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

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 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, and Nobelpharma Co., Ltd. reported that they have entered into an exclusive license and distribution agreement for the development and commercialization in Japan of DANYELZA for the treatment of patients with relapsed/refractory high-risk neuroblastoma and, upon agreement by the parties, potentially relapsed osteosarcoma (Press release, Y-mAbs Therapeutics, NOV 4, 2024, View Source [SID1234647672]).

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Under the terms of the agreement, Nobelpharma will employ its regulatory, marketing, sales and access expertise to carry out development work and to submit DANYELZA for approval by Japanese regulatory authorities, and to market, sell, and distribute DANYELZA in Japan, if approved. Pursuant to the agreement, Y-mAbs will receive an upfront payment of $2.0 million from Nobelpharma in connection with entering into the agreement and is entitled to receive up to $31.0 million in product and commercial milestone payments in addition to royalties in the low double digits on commercial sales on DANYELZA, if successfully approved and commercialized in Japan.

"Our exclusive license and distribution agreement with Nobelpharma in Japan is an important step in our continued global expansion efforts of DANYELZA," said Michael Rossi, President and Chief Executive Officer of Y-mAbs. "If approved in the region, we believe DANYELZA can deliver a meaningful impact to patients in Japan fighting relapsed/refractory high-risk neuroblastoma and improve long-term quality of life for these children."

"We believe that Nobelpharma is the right partner for Y-mAbs in Japan, and we are excited to work with Nobelpharma towards the potential approval and commercial launch of DANYELZA in the region," said Thomas Gad, Founder and Chief Business Officer of Y-mAbs. "DANYELZA, if approved in Japan for relapsed/refractory high-risk neuroblastoma, will provide a new out-patient anti-GD2 therapeutic option for physicians in the treatment of children facing this advanced form of pediatric cancer. We remain steadfast in our commitment to provide access to DANYELZA and improve the lives of children and families around the globe facing advanced cancers."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed DANYELZA (naxitamab-gqgk), which is exclusively licensed by MSK to Y-mAbs. MSK has institutional financial interests in the compound and Y-mAbs.

About DANYELZA (naxitamab-gqgk)

DANYELZA (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.

DANYELZA is currently not approved for the treatment of osteosarcoma in any jurisdiction.

On November 4, 2024, Syndax Pharmaceuticals, Inc. ("Syndax") reported to have entered into a Purchase and Sale Agreement (the "Purchase and Sale Agreement") with Royalty Pharma Development Funding, LLC ("Royalty Pharma"), pursuant to which Royalty Pharma purchased rights to certain revenue streams from net sales of products comprising or containing axatilimab (including Niktimvo) (collectively, the "Product") by Syndax, its affiliates and its licensees in the United States and its respective territories, districts, commonwealths and possessions (including Guam and Puerto Rico) (the "Territory") in exchange for $350 million (Press release, Syndax, NOV 4, 2024, View Source [SID1234647671]).

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Pursuant to the Purchase and Sale Agreement, Royalty Pharma purchased the right to receive a percentage of net sales equal to a royalty rate of 13.8% on quarterly net sales of the Product in the Territory; provided that the royalty rate is subject to certain adjustments based on future aggregate net sales of the Product in the Territory (the "Revenue Participation Right"). Aggregate payments made to Royalty Pharma in respect of the Revenue Participation Right will be capped at $822.5 million (the "Royalty Cap").

The Purchase and Sale Agreement contains customary representations, warranties and indemnities of Syndax and Royalty Pharma and customary covenants relating to the royalty payments, including the grant of a back-up security interest in the purchased royalties and certain assets related to the Product and restrictions on the incurrence of additional indebtedness and on the existence of liens on Syndax’s assets related to the Product.

Upon a change of control, Syndax will have the right, but not the obligation, to repurchase the Revenue Participation Right at a repurchase price set forth in the Purchase and Sale Agreement. In addition, the Purchase and Sale Agreement provides that if certain events of default occur, including certain bankruptcy events or certain termination events with respect to Syndax’s license agreement with UCB Biopharma Srl, Royalty Pharma may require Syndax to repurchase Royalty Pharma’s interests in the Revenue Participation Right at a repurchase price equal to the Royalty Cap.

The foregoing description of the terms of the Purchase and Sale Agreement does not purport to be complete and is qualified in its entirety by the full text of the agreement. Syndax intends to file a copy of the Purchase and Sale Agreement with its Annual Report on Form 10-K for the year ending December 31, 2024.

On November 4, 2024 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that the company will have five presentations at the 15th Annual World ADC Conference, taking place in San Diego, November 4-6, 2024 (Press release, Sutro Biopharma, NOV 4, 2024, View Source;utm_medium=rss&utm_campaign=sutro-biopharma-demonstrates-meaningful-adc-innovation-with-five-presentations-at-the-15th-annual-world-adc-conference [SID1234647670]).

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Presentation Details:
Development of Dual-Payload Antibody Drug Conjugates
Presenter: Daniel Calarese, Ph.D.
Date/Time: November 4, 2024, 2:00pm PT
Showcasing Clinical Update & Learnings for Luvelta Targeting Folate Receptor
Presenter: Hanspeter Gerber, Ph.D.
Date/Time: November 5, 2024, 11:30am PT
Characterizing ADC Safety & Activity in Preclinical Development of STRO-004
Presenter: Alice Yam, Ph.D.
Date/Time: November 5, 2024, 2:00pm PT
Leveraging Cell-Free Protein Synthesis for Site- Specific Conjugation to Enhance ADC Therapeutic Index
Presenter: Gang Yin, Ph.D.
Date/Time: November 5, 2024, 2:30pm PT
Optimizing High DAR & Dual Payload ADCs: Discovery of Hydrophilic β-glu Cleavable Linker Payloads for Superior Efficacy and Safety
Presenter: Krishna Bajjuri, Ph.D.
Date/Time: November 6, 2024, 3:00pm PT

Following the event, the content will be made available in the Clinical/Scientific Presentation and Publication Highlights section of Sutro Biopharma’s website at www.sutrobio.com.