On December 7, 2022 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated oncology therapeutics, reported that Phase 2 data for CX-2009, a conditionally activated antibody drug conjugate (ADC) targeting CD166, will be presented at the San Antonio Breast Cancer Symposium on December 8th (Press release, CytomX Therapeutics, DEC 7, 2022, View Source [SID1234624885]). The poster details the results from patients treated with monotherapy praluzatamab ravtansine for the treatment of advanced HR+/HER2- breast cancer and triple negative breast cancer (TNBC).

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"We thank our investigators and the patients and families who contributed to our comprehensive evaluation of praluzatamab ravtansine in breast cancer. Although we elected previously in 2022 not to advance this program further without a partner, this research has benefited many patients, provided important insights into our conditionally activated ADC strategy and informed our next generation of Probody therapeutic candidates," said Sean McCarthy, D.Phil, CEO and Chairman of CytomX.

Details for the poster presentation are as follows:
Presentation Title: Results from a phase 2 study of praluzatamab ravtansine (CX-2009) in patients with advanced breast cancer (ABC)
Poster: P4-01-15
Session and Location: Poster Session 4 – Hall 1
Session Date and Time: December 8, 2022, 7:00 am – 8:15 am CT
Presenting Author: Dr. Kathy Miller, Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, IN, USA

On December 7, 2022 Paragon Therapeutics, a biotechnology company dedicated to discovering and developing best-in-class biologics for a range of diseases with high unmet need, reported the launch of Apogee Therapeutics, LLC, its first spinout (Press release, Biosortia Pharmaceuticals, DEC 7, 2022, View Source [SID1234624884]). Apogee is advancing a pipeline of product candidates discovered and developed at Paragon that have potential to reach millions of people living with inflammatory and immunological disorders.

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Building on validated protein engineering technologies, Paragon leverages cutting-edge science and technology to rapidly identify and propel biologics from ideation to the clinic. The company’s process combines high-throughput screening systems and optimization techniques to isolate the best possible drug candidates with a CMC model that enables quick and reliable production—aimed at delivering targeted treatment options to patients.

"At Paragon, we are thrilled to announce the launch of Apogee Therapeutics as our first independent company, and we are confident that the Apogee team is well positioned to execute and demonstrate therapeutic leadership in areas of high unmet need," said K. Evan Thompson, Ph.D., Chief Operating Officer of Paragon. "The debut of Apogee validates our approach to advancing best-in-class biologics to patients through a range of opportunities, from new company creation and strategic partnerships to shaping programs in-house with our experienced and proven team."

Apogee was founded in 2022 by Fairmount and Venrock Healthcare Capital Partners and has raised $169 million in financing to date, including an oversubscribed $149 million Series B round co-led by Deep Track Capital and RTW Investments, LP. Under the guidance of CEO Michael Henderson, M.D., the funding is expected to support key leadership, science, and clinical team hires and progress its lead pipeline program, APG777, to the clinic in 2023. As part of its agreement with Paragon, Apogee has an option for exclusive development and commercial rights to a suite of top-tier antibodies specifically engineered to target some of the largest and highest unmet needs in inflammatory and immunological conditions.

"Paragon has mastered the design and development of transformative therapies that meet the highest needs for inflammatory and immune diseases," said Dr. Henderson. "We are excited to build on their work to deliver life-changing therapies that improve patients’ lives."

Paragon was founded in 2021 by Fairmount and is led by a team of innovators with deep expertise in biologics engineering and development. The company’s collaboration with FairJourney Biologics expands its reach and capabilities through dedicated antibody discovery experts and resources. In addition to those partnered with Apogee, Paragon is currently advancing multiple differentiated programs for a range of diseases.

On December 7, 2022 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported the enrollment and dosing of the first patient in a Phase 1/1b clinical trial of BP1001-A (liposomal Grb2) in patients with solid tumors, including ovarian, endometrial, pancreatic and breast cancer (Press release, Bio-Path Holdings, DEC 7, 2022, View Source [SID1234624883]).

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"The dosing of the first patient in this study of BP1001-A is an important achievement that brings us closer to delivering this potentially life-saving treatment to patients with solid tumor cancers that have few or limited treatment options," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "Solid tumors continue to be a treatment challenge with many therapies failing to provide durable benefit to patients. We are excited and hopeful that BP1001-A will prove to be both safe and effective in fighting these most difficult to treat tumors."

BP1001-A is a modified drug product with the same drug substance as prexigebersen but includes formulation enhancements to produce smaller drug nanoparticles. The goal of this product enhancement is to produce smaller drug nanoparticles that can pass through vasculature pore spaces, thereby enabling release of the drug product into the interior of the tumor to enhance drug effectiveness.

The dose escalation portion of the Phase 1/1b clinical trial is planned to be conducted at more than six leading cancer centers in the United States, including The University of Texas MD Anderson Cancer Center, The Mary Crowley Cancer Research Center, and Karmanos Cancer Center. Initially, a total of nine evaluable patients are scheduled to be treated with BP1001-A monotherapy in a standard 3+3 design, with a starting dose of 60 mg/m2. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days. The Phase 1b portion of the study will commence after successful completion of BP1001-A monotherapy cohorts and will assess the safety and efficacy of BP1001-A in combination with paclitaxel in patients with recurrent ovarian or endometrial tumors.

On December 7, 2022 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral kinase inhibitors to treat hematologic malignancies, reported that the company’s management team will provide a corporate update on Sunday, December 11, 2022, at 10:00 AM EST / 9:00 CST, in conjunction with poster presentations at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, being held in New Orleans, LA (Press release, Aptose Biosciences, DEC 7, 2022, View Source [SID1234624882]). The webcast event will include a comprehensive review of current clinical data for Aptose’s lead compound tuspetinib, formerly HM43239, a myeloid kinase inhibitor, as well as an update on luxeptinib, Aptose’s oral, dual lymphoid and myeloid kinase inhibitor.

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Tuspetinib, administered as a once-daily oral tablet, is a precision targeted kinase inhibitor designed to suppress a select handful of kinases known to drive the proliferation of acute myeloid leukemia (AML) but avoids other kinases that can compromise safety. The data review will highlight results from the recently completed Phase 1/2 dose escalation clinical trial of tuspetinib.

Aptose Clinical Update Details

Date & Time: Sunday, Dec 11, 2022, 10:00 AM EST; 9:00 AM CST

Participant Webcast Link: Link

Participant Dial-in:

Toll Free Investors Dial: 1-877-407-9039

Toll/International Investors Dial: 1-201-689-8470

Conference ID: 13734698

The slides will be available on Aptose’s website here and the webcast of the presentation will be archived shortly after the conclusion of the event.

As announced prior, the Aptose poster presentations at ASH (Free ASH Whitepaper) are listed below. Note that the poster presentations will include additional data not found in the previously published abstracts.

Poster Presentation Details

Publication Number 2758: A Phase 1/2 Dose Escalation Study of the Myeloid Kinase Inhibitor HM43239 in Patients with Relapsed or Refractory Acute Myeloid Leukemia
Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster II
Session Date & Time: Sunday, December 11, 2022, 6:00 – 8:00 PM ET
Location: Ernest N. Morial Convention Center, Hall D

Publication Number 2767: A Phase 1a/b Dose Escalation Study of the FLT3/BTK Inhibitor Luxeptinib (CG-806) in Patients with Relapsed or Refractory Acute Myeloid Leukemia
Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster II
Session Date & Time: Sunday, December 11, 2022, 6:00 – 8:00 PM ET
Location: Ernest N. Morial Convention Center, Hall D

Publication Number 2893: A Phase 1a/b Dose Escalation Study of the BTK/FLT3 Inhibitor Luxeptinib in Patients with Relapsed or Refractory B-Cell Malignancies
Session Name: 623. Mantle Cell, Follicular, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster II
Session Date & Time: Sunday, December 11, 2022, 6:00 – 8:00 PM ET
Location: Ernest N. Morial Convention Center, Hall D

On December 6, 2022 ANDARIX Pharmaceuticals, a leader in the discovery and development of targeted peptide therapy for cancer reported that it will present its clinical strategy and results at the upcoming clinical trials in rare diseases conference (Press release, Andarix Pharmaceuticals, DEC 7, 2022, View Source [SID1234624880]). The Clinical Trials in Rare Diseases Conference 2022 is focused on exploring the challenges and opportunities for planning and conducting clinical studies in rare disease. The virtual conference will take place on December 7, 2022.

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About Tozaride
Tozaride is a novel, best-in-class cancer therapy based on a radio-labeled somatostatin peptide analogue. Early clinical studies of Tozaride demonstrated that it is well tolerated and may produce prolonged stable disease and improved overall survival in advanced lung cancer patients whose disease has continued to progress after failing other therapies. Tozaride targeted radiotherapy represents a new treatment paradigm which is expected to yield significant clinical benefit for both lung cancer (SCLC, NSCLC), and pancreatic cancer patients. Along with its companion diagnostic that helps identify patients most likely to respond – those with sufficient expression of the peptide’s target – Tozaride could provide another treatment option for patients who are not eligible for, or who have not responded to current therapies.