On April 30, 2024 TriSalus Life Sciences Inc., (Nasdaq: TLSI), reported the closing of a debt financing facility for up to $50 million with OrbiMed, a healthcare investment firm (Press release, TriSalus Life Sciences, APR 30, 2024, View Source [SID1234642486]). The capital is expected to provide financial flexibility to support the execution of strategic expansion plans and fuel continued growth.

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Under the terms of the Credit Agreement (the "Credit Agreement") with OrbiMed, the Company borrowed $25 million at closing. In addition, an aggregate of up to an additional $25 million is available in two tranches at the Company’s option, based on the achievement of certain revenue thresholds. The Credit Agreement has a five-year term that matures in April 2029. In connection with the funding of the closing amount, the Company also issued OrbiMed a warrant to purchase 130,805 shares of the Company’s common stock, with an exercise price of $9.5562. Including the full funding in the Credit Agreement and current cash and cash equivalents on hand, the Company expects its cash runway will extend through 2025.

"We are excited to be partnering with OrbiMed," said Mary Szela, Chief Executive Officer of TriSalus Life Sciences. "This transaction provides us with the needed capital to execute strategic growth initiatives for TriNav, our Pressure Enabled Drug Delivery (PEDD) technology, which increases delivery of therapeutics in liver and pancreatic tumors. Additionally, this funding allows us to advance our technology pipeline as we continue to transform our business. We believe this financing provides us sufficient capital to reach break-even EBITDA for our TriNav business in 2025 and reduces the near-term need of equity financing."

Matthew Rizzo, General Partner of OrbiMed, added, "We are excited to support TriSalus Life Sciences as they pursue their strategic objectives, providing them with the necessary capital for financial flexibility, and enabling TriNav commercial and technology pipeline expansion."

TriSalus Life Sciences was represented in this transaction by Cantor Fitzgerald & Co., who served as sole placement agent and Cooley LLP, who served as legal counsel. OrbiMed was represented in this transaction by Covington & Burling LLP, who served as legal counsel.

On April 30, 2024 Medivir reported preparations for the planned phase 2b study continue according to plan after the completed Type C meeting with the FDA, strengthened by the fact that the median time to progression with fostrox + Lenvima increased to 7 months (Press release, Medivir, APR 30, 2024, View Source;interim-report-january–march-2024-302131228.html [SID1234642485]).

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January – March

Financial summary for the quarter

Net turnover amounted to SEK 0.5 (0.4) million.
The loss before interest, tax, depreciation and amortization (EBITDA) amounted to SEK -26.7 (-18.9) million. Basic and diluted earnings per share amounted to SEK -0.23 (-0.34) and SEK -0.23 (-0.34) respectively.
Cash flow from operating activities amounted to SEK -35.0 (-16.1) million.
Cash and cash equivalents at the end of the period amounted to SEK 153.4 (100.8) million
Significant events during the quarter

In January Tango Therapeutics announced that it has dosed the first patient with TNG348, a new USP1-inhibitor from the preclinical USP1 program in-licensed from Medivir in 2020.
Positive results from the ongoing phase 1b/2a study in advanced liver cancer (HCC) showing further improved response and time to progression were presented at the ASCO (Free ASCO Whitepaper) GI Symposium in San Francisco.
In January, a directed issue to Hallberg Management AB was carried out amounting to approximately SEK 20 million before deduction of issuance costs.
In February, a change in Medivir’s nomination committee announced as Anders Hallberg, appointed by Healthinvest Partners, leaves the nomination committee and is replaced by Stefan Bengtsson, appointed by CA Fastigheter AB.
Events after the end of the period

In April it was announced that Medivir’s partner Vetbiolix, a veterinary biotechnology company based in France, reported positive results from a proof-of-concept clinical trial in canine periodontitis with its drug candidate VBX-1000, formerly known as MIV-701.
In April it was announced that Medivir has completed a so-called Type C meeting with the FDA and that the company’s preparations for the planned phase 2b study are continuing as planned, with a couple of adjustments in study design with limited impact on the timeline and size of the study.
In April MIV-711 was granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation (ODD) from the FDA for the treatment of Legg-Calvé-Perthes disease (LCPD), an uncommon hip disorder affecting children aged 2-12 years.
Conference call for investors, analysts and the media

The Interim Report January – March 2024 will be presented by Medivir’s CEO, Jens Lindberg.

Time: Tuesday, April 30, 2024, at 10.00 (CET).

To access the webcast and find information about the teleconference, please click HERE!

The conference call will also be streamed via a link on the website: www.medivir.com/investors/calendar

The presentation will be available on Medivir’s website after completion of the conference.

On April 30, 2024 Infinitopes Precision Immunomics, an integrated cancer biotech combining world leading platforms in precision antigen discovery with vaccine vectors capable of durably stimulating protective immune responses, reported the completion of a £12.8m seed funding round led by Octopus Ventures (Press release, Infinitopes, APR 30, 2024, View Source [SID1234642484]). The round was heavily oversubscribed, also drawing in funds from Cancer Research Horizons, Cancer Research Institute, CRIS Cancer Foundation, Kindred Capital, Manta Ray, Martlet Capital, Meltwind Advisory, Saras Capital, Wilbe Capital, and expert angel investors. The total funds raised combine new equity investment and a prestigious non-dilutive award from Innovate UK’s Future Economy Investor Partnership scheme.

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Right targets, right vectors, right patients, right time

Since incorporation in 2021, Infinitopes has moved swiftly to cement its leadership position in cancer vaccines by overcoming three key challenges in the field. Firstly, using its Precision ImmunomicsTM antigen discovery technologies, the Company can identify and rank tumour signatures, without prior bias, enabling the accurate selection of novel, synergistic tumour targets. Secondly, Infinitopes continues to develop safe and effective, proprietary vector delivery systems, capable of stimulating durable T-cell responses necessary to prevent the recurrence of life-threatening cancer metastases. Finally, the Company leverages its deep knowledge of immunology, partnering with disease KOLs, in order to optimally schedule therapies to drive maximal protection for patients.

Lead phase I/IIa on schedule to begin this autumn

Infinitopes’ lead asset, a novel cancer vaccine called ITOP1, is scheduled to commence a phase I/IIa study in first line cancer patients in the third quarter of 2024. This rapid transition into the clinic has become possible after receiving an Innovative Licensing & Access Pathway (ILAP) innovation passport from the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) in August 2022.

Best-in-class antigen discovery

The new investment accelerates the installation of best in class, next generation LC-MS/MS mass spectrometer equipment, enhancing the company’s proprietary tumour antigen discovery and computational immunobiology/AI/machine learning techniques, to identify and rank the best target combinations, to treat five more cancers.

Supported by Cancer Research UK

Infinitopes is a Cancer Research UK (CRUK)-led spinout from Oxford University, combining underlying technologies, know-how, patents and licenses that were developed with CRUK funding across the laboratories of Professor Paul Klenerman and Associate Professor Nicola Ternette, and clinical programmes led by Professor Mark Middleton.

Jonathan Kwok, CEO and co-founder of Infinitopes said:

"Since founding in September 2021, Infinitopes has established world leading capabilities to design, develop, and clinically evaluate an exciting new class of precision targeted, durable cancer vaccines. Our therapies are emerging at a time when blockbuster checkpoint inhibitors are hitting their peak, capable of preventing tumour recurrence in 30-40 per cent of patients at best. Our preclinical results suggest that our vaccines may significantly outperform them, to transform care for future cancer patients. We’re excited to announce this fundraise, which enables us to pursue our uniquely integrated strategy of selecting the right targets, with the right vectors, for the right patients, at the right time in their treatment journey. We continue to seek academic and Big Pharma collaborators, smart technical investors, and passionate new hires and interns to join our mission to cure cancer."

Phil Masterson, Associate Director, Cancer Research Horizons commented:

"Infinitopes is at the forefront of the cancer vaccine revolution emerging from Covid-era technology advances. Cancer Research Horizons’ investment strategy focuses on maximising patient impact – Infinitopes is empowering the immune system to fight the cancer metastases that cause 70 to 90 percent of cancer deaths through better targeting, better delivery mechanisms and better clinical trials. We are delighted to support the building of a leading company based on innovative CRUK-funded foundational science."

Hugo Villanueva, Octopus Ventures, said:

"At Octopus Ventures, we back the entrepreneurs who are revitalising healthcare. The Infinitopes team is a great example of this ─ their work to design, develop and clinically assess novel cancer vaccines is incredibly important, and we’re delighted to support them in their work to combat cancer."

John W Cassidy, General Partner, Kindred Capital, added:

"At Kindred, we don’t just invest; we partner with trailblazers who reimagine the future. Infinitopes exemplifies this spirit, weaving together scientific acumen with technological foresight to architect the next frontier in cancer care. This significant funding milestone underscores our collective commitment to empower healthcare innovation that promises not only to challenge the current paradigms but to redefine them. Infinitopes is charting a bold course towards a world where cancer is no longer a formidable foe but a conquerable condition. We are delighted to support them in this mission."

Julia Schrameier, Investor at Manta Ray, added:

"Our initial investment in Infinitopes in December 2022 was driven by our strong conviction that they were the right team at the right time to create a leading computational, proteomics-driven antigen discovery platform. Their focus on accessible, non-personalised treatments, combined with the team’s deep scientific expertise and remarkable track record, distinctly set them apart from other companies in the space. After observing their impressive progress and growth over the past year, our conviction has only strengthened. Working with Jonathan and his team has been remarkable, and we are excited to follow our initial investment and continue supporting Infinitopes on its journey to cure cancer, one epitope at a time."

Infinitopes presented at the 8th Immuno Oncology Europe (London, April 23-25) and Immuno’24 (London, April 25-26) last week, and will attend the 7th European Neoantigen Summit (Amsterdam, April 29-May 1), and BioEquity (San Sebastián, May 12-14).

On April 30, 2024 Jacobio Pharma (1167.HK) reported that the data from the Phase II registrational study of the KRAS G12C inhibitor glecirasib were offically reported at the April ASCO (Free ASCO Whitepaper) Plenary Series, which was held online (Press release, Jacobio Pharmaceuticals, APR 30, 2024, View Source [SID1234642483]).

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Prof. Yuankai Shi, chief physician of Cancer Hospital Chinese Academy of Medical Sciences, the lead principal investigator of this clinical trial, presented the data in the form of an online oral presentation (Abstract 468214).

The efficacy data showed that among second-line non-small cell lung cancer patients receiving monotherapy treatment, the confirmed objective response rate (cORR) was 47.9% (56/117), including 4 patients achieved a complete response (CR) and 36 patients with tumor reduction exceeding 50%. Disease control rate (DCR) was 86.3%.

The median progression-free survival (mPFS) was 8.2 months, and median overall survival (mOS) was 13.6 months. The median duration of response (mDoR) has not been reached:6-month and 12-month DOR rates were 73.6% and 56.6%, respectively.

Safety data showed that glecirasib has a manageable safety profile. No grade 5 treatment related adverse event (TRAE) was observed, and only 5.0% of patients discontinued the treatment due to TRAEs. Gleciasib has a favorable gastrointestinal (GI) profile compared to other KRAS G12C inhibitors.

"If glecirasib can match or even bypass current efficacy data with an overall improved side effect profile, this agent would be an attractive treatment option." commented Julia Rotow, MD, of the Dana-Farber Cancer Institute, who critiqued the glecirasib findings. She said that the unique toxicity profile of glecirasib may offer the potential for combination with agents that cannot be readily combined with other existing KRAS G12C inhibitors due to overlapping toxicities.

"The trend in the treatment of lung cancer is to reduce the use of chemotherapy. Currently, for lung cancer patients harboring the KRAS G12C mutation who fail first-line treatment, chemotherapy such as docetaxel is the main second-line treatment in China. The ORR is 14%, mPFS is 3.0 months, and OS is 9.1 months. Existing clinical data show that glecirasib is more effective and safer than chemotherapy and is expected to bring more treatment options to patients." Said Prof. Yuankai Shi.

About Glecirasib

Glecirasib is a KRAS G12C inhibitor developed by Jacobio. A number of Phase I/II clinical trials of glecirasib are currently ongoing in China, the United States and Europe for patients with advanced solid tumors harboring KRAS G12C mutation. These include a pivotal clinical trial in NSCLC in China; a monotherapy study for STK11 co-mutated NSCLC in the front-line setting, and combination therapy trials with SHP2 inhibitor JAB-3312 in NSCLC and with Cetuximab in colorectal cancer. The pancreatic cancer indication has obtained orphan drug designation in the United States and breakthrough therapy designation in China.

On April 30, 2024 Caris Life Sciences(Caris), the leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition using molecular science and AI, and COTA, Inc. (COTA), an oncology real-world data (RWD) and analytics company used by the world’s leading pharmaceutical companies, reported a collaboration to expand their multi-modal data offerings to support and accelerate biopharmaceutical drug development and patient care (Press release, Caris Life Sciences, APR 30, 2024, View Source [SID1234642482]).

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The combination of the breadth and depth of Caris’ genomic, transcriptomic, proteomic and imaging data and COTA’s high-quality curated clinical data that captures the treatment journeys and outcomes of cancer patients will result in a broad real-world, multi-modal data offering, at scale, to power the next wave of cancer therapeutics.

"Caris’ partnership with COTA will enable biopharma to leverage a more complete dataset to power research and AI approaches for therapeutic development. This breadth of data allows the flexibility to build specific cohorts for understanding mechanisms of resistance, determinants of response and relevant biomarkers to improve success of their clinical trials," said Brian Lamon, PhD, Chief Business Officer at Caris.

As the pioneer in precision medicine and molecular profiling, Caris has created a molecular-rich, multi-modal database generated from nearly 10 million tests that contains more than 60 petabytes of oncology-specific genomic, transcriptomic, proteomic and imaging data. Caris was the first in the molecular diagnostic industry to provide Whole Exome Sequencing (WES) DNA coverage and Whole Transcriptome Sequencing (WTS) RNA coverage for every viable sample.

"By combining COTA’s high-quality, curated data sourced from electronic health records with Caris’ molecular data, life sciences researchers will be able to capture previously unseen insights to optimize cancer treatments that can improve a patient’s prognosis and quality of life," said C.K. Wang, MD, Chief Medical Officer at COTA.

COTA’s data includes more than two million cancer patients who have received treatment across 200 sites of care in both academic medical centers and community practices in rural and urban settings, providing a powerful representative picture of cancer care across the U.S. COTA synthesizes those records into data that life sciences companies use to develop better, more personalized cancer treatments.