On February 29, 2024 Neobe Therapeutics, a pioneering synthetic biology startup at the forefront of immuno-oncology innovation, reported the successful closure of a $2.34M financing round (Press release, Neobe Therapeutics, FEB 29, 2024, View Source [SID1234646112]).

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This significant financial milestone was achieved with the support of new investors Pioneer Group* (lead) and 2048 Ventures, alongside existing backers Deep Science Ventures*, Cancer Research Horizons*, and Discovery Park Ventures. Additionally. Additionally, the round received a non-dilutive grant award from Innovate UK’s Cancer Therapeutics fund through the Investor Partnership programme.

Neobe has built a synthetic biology platform to engineer safe microbial strains to disrupt the microenvironment of solid tumours, without affecting healthy tissues. These programmable microscopic trojan horses enable immunotherapy responses by breaking down barriers to immune infiltration locally. Since its inception Neobe has successfully engineered two differentiated proprietary products aimed at enabling immunotherapy efficacy in patients with colorectal, pancreatic and breast cancer, with demonstrated pre-clinical efficacy.

Neobe was founded by Pedro Correa de Sampaio and Annelise Soulier in 2021, from a venture creation alliance between Deep Science Ventures and Cancer Research Horizons established to help founder-type scientists build high-impact ventures in oncology, using DSV’s proven approach to ideation-based innovation. Neobe was created specifically to address the key issue of existing barriers created by the local microenvironment of solid tumours which prevent the infiltration of cancer reactive immune cells. This "immune exclusion" is a key contributing factor in why about 80% of patients with solid tumours still do not respond to life changing immunotherapies.

"We are immensely grateful for the continued backing of our existing investors and thrilled to have Pioneer Group and 2048 Ventures join Neobe’s journey", said Pedro Correa de Sampaio, CEO and co-founder of Neobe. "The trust and support of all our investors as well as Innovate UK truly validates our innovative approach, harnessing synthetic biology to build safer and more effective strategies to enable therapeutic efficacy in cancer patients. Our mission continues to be to transform cancer treatment through engineered live biotherapeutics, and with this support, we are one step closer to making that a reality."

""Supporting Neobe in addressing previously untreatable cancers is truly exciting. Their pioneering approach holds immense promise in broadening access to immunotherapies, potentially transforming treatment and importantly preserving life for many patients. We’re honoured to welcome Neobe to our portfolio and recognise the pivotal role they play in advancing this vital mission of making cancer treatment more accessible." " — Imelda Juniarsih, Investment Director at Pioneer Group

"At 2048 Ventures, we look to invest in platform plays that solve huge healthcare challenges. Neobe’s stromal remodeling microbes represent the best application of a synbio platform, which is using biology to engineer life-saving therapies for cancer patients. We are excited to partner with Neobe and join their mission in unlocking immunooncology treatments for all patients."— Julie Wolf, 2048 Ventures

Neobe is on a mission to unlock the full potential of immuno-oncology therapeutics," said Tony Hickson, Chief Business Officer at Cancer Research Horizons. "Since its inception from one of our venture creation programmes, we have been impressed by the entrepreneurial activities of the Neobe team. We are excited to continue to work with Neobe’s innovative team to support the company’s next phase of growth and realize its full potential to deliver much needed therapeutic solutions for patients."

On February 29, 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 the publication in Current Medical Research and Opinion a manuscript detailing a real-world study of the use of the pressure-enabled drug delivery (PEDD) method with the TriNav device for trans-arterial chemoembolization (TACE) and trans-arterial radioembolization (TARE) in patients with hepatocellular carcinoma (HCC) and liver metastases (Press release, TriSalus Life Sciences, FEB 29, 2024, View Source [SID1234640689]).

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The data presented in this study captured real-world safety and clinical outcomes data for TriNav in its launch phase (2020-2022) utilizing a large, 300 million patient dataset covering 98% of US payers. These data provide valuable insights into the important benefits of this technology that would otherwise take many years to accumulate through alternative approaches using clinical trials. Key findings include that TriNav patients, despite a higher baseline disease burden and clinical complexity, showed overall clinical results comparable to patients with lower disease burden. The study also revealed that:

In TACE procedures, interventional radiologists could deliver significantly more chemotherapeutic to the tumor when using TriNav vs. the amount delivered using standard catheters, a critical treatment goal.
In a matched cohort comparison, TriNav patients had fewer 30-day inpatient visits post-procedure than non-TriNav patients.
TriNav HCC patients were more likely to have a post-procedure liver transplant in a matched cohort comparison.
TriNav TARE patients with liver metastases had fewer clinical complications post-procedure vs. non-TriNav patients in a matched cohort comparison.
TriNav TARE patients with liver metastases had lower rates of post-procedure fatigue vs. non-TriNav patients.
These study data clearly demonstrate that TriNav is preferentially selected to treat patients with a higher burden of disease than patients treated with standard catheters, yet these patients show similar results post-treatment compared to patients with a lower disease burden. TriNav patients showed impressive trends toward better outcomes in matched cohort comparisons, including an increased rate of liver transplants. The results also demonstrate how real-world data complement traditional clinical trials to provide a more robust and timely understanding of the benefits realized by patients. TriSalus is committed to updating this data set continuously and affirming the benefit TriNav and the PEDD approach bring to patients, providers, and payers.

"Analyses of real-world data are critical to obtaining a holistic understanding of the benefits of treatment with TriNav. The ability of the PEDD method to impact more complex patients when compared to standard-of-care drug delivery systems is potentially game-changing and brings us closer to addressing the limitations of current treatment options for HCC and other liver cancer patients," said Mary Szela, Chief Executive Officer of TriSalus. "This important, peer-reviewed, real-world study speaks to our commitment to improve patient care and outcomes. These data, together with the recent, new Centers for Medicare and Medicaid (CMS) Healthcare Common Procedure Coding System (HCPCS) code effective as of this year, are a testament to TriNav’s continued emergence as a potentially best-in-class and cost-effective drug delivery method for patients with liver and pancreatic tumors."

"These new population-based findings resonate well with previously published clinical studies that indicate PEDD improves therapeutic uptake, accuracy of therapeutic delivery, and clinical outcomes in liver cancer patients. The ability of the TriNav’s SmartValve to favorably modulate drug delivery pressure and flow within target blood vessels gives liver cancer patients, even those with major medical co-morbidities and large tumor burdens, the opportunity to achieve better outcomes," said Steven C. Katz, M.D., FACS, Chief Medical Officer at TriSalus. "This large sample size study underscores the particular benefits of the TriNav device compared to standard drug delivery systems."

About the TriNav Infusion System

TriNav is a flexible, ultra-thin therapy delivery system with SmartValve technology, a self-expanding, nonocclusive one-way dynamic microvalve that opens and closes in synchrony with the patient’s heart to modulate pressure and flow. This system uses the Pressure-Enabled Drug Delivery approach and has demonstrated the ability to overcome intratumoral pressure in solid tumors and potentially improve distribution and penetration of therapy during Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Radioembolization (TARE) procedures. For more information, please visit www.trinavinfusion.com.

On February 29, 2024 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported that members of its senior management team will participate at two upcoming investor conferences. Details for the presentations are as follows (Press release, Repare Therapeutics, FEB 29, 2024, View Source [SID1234640688]).

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TD Cowen 44th Annual Healthcare Conference
Panel Discussion: Gynecological Cancers
Date: Tuesday, March 5, 2024
Time: 10:30 a.m. Eastern Time
Location: Boston, MA

Bloom Burton 2024 Healthcare Investor Conference
Company Overview
Date: Tuesday, April 16, 2024
Time: 3:30 p.m. Eastern Time
Location: Toronto, ON

A live webcast of the TD Cowen corporate panel discussion and Bloom Burton company overview can be accessed in the Investor section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for at least 30 days.

On February 29, 2024 Indapta Therapeutics, Inc., a privately held biotechnology company developing next-generation differentiated cell therapies for the treatment of cancer and other immune-mediated diseases, reported that the U.S. FDA has granted Fast Track designation for its lead clinical program, IDP-023, for the treatment of patients with non-Hodgkin’s lymphoma and multiple myeloma (Press release, Indapta Therapeutics, FEB 29, 2024, View Source [SID1234640687]).

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The FDA’s Fast Track process is designed to get drugs to patients more quickly by facilitating the development and expediting the review of drugs to treat serious conditions and fill an unmet medical need. Companies granted Fast Track designation may be eligible for more frequent interactions with the FDA, Accelerated Approval and Priority Review, and Rolling Review of a Biologic License Application (BLA).

"This designation highlights the promise of Indapta’s highly potent NK cell platform and will further accelerate clinical development of our lead drug candidate, IDP-023, for two of the largest unmet needs in B-cell driven blood cancers, non-Hodgkin’s lymphoma and multiple myeloma," said Dr. Mark Frohlich, CEO of Indapta.

Patients being enrolled now in Indapta’s Phase 1 clinical trial are receiving up to three planned doses of IDP-023 with or without interleukin-2. Once safety of multiple doses in combination with interleukin-2 has been established, cohorts of patients with lymphoma and multiple myeloma will receive treatment with IDP-023 in combination with the monoclonal antibodies, rituximab and daratumumab, respectively.

Indapta’s Differentiated G-NK Cell Therapy

Indapta’s universal, allogeneic NK cell therapy platform consists of a potent subset of naturally occurring NK cells, known as "G minus" NK cells, or "g-NK" that have markedly greater killing capacity than conventional NK cells, without the need for genetically engineering the cells. G-NK cells arise from epigenetic changes resulting from exposure to cytomegalovirus (CMV). To generate IDP-023, Indapta preferentially expands g-NK cells from healthy donors with increased numbers of g-NK cells, with low donor-to-donor variability.

Indapta’s g-NK are capable of releasing dramatically more immune activating cytokines and cancer-killing compounds than conventional NK cells. In preclinical studies, IDP-023 has demonstrated more potent and durable antitumor activity when combined with cancer targeting monoclonal antibodies as compared to conventional NK cells. (Bigley et al., Blood Advances 2021, View Source)

On February 29, 2024 Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update (Press release, Nuvation Bio, FEB 29, 2024, View Source [SID1234640686]).

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"We are pleased to announce completion of a Phase 1 monotherapy study of NUV-868 and determination of a MTD that will help inform our ongoing Phase 1b combination studies. As we announced in January, we received FDA clearance of our IND application for NUV-1511 and look forward to initiating a Phase 1/2 study for the first clinical candidate from our DDC platform in the first half of this year," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "Nuvation strongly executed across our pipeline of cancer therapies in 2023 and we plan to build on this progress in 2024 as we remain committed to bringing novel and differentiated therapies to patients with the most difficult-to-treat cancers."

Recent Business Updates

NUV-868, BD2-selective BETi: Advanced solid tumors

Phase 1 monotherapy study is complete. Nuvation Bio has completed the Phase 1 monotherapy study in advanced solid tumors and determined the MTD in patients.
Phase 1b combination studies remain ongoing. Nuvation Bio continues to conduct the Phase 1b studies of NUV-868 in combination with olaparib in patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer and other solid tumors, and in combination with enzalutamide in patients with mCRPC.
NUV-1511, Drug-Drug Conjugate Platform: Advanced solid tumors

IND cleared for first clinical candidate, NUV-1511. Nuvation Bio received IND clearance from the FDA for the treatment of patients with various advanced solid tumors and remains on track to dose the first patient in a Phase 1/2 study of NUV-1511 in the first half of 2024.
Corporate Update:

Appointed Dr. Robert Mashal to Board of Directors. Dr. Mashal’s experience as a seasoned pharmaceutical executive and medical oncologist will provide valuable insights.
Fourth Quarter and Full Year 2023 Financial Results

As of December 31, 2023, Nuvation Bio had cash, cash equivalents and marketable securities of $611.2 million.

For the three months ended December 31, 2023, research and development expenses were $15.4 million, compared to $16.9 million for the three months ended December 31, 2022. The decrease was primarily due to a $1.7 million decrease in third-party costs related to research services and manufacturing driven by the termination of the NUV-422 program offset by a $0.2 million increase in personnel-related costs. Research and development expenses for the year ended December 31, 2023 were $71.3 million compared to $87.8 million for the year ended December 31, 2022.

For the three months ended December 31, 2023, general and administrative expenses were $5.5 million, compared to $7.4 million for the three months ended December 31, 2022. The decrease was primarily due to a $1.3 million decrease in personnel-related costs, $0.6 million decrease in insurance, a $0.2 million decrease in professional fees, a $0.1 million decrease in taxes and a $0.1 million decrease in miscellaneous expenses offset by $0.2 million increase in legal fees, and a $0.2 million increase in occupancy. General and administrative expenses for the year ended December 31, 2023 were $28.5 million compared to $31.9 million for the year ended December 31, 2022.

For the three months ended December 31, 2023, Nuvation Bio reported a net loss of $13.8 million, or $(0.06) per share. This compares to a net loss of $20.8 million, or $(0.10) per share, for the comparable period in 2022. Net loss for the year ended December 31, 2023 was $75.8 million compared to $104.2 million for the year ended December 31, 2022.