On June 23, 2021 xCures Inc., the leader in the patient-centric use of artificial intelligence (AI) and predictive modeling, reported that it has raised $12.69 million in Series A funding (Press release, xCures, JUN 23, 2021, View Source [SID1234584293]). This investment, led by Boehringer Ingelheim Venture Fund and joined by Vanedge Capital, Harmonix Fund, Metaplanet, as well as other investors, will be used to accelerate adoption and further development of xCures’ AI-Powered platform for precision oncology decision making.

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We’re confident that xCures will continue to develop their platform and work to make a meaningful impact for patients

The xCures platform transforms complex unstructured medical data directly from the patient’s medical records into structured data suitable for analysis and machine learning. The AI engine then actively cross-references this data against a vast digital library of oncology data to match patients with potential treatments and predict outcomes, thereby empowering patients as well as their oncologists to make more informed and effective treatment decisions.

"This new investment enables us to leverage our experience in helping over 1000 patients on our platform to dramatically increase both platform usage and the insights we are generating," stated Mika Newton, CEO of xCures. "Working with the Boehringer Ingelheim Venture Fund and our other investors, we are leading the field of patient-centric research, AI-powered clinical decision support, and prospectively generating regulatory-grade real-world evidence."

xCures has developed the infrastructure and products to directly engage patients and access their raw unstructured medical records from anywhere in the United States. These records are then processed into structured data and stored in a HIPAA and CFR Part 11 compliant system. Patients and their physicians receive a crisp summary of their case in the form of a Cancer Journey. The platform then integrates knowledge and insights from this real-world evidence into xINFORM, providing powerful AI-driven clinical decision support tools. Also, the acquired real-world evidence is helpful for biopharmaceutical companies and payors to accelerate novel therapies and guide the optimization of precision medicine approaches to cancer treatment.

"The Boehringer Ingelheim Venture Fund sees the potential of the xCures platform to provide valuable options for advanced cancer patients, while at the same time, generating real-world evidence that could lead to important therapeutic insights," said Mark Ralph, Executive Director of the Boehringer Ingelheim Venture Fund focused on Digital Health Investments, and who is joining the xCures Board of Directors. "We’re confident that xCures will continue to develop their platform and work to make a meaningful impact for patients."

On June 23, 2021 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, reported that, at the first interim analysis of the three-arm randomized Phase 2 ARC-7 study, both arms with domvanalimab-based combinations showed encouraging clinical activity (measured by overall response rate; ORR) when given as an initial treatment (first-line) to people with metastatic, PD-L1≥50% non-small cell lung cancer (NSCLC) (Press release, Arcus Biosciences, JUN 23, 2021, View Source [SID1234584292]). The zimberelimab monotherapy arm showed activity similar to that of marketed anti-PD-1 antibodies studied by other companies in this setting. At the time of data cut off, no unexpected safety signals were observed; and the current safety profile for each arm of the study appears to be consistent with known immune checkpoint inhibitors in this setting. All three arms of the ARC-7 trial, and the ongoing ARC-10 Phase 3 registrational study, will continue to enroll as planned; and ARC-7 data will be submitted later this year for presentation at a medical conference."

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Our partner Gilead Sciences has an exclusive option to co-develop and co-commercialize domvanalimab and is anticipated to make a decision regarding opting into the anti-TIGIT program later this year. Arcus and Gilead will continue preparations for additional Phase 3 studies of domvanalimab-based combinations and explore development plans for combinations including domvanalimab and etrumadenant.

"This analysis of the dataset for the ongoing ARC-7 study revealed encouraging clinical activity for the anti-TIGIT domvanalimab-based combinations, and furthermore, that the anti-PD-1 zimberelimab monotherapy arm showed activity similar to that of marketed anti-PD-1 antibodies studied in this setting," said Bill Grossman, M.D., Ph.D., Chief Medical Officer of Arcus. "Next steps are to complete enrollment in all our open domvanalimab studies, execute on our broader plans for Phase 3 studies for domvanalimab across multiple cancer types, and further explore combinations with domvanalimab and etrumadenant."

Conference call details

Arcus will host a conference call and live webcast today, Wednesday, June 23, 2021 at 2:00 p.m. Pacific Time/5:00 p.m. Eastern Time to provide an update on its ongoing domvanalimab program. Investors interested in listening to the conference call may do so by dialing (877) 209-6698 in the U.S. or (825) 312-2373 internationally, using Conference ID: 6891607. In addition, the live webcast and accompanying slides will be available on the "Investors" section of the Arcus website at www.arcusbio.com. Following the live webcast, a replay will be available on the Company’s website for approximately 30 days.

About ARC-7 and the domvanalimab Development Program

ARC-7 is an open-label randomized Phase II study evaluating the safety and efficacy of domvanalimab plus zimberelimab (anti-PD1 antibody) vs. zimberelimab alone vs. domvanalimab plus zimberelimab and etrumadenant (dual adenosine A2a/A2b receptor antagonist) in 150 people as a first-line treatment for PD-L1 ≥ 50% and EGFR/ALK wild-type, metastatic NSCLC. Participants are being randomized 1:1:1 across three study arms and treated until disease progression or loss of clinical benefit. Co-primary endpoints are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include safety, duration of response and disease control rates. In this first interim analysis, data were not mature, and PFS was not assessed.

In addition to ARC-7, domvanalimab is currently being evaluated in ARC-10, an ongoing registrational Phase 3 study evaluating domvanalimab plus zimberelimab vs. zimberelimab alone vs. chemotherapy in first-line locally advanced or metastatic, PD-L1>50% NSCLC. Based on the ARC-7 data, additional Phase 3 studies are planned for domvanalimab-based combination across various cancer types.

About domvanalimab and Arcus’ anti-TIGIT program

Domvanalimab, Arcus’ most advanced anti-TIGIT candidate, is an Fc-silent investigational monoclonal antibody that binds to TIGIT, a protein receptor on immune cells that acts as a brake on the immune response. Cancer cells can exploit TIGIT to avoid detection by the immune system. Domvanalimab binds to TIGIT to free up immune activating pathways and activate immune cells to attack and kill cancer cells.

Arcus is developing a second anti-TIGIT candidate, AB308, an Fc-enabled investigational monoclonal antibody in clinical development, with a potential focus on hematological malignancies. AB308 is currently in Phase I studies for advanced malignancies.

On June 23, 2021 BioAffinity Technologies, a privately held biotech company, reported that it will present the Company’s discoveries in the field of cancer diagnostics and therapeutics at the RNA Therapeutics Institute’s 2021 RNA Therapeutics Symposium June 23 – 25, 2021, and the International Conference on Porphyrins and Phthalocyanines (ICPP) June 28 – July 3, 2021 (Press release, BioAffinity Technologies, JUN 23, 2021, View Source [SID1234584291]).

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"The presentation describes the novel mechanism by which the porphyrin TCPP, which is used in bioAffinity Technologies’ non-invasive test for the early detection of lung cancer, is incorporated into cancer cells"

bioAffinity Senior Vice President of Therapeutics, William Bauta, Ph.D., will present "Selective Cancer Cell Killing by Dual siRNA Knockdown of CD320 and LRP2 Receptors" on June 23 at the RNA Therapeutics Institute’s Symposium sponsored by the University of Massachusetts Medical School. Dr. Bauta will discuss how bioAffinity has successfully used RNA interference to knock down expression of two genes that results in killing cancer cells with little or no effect on normal cells. Dr. Bauta’s live presentation will be Wednesday, June 23, from 3:30 p.m. to 4:15 p.m. EDT. A video presentation by bioAffinity Vice President of Research, David Elzi, Ph.D., also will be available throughout the conference for viewing by conference participants.

"bioAffinity’s discovery of a fundamental vulnerability of cancer opens the way to new therapies that kill cancer without harm to normal tissue," Dr. Bauta said. "In particular, bioAffinity’s research shows how the Company has designed and used siRNAs to kill multiple cancers at the cellular level including prostate, lung, breast, brain and skin cancers without harm to normal cells."

"Recent scientific discoveries and their application in medicine related to RNAs has been astonishing, leading to life-saving therapies including the use of mRNA vaccines to eradicate the SARS-Cov-2 virus causing the COVID-19 pandemic," said bioAffinity President and CEO Maria Zannes. "We are honored to be part of the 2021 RNA Symposium that brings together leaders in the field to discuss what the world is witnessing – that RNA can be the future of therapeutics."

Dr. Bauta also will present the poster "Meso-tetra (4-carboMeso-tetra (4-carboxyphenyl) porphyrin (TCPP) is taken up in cancer cells by the CD320 receptor" at the International Conference on Porphyrins and Phthalocyanines (ICPP) ICPP-11 from June 28 through July 3.

"The presentation describes the novel mechanism by which the porphyrin TCPP, which is used in bioAffinity Technologies’ non-invasive test for the early detection of lung cancer, is incorporated into cancer cells," Ms. Zannes said. "Our discoveries have furthered the understanding of TCPP for use in diagnostics, including the Company’s first product, CyPath Lung, a flow cytometry test used to diagnose lung cancer at early stage."

A test validation trial comparing people at high risk for lung cancer to patients with the disease resulted in CyPath Lung sensitivity of 92% and specificity of 87% for individuals with nodules less than 20 mm.

Precision Pathology Services, a CAP/CLIA laboratory in San Antonio, Texas, is completing validation of CyPath Lung as a Laboratory Developed Test for sale to physicians who will order the test for their patients suspected of having lung cancer. Patients collect a sputum sample non-invasively at home and ship the sample overnight to the laboratory where it is analyzed for cell types and populations indicating a tumor in the lung.

"CyPath Lung is a well-balanced, highly accurate test allowing patients to collect their sample in the privacy of their own home," Ms. Zannes said. "Precision Pathology’s commercial validation of the test is going very well and expected to be complete this summer."

On June 23, 2021 Tvardi Therapeutics, Inc. ("Tvardi") a privately held, clinical-stage biopharmaceutical company focused on the development of STAT3 inhibitors, reported that it has closed a $74 million Series B financing (Press release, Tvardi Therapeutics, JUN 23, 2021, View Source [SID1234584290]). The financing was led by new investors Slate Path Capital, Palkon Capital, ArrowMark Partners, and 683 Capital, with continued support and participation by existing investors, including Sporos Bioventures. In conjunction with the financing, Jamie McNab, Partner at Slate Path Capital, will join the Tvardi Board of Directors.

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Proceeds from this financing will be used to advance Tvardi’s product candidates through multiple clinical data readouts in mid-stage trials for cancer and fibrosis. The company’s lead product, TTI-101, is currently being studied in a Phase 1 trial of patients with advanced solid tumors who have failed all lines of therapy. To date, TTI-101 has been well-tolerated and demonstrated multiple durable radiographic objective responses in cancer patients treated with TTI-101 monotherapy.

"We are thrilled to move out of stealth mode and partner with this lineup of long-term institutional investors," said Imran Alibhai, Ph.D., chief executive officer at Tvardi. "With this financing we are positioned to advance the clinical development of our small molecule inhibitors of STAT3 into mid-stage trials as well as grow our team."

Jamie McNab added, "I am excited to join the Board of Directors. Tvardi is the leader in the field of STAT3 biology and has compelling proof of concept clinical data. I look forward to partnering with the management team to advance Tvardi’s mission to develop a new class of breakthrough medicines for cancer, chronic inflammation, and fibrosis."

Keith Flaherty, M.D., a member of Tvardi’s Scientific Advisory Board, Professor of Medicine at Harvard Medical School, and founder of Loxo Oncology and Scorpion Therapeutics said, "STAT3 is a compelling and validated target. Beyond its clinical activity, Tvardi’s lead molecule, TTI-101, has demonstrated direct downregulation of STAT3 in patients. As a physician, I am eager to see the potential of Tvardi’s molecules in diseases of high unmet medical need where STAT3 is a key driver."

On June 23, 2021 Orum Therapeutics, a biotech company pioneering the development of targeted protein degraders to treat cancer, reported the close of a $84 million Series B financing (Press release, Orum Therapeutics, JUN 23, 2021, View Source [SID1234584289]). This includes a previously announced $30 million financing and $54 million in new funds led by IMM Investment and joined by new investors (KDB Investment and Atinum, among others) and existing investors (Intervest and KB Investment, among others). Orum plans to use the proceeds to advance the Company’s lead therapeutic candidates into clinical trials, explore additional payload chemistries to develop additional payloads that modulate the ubiquitin pathway, and other general corporate purposes.

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Orum’s Antibody neoDegrader Conjugate (AnDC) platform is built on novel targeted protein degrader payloads combined with the precise tumor cell delivery mechanisms of antibodies to generate innovative, first-in-class antibody drug conjugates (ADCs) for the treatment of cancer. The company has developed a new class of ADC payloads, called neoDegraders, to specifically degrade intracellular target proteins within cancer cells via the E3 ubiquitin ligase pathway. Conjugated to antibodies, neoDegraders are designed to be delivered specifically to cancer cells and degrade the intracellular target protein and cause tumor cell death.

"AnDCs leverage the strengths of both targeted protein degraders and ADCs while overcoming the limitations of each modality. Advances in ADC therapies have been hampered by a lack of diversity in payloads with a novel mechanism of action to inhibit tumor cell growth, and small molecule degraders do not possess tissue specificity," said Peter U. Park, Ph.D., Chief Scientific Officer of Orum Therapeutics. "The team at Orum has created a unique set of payloads that can target intracellular proteins for degradation. These first-in-class targeted ADC protein degraders have the potential to deliver precise and catalytic tumor-killing action to improve cancer treatment."

The lead therapeutic programs from Orum’s AnDC platform are ORM-5029 for the treatment of solid tumors and ORM-6151 for the treatment of hematological cancers. Each program employs a different antibody drug to specifically deliver Orum’s lead neoDegrader to tumor cells. The company plans to file Investigational New Drug (IND) applications for ORM-5029 and ORM-6151 in 2022 and 2023, respectively.

"We are grateful for the support of our new and returning investors as we continued to pursue our mission of developing new therapeutics to target ‘undruggable’ proteins and help patients with limited treatment options," said Sung Joo Lee, Ph.D., Founder and CEO of Orum Therapeutics. "We believe our AnDC platform overcomes the lack of diversity in ADC payloads and the limitations of current targeted protein degrader technologies. With encouraging preclinical data on our two lead therapeutic candidates, we are excited to use the proceeds to continue to advance our first-in-class tumor-directed targeted protein degraders into the clinic for the treatment of cancer."