On August 21, 2024 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its executives will be speaking at the following investor conferences (Press release, Gilead Sciences, AUG 21, 2024, View Source [SID1234646035]):

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!

Wells Fargo Healthcare Conference on Wednesday, September 4 at 11:00 AM Eastern Time
Morgan Stanley Annual Global Healthcare Conference on Thursday, September 5 at 12:20 PM Eastern Time
Baird Global Healthcare Conference on Tuesday, September 10 at 10:50 AM Eastern Time

The live webcasts can be accessed at the company’s investors page at investors.gilead.com . The replays will be available for at least 30 days following the presentation.

On August 21, 2024 Starpharma (ASX: SPL, OTCQX: SPHRY), an innovative biotechnology company with two decades of experience in advancing dendrimer technology from the lab to the patient, reported its annual report and full-year financial results for the year ended 30 June 2024 (Press release, Starpharma, AUG 21, 2024, View Source;mc_eid=bf52dd3418 [SID1234646036]).

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!

Starpharma’s Chief Executive Officer, Cheryl Maley, commented:

"Starpharma is pleased to present its annual report and full-year financial results for the 2024 financial year. Starpharma achieved several important milestones during the year, including reporting results from multiple clinical studies, advancing key projects in our pipeline, and forming new partnerships, all of which will contribute to our continued growth.

"Our primary focus remains on delivering impactful healthcare, medical, and pharmaceutical solutions that not only drive value for our shareholders but also make a meaningful difference in the lives of people, especially those battling serious illnesses like cancer.

"We are aware of the challenges we face with our underperforming share price and small market capitalisation. Everyone at Starpharma is committed to realising our strategic imperatives – maximising DEP asset value, accelerating early asset development, and building long-term sustainability – and we are taking the necessary steps to achieve them. We are confident that reaching these goals will help to increase shareholder value, and we look forward to sharing our progress with our shareholders as it unfolds.

"Importantly, we have sufficient capital to support our objectives, with a cash balance of $23.4 million as at 30 June 2024. The completion of several clinical programs has led to a reduction in our research and development expenses, extending our cash runway. Shareholders should know that we are focusing on increasing revenue, with a number of opportunities on the horizon."

Key Financial Results

Ended the 2024 financial year with $23.4 million cash on hand.
Reported loss down 48% to $8.2M (FY23: $15.6M).
Net cash outflow of $11.8 million (FY23 $14.8 million), with cash outflow from operations of $6.9 million, down $7.4 million from FY23 ($14.3 million)
Revenue up 132% to $9.8M (FY23: $4.2M), including the one-time $6.6M cash payment from Mundipharma on termination of the VivaGel BV license and supply agreement.
Starpharma received a $7.2 million FY23 R&D tax incentive refund in October 2023, with a further FY24 R&D tax incentive refund of approximately $5.0 million expected in H1 FY25.
Operational Highlights

Reported the results from all three Phase II clinical trial programs – DEP SN38, DEP cabazitaxel, and DEP docetaxel. All three programs provided clinical validation of the DEP technology; over 350 patients have now been treated using DEP products. The trials showed promising anti-tumour activity and improvements in efficacy, including longer median progression-free survival (mPFS) and higher overall survival (OS) rates, than published data on standard-of-care treatment regimens. The DEP products also demonstrated improved tolerability profiles in patients with advanced, heavily pre-treated cancers, including lower rates of severe adverse events, compared with standard-of-care treatments. Importantly, the DEP treatments extended the lives of many patients and allowed many to live more fulfilling and enriched lives.

Confirmed plans to progress Starpharma’s DEP HER2 radiodiagnostic program towards a first-in-human clinical trial, following promising early-stage imaging data in HER2-positive (HER2+) cancers. Starpharma’s DEP radiopharmaceuticals program continues to show that DEP dendrimers are a promising, versatile, and multifunctional platform for developing precision radiotheranostics for cancer imaging and therapeutic applications. This dendrimer technology bridges the gap between small molecules and large antibodies, offering the potential to improve performance and overcome limitations associated with existing technologies and treatments.

Partnered with Medicxi, a leading life sciences investment firm, to co-found Petalion Therapeutics, an asset-centric company focusing on developing a novel cancer therapy using Starpharma’s dendrimer technology. Starpharma receives an equity holding of 22.5% in Petalion in return for licensing certain intellectual property for the research, development, and commercialisation of this potential new cancer therapy.

Presented the advantages of Starpharma’s DEP dendrimer technology in oncology at multiple international industry conferences, including the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in the US, the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in the US, the International Conference on Molecular Targets, co-hosted by the American Association of Cancer Research (AACR) (Free AACR Whitepaper), National Cancer Institute (NCI), and the European Organisation for Research and Treatment of Cancer (EORTC) in the US, and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting in Canada.

Partnered with ITROM Pharmaceutical Group to sell and distribute VivaGel BV in 13 countries across the Middle East and North Africa region. Bacterial vaginosis is highly prevalent in this region, presenting a market need and commercial opportunity for new and effective therapeutic approaches. This agreement came shortly after Starpharma terminated the VivaGel BV license to Mundipharma, regained the commercial rights to Mundipharma’s territories, and received a one-time A$6.6 million cash payment from Mundipharma.

Generated clinical evidence demonstrating the effectiveness of Viraleze in humans. The results from the post-market clinical study of Viraleze in COVID-19 patients showed that Viraleze achieved a statistically significant reduction in SARS-CoV-2 viral load in the cohort of patients aged 45 and over. This data will support the regulatory transition to the new European Medical Device Regulations, which come into full effect in 2029. The findings will also support ongoing marketing and commercial activities.

Achieved Great Place to Work certification for the second consecutive year. This external recognition is a testament to our team’s positive workplace environment and company culture.

On August 21, 2024 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that Company management will participate in the following investor conferences (Press release, Jazz Pharmaceuticals, AUG 21, 2024, View Source [SID1234646037]):

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!

Wells Fargo Healthcare Conference on Wednesday, September 4, 2024

Fireside chat at 7:15 a.m. PT / 10:15 a.m. ET / 3:15 p.m. IST

Bank of America Global Healthcare Conference on Wednesday, September 18, 2024

Fireside chat at 7:55 a.m. PT / 10:55 a.m. ET / 3:55 p.m. IST

Audio webcasts of the fireside chats will be available via the Investors section of the Jazz Pharmaceuticals website at View Source A replay of the webcasts will be archived on the website for 30 days.

On August 21, 2024 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported that China’s National Medical Products Administration (NMPA) has approved Dupert（fulzerasib）for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation who have received at least one systemic therapy (Press release, Innovent Biologics, AUG 21, 2024, View Source [SID1234646038]). As China’s first approved KRAS G12C inhibitor, Dupert is Innovent’s eleventh product in its commercial portfolio and is anticipated to soon benefit more lung cancer patients with the KRAS G12C mutation.

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!

Lung cancer has one of the highest incidence and mortality rates worldwide, with non-small cell lung cancer (NSCLC) being the most common type, comprising about 85% of all lung cancer cases. KRAS mutations are common driver gene mutations in NSCLC but rarely co-exist with other driver mutations like EGFR and ALK. As a result, patients with advanced NSCLC and KRAS G12C mutations often cannot benefit from the multiple drugs currently available that target these mutations or rearrangements. After the initial standard treatment for this population, there are limited second-line options, which have low effectiveness and poor prognosis.

The NDA approval is based on the results from a single-arm registrational Phase 2 clinical study (NCT05005234) intended to evaluate the efficacy and safety of fulzerasib monotherapy in advanced NSCLC patients with KRAS G12C mutation who failed or were intolerant to the standard treatment in China. The updated data from this registration study has been published in full manuscript in the Journal of Thoracic Oncology (JTO).

As of the data cutoff date (Dec 13, 2023), a total of 116 NSCLC subjects were enrolled and evaluable. Fulzerasib was generally well-tolerated and demonstrated encouraging antitumor activity. The confirmed objective response rate (ORR) assessed by the Independent Radiology Review Committee (IRRC) was 49.1% (95% CI: 39.7-58.6). Disease control rate (DCR) was 90.5% (95%CI: 83.7, 95.2). The median duration of response (DoR) was not reached. Median progression-free survival (PFS) was 9.7 months (95%CI: 5.6-11.0), and median overall survival (OS) was not yet reached.

Professor Yi-Long Wu from Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital, stated: "KRAS has long been considered an ‘undruggable’ target despite being a common oncogenic driver mutation. The advent of KRAS G12C inhibitors has opened new avenues for precision medicine in cancers harboring this mutation. We are proud to be part of the clinical research and development of Dupert, the first KRAS G12C inhibitor approved in China. We hope that Dupert will soon benefit more patients with advanced lung cancer harboring KRAS G12C mutations, driving the progress of precision treatment for lung cancer."

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "Patients with advanced NSCLC harboring KRAS G12C mutations have limited treatment options, with traditional chemotherapy offering minimal benefits. We are excited that Dupert has become the first KRAS G12C inhibitor approved in China, marking the beginning of a new era in targeted therapy for KRAS mutations. As Innovent’s eleventh drug, Dupert further strengthens our robust oncology portfolio. Innovent will continue to leverage its leadership and expertise in oncology to drive innovation in cancer treatment and serve more patients in need."

About Dupert (Fulzerasib, KRAS G12C Inhibitor)

RAS protein family can be divided into KRAS, HRAS and NRAS categories. KRAS mutation are detected in nearly 90% of pancreatic cancer, 30-40% of colon cancer, and 15-20% lung cancer patients. The occurrence of KRAS G12C mutation subset is more frequently observed than those with ALK, ROS1, RET and NTRK 1/2/3 mutations combined.

Fulzerasib is a novel, orally active, potent KRAS G12C inhibitor designed to effectively target the GTP/GDP exchange, an essential step in pathway activation, by modifying the cysteine residue of KRAS G12C protein covalently and irreversibly. Preclinical cysteine selectivity studies demonstrated high selectivity of fulzerasib towards G12C. Subsequently, fulzerasib effectively inhibits the downstream signal pathway to induce tumor cells’ apoptosis and cell cycle arrest.

In September 2021, Innovent and GenFleet Therapeutics entered into an exclusive license agreement for the development and commercialization of fulzerasib (Innovent R&D code: IBI351, GenFleet R&D code: GFH925) in China (including mainland China, Hong Kong, Macau and Taiwan).

In January 2023, the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for fulzerasib for the treatment of patients with advanced NSCLC harboring KRAS G12C mutation who have received at least one systemic therapy. In May 2023, the CDE of China’s NMPA granted another BTD for fulzerasib for the treatment of advanced CRC patients with KRAS G12C mutation who have received at least two systemic therapies.

In August 2024, the CDE of NMPA has approved fulzerasib for the treatment of advanced NSCLC adult patients harboring KRAS G12C mutation who have received at least one systemic therapy.

On August 20, 2024 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that the first patient has joined its Multi-Cancer Early Detection (MCED) Falcon Registry Real-World Evidence (RWE) study at Baylor Scott & White, the primary study site and largest not-for-profit health system in Texas (Press release, Exact Sciences, AUG 20, 2024, View Source [SID1234646006]). The multi-site study will enroll up to 25,000 patients, evaluating the clinical performance, patient and provider experience, and psychological impact of MCED testing over a five-year period. Endeavor Health, a Chicago-area health system serving more than 1.4 million patients, will start enrolling patients this fall. The U.S. Food and Drug Administration (FDA) recently authorized an investigational device exemption (IDE) for the Exact Sciences MCED test, allowing its use in the Falcon Registry. This study will provide valuable insight to further inform the development and commercialization of the company’s future MCED test and support discussions with regulatory agencies, payers, and guideline bodies.

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!

"Exact Sciences is dedicated to advancing an MCED test, as it offers a highly promising way to make an impact on the burden of cancer," said Tom Beer, M.D., chief medical officer and vice president, multi-cancer early detection, Exact Sciences. "Too often, cancers go undetected until symptoms appear, resulting in diagnoses at advanced, less treatable stages. Early detection through screening improves outcomes, yet two-thirds of cancer cases and deaths are due to cancers that do not have recommended screening options. 1 Our collaboration with Baylor Scott & White and Endeavor Health is a crucial step forward and represents a tremendous opportunity to help transform cancer care."

To better understand the impact of MCED testing on patient care, the study will use a registry approach, tracking patient data over time to evaluate outcomes and improve future treatments. Up to 25,000 patients ages 50-80 with no history of cancer will participate in annual MCED testing for three years and two additional years of follow-up data collection. Data will also be collected for a comparator cohort of up to 50,000 patients, demographically and clinically similar to the study cohort but receiving standard care without the MCED test. The Exact Sciences MCED test features two high-performing biomarker classes known for their ability to identify cancer early, offering sensitivity and specificity that can detect aggressive cancers and those lacking current standard of care screening. 2

"With this important work, we aim to intercept cancer earlier than ever before," said Ronan Kelly, M.D., principal investigator of the MCED Falcon Registry Real-World Evidence study. Dr. Kelly is the director of oncology, Baylor Scott & White Charles A. Sammons Cancer Center at Baylor University Medical Center — Dallas, and chief of oncology, North Texas Division, Baylor Scott & White Health. "We are eager to do our part in the national effort to decrease cancer mortality by 50% over the next 25 years, as outlined in the U.S. government’s Cancer Moonshot initiative. This important study is helping advance proactive cancer detection efforts, and we are excited to help close gaps in existing cancer screening programs."

Cancer remains the second leading cause of death in the United States, with over 2 million new cases and approximately 611,000 deaths projected for 2024. 3 Advancing early detection through innovative approaches like MCED testing has never been more critical. Baylor Scott & White and Endeavor Health, located in distinct parts of the country and serving a diverse range of communities, will help reach a broad representative group of Americans and provide insights on the potential benefits of early detection across diverse populations.

"Implementing MCED testing and advancing preventative genomics are crucial steps in addressing the ‘last mile’ problem in health care," said Peter Hulick, M.D., the Janardan D. Khandekar, M.D., chair of personalized medicine and the director of the Mark R. Neaman Center for Personalized Medicine at Endeavor Health. "The Falcon Registry is a pivotal research study to meet the real-world challenges of implementation and aligns with the broader vision of the Davis Family Center for Preventive Genomics at Endeavor Health, which is to assist patients, their families, and caregivers in making better-informed decisions about early diagnosis, prevention strategies, and personalized treatment options."

The Exact Sciences MCED test is available to patients who have consented and enrolled in the Falcon Registry study. It has not been cleared or approved by the U.S. Food and Drug Administration or other notified regulatory authority. The test was developed and its performance characteristics validated by Exact Sciences Laboratories following College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) regulations. The test is performed at Exact Sciences Laboratories. Exact Sciences Laboratories is accredited by CAP, certified under CLIA regulations, and qualified to perform high-complexity clinical laboratory testing.