On September 3, 2024 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), reported that Russell Trenary, President and CEO of Outlook Therapeutics will present at the H.C. Wainwright 26th Annual Global Investment Conference being held September 9-11, 2024 in New York, NY (Press release, Outlook Therapeutics, SEP 3, 2024, View Source [SID1234646303]).

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In addition to the presentation, management will be available to participate in in-person one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information, please visit the conference website.

A video webcast of the presentation will be accessible for viewing on-demand beginning on Monday, September 9, 2024, at 7:00 AM ET for those registered for the event and will be accessible on the Events page in the Investors section of the Company’s website (outlooktherapeutics.com). The webcast replay will be archived for 90 days following the event.

On September 3, 2024 Acepodia (6976:TT), a clinical-stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) and allogeneic gamma delta 2 (γδ2) T cell platforms, reported that it has entered a strategic clinical collaboration with Pfizer Ignite to support the development of its therapies in autoimmune diseases (Press release, Acepodia, SEP 3, 2024, View Source [SID1234646320]). Pfizer Ignite is an end-to-end offering that leverages Pfizer’s significant resources, scale, and expertise, alongside a proven track record in the development of breakthroughs, to support biotechs seeking to accelerate their innovations from preclinical R&D through the development lifecycle. Under this new agreement, Pfizer Ignite will provide strategic guidance and resources to Acepodia as the company develops its cell therapies for oncology and autoimmune diseases.

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Acepodia’s ACC platform, which uses bioorthogonal chemistry and is based on the pioneering work of 2022 Nobel laureate Dr. Carolyn Bertozzi, who applied click chemistry to living systems, creates an off-the-shelf, non-genetically engineered version of CAR-T cell therapy that is more easily scaled and avoids cytokine release storms, neurotoxicity, and other side effects associated with CAR-T cell therapies. Acepodia’s lead clinical candidate, ACE1831, is currently being evaluated in a Phase 1 first-in-human clinical trial for patients with non-Hodgkin’s lymphoma and has demonstrated a robust and durable effect after a single treatment at the lowest dose.

"The significant unmet needs that exist in autoimmune diseases combined with the early positive results that have been seen with CAR-T therapies have opened the door for potential innovations that could provide the efficacy of CAR-T therapy without the challenges that have made routine use of CAR-T in autoimmune diseases difficult," said Sonny Hsiao, Ph.D., chief executive officer of Acepodia. "We see a significant opportunity to bring the benefits of our ACC platform to autoimmune diseases, and working with Pfizer Ignite will position us well to deliver our immunotherapies to patients in desperate need of new options."

By collaborating with Pfizer Ignite, Acepodia will benefit from Pfizer’s resources, deep expertise and R&D capabilities, covering multiple stages such as clinical trial design and regulatory strategies to improve the process of developing innovative drugs.

"Pfizer Ignite is focused on supporting the delivery of innovative therapies that are strategically aligned with Pfizer’s priority areas and have the potential to address significant gaps in patient care, " said Kathy Fernando, SVP, Head of Pfizer Ignite. "Drawing on Pfizer’s deep expertise in oncology and immunology, we look forward to collaborating with Acepodia to help translate their compelling scientific platform into impactful new medicines for patients with unmet need."

On September 3, 2024 Circle Pharma, a clinical-stage biopharmaceutical company dedicated to discovering and developing cell-permeable macrocycles as a new class of therapies, reported the successful closing of a $90 million Series D financing round, which includes the conversion of a convertible note (Press release, Circle Pharma, SEP 3, 2024, View Source;utm_medium=rss&utm_campaign=circle-pharma-closes-90-million-series-d-financing-to-advance-innovative-oral-macrocycle-therapies [SID1234646287]). The financing was led by The Column Group with participation from new and existing investors, including Nextech Invest and Euclidean Capital.

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The proceeds from the financing will be used to fund the clinical development of CID-078, Circle Pharma’s first-and-only-in-class cyclin A/B RxL inhibitor, and to support the development of the company’s portfolio of discovery programs built with its MXMO macrocycle platform.

"We are grateful for the continued support of such a strong syndicate of investors as we advance our pioneering work in macrocycle therapeutics," said David Earp, JD, Ph.D., CEO of Circle Pharma. "This financing not only enables us to progress CID-078 through critical stages of clinical development but also allows us to further advance our pipeline of innovative therapies targeting cancer and other serious diseases."

With this latest round of funding, Circle Pharma is well positioned to advance its mission of creating effective treatments for cancer and other serious illnesses.

On September 3, 2024 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported dosing of 5 new patients in the ACHIEVE Phase 2b trial ongoing in the UK (Press release, TC Biopharm, SEP 3, 2024, View Source [SID1234646321]).

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Currently, the trial has successfully dosed 6 patients with their first of 4 possible doses at the higher dose level. Each 5mL dose contains up to 230 million gamma delta T cells, and a patient is expected to receive up to an approximate 1 billion gamma delta T cells over four doses. Five patients have received their second dose, with 2 of these patients having also received their third dose. This correlates with TCBP’s step-wise approach to process improvements, as implemented in Q4 2023, and further steps taken to amend the trial protocol in the first quarter of 2024. New patients will continue to be identified, screened, and enrolled into the study.

"TCBP is excited to announce our rapid progression in the ACHIEVE Phase 2b trial with very strong enrolment in the second part of the trial using the higher dose," stated, Bryan Kobel, CEO of TC BioPharm. "TCB008 is potentially a game-changing monotherapy for blood cancers, and the strong recruitment and patient retention rates are testament to clinician/physician interest in TCB008 as a monotherapy in leukemia. We’re proud of the milestones accomplished to date, having rapidly dosed 6 patients with an additional 10 patients lined up. It is encouraging to see re-dosing of several patients, which we believe reflects positively on the steps the organization took in 2023 and early 2024. TCBP remains poised to execute on our clinical trial plans in 2024 and into 2025, including ACHIEVE and ACHIEVE2, as well as our expanded manufacturing capabilities to enhance our operational capabilities and our economic efficiencies."

The ACHIEVE UK clinical trial is an open-label, phase II study designed to evaluate the efficacy and effectiveness of TCB008 in patients with AML or MDS/AML, with either refractory or relapsed disease.

On September 3, 2024 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported several updates from the company’s ongoing registration-directed clinical trials of its potential best-in-class KIT mutant inhibitor, bezuclastinib (Press release, Cogent Biosciences, SEP 3, 2024, View Source [SID1234646288]).

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Patient enrollment is now complete in Cogent’s Phase 3 PEAK trial evaluating bezuclastinib in combination with sunitinib for the treatment of patients with gastrointestinal stromal tumors (GIST). Based on strong global patient interest, a total of 413 patients were enrolled in the study. In addition, Cogent recently completed a pre-planned interim futility analysis, and the Independent Data Monitoring Committee (IDMC) recommended continuing the PEAK study without modification. This pre-specified analysis was based on an assessment of progression-free survival (PFS) as determined by independent central review and did not include the option for early stopping due to efficacy. 

Separately, based on significant patient interest in the ongoing SUMMIT trial in nonadvanced systemic mastocytosis (NonAdvSM), Cogent also announced today that it expects to complete enrollment in this study during Q1 2025, approximately three months earlier than originally projected.

"We are excited to announce these important updates to the PEAK and SUMMIT studies today," said Andrew Robbins, Cogent’s President and Chief Executive Officer. "Strong continued interest from patients around the world to participate in our bezuclastinib trials has allowed us to accelerate development and surpass our original enrollment timelines. Completing enrollment in our Phase 3 PEAK trial of bezuclastinib and sunitinib for second-line GIST patients several months ahead of schedule represents a significant milestone for the program and we are extremely grateful to the patients, families, caregivers, advocacy groups and clinical investigators for their participation in, and support of, the PEAK trial." 

PEAK is a randomized, open-label, global Phase 3 clinical trial evaluating bezuclastinib in combination with sunitinib vs. sunitinib alone in GIST patients previously treated with imatinib. The primary endpoint of the trial is median progression free survival (mPFS). PEAK is a registration study intended to support a New Drug Application (NDA) in GIST. 

SUMMIT is a randomized, blinded, global, registration-directed clinical trial evaluating bezuclastinib vs. placebo in NonAdvSM patients. The primary endpoint of the trial is mean improvement in patient symptoms measured at 24 weeks. SUMMIT is intended to be a registrational study designed to support a New Drug Application (NDA) in NonAdvSM. 

Appointment of Darara Dibabu as Vice President of Marketing
In addition to the updates to PEAK and SUMMIT trials, Cogent announced today that Mr. Dibabu has joined Cogent as the VP of Marketing. Mr. Dibabu has 25 years of experience in the biopharmaceutical industry, most recently as the Global Brand Lead of TUKYSA at Pfizer and SeaGen, where he led the global launch and marketing strategy of the product for metastatic breast cancer patients. Previously, he served in various roles of increasing responsibility at Seagen, Bayer and Merck. Mr. Dibabu holds a bachelor’s degree in Biology from the University of Southern California. In connection with Mr. Dibabu joining the company, he was granted an "inducement" equity award in accordance with Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market.  The award was approved by the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, as an inducement material to Mr. Dibabu’s employment. The award consists of nonqualified options to purchase 100,000 shares of Cogent common stock with a 10-year term, at an exercise price of $10.74 per share, and a 4-year vesting schedule with 25% vesting on the 1-year anniversary of Mr. Dibabu’s employment and the remainder vesting in equal monthly installments over the subsequent 36 months, provided Mr. Dibabu’s remains employed through each such vesting date.