On May 25, 2023 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, reported biomarker data for FLX475 from its ongoing FLX475-02 Phase 1/2 clinical trial which corroborate the clinical activity of FLX475 reported in Epstein-Barr virus-positive (EBV+) lymphoma, EBV+ gastric cancer and non-small cell lung cancer (NSCLC), as well as the mechanism of this novel CCR4 antagonist (Press release, RAPT Therapeutics, MAY 25, 2023, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-present-biomarker-data-corroborating [SID1234632070]). These data will be presented in a poster at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting taking place next week at the McCormick Place Convention Center in Chicago, IL.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

FLX475 is a potent and selective CCR4 antagonist, designed to block the recruitment of immunosuppressive regulatory T cells (Treg) into tumors without affecting healthy tissues. In December 2022 at ESMO (Free ESMO Whitepaper)-IO, a clinical update from the Phase 1/2 trial reported evidence of monotherapy and combination activity. FLX475 monotherapy induced confirmed complete metabolic responses in two of the six evaluable patients with EBV+ NK/T cell lymphoma. In patients with checkpoint inhibitor naïve NSCLC, the overall confirmed objective response rate was 31% (4/13 patients), and the confirmed objective response rate in PD-L1+ tumors was 38% (3/8 patients) following treatment with FLX475 plus pembrolizumab.

As part of the clinical trial protocol, the company analyzed peripheral blood and tumor tissue biomarker data from patients with a broad range of tumor types treated with FLX475 monotherapy. These data substantiate the mechanism of action and support the combination of FLX475 with pembrolizumab. In peripheral blood, FLX475 monotherapy resulted in a small, but significant, increase in the proportion of circulating Treg, consistent with blocking the migration of Treg into the TME. In tumor tissues, changes in the TME conducive to anti-PD(L)1 response were observed. First, FLX475 monotherapy resulted in a decrease in Treg cell populations and an increase in the distance between CD8+ effector T cells and Treg in the TME. Second, transcriptomic profiles from tumors after FLX475 monotherapy exhibited significant changes known to be correlated with an enhanced response to checkpoint inhibitor therapy.

"These biomarker data provide further evidence that FLX475 reduces Treg in the tumor and promotes a permissive environment that should enhance immune-based therapy including checkpoint inhibitors," said Dirk Brockstedt, Ph.D., chief scientific officer of RAPT. "In addition to inhibiting the recruitment of regulatory T cells, which are highly potent suppressors of an antitumor immune response, we saw a concomitant increase in cancer fighting effector T cells and additional beneficial changes in the tumor microenvironment that have been shown to correlate with a favorable response to anti-PD(L)1 therapy. These data are consistent with and support the clinical activity we’ve seen with FLX475 as monotherapy and in combination therapy with pembrolizumab."

About FLX475
FLX475 is a small molecule CCR4 antagonist designed to block the migration of regulatory T cells (Treg) specifically into tumors, but not healthy tissues. Treg represent a dominant pathway for downregulating the immune response, generally correlate with poor clinical outcomes, and may limit the effectiveness of currently available therapies such as checkpoint inhibitors. FLX475 may restore naturally occurring antitumor immunity alone and may synergize with a variety of both conventional and immune-based therapies, such as radiation, chemotherapy, checkpoint inhibitors, immune stimulators, cancer vaccines, and adoptive T cell therapy.

On May 25, 2023 Propanc Biopharma, Inc. (OTC Pink: PPCBD) ("Propanc" or the "Company"), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, reported that the Company’s intellectual property (IP) portfolio made important advancements in Europe (Press release, Propanc, MAY 25, 2023, View Source [SID1234632069]). The dosing patent, describing claims for the dosing regimen of the Company’s lead product candidate, PRP, has now been validated in 12 countries across Europe. In further news, the Company’s method to treat cancer stem cells (CSCs) using PRP received a notice of allowance from the European Patent Office (EPO). This is the third patent allowed, or granted to the Company in Europe, with further applications under examination by the EPO.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As a result of validating the dosing patent in this major global region, Propanc now has enforceable patent rights in the UK, France, Germany, Spain, Italy, Denmark, Belgium, Czech Republic, Sweden, Switzerland/ Liechtenstein and Ireland. In 2022, the worldwide pharmaceutical market was valued at approximately $1.48 trillion by Statista.com and Europe accounted for 23.4% of global pharmaceutical sales in 2021, according to the European Federation of Pharmaceutical Industries and Associations (EFPIA). As a result of validating the dosing patent across Europe, the Company’s IP portfolio has grown to 76 patents either allowed, or granted in major jurisdictions around the world.

For the allowed CSCs patent, the claims cover a method to minimize the progression of cancer in a patient who has already received a first line treatment by detecting the presence of CSCs followed by administering PRP. This patent describes the clinical application of PRP when the patient experiences a relapse and the cancer returns after primary standard of care has been applied.

"The advancement and growth of our IP portfolio represents a cornerstone for our company as we progress PRP towards entering the clinical development phase and our next major milestone," said James Nathanielsz, BAS, MEI, Propanc’s Chief Executive Officer. "We have reached out to potential licensing partners and identified a potential suitor who expressed interest to see results from our planned Phase I, First-In-Human study in advanced cancer patients. Having an established IP portfolio with a novel, first-in-class therapy for the treatment and prevention of metastatic cancer has us well placed to seek a licensing partner for PRP, as we progress to the next major development milestones, which we hope to achieve in the not-too-distant future."

PRP is a mixture of two proenzymes, trypsinogen and chymotrypsinogen from bovine pancreas, administered by intravenous injection. A synergistic ratio of 1:6 inhibits growth of most tumor cells. Examples include kidney, ovarian, breast, brain, prostate, colorectal, lung, liver, uterine, and skin cancers.

On May 25, 2023 PDS Biotechnology presented its corporate presentation (Presentation, PDS Biotechnology, MAY 25, 2023, View Source [SID1234632067]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On May 25, 2023 NKGen Biotech Inc. ("NKGen"), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous, allogeneic and CAR-NK natural killer cell therapeutics, reported an upcoming poster presentation by its parent company, NKMax Co., Ltd., on preclinical and clinical data from a Phase I/IIa study of SNK01 in combination with cytotoxic chemotherapy in non-small cell lung cancer, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting to be held at the McCormick Place Convention Center in Chicago, Illinois from June 2-6, 2023 (Press release, NKMax America, MAY 25, 2023, View Source [SID1234632066]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Presentation Details:

Title: The safety and efficacy of SNK01 (autologous natural killer cells) in combination with cytotoxic chemotherapy after failure of prior tyrosine kinase inhibitor in non-small cell lung cancer: Preclinical mouse model and phase I/IIa clinical study

Authors: Myeong Geun Choi, Gun Woo Son, Dae-Hyun Ko, Wonjun Ji, Jin Kyung Rho, Jae Cheol Lee, Yong Man Kim, Jae Seob Jung, Paul Y. Song, Byeong Gon Yoon, Jong-min Jo, Mi Young Choi, Chang-Min Choi

Abstract Number: 9057

Session Type: Poster

Session Title: Lung Cancer – Non-Small Cell Metastatic

Poster Board Number: 45

Session Time: Sunday, June 4, 2023; 8:00 a.m. – 11:00 am CT

Location: Hall A

Full abstracts will be released at 5:00 pm ET on Thursday, May 25, 2023. Visit the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting website at View Source for more information.

On May 25, 2023 Mythic Therapeutics, a clinical-stage biotechnology company focused on the development of next-generation antibody-drug conjugate therapies for the treatment of a wide range of cancers, reported that it will present a Trial in Progress poster on its investigational cMET-targeting ADC, MYTX-011, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago, IL, from June 2-6, 2023 (Press release, Mythic Therapeutics, MAY 25, 2023, View Source;utm_medium=rss&utm_campaign=mythic-therapeutics-presents-trial-in-progress-poster-on-investigational-cmet-targeting-antibody-drug-conjugate-adc-mytx-011-at-american-society-of-clinical-oncology-asco-annual-meeting [SID1234632065]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The poster presentation will highlight the trial design, dosing regimen and study protocol for the company’s ongoing Phase 1 KisMET-01 clinical trial evaluating the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of MYTX-011 in subjects with locally advanced, recurrent or metastatic NSCLC (NCT05652868).

"We’re looking forward to the presentation of this Trial in Progress poster and to the potential of our KisMET-01 Phase 1 clinical trial in NSCLC. This presentation follows the announcement of our first patient dosed earlier this year," said Gilles Gallant, BPharm, PhD, FOPQ, Chief Development Officer at Mythic Therapeutics. "By harnessing our novel FateControl technology, designed to improve ADC efficacy against a broad set of molecular targets and patient profiles, we aim to expand the use of ADCs to patients who have previously not been eligible for treatment due to their level of target expression or tumor type."

Details of the presentation are as follows:

Title: Phase 1 Multicenter Dose Escalation and Dose Expansion Study of Antibody-Drug Conjugate (ADC) MYTX-011 in Subjects with Non-Small Cell Lung Cancer.
Presenter: Alexander Spira, MD, PhD, FACP, Next Oncology Virginia
Session Title: Lung Cancer—Non-Small Cell Metastatic
Session Date and Time: Sunday, June 4, 2023, from 8:00 AM – 11:00 AM CDT / 9:00 AM – 12:00 PM ET
Location: Hall A
Poster Board Number: 131a
Published Abstract Number: TPS9147

"There continues to be a high unmet need for patients with NSCLC as many either do not respond to, or develop resistance to, existing treatment options," said presenting author and KisMET-01 study investigator Alexander Spira, MD, PhD, FACP, Next Oncology Virginia. "Additionally, we’re excited to explore the potential for MYTX-011 in the Phase 1 KisMET-01 trial to provide a solution for the limitations of traditional ADCs, which have demonstrated potential efficacy as monotherapy only in patients whose tumors express high levels of cMET."

The KisMET-01 Phase 1 clinical trial will be conducted in two parts—dose escalation and dose expansion—with patients receiving MYTX-011 intravenously every 21 days. Part 1 will assess the safety and tolerability of escalating doses of MYTX-011 as a single-agent in patients with advanced NSCLC to identify the recommended Phase 2 dose (RP2D). The dose escalation schedule is based on the Bayesian Optimal Interval (BOIN) design and doses may be escalated or de-escalated based on the BOIN algorithm. The recommended Phase 2 dose to be studied in Part 2 will be identified as a biologically active dose at or below the maximum tolerated dose.

Part 2 will include patients with NSCLC with cMET overexpression or MET amplification/exon 14 skipping mutations and will be initiated once the RP2D has been determined. Patients will be enrolled into different cohorts based on cMET overexpression and/or presence of MET genetic alterations and the safety, tolerability and preliminary anti-tumor activity of MYTX-011 will be assessed. cMET positivity thresholds for enrollment into the dose expansion cohorts were selected based on anti-tumor activity of MYTX-011 in preclinical models, published data for responses to cMET targeting agents and on the prevalence of cMET expression in clinical NSCLC samples.

Preclinical proof of concept data for MYTX-011 were recently presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023.

About MYTX-011

MYTX-011, an investigational cMET-targeting ADC, leverages Mythic’s innovative FateControl technology, which allows ADCs to actively navigate inside of cells to potentially increase delivery of anti-cancer agents to tumor cells with less impact on healthy cells. This breakthrough approach takes the next step beyond linker-payload technologies and is designed to improve ADC efficacy against a broad set of molecular targets and patient profiles.