On August 29, 2023 PureTech Health plc reported its half yearly results for the six months ended June 30, 2023. The following information will be filed on Form 6-K with the United States Securities and Exchange Commission (the "SEC") and is also available at View Source (Press release, PureTech Health, AUG 29, 2023, View Source [SID1234634953]).

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!

Commenting on PureTech’s half-yearly results, Daphne Zohar, Founder and Chief Executive Officer of PureTech, said:

"The first half of 2023 has been a strong period across both our Founded Entities and Wholly Owned Pipeline. We have achieved important clinical and financial milestones, while executing on our mission of giving life to new classes of medicine to change the lives of patients with devastating diseases. Our R&D engine has produced 27 new therapeutics and therapeutic candidates, with two taken from inception at PureTech to U.S. Food and Drug Administration (FDA) and European regulatory clearances and a third that is expected to be filed soon for FDA approval. We are proud that our track record of clinical success is six times greater than the industry average.2

"The maturation of our Wholly Owned Programs now gives us several pathways to realize their value as we determine the ideal path for each program’s advancement – this may be through internal development, the creation of new Founded Entities, asset sales, and/or partnering and royalty transactions – and we will be guided by the optimal route to generate value for our shareholders. We are proud that for nearly six years, including during a time that was extremely challenging to the biotech sector at large, we not only created important new medicines, but we also generated almost $800 million in cash without approaching the capital markets or diluting our shareholders. This has allowed us to focus on what we do best: recognize value in potential new medicines before anyone else sees it and unlock that value through focused experiments, relentlessly prioritizing and advancing programs with the highest probability of success.

"Our unique model and disciplined execution have provided a safe harbor through the stormy market challenges, and while we can navigate in any environment, we are also very well-positioned to benefit if the tides potentially turn in favor of the biotech sector.

"I am tremendously proud of the achievements across our Founded Entities and Wholly Owned Pipeline, and I am grateful to our skilled and dedicated team who continue to shepherd this important work forward. I look forward to another exciting period ahead and to sharing more about our progress in the coming months."

On August 29, 2023 Evotec reported its Half-year Interim Report 2023 (Filing, 3 mnth, JUN 30, Evotec, 2023, AUG 29, 2023, View Source [SID1234634894]).

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 August 29, 2023 Diversified biotechnology company CCM Biosciences reported it launched from stealth today with more than ten drug programs, many of which originated from CCM Biosciences’ proprietary drug discovery platforms (Press release, CCM Biosciences, AUG 29, 2023, View Source [SID1234634784]). CCM Biosciences is partnered with the global chemical and pharmaceutical manufacturing company PMC Group for the Chemistry, Manufacturing, and Controls (CMC) of its drug programs. The CCM-PMC partnership offers a fully integrated ecosystem for the discovery, development, and manufacturing of drug candidates addressing some of the most significant unmet medical needs. The company has raised more than $25M in financings including Series A1 and A2 rounds at a multi-hundred million dollar valuation.

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!

Diverse Portfolio of First-in-Class Drug Candidates
CCM Biosciences possesses an expansive portfolio of novel product candidates including disruptive KRAS therapeutics that target the oncogene responsible for 25% of all cancers, selective first-in-class degraders of oncogenic kinases for lung cancer and leukemia, inhibitors of the master immune regulator cGAS for autoimmune disorders, therapies for nonsense mutations that account for 10% of all genetically inherited diseases, and disruptive drug candidates for mitochondrial upregulation relevant to a host of age-related disorders such as Parkinson’s, Alzheimer’s, and infertility.

Several of CCM Biosciences’ novel drug candidates have already reached significant development milestones. Extensive validation of the drugs’ scientific foundations has appeared in multiple peer-reviewed publications. Investigational New Drug applications are expected to be filed with the FDA in the near future, based on clinical trial plans developed with leading medical experts from institutions including Cleveland Clinic and Ohio State University. Dr. Sudipto Mukherjee, clinical trials investigator for CCM Biosciences’ autophagy inhibitor drug program and a hematologist-oncologist at Cleveland Clinic’s Taussig Cancer Institute, expressed his enthusiasm about the program saying, "CCM’s program, in-licensed from Cleveland Clinic and lead optimized at CCM, has the potential to address a significant unmet need in leukemia treatment."

Leadership Team with Deep Expertise in Scientific Innovation, Chemical Engineering and Finance
Dr. Raj Chakrabarti (Harvard AB, Princeton PhD; formerly Professor of Chemical Engineering at Carnegie Mellon and Purdue Universities), co-founder and CEO of CCM Biosciences and President of PMC Group International, founded CCM Biosciences based on technology platforms he developed in academia in the areas of chemical biology, computational biophysics, systems biology, and synthetic biology. These platforms, which merge experimental high-throughput screening with physics-based computational methods and learning algorithms, have been responsible for the discovery of more than half of CCM Biosciences’ drug candidates and all its diagnostic tests and continuously feed its pipeline of drug leads to address areas with significant unmet need. CCM’s diagnostic technology platform builds off of patented technologies originating in the PhD thesis work in nucleic acid polymerization and sequencing of Chakrabarti that are licensed to CCM Biosciences and are among the top 5 revenue-generating patents in the history of Princeton University, according to the university’s Office of Technology Licensing. Chakrabarti’s patent income as a biotechnology inventor provided $2M seed funding for CCM.

Dr. Anisha Ghosh, co-founder of CCM Biosciences and Professor of Finance at McGill University, oversees the choice of drug programs comprising the company’s portfolio, as well as allocation of capital among them based on modern quantitative methods for asset management, given the diversity of the company’s portfolio. Ghosh’s research in asset pricing and portfolio management has been published in leading journals including the Journal of Finance and Review of Financial Studies, and has been the subject of invited lectures at leading venues ranging from the National Bureau of Economic Research to the Institute for Quantitative Research in Finance. She stated: "Our cost-effective approach to reaching the current stage in CCM Biosciences’ lifecycle offers a unique story against the backdrop of heavily funded, albeit risky biotech companies."

PMC Group’s leadership, having helmed the growth of one of the fastest-growing chemical companies in the US for over 25 years, also brings market-leading expertise in chemical manufacturing to the partnership.

On August 29, 2023 Novocure (NASDAQ: NVCR) reported that data from the randomized phase 3 LUNAR clinical trial evaluating the use of Tumor Treating Fields (TTFields) therapy together with standard systemic therapies for the treatment of metastatic non-small cell lung cancer (NSCLC) following progression on or after platinum-based therapy have been published in The Lancet Oncology (Press release, NovoCure, AUG 29, 2023, View Source [SID1234634769]).

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 presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, the LUNAR trial met its primary endpoint, showing a statistically significant and clinically meaningful 3-month improvement in median overall survival (OS) when TTFields therapy was added to physician’s choice of immune checkpoint inhibitor (ICI) or docetaxel (HR: 0.74, P=0.035). The data demonstrate the efficacy and safety of TTFields therapy in this setting, with no systemic toxicities or new safety signals. In addition, patient-reported data suggest there was no quality-of-life burden associated with adding TTFields therapy to standard therapy.

"The results of the LUNAR trial support the use of Tumor Treating Fields therapy in metastatic NSCLC in the second line and beyond," said primary investigator Ticiana Leal, M.D., a researcher and medical oncologist at Winship Cancer Institute of Emory University and associate professor and director of the Thoracic Medical Oncology Program in the Department of Hematology and Medical Oncology at Emory University School of Medicine in Atlanta. "This is a promising development for a population of patients with limited treatment options. The results suggest that Tumor Treating Fields therapy can safely be used along with standard systemic therapies to extend survival without reducing quality of life."

Patients randomized to receive TTFields therapy together with standard therapies (n=137) demonstrated median OS of 13.2 months compared to 9.9 months in patients treated with standard therapies alone (n=139). Patients randomized to receive TTFields therapy and physician’s choice ICI (n=66) demonstrated a median OS of 18.5 months versus a median OS of 10.8 months in patients treated with an ICI alone (n=68; HR=0.63; P=0.03). Patients randomized to receive TTFields therapy and docetaxel (n=71) had a positive survival trend with a median OS of 11.1 months vs 8.7 months in patients treated with docetaxel alone (n=71). TTFields therapy was well-tolerated with no added systemic toxicities and few grade 3 (no grade 4 or 5) device-related adverse events.

"We are pleased the LUNAR trial results have been published in The Lancet Oncology, one of the most influential medical journals in the field of cancer research," said William Doyle, Novocure’s Executive Chairman. "The LUNAR data demonstrate the benefit of TTFields therapy for patients with metastatic non-small cell lung cancer. We are eager to make our therapy available to this patient population with high unmet needs, and we are confident TTFields therapy has a place in current and future standards of care."

The LUNAR clinical trial data are expected to serve as the basis for a Premarket Approval (PMA) submission to the U.S. Food and Drug Administration in the second half of 2023. Novocure recently completed the LUNAR submission for CE mark.

Read the full article in the latest issue of The Lancet Oncology.

About LUNAR

LUNAR was a phase 3 trial testing the safety and effectiveness of TTFields therapy when used together with ICI or docetaxel (experimental arm) versus ICI or docetaxel alone (control arm) for patients with metastatic NSCLC who progressed during or after platinum-based therapy. It is estimated that approximately 46,000 patients receive second-line treatment for metastatic NSCLC each year in the U.S. The primary endpoint was superior overall survival of patients treated with TTFields therapy plus ICI or docetaxel versus ICI or docetaxel alone. The powered secondary endpoints were superior overall survival of patients treated with TTFields therapy plus ICI versus ICI cohort and superior overall survival of patients treated with TTFields therapy plus docetaxel versus docetaxel alone. TTFields therapy is intended principally for use with other concomitant standard therapies, and LUNAR was designed to generate data that contemplates multiple outcomes, all of which Novocure believes will be clinically meaningful.

About NSCLC

Lung cancer is the most common cause of cancer-related death worldwide, and NSCLC accounts for approximately 85% of all lung cancers. It is estimated that approximately 193,000 patients are diagnosed with NSCLC each year in the U.S. Physicians use different combinations of surgery, radiation and pharmacological therapies to treat NSCLC, depending on the stage of the disease. Surgery, which may be curative in a subset of patients, is usually used in early stages of the disease. Since 1991, radiation with a combination of platinum-based chemotherapy drugs has been the first-line standard of care for locally advanced or metastatic NSCLC. Certain immune checkpoint inhibitors have been approved for the first-line treatment of NSCLC and the standard of care in this setting appears to be evolving rapidly. The standard of care for second-line treatment is also evolving and may include platinum-based chemotherapy for patients who received immune checkpoint inhibitors as their first-line regimen, docetaxel, immune checkpoint inhibitors or pemetrexed.

On August 29, 2023 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported that its management team will present at the 21st Annual Morgan Stanley Global Healthcare Conference on Tuesday, September 12, 2023 at 4:55 p.m. Eastern Time in New York, NY at the Sheraton New York (Press release, Personalis, AUG 29, 2023, View Source [SID1234634768]).

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!