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.

On October 12, 2023 Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported dosing of the first participant in Part 3 of its Phase 1 clinical trial of sudocetaxel zendusortide in patients with advanced ovarian cancer (Press release, Theratechnologies, OCT 12, 2023, View Source [SID1234635892]). Sudocetaxel zendusortide is an investigational, first-in-class peptide-drug conjugate (PDC) that targets the sortilin (SORT1) receptor and expedites the internalization and delivery of a cytotoxic payload directly into cancer cells.

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"We are excited to dose the first of six patients in Part 3 of the Phase 1 trial of sudocetaxel zendusortide with its modified design and dosing regimen," said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies. "We look forward to building on the efficacy we’ve observed so far, which is mainly long-term disease stabilization in a number of advanced patients. This first-patient-dosed milestone, thus extends the momentum of our oncology clinical development program."

"Patients with chemo-resistant ovarian cancer are in dire need of effective treatment options," said Ira Winer, M.D., Ph.D., FACOG, Gynecologic Oncology and Phase I multidisciplinary member at Karmanos Cancer Center and trial investigator. "Based on promising preliminary data during the first parts of the Phase 1 trial for sudocetaxel zendusortide, I hope to see both improved tolerability and continued benefit in this patient population as the trial moves onto this next phase."

The announcement follows U.S. Food and Drug Administration (FDA) acceptance on June 2, 2023 of the Company’s amended protocol for the Phase 1 trial. The revised protocol is designed to improve the therapeutic window of sudocetaxel zendusortide and extend its duration of therapy. It includes weekly administration and also narrows the patient population to focus on individuals with high-grade serous ovarian cancer, including high-grade peritoneal or fallopian tube cancer, or high-grade endometrioid cancer – a population in which sudocetaxel zendusortide has demonstrated preliminary efficacy. After establishing the safety of the initial dose in the first six patients, the study aims to enroll a total of 16 patients in Part 3.

Enrollment of the first patient in Part 3 of the trial follows closely upon demonstration of antitumor activity in Parts 1 and 2, as presented at the 2023 annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). Details about the study design, participation criteria and contact information for the five U.S. sites simultaneously enrolling patients can be found at: View Source

About Sudocetaxel Zendusortide (TH1902) and SORT1+ Technology

Sudocetaxel zendusortide is a first-of-its-kind sortilin- (SORT1) targeting PDC, and the first compound to emerge from the SORT1+ TechnologyTM platform. A new chemical entity, sudocetaxel zendusortide employs a cleavable linker to conjugate (attach) a proprietary peptide to docetaxel, a well-established cytotoxic chemotherapeutic agent used to treat many cancers. The FDA granted Fast Track designation to sudocetaxel zendusortide as a single agent for the treatment of all sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy. Sudocetaxel zendusortide is currently being evaluated in a Phase 1 clinical trial.

Theratechnologies has established its SORT1+ TechnologyTM platform as an engine for the development of proprietary PDCs that target SORT1 receptor, which is expressed in multiple tumor types. SORT1 is a "scavenger" receptor that plays a significant role in protein internalization, sorting, and trafficking. Expression of SORT1 is associated with aggressive disease, poor prognosis, and decreased survival. It is estimated that SORT1 is expressed in 40% to 90% of endometrial, ovarian, colorectal, triple-negative breast (TNBC), and pancreatic cancers, making this receptor an attractive target for anticancer drug development.

On October 12, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported an update on its Phase 3 open-label registrational clinical trial (the REGAL study) for galinpepimut-S (GPS) in patients with acute myeloid leukemia (AML) who have achieved complete remission following second-line salvage therapy (CR2 patients) (Press release, Sellas Life Sciences, OCT 12, 2023, View Source [SID1234635891]).

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The Company expects to complete enrollment in the REGAL study, other than the 20-25 patients anticipated to be enrolled in China, in November 2023. The number of patients needed for the pre-specified interim and final analyses have already been enrolled. The interim analysis (after 60 events) is on track to occur in late 2023 or early 2024 and the final analysis (after 80 events) is on track to occur by the end of 2024. Because these analyses are event driven, they may occur at a different time than currently expected.

The Company anticipates that 3D Medicines Inc. (3D Medicines), its commercialization partner for GPS in Greater China, will begin enrolling patients in China in the REGAL study in the fourth quarter of 2023 which will trigger two development milestone payments totaling $13.0 million. The Company and 3D Medicines had previously projected that enrollment in China would commence in the third quarter of 2023, however, unforeseen supply-chain delays in China impacted the projected timeline. 3D Medicines has successfully obtained all regulatory permits, recruited investigators, and set up an expansive network of 11 treatment centers across China for participation in the REGAL study.

The next meeting of the Independent Data Monitoring Committee for the REGAL study is scheduled for the end of November 2023.

"We are pleased to be so close to achieving this most important milestone – the completion of enrollment in the REGAL study – and, at the same time, it is important to note that we already have a sufficient number of patients enrolled for the pre-specified analyses," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "Furthermore, 3D Medicines’ enthusiasm for the REGAL study remains high. We expect the first patient dosing in China to take place this quarter which will trigger the milestone payment, and we are exploring options to potentially expedite the payment. Importantly, adding approximately 25 patients from China could potentially facilitate drug approval in this significant market, assuming positive data, further yielding additional milestone payments and royalties for SELLAS."