On October 12, 2023 Independent biopharmaceutical company Specialised Therapeutics Asia Pte Ltd (ST) reported to have signed a license deal with Korea-based CanariaBio Inc., acquiring the exclusive license to a new monoclonal antibody therapy for patients with ovarian cancer in Australia, New Zealand and in select Southeast Asian countries (Press release, Specialised Therapeutics Asia, OCT 12, 2023, View Source [SID1234635897]).

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The therapy, known as oregovomab, is currently in a pivotal phase III international clinical trial known as the FLORA-5 study.2 This investigation is examining oregovomab in combination with chemotherapy agents carboplatin and paclitaxel for patients with advanced ovarian cancer.

Under the terms of the arrangement, ST will be responsible for all commercial, medical, regulatory and distribution activities for oregovomab in its key territories of Australia, New Zealand, Singapore, Thailand, Vietnam, Brunei and Malaysia. CanariaBio will be responsible for the manufacture and supply of oregovomab to ST.

Announcing the partnership, ST Chief Executive Officer Carlo Montagner said he was pleased CanariaBio had selected ST as a partner for this highly promising therapy.

"ST has a portfolio of anti-cancer therapies targeting multiple solid tumours with the exception of ovarian cancer, and now oregovomab becomes our first ovarian cancer agent," Mr Montagner said.

"Despite great advances in recent years, there remains a high unmet need in all our regions to treat this patient population. We look forward to working closely with our new partners at CanariaBio and pending the results of the pivotal Phase III registration study, making oregovomab available to eligible patients."

CanariaBio Chairman and CEO Michael Na said the company had selected ST for its regional expertise and strong track record commercialising oncology products.

"Formalising this agreement is a pivotal moment for our program. This collaboration is more than just a deal – it’s a shared commitment as we develop novel therapies to address unmet medical needs. At CanariaBio, we’ve always believed in the transformative power of partnerships, and teaming up with ST reinforces this belief."

Oregovomab works by targeting and binding specifically to a surface protein known as CA-125 found on the surface of ovarian cancer cells, then activating the patient’s own immune system to respond.3

In the Phase 2 study, the addition of oregovomab to chemotherapy yielded a median progression-free survival of 41.8 months compared with 12.2 months with standard chemotherapy alone (HR, 0.46, P=0.0027). The overall survival hazard ratio was 0.35.1

The Phase 3 FLORA-5 study is fully enrolled and ongoing. Final results are expected in 2025.

On October 12, 2023 SK Biopharmaceuticals, a global biotech focused on the research, development and commercialization of treatments for disorders of the central nervous system (CNS) and oncology, and its U.S. R&D subsidiary, Proteovant Therapeutics, reported data showing that selectively degrading the epigenetic protein p300, with minimal impact on its paralog CBP, results in suppression of androgen receptor signaling and inhibition of tumor growth in a mouse model of androgen receptor (AR) positive prostate cancer (Press release, SK biopharmaceuticals, OCT 12, 2023, View Source [SID1234635896]). Findings are being presented today at the American Association for Cancer Research (AACR) (Free AACR Whitepaper), National Cancer Institute (NCI), and the European Organisation for Research and Treatment (EORTC) AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) being held in Boston.

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The AACR (Free AACR Whitepaper)-NCI-EORTC Conference attracts researchers from around the world to discuss innovations in drug development, target selection, the impact of new discoveries in cellular and molecular biology, and early clinical trials. Today’s presentation is the second in a series of important meetings at which the Proteovant team is sharing research findings that show potential best- and first-in-class protein degraders.

"Although strategies targeting androgen receptor in the treatment of prostate cancer have shown benefits for patients, the reality is that cancer cells ultimately find ways to bypass these therapies, resulting in disease progression," said Zhihua Sui, Ph.D., Chief Scientific Officer of Proteovant Therapeutics. "These data showcase a first-in-class opportunity for therapeutic intervention that suppresses AR signaling through an androgen-independent mechanism."

"We are excited about what our Proteovant team is doing to find novel approaches to treat metastatic castration-resistant prostate cancer," Donghoon Lee, President and CEO of SK Biopharmaceuticals and SK Life Science. "The presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC Conference further demonstrates the value of Proteovant’s work to support our growing pipeline and how it is helping SK Biopharmaceuticals and SK Life Science deliver on our commitment to change the future of CNS and cancer care."

AACR-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper)

Title: Discovery and characterization of a p300-selective degrader demonstrates potent anti-tumor activity in preclinical models of prostate cancer
Presenter: Mike Russell, Ph.D. Director of Biology
Date/Time: Thursday, October 12, 12:30-4:00pm

On October 12, 2023 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported the presentation of preclinical data for FPI-2068, a clinical stage bispecific IgG-based targeted alpha therapy (TAT) designed to deliver actinium-225 to various solid tumors that co-express EGFR-cMET (Press release, Fusion Pharmaceuticals, OCT 12, 2023, View Source,-a-Novel-Targeted-Alpha-Therapy-for-EGFR-cMET-Expressing-Cancers [SID1234635895]). Fusion is jointly developing FPI-2068 with AstraZeneca (LSE/STO/Nasdaq: AZN) under the companies’ multi-asset collaboration agreement. The data are being presented in a poster presentation at the 2023 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), being held October 11-15 in Boston, Massachusetts.

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"We are pleased to share preclinical data demonstrating potent anti-tumor activity and evidence of mechanism of action of FPI-2068. EGFR and cMET are each validated targets, widely expressed in multiple solid tumor types. FPI-2068 combines the potency of an alpha-emitting isotope with the dual antigen targeting capability of the bispecific antibody to deliver a differentiated mechanism of action molecule that we believe has the potential to enhance therapeutic index, said Fusion Pharmaceuticals Chief Scientific Officer Christopher Leamon, Ph.D. "Following the IND clearance obtained earlier this year, we look forward to advancing FPI-2068 into clinical trials given the substantial unmet need for patients with non-small cell lung cancer and other cancer types that are known to co-express EGFR-cMET."

Data from a preclinical study of FPI-2068 are being presented in a poster presentation titled, "FPI-2068: A novel anti-EGFR/cMET, alpha-particle emitting, radioimmunoconjugate for cancer therapy."

In the preclinical study, FPI-2068 demonstrated anti-tumor efficacy in colorectal and lung tumor xenograft mouse models, and single dose administration of FPI-2068 led to prolonged tumor regression. Further, FPI-2068 caused activation of the DNA damage response (DDR) pathway as well as apoptosis, suggesting an inability of the cellular machinery to repair the DNA damage induced by the alpha radiation, consistent with the proposed primary mechanism of action.

These data provide further evidence supporting the clinical development of FPI-2068, which is expected to enter a Phase 1 study for the treatment of solid tumors co-expressing EGFR-cMET. EGFR and cMET are both validated targets that are co-expressed in multiple tumor types, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma.

Copies of the poster presentation can be found at: View Source following the conclusion of the AACR (Free AACR Whitepaper)-NCI-EORTC Annual Meeting.

About FPI-2068

[225Ac]-FPI-2068 (FPI-2068) is a targeted alpha therapy (TAT) designed to deliver actinium-225 to various solid tumors that co-express EGFR and cMET. EGFR and cMET are validated cancer targets that are co-expressed in multiple tumor types, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma.

On October 12, 2023 OmniAb, Inc. (Nasdaq: OABI) reported it will hold a virtual Research & Technology event on Thursday, November 9 beginning at 11:00 a.m. Eastern time (Press release, OmniAb, OCT 12, 2023, View Source;Technology-Virtual-Event-on-November-9/default.aspx [SID1234635894]). The event is expected to last approximately two hours and will include a review of the company’s latest technology offerings and financial results for the three and nine months ended September 30, 2023, which will be announced earlier that morning.

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Matt Foehr, Chief Executive Officer, will be joined by members of OmniAb’s senior management team, with a Q&A session to follow management’s presentations.

The webcast and replay, including audio, video and presentation slides, will be available on the Investors portion of OmniAb’s website. Additional information about speakers and their presentations, as well as instructions about how to participate will be announced at a later date.

On October 12, 2023 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for rare and ultrarare diseases, reported the grant of 80,366 restricted stock units of the company’s common stock and the grant of non-qualified stock options to purchase an aggregate of 140,469 shares of common stock of the company to Howard Horn, its newly appointed Chief Financial Officer and Executive Vice President, Corporate Strategy (Press release, Ultragenyx Pharmaceutical, OCT 12, 2023, View Source [SID1234635893]). The awards were approved by the compensation committee of the company’s board of directors and granted under the Ultragenyx Employment Inducement Plan, as amended, with a grant date of October 9, 2023, as an inducement material to the new employees entering into employment with Ultragenyx in accordance with Nasdaq Listing Rule 5635(c)(4).

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The restricted stock units vest over four years, with 25% of the underlying shares vesting on each anniversary of the grant date, subject to Mr. Horn being continuously employed by the company as of such vesting dates. The stock options vest over four years, with 25% of the shares underlying the option vesting on the first anniversary of the grant date and the remainder vesting with respect to 1/48th of the shares underlying the options on each monthly anniversary thereafter, subject to Mr. Horn being continuously employed by the company as of such vesting dates. The stock options have a ten-year term and an exercise price of $35.68 per share, equal to the per share closing price of Ultragenyx’s common stock on October 9, 2023.