Ipsen delivers strong results in the first half of 2024, progresses on launches and upgrades its full-year guidance

On July 25, 2024 Ipsen, a global specialty-care biopharmaceutical company, reported its financial results for the first half of 2024 (Press release, Ipsen, JUL 25, 2024, View Source [SID1234645314]).

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!

Business highlights
» U.S. regulatory approvals and launches of Onivyde (irinotecan) in first-line pancreatic cancer and Iqirvo (elafibranor) in second-line primary biliary cholangitis, respectively
» In-licensing of tovorafenib outside the U.S.: an attractive addition to our Oncology pipeline
» Multiple early-stage external-innovation transactions across Oncology and Neuroscience

Financial highlights
» Total-sales growth of 9.5% at CER1 , or 8.0% as reported, driven by the performances of Cabometyx (cabozantinib) and Dysport (abobotulinumtoxinA), as well as contributions from Bylvay (odevixibat) and Onivyde
» Core operating margin of 32.4%, a decline of 1.6% points, driven mainly by enhanced R&D investment. An unchanged IFRS operating margin of 19.2%
» Upgraded 2024 financial guidance: total-sales growth greater than 7.0% at CER1 (prior guidance: greater than 6.0% at CER1 ); core operating margin greater than 30.0% of total sales (prior guidance: around 30%)

Novocure Reports Second Quarter 2024 Financial Results

On July 25, 2024 Novocure (NASDAQ: NVCR) reported financial results for the quarter ended June 30, 2024 (Press release, NovoCure, JUL 25, 2024, View Source [SID1234645100]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields).

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 second quarter was a period of consistent execution at Novocure," said Asaf Danziger, Novocure’s Chief Executive Officer. "We began the year with three key objectives – grow our commercial business in glioblastoma, launch our next indication in non-small cell lung cancer, and deliver on the promise of our clinical and product development pipelines. I am pleased to share we have made significant progress on all fronts this quarter."

Financial updates for the second quarter ended June 30, 2024:

Total net revenues for the quarter were $150.4 million, an increase of 19% compared to the same period in 2023. This increase is primarily driven by our successful launch in France and improved U.S. approval rates.
The United States, Germany, France and Japan contributed $95.7 million, $15.1 million, $14.3 million and $7.7 million, respectively, with other active markets contributing $11.8 million.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $5.8 million.
Improved approval rates in the U.S. resulted in $5.0 million of increased net revenue from prior period claims during the quarter. In addition, we received $2.6 million in net revenues from a private payer in the United Kingdom where payments are not routine. We do not expect these two benefits, totaling $7.6 million, to recur.
Gross margin for the quarter was 77%.
Research, development and clinical studies expenses for the quarter were $55.0 million, a decrease of 1% from the same period in 2023.
Sales and marketing expenses for the quarter were $56.6 million, a decrease of 3% compared to the same period in 2023. This primarily reflects lower personnel expenses associated with support functions.
General and administrative expenses for the quarter were $37.7 million, a decrease of 8% compared to the same period in 2023. This primarily reflects lower personnel expenses.
Net loss for the quarter was $33.4 million with loss per share of $0.31.
Adjusted EBITDA* for the quarter was $1.1 million.
Cash, cash equivalents and short-term investments were $951.2 million as of June 30, 2024.
Operational updates for the second quarter ended June 30, 2024:

1,634 prescriptions were received in the quarter, an increase of 5% compared to the same period in 2023. Prescriptions from the United States, Germany, France and Japan contributed 957, 206, 176 and 108 prescriptions, respectively, with the remaining 187 prescriptions received in other active markets.
As of June 30, 2024, there were 3,963 active patients on therapy, an increase of 11% compared to the same period in 2023. Active patients from the United States, Germany, France and Japan contributed 2,175, 538, 369 and 403 active patients, respectively, with the remaining 478 active patients contributed by other active markets.
Quarterly updates and achievements:

In June, we presented positive results from the phase 3 METIS trial, evaluating the use of TTFields therapy and supportive care for the treatment of patients with brain metastases from non-small cell lung cancer (NSCLC) following stereotactic radiosurgery at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. The METIS trial met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression for adult patients treated with TTFields therapy and supportive care compared to patients treated with supportive care alone.
In June, we presented top-line results from the prospective, non-interventional TIGER study at the 2024 ASCO (Free ASCO Whitepaper) annual meeting. TIGER investigated the use of TTFields therapy in routine clinical use in the treatment of newly diagnosed GBM in Germany. The outcomes observed in the TIGER study are consistent with the survival and safety results from our phase 3 EF-14 clinical trial. TTFields therapy use was not associated with an increase in systemic toxicity and was well tolerated.
Anticipated clinical milestones:

Top-line data from phase 3 PANOVA-3 clinical trial in locally advanced pancreatic cancer (Q4 2024)
Conference call details

Novocure will host a conference call and webcast to discuss second quarter 2024 financial results at 8:00 a.m. EDT today, Thursday, July 25, 2024. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link.

The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

Summit Therapeutics and MD Anderson Announce Strategic Collaboration to Accelerate Development of Ivonescimab

On July 25, 2024 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") and The University of Texas MD Anderson Cancer Center (MD Anderson) reported a strategic five-year collaboration agreement for the purpose of accelerating the development of ivonescimab (Press release, Summit Therapeutics, JUL 25, 2024, View Source [SID1234645099]).

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!

Leveraging MD Anderson’s clinical infrastructure and research expertise together with Summit’s innovative, investigational, potential first-in-class PD-1 / VEGF bispecific antibody, the collaboration is designed to quickly discover additional opportunities for ivonescimab, including several tumors outside of its current development plan. MD Anderson will lead multiple clinical trials in several tumor types to evaluate the safety and potential clinical benefit of ivonescimab, including the possibility of identifying biomarkers through additional research activities.

"We are excited to collaborate with MD Anderson to provide unique insights and expertise to further broaden the development of ivonescimab," stated Allen S. Yang, MD, PhD, Chief Medical Officer of Summit. "This collaboration will help accelerate the growing clinical development efforts for ivonescimab and help bring this innovative advancement on immunotherapy and anti-angiogenic standards to as many patients who may benefit as possible."

Early work may include certain types of renal cell carcinoma, colorectal cancer, skin cancer, and breast cancer and glioblastoma, which has the potential to rapidly expand the breadth and depth of the ivonescimab development program. The bispecific antibody has shown significant promise in recent read-outs from the randomized Phase III non-small cell lung cancer clinical trials, HARMONi-A and HARMONi-2, conducted by Summit’s partner, Akeso, in addition to promising Phase II data in other solid tumors.

"Through our extensive clinical research efforts, we are committed to bringing impactful new medicines to patients in need as rapidly as possible," said Christopher Flowers, M.D., Division Head of Cancer Medicine at MD Anderson. "We are pleased to be collaborating with Summit to broaden the clinical development efforts of ivonescimab and its unique mechanism of action to support our mutual goal to improve the therapeutic options for patients with cancer."

MD Anderson and Summit will collaborate on the design and conduct of preclinical and clinical studies with oversight from a joint steering committee. This research is expected to begin later this year.

About Ivonescimab

Ivonescimab, known as SMT112 in Summit’s license territories, the United States, Canada, Europe, Japan, Latin America, including Mexico and all countries in Central America, South America, and the Caribbean, the Middle East, and Africa, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. Ivonescimab displays unique cooperative binding to each of its intended targets with multifold higher affinity when in the presence of both PD-1 and VEGF.

This could differentiate ivonescimab as there is potentially higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) in the tumor microenvironment with over 18-fold increased binding affinity to PD-1 in the presence of VEGF in vitro, and over 4-times increased binding affinity to VEGF in the presence of PD-1 in vitro (Zhong, et al, SITC (Free SITC Whitepaper), 2023). This tetravalent structure, the intentional novel design of the molecule, and bringing these two targets into a single bispecific antibody with cooperative binding qualities have the potential to direct ivonescimab to the tumor tissue versus healthy tissue. The intent of this design, together with a half-life of 6 to 7 days (Zhong, et. al., SITC (Free SITC Whitepaper), 2023), is to improve upon previously established efficacy thresholds, in addition to side effects and safety profiles associated with these targets.

Ivonescimab was engineered by Akeso Inc. (HKEX Code: 9926.HK) and is currently engaged in multiple Phase III clinical trials. Over 1,800 patients have been treated with ivonescimab in clinical studies globally.

Summit has begun its clinical development of ivonescimab in non-small cell lung cancer (NSCLC), commencing enrollment in 2023 in two multi-regional Phase III clinical trials, HARMONi and HARMONi-3.

HARMONi is a Phase III clinical trial which intends to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a 3rd generation EGFR TKI (e.g., osimertinib).

HARMONi-3 is a Phase III clinical trial which is designed to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic squamous NSCLC.

In addition, Akeso has recently had positive read-outs in two single-region (China), randomized Phase III clinical trials for ivonescimab in NSCLC, HARMONi-A and HARMONi-2.

HARMONi-A was a Phase III clinical trial which evaluated ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with an EGFR TKI.

HARMONi-2 is a Phase III clinical trial evaluating monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression (PD-L1 TPS >1%).

Ivonescimab is an investigational therapy that is not approved by any regulatory authority in Summit’s license territories, including the United States and Europe. Ivonescimab was approved for marketing authorization in China in May 2024.

Immunome Provides Update on Recent Business Development Activity Expected to Expand ADC Capabilities

On July 25, 2024 Immunome, Inc. (Nasdaq: IMNM), a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported an update on recent business development activity, including three recently closed transactions that are expected to enhance the company’s antibody-drug conjugate (ADC) capabilities (Press release, Immunome, JUL 25, 2024, View Source [SID1234645098]). Immunome acquired worldwide, exclusive rights to:

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!

A panel of antibodies against an undisclosed solid tumor target from Nectin Therapeutics
A panel of antibodies against an undisclosed solid tumor target from Bluefin Biomedicine
Four antibodies against undisclosed targets from OncoResponse

In addition, the company previously announced the purchase of 28 antibodies from Atreca in May 2024 and the exclusive license of IM-1021 along with the underlying ADC platform technology from Zentalis in January 2024. None of the acquired antibodies are known to share the same target as an FDA approved ADC.

"Immunome’s long-term vision remains centered on a broad pipeline of targeted therapies, particularly ADCs against novel targets," said Clay Siegall, PhD, President and Chief Executive Officer of Immunome. "Focused business development activity complements our highly productive internal discovery efforts and has led to an advancing pipeline of product candidates."

"Successful ADC development requires addressing the unique biology of each target with appropriate antibodies, linkers and payloads," added Jack Higgins, PhD, Chief Scientific Officer of Immunome. "Our research team has identified multiple promising ADC targets. We have also established a toolbox that includes multiple linkers, our differentiated proprietary TOP1 inhibitor and numerous antibodies. We believe that the next generation of ADCs will bring tremendous benefit to cancer patients."

Immunovia presents data from discovery study at 2024 PancreasFest medical conference

On July 25, 2024 Immunovia (Nasdaq Stockholm: IMMNOV), the pancreatic cancer diagnostics company, reported detailed discovery study results for the company’s next-generation early detection test for pancreatic cancer at the PancreasFest 2024 Annual Meeting (abstract #P33) (Press release, Immunovia, JUL 25, 2024, View Source [SID1234645097]).

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!

PancreasFest is an annual conference of physicians and translational researchers with special interest in the pancreas who convene to find new ways to improve the care of patients with pancreatic disease, including pancreatic cancer. It is organized by the Collaborative Alliance for Pancreatic Education and Research. Abstracts submitted to this medical conference undergo a rigorous peer-review and selection process in which only a subset of studies are chosen for presentation at the meeting.

Results presented at PancreasFest reflect a detailed scientific presentation of the initial positive data the company shared in a 7 November 2023 press release.

The discovery study, the most comprehensive pancreatic cancer proteomics study done to date, identified 15 promising protein biomarkers that were shown to strongly correlate with the presence of pancreatic ductal adenocarcinoma (PDAC). These protein biomarkers demonstrated the ability to differentiate PDAC cases from non-PDAC controls. Over 3,000 proteins were evaluated in 329 blood samples from Stage 1 and II PDAC and non-PDAC matched control patients using Olink multiplex technology and conventional immunoassays.

"We are honored to have been chosen to present the discovery study results at this important conference. We look forward to discussing the detailed study data and receiving scientific and clinical insights from this key group of physicians and researchers who are experts in pancreatic cancer," said Norma Palma PhD, Vice President of Clinical and Medical Affairs at Immunovia.