On August 30, 2024 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that overcome tumor immune evasion and drug resistance, reported its executive management will participate in the H.C. Wainwright 26th Annual Global Investment Conference in a Fireside Chat presentation (virtual) and one-on-one meetings (Press release, Purple Biotech, AUG 30, 2024, View Source;id=318527&p=2338652&I=1206939-c7Z3G6f3m8 [SID1234646238]).

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 conference is being held on September 9-11, 2024, and the virtual Fireside Chat will be available on-demand starting on Monday, September 9 at 7:00 AM ET on the Investor section of Purple Biotech’s website at www.purple-biotech.com for 30 days. Institutional investors interested in listening to Purple Biotech’s Fireside Chat may click on the following link (www.hcwevents.com/annualconference) to register for the conference.

Purple Biotech’s CEO, Gil Efron, will also conduct in-person one-on-one meetings with institutional investors at the conference’s in-person venue at the Lotte New York Palace Hotel in New York City.

On August 30, 2024 Rakovina Therapeutics Inc. (TSX-V: RKV, the "Company") a biopharmaceutical company committed to advancing new cancer therapies based on novel DNA-damage response technologies reported the financial results for the second quarter ending June 30, 2024, and provides an update to corporate activities (Press release, Rakovina Therapeutics, AUG 30, 2024, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-announces-2024-q2-financial-results-and-provides-corporate-update [SID1234646237]).

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!

"We are thrilled by the rapid progress and strategic advancements we’ve made at Rakovina Therapeutics since announcing our collaboration with Prof. Artem Cherkasov and exclusive access to the groundbreaking Deep Docking AI platform. AI has propelled us into an exciting new era of precision medicine, allowing us to screen billions of molecular structures and identify promising candidates for clinical development," said Executive Chairman Jeffrey Bacha.

"The overwhelming support shown through our successful $2 million private placement and the expansion of our research collaborations with UBC and Pharma Inventor Inc. further solidifies our commitment to pioneering innovative cancer therapies. Together, these milestones bring us closer to our goal of delivering life-changing treatments to patients worldwide," added Bacha.

2024 Q2 Highlights and Recent Developments

Earlier this spring, we announced a strategic pivot in our business model that positions Rakovina Therapeutics at the forefront of artificial intelligence-driven (AI) precision medicine through a collaboration with Prof. Artem Cherkasov, which provides us with exclusive access to the proprietary Deep Docking (trademarked) AI platform for DNA-damage response targets. In the past three months, we have evaluated more than 1.5 billion molecular structures against DNA damage response targets as potential lead candidates utilizing the Deep Docking AI platform. This iterative process will eventually screen more than seven billion drug candidates and provide a "short list" of recommended novel small molecule structures for synthesis and validation in our laboratories as potential lead candidates for advancement to human clinical trials in collaboration with pharmaceutical partners.
On July 26, 2024, we announced the final closing of an over-subscribed non-brokered private placement financing of units priced at $0.10 per unit with each unit consisting of one common share and one common share purchase warrant with an exercise price of $0.20 per warrant and a term of three years for gross proceeds to the Company of $2 million (the "2024 Private Placement"). Each Warrant entitles the holder thereof to subscribe for and purchase one Common Share at a purchase price of $0.20 for a period of three years from the date of issuance. If the closing price for the Common Shares on the TSX Venture Exchange is $0.25 or greater for five consecutive trading days, the Company will have the right to accelerate the expiry date of the Warrants, upon written notice to the holder, to the date that is 30 days following such notice.
On May 8, 2024, we announced the expansion of our collaborations with the University of British Columbia ("UBC") and our medicinal chemistry partner, Pharma Inventor Inc. The expansion of our research collaborations was initiated to support our AI Drug Discovery Platform. The wet lab infrastructure at UBC combined with the additional medicinal chemistry resources will allow the Company to quickly synthesize and evaluate lead drug candidates identified by the AI platform.
Summary Financial Results for the quarter ended June 30, 2024

For the three and six months ended June 30, 2024, the Company reported a net loss of $820,580 and $1,572,963, respectively. Research and development expenses were $479,785 and $918,768 for the three and six months ended June 30, 2024, respectively.

General and administrative expenses were $276,184 and $527,274 for the three and six months ended June 30, 2024, respectively. Total cash expenses related to research and development and general and administrative expenses for the three and six months ended June 30, 2024, were $605,465 and $1,128,170, respectively.

Selected Financial Information

As at June 30, 2024 $
Cash & cash equivalents 1,386,372
Working capital 932,980
Intangible assets 4,247,731
Total Assets 6,227,085
Total liabilities 2,420,349
Deficit (12,498,274)
Total equity 3,806,736
Statements of net loss and comprehensive loss data:

Description For the three months ended June 30, 2024 For the six months ended June 30, 2023
Research & Development $479,785 $918,768
General and Administrative $276,184 $527,274
Net loss and comprehensive loss $820,611 $1,572,963
Basic and diluted income (loss) per share $(0.01) $(0.02)
Operating cash burn $605,465 $1,128,170
Weighted average shares outstanding 70,709,288 70,397,106
Rakovina Therapeutics’ financial statements as filed with SEDAR can be accessed from the Company’s website at: View Source

Senior management of Rakovina Therapeutics will hold an information and update webinar on Wednesday, Sept. 4, 2024, at 9:30 A.M. Pacific Time/12:30 P.M. Eastern Time. Interested parties may sign up at https://bit.ly/3ACQCxe

On August 30, 2024 Kuano reported the successful completion of their Innovate UK funded project "Streamlined and Targeted Design of NOTUM Inhibitors as Colorectal Cancer Drugs" (Press release, Kuano, AUG 30, 2024, View Source [SID1234646235]).

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!

This work delivered in-vivo efficacy data for compounds designed using their computational platform. Launched in December 2022, the programme exceeded initial goals to demonstrate efficacy in cellular assays and validated the ability of Kuano’s combination of quantum simulation and artificial intelligence to accelerate drug discovery. These results provide the basis for the company to develop the lead molecule, further to provide a first in class drug addressing the challenge of treatment resistance in colorectal cancer.

The project funding not only allowed the development of novel drug candidates but the enhancement of the computational platform used to produce them. Kuano’s "Quantum Pharmacophore" provides unique insights into how molecules bind to target enzymes, enabling the identification of potential drug molecules in new areas of chemical space and facilitating their rapid refinement. Use of this approach enables Kuano to identify a lead molecule capable of reducing tumour size in less than 200 molecules, more than an order of magnitude more efficient than conventional approaches.

Molecules designed in-silico by the platform were tested in-vitro using a bespoke assay cascade developed during the project. The most advanced compound was as effective as a highly toxic chemotherapy agent (cisplatin) at killing bowel cancer cells, but had a much improved safety profile for healthy cells. This success provided us with the confidence to test the compound in mouse models (a cell derived xenograft). The data produced showed our compound is tolerated at high doses and reduced tumour size. To enable further development of the compound, and identification of the patient populations most likely to benefit, Kuano is planning further experiments (including organoid studies) starting in August 2024.

Vid Stojevic, CEO of Kuano Ltd, expressed his enthusiasm for the project’s progress:

"This project provides the first evidence that our vision for quantum informed drug design can provide transformational impacts by tailoring chemistry to meet the needs of specific targets. Ultimately this will enable us to develop a new generation of drugs to save and improve the lives of patients with hard to treat cancers."

Chris Sawyer, Innovation Lead, Digital Health at Innovate UK, added:

"Innovate UK is delighted to be able to support innovative projects like Kuano’s that is designed to meet the needs of patients with major diseases like bowel cancer."

On August 30, 2024 IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, off-the-shelf, immune-modulating therapeutic cancer vaccines based on its T-win platform, reported that an Independent Data Monitoring Committee (IDMC) recommended continuation of the company’s pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) of its lead investigational therapeutic vaccine, IO102-IO103, following a per-protocol interim analysis (Press release, IO Biotech, AUG 30, 2024, View Source [SID1234646234]). The trial is evaluating IO102-IO103 in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, as a first-line treatment for patients with unresectable or metastatic (advanced) melanoma. Based on their review of the safety and efficacy data, the IDMC recommended that the trial continue without modifications and noted that no new safety signals were observed. The primary endpoint of progression-free survival (PFS) is projected to be reached in the first half of 2025.

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 per-protocol interim analysis was performed one year after 225 patients were randomized in the trial. The interim efficacy analysis was intentionally set with a high statistical bar (p≤0.005), and based on the analysis, the IDMC determined that the data did not meet the criteria to declare superiority of ORR. The trial was designed to preserve most of the statistical alpha for the trial’s primary endpoint of PFS. The PFS analysis is event-driven and will be conducted when 226 events (disease progression or death) have been reported in the trial with independent central review. With 407 patients randomized, the trial is powered at 89% to detect a 35% reduction in the risk of an event.

"To date, none of the approved immunotherapeutic combinations for the treatment of advanced melanoma demonstrated statistical significance in ORR in large Phase 3 trials; nevertheless, these trials achieved statistical significance on PFS," said Mai-Britt Zocca, PhD, President and CEO of IO Biotech. "Based on the 25.5 months median PFS we observed in the Phase 1/2 trial of IO102-IO103 in combination with a PD-1 inhibitor in advanced melanoma, with no added significant systemic toxicity than that typically seen with anti-PD-1 monotherapy, we remain optimistic about meeting the primary endpoint of PFS, projected to occur in the first half of 2025."

Igor Puzanov, MD, MSCI, FACP, Director, Center for Early Phase Clinical Trials, Chief, Division of Melanoma, Department of Medicine and Investigator for the Phase 3 Study at Roswell Park Comprehensive Cancer Center, Buffalo, New York commented, "The incidence of melanoma is on the rise and new treatments are needed. This is a novel investigational immune-modulatory therapeutic cancer vaccine combined with an anti-PD-1 therapy that has the potential to transform the treatment paradigm with a new and better option for people battling advanced melanoma. I am eagerly awaiting the PFS primary endpoint readout of this Phase 3 trial that could further validate this novel cancer vaccine’s ability to help patients with advanced melanoma who are seeking more efficacious, low treatment-induced toxicity therapy options."

Jessica Hassel, MD, Head of the Section for Dermato-Oncology at the University Hospital Heidelberg, investigator and lead enroller for the Phase 3 trial added, "We have been seeing promising results using combination immunotherapeutic treatments and I remain confident that IO102-IO103 in combination with pembrolizumab could offer new hope for treating patients with advanced melanoma. I look forward to the full readout of data at the end of this trial to further understand the full potential of this investigational therapeutic cancer vaccine combined with an anti-PD-1 agent."

Dr. Zocca continued, "We continue to be enthusiastic about the encouraging preliminary data from our Phase 2 basket trial evaluating IO102-IO103 in combination with pembrolizumab for the treatment of metastatic non-small cell lung cancer (NSCLC) or recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). Data from the SCCHN cohort has been accepted for poster presentation at the ESMO (Free ESMO Whitepaper) congress, and data from the NSCLC cohort has been accepted to another medical meeting in the fall. We believe these data could provide further evidence to support the broader potential of therapeutic cancer vaccines for the benefit of patients in additional cancer indications."

About the IOB-013/KN-D18 Clinical Trial

IOB-013/KN-D18 (Clinical Trials.gov: NCT05155254) is an open label, randomized Phase 3 pivotal clinical trial of IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated, unresectable or metastatic (advanced) melanoma. A total of 407 patients have been enrolled from more than 100 centers across the United States, Europe, Australia, Turkey, Israel and South Africa. The primary endpoint of the study is progression-free survival, an event-driven analysis conducted when 226 events, defined as disease progression or death, have been reported in the study. Secondary endpoints include overall response rate (ORR), overall survival (OS), durable objective response (DRR), complete response rate (CRR), duration of response (DoR), time to complete response (TTCR), disease control rate (DCR), and incidence of AEs and SAEs (safety and tolerability). Biomarkers in the blood and tumor tissue will also be assessed. IO Biotech is sponsoring the Phase 3 trial and Merck is supplying pembrolizumab.

About IO102-IO103

IO102-IO103 is an investigational off-the-shelf therapeutic cancer vaccine designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase (IDO) positive and/or programmed death-ligand 1 (PD-L1) positive cells. The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) investigating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with advanced melanoma, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) investigating IO102-IO103 in combination with pembrolizumab as first line treatment in patients with solid tumors, and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) investigating IO102-IO103 in combination with pembrolizumab as neo-adjuvant/adjuvant treatment of patients with solid tumors.

The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck, which is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

On August 30, 2024 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported that it has voluntarily withdrawn its supplemental New Drug Application ("NDA") in China for fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric or gastroesophageal junction adenocarcinoma and will evaluate a new route forward (Press release, Hutchison China MediTech, AUG 30, 2024, View Source [SID1234646233]). Following an additional internal review of the current data package, in light of recent discussions with the National Medical Products Administration of China ("NMPA"), HUTCHMED has determined that the submission is unlikely to support an approval in China at this time.

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!

This supplemental NDA for fruquintinib was based on data from the Phase III FRUTIGA study, which was declared positive due to a statistically significant improvements in many clinically meaningful endpoints, including progression-free survival ("PFS"), which served as one of two primary endpoints. However, while an improvement was also observed in the second primary endpoint of median overall survival ("OS"), it was not statistically significant. Extensive subsequent analyses conducted indicate that, although the high and imbalanced proportion of patients receiving subsequent antitumor therapies confounded the OS effect, fruquintinib plus paclitaxel demonstrated meaningful clinical benefit and favorable OS trends through a variety of models. Furthermore, no new safety signals were observed, and fruquintinib plus paclitaxel showed a tolerable safety profile. However, it became clear from dialogue with the Centre for Drug Evaluation (CDE) of the NMPA and its external committee members that the current understanding and interpretation of the OS results could not serve as the basis of the supplemental NDA approval, and that further work needs to be undertaken.

Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED, commented, "Whilst disappointed by this outcome, we remain optimistic about the utility of fruquintinib in the treatment of gastric cancer. The data set from FRUTIGA demonstrates that fruquintinib plus paclitaxel could offer a promising new treatment option to certain patients in future, and we are driven to investigate this possibility thoroughly. We look forward to evaluating a path forward and would like to thank both the patients and principal investigators who took part in this study for contributing to a better understanding of this devastating disease."

Dr Rui-Hua Xu, Professor at the Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, added, "Gastric cancer is the fifth most common cancer worldwide and patients in China are currently underserved by available treatment options. Although the current data package would not support approval on this occasion, the Phase III study demonstrated clear benefits of this fruquintinib combination across many clinically meaningful endpoints and the team are committed to evaluating all options. Promising subgroup analyses are helping us to better understand how we can effectively combat this disease, and we remain hopeful that this study forms part of an important journey to a much-needed new therapy."

Fruquintinib is approved in China, the US and Europe for the treatment of previously-treated patients with metastatic colorectal cancer ("CRC"), and regulatory applications for this indication are progressing as expected in over a dozen jurisdictions. It works as an anti-cancer therapy by blocking tumor angiogenesis, a proliferation of blood vessels that is critical for cancer growth. It is a selective oral inhibitor of vascular endothelial growth factor receptors ("VEGFRs") 1, 2 and 3, and this pathway plays a key role in the pathogenesis of many solid tumors including gastric cancer.

An NDA in China for fruquintinib in combination with sintilimab in endometrial cancer was accepted with priority review status in April 2024, and a Phase III trial in China of fruquintinib in combination with sintilimab in renal cell carcinoma was fully enrolled in December 2023.

About the Phase III FRUTIGA Trial
FRUTIGA (NCT03223376) was a 1:1 randomized, double-blind, Phase III study conducted across 35 sites in China. It evaluated fruquintinib in combination with paclitaxel chemotherapy, compared with paclitaxel monotherapy, for second-line treatment in 703 patients with advanced gastric or gastroesophageal junction adenocarcinoma. The study was declared positive due to a statistically significant improvement in progression-free survival ("PFS"), one of two dual primary endpoints. Median PFS for patients who received fruquintinib plus paclitaxel was 5.6 months, compared to 2.7 months for those who received paclitaxel monotherapy (stratified hazard ratio ["HR"] = 0.569; p < 0.0001). An improvement was also observed in the dual primary endpoint of median overall survival (OS), (9.6 months vs. 8.4 months) but this was not statistically significant. Fruquintinib plus paclitaxel demonstrated statistically significant improvements in multiple other endpoints including objective response rate (ORR), disease control rate (DCR) and duration of response (DoR). It was well tolerated, with a safety profile consistent with expectations and previously reported studies.

Results were published in Nature Medicine and presented at the ASCO (Free ASCO Whitepaper) 2024 Annual Meeting, concluding that fruquintinib plus paclitaxel could be a promising second-line treatment option for patients with advanced gastric or gastro­esophageal adenocarcinoma, who have failed fluoropyrimidine- or platinum-containing chemotherapy.

About Gastric Cancer
Gastric cancer is a cancer that starts in the stomach. It is the fifth most common cancer worldwide in 2022. It was estimated to have caused approximately 660,000 deaths worldwide.[2] In China, it was estimated that over 359,000 people were diagnosed with gastric cancer, and approximately 260,000 people died from gastric cancer.

About Fruquintinib
Fruquintinib is a selective oral inhibitor of VEGFR-1, -2 and -3. VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for high drug exposure, sustained target inhibition, and flexibility for the potential use as part of combination therapy. Fruquintinib has demonstrated a manageable safety profile and is being investigated in combinations with other anti-cancer therapies.

About Fruquintinib Approval for metastatic CRC in China
Fruquintinib is approved for marketing in China, where it is co-marketed by HUTCHMED and Lilly under the brand name ELUNATE. It was included in the China National Reimbursement Drug List (NRDL) in January 2020. The approval was based on data from the FRESCO study, a Phase III pivotal registration trial of fruquintinib in 416 patients with metastatic CRC in China, which were published in The Journal of the American Medical Association, JAMA. Since its launch, fruquintinib has benefited over 100,000 patients in China.