On January 13, 2021 IO Biotech, a clinical-stage biopharmaceutical company developing novel, immune-modulating anti-cancer therapies based on its proprietary T-win technology, reported that it has raised EUR 127 million in Series B financing (Press release, IO Biotech, JAN 13, 2021, View Source [SID1234573924]). The financing round was led by HBM Healthcare Investments, and other new investors joining the round included Vivo Capital, Kurma Partners, Avoro Capital, RA Capital Management, Samsara Biocapital, Idinvest Partners1, PFM Health Sciences, Soleus Capital, Eir Ventures and Serrado Capital, with the participation of existing investors Novo Seeds, Lundbeckfonden Emerge and Sunstone Life Science Ventures. Additionally, Dr. Priyanka Belawat of HBM Partners, Jack B. Nielsen of Vivo Capital and Vanessa Malier of Kurma Partners will join IO Biotech’s board of directors as part of the closing of the financing.

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On December 15, 2020, the U.S. Food and Drug Administration (FDA) granted IO Biotech breakthrough therapy designation for a combination of the potential therapies IO102 and IO103 with anti-PD-1 monoclonal antibodies for patients with unresectable or metastatic melanoma. IO Biotech intends to use the net proceeds of the transaction towards the funding of clinical trials for its early and late-stage immuno-oncology programs, including a large randomized trial for IO102 and IO103 with anti-PD-1 monoclonal antibodies in metastatic melanoma.

"We are excited to have such a strong group of investors backing our company at this stage, and I am proud that this financing round had such high interest and can close oversubscribed," said Mai-Britt Zocca, PhD, Chief Executive Officer, and founder of IO Biotech. "The funding will enable us to execute on our breakthrough therapy designation grant and advance our lead programs in late-stage clinical development, as we are committed to bringing our treatment to patients as soon as possible."

"HBM is excited to be joining IO Biotech as a shareholder. IO Biotech offers a unique treatment modality in oncology, harnessing novel immunomodulatory mechanisms through proprietary vaccine candidates. The financing will help the company bring forward its promising clinical and pre-clinical pipeline closer to the patients in medical need," said Dr. Priyanka Belawat, Investment Advisor at HBM Partners.

"IO Biotech is building a significant immunotherapy pipeline based on compelling scientific and clinical validation. On behalf of existing investors, I warmly welcome the new investors to the company," said Christian Elling, Managing Partner at Lundbeckfonden Emerge. "Together we can accelerate the development of the company’s unique breakthrough cancer medicines to the benefit of patients and physicians."

About IO102 and IO103
IO102 and IO103 are IO Biotech’s lead immuno-oncology candidates. Both compounds are based on IO Biotech’s proprietary T-win technology platform which enables the identification of compounds with a dual mechanism of action targeting and directly killing immunosuppressive cells and tumor cells while indirectly activating other T-effectors, leading to strong anti-tumor responses without adding additional safety concern. Specifically, IO102 and IO103 are first-in-class, immune modulatory vaccines designed to engage and activate IDO and PD-L1 specific human T-cells.

The FDA decision to grant breakthrough therapy designation was based on data from the MM1636 Phase 1/2 clinical trial of 30 patients with metastatic melanoma receiving IO102, IO103 and anti-PD-1 monoclonal antibodies. According to the data recently presented in a late-breaking abstract at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, the combination of IO102 and IO103 vaccines and nivolumab was shown to be safe with encouraging early efficacy data; an overall response rate (ORR) of 79 percent was reached and 45 percent of patients achieved a complete response (CR), or complete disappearance of their tumors. Vaccine specific T-cells were located in the peripheral blood mononuclear cells (PBMCs) and at the tumor site.

On January 13, 2021 Harpoon Therapeutics, Inc. (NASDAQ: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for HPN217 for the treatment of multiple myeloma (Press release, Harpoon Therapeutics, JAN 13, 2021, View Source [SID1234573968]). HPN217, a tri-specific T cell activating recombinant protein construct (TriTAC) targets B-cell maturation antigen (BCMA), a well-validated antigen expressed on malignant multiple myeloma cells. Harpoon has four drug product candidates in clinical development for the treatment of solid and hematologic malignancies based on its proprietary TriTAC platform.

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"Orphan Drug Designation for multiple myeloma represents a significant milestone in the development of HPN217 and recognizes its potential to address a significant unmet medical need for the patients suffering from this condition," said Jerry McMahon, Ph.D., President and Chief Executive of Harpoon Therapeutics. "I am pleased with the clinical progress we are making with this program and we are planning to present interim data from the ongoing Phase 1/2 dose escalation trial later this year."

The FDA’s Orphan Drug Designation program provides orphan status to drugs defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States. Orphan Drug Designation qualifies the sponsor of the drug for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval.

About the Phase 1/2 Trial for HPN217

In April 2020, Harpoon announced dosing of the first patient with HPN217 (BCMA TriTAC) in a Phase 1/2 clinical trial focused on relapsed/refractory multiple myeloma (RRMM). HPN217 is covered by a global development and option agreement with AbbVie Inc. (NYSE: ABBV). Dose escalation for HPN217 in the Phase 1/2 clinical trial is progressing rapidly. HPN217 has been well tolerated, and no DLTs had been observed as of the most recent December 1, 2020 data cutoff date. A presentation of interim data is anticipated in 2021, with initiation of a dose expansion cohort in the second half of 2021.

On January 13, 2021 Strata Oncology, Inc., a precision oncology company advancing molecular indications for cancer therapies, reported plans to begin enrolling the Sentinel Trial in the first half of 2021 (Press release, Strata Oncology, JAN 13, 2021, View Source [SID1234573985]). Sentinel is a prospective, observational study designed to enroll approximately 100,000 patients diagnosed with stage 1-3 solid tumors and indicated for surgery or definitive therapy. The study will evaluate the ability of Strata’s investigational liquid biopsy assay to detect disease recurrence and to monitor treatment effectiveness in patients across solid tumors.

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"The Sentinel Trial will support the validation of our personalized recurrence monitoring assay for patients with solid tumors in a diverse population," said Dan Rhodes, PhD, co-founder and Chief Executive Officer, Strata Oncology. "The study will also evaluate the utility of our approach for guiding treatment decisions in patients with early-stage solid tumors. To date, most advances in precision oncology have been in late-stage cancer. The clinical and molecular information generated in this study has the potential to advance precision cancer care to the early-stage."

The Sentinel Trial will pair simultaneous DNA and RNA tissue-based molecular profiling with liquid biopsy-based recurrence monitoring. Study participants will receive the StrataNGS comprehensive genomic profiling test upfront to identify a personalized mutation profile and a treatment selection profile. Results will inform custom design of a personalized liquid biopsy test to detect tumor-specific genomic alterations with high clinical sensitivity and specificity.

Strata Oncology recently made StrataNGSTM broadly available in the U.S. based on its experience processing more than 40,000 tissue specimens from patients with advanced cancer through the Strata Trial. Recent data showed that the StrataNGS test’s performance on small tumor tissue samples may provide treatment selection results for 50% more patients than other leading tumor profiling tests.

About StrataNGS

StrataNGS is a comprehensive genomic profiling (CGP) test that features the lowest tumor tissue requirements in the industry (>2mm2 surface area). The 429-gene assay is performed on co-isolated RNA and DNA. Single-/multi-nucleotide variants (SNVs), short insertions and deletions (indels), copy number alterations (CNAs; amplifications and deep deletions), microsatellite instability (MSI) status, gene fusions, and tumor mutation burden (TMB) are assessed simultaneously.

On January 13, 2021 Kintara Therapeutics, Inc. (Nasdaq: KTRA) ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that patient recruitment has commenced in the Global Coalition for Adaptive Research (GCAR) registrational Phase 2/3 clinical trial for glioblastoma (GBM) (Press release, Kintara Therapeutics, JAN 13, 2021, View Source [SID1234573969]). The trial, titled GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment), is a revolutionary, patient-centered, adaptive platform trial for registration evaluating multiple therapies for patients with newly-diagnosed and recurrent GBM.

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Key GBM AGILE Highlights for VAL-083

Only therapeutic agent currently being evaluated in all three GBM patient subtypes: newly-diagnosed methylated MGMT; newly-diagnosed unmethylated MGMT; and recurrent
May accelerate VAL-083’s time to pivotal trial completion and potential regulatory submission by up to 18 months
Cost-effective opportunity to advance VAL-083 due to the GBM AGILE study’s expense sharing protocol
Anticipating rapid enrollment, targeting 150-200 patients with 34 active and recruiting U.S. sites with plans to increase to 40 sites during Q1, 2021, including Canada and other international locations to follow
"The entire Kintara team is grateful and excited to participate in GCAR’s groundbreaking GBM AGILE study as it offers an extraordinary opportunity to facilitate the advancement of VAL-083’s clinical development in a premier GBM study," commented Saiid Zarrabian, Kintara’s Chief Executive Officer. "This is truly an important milestone for Kintara as we believe the study will generate important insights into the breadth of VAL-083’s potential to address this deadliest form of brain cancer in all patient subtypes, while potentially bringing the program to the doorstep of commercialization."

GBM AGILE is an international, innovative platform trial designed to more rapidly identify and confirm effective therapies for patients with glioblastoma through response adaptive randomization and a seamless Phase 2/3 design. The trial, conceived by over 130 key opinion leaders, is conducted under a master protocol allowing multiple therapies or combinations of therapies from different pharmaceutical partners to be evaluated simultaneously. With its innovative design and efficient operational infrastructure, data from GBM AGILE can be used as the foundation for a new drug application and biologics license application submissions and registrations to the FDA and other health authorities.

Kintara’s VAL-083 is a "first-in-class," small molecule bifunctional alkylating agent that crosses the blood-brain barrier. VAL-083 is independent of the MGMT resistance mechanism and has been assessed in over 40 Phase 1 and Phase 2 clinical trials in multiple indications sponsored by the U.S. National Cancer Institute (NCI). Published pre-clinical and clinical data indicate that VAL-083 has activity against a range of tumor types, including lung, brain, cervical, ovarian tumors and hematologic (blood) cancers. VAL-083 has been granted Orphan Drug Designation for GBM by the FDA and EMA and has also been granted Orphan Drug Designations for medulloblastoma and ovarian cancer by the FDA. In addition, the FDA granted Fast Track Designation for VAL-083 in recurrent GBM. VAL-083 is approved as a cancer chemotherapeutic in China for the treatment of chronic myelogenous leukemia and lung cancer. VAL-083 has not been approved for any indications outside of China.

On January 13, 2021 Netcapital Inc. (OTC: NCPL) reported it will partner with C-Reveal Therapeutics to advance the company’s patent pending approach to exposing tumors to immune responses and therapies (Press release, C-Reveal Therapeutics, JAN 13, 2021, View Source [SID1234573991]). As an indication of its high conviction in the company, Netcapital Inc. has taken an equity ownership stake in C-Reveal, adding the innovative immuno-oncology drug development company to its portfolio. C-Reveal Therapeutics is currently engaged in a round of equity fundraising via Netcapital. Additionally, C-Reveal will be attending the upcoming BIO Partnering at JPM Virtual conference and meeting with a number of major pharmaceutical firms to facilitate potential strategic partnerships.

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"In 2019, new cancer cases impacted 1.8 million people in the US alone, and that number is growing. C-Reveal’s mission is to leverage a proprietary novel mechanism of action to enable the body’s immune system to attack and kill cancer," said Thomas Haag, Ph.D, J.D., C-Reveal Co-founder. "Our ground-breaking technology originated in Mark Cobbold’s lab at the Harvard Medical School and we are excited to be partnering with veteran precision oncology drug developer Keith Flaherty to bring new treatment options to patients in need."

"Netcapital Advisors immediately recognized the potential of our important work. Their incredible team of former investment professionals and digital marketing specialists provided unique expertise and spent countless hours readying us for our capital raise; their entire team was truly dedicated to our success."

"C-Reveal’s leadership affords extensive experience in oncology research and development as well as a successful track record in building valuable bio-pharma companies," commented Cecilia Lenk, Netcapital Inc.’s CEO. "We’re thrilled to be able to partner with such a high caliber team to help advance C-Reveal’s innovative approach to increasing the efficacy of immune therapies in the treatment of cancer."