On March 26, 2024 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next generation oncology therapeutics, reported the closing of an oversubscribed $150 million Series A-1 financing (Press release, Avenzo Therapeutics, MAR 26, 2024, View Source [SID1234641470]). The total capital raised since the company’s founding in August 2022 is $347 million. The financing round includes nine new investors and was led by New Enterprise Associates (NEA), Deep Track Capital, Sofinnova Investments, and Sands Capital, with participation from additional new investors, including INCE Capital, TF Capital, Delos Capital, and Quan Capital. In conjunction with the announcement, Jakob Dupont, M.D., Executive Partner, Private Equity, Sofinnova Investments, will join the Avenzo Board of Directors.

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Proceeds from the financing will be used to advance Avenzo’s emerging oncology pipeline which is led by AVZO-021, a potentially best-in-class cyclin-dependent kinase 2 (CDK2) selective inhibitor being studied in an ongoing U.S.-based Phase 1 clinical study for the treatment of HR+/HER2- metastatic breast cancer and other advanced solid tumors.

"The team at Avenzo has made great progress over the past 18 months since formation on our mission to advance the next generation of oncology therapies for patients," said Athena Countouriotis, M.D., Co-founder, President and CEO of Avenzo. "With the support of our new and existing investors, including OrbiMed, Foresite Capital, SR One, Lilly Asia Ventures and Surveyor Capital (a Citadel company), we are in a strong position to advance our potentially best-in-class CDK2 inhibitor, AVZO-021, expand our pipeline with additional assets, and continue to grow our team."

"We see significant opportunity with AVZO-021 and this team to advance potential best-in-class therapies for some of the most pressing needs in oncology today," said Jakob Dupont, M.D., Executive Partner, Private Equity, Sofinnova Investments. "I have been impressed by the progress Avenzo has made to date and look forward to supporting Athena and the Board as they advance their emerging oncology pipeline and grow their promising company."

Dr. Dupont brings more than two decades of experience in the field of oncology and other therapeutic areas, in developing therapies and programs dedicated to addressing high unmet medical needs. Prior to joining Sofinnova Investments, Dr. Dupont served in key leadership roles at Atara Biotherapeutics, Gossamer Bio, Genentech/Roche and OncoMed Pharmaceuticals, Inc.

On March 26, 2024 TriSalus Life Sciences Inc. (Nasdaq: TLSI), an oncology company integrating its novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, reported that its technology was featured in two oral presentations at the Society of Interventional Radiology Annual Scientific Meeting (Press release, TriSalus Life Sciences, MAR 26, 2024, View Source [SID1234641469]).

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PERIO-03 Phase 1/1b Update

TriSalus is studying an investigational class C toll-like receptor-9 (TLR9) agonist, nelitolimod (formerly SD-101), delivered intravascularly using the Company’s proprietary Pressure-Enabled Drug Delivery (PEDD) method of administration in three Phase 1 trials (periotrial.com). In PERIO-03, nelitolimod is delivered via the PEDD method with the TriSalus Infusion System using a retrograde venous approach, leveraging established interventional radiology access techniques.

Early safety and feasibility data from the PERIO-03 trial for locally advanced pancreatic adenocarcinoma showed technical success in all five patients who had received eight treatment interventions at data cutoff. There were no immediate complications from the procedure, and there was no evidence of hemorrhage or thrombosis. This follows a previous report indicating evidence of encouraging immune signals such as decreases in myeloid derived suppressor cells (MDSC) in the treated pancreatic tumors with evidence of T-cell activation.

PEDD Performance in Hypovascular Solid Tumors

In a retrospective study, investigators from The University of Texas MD Anderson Cancer Center reported on a variety of tumor types, the majority of which were notable for being hypovascular metastases and for which embolization may be clinically challenging. Technical success for embolization using the TriNav microcatheter was 100%. Tumors were treated in the liver (88%), bone (9.4%), and adrenal gland (3.1%). Local tumor progression-free survival rates across organs at one month, six months, and one year were 94%, 80%, and 70%, respectively.

"The data presented at the Society of Interventional Radiology meeting provide further evidence that the Pressure Enabled Drug Delivery method has the potential to improve therapeutic uptake and clinical outcomes at multiple disease sites, including the liver and pancreas. The data, which suggest the PEDD method can address solid tumor delivery challenges, align well with the 2024 outcomes research study from Current Medical Research and Opinion, which provides support for the recently awarded Centers for Medicare & Medicaid Services reimbursement code for procedures involving the TriNav system," said Steven C. Katz, M.D., FACS, Chief Medical Officer at TriSalus.

Both TriSalus presentations from SIR are available here.

About Pressure-Enabled Regional Immuno-Oncology (PERIO) clinical trials The Pressure-Enabled Regional Immuno-Oncology (PERIO) clinical trials are studying an investigational class C toll-like receptor-9 agonist, nelitolimod, delivered intravascularly by TriSalus’ TriNav Infusion System (TriNav) using the Company’s proprietary Pressure-Enabled Drug Delivery (PEDD) method of administration in three Phase 1 trials:

The PERIO-01 Phase 1 clinical study for uveal melanoma with liver metastases (UMLM) is studying nelitolimod delivered via PEDD with TriNav in combination with intravenous checkpoint inhibitors.

The PERIO-02 Phase 1b clinical study for hepatocellular carcinoma and intrahepatic cholangiocarcinoma, is studying nelitolimod delivered via PEDD with TriNav in combination with intravenous checkpoint inhibitors.

The PERIO-03 Phase 1 clinical study for locally advanced pancreatic adenocarcinoma, is studying nelitolimod delivered via PEDD with TriNav in combination with intravenous checkpoint inhibitors.

On March 26, 2024 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that it has entered into definitive agreements for the purchase and sale of an aggregate of 578,643 shares of common stock at a purchase price of $2.295 per share, in a private placement to accredited investors (Press release, MAIA Biotechnology, MAR 26, 2024, View Source [SID1234641467]). Each share of common stock is being offered together with a warrant to purchase one share of common stock at an exercise price of $2.55 per share, which price represents the greater of the book or market value of the stock on the date the definitive agreements were executed (subject to customary adjustments as set forth in the warrants). The warrants are exercisable commencing six months following issuance and have a term of five years from the initial exercise date. The private placement is expected to close on or about March 28, 2024, subject to the satisfaction of customary closing conditions.

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The gross proceeds from the offering are expected to be approximately $1.33 million, prior to offering expenses payable by the Company. The Company intends to use the net proceeds from the offering for to fund research and development activities, such as to fund the first third of the pivotal accelerated approval Part C of the THIO-101 trial in non-small cell lung cancer (NSCLC).

The securities described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On March 26, 2024 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported a new publication validating the company’s NeXT Personal test, an ultra-sensitive, tumor-informed circulating tumor DNA (ctDNA) assay (Press release, Personalis, MAR 26, 2024, View Source [SID1234641466]). NeXT Personal is designed to help detect minimal residual disease (MRD), monitor therapy response, and identify recurrence with high analytical sensitivity and accuracy, enhancing the decision-making process and ultimately improving patient outcomes in the ongoing battle against cancer.

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"The robust validation results in this publication provide a foundational building block towards achieving Medicare coverage for NeXT Personal," said Richard Chen, MD, MS, Chief Medical Officer and Executive Vice President, R&D of Personalis. "We are laser-focused on developing and publishing data to establish NeXT Personal as a leading MRD test."

In the analytical validation study published in Oncotarget, scientists from Personalis evaluated NeXT Personal by testing samples from over 120 patients across nine cancer types and paired tumor and normal cell lines. The NeXT Personal technology leverages whole genome sequencing (WGS) and advanced noise suppression with NeXT SENSE technology to identify a unique genetic signature derived from a patient’s tumor based on up to ~1,800 variants. Through NeXT Personal, a custom panel is created to detect trace amounts of ctDNA from patient blood samples.

The analytical range measurements demonstrated a detection threshold of 1.67 parts per million (PPM) of ctDNA with a LOD95 of 3.45 PPM, highlighting NeXT Personal’s ultra-high analytical sensitivity. Results of the study showed 100% measured analytical specificity, with a confidence interval spanning 99.92 to 100%.

"We designed NeXT Personal to enable another big leap in ctDNA sensitivity and specificity," said Chen. "Taken together, the results show NeXT Personal’s capability for ultra-sensitive detection of ctDNA in patient plasma samples and the test’s potential to reliably inform clinicians and patients on residual cancer, cancer treatment response, and cancer recurrence through ctDNA detection, earlier than conventional detection approaches," Chen noted.

At the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, initial findings showed that NeXT Personal’s significantly improved detection rates could translate into clinical benefit in early-stage lung cancer, including lung adenocarcinoma (LUAD), one of the most common and challenging subtypes of non-small cell lung cancer (NSCLC) to identify in blood samples. This data from the TRACERx Study demonstrated the assay was able to find cancer nearly a year ahead of imaging and was predictive of clinical outcomes in early-stage lung cancer patients.

On March 26, 2024 ImmPACT Bio USA, Inc. ("ImmPACT Bio"), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer and autoimmune diseases, reported that it will participate at the 2024 Cell and Gene Meeting on the Med, to be held from April 9-11, 2024 in Rome, Italy (Press release, ImmPACT-Bio, MAR 26, 2024, View Source [SID1234641465]).

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Sumant Ramachandra, M.D., Ph.D., ImmPACT Bio’s chief executive officer, will provide a company presentation on Tuesday, April 9, 2024 at 12:00 PM CET. Dr. Ramachandra will also participate in an individual presentation and panel discussion entitled, "Advances in Targeting Autoimmune Disease," on Wednesday, April 10, 2024 at 10:45 AM CET.

Virtual attendance is available which includes a livestream of ImmPACT Bio’s presentation and the ability to view all conference sessions on-demand. Please visit View Source for full information including registration.