On May 7, 2024 Massive Bio, Inc. reported that it is set to showcase its pioneering AI technology at the ASCO (Free ASCO Whitepaper) Annual Meeting 2024, highlighting a major leap in patient and physician engagement in cancer care (Press release, Massive Bio, MAY 7, 2024, View Source [SID1234642822]). The company will unveil its latest advancements in the Massive Bio Deep Learning Clinical Trial Matching System (DLCTMS, aka Synergy-AI), an AI platform designed to transform how cancer clinical trials are accessed and managed globally by structuring vast oncological/hematological data and personalizing patient trial matches in real time.

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Selin Kurnaz, PhD, CEO of Massive Bio, states, "At Massive Bio, our mission transcends traditional clinical trial matching. With our AI-driven system, we’re not just facilitating connections; we’re revolutionizing how oncologists/hematologists, patients, and trials interact. Synergy-AI epitomizes our commitment to harnessing cutting-edge technology to expedite R&D and enhance patient care, ensuring that every cancer patient has access to the trials they need, when they need them. With more than 120,000 patients, 5,000 physicians, 40 Pharma and CRO Customers, and 50 Partners, we have been building the largest oncology/hematology network to transform patient recruitment at scale despite the fact that we are just starting to scratch the surface, our ambition is massive."

Dr. Arturo Loaiza-Bonilla, Co-Founder and Chief Medical Officer at Massive Bio, adds, "Our platform does more than just match patients to trials. It integrates predictive analytics and real-time updates, making over 14,000 trials accessible within seconds. This not only maximizes trial enrollment potentials but also significantly cuts down on screen failures, ensuring that patients receive personalized care tailored to their specific conditions and preferences."

Innovative Features and Global Impact:

Real-time, AI-driven Matching: Synergy-AI can analyze and summarize extensive medical records, including biomarker data from multiple sources, to match patients with clinical trials instantly.
Global Accessibility: Deployed via cloud to physician practices and research sites worldwide, including Europe, LATAM, and expanding into APAC, Synergy-AI supports a wide array of international compliance standards such as GDPR, PIPEDA, and HIPAA.
Extensive Collaborative Network: Massive Bio collaborates with top-tier pharma companies, CROs, advocacy groups, and other stakeholders in the healthcare ecosystem to enhance the societal impact of its innovations.
Enhanced Patient and Physician Interfaces: Building on the success of our chatbots Fiona AI and Dr Arturo AI, Massive Bio has further refined these tools to improve interactions, making the user experience more intuitive and supportive.
Invitation to Collaborate: Massive Bio is extending an open invitation to all ASCO (Free ASCO Whitepaper) 2024 attendees to visit booth #29137 to experience firsthand how Synergy-AI can transform their approach to cancer care and clinical trials. "Join us in advancing the future of oncology, where AI empowers more precise, efficient, and patient-centric clinical practices," encourages Dr. Kurnaz.

With its unparalleled technology and comprehensive approach, Massive Bio is not just participating in the market—it’s leading the way to a future where every cancer patient can access personalized, innovative care options, accelerating the journey towards a cure.

On May 7, 2024 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported financial results for the first quarter ended March 31, 2024 and provided a business update (Press release, Janux Therapeutics, MAY 7, 2024, View Source [SID1234642821]).

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"We continue to focus on enrollment in the two clinical studies for PSMA-TRACTr JANX007 and EGFR-TRACTr JANX008, and we are pleased with the progress," said David Campbell, Ph.D., President and CEO of Janux. "As we advance our clinical programs and gather additional clinical data, we are also expanding our pipeline so that we can create further value from our technology platforms and, most importantly, accelerate the development of new meaningful therapies for cancer patients."

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

JANX007 continues to enroll in the first-in-human Phase 1 clinical trial in mCRPC (NCT05519449).
JANX008 continues to enroll in the first-in-human Phase 1 clinical trial in advanced or metastatic solid tumors (NCT05783622).
An update on JANX007 data and doses selected for expansion cohorts is anticipated in the second half of 2024. An update on JANX008 data is expected in 2025.

FIRST QUARTER 2024 FINANCIAL RESULTS:

Cash and cash equivalents and short-term investments: As of March 31, 2024, Janux reported cash and cash equivalents and short-term investments of $651.8 million compared to $344.0 million at December 31, 2023.
Research and development expenses: For the quarter ended March 31, 2024, Janux reported research and development expenses of $14.1 million compared to $15.9 million for the comparable period in 2023.
General and administrative expenses: For the quarter ended March 31, 2024, Janux reported general and administrative expenses of $7.3 million compared to $6.5 million for the comparable period in 2023.
Net loss: For the quarter ended March 31, 2024, Janux reported a net loss of $14.8 million compared to $17.5 million for the comparable period in 2022.
Janux’s TRACTr and TRACIr Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets PSMA and is being investigated in a Phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC). Janux’s second clinical candidate, JANX008, is a TRACTr that targets EGFR and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal cancer, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma. We are also generating a number of additional TRACTr and TRACIr programs for potential future development, some of which are at development candidate stage or later. We are currently assessing priorities in our preclinical pipeline.

On May 7, 2024 AbCellera (Nasdaq: ABCL) reported financial results for the first quarter of 2024 (Press release, AbCellera, MAY 7, 2024, View Source [SID1234642820]). All financial information in this press release is reported in U.S. dollars, unless otherwise indicated.

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"We continue to execute on advancing our internal pipeline, completing capital investments in forward integration, and expanding strategic partnerships," said Carl Hansen, Ph.D., founder and CEO of AbCellera. "This quarter, presentations on our T-cell engager platform, which includes our highly differentiated CD3 panel, demonstrated how we can repeatedly generate TCEs that maximize tumor-cell killing without inducing excessive cytokine release. With our TCE platform in place, we are moving programs towards in vivo studies."

Q1 2024 Business Summary

Announced a new collaboration with Biogen Inc. to discover antibodies for neurological conditions.
Announced a new collaboration with Viking Global Investors and ArrowMark Partners to launch new biotech companies.
Presented new data on its T-cell engager (TCE) programs at the American Association for Cancer Research (AACR) (Free AACR Whitepaper)Ⓡ Annual Meeting 2024 that demonstrate how AbCellera’s TCE platform is able to generate TCEs that achieve potent cell killing with low toxicity associated with cytokine release.
Reported the start of three additional partner-initiated programs with downstreams to reach a cumulative total of 90 partner-initiated program starts with downstreams.
Maintained a cumulative total of 13 molecules advanced to the clinic.
Key Business Metrics

Cumulative Metrics

March 31, 2023

March 31, 2024

Change %

Partner-initiated program starts with downstreams

75

90

20

%

Molecules in the clinic

9

13

44

%

AbCellera started discovery on an additional three partner-initiated programs with downstreams to reach a cumulative total of 90 partner-initiated program starts with downstreams in Q1 2024 (up from 75 on March 31, 2023). AbCellera’s partners have advanced a cumulative total of 13 molecules into the clinic (up from nine on March 31, 2023).

Discussion of Q1 2024 Financial Results

Revenue – Total revenue was $10.0 million, compared to $12.2 million in Q1 2023. Partnerships generated research fees of $9.8 million, compared to $10.6 million in Q1 2023. Licensing revenue was $0.2 million.
Research & Development (R&D) Expenses – R&D expenses were $39.3 million, compared to $52.6 million in Q1 2023, reflecting underlying continued growth in program execution, platform development, and investments in internal programs, partially offset by the non-recurrence of specific one-time investments in co-development and internal programs.
Sales & Marketing (S&M) Expenses – S&M expenses were $3.4 million, compared to $3.8 million in Q1 2023.
General & Administrative (G&A) Expenses – G&A expenses were $17.4 million, compared to $15.1 million in Q1 2023.
Net Loss – Net loss of $40.6 million, or $(0.14) per share on a basic and diluted basis, compared to net loss of $40.1 million, or $(0.14) per share on a basic and diluted basis in Q1 2023.
Liquidity – $725.3 million of total cash, cash equivalents, and marketable securities and with approximately $240 million in available non-dilutive government funding to execute on our strategy, bringing our total available liquidity to just under $1 billion.
Conference Call and Webcast

AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time).

The live webcast of the earnings conference call can be accessed on the Events and Presentations section of AbCellera’s Investor Relations website. A replay of the webcast will be available through the same link following the conference call.

On May 7, 2024 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported its participation in the congress, and two abstract presentations at the AUA 2024: the American Urological Association Annual Congress 2024 was held May 3-6, 2024, in San Antonio, TX, USA (Press release, PhotoCure, MAY 7, 2024, View Source [SID1234642818]). The results of the BRAVO study performed within the VA healthcare system showed significant decreases in the risk of recurrence and progression, as well as the potential for improved overall survival in patients who received a blue light cystoscopy (BLC) compared to patients whose cystoscopy was only performed under white light. Another comparison of BLC with Hexvix/Cysview and white light cystoscopy (WLC), for the detection of bladder cancer using modern HD 4K equipment, was presented in an abstract from the multicenter phase III study of Hexvix in China, including new real world evidence data.

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On Sunday, May 5th, Dr. Sanjay Das presented the study, "Use of Blue Light Cystoscopy Among Non-Muscle Invasive Bladder Cancer Patients and Outcomes in an Equal Access setting: A Propensity Scored Matched Analysis."

The study, known as BRAVO (Bladder Cancer Recurrence Analysis in Veterans and Outcomes), is a retrospective, propensity score matched analysis that evaluated oncologic outcomes following BLC compared to WLC alone in patients from the Veterans Affairs Healthcare System. The study addresses a lack of practical real-world data comparing the impact of BLC versus WLC, specifically for recurrence, progression, and survival. The results of this study confirm that BLC use is associated with positive and statistically significant impacts on these outcomes. The Veterans’ Affairs (VA) Healthcare system accepts all U.S. Veterans, regardless of financial background, and retains its patients, allowing for high-quality data capture over a long-term follow-up period, therefore serving as a robust real-world model for equal access.

626 patients were included in this study, 313 in each study arm (WLC versus BLC). Recurrence and progression data for BRAVO was measured at a 3-year time point. Overall survival follow-up was for 10 years.

Study results include:

Risk of recurrence was significantly lower following BLC (HR 0.60, 95% CI 0.29-0.61) – 40% reduction in risk of recurrence. This confirms data from multiple RCT studies.
Patients who underwent BLC had significantly reduced risk of progression (HR 0.51, 95% CI 0.36-0.99) compared to patients who underwent WLC.
There was improved overall survival among BLC vs. WLC (HR 0.41, 95% CI 0.30-0.72)
Additionally, in the equal-access setting of the VA Healthcare System, benefits of BLC were equitably shared between race/gender.
The Principal Investigator of the BRAVO Study, Dr. Steven Williams, commented: "The results of the BRAVO study performed within the VA healthcare system showed significant decreases in the risk of recurrence and progression, as well as the potential for improved overall survival in patients who received a BLC compared to patients who received WLC only. These findings demonstrate the benefit of BL-enhanced cystoscopy as part of comprehensive care for NMIBC* patients, especially as improved tumor visualization helps to appropriately make determination of intravesical therapy use, such as BCG. The results are encouraging and consistent with prior clinical trial long-term oncological outcomes. It supports the generalizability of prior clinical trial results in the real-world clinical practice setting. The demonstrated impact on overall survival warrants future studies to better understand the oncologic benefit of BLC in NMIBC."

Read the abstract: View Source

On Monday, May 6th, a Poster presentation by Dr. Hailong Hu: Blue Light Cystoscopy versus White Light Cystoscopy for the Detection of Bladder Cancer using modern HD 4K equipment: An Analysis of Pivotal Trial and Real-World Data

This pooled meta-analysis presented data from a randomized clinical trial and a supporting real-world evidence study conducted in China. Both studies enrolled patients with known or suspected bladder cancer. A total of 177 patients were enrolled, 128 patients underwent blue light cystoscopy (BLC) with Cysview (HAL) and were included in the full analysis set. Among patients diagnosed with Ta, T1, or CIS, 46 out of 109 patients (42.2%) had at least one lesion detected by BLC but not by white light cystoscopy (WLC) (p<0.0001). Fifteen patients had CIS of which 12 (80%) showed at least one additional CIS lesions found by BLC but not by WLC. The BLC detection rates for CIS, Ta, T1, and T2-T4 tumors were 95.2%, 100%, 98.3%, and 100%, respectively, while the WLC detection rates were 42.9%, 76.5%, 91.7%, and 100%, respectively.

This study confirms the superiority of HAL BLC over WLC in the detection of bladder cancer even if improved WLC using HD 4K equipment is utilized. In particular, additional high-risk difficult to see CIS lesions have been identified in 80% of CIS patients only by HAL BLC. The quality of resection is still a key cornerstone in the treatment of NMIBC of which BLC remains a crucial part despite the further development of WLC imaging.

Read the abstract: View Source

Beyond this groundbreaking data on BLC/WLC comparison, Photocure provided attendees with hands-on experience in the blue light cystoscopy with Cysview procedure on its congress booth, that featured a Saphira HD equipment tower.

*NMIBC: Non muscle-invasive bladder cancer

On May 7, 2024 Myeloid Therapeutics, Inc. ("Myeloid"), a clinical stage immunology company, reported multiple poster presentations at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 2024 Annual Meeting, taking place May 7 – 11, 2024, in Baltimore, MD and virtually (Press release, Myeloid Therapeutics, MAY 7, 2024, View Source;cell-therapy-asgct-2024-annual-meeting-302137520.html [SID1234642817]).

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"The data presented at ASGCT (Free ASGCT Whitepaper) showcase that Myeloid continues to lead the field of in vivo immune cell engineering and RNA-enabled gene editing and delivery. The data presented today underlies our in vivo mRNA CAR, MT-302, that continues to progress well in the ongoing clinical study. We are expanding plans for MT-302’s clinical use, given several inherent product advantages for patients," said Daniel Getts, Ph.D., Chief Executive Officer of Myeloid. "In addition, our groundbreaking CREATE platform demonstrates a full-scale revolution in gene editing. CREATE provides the ability to deliver large payloads with precision and solely using mRNA, which highlights the broad potential at Myeloid to transform cancer treatments in addition to rare disease indications."

Poster presentation details and abstract highlights include:

Title: "In vivo Programming of Immune Cells Using mRNA-LNP Chimeric Antigen Receptors"
Date & Time: Thursday, May 9, 2024, 12:00 PM-7:00 PM ET
Poster Session: Targeted Gene and Cell Therapy
Location: Poster Session F3
Session Title: Cancer – Targeted Gene and Cell Therapy
Published Abstract Number: 1284

Myeloid has designed novel CARs that achieve expression and function in targeted immune cell populations. These CARs, by activating innate and adaptive immune responses following the in vivo delivery of LNP-formulated mRNA encoded CARs, are capable of eliciting anti-tumor efficacy against a range of multiple target antigens evaluated.
Myeloid has demonstrated CAR activity in human cells, and following systemic mRNA/LNP delivery in mouse and non-human primates.
MT302, an in vivo CAR targeting TROP2+ epithelial malignancies (NCT05969041), is being evaluated in a Phase 1 clinical trial to assess the candidate’s safety and preliminary efficacy.
Title: "CRISPR-Enabled Autonomous Transposable Element (CREATE) for RNA-mediated gene editing and delivery"
Date & Time: Wednesday, May 8, 2024, 12:00 PM-7:00 PM ET
Poster Session: Gene Targeting and Gene Correction New Technologies
Location: Poster Session F3, Exhibit Hall
Session Title: Cancer – Targeted Gene and Cell Therapy
Published Abstract Number: 719

Myeloid developed a proprietary, RNA-based genome editing system called CREATE – CRISPR-Enabled Autonomous Transposable Element, that combines Prime Editing with a DNA transposase to overcome the current limitations of gene delivery technologies.
CREATE merges the capabilities of CRISPR/Cas9 with human L1 retrotransposon to insert gene-sized payloads without DNA donors or double strand breaks.
Mechanistic studies reveal that the CREATE system is highly specific with no observed off-target events.
These data establish CREATE system as a programmable gene delivery platform solely based on RNA components, enabling large-scale in vivo genome engineering with broad therapeutic potential.
More information on ASGCT (Free ASGCT Whitepaper) can be found here. More information on Myeloid’s CREATE platform can be found here.