan Molineaux, PhD, president and chief executive officer of Calithera. “We look forward to sharing data from the ongoing mivavotinib and sapanisertib phase 2 trials by the first quarter of 2023, as well as providing an update on the progress of our preclinical synthetic lethality VPS4 program by the end of 2022.” Second Quarter 2022 and Other Recent Highlights Initiated patient enrollment in phase 2 trial evaluating mivavotinib (SYK inhibitor) in r/r non-GCB DLBCL. In June, Calithera announced enrollment of the first patient in a multicenter phase 2 clinical trial (NCT05319028) evaluating the spleen tyrosine kinase (SYK) inhibitor mivavotinib (CB-659) in patients with relapsed/refractory non-germinal center B-cell like (non-GCB) diffuse large B-cell lymphoma (DLBCL), a DLBCL subpopulation that primarily comprises patients with activated B-cell like disease (ABC). The main study objectives are to confirm previously seen single-agent activity in non-GCB DLBCL patients, evaluate activity according to MYD88/CD79b mutational status, and refine dose/schedule in this patient population. The primary endpoints of the study are overall response rate as assessed by an independent radiology review committee and safety. Mivavotinib has the potential to be the first treatment specifically for non-GCB DLBCL, a population of patients with a historically poorer prognosis and therefore high unmet need, and potential to be the first treatment for a genetically-defined subset of ABC in patients with MyD88/CD79 mutations. Approximately 50% of all ABC DLBCL tumors have one or both of these mutations. Data from the ongoing phase 2 trial could position Calithera to initiate a study with registrational intent in biomarker-specific DLBCL populations. Calithera plans to share data from this trial by the first quarter of 2023.In July, Calithera presented a trial-in-progress poster at the Pan Pacific Lymphoma Conference detailing the design of this phase 2 study. Initiated patient enrollment in phase 2 trial sapanisertib (dual mTORC 1/2 inhibitor) in sqNSCLC. In July, Calithera announced enrollment of the first patient in a phase 2 clinical trial (NCT05275673) of the dual mTORC 1/2 inhibitor sapanisertib (CB-228) in patients with relapsed/refractory NRF2 (NFE2L2)-mutated squamous non-small cell lung cancer (sqNSCLC). The study is designed to confirm the selective activity of sapanisertib in NRF2-mutated tumors compared to wild-type tumors, and to refine dose in this biomarker-defined population. The primary endpoints of the study are investigator-assessed overall response rate (ORR) per RECIST v1.1, and safety. Data from this study could position Calithera to initiate a study with registrational intent in biomarker-specific sqNSCLC populations. Calithera plans to share data from this trial by the first quarter of 2023.Announced presentation of phase 1/2 data from sapanisertib/telaglenastat combination study. In a mini oral session at the International Association for the Study of Lung Cancer (IASLC) 2022 World Conference on Lung Cancer (WCLC), Jonathan W. Riess, MD, MS, director of Thoracic Oncology and associate professor at UC Davis Comprehensive Cancer Center, presented dose-escalation findings from a multi-center phase 1/2 investigator-initiated study evaluating sapanisertib in combination with telaglenastat, an investigational glutaminase inhibitor, in biomarker-defined cohorts of patients with advanced non-small cell lung cancer (NSCLC). After evaluating five combination dosing levels in 13 patients, researchers determined that the sapanisertib/telaglenastat combination has a favorable tolerability profile at the recommended expansion dose. Early evidence of clinical benefit was observed in the dose-escalation cohort, including a partial response in a patient with NRF2-mutant squamous NSCLC and stable disease in a patient with KEAP1/NRF2-mutant adenosquamous NSCLC. As a next step, study investigators plan to enroll patients into one of four expansion cohorts evaluating sapanisertib plus telaglenastat in squamous NSCLC with and without NRF2 or KEAP1 mutations, and adenocarcinoma NSCLC with KRAS and KEAP1 or NRF2 mutations.Continued to advance VPS4 program through lead optimization. Calithera previously announced internal discovery of a novel series of small-molecule inhibitors of vacuolar protein sorting-associated protein 4A (VPS4A) and VPS4B, as well as the presentation of data validating the synthetic-lethal interaction between the gene paralogs at the American Association for Cancer Research (AACR) 2022 Annual Meeting. Calithera believes these VPS4 inhibitors are the first active, on-target inhibitors of VPS4. Potent, selective, and pharmacologically active VPS4 inhibitors are expected to be well-tolerated and have strong single-agent activity in tumors with these mutations. Calithera continues to advance multiple VPS4 series through lead optimization and plans to share updates on this program by the end of the year. Selected Second Quarter 2022 Financial Results Cash and cash equivalents totaled $41.8 million at June 30, 2022. Research and development expenses for the second quarter 2022 were $7.8 million, compared to $12.8 million in the same period prior year. The decrease of $5.0 million was primarily due to decreases in the telaglenastat and CB-280 programs, partially offset by increases in the sapanisertib and mivavotinub programs. General and administrative expenses for the second quarter 2022 were $3.6 million, compared to $4.5 million in the same period prior year. The decrease of $0.9 million was primarily due to decreased personnel-related costs. Other income, net for the second quarter 2022 was $2.3 million, compared to other expense of $4,000 in the same period prior year, primarily attributable to the decrease in fair value of warrant liabilities. Net loss was $9.1 million for the three months ended June 30, 2022. Conference Call Information Calithera will host an update conference call today, Monday, August 15, at 2:00 p.m. Pacific Time/5:00 p.m. Eastern Time. To register for dial-in access to the call, please use this link. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days. About Calithera Calithera Biosciences is a clinical-stage, precision oncology biopharmaceutical company developing targeted therapies to redefine treatment for biomarker-specific patient populations. Driven by a commitment to rigorous science and a passion for improving the lives of people impacted by cancer, Calithera is advancing a robust pipeline of investigational, small-molecule oncology compounds with a biomarker-driven approach that targets genetic vulnerabilities in cancer cells to deliver new therapies for patients suffering from aggressive hematologic and solid tumor cancers for which there are currently limited treatment options. Calithera is headquartered in South San Francisco, California. For more information about Calithera, please visit www.calithera.com. Forward Looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," "poised" and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These statements include those related to the safety, tolerability and efficacy of Calithera’s product candidates, the overall advancement of Calithera’s product candidates in preclinical development and clinical trials, including Calithera’s plan to initiate two phase 2 clinical trials for mivavotinib and sapanisertib and plan to share data from these trials by the first quarter 2023, Calithera’s ability to potentially initiate registrational studies in biomarker-specific populations in DLBC and relapsed or refractory squamous NSCLC, the expectation that VPS4 inhibitors will be well-tolerated and have strong single-agent activity in tumors with certain mutations, Calithera’s plan to advance multiple VPS4 series through lead optimization and plan to share updates on this program by the end of the year, the unmet need in the treatment of patients with advanced disease, and management’s expectation that Calithera’s cash and cash equivalents will be sufficient to meet its operating plan through the second quarter of 2023. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The potential product candidates that Calithera develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all. In addition, clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release. Such product candidates may not be beneficial to patients or be successfully commercialized. The failure to meet expectations with respect to any of the foregoing matters may have a negative effect on Calithera's stock price. Additional information concerning these and other risk factors affecting Calithera's business can be found in Calithera's periodic filings with the Securities and Exchange Commission at www.sec.gov. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, Calithera disclaims any obligation to update these forward-looking statements to reflect future events or circumstances. Calithera Biosciences, Inc. Selected Consolidated Statements of Operations Financial Data (in thousands) (unaudited) Three Months EndedJune 30, Six Months EndedJune 30, 2022 2021 2022 2021 Revenue: License revenue $— $3,000 $— $3,000 Total revenue — 3,000 — 3,000 Operating expenses: Research and development 7,758 12,820 17,324 28,159 General and administrative 3,618 4,487 7,878 9,915 Total operating expenses 11,376 17,307 25,202 38,074 Loss from operations (11,376) (14,307) (25,202) (35,074) Other income (expense): Transaction costs allocable to warrant liabilities (475) — (475) — Change in fair value of warrants liabilities 2,706 — 2,706 — Interest and other income (expense), net 68 (4) 59 368 Other income (expense), net 2,299 (4) 2,290 368 Net loss $(9,077) $(14,311) $(22,912) $(34,706) Calithera Biosciences, Inc. Selected Consolidated Balance Sheet Financial Data (in thousands) (unaudited) June 30, December 31, 2022 2021 Balance Sheet Data: Cash and cash equivalents$41,789 $59,537 Working capital 33,930 47,446 Total assets 45,558 64,756 Total liabilities 10,307 15,672 Convertible preferred stock 22,342 40,702 Accumulated deficit (495,878) (491,326) Total stockholders’ equity 35,251 8,382 CONTACTS:Stephanie Wong ir@Calithera.com650.870.1063 INVESTORS:Burns McClellanLee Roth212.213.0006lroth@burnsmc.com MEDIA:Sam Brown, Inc.Hannah Hurdle805.338.4752hannahhurdle@sambrown.com

Financial StatementAACR

100 Deals associated with Telaglenastat

External Link

KEGG	Wiki	ATC	Drug Bank
D11738	-	-	DB15232

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic castration-resistant prostate cancer	Phase 2	US	Calithera Biosciences, Inc.	01 Jul 2021
Metastatic castration-resistant prostate cancer	Phase 2	US	Pfizer Inc.	01 Jul 2021
Metastatic Prostate Carcinoma	Phase 2	US	Pfizer Inc.	01 Jul 2021
Metastatic Prostate Carcinoma	Phase 2	US	Calithera Biosciences, Inc.	01 Jul 2021
Non-squamous non-small cell lung cancer	Phase 2	US	Calithera Biosciences, Inc.	24 Jul 2020
Advanced Lung Non-Small Cell Carcinoma	Phase 2	US	National Cancer Institute	16 Mar 2020
EGFR-mutated non-small Cell Lung Cancer	Phase 2	US	National Cancer Institute	16 Mar 2020
Neurofibrosarcoma	Phase 2	US	National Cancer Institute	14 Dec 2019
Unresectable Malignant Solid Neoplasm	Phase 2	US	National Cancer Institute	14 Dec 2019
Colorectal Cancer	Phase 2	US	Calithera Biosciences, Inc.	20 May 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02861300 (CTgov)	Phase 1/2	Rectal Cancer \| RAS mutant Colorectal Cancer \| Colonic Cancer ... View more	50	CB-839+capecitabine (Phase I)	azaeqgdzmd(wxdyopoxjc) = znvfaanwkt utjriqdkds (xsnrhuhlvs, nalftrgdpf - wnlbibcuoz)	-	19 Dec 2024
				CB-839+Capecitabine (Phase I Dose -1)	uzlwufxxux(urhhuvurtw) = pouotkzxet yzlnsytbke (lzbedzumal, twdummyrrs - bvemzkskzs) View more
NCT03047993 (Pubmed \| Nat Cancer) Manual	Phase 1/2	Myelodysplastic Syndromes glutamine transporter solute carrier family 38 member 1	30	Telaglenastat (CB-839) + Azacytidine (AZA)	qzpgekisqj(ulhtghjwds) = sapnowevun rmgtctyftp (hxirjqxvts ) View more	Positive	19 Sep 2024
NCT03263429 (P-187, CTgov)	Phase 1/2	Refractory Colorectal Carcinoma \| Metastatic Colorectal Carcinoma \| RAS Wild Type Colorectal Cancer	29	Imaging+Glutaminase Inhibitor CB-839+Irinotecan Hydrochloride (phase I only)+Panitumumab	dehzbodjhb(hlnaubxsgu) = jfwmvtydnl fzlurqfbqp (rtanmdrqeh, dwxwmuoddb - snebfwvyxo) View more	-	30 Aug 2024
NCT03047993 (CTgov)	Phase 1/2	High Risk Myelodysplastic Syndrome \| Acute myeloid leukemia with multilineage dysplasia \| Chronic Myelomonocytic Leukemia	28	Glutaminase Inhibitor CB-839+Azacitidine	vunolvucas(coaqanoiow) = steyiqxnhl euvewbksog (ztwybwxtog, ephsdovvbf - smlwvqcjvd) View more	-	14 May 2024
NCT03428217 (CANTATA, CTgov)	Phase 2	Metastatic Renal Cell Carcinoma \| Advanced Renal Cell Carcinoma \| Metastatic Clear Cell Renal Cell Carcinoma	444	Placebo+Cabozantinib (Pbo-Cabo)	daujizfdha(mhahtvfxsf) = fsxiflxjjp ibpzzqitlq (xiullncrey, fanetqlkif - mpfnceqvuh) View more	-	20 Mar 2023
				CB-839+Cabozantinib (CB-Cabo)	daujizfdha(mhahtvfxsf) = cvzmwlujxj ibpzzqitlq (xiullncrey, klmkiptabm - hbvvkhdbbf) View more
NCT02771626 (O16, CTgov)	Phase 1/2	Renal Cell Carcinoma \| Non-Small Cell Lung Cancer \| Metastatic melanoma ... View more	118	nivolumab+CB-839 (Telaglenastat 600 mg + Standard Dose Nivolumab)	gemiwkfpgx(qiuexstvew) = ulgwducsfm ustyliuqzo (pcemsjyrqc, tvccivjgek - ntqzixumuk) View more	-	17 Mar 2023
				nivolumab+CB-839 (Telaglenastat 800 mg + Standard Dose Nivolumab: ccRCC Naïve to Checkpoint Inhibitors)	gemiwkfpgx(qiuexstvew) = dnzfyyvqgf ustyliuqzo (pcemsjyrqc, mfkrmozzmw - csniqcrmoc) View more
NCT03798678 (ASH 12022 \| ASH 22022) Manual	Phase 1	Relapse multiple myeloma	21	Dexamethasone+Carfilzomib+Telaglenastat	jyommyhlqx(fcybxeeaua) = bcrayrfszj yguzwbixpt (uvjbzjxhps ) View more	Positive	15 Nov 2022
NCT03057600 (P6-20-07, CTgov)	Phase 2	Advanced Triple-Negative Breast Carcinoma	52	CB-839+Paclitaxel (Cohort 1 - African Ancestry, 3rd Line+)	ffgirycrxn(ebwterqygd) = wjquasmall oqyocwxjoh (zhigrszinr, hgdluvmlxx - tbqxwmdgda) View more	-	28 Sep 2022
				CB-839+Paclitaxel (Cohort 2 - African Ancestry, 1st Line)	ffgirycrxn(ebwterqygd) = gmriuksipv oqyocwxjoh (zhigrszinr, ndpftvoxtv - xoqxkupzws) View more
NCT03163667 (ENTRATA, CTgov)	Phase 2	Metastatic Clear Cell Renal Cell Carcinoma	69	Placebo+everolimus (Placebo + Everolimus)	osxpdvngiu(ienkvmxfhr) = bexjhrqaex vupxpluyez (rwyauzvque, iaerzijrme - dxzypzxyvc) View more	-	15 Sep 2022
				CB-839+everolimus (CB-839 + Everolimus)	osxpdvngiu(ienkvmxfhr) = csyzxqcnpw vupxpluyez (rwyauzvque, jkbaorborl - pvlhqjocfi) View more
NCT03428217 (CANTATA, Pubmed \| JAMA Oncol) Manual	Phase 2	Advanced Renal Cell Carcinoma	444	Cabozantinib-Malate+Telaglenastat	ybdhpoicig(gbmrkozagd) = tvywkavpja pmbwghdzip (zojopxdtvw ) View more	Negative	01 Sep 2022
				Cabozantinib+Placebo	ybdhpoicig(gbmrkozagd) = ilnxwxrjwk pmbwghdzip (zojopxdtvw ) View more

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