On May 20, 2024 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) (the "Company" or "Sonnet"), a clinical-stage company developing targeted immunotherapeutic drugs, reported that the safety of SON-1010 dosing has been formally reviewed in both of the current Phase 1 clinical trials and the Company is now increasing the target dose of SON-1010 during dose escalation (Press release, Sonnet BioTherapeutics, MAY 20, 2024, View Source [SID1234643461]). SON-1010 is a proprietary version of recombinant human interleukin-12 (rhIL-12), configured using Sonnet’s Fully Human Albumin Binding (FHAB) platform, which extends the half-life and activity of the IL-12 component due to binding native albumin in the serum and targets the tumor microenvironment (TME) by strongly binding gp60 and Secreted Protein Acidic and Rich in Cysteine (SPARC). SB101 is a Phase 1 multiple-ascending dose (MAD) trial in adult patients with advanced solid tumors (NCT05352750) that commenced in Q2 2022 and is currently enrolling the sixth dose cohort. SB221 is a Phase 1b/2a dose-escalation and proof-of-concept study of the combination of SON-1010 with atezolizumab (in collaboration with Genentech, a member of the Roche Group), in a study focused on platinum-resistant ovarian cancer (PROC) (NCT05756907) that started in Q4 2023, now enrolling the fourth dose cohort. In addition, SON-1010 was studied in SB102, which was a Phase 1 single-ascending dose (SAD) trial in healthy volunteers (NCT05408572) that started in Q3 2022; the results were recently published (Kenney, et al, Frontiers in Immunology, 2024).

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Safety in both of the active cancer trials has been reviewed by their respective Safety Review Committees at each step during dose escalation. Both trials use a ‘desensitizing’ first dose to take advantage of the known tachyphylaxis with rhIL-12, which minimizes toxicity and allows higher maintenance doses. No dose-limiting toxicities or related serious adverse events have occurred to date. The safety and toxicity profile that has developed is typical for a Phase 1 oncology trial, with the majority of adverse events (AEs) being reported as mild. All have been transient, with no evidence of cytokine release syndrome. Of the 25 cancer patients dosed to date and evaluable for follow-up at this latest cutoff, 15 (60%) had stable disease at their first follow-up scan, 8 of whom were progressing at study entry. At four months follow-up, 8 of 23 evaluable patients remained stable at the second CT scan, suggesting clinical benefit of SON-1010 in 35% of the patients.

"We have now dosed 18 cancer patients at increasing SON-1010 drug levels in the SB101 study, completed dosing in 31 healthy volunteers in SB102, and are rapidly filling the dose-escalation cohorts with 12 subjects enrolled in the first four cohorts of the SB221 combination study," said Richard Kenney, M.D., Sonnet’s Chief Medical Officer. "The overall safety and toxicity profile for SON-1010, primarily including local reactions, headache, myalgia, and fatigue, mimics the published experience with rhIL-12, which prompted us to raise the target dose to enhance potential efficacy. The SB102 study allowed us to generate clean data for the pharmacokinetic (PK) and pharmacodynamic (PD) analyses, enabling simulation of the effect of multiple doses with the help of a continual reassessment model of PK and PD. This modeling suggests target-mediated drug disposition (TMDD), which supports the mechanism of the FHAB being directed to tumor tissue. The combination of SON-1010 with atezolizumab may benefit from the ability of IL-12 to turn ‘cold’ tumors ‘hot’, which upregulates the amount of PD-L1 in the TME."

One patient with progressive endometrial sarcoma receiving SON-1010 monotherapy in SB101 had stable disease (SD) for almost 2 years before progressing – her ascites had resolved and tumors had shrunk at one point but she never reached a partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) rules. Cytokine analysis following each dose in that study revealed controlled and prolonged induction of interferon gamma (IFNγ) that peaked at 24 to 48 hours and returned to baseline within 2 to 4 weeks. A small increase in IL-10 was observed with each dose as expected in response to IFNγ. There was either a minimal or no signal for IL-1β, IL-6, IL-8, and TNFα, and there was no indication of any potential for cytokine release syndrome (CRS) at these doses. One patient in Part 1 of SB221 with uterine sarcomas received 8 cycles of the SON-1010/atezolizumab combination therapy every 3 weeks before progressing; another two have received 8 and 10 cycles, respectively, and are continuing on the study. The stable AE profiles despite dose escalation led us to reevaluate the target dose, so the Company has added groups in both studies to evaluate 1200 ng/kg SON-1010 as a maintenance dose (the molar equivalent of 800 ng/kg rhIL-12). Finally, Part 2 of the SB221 combination study has been trimmed to remove the monotherapy arm.

"The findings to date in these two trials represent significant progress for the SON-1010 molecule", said Robert Wenham, M.D., Chair, Department of GYN Oncology at Moffitt Cancer Center and the Lead Principal Investigator for SB221. "Multiple strategies to present IL-12 safely have been tried over the past two decades with little evidence of improved tolerability in humans, yet the preclinical models continue to suggest that induction of IFNγ in the TME can activate an effective anti-tumor response. This also results in the local induction of PD-L1. Adding a cohort to increase the target MTD of SON-1010, an extended PK molecule that is concentrated in the TME, is the right approach at this stage. This will provide a chance to study the safety of SON-1010 monotherapy in SB101, and then in combination with atezolizumab in SB221, along with the clinical effect of the combination on PROC in a limited set of subjects in the expansion cohort later this year. Defining the best dose for SON-1010 is required to allow a direct randomized comparison of the strategy with the standard of care therapy in Part 2."

"We are very pleased with the data we are seeing at these higher dose levels of SON-1010, with safety and tolerability being well within expected levels, as well as displaying SON-1010 extended PK/PD, tumor targeting, and clinical activity during treatment," said Pankaj Mohan, Ph.D., Sonnet Founder and Chief Executive Officer. "Research on rhIL-12 in humans has been hindered by toxicity for decades. We believe that the IL-12 component in SON-1010 is presented in a way that is safer, due to the longer half-life, and it is concentrated in the tumor, due to the recurrent binding of the FHAB-associated albumin to SPARC in the TME. It is important to note that many of these patients have been fighting their cancers for a very long time and have exhausted all approved treatment regimens available to them, so seeing tumor shrinkage at any dose is both difficult to achieve and encouraging for future results. We are excited to continue testing the impact of SON-1010 in combination with atezolizumab at these higher dose levels in patients with PROC, who represent a significant unmet medical need, and we expect to have a further update early next year."

About SON-1010

SON-1010 is a candidate immunotherapeutic recombinant drug that links unmodified single-chain human IL-12 with the albumin-binding domain of the single-chain antibody fragment A10m3. This was selected to bind both at normal pH, as well as at the acidic pH typically found in the TME. The FHAB technology targets tumor and lymphatic tissue, providing a mechanism for dose sparing and an opportunity to improve the safety and efficacy profile of not only IL-12, but a variety of potent immunomodulators that can be added using the platform. Interleukin-12 can orchestrate a robust immune response to many cancers and pathogens. Given the types of proteins induced in the TME, such as the Secreted Protein and Rich in Cysteine (SPARC) and glycoprotein 60 (GP60), several types of cancer such as non-small cell lung cancer, melanoma, head and neck cancer, sarcoma, and some gynecological cancers are particularly relevant for this approach. SON-1010 is designed to deliver IL-12 to local tumor tissue, turning ‘cold’ tumors ‘hot’ by stimulating IFNγ, which activates innate and adaptive immune cell responses and increases the production of Programed Death Ligand 1 (PD-L1) on tumor cells.

About the SB101 Phase 1 Trial

This first-in-human study is primarily designed to evaluate the safety of multiple ascending doses of SON-1010 in cancer patients and will be conducted at several sites across the United States. While the optimal dose is unknown at this stage, the potential to target tumors, the extended PK mechanism and our preclinical data suggest the therapeutic dose may be lower compared to native human IL-12. The study, utilizing a standard 3+3 oncology design in at least five cohorts, should establish the MTD and the recommended Phase 2 dose (RP2D) using monthly subcutaneous injections of SON-1010. The primary endpoint explores the safety and tolerability of SON-1010, with key secondary endpoints intended to measure pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and anti-tumor activity. This study will form the basis for potential combinations with other types of immunotherapies and the future development of bispecific candidates using the FHAB platform.

About the SB221 Phase 1b/2a Trial

SB221 is a global Phase 1b/2a multicenter, dose-escalation and randomized proof-of-concept study to assess the safety, tolerability, PK, PD, and efficacy of SON-1010 administered subcutaneously (SC), either alone or in combination with atezolizumab given intravenously (IV). The study is designed in Part 1 to rapidly establish the maximum tolerated dose (MTD) of the combination in patients with advanced solid tumors at the lower dose levels. The focus shifts to PROC at higher dose levels using small dose-escalation groups with expansion of the dataset at the recommended Phase 2 dose (RP2D). This would be followed in Part 2 by an assessment in patients with PROC of the potential for improved efficacy of the combination versus the standard of care. Both companies look forward to this collaboration as an opportunity to improve outcomes for patients with ovarian cancer.

On May 20, 2024 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, reported the opening of its proposed $100 million tender offer (the "Tender Offer") (Press release, PureTech Health, MAY 20, 2024, View Source [SID1234643460]).

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Tender Offer Highlights

•
The Tender Offer opens today 20 May 2024. Subject to the terms and conditions of the Tender Offer, the Company will purchase for cash a maximum of $100 million in value of ordinary shares of one pence each in the capital of the Company ("Ordinary Shares") (including Ordinary Shares represented by the Company’s American Depositary Shares each representing 10 Ordinary Shares ("ADSs")).

•
The Tender Offer for the Company’s Ordinary Shares will close at 1:00 p.m. London time on Thursday 20 June 2024 (the "Ordinary Share Closing Date"), and the Tender Offer for the Company’s ADSs will close at 5:00 p.m. New York City time on Tuesday 18 June 2024 (the "ADS Closing Date"), unless the Tender Offer is extended.

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The Company is offering to purchase up to 33,500,000 Ordinary Shares (including Ordinary Shares represented by ADSs) representing approximately 12 percent of the Company’s issued ordinary share capital as at 16 May 2024 (being the latest practicable date before publication of this announcement ("Latest Practicable Date")) at a fixed price of 250 pence per Ordinary Share (equivalent to £25.00 per ADS) (the "Tender Price") up to a maximum aggregate amount of $100 million. The maximum amount of $100 million will be translated into a pounds sterling amount on the Ordinary Share Closing Date, and that pounds sterling amount shall determine the maximum number of shares to be accepted for payment in the Tender Offer.

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The Tender Price represents a premium of 25 percent to PureTech’s trailing volume weighted average price per Ordinary Share over the three days prior to 19 March 2024, the date of the Company’s initial announcement of the Tender Offer proposals and a premium of 12.6 percent to the closing price of 222 pence per Ordinary Share on the Latest Practicable Date.

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If the full $100 million is not returned through the Tender Offer, then, if there is sufficient surplus, the Company’s board of directors ("Board") intends to return such surplus by way of a special dividend following completion of the Tender Offer, without interest, less any applicable withholding taxes and subject to market and industry conditions at the time and any relevant legal restrictions (the "Special Dividend").

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Completion of the Tender Offer will be conditional, among other things, on shareholder approval at a general meeting of the Company to be held at 11:00 a.m. New York City time (4:00 p.m. London time) on 6 June 2024 at the Company’s offices at 6 Tide Street, Boston, Massachusetts, 02210, United States (the "General Meeting").

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Full details of the Tender Offer are included in a circular to the Company’s Shareholders (the "Circular") which will be mailed to Shareholders and ADS Holders today and available on a website set up by the Company for the purposes of the Tender Offer. The website is available at View Source Copies of the Circular will be submitted to the National Storage Mechanism and will be available for inspection at View Source The Circular will also be included as an exhibit to the Schedule TO to be filed with the Securities and Exchange Commission and will be available for inspection at View Source

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SHAREHOLDERS AND ADS HOLDERS ARE ADVISED TO CONSULT WITH THEIR PROFESSIONAL TAX ADVISORS IN CONNECTION WITH CERTAIN US FEDERAL WITHHOLDING TAX CONSIDERATIONS DESCRIBED IN FURTHER DETAIL BELOW (SEE "Certain US Federal Income Tax Considerations with Respect to the Tender Offer").

Structure of the Tender Offer

The Tender Offer will be implemented on the basis of Jefferies International Limited ("Jefferies") acquiring, as principal, the successfully tendered Ordinary Shares (including Ordinary Shares represented by ADSs) at the Tender Price. In turn, Jefferies has the right to require the Company to purchase such Ordinary Shares (including Ordinary Shares represented by ADSs) from it at the same Tender Price pursuant to an option agreement entered into between the Company and Jefferies (the "Option Agreement"). If Jefferies does not exercise its right to require the Company to purchase such Ordinary Shares (including Ordinary Shares represented by ADSs), the Company has the right to require Jefferies to sell such Ordinary Shares (including Ordinary Shares represented by ADSs) to it at the same price. The Company intends to cancel the Ordinary Shares (including Ordinary Shares represented by ADSs) purchased by it pursuant to the Tender Offer.

Shareholders can decide whether they want to tender all, some or none of their Ordinary Shares or ADSs in the Tender Offer.

If the aggregate value at the Tender Price of all validly tendered Ordinary Shares (including Ordinary Shares represented by ADSs) exceeds $100 million (based on the applicable exchange rate of US dollars to pounds sterling on the Ordinary Share Closing Date) or the number of validly tendered Ordinary Shares (including Ordinary Shares represented by ADSs) exceeds 33,500,000 Ordinary Shares, then not all of the Ordinary Shares (including Ordinary Shares represented by ADSs) validly tendered will be accepted and purchased. In these circumstances, tenders will be scaled down pro-rata to the total number of Ordinary Shares (including Ordinary Shares represented by ADSs) so tendered by that shareholder, such that the total cost of Ordinary Shares (including Ordinary Shares represented by ADSs) purchased pursuant to the Tender Offer does not exceed $100 million or the total number of validly tendered Ordinary Shares (including Ordinary Shares represented by ADSs) does not exceed 33,500,000 Ordinary Shares.

Certain US Federal Income Tax Considerations with Respect to the Tender Offer

Shareholders and ADS Holders should consult their professional tax advisors in connection with the Tender Offer.

Shareholders and ADS Holders should note that, due to the circumstances of its formation and the application of Section 7874 of the United States Internal Revenue Code of 1986, as amended ("Code"), the Company is treated as a US domestic corporation for US federal income tax purposes. Accordingly, the Company is subject to US federal income tax as if it were a US corporation, and distributions made by the Company (including certain payments in respect of the Tender Offer that are treated as distributions for US federal income tax purposes) are generally treated as US-source dividends, as if the Company were incorporated in the US. As a result, both US Holders and Non-US Holders (each as defined in the Circular) may be subject to US federal income tax withholding on receipt of cash proceeds from any tendered Ordinary Shares or ADSs accepted in the Tender Offer and the Special Dividend (if any).

The attention of Shareholders and ADS Holders is drawn to Part VI of the Circular, which provides a summary of certain material UK tax and US federal income tax consequences for Shareholders and ADS Holders of accepting the Tender Offer or receipt of the Special Dividend (if any).

All Shareholders and ADS Holders should receive a Section 302 Certification. Copies of the Section 302 Certification, IRS Form W-9, and IRS Forms W-8, as well the IRS instructions with respect to such IRS Forms, are also available on the Microsite set up by the Company for the purposes of the Tender Offer. The Microsite is available at View Source

In consultation with their professional tax advisors regarding their individual circumstances, Shareholders and ADS Holders should complete the Section 302 Certification and an IRS Form W-9 or applicable IRS Form W-8, as applicable, in accordance with the instructions thereon. Shareholders and ADS Holders should return the properly completed Section 302 Certification and the IRS Form W-9 or applicable IRS Form W-8, as applicable, in accordance with the instructions set forth the Circular, the Tender Form, the Letter of Transmittal and the Section 302 Certification, as applicable. Part VI of the Circular also provides additional information to Shareholders and ADS Holders on the process for returning a Section 302 Certifications and an IRS Form W-9 or applicable IRS Forms W-8, as applicable.

The appropriate IRS Form W-9 or Form W-8 should be returned whether or not a Shareholder plans to participate in the Tender Offer, if not previously provided. IRS Form W-9 and IRS Form W-8 will also be relevant in connection with the Special Dividend (if any).

This information is not tax advice, and the Company cannot advise you with respect to taxes. Shareholders and ADS Holders should consult their professional tax advisors, in particular regarding their individual tax position and the exemptions or reductions of US withholding tax that may be available to them. For more information, Shareholders and ADS Holders should read the full text of this announcement of the Tender Offer, the Circular, the Tender Form, and the Letter of Transmittal.

General Meeting

Implementation of the Tender Offer is conditional upon, amongst other things, the approval of the shareholders of the resolution necessary to implement the Tender Offer (the "Resolution"). For this purpose, the Company is convening the General Meeting for 11 a.m. New York City time (4 p.m. London time) on 6 June 2024 to be held at 6 Tide Street, Boston, Massachusetts, 02210, United States to consider and, if thought fit, pass the Resolution to approve the terms on which the Tender Offer will be effected. A notice convening the General Meeting is set out at the end of the Circular.

Participating in the Tender Offer

If you are a Shareholder and hold your Ordinary Shares in Certificated Form and you wish to tender all or any of your Ordinary Shares, you should complete the Tender Form in accordance with the instructions printed on it and in Part V of the Circular and return it by post in the accompanying reply-paid envelope (for use in the UK only) to the Receiving Agent, at the Pavilions, Bridgewater Road, Bristol, BS99 6AH so as to be received by no later than 1:00 p.m. (London time) on Thursday 20 June 2024, together with your share certificate(s) in respect of the Ordinary Shares tendered.

If you are a Shareholder and hold your Ordinary Shares in Uncertificated Form and you wish to tender all or any of your Ordinary Shares, you should send the TTE Instruction through CREST so as to settle by no later than 1:00 p.m. (London time) on Thursday 20 June 2024.

Any ADS Holder who holds ADSs on the books of the Depositary who wishes to tender pursuant to the Tender Offer should properly complete and duly execute a Letter of Transmittal (or facsimile thereof), together with any required signature guarantees and any other required documents, and deliver such documents to the tender agent for the ADSs, Citibank, N.A. (the "Tender Agent"), at the appropriate address set forth in the Letter of Transmittal so as to be received no later than 5:00 p.m. (New York City time) on the ADS Closing Date (unless the Tender Offer is extended). In addition, the ADRs evidencing the tendered ADSs must be received by the Tender Agent at the appropriate address or be delivered pursuant to the procedures for book-entry transfer set forth below (and a confirmation of receipt of such transfer must be received by the Tender Agent) so as to be received no later than 5:00 p.m. (New York City time) on the ADS Closing Date.

If the ADSs are held through a broker, dealer, commercial bank, trust company or other securities intermediary and the ADS Holder wishes to participate in the Tender Offer, such ADS Holder should provide tender instructions in accordance with the instructions provided by such intermediary in sufficient time so as to ensure that such intermediary can provide such instructions to the Tender Agent so as to be received no later than 5:00 p.m. (New York City time) on the ADS Closing Date (unless the Tender Offer is extended).

Timetable

A summary expected timetable of principal events is set out in Appendix I to this announcement.

On May 20, 2024 Prescient Therapeutics Ltd (ASX:PTX, OTC:PSTTF) reported that it has been invited to present PTX-100 Phase 1b results at the 15th Annual T-Cell Lymphoma Forum (TCLF) to be held in California from June 6 to 8 (Press release, Prescient Therapeutics, MAY 20, 2024, View Source;utm_medium=rss&utm_campaign=prescient-therapeutics-to-present-ptx-100-results-at-t-cell-lymphoma-forum-in-california [SID1234643459]).

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Primary goals met
The Phase 1b study of PTX-100, which targeted patients with relapsed and refractory T-cell lymphomas (r/r TCLs), has met its primary goals of demonstrating safety and determining both pharmacokinetics – how the drug is absorbed, distributed, metabolised and excreted in the body – and pharmacodynamics, or the effects of the drug on the body.

Additionally, the study has shown promising preliminary efficacy in r/r TCL patients, surpassing the typical results expected from standard treatments, with an overall response rate of 45%.

This means that five out of 11 evaluable TCL patients responded positively to the treatment.

Orphan disease designation
T-cell lymphomas (TCLs) are a type of non-Hodgkin lymphoma that originates from T-cells, a kind of white blood cell.

TCLs are considered an orphan disease, which means they are rare, with around 30,000 cases. There is a significant need for more effective treatments for TCLs, especially for those with relapsed and refractory disease.

Accordingly, PTX-100 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA), a status given to drugs intended for the treatment of rare diseases.

The 15th annual T-Cell Lymphoma Forum (TCLF) is a specialised conference focusing on the latest and most significant advancements in T-cell lymphomas, including new agents and treatment approaches.

It brings together clinicians, scientists and industry professionals dedicated to TCLs.

The PTX-100 study results will be presented in a plenary address by the study’s Principal Investigator, Professor H. Miles Prince, AM, a distinguished haematologist and globally recognized expert in TCLs.

Esteemed platform
Prescient Therapeutics managing director and CEO Steven Yatomi-Clarke said: "The TCLF is an esteemed platform for sharing the latest research and developments in the field of TCLs.

"To be invited to present our data in a coveted slot to world leaders in the field of TCLs showcases the relevance and potential of PTX-100 in this area of unmet need.

"It also highlights the momentum and standing that Prescient has in this specialised community of TCL clinicians and drug developers, having previously presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) 65th Annual Meeting and the 5th World Congress of Cutaneous Lymphomas.

"Prescient is committed to advancing into a Phase 2 trial in r/r TCL, with the study aiming to commence in Q3 2024. The company believes this will be a big catalyst for Prescient, potentially offering a new beacon of hope for patients with limited treatment options."

On May 20, 2024 LIXTE Biotechnology Holdings, Inc. ("LIXTE" or the "Company") (Nasdaq: LIXT and LIXTW), a clinical-stage pharmaceutical company developing a new class of cancer therapy to enhance chemotherapy and immunotherapy, reported an update on the Company’s recent activities, including notable pre-clinical developments (Press release, Lixte Biotechnology, MAY 20, 2024, View Source [SID1234643458]).

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"LIXTE continues to make progress with its proprietary compound, LB-100, in ongoing clinical trials for lung, ovarian and sarcoma cancers," said Bas van der Baan, LIXTE’s President and Chief Executive Officer. "We also are pleased with the findings of recent pre-clinical data with LB-100 in an entirely new field of cancer biology — activation lethality — that we believe has outstanding potential in advancing new treatment options."

Recent Company highlights include:

● Pre-clinical studies in a new field of cancer biology — activation lethality — have shown that LB-100 can force cancer cells to give up their cancer-causing properties. The findings open a potentially new treatment strategy in addition to LIXTE’s current three ongoing clinical trials. René Bernards, Ph.D., a leader in the field of molecular carcinogenesis and Senior Staff Scientist at the Netherlands Cancer Institute, presented the new pre-clinical data at the Joint Conference of European and American Associations for Cancer Research in Dublin, Ireland. The paper, "Paradoxical Activation of Oncogenic Signaling as a Cancer Treatment Strategy," was posted in the online medical journal Cancer Discovery on April 30, 2024. Dr. Bernards is a member of LIXTE’s Board of Directors.

● Bas van der Baan, LIXTE’s President and Chief Executive Officer, presented at the MedInvest Biotech and Pharma Investor Conference on April 3, 2024 in New York City. The two-day event featured presentations from more than 40 companies, developing and commercializing technologies across a broad spectrum of indications, including oncology. The conference also featured talks from key industry opinion leaders, investor panel discussions, and conversations with the National Cancer Institute on patenting, facilitating collaborations, licensing and technology analysis and marketing.

● LIXTE co-sponsored an international scientific workshop on "Therapeutic Over-Activation in Cancer" at Harvard University’s Dana Farber Cancer Institute in Boston, Massachusetts on May 9 and 10, 2024. The workshop brought together leading experts from the pharmaceutical industry and academia who discussed a radically different approach to cancer therapy that is being spearheaded by LIXTE’s outsourced research team at the Netherlands Cancer Institute.

LIXTE has clinical trials underway at the University of Texas MD Anderson Cancer (ovarian clear cell carcinoma); City of Hope Cancer Center and the Sarah Cannon Research Institute (small cell lung cancer); and the Spanish Sarcoma Group (advanced soft tissue sarcoma). In February 2024, LIXTE signed an exclusive patent license agreement with the National Institute of Neurological Disorders and Stroke (NINDS) and the National Cancer Institute (NCI), each an institute or center of the National Institute of Health (NIH).

Click here for a brief video overview by LIXTE’s Chief Executive Officer.

Filing of Quarterly Report on Form 10-Q for the three months ended March 31, 2024

Additional information with respect to LIXTE’s business, clinical trials and financial condition is contained in the Company’s Quarterly Report on Form 10-Q for the three months ended March 31, 2024, which has been filed with the U.S. Securities and Exchange Commission at www.sec.gov.

On May 20, 2024 Kiromic BioPharma, Inc. (OTCQB: KRBP) ("Kiromic" or the "Company") reported that UPMC in Pittsburgh, Pennsylvania has been activated as the fourth clinical trial site in the Deltacel-01 Phase 1 trial evaluating Deltacel (KB-GDT-01), Kiromic’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC) (Press release, Kiromic, MAY 20, 2024, View Source [SID1234643457]).

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UPMC is a world-renowned healthcare system that employs some of the nation’s top clinicians and medical researchers. UPMC Hillman Cancer Center is Western Pennsylvania’s only National Cancer Institute-designated Comprehensive Cancer Center.

The lead principal investigator for Deltacel-01, Jason J. Luke, MD, FACP, will also serve as principal investigator at the UPMC site. Dr. Luke is Associate Professor of Medicine at the University of Pittsburgh and UPMC Hillman Cancer Center, where he is Associate Director for Clinical Research and Director of the Immunotherapy and Drug Development Center.

"We’re delighted to have Dr. Jason Luke and UPMC participating in the conduct of research of our potentially transformative therapy. Dr. Luke is one of the world’s foremost investigators in immuno-oncology, having led clinical trials of immunotherapies across many cancer types. His expertise in early phase drug development for solid tumors has played a critical role in shaping our trial, and we are optimistic Deltacel will demonstrate continued favorable outcomes in this deadly disease as we expand treatment to patients across more sites. We expect to activate one more clinical trial site later this quarter and to begin enrolling patients at UPMC this summer," said Pietro Bersani, Chief Executive Officer of Kiromic.

Kiromic also announces favorable preliminary safety and tolerability data from the fourth patient in Deltacel-01, with early efficacy data on this patient expected by the end of May. The fifth and sixth patients are expected to be enrolled later in May and June, respectively.

About Deltacel-01

In Kiromic’s open-label Phase 1 clinical trial, titled "Phase 1 Trial Evaluating the Safety and Tolerability of Gamma Delta T Cell Infusions in Combination With Low Dose Radiotherapy in Subjects With Stage 4 Metastatic Non-Small Cell Lung Cancer" (NCT06069570), patients with stage 4 NSCLC will receive two intravenous infusions of Deltacel with four courses of low-dose, localized radiation over a 10-day period. The primary objective of the Deltacel-01 trial is to evaluate safety, while secondary measurements include objective response, progression-free survival, overall survival, time to progression, time to treatment response and disease control rates.

About Deltacel

Deltacel (KB-GDT-01) is an investigational gamma delta T-cell (GDT) therapy currently in the Deltacel-01 Phase 1 trial for the treatment of stage 4 metastatic NSCLC. An allogeneic product consisting of unmodified, donor-derived gamma delta T cells, Deltacel is the leading candidate in Kiromic’s GDT platform. Deltacel is designed to exploit the natural potency of GDT cells to target solid cancers, with an initial clinical focus on NSCLC, which represents about 80% to 85% of all lung cancer cases. Data from two preclinical studies demonstrated Deltacel’s favorable safety and efficacy profile when it was combined with low-dose radiation.