On November 3, 2023 Dizal reported that it will have four presentations from its hematological oncology pipeline, including golidocitinib and DZD8586, at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (2023 ASH (Free ASH Whitepaper), San Diego) (Press release, Dizal Pharma, NOV 3, 2023, View Source [SID1234636939]). Its global multicenter pivotal study of golidocitinib (JACKPOT8 PARTB) has been selected for oral presentation.

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Golidocitinib

Golidocitinib is the first and only Janus kinase 1 (JAK1) selective inhibitor in the NDA stage for the treatment of r/r PTCL. Dizal will release the latest results from two clinical studies: the full analysis of the multinational pivotal study of golidocitinib (JACKPOT8 PARTB) in r/r PTCL and a phase 2 study evaluating golidocitinib as a maintenance therapy in patients with PTCL after first-line systemic therapy (JACKPOT26).

Golidocitinib monotherapy demonstrated superior efficacy and safety profile in the full analysis of the JACKPOT8 PARTB study, which was consistent with the preliminary findings presented at 2023 ASCO (Free ASCO Whitepaper). An IRC-assessed overall response rate (ORR) was 44.3%, nearly double the existing treatment options. The response was durable. The final data for duration of response (DOR), progression-free survival (PFS), as well as overall survival (OS) will be reported at the meeting.

Approximately 40% of patients with complete response and 80% of patients with partial response have disease relapse within 2 years following first-line standard therapy, and the prognosis of relapsed patients was typically poor. According to the results of phase 2 study of golidocitinib as maintenance therapy in patients with PTCL after first-line systemic therapy (JACKPOT26), golidocitinib showed manageable safety profile and promising efficacy in maintaining and enhancing tumor response in patients with PTCL post first-line therapies.

DZD8586

DZD8586 is a rationally designed, oral, non-covalent, LYN and BTK dual inhibitor with excellent blood-brain barrier (BBB) penetration. Dizal will report its preclinical data as well as the ongoing clinical study results in B-NHL.

While Bruton’s Tyrosine Kinase (BTK) inhibitors have been approved for the treatment of B-NHL, resistance can emerge due to various mechanisms, including acquired mutations at residue C481 of BTK and non BTK-driven mutations. Currently, there is no targeted therapy available to address both resistance mechanisms, highlighting an urgent need for a safe and effective treatment option for patients with r/r B-NHL.

Preclinical studies have shown that DZD8586 can overcome resistance mutations observed with approved covalent and non-covalent BTK inhibitors. DZD8586 has exhibited potent inhibition of cell growth by blocking both BTK-dependent and BTK-independent signaling pathways.

Key highlights of DZD8586 are as follows:

Potent inhibition of LYN and BTK, with good selectivity against other kinases.
Significant inhibitory effects on mutations at residue C481 of BTK, as well as BTK mutations associated with resistance to Pirtobrutinib (LOXO-305).
Potent cell growth inhibition observed in diffuse large B-cell lymphoma (DLBCL) cell lines.
Excellent BBB penetration, as evidenced by a CSF-to-plasma concentration ratio (Kpuu,CSF) greater than 1 in animal models, suggesting potential effectiveness in humans.
Currently, DZD8586 is conducting two global phase 1 studies (TAI-SHAN1 and TAI-SHAN5) for the treatment of r/r B-NHL. The preliminary results of the studies have shown encouraging pharmacokinetic (PK) properties, safety profile and antitumor efficacy. The pooled analysis results from these two studies will be presented for the first time at 2023 ASH (Free ASH Whitepaper).

Dizal’s Presentation at 2023 ASH (Free ASH Whitepaper)

Lead Author

Abstract Title

Presentation Details

Prof. Yuqin Song

Golidocitinib in Treating Refractory or Relapsed Peripheral T- Cell Lymphoma: Full Analysis of the Multinational Pivotal Study Results (JACKPOT8)

Abstract #305

Session Type: Oral

Oral Abstract Session

Date and Time: December 9, 2023, 5 PM PST

Location: Hall B

Prof. Jie Jin

Phase 2 Study of Golidocitinib, a JAK1 Selective Inhibitor, As Maintenance Therapy in Patients with Peripheral T Cell Lymphomas after First-Line Systemic Therapy (JACKPOT26)

Abstract #4430

Poster Session

Date and Time: December 11, 2023, 6 PM – 8 PM PST

Location: Hall G-H

Dr. Yu Bai

Preclinical Study of DZD8586, a Non-Covalent LYN/BTK Dual Inhibitor with Excellent BBB Penetration, for the Treatment of B-Cell Non-Hodgkin Lymphoma (B-NHL)

Abstract #2822

Poster Session

Date and Time: December 10, 2023, 6 PM – 8 PM PST

Location: Hall G-H

Prof. Yuqin Song

First Report of Phase 1 Studies of DZD8586, a BBB Penetrant LYN/BTK Dual Inhibitor, in Patients with B-Cell Non-Hodgkin Lymphoma (B-NHL)

Abstract #4465

Poster Session

Date and Time: December 11, 2023, 6 PM – 8 PM PST

Location: Hall G-H

About golidocitinib (DZD4205)

Golidocitinib is the first-in-class Janus kinase 1 (JAK1) only inhibitor currently being evaluated in a global, multicenter pivotal study (JACKPOT8 PARTB) in r/r PTCL. At the data cut-off date of February 16, 2023, Golidocitinib has demonstrated robust and durable anti-tumor activity, with an ORR of 44.3%. More than 50% of the patients with tumor remission achieved a complete response. The median relative dose intensity was 100%. Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted the NDA and granted the Priority Review status for the treatment of r/r PTCL. And the Phase I clinical data of golidocitinib for the treatment of r/r PTCL (JACKPOT8 PARTA) was published in Annals of Oncology (Impact Factor: 51.8).

About DZD8586

DZD8586 is an orally available, highly selective small molecule inhibitor to target both BTK-dependent and BTK-independent B-cell receptor (BCR) signaling pathways, with full blood-brain barrier penetration. Pre-clinical research revealed that DZD8586 demonstrated good safety profile and could effectively inhibit the growth of B-NHL cells. A healthy volunteer study of DZD8586 has been conducted to investigate the clinical safety and PK/PD correlation. Additionally, a global phase I/II study is ongoing to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of DZD8586 in patients with r/r B-NHL. Preliminary results from the clinical trial suggest that DZD8586 exhibits favorable PK properties, good safety profile, and preliminary anti-tumor activity in patients with B-NHL.

On November 3, 2023 Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent" or the "Company"), a technology-based company with a well-established clinical diagnostic business and a therapeutic development business, reported financial results for its third quarter ended September 30, 2023 (Press release, Fulgent Genetics, NOV 3, 2023, View Source [SID1234636938]).

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Third Quarter 2023 Results:

Total Revenue of $85 million
Core Revenue1 grew 17% year-over-year to $66 million
GAAP loss of $13.1 million, or $0.44 per share
Non-GAAP loss of $11.7 million, or $0.39 per share
Adjusted EBITDA of $18.1 million
Generated cash flow from operations of $10.2 million
Cash, cash equivalents, and investments in marketable securities of $851 million as of September 30, 2023
Note:

1) Core Revenue excludes revenue from COVID-19 testing products and services including COVID-19 NGS testing revenue.

Non-GAAP income (loss), non-GAAP income (loss) per share, and adjusted EBITDA income (loss) are described below under "Note Regarding Non-GAAP Financial Measures" and are reconciled to the most directly comparable GAAP financial measure, GAAP income (loss), in the accompanying tables.

Commenting on the results, Ming Hsieh, Chairman of the Board and Chief Executive Officer, said, "We continue to see good momentum in our core business, with particular strength in precision diagnostics. I am pleased with the trajectory of the business and our ability to use our resources efficiently as we continue to grow our core revenue. At the same time, we are advancing our therapeutics development business, Fulgent Pharma, with ongoing clinical data of our lead drug candidate, FID-007, being presented tomorrow at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting in San Diego. We believe these data continue to support our program, and we are excited to initiate Phase 2 studies of FID-007 in head and neck cancer in the first quarter of 2024."

Paul Kim, Chief Financial Officer, added, "We are pleased with our performance as we near the end of 2023, with momentum in the business and a strong financial profile. Even as we continue to invest in our business and repurchase shares, we are maintaining an enviable cash position with which to execute our strategy in 2024 and beyond."

Outlook

For the full year 2023, Fulgent expects:

Core Revenue of approximately $260 million
GAAP loss of approximately $2.15 per share
Non-GAAP loss of $0.95 per share
Cash, cash equivalents, and investments in marketable securities of approximately $830 million as of December 31, 2023*
*Cash expenditures may be higher or lower than currently estimated due to a variety of facts and circumstances, including as a result of the Company’s ongoing stock repurchase program or other expenditures outside of ordinary course.

Conference Call Information

Fulgent will host a conference call for the investment community today at 8:30 AM ET (5:30 AM PT) to discuss its third quarter 2023 results. The call may be accessed through a live audio webcast on the Investor Relations section of the Company’s website, View Source An audio replay will be available at the same location.

On November 3, 2023 Calidi Biotherapeutics, Inc. (NYSE American: CLDI or "Calidi"), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, reported the presentation of new preclinical data from the company’s CLD-201 (SuperNova) allogeneic stem cell-based platform and announces readiness for clinical trial launch in 2024 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 38th Annual Meeting (Press release, Calidi Biotherapeutics, NOV 3, 2023, View Source [SID1234636937]). The meeting is taking place in San Diego from November 1-5, 2023.

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CLD-201 builds on decades of stem cell and oncolytic virus research and is a novel allogeneic solution with potential advantages over an autologous approach including enhanced potency, improved manufacturing reproducibility, lower cost, and the ability to treat multiple cancer types. CLD-201 consists of allogeneic mesenchymal stem cells loaded with the oncolytic vaccinia virus CAL1, which has the potential to target a variety of solid tumors.

The poster presentation details the evaluation of CLD-201 in in vitro and animal models in the presence of complement and neutralizing antibodies, and the assessment of immune cell infiltration in treated and untreated tumors. Tumor growth inhibition and induction of anti-tumor immunity were compared in mice treated with unprotected CAL1 virus and CLD-201. Additionally, the poster presents the readiness of the product and plans to launch clinical trial in 2024.

"This new CLD-201 data further supports the potential of our stem-cell based platform to effectively target a variety of solid tumors while exhibiting promising anti-tumor effects in multiple animal models," said Antonio F. Santidrian, PharmD, Ph.D., Chief Scientific Officer of Calidi Biotherapeutics. "We believe that CLD-201 is a very promising immunotherapy platform, based on its observed inhibition of tumor growth in multiple tumor types and its powerful anti-tumor immune effects, as well as its superiority to existing autologous therapies as an allogeneic alternative. We look forward to initiating a Phase 1 clinical trial in 2024 and generating additional data on the potential of CLD-201 to treat advanced solid tumors."

Key highlights from the poster presentation are below:

Multiple allogeneic adipose tissue-derived mesenchymal stem cell banks were generated, and one was selected for GMP manufacturing and loaded with the oncolytic vaccinia virus CAL1, creating CLD-201.
CLD-201 demonstrated greater resistance to inactivation by the humoral immune system compared to the unprotected CAL1 virus.
CLD-201 significantly inhibited the growth of the tumors even at the very low dose of 1.5×103 cells containing 1.6×104 viral plaque forming units (PFU).
CLD-201 has been successfully GMP manufactured, and its safety profile has been analyzed in both immunocompetent and immunocompromised pre-clinical models.
Full details for the poster presentation are below:

Title: A Novel Stem Cell-based Platform for Delivery and Potentiation of Oncolytic Virotherapies
Presenting Authors: Antonio F. Santidrian, PharmD, Ph.D., Chief Scientific Officer, Calidi Biotherapeutics
Boris R. Minev, MD. President, Medical & Scientific Affairs, Calidi Biotherapeutics
Abstract Number: 1419
Date: Friday, November 3, 2023
Time: 9:00 AM – 7:00 PM PDT

Following the meeting, a copy of the poster will be available on the Scientific Publications page of Calidi’s website at: View Source

On November 3, 2023 Synthekine Inc., an engineered cytokine therapeutics company, reported new data from preclinical studies of STK-026, its biased IL-12 partial agonist program, during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting in San Diego (Press release, Synthekine, NOV 3, 2023, View Source [SID1234636936]). STK-026 is designed to retain the potent antitumor activity of IL-12 while avoiding its systemic toxicities and is currently in IND-enabling studies.

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"In the quest for developing new and effective cancer treatments, the pro-inflammatory cytokine IL-12 has shown tremendous potential but clinical use of IL-12 is limited by systemic toxicities and a very narrow therapeutic window," said Martin Oft, M.D., chief scientific officer of Synthekine. "Through our deep insights into the biology of IL-12 and our industry-leading cytokine engineering capabilities, we designed STK-026 to uncouple efficacy from the toxicities that are typically seen with wild-type IL-12. The data presented today adds to the growing body of evidence that STK-026’s novel approach, biasing IL-12’s activity toward activated T cells and avoiding hyperactivation of NK cells, has potential to harness anti-tumor efficacy without dose-limiting toxicity."

Title: Preclinical Pharmacodynamic Characterization of STK-026: A Novel IL-12 Partial Agonist for Cancer with Maintained CD8 T cell activity, Reduced NK-mediated Toxicity and an Improved Therapeutic Window
Session Title: Immune-Stimulants and Immune Modulators
Session Date & Time: Friday, Nov. 3, 2023, 9 am – 7 pm PT
Poster Board Number: 1053
Summary & Key Findings:

STK-026 is a biased IL-12 agonist engineered to exhibit preferential activity on antigen-activated T cells, which drive the efficacy of IL-12, while avoiding broad systemic activation of resting T cells and NK cells, which are linked to the toxicity of IL-12.
In tumor bearing mouse models, a mouse surrogate of STK-026 was well-tolerated and showed meaningful anti-tumor efficacy as both a single agent and in combinations. Notably, compared to wild-type IL-12 treatment, STK-026 monotherapy demonstrated a substantial improvement in therapeutic window which was associated with reduced NK activation and systemic cytokine induction.
In cynomolgus macaques, STK-026 was well-tolerated at very high doses (up to 5mg/kg) without signs of CRS. Further, compared to wild-type IL-12, STK-026 treatment resulted in reduced induction of liver enzymes, organ weight gains and lymphocyte activation in peripheral tissues, thus avoiding the detrimental toxicity associated with IL-12 therapy.
Overall, assessments of STK-026 in mouse and cyno show that its properties successfully avoid spikes of early NK activation but still effectively activate T cells. Preclinical studies and pharmacology support the idea that this rebalancing of IL-12 driven innate and adaptive immune responses can achieve efficacy without dose-limiting toxicity.
The poster will be available on Synthekine’s website following presentation at the meeting.

On November 3, 2023 ProfoundBio, a clinical-stage biotechnology company developing novel antibody-drug conjugate (ADC) therapeutics for cancer, reported multiple data presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 38th Annual Meeting (SITC 2023) (Press release, ProfoundBio, NOV 3, 2023, View Source [SID1234636935]). The company shared initial results from the dose escalation portion of an ongoing Phase 1/2 trial of its lead ADC candidate, rinatabart sesutecan (Rina-S; PRO1184), as well as preclinical data on its Protein Tyrosine Kinase 7 (PTK7)-directed ADC PRO1107 and its continued ADC platform innovations.

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"We are thrilled to present proof-of-concept data from our novel sesutecan ADC platform with the initial clinical results for Rina-S," said ProfoundBio Chief Medical Officer Naomi Hunder, M.D. "We believe Rina-S’s encouraging Phase 1 activity and safety data are differentiated within the landscape of emerging targeted therapies for ovarian and endometrial cancers, as Rina-S elicited robust responses at well-tolerated doses in heavily pretreated patients, including in tumors expressing low levels of FRα. These data validate our platform and approach to developing ADCs with the potential for meaningfully improved outcomes for patients."

Abstract #708: A Phase 1/2 Study of Rinatabart Sesutecan (PRO1184), a Novel Folate Receptor Alpha-Directed Antibody-Drug Conjugate, in Patients with Locally Advanced and/or Metastatic Solid Tumors

Presented by Justin A. Call, M.D., of START Mountain Region, West Valley City, UT, on Saturday, November 4, 2023, Exhibit Halls A and B1, 9 a.m. to 8:30 p.m. PDT

Rina-S is an investigational folate receptor-alpha-(FRα)-directed ADC based on a novel topoisomerase-1 linker-drug currently in Phase 1/2 development for a number of solid tumors. Key findings from initial Phase 1 clinical results of the Rina-S trial include data from 36 patients treated at dose levels from 60 mg/m2 to 180 mg/m2 administered every 21 days.

Enrolled patients had the following tumor types: ovarian cancer (n=17), endometrial cancer (n=9), breast cancer (n=3), non-small cell lung cancer (n=5), and mesothelioma (n=2).
Patients in the study were heavily pretreated with a median of 4.5 prior therapies; patients with ovarian cancer had a median of 6 prior therapies and patients with endometrial cancer had a median of 4 prior therapies.
Safety and activity highlights include:

Rina-S was well tolerated at doses from 60 mg/m2 to 120 mg/m2, with 140 mg/m2 still under evaluation as a potential maximum tolerated dose; the most common treatment-related adverse events (TRAEs) included cytopenias, gastrointestinal adverse events, and fatigue and were both reversible and manageable. Most TRAEs were Grade 1 or 2.
No interstitial lung disease, pneumonitis, infusion-related reactions, or corneal toxicity were observed.
Among 21 response-evaluable patients with ovarian and endometrial cancer, unselected for FRα expression, an initial objective response rate of 38% was observed (1 complete response (CR), 7 partial responses (PR)); an additional 9 patients had stable disease (SD), including 7 with decreasing tumor measurements, for a disease control rate (CR+PR+SD) of 81%.
Antitumor activity was seen across the full spectrum of FRα expression, with objective responses observed in 8 out of 12 (67%) response-evaluable patients with ovarian and endometrial cancer having >1% FRα expression in their tumors, including 3 PRs in 3 patients with FRα expression below 25% 1+ IHC staining intensity.
Responses were observed across a wide dose range from 60 to 140 mg/m2, with responses deepening over time for most patients.
One patient with ovarian cancer had prior treatment with mirvetuximab soravtansine (Elahere) and had a CR after receiving two doses of Rina-S.
Additional patients are being evaluated in Part A and Part B at multiple dose levels to further optimize the dose.

LD343 Platform and PRO1107 Preclinical Data Presentations, and PRO1160 Trial-In-Progress Presentation:

Abstract #1407: Expanding the Therapeutic Index of MMAE-Based Antibody-Drug Conjugates (ADCs) with a Novel Linker System (LD343)

Presented by Zhu Chen, Ph.D., ProfoundBio Chief Scientific Officer, on Friday, November 3, 2023, Exhibit Halls A and B1, 9 a.m. to 7:00 p.m. PDT

Data from ADCs incorporating ProfoundBio’s novel LD343 platform (a next-generation hydrophilic MMAE-based linker-drug) at a homogeneous drug-to-antibody ratio of 8 (DAR8) compared head-to-head with DAR4 vedotin ADCs highlights the potential to widen the therapeutic index of the clinically validated payload, MMAE.

Data highlights include:

ADCs incorporating the highly hydrophilic LD343 at DAR8 conferred improved physicochemical properties and PK/PD characteristics relative to vedotin.
LD343 ADCs demonstrated antitumor activity in multiple tumor types, with higher in vivo potency than vedotin even at double the amount of dosed payload.
LD343 enabled enhanced delivery of payload to tumor tissue and reduced exposure of payload in circulation.
LD343 enabled an approximately 4-fold increase in the tolerated drug load compared to vedotin ADCs in rats.
Abstract #1406: A Novel PTK7-Directed Antibody-Drug Conjugate (ADC) PRO1107 Demonstrated Broad Antitumor Activity with a Promising Safety Profile in Preclinical Models

Presented by Zhu Chen, Ph.D., ProfoundBio Chief Scientific Officer, on Saturday, November 4, 2023, Exhibit Halls A and B1, 9 a.m. to 8:30 p.m. PDT

The poster presentation for the anti-PTK7 ADC, PRO1107, highlights preclinical data for this ADC which incorporates LD343 at DAR8.

Data highlights include:

Superior tumor growth inhibition and tolerability relative to the precedent PTK7-directed ADC cofetuzumab pelidotin were observed in head-to-head preclinical studies.
Enhanced preclinical antitumor activity and tolerability are believed to be attributed to PRO1107’s increased hydrophilicity and improved physicochemical properties, augmented delivery of payload to the tumor, less systemic exposure of free payload, and a robust bystander antitumor effect.
Pharmacokinetics demonstrated PRO1107’s stability to be similar to that of the parent antibody.
Abstract #718: Phase 1/2 Study of PRO1160, a CD70-Directed Antibody-Drug Conjugate, in Patients with Advanced Solid Tumors and Hematologic Malignancies

Presented by Sharon Ma, MPH, ProfoundBio Director of Clinical Operations, on Saturday, November 4, 2023, Exhibit Halls A and B1, 9 a.m. to 8:30 p.m. PDT

The trial-in-progress poster presentation for the anti-CD70 sesutecan ADC, PRO1160, describes the currently recruiting PRO1160-001 Phase 1/2 study (NCT05721222) in patients with solid and liquid tumors.

About Rinatabart Sesutecan (Rina-S, PRO1184)

Rina-S is an ADC comprised of a folate receptor-alpha-directed antibody conjugated to sesutecan, ProfoundBio’s novel, proprietary hydrophilic exatecan-based linker-drug, LD038, at a homogeneous drug-to-antibody ratio (DAR) of 8. Exatecan is a highly potent, membrane permeable topoisomerase-1 inhibitor with strong bystander effect that has been extensively studied as a small molecule anticancer agent. Sesutecan is a highly hydrophilic stable, cleavable linker designed to mask the hydrophobicity of conjugated exatecan on the ADC, enabling high DAR and efficient delivery of the exatecan payload to tumors while maintaining favorable physicochemical and pharmacokinetic properties of the ADC.

About the PRO1184-001 trial (NCT05579366)

This is a Phase 1/2 study of PRO1184, a folate receptor-alpha-(FRα) targeted antibody-drug conjugate, to evaluate the safety, tolerability, PK, and antitumor activity of PRO1184 in patients with selected locally advanced and/or metastatic solid tumors, including epithelial ovarian cancer, endometrial cancer, breast cancer, non-small cell lung cancer, and mesothelioma. The study consists of two parts, Part A: Dose Escalation and Part B: Dose Expansion.

About PRO1107

PRO1107 is an ADC comprised of a Protein Tyrosine Kinase 7 (PTK7)-targeted antibody conjugated to ProfoundBio’s novel, proprietary hydrophilic MMAE-based linker-drug, LD343, at a homogeneous DAR of 8. MMAE is a potent, membrane permeable microtubule inhibitor that has been clinically validated as an ADC payload by multiple vedotin-based ADCs incorporating MMAE at a DAR of 4. LD343 is a highly hydrophilic stable, cleavable linker designed to mask the hydrophobicity of conjugated MMAE on the ADC, enabling high DAR and efficient delivery of the MMAE payload to tumors while maintaining favorable physicochemical and pharmacokinetic properties of the ADC. The investigational new drug (IND) application for PRO1107 has been cleared by FDA and its Phase 1/2 clinical trial is expected to begin enrollment in early 2024.