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Oncology News (April 07 - April 13)

Oncology News (April 07 - April 13)

Geneos Therapeutics - Positive trial data, Apr 7, 2024
Geneos Therapeutics has released positive results from its GT-30 trial, showing promising safety and efficacy data for its personalized cancer vaccine (GNOS-PV02) in combination with pembrolizumab and IL-12 for advanced hepatocellular carcinoma patients. The vaccine demonstrated a significant improvement in response rate compared to historical controls, with confirmed induction of new T cell responses to vaccine-encoded neoantigens in all evaluated patients. These findings highlight the potential of personalized cancer vaccines in treating low tumor mutational burden cancers like HCC.

Full Article: https://www.prnewswire.com/news-releases/geneos-therapeutics-announces-positive-phase-12-data-for-gt-30-trial-of-personalized-therapeutic-cancer-vaccine-302109588.html

TScan Therapeutics - Executive Changes, Apr 8, 2024
TScan Therapeutics appoints Dr. Chrystal U. Louis as Chief Medical Officer, bringing extensive experience in hematology and oncology drug development to advance the company's cancer treatment programs. Dr. Louis succeeds Dr. Debora Barton, who transitions out of her role for personal reasons but will remain an advisor. Dr. Louis's background includes roles at Zentalis Pharmaceuticals, CRISPR Therapeutics, Bristol Myers Squibb, and Celgene, reflecting her expertise in clinical development. Her appointment comes at a crucial phase as TScan strives to deliver impactful therapies to patients.

Full Article: https://ir.tscan.com/news-releases/news-release-details/tscan-therapeutics-appoints-seasoned-hematology-and-oncology/?auth_token=2aba5703-2c15-47d3-8454-aae1810f335b

D3 Bio - Series A Investment, Apr 8, 2024
D3 Bio, a biotech firm focusing on cancer drug development, closes a Series A+ financing round led by Medicxi, with existing investors also participating. The $62M investment will accelerate the development of D3S-001, a promising KRAS G12C inhibitor currently in phase II trials for lung, colorectal, and pancreatic cancers. CEO Dr. George Chen highlights the partnership's importance in advancing breakthrough cancer treatments, while Medicxi's Co-founder Francesco De Rubertis praises D3 Bio's commitment to addressing unmet patient needs.

Full Article: https://www.biospace.com/article/releases/d3-bio-completes-series-a-round-to-advance-innovative-oncology-pipeline/

RenovoRx - Private Placement, Apr 8, 2024
RenovoRx Inc. announces a private placement with accredited investors, securing approximately $11.1 million in gross proceeds. This funding, combined with previous financing, extends RenovoRx's cash runway into 2026. The investment will advance their lead program, the Phase III TIGeR-PaC clinical trial for pancreatic cancer, and support expansion into other cancer indications. The private placement involves issuing common stock, Series A Warrants, and Series B Warrants, with a purchase price of $1.4075 per share. The transaction is expected to close on April 11, 2024.

Full Article: https://www.biospace.com/article/releases/renovorx-announces-11-1-million-at-market-private-placement/

Synthekine - Positive trial data, Apr 9, 2024
Synthekine presented positive initial results for its STK-012 therapy at the AACR Annual Meeting 2024. STK-012, a novel treatment for advanced solid tumors, showed promising safety and efficacy profiles in Phase 1a/1b trials, with notable induction of IFNγ and selective expansion of T cells. Initial data indicate encouraging response rates, including a confirmed partial response in a subject with Stage IV ccRCC, alongside manageable adverse events.

Full Article: https://www.biospace.com/article/releases/synthekine-presents-positive-initial-results-from-phase-1a-1b-clinical-trial-of-%CE%B1-%CE%B2-biased-il-2-stk-012-for-treatment-of-advanced-solid-tumors/

Phanes Therapeutics - FDA Fast Track, Apr 9, 2024
PT217, a bispecific antibody by Phanes Therapeutics, has received FDA fast track designation for treating extensive stage small cell lung cancer (ES-SCLC) post-platinum-based chemotherapy with or without a checkpoint inhibitor. It targets DLL3 and CD47, showing promise in various neuroendocrine cancers and is currently under evaluation in the SKYBRIDGE trial to determine its safety, efficacy, and recommended phase 2 dose. The trial focuses on patients with advanced refractory cancers expressing DLL3, emphasizing assessment of dose-limiting toxicity and overall safety.

Full Article: https://www.onclive.com/view/fda-grants-fast-track-designation-to-pt217-for-extensive-stage-small-cell-lung-cancer

enGene - Executive Changes, Apr 9, 2024
Dr. Raj Pruthi has joined enGene Holdings Inc. as SVP, Urologic Oncology and Clinical Development, to advance EG-70, their lead product candidate for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). With extensive experience in urology and previous leadership roles at Johnson & Johnson Innovative Medicine, Dr. Pruthi's appointment aims to accelerate enGene's clinical development efforts and explore EG-70's potential in additional urologic indications.

Full Article: https://www.prnewswire.com/news-releases/engene-announces-hiring-of-dr-raj-pruthi-as-senior-vice-president-urologic-oncology-and-clinical-development-302111799.html

RAPT Therapeutics - Positive trial data, Apr 9, 2024
RAPT Therapeutics presented promising phase 2 trial data at the American Association for Cancer Research Annual Meeting, demonstrating a 15.6% overall response rate (ORR) in advanced head and neck squamous cell carcinoma (HNSCC) patients treated with tivumecirnon alongside pembrolizumab. Patients with PD-L1 positive disease achieved a 17.4% ORR, while those with HPV positive disease had a 22.2% ORR. This combination therapy aims to enhance antitumor immunity by blocking regulatory T cells. Despite recent stock volatility, RAPT Therapeutics' financials indicate investor confidence, with analysts revising earnings upwards and the company maintaining a favorable cash-to-debt balance.

Full Article: https://www.investing.com/news/company-news/rapt-reports-positive-phase-2-cancer-trial-results-93CH-3371794

Moderna - Stock rising, Apr 9, 2024
Moderna's stock surged by over 6% after announcing positive results from an early trial of its personalized cancer vaccine for head and neck carcinoma, presented at the American Association for Cancer Research Annual Meeting. The study, involving 22 patients receiving Moderna's mRNA-4157 vaccine alongside Merck's Keytruda, showed safety and immune response activation. The vaccine, tailored to each individual's tumor genetic profile, utilizes mRNA to instruct the immune system on fighting cancer. Previous findings also demonstrated its efficacy in reducing the risk of recurrence or death in melanoma patients when combined with Keytruda.

Full Article: https://qz.com/moderna-cancer-vaccine-stock-1851398490

Synthekine - Positive trial data, Apr 10, 2024
STK-012, an α/β biased IL-2 partial agonist, selectively activates CD25+ T cells. Phase Ia trials showed promising efficacy and safety, prompting Phase Ib studies in solid tumors. Treatment-related adverse events were mostly mild. STK-012 demonstrated selectivity for T cells expressing IL-2Rα, inducing IFNγ production while limiting NK cells and Tregs. Three subjects achieved partial responses, and 12 had stable disease. Synthekine anticipates further evaluation.

Full Article: https://www.clinicaltrialsarena.com/news/synthekine-solid-tumour-trial-2/?cf-view

TORL BioTherapeutics - Series B-2 Financing, Apr 10, 2024
TORL BioTherapeutics secures $158 million Series B-2 financing led by Deep Track Capital, with participation from RA Capital Management and Perceptive Advisors. Funds will advance TORL-1-23 for CLDN 6+ tumors, notably in platinum-resistant ovarian cancer, through Phase 1 and pivotal Phase 2 trials starting in late 2024. CEO Mark Alles anticipates significant milestones from their oncology pipeline, supported by confidence in TORL's ADC platform.

Full Article: https://www.prnewswire.com/news-releases/torl-biotherapeutics-announces-158-million-oversubscribed-series-b-2-financing-to-advance-the-clinical-development-of-its-novel-antibody-drug-conjugate-adc-oncology-pipeline-302112553.html

OSE Immunotherapeutics - Grant, Apr 11, 2024
OSE Immunotherapeutics has received €8.4 million in non-dilutive funding under France's "i-Démo" call for projects, supporting their Phase 3 clinical trial of cancer vaccine Tedopi® for non-small cell lung cancer patients with acquired resistance to anti-PD-(L)1 immunotherapy. CEO Nicolas Poirier expressed gratitude for the support, highlighting the acceleration of Tedopi®'s clinical development to address critical medical needs.

Full Article: https://finance.yahoo.com/news/ose-immunotherapeutics-receives-8-4-160000694.html


Candel Therapeutics - FDA Orphan Drug Designation, Apr 11, 2024
Candel Therapeutics' CAN-2409, a leading biological immunotherapy candidate for pancreatic cancer, has received FDA Orphan Drug Designation. CEO Paul Peter Tak lauded the designation, citing phase 2 trial data showing doubled median overall survival when CAN-2409 was added to standard care. Chief Medical Officer Garrett Nichols highlighted its importance in advancing treatments for tough cancers. Recent trial results showed promising survival rates and tolerability, with evidence of tumor microenvironment modification and immune response activation.

Full Article: https://markets.businessinsider.com/news/stocks/candel-therapeutics-receives-fda-orphan-drug-designation-for-can-2409-for-the-treatment-of-pancreatic-cancer-1033241039

Curium - Drug commercialization, Apr 12, 2024
Pylclari, a PET imaging agent distributed by Curium, has made its commercial debut in the Netherlands, following FDA approval in 2021 and European Commission authorization in 2023. Clinical trials demonstrate its effectiveness in detecting PSMA-positive lesions in prostate cancer patients, with minimal adverse events reported. Curium's role in expanding access to this diagnostic tool emphasizes their commitment to improving cancer care across Europe, particularly for prostate cancer patients.

Full Article: https://www.urologytimes.com/view/piflufolastat-18f-enters-commercial-market-in-the-netherlands

D3 Bio - Series A Investment, Apr 12, 2024
On April 8, 2024, D3 Bio, a biotech company focusing on cancer therapies, completed its A+ round financing of USD 62 million led by Medicxi and Matrix Partners. Their flagship product, D3S-001, a KRAS G12C inhibitor, is in global Phase II trials for lung, colorectal, and pancreatic cancers. With previous funding successes, D3 Bio underscores the expanding international presence of Chinese biopharmaceutical firms. These funds will further drive D3S-001's global clinical trials, advancing cancer treatment innovation.

Full Article: https://equalocean.com/news/2024041220767

Agenus Inc. - Positive trial data, Apr 12, 2024
Agenus Inc. reported updated Phase 1 trial results for BOT/BAL combination therapy in metastatic CRC patients without MSS or dMMR. With a 23% ORR and promising OS rates, the median OS reached 21.2 months. Pending FDA meetings, Agenus plans a BLA submission this year and detailed efficacy results presentation in 2024. These findings highlight BOT/BAL's potential in solid tumors.

Full Article: https://www.businesswire.com/news/home/20240412973954/en/Agenus-Announces-Updated-Phase-1-Data-and-Progress-on-BOTBAL-Development-in-Metastatic-MSS-Colorectal-Cancer

Nurix Therapeutics, Inc. - Stock offerings, Apr 12, 2024
Nurix Therapeutics, Inc. has priced an upsized underwritten public offering, including common stock and pre-funded warrants, with gross proceeds expected to reach $175.0 million. Joint book-running managers include J.P. Morgan Securities LLC, Piper Sandler & Co., and Stifel, Nicolaus & Company, Incorporated. The funds will primarily support clinical development, research and development, and general corporate purposes.

Full Article: https://www.biospace.com/article/releases/-nurix-therapeutics-announces-pricing-of-upsized-175-0-million-public-offering/

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