On January 202, 2023 : Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, is pleased to reported further details of its HER-Vaxx and CF33 technologies being featured at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium currently being held in San Francisco (Press release, Imugene, JAN 20, 2023, View Source [SID1234626398]).

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The presentation and posters being presented at the event can be downloaded and viewed in full on the Imugene website at View Source

Imugene and its technologies featured in the following sessions:

Oral Abstract Session

HERIZON: A phase 2 study of HER-Vaxx (IMU-131), a HER2-targeting peptide vaccine, plus standard of care chemotherapy in patients with HER2-overexpressing metastatic or advanced gastric/GEJ adenocarcinoma— Overall survival analysis.

In presenting the session Dr Tanuj Chawla outlined the following conclusions:
• HER-Vaxx (IMU-131) + chemotherapy showed a statistically significant 45% overall survival benefit compared to chemotherapy alone (14.0 vs 8.3 months)
• Duration of response was longer in HER-Vaxx + chemotherapy arm over chemotherapy alone arm (30 vs 19 weeks)
• Vaccination with HER-Vaxx induced persistent HER-2 specific antibodies which correlated with clinical response as proof of concept for a first-in-class B Cell Immunotherapy based on HER-2 peptides
• No additive toxicity was seen when HER-Vaxx was administered in combination with chemotherapy
• Exploring alternative HER-Vaxx doses in single arm phase 2 extension study
• The nextHERIZON study (NCT05311176) is currently enrolling (TIP #16 @ASCO GI): HER-Vaxx plus ramucirumab /paclitaxel OR pembrolizumab following progression with trastuzumab treatment in GC

Trials in Progress Poster Session nextHERIZON:

A phase 2 study of HER-Vaxx, a HER2-targeting peptide vaccine, in combination with chemotherapy or pembrolizumab in patients with HER2 metastatic or advanced gastric/gastroesophageal adenocarcinoma that progressed on or after trastuzumab treatment.

Imugene’s CMO Dr Giovanni Selvaggi presented this poster as part of a Trials in Progress Poster Session, outlining an introduction to HER-Vaxx and its clinical programme, the study design, objectives and key eligibility criteria.

Poster Sessions

Development of a novel chimeric oncolytic viral platform, CF33 and its derivatives, for peritoneal-directed CF33-OV treatment of gastric cancer peritoneal carcinomatosis.

Dr Annie Yang from City of Hope presented the following results in this poster session:
•CF33-OVs infects and replicates in a dose dependent manner in both diffuse and intestine subtypes of human GC cell lines without attenuation caused by insertion of human transgenes
•Immunofluorescence imaging showed virus-encoded hNISand anti-PD-L1 antibody expression in CF33-OV-infected GC cells
•CF33-OVs killed a range of GC cell lines in a dose dependent manner
•Flow cytometry confirmed GC cell surface PD-L1 blockade by virus-encoded anti-PD-L1
•In the xenograft model, CF33-hNIS-antiPDL1 (IP; 3x105pfu x 3 doses) significantly reduced peritoneal tumors (p<0.0001), decreased amount of ascites (62.5% PBS vs. 25% CF33-hNIS-antiPDL1) and prolonged animal survival (p<0.01). At day 91, 6/8 mice were alive in the virus-treated group vs.1/8 in the control group.

The poster concluded that CF33-OVs demonstrates robust infection, replication, functional protein delivery and killing of GC in vitro. IP CF33-hNIS-antiPDL1 treatment improves survival of GCPM xenograft mouse models when compared to PBS controls.

Ex vivo oncolytic and immune activity of CF33-hNIS-antiPDL1 against fresh peritoneal cells from patients with gastric cancer with and without peritoneal metastases.

Dr Yanghee Woo from City of Hope presented the following key takeaways from this poster session:
• Oncolytic CF33-hNIS-antiPDL1 virus is effective in infecting and killing fresh human peritoneal cancer cells of GCPM with expression of functional anti-PD-L1 scFv.
•Phase I trial investigating the safety and biologic activity of intraperitoneal CF33-hNIS-antiPDL1 for the treatment of GC patients with peritoneal metastases is planned.The 20th iteration of the annual ASCO (Free ASCO Whitepaper) GI event highlights the latest developments and breakthroughs in the field of gastrointestinal oncology, attended by more than 4,000 scientific figures, clinical researchers, academics, oncologists and medical practitioners from around the world.

On January 19, 2023 BIOASIS TECHNOLOGIES INC. (OTCQB:BIOAF; TSX.V:BTI) (the "Company" or "Bioasis"), a multi-asset rare and orphan disease biopharmaceutical company developing clinical stage programs based on epidermal growth factor and a differentiated, proprietary xB3 platform for delivering therapeutics across the blood-brain barrier ("BBB") and the treatment of central nervous system ("CNS") disorders in areas of high unmet medical need, reported that it has filed its unaudited quarterly financial statements and management’s discussion and analysis for the period ended November 30, 2022 (Press release, Bioasis Technologies, JAN 19, 2023, View Source [SID1234626414]). All are available under the Company’s profile on SEDAR and on the Company’s website at www.bioasis.us/investors/.

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On January 19, 2023 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, reported a global collaboration with Boehringer Ingelheim to develop the company’s tissue-based comprehensive genomic profiling test, FoundationOneCDx, as a companion diagnostic for Boehringer Ingelheim’s investigational MDM2-p53 antagonist, BI 907828, in the United States, Japan and European Union (Press release, Foundation Medicine, JAN 19, 2023, View Source [SID1234626412]).

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BI 907828 is an investigational, oral, small molecule MDM2-p53 antagonist. It is currently being evaluated as monotherapy in Brightline-2 (NCT05512377), an ongoing Phase IIa/IIb, open-label, single-arm, multi-center trial for the treatment of patients with locally advanced or metastatic, MDM2 amplified, TP53 wild-type biliary tract cancer in patients who have progressed on standard of care therapy.

"Biliary tract cancers are rare and aggressive cancers and those impacted have limited treatment options along with poor prognosis," said Francesco di Marco, Senior Vice President, Head of Therapeutic Area Oncology, Boehringer Ingelheim. "At Boehringer Ingelheim, we take a diligent and broad approach in some of the most difficult, but potentially most impactful, areas of cancer. Foundation Medicine’s deep understanding of cancer biology and regulatory process makes them an ideal partner for us as we further investigate the role of the MDM2-p53 pathway in cancer development. Our hope is that through this collaboration, we will be able to address the challenges these patients continue to face."

Comprehensive genomic profiling is emerging as an important tool in the treatment of biliary tract cancer given the rapidly evolving therapeutic landscape in this disease area.1 Foundation Medicine has the only FDA-approved portfolio of comprehensive genomic profiling tests, offering physicians both blood- and tissue-based testing options for detecting genomic alterations that help guide personalized treatment decisions.

"High quality, well-validated genomic testing is critical to identify biliary tract cancer patients with complex alterations like MDM2 amplifications," said Sanket Agrawal, Chief Biopharma Business Officer, Foundation Medicine. "We’re proud to partner with Boehringer Ingelheim as they advance this investigational therapy and if approved, create access to it through companion diagnostic development."

On January 19, 2023 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported that the Company has received an approximately $1.5 million (¥200 million) research service payment from Ono Pharmaceutical Co., Ltd. ("Ono") (Press release, Repare Therapeutics, JAN 19, 2023, View Source [SID1234626410]). The payment reflects achievement of a specified research trigger, under the companies’ 2019 Strategic Partnership Agreement ("Ono Agreement"). Under the terms of the Ono Agreement, Repare is primarily responsible for carrying out research activities for its Polθ program, now known as RP-2119, until the first submission of an IND in the U.S. or Japan. "This reflects an important milestone in our RP-2119 Polθ program, as we undertake our IND-enabling studies and prepare for our previously guided initiation of clinical trials in the summer of 2023," said Kim A. Seth, Chief Business Officer of Repare.

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Ono Strategic Partnership Agreement

In January 2019, Repare entered into an exclusive strategic research, development and commercialization partnership with ONO Pharmaceutical Co., Ltd., for Repare’s small molecule Polθ inhibitor program, now known as RP-2119, in Japan, South Korea, Taiwan, Hong Kong, Macau and ASEAN countries, excluding mainland China. Repare retains all rights to develop and commercialize the products outside the ONO territory, including the US, Canada and EU. Under the terms of the Ono Agreement, Ono paid Repare approximately $8.1 million, comprised of an initial upfront fee and research service payments, and agreed to make additional research service payments upon (i) certain specified research triggers and (ii) the election by Ono to collaborate on the development and commercialization of a proposed product candidate. In October 2021, upon the occurrence of a specified research trigger, Repare became eligible to receive a portion, amounting to ¥100 million ($0.9 million), of the research service payments.

On January 19, 2023 LinKinVax, a clinical-stage biotechnology company specialized in innovative protein-based vaccines, and Gustave Roussy, first leading cancer center in Europe, ranked third Best Cancer Hospital in the world,reported a collaboration to conduct a first-in-human Phase I/IIa clinical trial with CD40HVac, a new therapeutic vaccine candidate against head and neck cancer associated with human papillomavirus (HPV) (Press release, LinKinVax, JAN 19, 2023, View Source [SID1234626409]).

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The objectives of the study (EUCT n° 2022-502930-25-00), sponsored by Gustave Roussy, are to demonstrate the safety and immunogenicity of the CD40HVac vaccine candidate with the Poly-ICLC adjuvant (Hiltonol) against oncogenic HPV in patients with head and neck cancer, and to determine the recommended Phase 2 dose based on the safety profile of the vaccine candidate and its ability to induce immune responses. Several exploratory objectives are also planned to estimate progression-free survival and overall survival.

LinKinVax develops CD40HVac, a therapeutic vaccine for HPV-associated malignancies, based on an innovative technology directly targeting dendritic cells (DC), which play a crucial role in the immune system by stimulating and regulating immune responses. A recent U.S. population-based study conducted by the Centers for Disease Control and Prevention (CDC) showed that 66% of cervical cancers, 55% of vaginal cancers, 79% of anal cancers, and 62% of oropharyngeal cancers are attributable to HPV 16 and 18.

Although many HPV-induced tumors can be cured with modern multidisciplinary treatment approaches, it is important to develop new and effective therapeutic vaccines against HPV-associated malignancies to better address the needs of patients.

Prof. Yves Levy, Chief Medical and Scientific Officer LinKinVax, commented: "This partnership with Gustave Roussy to launch of the first phase 1 study is a crucial step for the development of our CD40HVac vaccine in immuno-oncology. It represents a bridge between basic research and clinical research designed to accelerate innovation for the benefit of patients. Together with Gustave Roussy, we look forward to making what we hope will be a major contribution to the treatment of HPV related cancers".

Dr. Caroline Even, Department of Head and Neck Oncology at Gustave Roussy (Villejuif- Paris) added: "Both Gustave Roussy and LinKinVax place innovation at the heart of a human, scientific and technological revolution in the fight against cancer, thereby responding to the ongoing challenge of giving patients access to the most recent treatment advances. We hope that this first project will be inaugural of a long-standing and synergistic collaboration between LinKinVax and Gustave Roussy"