A Phase 2 Multi-arm, Open Label Study to Assess the Safety and Efficacy of EP0057 in Combination With Olaparib in Defined Populations of Patients With Relapsed Advanced Gastric Cancer and Small Cell Lung Cancer

The aim of EP0057 - 202 is to assess the safety and efficacy of EP0057 in combination with Olaparib (a PARP inhibitor) in two cancers where there is a high unmet need: extensive stage small cell lung cancer (SCLC) and ATM-negative gastric cancer (GC).
EP0057-202 is a non-comparative, multi-arm, multi-centre, open label, Phase 2 study to determine the efficacy, safety, and tolerability of EP0057 in combination with olaparib (an approved PARP inhibitor) in defined patient populations with relapsed* GC and SCLC.
*(see Eligibility Criteria for definition of "relapse" for each tumour type/population) The treatment cohorts will open sequentially at the Sponsor's discretion and patients may be enrolled into each cohort concurrently.
EP0057 is an investigational nanoparticle-drug conjugate administered intravenously. The rationale for developing EP0057 is to enable selective entry of EP0057 into tumour tissue and as a result create preferential accumulation of EP0057, and therefore of the payload Camptothecin, to translate into maximum tumour cell killing.

Start Date01 Apr 2023

Sponsor / Collaborator

Ellipses Pharma Ltd.

NCT04669002

/ CompletedPhase 2

Phase 2 Study to Evaluate the Safety & Efficacy of EP0057 in Combination With Olaparib in Advanced Ovarian Cancer Patients Who Have: Cohort 1 - Platinum Resistant Disease; Cohort 2 - Had at Least 1 Prior Line of Therapy Which Must Include at Least 1 Line of Platinum-based Chemotherapy Followed by PARP Inhibitor Maintenance

EP0057-201 is a Phase 2A/B adaptive design study. Phase 2A will test EP0057 in combination with Olaparib and Phase 2B, the randomised part of the study, will test EP0057 in combination with Olaparib against SOC chemotherapy. When EP0057 is combined with Olaparib, it is envisaged that the combination should improve therapeutic responses in the recurrent ovarian cancer disease setting.
EP0057 is an investigational nanoparticle-drug conjugate administered intravenously. The rationale for developing EP0057 is to enable selective entry of EP0057 into tumour tissue and as a result create preferential accumulation of EP0057, and therefore of the payload Camptothecin, to translate into maximum tumour cell killing.

Start Date14 Dec 2020

Sponsor / Collaborator

Ellipses Pharma Ltd.

NCT03531827

/ TerminatedPhase 2IIT

A Single Arm Phase II Study Combining CRLX101, a Nanoparticle Camptothecin, With Enzalutamide in Patients With Progressive Metastatic Castration Resistant Prostate Cancer Following Prior Enzalutamide Treatment

Background:
Some prostate cancer keeps growing even when testosterone in the body drops to very low levels. This is called castrate-resistant prostate cancer. One treatment is enzalutamide. This is a modern hormonal therapy. But it only works for a certain amount of time and then the cancer becomes resistant to it. Researchers want to see if adding the treatment CRLX101 (formerly IT-101) could make enzalutamide work again for people who have already had it.
Objective:
To test a new way of treating prostate cancer using CRLX101 plus enzalutamide in people with certain prostate cancer who already had enzalutamide treatment.
Eligibility:
Adults ages 18 years and older with metastatic, castration-resistant prostate cancer who have had enzalutamide treatment
Design:
Participants will be screened with a medical history and physical exam. They will have blood and urine tests. They will have a scan of the chest/abdomen/pelvis. They will have a bone scan.
Participants will get treatment in cycles. A cycle lasts 28 days. They will take enzalutamide by mouth once a day. They will get CRLX101 through an intravenous (IV) every 1 or 2 weeks.
Participants will repeat screening tests throughout the study.
Participants will have a follow-up visit 3-4 weeks after they stop taking the study drug. They will repeat most screening tests and have an electrocardiogram.

Start Date26 Mar 2019

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Camptothecin nanoparticle formulation(Insert Therapeutics)

100 Translational Medicine associated with Camptothecin nanoparticle formulation(Insert Therapeutics)

100 Patents (Medical) associated with Camptothecin nanoparticle formulation(Insert Therapeutics)

Literatures (Medical) associated with Camptothecin nanoparticle formulation(Insert Therapeutics)

01 Jun 2025·Current medicinal chemistry

Clinical Outcomes and Effectiveness of CRLX101 for Solid Tumors: A Systematic Review and Meta-analysis

Review

Author: Shamaeizadeh, Nahal ; Sadeghi, Erfan ; Varshosaz, Jaleh

Background::

While it has been demonstrated that delivery of cytotoxic chemotherapy using nanoparticles greatly improves patient drug tolerance and reduces toxicity when compared to the standard formulation, the crucial question of whether they also increase anticancer efficacy remains. The CRLX101 is a nanoparticle composed of cyclodextrin and 20(S)-camptothecin cytotoxic chemotherapy.

Objective::

In order to compare the efficacy of the CRLX101 to its corresponding traditional formulation, we carried out this systematic literature search for randomized clinical and non-randomized trials.

Methods::

Multiple electronic databases, including PubMed, Scopus, Embase, Web of Science, the Cochrane Library, and clinicaltrials.gov, were used to conduct a thorough literature search. By employing a technique akin to a random-effects model, the median of the study-specific was taken into account as the pooled median estimate with a 95% confidence interval.

Results::

Finally, nine clinical studies were chosen for the meta-analysis. The treatment and control groups' overall survival were examined in five and three trials, respectively. Additionally, six out of nine trials and two out of nine trials, respectively, examined the treatment and control groups for progression-free survival (PFS). Meta-analysis revealed that the treatment group had a lower median overall survival (OS) but a greater median progression-free survival than the control group.

Conclusion::

Our meta-analysis shows that CRLX101 outperforms camptothecin in PFS despite its inferior OS. Unresolved pharmacology limits carrier-mediated drug therapeutic application. Carrier-mediated dosages may differ from normal formulations because they are rarely studied.

01 Feb 2025·ANTICANCER RESEARCH

Camptothecin Triggers Apoptosis in Human and Mouse Drug-resistant Glioblastoma CellsviaROS-mediated Activation of the p53-p21-CD1/CDK2-E2F1-Bcl-xL Signaling Axis

Article

Author: Lin, Chien-Ju ; Cherng, Yih-Giun ; Chen, Jui-Tai ; Chen, Ruei-Ming ; Wu, Gong-Jhe ; Liu, Shing-Hwa

BACKGROUND/AIM:

Glioblastoma multiforme (GBM) is the most aggressive brain tumor. Temozolomide (TMZ) is the first-line treatment for GBM. However, most patients with GBM develop drug resistance. Our previous study showed the effects of camptothecin (CPT) and CRLX101, a nanoparticle of CPT, in suppressing GBM growth by targeting drug-sensitive glioblastoma cells. This study evaluated the effects of CPT on drug-resistant glioblastoma cells and explored the underlying molecular mechanisms.

MATERIALS AND METHODS:

Expression of type I topoisomerase (Topo-1) gene in GBM was analyzed using the UALCAN database. Human U87MG-R and mouse GL261-R TMZ-resistant glioblastoma cells were developed. After CPT treatment, apoptotic events were successively determined. The role of the p53-p21-cyclin D1 (CD1)/cyclin-dependent kinase 6 (CDK6)-E2F1-Bcl-xL signaling axis was subsequently investigated.

RESULTS:

The expression of Topo-1 gene was up-regulated in human GBM compared to normal human brains. Treatment of human U87MG-R cells with CPT decreased cell viability. Sequentially, exposure to CPT led to activation of caspase-3, fragmentation of chromosomal DNA, and cell apoptosis. Furthermore, intracellular reactive oxygen species (iROS) were augmented following CPT treatment. Suppression of iROS production concurrently alleviated CPT-triggered apoptotic insults. CPT enhanced the levels of p53, phosphorylated p53, and p21. In contrast, levels of CDK6, CD1, E2F1, and Bcl-xL were decreased by CPT. Attenuating p53 transactivation activity using pifithrin-α also mitigated the CPT-induced apoptosis. The effects of CPT on killing drug-resistant glioblastoma cells were further confirmed in mouse GL261-R cells.

CONCLUSION:

CPT could effectively induce apoptosis in drug-resistant glioblastoma cells via iROS-mediated activation of the p53-p21-CD1/CDK6-E2F1-Bcl-xL axis.

01 Apr 2024·International journal of pharmaceutics

Multifunctionality of cyclodextrin-based polymeric nanoparticulate delivery systems for chemotherapeutics, combination therapy, and theranostics

Review

Author: Di Martino, Piera ; Gigliobianco, Maria Rosa ; Censi, Roberta ; Casadidio, Cristina ; Devi, Lakshmi Sathi

As cancer being the most difficult disease to treat, different kinds of medications and therapeutic approaches have been prominently developed by scientists. For certain families of drugs, such as immuno-therapeutics or antibody-drug conjugates, efficient delivery systems are required during administration to protect the drugs from chemical degradation or biological inactivation. Delivery systems with the ability to carry different therapeutics or diagnostic agents or both, hold promising potential to tackle the abnormalities behind cancer. In this context, this review provides updated insights on how cyclodextrin-based polymeric nanosystems have become an effective treatment approach against cancer. Cyclodextrins (CDs) are natural oligosaccharides that are famously exploited in pharmaceutical research due to their exceptional quality of entrapping water-insoluble molecules inside their hydrophobic core and providing enhanced solubility with the help of their hydrophilic exterior. Combining the properties of CDs with polymeric nanoparticles (PNPs) brings out excellent versatile and tunable profiles, thanks to the submicron-sized PNPs. By introducing the significance of CD as a delivery system, a collective discussion on different binding approaches and release mechanisms of CD-drug complexation, followed by their characterization studies has been done in this review. Further, in light of recent studies, the article majorly focuses on conveying how promoting CD to a polymeric and nanoscale elevates the multifunctional advantages against cancer that can be successfully applied in combination therapy and theranostics. Moreover, CD-based delivery systems including CALAA-01, CRLX101, and CRLX301, have demonstrated improved tumor targeting, reduced side effects, and prolonged drug release in preclinical studies and clinical trials.

News (Medical) associated with Camptothecin nanoparticle formulation(Insert Therapeutics)

12 Nov 2024

·www.globenewswire.com

Vincerx Pharma Reports Third Quarter 2024 Financial Results

Continued enrollment and dose escalation in Phase 1 study of VIP943, a potentially best-in-class anti-CD123 antibody-drug conjugate (ADC); additional data expected by early 2025 Completed Phase 1 dose-escalation studies of small molecule drug-conjugate (SMDC), VIP236, and CDK9 inhibitor, enitociclib, and identified the maximum tolerated dose Expected cash runway into early 2025 PALO ALTO, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported financial results for the third quarter of 2024 and provided an overview of its clinical programs and anticipated milestones. “As we direct our efforts and resources toward our ADC technologies and programs, we are committed to advancing VIP943 based on the encouraging safety, efficacy, and tolerability results observed to date. We look forward to presenting additional data from patients at efficacious dose cohorts by early next year,” said Ahmed Hamdy, M.D., Chief Executive Officer. “Securing the funding necessary to advance our programs remains a priority. Alongside exploring financing options, we remain focused on strategic partnerships, particularly as pharmaceutical companies intensify their search for truly differentiated and transformative technologies.” THIRD QUARTER 2024 CLINICAL PROGRAM HIGHLIGHTS AND ANTICIPATED MILESTONES VIP943 VIP943 is a novel CD123-targeted ADC developed with the Company’s next-generation VersAptx platform.VIP943 has shown promising safety, efficacy, and tolerability in an ongoing Phase 1 dose-escalation study for patients with relapsed/refractory acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and B-cell acute lymphoblastic leukemia (B-ALL) (NCT06034275). In October, the Company reported two complete responses in this Phase 1 study: one out of four patients with relapsed AML in the 1 mg/kg dose cohort achieved complete remission with incomplete hematologic recovery (CRi), and one out of one patient with higher-risk MDS in the 1.3 mg/kg dose cohort achieved complete remission with limited count recovery (CRL).VIP943 has shown effective target engagement and elimination of CD123+ malignant cells, with pharmacodynamic data demonstrating decreases in CD123+ blasts after dosing. Preliminary pharmacokinetic data indicates minimal payload release (≤1% in plasma), signifying a stable linker.Given the favorable safety and tolerability observed for VIP943, the Company continues dose escalation to assess potential for additional efficacy. Enrollment in the once-weekly and twice-weekly (as an induction therapy) dosing schedules is ongoing.Vincerx expects to share additional Phase 1 study data for VIP943 by early 2025. Enitociclib Enitociclib is a highly selective CDK9 inhibitor designed to block the activation of RNA polymerase II, leading to inhibition of oncogenes, including MYC and MCL1.Enitociclib is currently in a Phase 1 dose-escalation study (NTC05371054) evaluating the combination of enitociclib, venetoclax, and prednisone in diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphoma (PTCL). This study is being conducted in collaboration with the National Institutes of Health (NIH). As of September 2024, the study reported four partial responses (PRs) in seven patients (57% overall response rate), including one patient with double hit lymphoma (DH-DLBCL) and three patients with PTCL.Enitociclib has successfully completed its Phase 1 dose-escalation study as a monotherapy (NCT02635672), enrolling 63 patients across dose-escalation and expansion cohorts. The treatment demonstrated a favorable safety profile, dose-proportional pharmacokinetics, and on-target pharmacodynamic activity. Clinical benefits included durable complete metabolic remissions in two patients with DH-DLBCL, lasting 3.7 and 2.3 years, with both remissions continuing more than two years after treatment cessation. In addition, a transformed follicular (tFL) patient achieved a PR with a 63% tumor reduction after nearly two years, a meaningful outcome given the historically poor prognosis of tFL. Furthermore, 13 patients with solid tumors achieved stable disease as their best response, including five ovarian cancer patients—indicating a promising path for future combination studies in this indication.The Company is actively focused on finding a strategic partner to continue the development of this asset. VIP236 VIP236 is a αVβ3 SMDC conjugated to an optimized camptothecin (CPT) payload developed with the Company’s VersAptx platform.VIP236 has completed its Phase 1 dose-escalation study (NCT05712889), identifying the maximum tolerated dose that could be utilized in future studies. As reported in October, a total of 29 patients were enrolled in the Phase 1 study, resulting in a 45% disease control rate. The drug demonstrated a favorable safety profile, distinguishing itself from other CPTs by showing no instances of common dose-limiting side effects such as life-threatening diarrhea, severe stomatitis/mucositis, or interstitial lung disease.The Company intends to identify a partner to champion VIP236 through further development. THIRD QUARTER 2024 FINANCIAL RESULTS Vincerx had approximately $10.1 million in cash, cash equivalents, and marketable securities as of September 30, 2024, as compared to approximately $16.3 million as of June 30, 2024. Based on its current business plans and assumptions, Vincerx believes its available capital will be sufficient to meet its operating requirements into early 2025.Research and development expenses for the third quarter ended September 30, 2024, were approximately $3.9 million, as compared to approximately $6.1 million for the same period in 2023. This decrease is primarily the result of decreases in research services of approximately $2.4 million and personnel-related expenses of approximately $0.8 million, offset by an increase in clinical-related expenses of approximately $0.9 million.General and administrative expenses for the third quarter ended September 30, 2024, were approximately $3.9 million, as compared to approximately $3.5 million for the same period in 2023. This increase was due to a $0.5 million increase in professional services, partially offset by a decrease in personnel-related expenses of $0.1 million.For the third quarter ended September 30, 2024, Vincerx reported a net loss of approximately $7.8 million, or $0.17 per share. For the third quarter ended September 30, 2023, Vincerx reported a net loss of approximately $9.0 million, or $0.42 per share. About Vincerx Pharma, Inc.Vincerx Pharma, Inc. is a clinical-stage biopharmaceutical company committed to developing differentiated and novel therapies to address the unmet medical needs of patients with cancer. Vincerx has assembled a seasoned management team with a proven track record of successful oncology drug development, approvals, and value creation. Vincerx’s diverse pipeline consists of the next-generation ADC VIP943, currently in Phase 1; SMDC VIP236, which has completed its Phase 1; CDK9 inhibitor enitociclib, which has completed a Phase 1 monotherapy study and continues in a Phase 1 study in collaboration with the NIH; preclinical ADC VIP924; and VersAptx, a versatile, next-generation bioconjugation platform. Vincerx is based in Palo Alto, California, and has a research subsidiary in Monheim, Germany. For more information, please visit www.vincerx.com and follow Vincerx on LinkedIn. Forward-Looking StatementThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, expectations and events, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “suggest,” “seek,” “intend,” “plan,” “goal,” “potential,” “on-target,” “on track,” “project,” “estimate,” “anticipate,” or other comparable terms. All statements other than statements of historical facts included in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, Vincerx’s business model, cash runway, pipeline, strategy, timeline, product candidates and attributes, and preclinical and clinical development, timing, and results. Forward-looking statements are neither historical facts nor assurances of future performance or events. Instead, they are based only on current beliefs, expectations, and assumptions regarding future business developments, future plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict, many of which are outside Vincerx’s control.Actual results, conditions, and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results, conditions, and events to differ materially from those indicated in the forward-looking statements include, but are not limited to, Vincerx’s capital requirements, availability and uses of capital, ability to raise additional capital and cash runway; risks associated with preclinical or clinical development and studies; failure to realize the benefits of Vincerx’s license agreement with Bayer; risks related to the timing of expected business and product development milestones; changes in the assumptions underlying Vincerx’s expectations regarding its future business or business model; Vincerx’s ability to successfully develop and commercialize product candidates; general economic, financial, legal, political, and business conditions; and the risks and uncertainties set forth in the Form 10-Q for the quarter ended June 30, 2024 and subsequent reports filed with the Securities and Exchange Commission by Vincerx. Forward-looking statements speak only as of the date hereof, and Vincerx disclaims any obligation to update any forward-looking statements. Vincerx, the Vincerx logo, and VersAptx are our trademarks. ContactsGabriela JairalaVincerx Pharma, Inc.gabriela.jairala@vincerx.com Totyana SimienInizio Evoke Commstotyana.simien@inizioevoke.com Vincerx Pharma, Inc. Condensed Consolidated Balance Sheets (in thousands) September 30, 2024 December 31, 2023 (unaudited) ASSETS Current assets: Cash and cash equivalents$2,942 $12,782 Short-term marketable securities 7,144 - Prepaid expenses 283 51 Grant receivable 1,063 1,044 Other current assets 316 856 Total current assets 11,748 14,733 Right-of-use assets 1,431 2,201 Property, plant and equipment, net 85 125 Other assets 1,683 1,158 Total assets$ 14,947 $ 18,217 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable$1,963 $2,497 Accrued expenses 1,724 1,755 Lease liability 1,274 1,162 Common stock warrant liabilities 463 191 Total current liabilities 5,424 5,605 Lease liability, net of current portion 365 1,340 Other noncurrent liabilities 50 50 Total liabilities 5,839 6,995 Total stockholders' equity 9,108 11,222 Total liabilities and stockholders' equity$ 14,947 $ 18,217 Vincerx Pharma, Inc.Condensed Consolidated Statements of Operations(unaudited)(in thousands, except per share amounts) For the three months ended For the nine months ended September 30, September 30, 2024 2023 2024 2023 Operating expenses: General and administrative$3,885 $3,508 $10,419 $11,816 Research and development 3,908 6,101 12,218 25,260 Total operating expenses 7,793 9,609 22,637 37,076 Loss from operations (7,793) (9,609) (22,637) (37,076) Other income (expense) Change in fair value of warrant liabilities (331) 112 (272) 12 Interest income 154 260 410 1,053 Other income (expense) 127 230 419 804 Total other income (expense) (50) 602 557 1,869 Net loss $ (7,843) $ (9,007) $ (22,080) $ (35,207) Net loss per common share, basic and diluted$(0.17) $(0.42) $(0.63) $(1.66) Weighted average common shares outstanding, basic and diluted 45,672 21,345 35,175 21,269

Phase 1Clinical ResultFinancial StatementADC

08 Aug 2024

·www.globenewswire.com

Vincerx Pharma Reports Second Quarter 2024 Financial Results

Vincerx continues to enroll its Phase 1 studies of antibody-drug conjugate (ADC) VIP943, with data expected by the end of Q4 2024, and small molecule drug-conjugate (SMDC) VIP236, with data expected at the end of Q3 2024 Expected cash runway through 2024 PALO ALTO, Calif., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported financial results for the second quarter of 2024 and provided an overview of its clinical programs and anticipated milestones. “During the second quarter, our team focused on execution and the continued enrollment of patients in our ongoing Phase 1 studies for our potentially best-in-class ADC, VIP943, and first-in-class SMDC, VIP236,” said Ahmed Hamdy, M.D., Chief Executive Officer. “We look forward to evaluating the results from additional cohorts and sharing data by end of Q3 for VIP236 and by end of year for VIP943.” SECOND QUARTER 2024 CLINICAL PROGRAM HIGHLIGHTS AND ANTICIPATED MILESTONES VIP943 VIP943, a novel CD123-targeted ADC created from Vincerx’s VersAptx™ platform, consists of an anti-CD123 antibody, a unique linker cleaved intracellularly by legumain, and a novel kinesin spindle protein inhibitor (KSPi) payload enhanced with Vincerx’s CellTrapper® technology. Its next-generation effector chemistry was designed to address challenges associated with many ADCs by improving efficacy and reducing severe toxicities.Vincerx expects to share additional Phase 1 study data for VIP943 for patients with relapsed/refractory acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and B-cell acute lymphoblastic leukemia (B-ALL) (NCT06034275) by the end of Q4 2024. VIP236 VIP236 is an αVβ3 SMDC conjugated to an optimized camptothecin (CPT) payload created from Vincerx’s VersAptx platform. VIP236 is a first-in-class drug designed to deliver its optimized CPT payload directly to tumor tissues to overcome chemotherapy-related side effects. Preclinical studies have shown 11 times more optimized CPT is delivered to the cancerous tissues than found circulating in the blood. In addition, the optimized CPT is designed to limit drug transporter liabilities, a common mechanism for cancer resistance to chemotherapy.Vincerx looks forward to sharing additional data from this Phase 1 study (NTC05371054) by the end of Q3 2024. Enitociclib Enitociclib is a highly selective CDK9 inhibitor designed to block the activation of RNA polymerase II, leading to the reduction of oncogenes, including MYC and MCL1.Enitociclib is currently in a Phase 1 dose-escalation study (NTC05371054) evaluating the combination of enitociclib, venetoclax and prednisone in diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphoma (PTCL). This study is being conducted in collaboration with the National Institutes of Health (NIH). At the AACR Advances in Malignant Lymphoma meeting in June 2024, the NIH presented the interim study results previously shared by Vincerx in January 2024 and May 2024. VIP924 VIP924 is a first-in-class CXCR5-targeted ADC created from Vincerx’s VersAptx platform.VIP924 can be evaluated in B-cell malignancies, including mantle cell lymphoma, follicular lymphoma, DLBCL, and chronic lymphocytic leukemia , as a monotherapy and in combination.IND application is anticipated in early 2026, pending funding. VersAptx™ Platform VersAptx is Vincerx’s versatile and adaptable, next-generation bioconjugation platform. The modular nature of this platform enables the combination of different targeting, linker, and payload technologies to develop bespoke bioconjugates to address different cancer biologies. SECOND QUARTER 2024 FINANCIAL RESULTS Vincerx had approximately $16.3 million in cash, cash equivalents and marketable securities as of June 30, 2024, as compared to approximately $5.1 million as of March 31, 2024. Based on its current business plans and assumptions, Vincerx believes its available capital, including the proceeds of its April financing of approximately $16.9 million, will be sufficient to meet its operating requirements through the end of 2024.Research and development expenses for the second quarter ended June 30, 2024 were approximately $3.8 million, as compared to approximately $8.2 million for the same period in 2023. This decrease is primarily the result of decreases in research services of approximately $1.8 million, manufacturing services associated with our ADC program of approximately $1.6 million, and personnel related expenses of approximately $0.8 million.General and administrative expenses for the second quarter ended June 30, 2024 were approximately $3.6 million, as compared to approximately $3.8 million for the same period in 2023. This decrease is primarily driven by decreases in personnel-related expenses of approximately $0.3 million.For the second quarter ended June 30, 2024, Vincerx reported a net loss of approximately $1.8 million, or $0.05 per share. For the second quarter ended June 30, 2023, Vincerx reported a net loss of approximately $11.6 million, or $0.54 per share. About Vincerx Pharma, Inc.Vincerx Pharma, Inc. is a clinical-stage biopharmaceutical company committed to developing differentiated and novel therapies to address the unmet medical needs of patients with cancer. Vincerx has assembled a seasoned management team with a proven track record of successful oncology drug development, approvals, and value creation. Vincerx’s diverse pipeline consists of the next-generation antibody-drug conjugate, VIP943, in Phase 1; small molecule-drug conjugate, VIP236, in Phase 1; preclinical antibody-drug conjugate, VIP924; CDK9 inhibitor, enitociclib, in an NIH-sponsored Phase 1; and VersAptx, its versatile and adaptable, next-generation bioconjugation platform. Vincerx is based in Palo Alto, California, and has a research facility in Monheim, Germany. For more information, please visit www.vincerx.com and follow Vincerx on LinkedIn. Forward-Looking StatementThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, expectations and events, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “suggest,” “seek,” “intend,” “plan,” “goal,” “potential,” “on-target,” “on track,” “project,” “estimate,” “anticipate,” or other comparable terms. All statements other than statements of historical facts included in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, Vincerx’s business model, cash runway, pipeline, strategy, timeline, product candidates and attributes, and preclinical and clinical development, timing, and results. Forward-looking statements are neither historical facts nor assurances of future performance or events. Instead, they are based only on current beliefs, expectations, and assumptions regarding future business developments, future plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict, many of which are outside Vincerx’s control. Actual results, conditions, and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results, conditions, and events to differ materially from those indicated in the forward-looking statements include, but are not limited to, general economic, financial, legal, political, and business conditions; risks associated with preclinical or clinical development and studies, including those conducted prior to Vincerx’s in-licensing; failure to realize the benefits of Vincerx’s license agreement with Bayer; risks related to the timing of expected business and product development milestones; changes in the assumptions underlying Vincerx’s expectations regarding its future business or business model; Vincerx’s ability to successfully develop and commercialize product candidates; Vincerx’s capital requirements, availability and uses of capital, and cash runway; and the risks and uncertainties set forth in the Form 10-Q for the quarter ended March 31, 2024 and subsequent reports filed with the Securities and Exchange Commission by Vincerx. Forward-looking statements speak only as of the date hereof, and Vincerx disclaims any obligation to update any forward-looking statements. Vincerx, the Vincerx logo, CellTrapper, and VersAptx are our trademarks. ContactsGabriela JairalaVincerx Pharma, Inc.gabriela.jairala@vincerx.com Cassidy McClainInizio Evoke CommsCassidy.McClain@inizioevoke.com Vincerx Pharma, Inc.Condensed Consolidated Balance Sheets(in thousands) June 30, 2024 December 31, 2023 (unaudited) ASSETS Current assets: Cash and cash equivalents$7,923 $12,782 Short-term marketable securities 8,396 - Prepaid expenses 530 51 Grant receivable 1,018 1,044 Other current assets 416 856 Total current assets 18,283 14,733 Right-of-use assets 1,693 2,201 Property, plant and equipment, net 98 125 Other assets 1,453 1,158 Total assets$ 21,527 $ 18,217 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable$1,536 $2,497 Accrued expenses 2,428 1,755 Lease liability 1,236 1,162 Common stock warrant liabilities 132 191 Total current liabilities 5,332 5,605 Lease liability, net of current portion 697 1,340 Other noncurrent liabilities 50 50 Total liabilities 6,079 6,995 Total stockholders' equity 15,448 11,222 Total liabilities and stockholders' equity$ 21,527 $ 18,217 Vincerx Pharma, Inc.Condensed Consolidated Statements of Operations(unaudited)(in thousands, except per share amounts) For the three months ended For the six months ended June 30, June 30, 2024 2023 2024 2023 Operating expenses: General and administrative$3,612 $3,811 $6,534 $8,308 Research and development 3,754 8,248 8,310 19,159 Total operating expenses 7,366 12,059 14,844 27,467 Loss from operations (7,366) (12,059) (14,844) (27,467)Other income (expense) Change in fair value of warrant liabilities 5,263 (118) 59 (100)Interest income 157 327 256 793 Other income (expense) 138 300 292 574 Total other income (expense) 5,558 509 607 1,267 Net loss $ (1,808) $ (11,550) $ (14,237) $ (26,200) Net loss per common share, basic and diluted$(0.05) $(0.54) $(0.48) $(1.23)Weighted average common shares outstanding, basic and diluted 38,339 21,274 29,869 21,231

Phase 1Financial StatementAACRADC

14 May 2024

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Vincerx Pharma Reports First Quarter 2024 Financial Results and Provides Corporate Update

Vincerx continued to progress Phase 1 dose-escalation studies for VIP943, a potentially best-in-class anti-CD123 antibody-drug conjugate (ADC), and VIP236, a first-in-class small molecule-drug conjugate (SMDC) The National Institutes of Health (NIH) and Vincerx announced positive results from enitociclib Phase 1 combination study, reporting a fourth partial response (PR) in a patient with peripheral T-cell lymphoma (PTCL) Vincerx reported the first PR in a patient with transformed follicular lymphoma (tFL) in its Phase 1 dose-escalation study of enitociclib as a monotherapy Recent financing provides expected cash runway through 2024 PALO ALTO, Calif., May 14, 2024 (GLOBE NEWSWIRE) -- Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, today reported financial results for the first quarter of 2024 and provided a corporate update. “During the first quarter, we maintained momentum across our highly differentiated pipeline and our VersAptx™ platform,” said Ahmed Hamdy, M.D., Chief Executive Officer. “Our recent financing provides capital to support the dose-escalation studies for our potentially best-in-class ADC, VIP943, and first-in-class SMDC, VIP236. We look forward to sharing an update on VIP236 by the end of Q3 and on VIP943 by the end of Q4. This timing will enable us to present more advanced dose-escalation data for both programs.” “We also continue to be excited by the clinical progress of enitociclib,” continued Dr. Hamdy. “We have one patient with tFL who has achieved a metabolic PR and continues on enitociclib monotherapy therapy after 33 cycles. In addition, in the NIH study of enitociclib in combination with venetoclax and prednisone, two-thirds of patients have achieved a PR. We believe these clinical results show enitociclib is a best-in-class CDK9 inhibitor and has the potential to be a preferred partner for innovative combination therapies for hard-to-treat cancers.” FIRST QUARTER 2024 CLINICAL PROGRAM HIGHLIGHTS VIP236 VIP236 is an αVβ3 SMDC conjugated to an optimized camptothecin (CPT) payload, created from Vincerx’s VersAptx platform. VIP236 is a first-in-class drug designed to deliver its optimized CPT payload directly to tumor tissues to overcome chemotherapy-related side effects. Preclinical studies have shown 11 times more optimized CPT is delivered to the cancerous tissues than found circulating in the blood. In addition, the optimized CPT is designed to limit drug transporter liabilities, a common mechanism for cancer resistance to chemotherapy. At the 2024 American Association for Cancer Research (AACR) Annual Meeting, Vincerx reported positive preliminary monotherapy data on VIP236 from a Phase 1 dose-escalation study demonstrating signs of clinical activity, including tumor reduction, and an improved safety pro heavily pretreated patients with metastatic solid tumors. As of March 25, 2024, the VIP236 open-label, multicenter, Phase 1 dose-escalation study (NTC05371054) had enrolled 20 patients with advanced or metastatic cancers unresponsive to standard therapies. Vincerx looks forward to sharing additional Phase 1 data by the end of Q3 2024. VIP943 VIP943, a novel CD123-targeted ADC created from Vincerx’s VersAptx platform, consists of an anti-CD123 antibody, a unique linker cleaved intracellularly by legumain, and a novel kinesin spindle protein inhibitor (KSPi) payload enhanced with Vincerx’s CellTrapper® technology. Its next-generation effector chemistry was designed to address challenges associated with many ADCs by improving efficacy and reducing severe toxicities. Enrollment has begun in the fourth cohort of the Phase 1 dose-escalation study of VIP943 in relapsed/refractory acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and B-cell acute lymphoblastic leukemia (B-ALL) (NCT06034275). Preliminary pharmacokinetic (PK) results on the first two cohorts were presented at the 2024 AACR Annual Meeting and as expected, showed very little payload circulating in the blood. In addition, no dose-limiting toxicities have occurred in the 11 patients who have received VIP943 so far. The preliminary PK and early observations of a favorable safety pro consistent with VIP943 preclinical data. Vincerx expects to present updated Phase 1 dose-escalation data for VIP943 by the end of Q4 2024. Enitociclib Enitociclib is a highly selective CDK9 inhibitor designed to block the activation of RNA polymerase II, leading to the reduction of oncogenes, including MYC and MCL1. Enitociclib is currently in a Phase 1 dose-escalation study (NTC05371054) evaluating the combination of enitociclib, venetoclax and prednisone in diffuse large B-cell lymphoma (DLBCL) and PTCL. This study is being conducted in collaboration with the NIH. In January 2024, Vincerx and the NIH reported two PRs in patients with PTCL with tumor reductions ranging from 86% to 91%. Additionally, one PR was reported in a patient with double-hit diffuse large B-cell lymphoma (DH-DLBCL) with an 80% reduction in tumor burden. Most recently, an additional PR was announced in PTCL with a reduction in lymph node size and skin lesions, totaling four PRs observed to date. Notably, these results were obtained with enitociclib doses below the anticipated efficacious levels. Currently, the study is enrolling patients for the third dose level (30 mg), which is the recommended dose established in the enitociclib monotherapy study. These data will be presented by the NIH at the upcoming AACR Advances in Malignant Lymphoma meeting in June 2024. In a Phase 1 dose-escalation study (NCT02635672) of enitociclib as a monotherapy, one newly confirmed metabolic PR was observed with 63% tumor reduction in a tFL patient who has been enrolled in the study for just under two years. This is particularly notable because outcomes of patients with tFL are historically poor. In total, this study enrolled 63 patients in the dose-escalation and expansion cohorts. Enitociclib showed a favorable safety profile, dose-proportional pharmacokinetics, and on-target pharmacodynamic activity. Significant clinical benefit across various indications includes two patients with DH-DLBCL who experienced durable complete metabolic remissions (3.7 and 2.3 years), which continued more than two years after stopping treatment. This long duration of treatment and response for patients with DH-DLBCL and tFL highlight enitociclib’s favorable safety pro monotherapy efficacy in hard-to-treat hematologic malignancies. Additionally, 13 patients with solid tumors achieved stable disease as their best response to monotherapy treatment. Notably, of these, five were patients with ovarian cancer, providing a promising signal for future combination studies in this indication. Research collaborations continue with the University of Calgary and the Pediatric Oncology Experimental Therapeutics Investigators’ Consortium (POETIC) to discover combination strategies for pediatric leukemia and central nervous system tumors. To date, these collaborations have shown that enitociclib has monotherapy and combination activity in preclinical models of rhabdomyosarcoma, neuroblastoma and KMT2A-rearranged pediatric leukemia. VIP924 VIP924 is a first-in-class CXCR5-targeted ADC created from Vincerx’s VersAptx platform. VIP924 can be evaluated in B-cell malignancies, including MCL, FL, DLBCL, and CLL and monotherapy and in combination. IND application is anticipated in late 2025 or early 2026, pending funding. VersAptx™ Platform VersAptx is Vincerx’s versatile and adaptable, next-generation bioconjugation platform. The modular nature of this platform enables the combination of different targeting, linker and payload technologies to develop bespoke bioconjugates to address different cancer biologies. At the AACR Annual Meeting, Vincerx reported data from preclinical studies applying the next-generation effector chemistry of its VersAptx platform to TRODELVY® and ENHERTU®, two marketed ADCs, demonstrating the potential to improve tumor toxicity of ADCs by orders of magnitude, while improving on safety and tolerability. These findings further support the versatility of VersAptx to address multiple cancer types and increase the efficacy and safety of ADCs. FIRST QUARTER 2024 FINANCIAL RESULTS Vincerx had approximately $5.1 million in cash and cash equivalents as of March 31, 2024, which does not include the proceeds from our recent financing in April, as compared to approximately $12.8 million as of December 31, 2023. Based on its current business plans and assumptions, Vincerx believes its available capital, including the recent financing proceeds of approximately $17.8 million, will be sufficient to meet its operating requirements through the end of 2024. Research and development expenses for the first quarter ended March 31, 2024 were approximately $4.6 million, as compared to approximately $10.9 million for the same period in 2023. This decrease is primarily the result of decreases in manufacturing services associated with our ADC programs of approximately $2.6 million, research services of approximately $2.6 million, and personnel-related expenses of approximately $1.1 million. General and administrative expenses for the first quarter ended March 31, 2024 were approximately $2.9 million, as compared to approximately $4.5 million for the same period in 2023. This decrease is primarily driven by decreases in personnel-related expenses of approximately $0.6 million, professional services of $0.5 million and facilities and other corporate overhead expenses of $0.3 million. For the first quarter ended March 31, 2024, Vincerx reported a net loss of approximately $12.4 million, or $0.58 per share. For the first quarter ended March 31, 2023, Vincerx reported a net loss of approximately $14.6 million, or $0.69 per share. About Vincerx Pharma, Inc. Vincerx Pharma, Inc. is a clinical-stage biopharmaceutical company committed to developing differentiated and novel therapies to address the unmet medical needs of patients with cancer. Vincerx has assembled a seasoned management team with a proven track record of successful oncology drug development, approvals, and value creation. Vincerx’s diverse pipeline consists of the next-generation antibody-drug conjugate, VIP943, in Phase 1; small molecule-drug conjugate, VIP236, in Phase 1; preclinical antibody-drug conjugate, VIP924; CDK9 inhibitor, enitociclib, in an NIH-sponsored Phase 1; and VersAptx, its versatile and adaptable, next-generation bioconjugation platform. Vincerx is based in Palo Alto, California, and has a research facility in Monheim, Germany. For more information, please visit and follow Vincerx on LinkedIn. Forward-Looking Statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe future plans, strategies, expectations and events, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “suggest,” “seek,” “intend,” “plan,” “goal,” “potential,” “on-target,” “on track,” “project,” “estimate,” “anticipate,” or other comparable terms. All statements other than statements of historical facts included in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, Vincerx’s business model, cash runway, pipeline, strategy, timeline, product candidates and attributes, and preclinical and clinical development, timing, and results. Forward-looking statements are neither historical facts nor assurances of future performance or events. Instead, they are based only on current beliefs, expectations, and assumptions regarding future business developments, future plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Forward-looking statements are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict, many of which are outside Vincerx’s control. Actual results, conditions, and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results, conditions, and events to differ materially from those indicated in the forward-looking statements include, but are not limited to, general economic, financial, legal, political, and business conditions; risks associated with preclinical or clinical development and trials, including those conducted prior to Vincerx’s in-licensing; failure to realize the benefits of Vincerx’s license agreement with Bayer; risks related to the timing of expected business and product development milestones; changes in the assumptions underlying Vincerx’s expectations regarding its future business or business model; Vincerx’s ability to successfully develop and commercialize product candidates; Vincerx’s capital requirements, availability and uses of capital, and cash runway; and the risks and uncertainties set forth in Form 10-K for the year ended December 31, 2023 and subsequent reports filed with the Securities and Exchange Commission by Vincerx. Forward-looking statements speak only as of the date hereof, and Vincerx disclaims any obligation to update any forward-looking statements. Vincerx, the Vincerx logo, CellTrapper, and VersAptx are our trademarks. This press release also contains trademarks and trade names that are the property of their respective owners. Contacts Gabriela Jairala Vincerx Pharma, Inc. gabriela.jairala@vincerx.com Totyana Simien Inizio Evoke Comms totyana.simien@inizioevoke.com Vincerx Pharma, Inc. Condensed Consolidated Balance Sheets (in thousands) March 31, 2024 December 31, 2023 (unaudited) ASSETS Current assets: Cash and cash equivalents $ 5,110 $ 12,782 Prepaid expenses 700 51 Grant receivable 1,025 1,044 Other current assets 842 856 Total current assets 7,677 14,733 Right-of-use assets 1,950 2,201 Property, plant and equipment, net 111 125 Other assets 1,345 1,158 Total assets $ 11,083 $ 18,217 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable $ 2,314 $ 2,497 Accrued expenses 1,727 1,755 Lease liability 1,198 1,162 Common stock warrant liabilities 5,395 191 Total current liabilities 10,634 5,605 Lease liability, net of current portion 1,021 1,340 Other noncurrent liabilities 50 50 Total liabilities 11,705 6,995 Total stockholders' equity (deficit) (622 ) 11,222 Total liabilities and stockholders' equity $ 11,083 $ 18,217 Vincerx Pharma, Inc. Condensed Consolidated Statements of Operations (unaudited) (in thousands, except per share amounts) For the three months ended March 31, 2024 2023 Operating expenses: General and administrative $ 2,922 $ 4,497 Research and development 4,556 10,911 Total operating expenses 7,478 15,408 Loss from operations (7,478 ) (15,408 ) Other income (expense) Change in fair value of warrant liabilities (5,204 ) 18 Interest income 99 466 Other income 154 274 Total other income (expense) (4,951 ) 758 Net loss $ (12,429 ) $ (14,650 ) Net loss per common share, basic and diluted $ (0.58 ) $ (0.69 ) Weighted average common shares outstanding, basic and diluted 21,400 21,188

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Extensive stage Small Cell Lung Cancer	Phase 2	United States	Ellipses Pharma Ltd.	01 Apr 2023
Extensive stage Small Cell Lung Cancer	Phase 2	China	Ellipses Pharma Ltd.	01 Apr 2023
Extensive stage Small Cell Lung Cancer	Phase 2	Taiwan Province	Ellipses Pharma Ltd.	01 Apr 2023
stomach adenocarcinoma	Phase 2	United States	Ellipses Pharma Ltd.	01 Apr 2023
stomach adenocarcinoma	Phase 2	China	Ellipses Pharma Ltd.	01 Apr 2023
stomach adenocarcinoma	Phase 2	Taiwan Province	Ellipses Pharma Ltd.	01 Apr 2023
Platinum-Resistant Ovarian Carcinoma	Phase 2	United States	Ellipses Pharma Ltd.	14 Dec 2020
Platinum-Resistant Ovarian Carcinoma	Phase 2	Hungary	Ellipses Pharma Ltd.	14 Dec 2020
Platinum-Resistant Ovarian Carcinoma	Phase 2	United Kingdom	Ellipses Pharma Ltd.	14 Dec 2020
Recurrent ovarian cancer	Phase 2	United States	NewLink Genetics Corp.	01 Jul 2015

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03531827 (CTgov)	Phase 2	Metastatic castration-resistant prostate cancer	4	enzalutamide+CRLX101	tgqizetpmr = mntznmyekg kjjxgmowcl (ncokswscej, sodeuxltac - ledsbkmodo) View more	-	12 Jul 2022
NCT01652079 (Pubmed) Manual	Phase 2	Recurrent ovarian cancer	63	CRLX101	ehzsglfuzk(uoffhgwpxw) = kocgpbdbvq hwzkxkettc (plplvqneyh ) View more	Positive	01 Sep 2021
				bevacizumab+CRLX101	ehzsglfuzk(uoffhgwpxw) = pyyvwtpvvw hwzkxkettc (plplvqneyh ) View more
NCT02389985 (Pubmed \| Gynecol Oncol)	Phase 2	Recurrent Primary Peritoneal Carcinoma	30	EP0057	zbisiyvnhg(topcodyyzv) = zgtkfwmgnc pkjxeskxfz (zvvsjaqfbn, 15.4% - 54.0%) View more	-	01 Mar 2021
NCT02010567 (Pubmed \| Nanomedicine (Lond))	Phase 1/2	Locally Advanced Rectal Carcinoma Neoadjuvant	32	CRLX101	zyaflhjxew(trerueququ) = zszaiiatlb stvwoufyhu (qcydvjqrmi ) View more	-	01 Jun 2019
NCT01612546 (CTgov)	Phase 2	recurrent gastric cancer \| Advanced Gastric Adenocarcinoma \| Adenocarcinoma of Esophagus ... View more	10	Pharmacological studies+cyclodextrin-based polymer-camptothecin CRLX101	ssuyousysq = vkrkxvrtiz rsejgahjkq (bplggavzqr, qatodyyfle - bijqfpzfzl) View more	-	27 Dec 2017
NCT02010567 (CTgov)	Phase 1/2	Locally Advanced Rectal Carcinoma	32	CRLX101 (Dose Escalation Phase Ib)	kddtptctwj = iaeoptqplw ovtguzbeka (svsfldypvc, jrdjyebrhn - wdxzlkmywb)	-	14 Nov 2017
				CRLX101+capecitabine (Cape) (All Participants)	ybzqqdstaz = lknlrngwxp ahhnqtbord (scyrlpoxfy, wmzouelcmf - uhgplgfayh) View more
NCT02187302 (Pubmed \| Ann Oncol) Manual	Phase 2	Advanced Renal Cell Carcinoma Third line \| Second line	111	bevacizumab+CRLX101	fbiyukedej(oflxihnsei) = tkfqbhyebx fysbpgxpyr (aglwtiquvu, 2.0 - 4.3) View more	Negative	01 Nov 2017
				standard of care	fbiyukedej(oflxihnsei) = xglcfndnrn fysbpgxpyr (aglwtiquvu, 2.2 - 5.4) View more
ASTRO2017	Phase 1/2	Locally Advanced Rectal Carcinoma Neoadjuvant	32	CRLX101 12 mg/m^2 QOW	qkptrsarka(kunpbinyfl) = Mean neoadjuvant rectal (NAR) score was 19 with standard deviation of 15. At the weekly MTD, 3/6 patients had pCR. drciwhkhkf (igmbqipdtp )	Positive	01 Oct 2017
				CRLX101 15 mg/m^2 QOW
NCT01380769 (CTgov)	Phase 2	Advanced Lung Non-Small Cell Carcinoma	157	CRLX101 (CRLX101)	fxkdpdrumw(ycfgonddmk) = wogjxerfct ggqntcrsnv (czmiylaosj, zfafumasoe - lnlplrsgbi) View more	-	24 May 2017
				Best Supportive Care (Best Supportive Care)	fxkdpdrumw(ycfgonddmk) = xpgvqqiquf ggqntcrsnv (czmiylaosj, bqpddbofak - yoowzmqutq) View more
NCT01625936 (Pubmed \| Ann Oncol) Manual	Phase 1/2	Metastatic Renal Cell Carcinoma	22	bevacizumab+CRLX101	aemmlnspep(xgxdyiznkj) = Grade ≥3 AEs related to CRLX101 included non-infectious cystitis (5 events), fatigue (3 events), anemia (2 events), diarrhea (2 events), dizziness (2 events), and 7 other individual events qfkmxuwgsp (vwdpdakipa )	Positive	01 Aug 2016

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