On March 8, 2024 Nerviano Medical Sciences S.r.l. (NMS), a member of NMS Group S.p.A and a clinical stage biotech discovering and developing innovative therapies for the treatment of cancer, reported its participation to the World ADC 2024 summit that will be held in London, UK (World ADC Europe) from March 12th to March 15th, 2024, with a poster presentation entitled (Press release, Nerviano Medical Sciences, MAR 8, 2024, View Source [SID1234640967]):

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"A payload-linker generating machine to quickly move from small molecules to characterized tool ADCs and PDCs"

NMS, leveraging on its proprietary chemical collection and applying a rigorous screening funnel, generated a portfolio of characterized payload linkers with diversified MoAs to target different tumor types.

Pillars of available technology are: 1) NMS-P945, a ‘plug-and-play’ thienoduocarmycin, active in chemoresistant cells, showing bystander effect and immunogenic cell death properties, highly efficacious in vivo in preclinical models and greater nonclinical safety profile, 2) next generation anthracycline payload linkers with improved stability and safety profile, both DNA damaging agents, 3) novel payloads.

NMS seek for collaborations with partners having an established expertise in biologics to launch new innovative projects.

On March 8, 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 fourth quarter and full year ended December 31, 2023, and provided a business update (Press release, Janux Therapeutics, MAR 8, 2024, View Source [SID1234640966]).

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"2023 was a critical year for Janux as we tested the potential power of our TRACTr platform in the clinic. We believe the data recently presented from both of our clinical programs displays the profound impact we can have on patients through our tumor-activated approach. We are excited to be helping cancer patients who need novel therapies and with our substantial cash runway we feel well-positioned to execute on our clinical plan," said David Campbell, Ph.D., President and CEO of Janux.

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

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Presented positive updated interim Phase 1 clinical trial data for PSMA-TRACTr JANX007 in prostate cancer in February 2024. As of February 12, 2024:
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Increasing depth of PSA declines and RECIST responses at higher doses were observed, while a favorable safety profile was maintained.
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83% (5/6) of subjects achieved PSA50 declines with first step dose ≥ 0.2mg.
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56% (10/18) of subjects achieved PSA50 declines with first dose ≥ 0.1mg.
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No CRS > Grade 2 observed in heavily pre-treated late stage mCRPC population.
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Majority of non-CRS treatment-related adverse events (TRAEs) were Grade 1 or 2.
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Low incidence of Grade 3 TRAEs, and no Grade 4 or 5 events were observed.
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JANX007 has been administered at doses up to 3mg, significantly exceeding the anticipated maximum tolerable dose for the parental T cell engager, while the maximum tolerable dose for the TRACTr has not yet been established.

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Also presented positive interim Phase 1 clinical trial data for EGFR-TRACTr JANX008 in solid tumors. As of February 12, 2024:
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A subject with NSCLC achieved a RECIST PR maintained through 18-weeks with 100% target lung lesion reduction and elimination of liver metastasis with no CRS or TRAEs.
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No CRS greater than Grade 1 observed in any cohort.
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Majority of non-CRS TRAEs were Grade 1 or 2.
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No treatment related SAEs or DLTs have been observed.
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Net proceeds of approximately $320.2 million (after deducting underwriting discounts, commissions and other estimated offering expenses) raised in an underwritten offering of common stock and pre-funded warrants in March 2024.

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Janux plans to deploy these funds to expand development of clinical programs, advance additional preclinical programs and extend corporate runway.

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JANX007 continues to enroll in the first-in-human Phase 1 clinical trial in mCRPC (NCT05519449).

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JANX008 continues to enroll in the first-in-human Phase 1 clinical trial in advanced or metastatic solid tumors (NCT05783622).

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Co-founder Dr. Tommy DiRaimondo promoted to Chief Scientific Officer. Tommy was instrumental in successfully transitioning Janux’s PSMA-TRACTr and EGFR-TRACTr programs from research into clinical trials. Tommy continues to manage the internal and external research operations and plays an integral role in managing the IP, discovery, creation, optimization and expansion of Janux’s preclinical pipeline.

An update on JANX007 data and doses selected for expansion cohorts is anticipated in the second half of 2024.

FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS:

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Cash and cash equivalents and short-term investments: As of December 31, 2023, Janux reported cash and cash equivalents and short-term investments of $344.0 million compared to $327.0 million at December 31, 2022.

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Research and development expenses: Research and development expenses were $12.2 million for the quarter and $54.9 million for the year ended December 31, 2023, compared to $15.4 million and $53.4 million for the same quarter and year in 2022.

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General and administrative expenses: General and administrative expenses were $6.4 million for the quarter and $26.1 million for the year ended December 31, 2023, compared to $5.7 million and $22.3 million for the same quarter and year in 2022.

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Net loss: Net loss was $11.8 million for the quarter and $58.3 million for the year ended December 31, 2023, compared to $16.1 million and $63.1 million for the same quarter and year 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 March 8, 2024 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that Company management will be attending the following upcoming investor conferences (Press release, Delcath Systems, MAR 8, 2024, View Source [SID1234640965]):

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Leerink Partners Global Biopharma Conference
Date: March 13, 2024
Location: Miami Beach, FL

36th Annual ROTH Conference
Date: March 18 – 19, 2024
Location: Dana Point, CA

Management is scheduled to host one-on-one meetings throughout the event. Investors interested in arranging one-on-one meetings should contact your conference representative. You may also call or email Ben Shamsian of Lytham Partners at 646-829-9701, or [email protected].

On March 8, 2024 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the year ended December 31, 2023 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, MAR 8, 2024, View Source [SID1234640963]).

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"2023 was a year of focused execution, as evidenced by the continued progress across our pipeline of DNAbilize programs," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "In the fourth quarter, we were delighted to announce important enrollment updates in our Phase 1/1b clinical trial of BP1002 in refractory/relapsed Acute Myeloid Leukemia (AML) and our Phase 1 clinical trial of BP1002 in refractory/relapsed lymphoma and refractory/relapsed Chronic Lymphocytic Leukemia (CLL). As we look to the months and year ahead, we expect to build on the clinical progress achieved to date to bring potentially life-saving new medicines to patients battling cancers."

Recent Corporate Highlights

● Hosted Key Opinion Leader (KOL) Event to Discuss Prexigebersen and Advances in the AML Treatment Landscape. In October, Bio-Path hosted a virtual KOL event to discuss the current AML treatment landscape and the growing body of clinical evidence in support of prexigebersen as a treatment for AML. The event featured presentations from Jorge Cortes, M.D., Director, Georgia Cancer Center, Augusta University and Maro Ohanian, D.O., Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center.

● Successfully Completed First Dose Cohort of Phase 1/1b Clinical Trial of BP1002 in Refractory/Relapsed Acute Myeloid Leukemia. In December, the Company announced the completion of the first dose cohort of the dose escalation portion of its Phase 1/1b clinical trial of BP1002 evaluating the ability of BP1002, a liposomal Bcl-2 nanoparticle antisense, to treat refractory/relapsed AML patients including venetoclax-resistant patients.

● Completed First Dose Cohort in Phase 1 Clinical Trial Evaluating BP1002 to Treat Refractory/Relapsed Lymphoma and Refractory/Relapsed Chronic Lymphocytic Leukemia Patients. In December, Bio-Path announced completion of the first dose cohort of the dose escalation portion of its Phase 1 clinical trial of BP1002 evaluating the ability of BP1002 for the treatment of refractory/relapsed lymphoma and refractory/relapsed CLL patients.

Financial Results for the Year Ended December 31, 2023

● The Company reported a net loss of $16.1 million, or $33.63 per share, for the year ended December 31, 2023, compared to a net loss of $13.9 million, or $38.12 per share, for the year ended December 31, 2022.

● Research and development expense for the year ended December 31, 2023 increased to $11.6 million, compared to $9.2 million for the year ended December 31, 2022 primarily due to manufacturing expenses related to drug product releases in 2023 as well as an increase in expense related to our clinical trial for prexigebersen in AML due to increased patient enrollment in 2023.

● General and administrative expense for the year ended December 31, 2023 decreased to $4.2 million, compared to $4.7 million for the year ended December 31, 2022 primarily due to decreased salaries and benefits expense as well as franchise tax expenses.

● Change in fair value of the Company’s warrant liability for the year ended December 31, 2023 resulted in a non-cash loss of $0.3 million. The company did not have the warrant liability in 2022.

● As of December 31, 2023, the Company had cash of $1.1 million, compared to $10.4 million as of December 31, 2022. Net cash used in operating activities for the year ended December 31, 2023 was $11.5 million compared to $15.1 million for the comparable period in 2022. Net cash provided by financing activities for the year ended December 31, 2023 was $2.2 million.

Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these full-year 2023 financial results and to provide a general update on the Company. To access the conference call please dial (833) 630-1956 (domestic) or (412) 317-1837 (international). A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.

On March 8, 2024 Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to develop a functional cure for people with chronic hepatitis B virus (cHBV) infection, reported that the Arbutus management team will participate in and host one-on-one meetings at the following two upcoming investor conferences which are being held in Miami, FL (Press release, Arbutus Biopharma, MAR 8, 2024, View Source [SID1234640962]):

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Barclays 26th Annual Global Healthcare Conference: Formal Presentation on March 12, 2024 at 2:05 pm ET
Jefferies Biotech on the Bay Summit: March 13, 2024

To access the live webcast of the presentation at the Barclays 26th Annual Global Healthcare Conference please visit: View Source An archived replay of the webcast will be available on the Arbutus website for a limited time after the event.