On July 25, 2024 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of Antibody Radiation Conjugates (ARCs) and other targeted radiotherapies, reported that the Company will participate in the 3rd Annual Targeted Radiopharmaceuticals Summit US, being held in San Diego, CA, from July 30 – August 1, 2024 (Press release, Actinium Pharmaceuticals, JUL 25, 2024, View Source [SID1234645081]). Actinium’s presentation titled, "Overcoming Adverse Cytogenetics, TP53, Other Mutations & Treatment Resistant Disease in Relapsed/Refractory AML Using Antibody Radiation Conjugates," will take place on Wednesday, July 31, 2024th. The presentation will highlight the following:

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Exploring Iomab-B, a CD45 I-131 ARC, to enable bone marrow transplant (BMT) in otherwise ineligible patients, while Actimab-A, a CD33 Ac-225 ARC, demonstrates strong anti-leukemic activity

Outlining responses in heavily pretreated patients for both Iomab-B and Actimab-A, including prior venetoclax treatment or TP53-mutated disease, to demonstrate how targeted radiotherapies offer broad therapeutic potential as backbone regimens

Revealing preclinical data to further show the benefits of combining Actimab-A with targeted therapies, such as FLT3 inhibitors, to enhance anti-tumor response
For more information about the Targeted Radiopharmaceutical Summit and the conference agenda, please visit View Source

On July 25, 2024 AbbVie (NYSE:ABBV) reported financial results for the second quarter ended June 30, 2024 (Press release, AbbVie, JUL 25, 2024, View Source [SID1234645080]).

"Our business continues to perform exceptionally well, with second quarter results meaningfully ahead of our expectations," said Robert A. Michael, chief executive officer, AbbVie. "Based upon the significant momentum of our ex-Humira growth platform, our continued investments in the business and our pipeline progress, we are very well positioned to deliver our top-tier long-term outlook."

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Second-Quarter Results

•Worldwide net revenues were $14.462 billion, an increase of 4.3 percent on a reported basis, or 5.6 percent on an operational basis.

•Global net revenues from the immunology portfolio were $6.971 billion, an increase of 2.3 percent on a reported basis, or 3.5 percent on an operational basis.
◦Global Humira net revenues of $2.814 billion decreased 29.8 percent on a reported basis, or 28.9 percent on an operational basis. U.S. Humira net revenues were $2.360 billion, a decrease of 31.6 percent. Internationally, Humira net revenues were $454 million, a decrease of 18.9 percent on a reported basis, or 12.5 percent on an operational basis.
◦Global Skyrizi net revenues were $2.727 billion, an increase of 44.8 percent on a reported basis, or 45.6 percent on an operational basis.
◦Global Rinvoq net revenues were $1.430 billion, an increase of 55.8 percent on a reported basis, or 59.2 percent on an operational basis.

•Global net revenues from the oncology portfolio were $1.634 billion, an increase of 10.5 percent on a reported basis, or 12.2 percent on an operational basis.
◦Global Imbruvica net revenues were $833 million, a decrease of 8.2 percent, with U.S. net revenues of $595 million and international profit sharing of $238 million.
◦Global Venclexta net revenues were $637 million, an increase of 11.5 percent on a reported basis, or 15.8 percent on an operational basis.
◦Global Elahere net revenues were $128 million.

•Global net revenues from the neuroscience portfolio were $2.162 billion, an increase of 14.7 percent on a reported basis, or 15.2 percent on an operational basis.
◦Global Botox Therapeutic net revenues were $814 million, an increase of 8.7 percent on a reported basis, or 9.6 percent on an operational basis.
◦Global Vraylar net revenues were $774 million, an increase of 17.6 percent.
◦Global Ubrelvy net revenues were $231 million, an increase of 17.5 percent.
◦Global Qulipta net revenues were $150 million, an increase of 56.3 percent.

•Global net revenues from the aesthetics portfolio were $1.390 billion, an increase of 0.5 percent on a reported basis, or 2.8 percent on an operational basis.
◦Global Botox Cosmetic net revenues were $729 million, an increase of 6.4 percent on a reported basis, or 8.6 percent on an operational basis.
◦Global Juvederm net revenues were $343 million, a decrease of 6.8 percent on a reported basis, or 3.1 percent on an operational basis.

•On a GAAP basis, the gross margin ratio in the second quarter was 70.9 percent. The adjusted gross margin ratio was 85.2 percent.

•On a GAAP basis, selling, general and administrative (SG&A) expense was 23.3 percent of net revenues. The adjusted SG&A expense was 22.9 percent of net revenues.

•On a GAAP basis, research and development (R&D) expense was 13.5 percent of net revenues. The adjusted R&D expense was 13.3 percent of net revenues.

•Acquired IPR&D and milestones expense was 6.5 percent of net revenues.

•On a GAAP basis, the operating margin in the second quarter was 27.6 percent. The adjusted operating margin was 42.6 percent.

•Net interest expense was $506 million.

•On a GAAP basis, the tax rate in the quarter was 36.0 percent. The adjusted tax rate was 18.8 percent.

•Diluted EPS in the second quarter was $0.77 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.65. These results include an unfavorable impact of $0.52 per share related to acquired IPR&D and milestones expense.

Recent Events

•As previously announced, Robert A. Michael assumed the role of chief executive officer (CEO) and has joined AbbVie’s Board of Directors, effective July 1, 2024. Mr. Michael succeeds Richard A. Gonzalez, who served as CEO since the company’s inception in 2013. Mr. Gonzalez has become executive chairman of the board of directors.

•AbbVie announced the U.S. Food and Drug Administration (FDA) approved Skyrizi (risankizumab) for adults with moderately to severely active ulcerative colitis (UC). AbbVie also announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Skyrizi for the treatment of adults with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional or biologic therapy. The FDA approval and positive CHMP opinion are based on results from two pivotal Phase 3 trials, INSPIRE and COMMAND, that evaluated the efficacy and safety of Skyrizi in adults with moderately to severely active UC. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

•AbbVie announced that it submitted applications for a new indication to the FDA and EMA for Rinvoq (upadacitinib) for the treatment of adult patients with giant cell arteritis (GCA). The regulatory submissions are supported by results from the SELECT-GCA Phase 3 study evaluating the safety and efficacy of Rinvoq in patients with GCA.

•At the 2024 Digestive Disease Week (DDW) Annual Meeting, AbbVie presented 15 abstracts, including three oral presentations, reinforcing AbbVie’s commitment to advancing the standards of care in inflammatory bowel diseases (IBD). Highlights included data from the SEQUENCE head-to-head trial comparing Skyrizi versus Stelara (ustekinumab) in Crohn’s disease (CD), as well as presentations that included efficacy and safety data evaluating clinical, endoscopic, and histologic outcomes from both the INSPIRE Phase 3 induction study and the COMMAND Phase 3 maintenance study of Skyrizi as a therapy for adults with moderately to severely active UC.

•AbbVie announced that it completed its acquisition of Landos Biopharma. The transaction adds the first-in-class investigational asset, ABBV-113 (NX-13), to AbbVie’s pipeline, which has the potential to offer a novel approach to the treatment of UC and CD.

•AbbVie and FutureGen Biopharmaceutical announced a license agreement to develop FG-M701, a next generation anti-TL1A antibody for the treatment of IBD, currently in preclinical development. FG-M701 is uniquely engineered with potential best-in-class functional characteristics compared to first-generation anti-TL1A antibodies, with the goal to drive greater efficacy and less frequent dosing as a therapy for IBD.

•AbbVie announced the acquisition of Celsius Therapeutics, a privately held biotechnology company pioneering new therapies for patients with inflammatory disease. Celsius’ lead investigational asset is CEL383, a potential first-in-class anti-TREM1 antibody for the treatment of IBD that has completed a Phase 1 clinical study.

•AbbVie announced the FDA approved Epkinly (epcoritamab) to treat patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of prior therapy. AbbVie also announced that the EMA’s CHMP adopted a positive opinion for Tepkinly (epcoritamab) for the treatment of adults with r/r FL. The FDA approval and positive CHMP opinion are based on results from the Phase 1/2 EPCORE NHL-1 clinical trial, which evaluated the safety and efficacy of Epkinly/Tepkinly in adult patients with r/r FL. Epkinly/Tepkinly is being co-developed by AbbVie and Genmab.

•AbbVie announced positive topline results from the Phase 2 PICCOLO trial evaluating Elahere (mirvetuximab soravtansine) monotherapy in heavily pre-treated patients with folate receptor-alpha (FRα) positive, platinum-sensitive ovarian cancer (PSOC). The trial met its primary endpoint with an objective response rate (ORR) of 51.9% and demonstrated a median duration of response (DOR), a key secondary endpoint, of 8.25 months. The safety profile of Elahere was consistent with findings from previous studies, and no new safety concerns were identified. Full data from the PICCOLO study will be presented at a future medical meeting.

•AbbVie announced the start of the Phase 3 CERVINO clinical trial which will evaluate the efficacy, safety, and tolerability of ABBV-383 monotherapy compared with standard available therapies (SATs) in patients with r/r multiple myeloma (MM) who have received at least two lines of prior therapy. The start of the CERVINO trial marks an important step forward in AbbVie’s continued commitment to advance new oncology treatments and elevate the standard of care for blood cancer patients.

•At the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, AbbVie showcased its solid tumor pipeline with new data from its innovative antibody-drug conjugate (ADC) platform. Highlights included new safety and efficacy data from a Phase 1 study of ABBV-400, a next-generation, potential best-in-class c-Met directed ADC, in patients with metastatic colorectal cancer (CRC); data from a first-in-human study of ABBV-706, a potential best-in-class SEZ6 directed ADC, in small cell lung cancer (SCLC), high-grade central nervous system (CNS) tumors and high-grade neuroendocrine neoplasms (NENs); data from the primary analysis of the Phase 2 LUMINOSITY trial evaluating Telisotuzumab vedotin (Teliso-V), a potential first-in-class c-Met directed ADC, in advanced non-small cell lung cancer (NSCLC); and data from the Phase 3 MIRASOL trial of Elahere in patients with platinum-resistant ovarian cancer (PROC) and high FRα expression.

•AbbVie announced it received a Complete Response Letter (CRL) from the FDA for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). In its letter, the FDA cited observations that were identified during inspection of a third-party manufacturer listed in the NDA. The CRL did not identify any issues related to the safety, efficacy or labeling of ABBV-951, including the device, and does not request that AbbVie conduct additional efficacy or safety trials related to the drug or device-related testing. AbbVie continues to work with the FDA to bring ABBV-951 to patients in the U.S. as quickly as possible.

•AbbVie and Gilgamesh Pharmaceuticals announced a collaboration and option-to-license agreement to develop next-generation therapies for psychiatric disorders. These next-generation therapies known as neuroplastogens target mechanisms that have shown potential to provide significant clinical benefits and are designed to minimize the challenging effects seen with first-generation compounds. This collaboration will leverage AbbVie’s expertise in psychiatry and Gilgamesh’s innovative research platform to discover novel neuroplastogens.

Full-Year 2024 Outlook
AbbVie is raising its adjusted diluted EPS guidance for the full year 2024 from $10.61 – $10.81 to $10.71 – $10.91, which includes an unfavorable impact of $0.60 per share related to acquired IPR&D and milestones expense incurred year-to-date through the second quarter 2024. The company’s 2024 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the second quarter of 2024, as both cannot be reliably forecasted.

On July 25, 2024 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the second quarter (interim results) of fiscal year 2024 (Press release, Chugai, JUL 25, 2024, View Source;category= [SID1234645070]).

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"In the interim period of 2024, revenue decreased year-on-year while profit grew. Although the temporary impact of the COVID-19 treatment Ronapreve, for which its supply to the government had been completed last year, remained significant, profit increased steadily due to solid business momentum. In Japan, sales of new products Phesgo and Vabysmo and a mainstay product Actemra grew, however, impacted by Ronapreve, NHI drug price revision, and the market penetration of biosimilars, domestic sales decreased by 30.7%. Overseas sales increased by 28.2%, with the substantial increase in exports of Hemlibra outweighing the decrease in Actemra exports. In research and development, PiaSky was launched in Japan ahead of other countries, followed by approval in the United States, and recommendation for approval in Europe. In addition, Alecensa received approval for an additional indication in Europe and China following the approval in the United States as a post-operative adjuvant therapy for ALK-positive non-small cell lung cancer, and has started to contribute to the treatment of patients. Early development also advanced, including the initiation of new clinical trials such as GYM329 for obesity and DONQ52 for celiac disease. Also, under the alliance with Roche, we have started new clinical trials, making progress in research and development in order to provide value to patients. Regarding our growth strategy "TOP I 2030," the initially planned initiatives have generally been progressing smoothly over the past three years. On the other hand, we recognize the need for further efforts in light of overall progress and changes in the business environment. We reconfirmed the path to achieve our challenging goals of "Double R&D output" and "Launch global in-house products every year" in 2030, and refined the details of the reforms. We will continue our efforts to realize the reforms and ensure achievement of our goals, aiming to become a top innovator," said Dr. Osamu Okuda, Chugai’s President and CEO.

Chugai reported decreased revenue and increased operating profit year-on-year for the second quarter (interim period, Core-basis).

Regarding revenue, domestic sales decreased by 30.7% year-on-year. In the oncology field, although mature products such as Avastin were impacted by the NHI drug price revision and biosimilars, the overall decrease was 6.1% contributed by growth of new product Phesgo. In the specialty field, sales decreased by 47.4%, mainly due to continued impact of the completion of Ronapreve supply to the government, which recorded ¥81.2 billion last year, while our new product Vabysmo, mainstay products including Actemra, Evrysdi, Enspryng performed well. Overseas sales increased by 28.2% year-on-year, greatly exceeding the same period last year, which was contributed by the increase in Hemlibra export which grew by 54.6% year-on-year. Other revenue increased by 18.9%, driven by the increase in Hemlibra related income and one-time income.

Cost to sales ratio improved by 13.3 percentage points year-on-year to 33.0%, mainly due to a change in the product mix. Research and development expenses increased mainly due to investments into drug discovery and early development, and increases associated with the progress of development projects. Selling, general and administration expenses increased by 3.6% due mainly to foreign exchange rate fluctuations and an increase in the enterprise tax (pro forma standard taxation). Other operating income (expense) was ¥0.8 billion in income. As a result, Core operating profit totaled ¥262.8 billion (+13.3%).

In addition, we refined our growth strategy TOP I 2030 launched in 2021. The initiatives we initially envisioned are steadily progressing. Given that this is a 10-year long-term strategy, we have reviewed progress over the past three years, current environmental changes and other factors, and reconfirmed the path toward our 2030 goals for the purpose of achieving our challenging goals with greater certainty. Specifically, we have updated the five reforms (Drug Discovery, Development, Pharmaceutical Technology, Value Delivery, and Foundation for Growth) and the mid-term milestones. To achieve the challenging goals of "Double R&D output" and "Launch global in-house products every year" set forth in TOP I 2030, each employee will strive to take the transformations as their own issue and to steadily make changes, in order to contribute to patients.

Chugai also made good progress in research and development, both in the early and late stages of developments, particularly in maximizing the value of in-house developed products and mainstay products.

For in-house products, PiaSky, an anti-complement (C5) Recycling antibody, has been launched in Japan for a rare disease paroxysmal nocturnal hemoglobinuria (PNH), for the first time in the world. This marks the second launch in Japan of an antibody drug applying Chugai’s proprietary Recycling Antibody technology. PiaSky has been approved in the U.S., and received a recommendation for approval from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in EU. Also, the drug is undergoing review by other regulatory authorities including Taiwan. In addition, the anti-IL-31RA, a humanized monoclonal antibody Mitchga(generic name: nemolizumab), has been launched in a new formulation in Japan by Maruho, the domestic out-licensing partner of nemolizumab, for the new indication of pruritus associated with atopic dermatitis in children and prurigo nodularis in adults and children. Furthermore, Alecensa has been granted additional indication in Europe and China following the U.S. for adjuvant treatment of ALK-positive non-small cell lung cancer. Additionally, rolling submission to the U.S. Food and Drug Administration (FDA) was initiated for the combination therapy of avutometinib, a RAF/MEK clamp being developed by Verastem Oncology, and defactinib, a selective FAK inhibitor, for the treatment of recurrent KRAS mutant low-grade serous ovarian cancer. In early development, a phase I clinical trial for the latent myostatin-sweeping antibody GYM329 has been initiated the treatment of obesity. A Phase Ic clinical trial has been initiated for the multi-specific antibody DONQ52 to evaluate its suppressive effect on the immune response induced by wheat intake in patients with celiac disease.

For projects in-licensed from Roche, a new Phase III clinical trial has been initiated for RG6299 in IgA nephropathy, and a new Phase I/II clinical trial has been initiated for zilebesiran in hypertension.

[2024 second quarter (interim) results]

Billion JPY 2024
Jan – Jun 2023
Jan – Jun % change
Core results
　Revenue 552.9 579.7 -4.6%
　　Sales 485.5 523.0 -7.2%
　　Other revenue 67.3 56.6 +18.9%
　Operating profit 262.8 232.0 +13.3%
　Net income 189.5 171.4 +10.6%
IFRS results
　Revenue 552.9 579.7 -4.6%
　Operating profit 258.2 210.9 +22.4%
　Net income 186.3 156.7 +18.9%
[Sales breakdown]

Billion JPY 2024
Jan – Jun 2023
Jan – Jun % change
Sales 485.5 523.0 -7.2%
　Domestic sales 217.2 313.6 -30.7%
　　Oncology 118.8 126.5 -6.1%
　　Specialty 98.4 187.1 -47.4%
　Overseas sales 268.4 209.4 +28.2%
[Oncology field (Domestic) Top5-selling medicines]

Billion JPY 2024
Jan – Jun 2023
Jan – Jun % change
　Tecentriq 31.1 31.6 -1.6%
　Avastin 17.4 26.2 -33.6%
　Polivy 15.7 15.9 -1.3%
　Alecensa 14.9 14.5 +2.8%
　Perjeta 11.3 16.1 -29.8%
[Specialty field (Domestic) Top5-selling medicines plus Ronapreve]

Billion JPY 2024
Jan – Jun 2023
Jan – Jun % change
　Hemlibra 27.4 26.7 +2.6%
　Actemra 22.4 21.1 +6.2%
　Enspryng 11.6 10.9 +6.4%
　Vabysmo 9.1 6.7 +35.8%
　Evrysdi 7.5 6.6 +13.6%
　Ronapreve* - 81.2 -100.0%
*Ronapreve has not been listed in the National Health Insurance (NHI) price list.

[Progress in R&D activities from Apr 25th, 2024 to Jul 25th, 2024]

2024 Q2 R&D Progress
About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and as the basis for payment-by-results such as a return to shareholders.

Trademarks used or mentioned in this release are protected by law.

On July 25, 2024 AstraZeneca’s Chief Executive Officer, Pascal Soriot reporting on the quarterly results said (Press release, AstraZeneca, JUL 25, 2024, View Source [SID1234645069]):

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"Building on our strong growth in the first half of the year and continued underlying demand for our medicines we are upgrading our FY 2024 guidance for both Total Revenue and Core EPS.

At our Investor Day in May we set out a new revenue ambition to deliver $80 billion of Total Revenue by 2030. This is a clear reflection of the substantial growth potential we see from both our approved medicines and those in our late-stage pipeline. Already this year we have announced five positive, potentially practice-changing Phase III studies that are anticipated to meaningfully contribute to our growth.

In the year to date we have continued to make encouraging progress with several disruptive technologies, including antibody drug conjugates, bispecifics, cell and gene therapies, radioconjugates, and weight management medicines, all of which have the potential to drive our growth beyond 2030."

On July 25, 2024 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), reported that three (3) patients enrolled in the Company’s Phase 2a clinical trial investigating narmafotinib in the treatment of advanced pancreatic cancer (the ACCENT trial) have recorded a confirmed partial response (Press release, Amplia Therapeutics, JUL 25, 2024, View Source [SID1234645068]). The formal term ‘confirmed partial response’ means there is at least a 30% decrease in the overall size of tumour lesions, and no new tumour lesions, in these patients sustained over a two month period.

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Of the six (6) patients currently assessed at the four month time point, in addition to the three (3) confirmed partial responses, two (2) additional patients have recorded sustained stable disease.

Amplia CEO and MD Dr Chris Burns commented: "To be reporting that three confirmed partial responses have been observed so early in this stage of the trial is extremely encouraging. We are well on track to reach the efficacy threshold of six confirmed partial or complete responses by the end of this quarter, which will then allow us to restart the trial to recruit the full cohort of fifty patients."

The Company recently announced completion of enrolment of the first 26 patients in the trial as part of the industry-standard Simon’s Two-Stage Trial design. Once six (6) confirmed partial or complete responses are obtained then an additional 24 patients will be enrolled, giving a total of 50 patients for the trial.

The Company will provide further updates on the trial as recruitment proceeds.

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics.

About Narmafotinib

Narmafotinib (AMP945) is the company’s best-in-class inhibitor of the protein FAK, a protein overexpressed in pancreatic and other cancers, and a drug target gaining increasing attention for its role in solid tumours. The drug, which is a highly potent and selective inhibitor of FAK, has shown promising data in a range of preclinical cancer studies. The drug has successfully completed a healthy volunteer study, and is currently in an open-label Phase 2a trial in pancreatic cancer where a combination of narmafotinib and the chemotherapies gemcitabine and Abraxane is being assessed for safety, tolerability and efficacy.

About the ACCENT Trial

The ACCENT trial is entitled ‘A Phase 1b/2a, Multicentre, Open Label Study of the Pharmacokinetics, Safety and Efficacy of AMP945 in Combination with Nab-paclitaxel and Gemcitabine in Pancreatic Cancer Patients’.

The ACCENT trial explores the use of narmafotinib in combination with standard-of-care chemotherapy of gemcitabine and Abraxane in first-line patients with advanced pancreatic cancer. The trial is a single-arm open label study conducted in two stages. The firststage (Phase 1b), completed in November 2023, identified a 400 mg oral daily dose of narmafotinib, given in the days preceding regular chemotherapy infusion, as safe and well tolerated.

This second stage (Phase 2a) of the trial is designed to assess drug efficacy in combination with gemcitabine and Abraxane. The primary endpoints are Objective Response Rate (ORR) and Duration on Trial (DOT) with secondary endpoints being Progression Free Survival (PFS) and Overall Survival (OS). Safety and tolerability will continue to be assessed.

More information about the ACCENT trial, including a list of participating sites, can be found via the Amplia Therapeutics website and at ClinicalTrials.gov under the identifier NCT05355298.