On August 30, 2024 Jacobio Pharma (1167.HK), a clinical-stage oncology company focusing on undruggable targets, reported that it has granted the China rights (including mainland China, Hong Kong, Macau, and Taiwan) of KRAS G12C inhibitor glecirasib and SHP2 inhibitor JAB-3312 to Shanghai Allist Pharmaceuticals Co., Ltd (688578.SH) (Press release, Jacobio Pharmaceuticals, AUG 30, 2024, View Source [SID1234646240]).

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According to the terms of the agreement, Jacobio shall receive around RMB200 million in the near term, which includes an upfront payment of RMB150 million, and around RMB50 million of compensation for research and development expenses and other payments. Additionally, the potential milestone payments upon achieving certain development, regulatory and commercial milestones are up to RMB700 million. Jacobio is also entitled to receive tiered double-digit royalty payments on net sales of glecirasib and JAB-3312 from Allist, among which the royalty payments on net sales of JAB-3312 is up to 20%. The above amount includes value-added tax. Allist will be responsible for the commercialization of glecirasib and JAB-3312 in China and pay the subsequent clinical development costs in China. This marks that Jacobio has officially entered the commercialization stage, and the research and development of SHP2 has also ushered in a new milestone.

Dr. Wang Yinxiang, Chairman and CEO of Jacobio, said: "We are delighted to reach this cooperation with Allist. Allist has strong commercialization capabilities in the field of lung cancer, and the first indication for glecirasib submitted the new drug application is lung cancer. We believe that with the deep fit of the advantages of both parties, this collaboration will demonstrate great clinical and commercial value. In addition to the cooperation with glecirasib, Allist also licensed-in the SHP2 inhibitor JAB-3312, which is the first SHP2 inhibitor entering a registrational trial globally. It is expected to become a first-line therapy in combo with glecirasib, which reflects Allist’s foresight into the future of pipelines. We also look forward to jointly accelerating the development and commercialization of the two products to meet the clinical needs of more patients. "

Jinhao Du, the Chairman and general manger of Allist, said: "we are please to cooperate with Jacobio, and the cooperation will surely benefit the growth of both companies. For many years, Allist has taken ‘Technology Cares for Life’ as our corporate mission, focusing on scientific exploration and drug development in the field of cancer therapies, and is committed to developing and introducing superior pipelines consisting of best-in-class and first-in-class drugs. While we successfully independently developed and launched furmonertinib, we have built a commercial team that focuses on lung cancer, has professional academic promotion capabilities, and has a wide sales channel coverage. Since its launch, furmonertinib has achieved remarkable sales performance. Jacobio is a very outstanding innovative biotech company that has successfully developed and promoted a number of excellent products with great clinical value, including the KRAS G12C inhibitor glecirasib and the SHP2 inhibitor JAB-3312. We are very optimistic about the clinical advantages and market prospects of these two products. In this cooperation, Allist will give full play to its advantages in clinical development and commercialization capabilities to benefit more Chinese patients and create value for both companies."

The new drug application for glecirasib monotherapy for second-line non-small cell lung cancer (NSCLC) with KRAS G12C mutation was granted priority review on May 21, 2024. In December 2022, it was granted breakthrough therapy designation (BTD) Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the second-line and above treatment of patients with advanced or metastatic NSCLC with KRAS G12C mutation. In April 2024, the data of the pivotal Phase II study of glecirasib published by Jacobio in the ASCO (Free ASCO Whitepaper) Plenary Series showed that in patients with second-line NSCLC, the confirmed objective response rate (cORR) was 47.9% (56/117), including 4 patients achieved a complete response (CR) and 36 patients with tumor reduction exceeding 50%. Disease control rate (DCR) was 86.3%. The median progression-free survival (mPFS) was 8.2 months, and median overall survival (mOS) was 13.6 months.

The first patient dosed in the Phase III clinical trial of KRAS G12C inhibitor glecirasib and SHP2 inhibitor JAB-3312 versus standard care (chemotherapy and anti-PD-1 antibody) in front-line KRAS G12C mutant NSCLC in August 2024. According to the Phase I/IIa data presented at the ASCO (Free ASCO Whitepaper) Annual Meeting, the optimal dose group was glecirasib at 800mg daily combined with JAB-3312 at 2mg daily one week on and one week off. The cORR of the optimal dose group was 77.4% (24/31), and 54.8% (17/31) of patients achieved a deep response with tumors shrinking by more than 50%. Regarding on the safety data, among the 194 all-dosage patients, the incidence of grade 3 or 4 treatment-related adverse events (TRAE) was 43.8%, and there was no treatment-related death. The overall safety is manageable.

In addition, the pivotal studies of glecirasib monotherapy for second-line or above pancreatic cancer, glecirasib monotherapy and in combination with cetuximab for colorectal cancer with are also undergoing. In terms of pancreatic cancer, in April 2024, glecirasib was granted orphan drug designation from Food and Drug Administration (FDA) for pancreatic cancer indications; in August 2023, it was granted BTD by CDE of NMPA for the treatment of second-line or above pancreatic cancer patients with KRAS G12C mutations. The combination of glecirasib and cetuximab for the treatment of colorectal cancer was approved for registrational phase III clinical trial in China in May 2024.

About Glecirasib
Glecirasib is a KRAS G12C inhibitor developed by Jacobio. A number of clinical trials of glecirasib are currently ongoing in China, the United States and Europe for patients with advanced solid tumors harboring KRAS G12C mutation. These include combination therapy trials with SHP2 inhibitor JAB-3312 in NSCLC and with cetuximab in colorectal cancer. The pancreatic cancer indication has obtained orphan drug designation in the United States and breakthrough therapy designation in China.

About JAB-3312
JAB-3312 is a highly selective SHP2 allosteric inhibitor with best-in-class potential. Jacobio is currently conducting clinical trials of JAB-3312 in monotherapy and combination therapies with glecirasib and other agents in China, the United States and Europe. The phase III study in combination with KRAS G12C inhibitor glecirasib has been approved by China CDE in Feb 2024.

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]).

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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]).

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"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]).

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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.

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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.