PTK7

– Proceeds to support development of ProfoundBio's differentiated clinical-stage ADC pipeline, including the planned pivotal trial of rinatabart sesutecan (Rina-S) – Financing led by Ally Bridge Group, bolstered by contributions from world-class healthcare dedicated and mutual fund institutional investors, including Nextech Invest, T. Rowe Price, Janus Henderson Investors, RA Capital Management, and OrbiMed, among others – Andrew Lam, Eric Dobmeier and Enoch Kariuki to join ProfoundBio Board of Directors SEATTLE, Feb. 13, 2024 /PRNewswire/ -- ProfoundBio, a clinical-stage biotechnology company developing novel antibody-drug conjugate (ADC) therapeutics for patients with cancer, today announced an oversubscribed $112 million Series B financing supported by a syndicate of top healthcare dedicated and mutual fund institutional investors. This financing underscores the new and existing investor confidence in ProfoundBio's innovative approach to cancer treatment and is expected to accelerate the development of its comprehensive ADC portfolio, including the planned pivotal trial of rinatabart sesutecan (Rina-S) for the treatment of ovarian cancer. The funding round was led by Ally Bridge Group, with substantial contributions from new investors including Nextech Invest, funds and accounts advised by T. Rowe Price Associates, Inc., Janus Henderson Investors, RA Capital Management, OrbiMed, Surveyor Capital (a Citadel company), Medicxi, Logos Capital, Octagon Capital, Piper Heartland Healthcare Capital and LifeSci Venture Partners, as well as continued support from existing investors Lilly Asia Ventures (LAV) and LYFE Capital. "We are excited to welcome this premier group of life science investors. Their commitment is a testament to our progress and our mission to develop innovative ADCs with the potential for improved clinical outcomes for patients," said Erin Lavelle, Chief Operating Officer and Chief Financial Officer of ProfoundBio. "This investment boosts our momentum, especially with three clinical-stage candidates in our portfolio and another poised for clinical trials in the next few months. It's a pivotal step in enabling significant milestones and delivering key data readouts this year and through 2025. The addition of Andrew Lam, Eric Dobmeier, and Enoch Kariuki to our board brings invaluable expertise, strengthening our path to redefine patient care." Commitment to Innovative Cancer Therapy The capital raised will support ProfoundBio's diverse array of clinical and preclinical ADC programs, primarily targeting solid tumor cancers. Key programs include: Rina-S, a folate receptor-alpha (FRα) targeted ADC, in Phase 2 trials for ovarian and endometrial cancers, with pivotal studies in ovarian cancer planned for later this year. PRO1160, a CD70 targeted ADC, in Phase 1 trials with initial results expected in 2024. PRO1107, a protein tyrosine kinase 7 (PTK7) targeted ADC, in Phase 1 trials with initial results anticipated in 2025. PRO1286, a bi-specific ADC, anticipated to enter the clinic in 2024. Baiteng Zhao, Ph.D., Chairman of the Board and Chief Executive Officer of ProfoundBio stated, "This Series B financing is an important milestone in our mission to redefine cancer treatment. Our ADC pipeline programs, led by Rina-S, demonstrate our dedication to bringing groundbreaking therapies to patients with cancer. With this support, we are better positioned to advance our clinical trials and offer new differentiated approaches. We welcome our new board members and look forward to this next chapter of ProfoundBio." New Board of Directors Appointments ProfoundBio strengthens its board of directors with the addition of Andrew Lam from Ally Bridge Group, alongside two independent directors, Eric Dobmeier and Enoch Kariuki, who bring a breadth of experience in biotechnology and investment. Andrew Lam, Pharm.D., Managing Director and Head of Biotech Private Equity at Ally Bridge Group, is known for his strategic and capital markets insights based on his extensive expertise in the life sciences sector. Eric Dobmeier brings over two decades of leadership, operating and business development experience in biotechnology companies, having led significant growth initiatives at Seagen and Chinook Therapeutics. Enoch Kariuki, Pharm.D., brings extensive background in healthcare strategy, investment banking, and venture capital, contributing valuable financial and strategic acumen. Joining existing board members Baiteng Zhao, Ph.D. (co-founder), Lynn Yang (HongShan), and Josh Jin (LAV), these new members bring considerable experience and expertise to ProfoundBio. "ProfoundBio is led by an experienced management team with a proven track record of global approvals of ADC therapeutics and decades of research and development experience focused on this modality," said Dr. Lam. "We are proud to be supporting a great team that has advanced an exciting pipeline of differentiated and potentially best-in-class and first-in-class ADCs." ProfoundBio's Cutting-Edge Investigational ADC Programs Rinatabart sesutecan (Rina-S, PRO1184) is a FRα-targeted ADC being developed as a novel treatment option for patients with ovarian and endometrial cancer, and potentially other FRα-expressing cancers. Rina-S is comprised of a FRα-directed antibody conjugated to sesutecan, ProfoundBio's novel, proprietary hydrophilic exatecan-based linker-drug, at a homogeneous drug-to-antibody ratio (DAR) of 8. Exatecan is a highly potent, membrane permeable topoisomerase-1 inhibitor with strong bystander effect. The linker component of sesutecan is a highly hydrophilic, stable, cleavable linker designed to mask the hydrophobicity of exatecan, enabling high DAR and efficient delivery of the exatecan payload to tumors while maintaining favorable physicochemical and pharmacokinetic properties of the ADC. Rina-S is currently being evaluated in a Phase 1/2 clinical trial (NCT05579366) and has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer. PRO1160 is an ADC consisting of a CD70-targeted antibody conjugated to ProfoundBio's novel, proprietary hydrophilic exatecan-based linker-drug, sesutecan. CD70 is a protein expressed on both solid tumors and hematological malignancies including renal cell carcinoma, nasopharyngeal carcinoma, and non-Hodgkin lymphoma, yet is largely absent in normal tissues. With preclinical results showcasing encouraging pharmacokinetics, efficacy, and tolerability, PRO1160 is emerging as a potential advancement in the treatment of these cancers and is currently being evaluated in a Phase 1/2 clinical trial (NCT05721222). PRO1107 is an ADC consisting of a 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 marketed ADCs incorporating MMAE in the linker-drug vedotin at a DAR of 4. The linker component of LD343 is a highly hydrophilic stable, cleavable linker designed to mask the hydrophobicity of MMAE, enabling high DAR and efficient delivery of the MMAE payload to tumors while maintaining favorable physicochemical and pharmacokinetic properties of the ADC. PRO1107 is currently being evaluated in a Phase 1/2 clinical trial (NCT06171789). PRO1286 is a bispecific ADC that has the potential to treat multiple tumor types. PRO1286 is built on the clinically validated sesutecan platform and is anticipated to begin clinical trials in 2024. About ProfoundBio ProfoundBio is a clinical-stage biotechnology company focused on the development of novel antibody-based therapeutics for patients with cancer. Built on internally developed, innovative, and proprietary technology platforms, ProfoundBio has developed a pipeline consisting of multiple ADC drug candidates targeting solid tumors and hematological malignancies. The company's disclosed development pipeline consists of rinatabart sesutecan (Rina-S; PRO1184), an ADC targeting FRα; PRO1160, an ADC targeting CD70; PRO1107, an ADC targeting PTK7; and PRO1286, a bispecific ADC targeting two clinically validated, broadly expressed solid tumor antigens. ProfoundBio is headquartered in Seattle, Washington. For more information, please visit and follow us on LinkedIn. Investor Contact: ir@profoundbio.com Media Contact: Priyanka Shah 908-447-6134 pshah@elephantheadcommunicationsllc.com SOURCE ProfoundBio

SEATTLE , Feb. 5, 2024 /PRNewswire/ -- ProfoundBio, a clinical-stage biotechnology company developing novel antibody-drug conjugate (ADC) therapeutics for cancer, today announced dosing has initiated in the Phase 1/2 first-in-human clinical trial of PRO1107 (NCT06171789). "By bringing the first ADC with our next generation MMAE linker-drug platform to the clinic, we are furthering our commitment to developing ADCs with the potential for improved outcomes for patients," said Naomi Hunder, MD, chief medical officer of ProfoundBio. "We believe our preclinical data support the potential of PRO1107 to provide much improved safety and activity compared to prior PTK7 ADCs, demonstrating the compelling attributes of our LD343 platform, which incorporates our novel highly hydrophilic linker combined with the clinically validated MMAE payload conjugated at a high drug-antibody ratio of 8. We look forward to evaluating PRO1107 as a treatment for the broad population of patients with PTK7-expressing tumors, and we are thankful to the investigators and patients who make this research possible." PRO1107 is being evaluated in a global, open-label, multicenter Phase 1/2 trial. This trial is designed to determine the safety, tolerability, pharmacokinetics, and antitumor activity of PRO1107 in patients with advanced solid tumors, including non-small cell lung, breast, and ovarian cancer. It is designed as a two part study: Part A, which is aimed at determining the recommended optimal dose regimen(s) through dose escalation and expansion, and Part B, which focuses on the expansion of treatment to specific tumor types. "With three clinical-stage programs derived from two distinct proprietary ADC technology platforms, ProfoundBio is demonstrating our capability to efficiently bring innovative ADCs with best- and/or first-in-class potential to patients with unmet medical need. We first showcased this program and the LD343 linker-drug technology in our preclinical presentations at SITC 2023, and we are thrilled to potentially provide benefit to patients across a wide range of PTK7-expressing tumors," said Baiteng Zhao, PhD, chief executive officer of ProfoundBio. About PRO1107 PRO1107 is an ADC consisting of a Protein Tyrosine Kinase 7 (PTK7)-targeted antibody conjugated to ProfoundBio's novel, proprietary hydrophilic MMAE-based linker-drug, LD343, at a homogeneous drug-antibody ratio (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 incorporates 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. About ProfoundBio ProfoundBio is a clinical-stage biotechnology company focused on the development of novel antibody-based therapeutics for patients with cancer. Built on internally developed, innovative, and proprietary technology platforms, ProfoundBio has developed a pipeline consisting of multiple antibody-drug conjugate (ADC) drug candidates targeting solid tumors and hematological malignancies. The company's disclosed development pipeline consists of rinatabart sesutecan (Rina-S; PRO1184), an ADC targeting folate receptor-alpha; PRO1160, an ADC targeting CD70; PRO1107, an ADC targeting PTK7; and PRO1286, a bispecific ADC targeting two clinically validated, broadly expressed solid tumor antigens. ProfoundBio is headquartered in Seattle, Washington. For more information, please visit and follow us on LinkedIn. SOURCE ProfoundBio

SEATTLE, Jan. 5, 2024 /PRNewswire/ -- ProfoundBio, a clinical-stage biotechnology company developing novel antibody-drug conjugate (ADC) therapeutics for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for rinatabart sesutecan (Rina-S; PRO1184), a folate receptor alpha (FRα) targeted ADC, for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer. Fast Track designation is intended to facilitate the development and expedited review of drugs with demonstrated potential to improve over available therapy for serious conditions with unmet medical need. "Our receipt of Fast Track designation from the FDA underscores our belief in the tremendous promise of Rina-S as a potential best-in-class FRα ADC to address the significant need for improved treatment options for advanced ovarian cancer," said Naomi Hunder, Chief Medical Officer of ProfoundBio. "FRα is a highly prevalent antigen in ovarian cancer and Rina-S has shown encouraging antitumor activity and tolerability in our Phase 1 dose escalation study in ovarian and endometrial cancer patients across the full spectrum of FRα expression. We look forward to working closely with the FDA as we progress further clinical development and registrational studies for Rina-S." About Rinatabart Sesutecan (Rina-S, PRO1184) Rina-S is a folate receptor-alpha (FRα) targeted ADC being developed as a novel treatment option for patients with ovarian and endometrial cancer, and potentially other FRα-expressing cancers. Rina-S is comprised of a FRα-directed antibody conjugated to sesutecan, ProfoundBio's novel, proprietary hydrophilic exatecan-based linker-drug, at a homogeneous drug-to-antibody ratio (DAR) of 8. Exatecan is a highly potent, membrane permeable topoisomerase-1 inhibitor with strong bystander effect. 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. Status of PRO1184-001 Phase 1/2 Study (NCT05579366) PRO1184-001 is a Phase 1/2 study of rinatabart sesutecan 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. Initial results from Part A were reported in November 2023, demonstrating encouraging antitumor activity at well tolerated doses in heavily pretreated ovarian and endometrial cancer patients unselected for FRα expression. Part B is currently enrolling patients at multiple sites in the U.S. and China. About ProfoundBio ProfoundBio is a clinical-stage biotechnology company focused on the development of novel antibody-based therapeutics with curative potential for patients with cancer. Built on internally developed, innovative, and proprietary technology platforms, ProfoundBio has developed a pipeline consisting of multiple antibody-drug conjugate (ADC) drug candidates targeting solid tumors and hematological malignancies. The company's disclosed development pipeline consists of rinatabart sesutecan (Rina-S; PRO1184), an ADC targeting folate receptor-alpha; PRO1160, an ADC targeting CD70; PRO1107, an ADC targeting PTK7; and PRO1286, a bispecific ADC targeting two clinically validated, broadly expressed solid tumor antigens. ProfoundBio is headquartered in Seattle, Washington. For more information, please visit and follow us on LinkedIn. SOURCE ProfoundBio