On November 4, 2024 OncoResponse, a clinical-stage biotech company advancing immunotherapies derived from the immune systems of Elite Cancer Responders, reported that it will present Phase 1 results for the clinical study of OR502, a novel, humanized anti-leukocyte immunoglobulin like receptor B2 (LILRB2) antibody that rescues innate and adaptive immune responses from LILRB2 mediated immune suppression (Press release, OncoResponse, NOV 4, 2024, View Source [SID1234647675]). The Phase 1 study results will be presented as a late-breaker poster presentation at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2024), taking place in Houston, Texas, November 8-10, 2024.

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Details are as follows:

Title (Late-Breaking Abstract): Phase 1 results of OR502, an antibody against leukocyte immunoglobulin-like receptor B2 (LILRB2), in subjects with advanced cancers

Abstract Number: 1464
Details: Saturday, November 9, George R. Brown Convention Center

Title: Adaptive design elements in a Ph 1-2 study of OR502, a novel antibody against leukocyte immunoglobulin-like receptor B2 (LILRB2), in response to evolving Ph 1 data and changing regulatory environment

Abstract Number: 680
Details: Saturday, November 9, George R. Brown Convention Center

OncoResponse poster presentations from SITC (Free SITC Whitepaper) are available on the Publications page of the Company website following their respective sessions.

On November 4, 2024 Cellectis, a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, reported business updates and reported financial results for the nine-month period ending September 30, 2024 (Press release, Cellectis, NOV 4, 2024, View Source [SID1234649626]).

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"This quarter, we were thrilled to welcome Dr. Kilcoyne to Cellectis as Chief Medical Officer. Dr. Kilcoyne joins us at a pivotal time for the Company, bringing extensive experience in drug development as we are progressing in our clinical programs. We expect to present Phase 1 dataset and late-stage development strategy in 2025 for UCART22 in ALL and UCART20x22 for NHL" said André Choulika, Ph.D., Chief Executive Officer at Cellectis.

"Additionally, we are excited to announce that research and development activities have started for three programs under our collaboration and research agreement with AstraZeneca: one allogeneic CAR T for hematological malignancies, one allogeneic CAR T for solid tumors, and one in vivo gene therapy for a genetic disorder.

On November 4, 2024 Ring Therapeutics, a life sciences company founded by Flagship Pioneering to revolutionize gene therapy with its commensal virome platform, reported new strategic partnerships with the Agency for Science, Technology, and Research (A*STAR), Singapore’s lead public sector R&D agency; and the Singapore Eye Research Institute (SERI) to advance innovative R&D efforts and support the continued development of the biomedical science ecosystem in the region (Press release, Ring Therapeutics, NOV 4, 2024, View Source [SID1234656557]).

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"The strategic benefits for the company are profound and span the entirety of the platform, from early discovery work where we plan to characterize novel anellovirus genomes to enable ophthalmology and oncology applications, to indication portfolio expansion via the testing of novel payloads across multiple therapeutic areas, to enhancing process performance for our next-generation manufacturing platform," said Tuyen Ong, MD, MBA, Chief Executive Officer at Ring Therapeutics and CEO-Partner at Flagship Pioneering. "Through engaging a global ecosystem of R&D experts, these partnerships will further expand the potential of our Anellogy platform and aim to accelerate the clinical translation of our AnelloVector therapeutics."

The A*STAR and SERI partnership will accelerate the creation of new potential treatments for eye diseases (ophthalmology) and cancer (oncology), while also improving the methods and technologies needed to produce these treatments. The collaboration will bring together synergistic expertise in scale-up manufacturing and capabilities for continued advancements of scientific breakthroughs and technological development in the region.

Professor Tan Sze Wee, Assistant Chief Executive, Biomedical Research Council, A*STAR, added, "We are excited to partner with Ring Therapeutics, whose pioneering platform technology complements our mission to advance innovative medicines. By bringing together our technologies and premier research capabilities, this collaboration holds great promise for translating groundbreaking discoveries into impactful therapeutic solutions for patients. We believe this strategic fit will foster continued scientific collaboration and inspire advanced R&D development within the Singapore biotech ecosystem, ultimately bringing impact and benefiting those in need."

Professor Jodhbir Mehta, Executive Director, SERI, added, "Gene therapy presents an exciting opportunity to treat ophthalmic diseases that previously had no effective treatments. This partnership will allow SERI to further develop Ring’s novel class of viral vector that has higher tropism and is potentially redosable. We look forward to making significant strides in developing groundbreaking therapies that will reduce vision impairment."

On November 4, 2024 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, reported that it has received clearance from the FDA to commence its Phase II oncology trial (Press release, CytoDyn, NOV 4, 2024, View Source [SID1234647657]). The study will evaluate the efficacy of leronlimab in patients with relapsed/refractory microsatellite stable colorectal cancer ("CRC").

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This milestone reflects the continued positive development of the Company’s improved relationship with the FDA. Clearance for the Phase II oncology trial was achieved following productive feedback sessions with the FDA over the past few months and the submission of a final study protocol to the FDA in September 2024. As previously announced, the trial will be conducted in partnership with Syneos Health. A trial kickoff meeting has been set for late November 2024 and patient enrollment will begin in early 2025.

"We have appreciated the opportunity to work constructively with the FDA on the review and finalization of our CRC protocol," said Dr. Jacob Lalezari CEO. "With the agency’s input and our partnership with Syneos Health, we are well positioned to advance our clinical evaluation of leronlimab for oncology and make real strides towards developing the treatment paths of tomorrow."

On November 4, 2024 Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, reported that the U.S. Food and Drug Administration (FDA) has granted a Type C meeting with the Company in December 2024 to discuss the potential pathways to registration of Kazia’s blood brain barrier penetrant PI3K/mTOR inhibitor, paxalisib, for the treatment of patients with newly diagnosed GBM (Press release, Kazia Therapeutics, NOV 4, 2024, View Source [SID1234647676]).

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In July 2024, the Company announced results from the Phase II/III clinical trial, GBM-AGILE, in which newly diagnosed unmethylated patients with glioblastoma treated with paxalisib showed clinically meaningful improvement in a prespecified secondary analysis for overall survival. Full data including secondary endpoints from the paxalisib arm of the GBM-AGILE study is expected to be presented at a scientific meeting later this year.

Paxalisib has previously received orphan drug designation and fast track designation from the FDA for glioblastoma in unmethylated MGMT promoter status patients, following radiation plus temozolomide therapy.

Updated corporate presentation
Today, the Company also announced that it has updated its corporate presentation, which now incorporates preliminary data from the GBM AGILE Phase II/III clinical trial evaluating paxalisib versus the standard of care for the treatment of in patients with glioblastoma. The updated presentation can be found at View Source

Participation in Upcoming and Recent Medical and Investor Conferences

The company plans on attending the following medical conferences in the fourth quarter of 2024:

Society for Neuro-Oncology 29th Annual Meeting and Education Day, November 21-24, 2024, in Houston, TX
San Antonio Breast Cancer Symposium, December 10-13, 2024, in San Antonio, TX
These events provide Kazia with the opportunity to engage with key stakeholders and share the Company’s vision to make a difference in the lives of patients by developing innovative cancer treatments. Kazia looks forward to meeting with investors in person at these events and invites discussion regarding partnering and investment opportunities.

Over the last several months, the Company has also participated and presented at a number of medical and investor conferences, including:

H C Wainwright 26th Annual Global Investment Conference from Sep. 9-11, 2024
15th Biennial AACR (Free AACR Whitepaper) Ovarian Cancer Research Symposium, Sep. 20 – 21, 2024
Oppenheimer Oncology Summit, in collaboration with MD Anderson Cancer Center, Sep. 26, 2024
American Society for Radiation Oncology Annual Meeting, Sep. 29 – Oct. 1, 2024
Deerfield CEO Conference, Oct. 8-9, 2024
Maxim Group’s 2024 Healthcare Virtual Summit, Fireside Chat, Oct. 15, 2024