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.

On May 20, 2024 Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease, Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, reported that it has entered into a securities purchase agreement with a single institutional investor to purchase 1,672,452 shares of common stock (or pre-funded warrants in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Inhibikase Therapeutics, MAY 20, 2024, View Source [SID1234643456]). In a concurrent private placement, the Company also agreed to issue unregistered Series A warrants to purchase up to an aggregate of 1,672,452 shares of common stock, and unregistered Class B warrants to purchase up to an aggregate of 1,672,452 shares of common stock. Each share of common stock (or pre-funded warrant in lieu thereof) is being sold with one Series A warrant to purchase one share of common stock and one Series B warrant to purchase one share of common stock at a combined purchase price of $1.68. The Series A and Series B warrants will each have an exercise price of $1.68 per share, will be exercisable beginning on the effective date of stockholder approval and, in the case of Series A warrants, will expire on the one-year anniversary from the date of stockholder approval, and in the case of Series B warrants, will expire on the five-year anniversary from the date of stockholder approval.

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The Company has also entered into a warrant inducement agreement with the investor to exercise certain outstanding warrants that the Company issued in January 2023. Pursuant to the warrant inducement agreement, the investor has agreed to exercise outstanding warrants to purchase an aggregate of 708,500 shares of the company’s common stock at an amended exercise price of $1.68. In consideration for the immediate exercise of the warrants, the Company also agreed to reduce the exercise price of the remaining unexercised portion of such warrants to purchase 1,229,484 shares of common stock to $1.68, and to issue the investor unregistered Series C warrants to purchase an aggregate of 708,500 shares of the Company’s common stock, and Series D warrants to purchase an aggregate of 708,500 shares of the Company’s common stock. The Series C and Series D warrants will each have an exercise price of $1.68 per share, will be exercisable beginning on the effective date of stockholder approval and, in the case of Series C warrants, will expire on the one-year anniversary from the date of stockholder approval, and in the case of Series D warrants, will expire on the five-year anniversary from the date of stockholder approval.

The gross proceeds to the Company from the registered direct offering, concurrent private placement and warrant inducement are estimated to be approximately $4.0 million before deducting the placement agent’s fees and other estimated offering expenses payable by the Company. The offering is expected to close on or about May 22, 2024, subject to the satisfaction of customary closing conditions.

Maxim Group LLC is acting as the sole placement agent in connection with the offering.

The shares of common stock (or pre-funded warrants in lieu thereof) are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-262551), which was declared effective by the U.S. Securities and Exchange Commission (the "SEC") on February 11, 2022. The warrants to be issued in the concurrent private placement and the shares issuable upon exercise of such warrants were offered pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Act") under Section 4(a)(2) thereof and Regulation D promulgated thereunder and have not been registered under the Act or applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A prospectus supplement relating to the shares of common stock and pre-funded warrants will be filed by the Company with the SEC. When available, copies of the prospectus supplement relating to the registered direct offering, together with the accompanying prospectus, can be obtained at the SEC’s website at www.sec.gov or from Maxim Group LLC, 300 Park Avenue, New York, NY 10022, Attention: Syndicate Department, or via email at [email protected] or telephone at (212) 895-3500.

On May 20, 2024 Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, reported financial results for the first quarter ended March 31, 2024 and provided a corporate update (Press release, Compugen, MAY 20, 2024, View Source [SID1234643455]).

"I am proud of our continued progress across our pipeline in the first quarter of 2024, and planned catalyst rich 2024 ahead of us," said Anat Cohen-Dayag, Ph.D., President and Chief Executive Officer of Compugen. "We are on track to present data from our ongoing studies this year. First up, microsatellite stable colorectal cancer (MSS CRC) at ASCO (Free ASCO Whitepaper) followed by platinum resistant ovarian cancer in the fourth quarter of 2024. We are also well advanced in our preparation for a COM503 Phase 1 study. In addition, our partner, AstraZeneca, has advanced its PD-1/TIGIT bispecific, rilvegostomig, into its second Phase 3 program, in nonsquamous NSCLC, bringing us closer to realizing potential future milestone payments and royalties."

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Dr. Cohen-Dayag continued, "Our first data will come from the very difficult to treat MSS CRC patient population, the majority of whom have liver metastases. This patient population historically have not responded to immune-oncology (IO) therapies. We pursued this indication based on an encouraging 12% overall response rate in the liver metastases population supported by immune activation in the tumor microenvironment suggestive of COM701 mediated activity. The data planned to be presented in June at ASCO (Free ASCO Whitepaper) remains supportive of COM701’s activity and safety with some patients continuing treatment at the data cutoff date. However, based on the data planned to be presented at ASCO (Free ASCO Whitepaper), we believe that IO-IO approach in patients with MSS CRC and liver metastases is not the way forward for Compugen at this time."

Dr. Cohen-Dayag added, "Our second data set this year will come from our platinum resistant ovarian cancer study, which is biologically distinct from MSS CRC, and in which our reported data suggest more dominant PVRIG pathway expression levels. We selected this indication to be pursued in the ongoing triplet study based on the deep durable responses, associated immune activation and potential associated biomarker data observed in our prior study, following treatment with our COM701 triple combination. It is important to note that observations made in tumors that are biologically distinct from each other, such as MSS CRC and platinum resistant ovarian cancer, are not indicative of each other. We believe that data showing clinical benefit in platinum resistant ovarian cancer would allow us to pursue the next studies towards a path to registration."

Dr. Cohen-Dayag concluded, "Compugen is a pioneer in computational discovery of novel drug targets. Our discovery platform, powered by AI and machine learning is fueling our pipeline and provides us with a competitive advantage. It has already delivered multiple proprietary clinical assets, multiple validating partnerships with pharma, and multiple early-stage undisclosed assets, all having the potential to deliver long term value creation."

Upcoming Expected Milestones
COM701 +COM902 + pembrolizumab proof-of-concept studies
•
Microsatellite stable colorectal cancer – ASCO (Free ASCO Whitepaper) poster presentation, June 1, 2024
•
Platinum resistant ovarian cancer – planned data presentation in the fourth quarter of 2024

COM503 (licenced to Gilead, Compugen lead through Phase 1 development)
•
IND submission in the second half of 2024 with subsequent initiation of the Phase 1 study following IND clearance

Rilvegostomig (AstraZeneca’s PD-1/TIGIT bispecific, TIGIT component derived from COM902)
•
Data in the second half of 2024 from Phase 1/2 ARTEMIDE-01 trial in advanced/metastatic NSCLC

First Quarter 2024 Financial Highlights
Cash: As of March 31, 2024, Compugen had approximately $101.3 million cash, cash equivalents, restricted cash, and cash investments, compared with approximately $51.1 million as of December 31, 2023. The cash balance as of March 31, 2024, includes $60 million upfront payment received from Gilead related to the licensing of COM503 and $10 million milestone payment received from AstraZeneca on dosing the first patient in the Phase 3 ARTEMIDE-Biliary01 study in biliary tract cancer. All payments from Gilead are subject to a 15% withholding tax. During the three months ended March 31, 2024, the Company sold approximately 0.3 million ordinary shares, under its at the market offering (ATM) facility pursuant to a sales agreement entered into with Leerink Partners on January 31, 2023, for aggregate gross proceeds of approximately $0.6 million.

Compugen expects that its cash and cash-related balances together with a $30 million milestone payment on COM503 IND clearance expected in 2024, will be sufficient to fund its operating plans into 2027. This does not include any additional cash inflows from partners. The Company has no debt.

Revenue: Compugen reported approximately $2.6 million in revenue for the first quarter ended March 31, 2024, compared to no revenue for the comparable period in 2023. The revenue reported reflects recognition of a portion of the upfront payment from the license agreement with Gilead.

R&D expenses for the first quarter of 2024 were approximately $6.4 million compared with approximately $7.4 million for the comparable period in 2023.

G&A expenses for the first quarter of 2024 were approximately $2.4 million, compared with approximately $2.6 million for the comparable period in 2023.

Net loss for the first quarter of 2024 was approximately $7.3 million, or $0.08 per basic and diluted share, compared with a net loss of approximately $9.3 million, or $0.11 per basic and diluted share, in the first quarter of 2023.

Full financial tables are included below.

Conference Call and Webcast Information
Compugen will hold a conference call today, May 20, 2024, at 8:30 AM ET to review its first quarter 2024 results. To access the live conference call by telephone, please dial 1-866-744-5399 from the U.S., or +972-3-918-0644 internationally. The call will be available via live webcast through Compugen’s website, located at the following link. Following the live webcast, a replay will be available on Compugen’s website.