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Oncology News (June 9 - June 15)

J INTS BIO - Positive Trial Data, Jun 10, 2024

J INTS BIO updated its Phase 1 study of JIN-A02, a 4th generation EGFR-TKI for NSCLC, at the 2024 ASCO Annual Meeting. The study reported a second Partial Response (PR) in Cohort 4 (100mg daily) and the first brain tumor activity. To date, there are two PRs and three Stable Diseases with no significant side effects. Cohort 5 (150mg daily) will begin in June, and Phase 2 is planned for year-end.

Full Article: J INTS BIO ASCO 2024: JIN-A02 Showed Tumor Reductions, Including Brain Metastasis, in the Ongoing First-in-Human Dose-Finding Phase 1 Clinical Study

Cumulus Oncology - Executive Changes, Jun 10, 2024

Cumulus Oncology appoints Catherine Lewis La Torre to its Board of Directors. With over 30 years of investment expertise, including leadership roles at British Business Investments and British Patient Capital, her experience will aid Cumulus's growth and Series A financing. This follows Cumulus's recent £9m raise and expansion efforts. Catherine is eager to support Cumulus's mission of developing innovative oncology therapeutics.

Full Article: Cumulus Oncology Appoints Catherine Lewis La Torre to Its Board of Directors

Oncology News - Innovations & Discovery, Jun 10, 2024

A new fluorescent dye for prostate cancer surgery allows surgeons to see cancer cells more clearly, aiding in their removal while preserving healthy tissue. Developed with Cancer Research UK funding, the dye, combined with a targeting molecule, highlights cancer cells, potentially transforming cancer treatment by improving surgical precision.

Full Article: Glowing Dye That Clings to Cancer Cells Gives Doctors Second Pair of Eyes

Bright Peak Therapeutics - Series C Investment, Jun 11, 2024

Bright Peak Therapeutics secured $90 million in a Series C financing round led by Johnson & Johnson Innovation – JJDC, with participation from new investors Venrock, KB Investment, and Northleaf Capital Partners, and existing investors like Versant Ventures and Fidelity Management & Research Company. The funding will advance BPT567, a novel PD1-IL18 immunoconjugate, into clinical trials and expedite the development of other immunotherapies. CEO Fredrik Wiklund expressed enthusiasm about bringing innovative treatments to cancer patients.

Full Article: Bright Peak Therapeutics Announces $90 Million in Series C Financing

Adcytherix - Seed Funding, Jun 11, 2024

France's Adcytherix, a new biopharmaceutical company, has launched with €30 million ($32.2 million) in seed funding focused on developing antibody-drug conjugates (ADCs) for cancer treatment. Led by CEO Jack Elands and backed by investors like Pontifax Venture Capital, RA Capital Management, Pureos Bioventures, and Dawn Biopharma, the company aims to address unmet medical needs in cancer treatment through ADC development.

Full Article: Adcytherix Launches with €30 Million in Seed Funding for ADC Development

Candel Therapeutics - Company Growth, Jun 11, 2024

Candel Therapeutics, specializing in cancer immunotherapies, will join the Russell 3000 Index on July 1, 2024, due to its market capitalization growth. This inclusion could enhance investor visibility and attract institutional investment. Candel's lead therapy, CAN-2409, is in trials for several cancers, while CAN-3110, targeting aggressive brain cancer, has received Orphan Drug Designation from the FDA. The company aims to develop novel immunotherapies for unmet medical needs.

Full Article: Candel Therapeutics to Join Russell 3000 Index

SELLAS Life Sciences - Positive Trial Data, Jun 11, 2024

SELLAS Life Sciences announced positive initial results and completion of enrollment for a phase 2a trial of SLS009, a CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (AML). The trial showed SLS009 was well tolerated with no safety issues and an overall response rate (ORR) of 29.6%, peaking at 50% with a 30 mg twice-weekly dose. Notably, SLS009 increased median overall survival from 2.5 months to 5.4 months when combined with venetoclax and azacitidine. High efficacy was observed in patients with ASXL1 mutations, achieving a 100% response rate at the 30 mg biweekly dose.

Full Article: Phase 2a SLS009 Trial in R/R AML Completes Enrollment and Shows Efficacy

Processa Pharmaceuticals - Positive Trial Data, Jun 11, 2024

Processa Pharmaceuticals reported positive results from its Phase 1b trial of Next Generation Capecitabine (NGC-Cap) for advanced gastrointestinal cancer. The trial established the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose Range (RP2DR), showing NGC-Cap increased 5-FU delivery compared to standard capecitabine. Preliminary results showed 66.7% of patients had partial responses or stable disease, with progression-free survival (PFS) of 5-11 months. These findings support further development in a Phase 2 breast cancer trial planned for 2024.

Full Article: Processa Pharmaceuticals Announces Positive Efficacy Results from Preliminary Evaluation of Phase 1b Dose-Escalating Trial with NGC-Cap in Gastrointestinal Cancer

Repare Therapeutics - Clinical Trial Updates, Jun 11, 2024

Repare Therapeutics announced that the first NSCLC patient received its ATR kinase inhibitor camonsertib in a Phase I/II trial. This study assesses camonsertib's safety and efficacy alone and with Pfizer's Talzenna or gemcitabine in advanced cancers with ATR inhibitor sensitizing mutations. Previously, combinations showed a 48% clinical benefit rate. Repare will enroll up to 20 patients with ATM-mutated NSCLC, aiming to address the unmet needs of these patients. Repare regained camonsertib rights after Roche ended their collaboration in February 2023.

Full Article: Repare Therapeutics Begins Testing ATR Kinase Inhibitor in Lung Cancer

PDS Biotech - Clinical Trial Updates, Jun 12, 2024

PDS Biotechnology released updated data from its ongoing Phase 2 VERSATILE-002 trial for HPV16-positive head and neck cancer, showing a median overall survival (mOS) of 30 months. The trial combines Versamune® HPV and KEYTRUDA® in patients who haven't received immune checkpoint inhibitors. Of 53 patients, 27 are still alive. PDS plans a Phase 3 trial, comparing this combination with a triple regimen adding PDS01ADC. The company aims to start a pivotal trial in 2024 and has sufficient funds until Q4 2025. B.Riley revised PDS's share target to $9 but maintained a buy rating.

Full Article: PDS Biotech Reports Steady Survival Rates in Phase 2 Cancer Trial

T-Therapeutics - Executive Changes, Jun 12, 2024

T-Therapeutics appointed Dr. David Hung, known for founding Medivation and leading XTANDI® to blockbuster status, as Chairman of its Board. Dr. Hung, currently President of Nuvation Bio, brings deep expertise in oncology drug development. T-Therapeutics focuses on advancing next-generation TCR therapeutics, recently raising £48m in series A funding for cancer treatment innovation.

Full Article: T-Therapeutics Appoints Dr. David Hung as Chairman

Zumutor Biologics - Clinical Trial Updates, Jun 13, 2024

Zumutor Biologics Inc. has begun a Phase 1 trial for ZM008, a novel monoclonal antibody aimed at enhancing NK and T cell activity against tumors. The study will assess ZM008 alone and with pembrolizumab in patients with advanced solid tumors to determine safety, optimal dosing, and antitumor activity. This trial targets multiple cancer types and aims to improve outcomes for patients resistant to current immunotherapies.

Full Article: Zumutor Biologics Announces Dosing of First Patient with ZM008

InduPro - Series A Investment, Jun 13, 2024

InduPro, Inc., a biotech company developing novel cancer and autoimmune disease therapies, secured $85 million in Series A financing led by The Column Group and Vida Ventures. This funding will support their first clinical product candidate and a pipeline of bispecific antibodies and ADCs. New CEO Prakash Raman, Ph.D., brings significant biopharmaceutical expertise. Using its ProXiMATE platform, InduPro maps protein proximities to discover highly selective disease targets, aiming to create first-in-class therapeutics for unmet medical needs.

Full Article: InduPro Raises $85 Million in Series A Financing

Bright Peak Therapeutics - Series C Investment, Jun 13, 2024

Bright Peak Therapeutics raised $90 million in Series C financing led by Johnson & Johnson Innovation – JJDC, with participation from new and existing investors. The funds will advance BPT567, a PD1-IL18 immunoconjugate, into a Phase 1/2a trial and accelerate their pipeline of next-gen immunotherapies. BPT567 aims to block the PD-1 pathway and deliver IL-18 signaling to T cells, showing strong anti-tumor activity in preclinical models. CEO Fredrik Wiklund emphasized the funding's role in driving innovation and clinical progress.

Full Article: Bright Peak Therapeutics Announces $90 Million in Series C Financing

TScan Therapeutics - Executive Changes, Jun 14, 2024

TScan Therapeutics, Inc. appointed Garry A. Nicholson to its Board of Directors, replacing retiring Chair Timothy Barberich. Stephen Biggar, M.D., Ph.D., will become the new Chair. Nicholson, with over 35 years in oncology, including as Pfizer Oncology president, brings extensive expertise to support TScan's clinical advancements.

Full Article: TScan Therapeutics Announces Updates to Its Board of Directors

Johnson & Johnson - Executive Changes, Jun 14, 2024

William Hait, M.D., Ph.D., executive vice president and chief external innovation and medical officer at Johnson & Johnson, will retire this September after 17 years. Hait joined J&J in 2007, leading hematology and oncology for Janssen and serving as global head of innovative medicine R&D, launching over 20 products. Before J&J, Hait was the founding director of the Rutgers Cancer Institute and a professor at Rutgers Robert Wood Johnson Medical School.

Full Article: Long-Time J&J Exec William Hait to Retire

Bayer - Executive Changes, Jun 14, 2024

Amid Bayer’s restructuring, Jens Vogel, Ph.D., SVP and Global Head of Biotech, has departed. Vogel, who joined Bayer in March 2020 after nearly 11 years at Boehringer Ingelheim, leaves as Bayer eliminates the head biotech role. Tina Self, now Global Head of Biologics Manufacturing, leads the new “biologics manufacturing capability cluster” and serves as the first female site head at Bayer Berkeley.

Full Article: Bayer's Biotech Head Jens Vogel Says Good-Bye After 4 Years

LIXTE Biotechnology - Collaboration, Jun 14, 2024

LIXTE Biotechnology Holdings, Inc. announced a collaboration with Roche and the Netherlands Cancer Institute (NKI) to conduct a clinical trial in MSI Low metastatic colon cancer, unresponsive to current immunotherapies. The trial (NCT06012734) will test LIXTE’s LB-100 and Roche's atezolizumab (Tecentriq®) through the imCORE Network. Principal investigator Neeltje Steeghs, M.D., Ph.D., highlighted the potential to make immunotherapy effective for the 85% of colon cancer patients with MSI Low tumors. CEO Bas van der Baan emphasized the trial's significance and noted similar ongoing research supported by GSK.

Full Article: LIXTE Biotechnology Announces Collaboration on a New Colon Cancer Clinical Trial

InduPro - Series A Investment, Jun 14, 2024

InduPro, a biotech company, raised $85M in Series A funding to advance its cancer therapeutics. The round was led by The Column Group and Vida Ventures. The funds will support the development of its first clinical product and a pipeline of bispecific antibodies and ADCs, with an IND filing expected by Q4 2025. InduPro, led by CEO Prakash Raman and CSO Scott Lesley, uses proprietary technology to target cell surface proteins in cancer and autoimmune diseases.

Full Article: InduPro Raises $85 Million in Series A Financing

Cartherics - Milestones & Achievements, Jun 14, 2024

Cartherics Pty Ltd, a biotech firm developing immune cell therapies for cancer, received its first Australian patent for "Genetically modified cells and uses thereof," supporting its CAR technology targeting TAG-72 in adenocarcinomas like ovarian and gastric cancers. This patent, part of a broader international application, marks a key milestone for Cartherics' lead product, CTH-401, aimed at treating relapsed or refractory ovarian cancer. CEO Prof. Alan Trounson AO highlighted the patent's role in strengthening Cartherics' global position in cancer therapy.

Full Article: Cartherics Receives First Australian Patent for Genetically Modified Cells

Shattuck Labs - Positive Trial Data, Jun 14, 2024

Shattuck Labs announced positive interim data from its Phase 1B trial of SL-172154 for HR-MDS and TP53m AML patients at EHA 2024. The treatment showed a 67% response rate in HR-MDS and 43% in TP53m AML, with improved complete remission rates and manageable safety. Shattuck will focus on these indications due to strong results and potential for faster approval, while pausing further ovarian cancer trials.

Full Article: Shattuck Labs Announces Updated Positive Interim Data from Phase 1B Trial

Wugen - Clinical Trial Updates, Jun 14, 2024

WU-CART-007, an anti-CD7 CAR T-cell therapy, demonstrated manageable side effects and promising early efficacy in relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LBL). At the 2024 EHA Congress, data showed 61.5% of patients experienced grade 3 or higher treatment-related adverse effects, and 88.5% had cytokine release syndrome, primarily grade 1/2. The therapy achieved a 91% overall response rate and 73% complete response rate, prompting further study in the pivotal WUC007-03 trial.

Full Article: WU-CART-007 Shows Preliminary Activity in Leukemia & Lymphoma Subtypes

Sumitomo Pharma America - Clinical Trial Updates, Jun 15, 2024

Sumitomo Pharma America presented Phase 1/2 study data of DSP-5336 at the EHA 2024 Congress. DSP-5336, targeting relapsed or refractory acute leukemia, showed a 57% response rate among 57 patients, especially in those with NPM1 mutations or KMT2A rearrangements. The drug was well-tolerated with no severe side effects. SMPA's CMO, Jatin Shah, highlighted DSP-5336's potential to meet unmet needs in AML treatment.

Full Article: Sumitomo Pharma America Presents Phase 1/2 Study Data

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