On August 24, 2022 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained regulatory approval today from the Ministry of Health, Labour and Welfare for the anticancer agent/antimicrotubule binding anti-CD79b monoclonal antibody Polivy intravenous infusion 30 mg and 140 mg [generic name: polatuzumab vedotin (genetical recombination)] for an additional indication of treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL) (Press release, Chugai, AUG 24, 2022, View Source [SID1234618592]).

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!

"We are very pleased to be able to offer the first new treatment in 20 years to patients with previously untreated diffuse large B-cell lymphoma (DLBCL) through this line extension approval," said Chugai’s President and CEO Dr. Osamu Okuda. "Based on our long experience and expertise in hematological cancer, we will continue to provide information on the proper use of Polivy for the benefit of patients with untreated DLBCL, as well as those with relapsed or refractory DLBCL."

Polivy is an antibody-drug conjugate, which is a combination of an antibody and a small molecule compound. This approval is based on the global phase III clinical study (POLARIX study) in patients with previously untreated DLBCL. The study, which Japan participated in, is a phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and pharmacokinetics of Polivy plus R-CHP versus R-CHOP. 879 patients were enrolled, and the primary endpoint was progression-free survival (PFS) as assessed by the investigator using the Lugano Response Criteria for malignant lymphoma.

As a leading company in the field of oncology in Japan, Chugai is committed to contribute to patients and medical professionals through offering innovative drugs to fulfill unmet medical needs in cancer treatment.

Approval Information *Changes are underlined.

Indication:
Diffuse large B-cell lymphoma

Dosage and administration:
The usual adult dosage is 1.8 mg/kg (body weight) polatuzumab vedotin (genetical recombination) administered by intravenous infusion every 3 weeks for 6 doses, in combination with the antineoplastic agents given below. Administer the first infusion over 90 minutes. If the first infusion is well tolerated, subsequent infusions may be administered over a shorter time of at least 30 minutes. Reduce the dose as necessary in accordance with the patient’s condition.

Administration in combination with rituximab (genetical recombination), cyclophosphamide hydrate, doxorubicin hydrochloride, and prednisolone or methylprednisolone
Administration in combination with bendamustine hydrochloride preparation and rituximab (genetical recombination)
[Reference Information]
Chugai Files for Additional Indication of Polivy for Previously Untreated Diffuse Large B-cell Lymphoma (Press release issued on December 10, 2021)
View Source

Roche’s Polivy combination reduced the risk of disease worsening or death by 27% in people with previously untreated aggressive form of lymphoma (Press release issued by Roche on December 14, 2021)
View Source

About Polivy (polatuzumab vedotin)
Polatuzumab vedotin was developed by Roche using Seagens’ ADC technology. It is a first-in-class anti-CD79b antibody-drug conjugate (ADC), comprising the anti-CD79b humanized monoclonal antibody and a tubulin polymerization inhibitor attached together using a linker. The CD79b protein is expressed specifically in the majority of B-cells, making it a promising target for the development of new therapies.1, 2) Polatuzumab vedotin binds to CD79b and destroys these B-cells through the delivery of an anti-cancer agent, which is thought to suppress the effects on normal cells.3, 4) Polatuzumab vedotin was granted accelerated approval in the US in June 2019 and conditional marketing authorization in the EU in January 2020, respectively.

About POLARIX study
POLARIX (NCT03274492) is an international phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and pharmacokinetics of Polivy plus Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) versus Rituxan, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in people with previously untreated diffuse large B-cell lymphoma (DLBCL). 879 patients were randomized 1:1 to receive either Polivy plus R-CHP plus a vincristine placebo for six cycles, followed by Rituxan for two cycles; or R-CHOP plus a Polivy placebo for six cycles, followed by two cycles of Rituxan.

The primary outcome measure is progression-free survival as assessed by the investigator using the Lugano Response Criteria for malignant lymphoma.
Data from the pivotal phase III POLARIX study showed a significant improvement in PFS with Polivy plus R-CHP versus R-CHOP in patients with previously untreated DLBCL after a median follow-up of 28.2 months (hazard ratio [HR] 0.73; 95% CI: 0.57–0.95; P<0.02).The safety profile was comparable for Polivy plus R-CHP versus R-CHOP, including rates of grade 3-4 adverse events (AEs; 57.7% versus 57.5%), serious AEs (34.0% versus 30.6%), grade 5 AEs (3.0% versus 2.3%), and AEs leading to dose reduction (9.2% versus 13.0%), respectively.5)

POLARIX is being conducted in collaboration with The Lymphoma Study Association (LYSA) and The Lymphoma Academic Research Organisation (LYSARC).

About the LYSA and the LYSARC
The Lymphoma Study Association, or LYSA, is the internationally leading cooperative group for lymphoma research in Europe, conducting clinical studies ranging from the first tests of new medicines in humans to the establishment of reference therapeutic strategies. LYSA includes in its network more than 120 care centers distributed throughout three countries (France, Belgium, Portugal), and collaborates with many scientific teams at the international level.
The Lymphoma Academic Research Organisation, or LYSARC, is the LYSA operational structure that conducts clinical research projects on lymphomas at the international level.

About diffuse large B-cell lymphoma (DLBCL)
DLBCL is the most common form of non-Hodgkin lymphoma (NHL), accounting for about one in three cases of NHL.6) DLBCL is an aggressive type of NHL.7) While it is generally responsive to treatment in the frontline, as many as 40% of patients will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.7) Approximately 150,000 people worldwide are estimated to be diagnosed with DLBCL each year.8)

Salvage therapy: Salvage chemotherapy or salvage therapy is used to treat patients with hematologic malignancy who experienced no therapeutic effects (refractory), or recurrence/relapse of the disease. Applicable treatment may vary depending on the type of cancer. Combination therapies of multiple drugs including anticancer agents9) are generally used.

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

On August 24, 2022 LumaBridge (formerly known as Cancer Insight), a clinical research organization (CRO) dedicated to discovering, developing, and testing emerging biotechnologies related to cancer therapies, and the Parker Institute for Cancer Immunotherapy (PICI), the largest network of immuno-oncology expertise in the world, reported a new strategic partnership aimed at accelerating breakthrough immunotherapies from bench to bedside with greater ease (Press release, Cancer Insight, AUG 24, 2022, View Source [SID1234618589]). The new collaboration offers affiliated scientists and organizations a one-stop shop to advance research studies.

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 two organizations are collaborating to provide PICI Affiliated Partners—PICI Network institutions and investigators, affiliated companies, and nonprofit collaborators—direct access to the full suite of clinical trial services from LumaBridge. Offerings range from clinical trial design through regulatory strategy support, including patient accrual, clinical operations, quality assurance, data management, medical writing and biostatistics, pharmacovigilance, and beyond.

"PICI was founded to clear the path from scientific idea to best possible clinical outcomes," said Ute Dugan, MD, PhD, chief medical officer of PICI, based in San Francisco. "By combining our focus with additional expertise in clinical trial design and oversight, we aim to streamline the development process and ultimately accelerate novel immunotherapies to patients."

PICI’s first valued CRO partner, LumaBridge also is focused on accelerating the development of immunological cures for cancer through innovative science, advanced technologies, and new modes of research collaboration. Through this mission-focused alliance, PICI Affiliated Partners gain preferred access to and pricing for an array of clinical trial services and expertise, including early consulting on clinical trial design and development, protocol development, regulatory support, and full-service clinical trial support.

"Patients awaiting new therapies deserve an effective, efficient process," said George E. Peoples, MD, FACS, founder and chief medical officer of San Antonio-based LumaBridge. "Through this partnership, we will harness our pioneering experience in immuno-oncology research alongside the expertise of academic, clinical, and industry partners to reduce turnaround time and safely test the most promising novel therapies for our cancer patients."

More specifically, available LumaBridge services include:

Regulatory support for pre-investigational new drug meetings and investigational new drug (IND) preparation, publishing, filing, and maintenance
Clinical trial design, execution, and support such as medical monitoring, clinical operations, data management, and quality assurance
Medical writing and biostatistics support such as statistical analysis, US Food and Drug Administration (FDA) application writing, and abstract or journal publication preparation
Guidance in navigating government/military contracts and funding
Clinical development and commercialization strategies for Cancer Prevention and Research Institute of Texas (CPRIT) applicants
The partnership advances PICI’s focus on bringing together top researchers, nonprofits and industry collaborators, providing resources and eliminating barriers to get treatments to patients faster.

"Collaboration is critical to achieving our mission," said Tarak Mody, PhD, chief business officer of PICI. "By offering access to LumaBridge’s services and expertise to our PICI Affiliated Partners, we intend to accelerate breakthrough scientific discoveries, moving them into the clinic sooner to deliver patient impact."

On August 24, 2022 Almac Discovery, a research driven biotech company and member of the Almac Group, reported that is delighted that its novel AKT kinase inhibitor (known as VAD044) is being advanced into a proof-of-concept Phase 1b clinical study for patients suffering from Hereditary Haemorrhagic Telangiectasia (HHT) (Press release, Almac, AUG 24, 2022, View Source [SID1234618588]).

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!

This patent-protected, allosteric subtype selective AKT kinase inhibitor, which was discovered and taken into early pre-clinical development by Almac Discovery, was out-licensed for all uses, worldwide, to Vaderis Therapeutics AG in May 2020.

After Vaderis’s successful Phase 1a, VAD044 will now be studied by Vaderis Therapeutics AG in their INSIGHT proof-of-concept trial, which aims to provide a thorough understanding of the safety of a once daily, orally administered, AKT inhibitor medication in HHT patients. A total of 80 HHT patients across North America and Europe will be randomised in a double-blind, controlled trial comparing two doses of the medication to placebo. Initiation of the INSIGHT trial follows Health Authority approvals including FDA, Health Canada and key European agencies.

Professor Tim Harrison, Vice President Drug Discovery, commented: "This excellent news from our out-licensing partner, Vaderis Therapeutics AG, represents a further example of Almac Discovery’s mission to discover new, innovative drug candidates for development through external partnerships and collaboration. We look forward, with great anticipation, to monitoring the findings of the INSIGHT trial and wish Vaderis every success as they emerge from stealth mode and progress through the next phase of clinical development for the benefit of HHT patients across the globe."

About Almac Discovery

Almac Discovery is a research driven biotech company dedicated to the discovery and development of First in Class therapeutics across a range of therapeutic areas including neuroscience, muscle-wasting, oncology and inflammation. Almac Discovery focuses on the discovery to preclinical stage, seeking to licence programmes and/or collaborate with a pharmaceutical partner for further development and commercialisation.

On August 24, 2022 Medtronic plc (NYSE:MDT) reported financial results for its first quarter of fiscal year 2022, which ended July 30, 2021 (Press release, Medtronic, AUG 24, 2022, View Source [SID1234618565]).

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!

Key Highlights

Q1-FY22-Earnings-infographic
View File Download File
Q1-FY22-Earnings-infographic
FY22-Q1-Earnings-animation
Play File
FY22-Q1-Earnings-animation
Revenue of $8.0 Billion Increased 23% Reported and 19% Organic
GAAP Diluted EPS of $0.56; Non-GAAP Diluted EPS of $1.41
Company Reiterates FY22 Revenue Guidance; Raises Lower End of FY22 EPS Guidance by 5 cents

"FY22 is off to a strong start – Q1 reflects solid execution & continued procedure recovery"
Chairman & CEO Geoff Martha

The company reported first quarter worldwide revenue of $7.987 billion, an increase of 23% as reported and 19% on an organic basis, which excludes the $245 million benefit of foreign currency translation. Revenue growth rates have not been adjusted for the negative impact of the extra selling week in the first quarter of last fiscal year. The company’s first quarter results reflect a strong recovery from the impact of the COVID-19 pandemic on elective procedures that the company experienced in 2020. Unless otherwise stated, all revenue growth rates in this press release are stated on an organic basis, which excludes the impact of foreign currency translation.

As reported, first quarter GAAP net income and diluted earnings per share (EPS) were $763 million and $0.56, respectively, increases of 57% and 56%, respectively. As detailed in the financial schedules included at the end of this release, first quarter non-GAAP net income and non-GAAP diluted EPS were $1.908 billion and $1.41, respectively, increases of 128% and 127%, respectively.

First quarter U.S. revenue of $4.101 billion represented 51% of company revenue and increased 22%. Non-U.S. developed market revenue of $2.601 billion represented 33% of company revenue and increased 20% as reported and 11% organic. Emerging Markets revenue of $1.286 billion represented 16% of company revenue and increased 31% as reported and 25% organic.

"Fiscal 2022 is off to a strong start with our first quarter results coming in ahead of our expectations, reflecting solid execution and continued procedure volume recovery, with most of our businesses at or above pre-COVID levels," said Geoff Martha, Medtronic chairman and chief executive officer. "In addition, we drove market share gains across a number of our businesses, including three of our largest: Cardiac Rhythm Management, Surgical Innovations, and Cranial & Spinal Technologies. Looking ahead, we have some big opportunities in front of us, with near-term milestones in both our renal denervation and surgical robotics businesses. These opportunities, combined with the broader investments we’re making in our pipeline, set us up well to accelerate our top line growth."

Cardiovascular Portfolio
The Cardiovascular Portfolio includes the Cardiac Rhythm & Heart Failure (CRHF), Structural Heart & Aortic (SHA), and Coronary & Peripheral Vascular (CPV) divisions. Cardiovascular first quarter revenue of $2.890 billion increased 19% as reported and 15% organic, driven by low-twenties organic growth in SHA, mid-teens organic growth in CRHF, and high-single digit growth in CPV.

Cardiac Rhythm & Heart Failure first quarter revenue of $1.483 billion increased 19% as reported and 15% organic. Adjusting for the discontinuation of HVAD System sales, CRHF revenue increased 19% organic. Cardiac Rhythm Management revenue increased in the high-teens, driven by low-double digit growth in Defibrillation Solutions and low-twenties growth in Cardiac Pacing Therapies, including low-thirties growth in Leadless Pacemakers on the continued global adoption of the Micra transcatheter pacing system. Cardiac Ablation Solutions revenue increased in the low-thirties on strong adoption of Arctic Front Advance cryoballoon catheters and consoles. Cardiovascular Diagnostics revenue grew in the low-double digits.
Structural Heart & Aortic first quarter revenue of $787 million increased 26% as reported and 21% organic. Structural Heart grew in the high-thirties, driven by mid-thirties growth in transcatheter aortic valves (TAVR), including high-forties TAVR growth in the United States. Cardiac Surgery increased in the high-teens. Aortic declined in the low-single digits, as the financial impact of the previously announced global recall of the Valiant Navion thoracic stent graft system offset low-twenties growth in abdominal aortic aneurysm (AAA) stent grafts.
Coronary & Peripheral Vascular first quarter revenue of $620 million increased 11% as reported and 7% organic. Coronary & Renal Denervation (CRDN) declined in the low-single digits, given the impact of previously announced coronary tenders in China. Excluding China, CRDN revenue grew in the high-single digits. Peripheral Vascular Health increased in the low-twenties, with mid-teens growth in IN.PACT drug-coated balloons and mid-fifties endoVenous growth on strong sales of VenaSeal and ClosureFast superficial vein products and Abre venous stents.
Medical Surgical Portfolio
The Medical Surgical Portfolio includes the Surgical Innovations (SI) and the Respiratory, Gastrointestinal & Renal (RGR) divisions. Medical Surgical first quarter revenue of $2.322 billion increased 29% as reported and 25% organic, with high-thirties organic growth in SI and mid-single digit organic growth in RGR.

Surgical Innovations first quarter revenue of $1.554 billion increased 44% as reported and 39% organic. The division had low-forties growth in Vessel Sealing and high-thirties growth in Advanced Stapling, driven by the continued adoption of the company’s LigaSure, Sonicision, and Tri-Staple technologies. Hernia & Wound Management increased in the mid-thirties, with strength in sutures and hernia product lines.
Respiratory, Gastrointestinal & Renal first quarter revenue of $768 million increased 7% as reported and 3% organic. Patient Monitoring increased in the mid-twenties, with mid-thirties growth in the company’s Nellcor pulse oximetry products. Respiratory Interventions decreased in the mid-twenties, with sales of ventilators declining in the low-forties as demand returns to pre-pandemic levels. Gastrointestinal revenue increased in the high-twenties on low-fifties growth in Esophageal & Gastric. Renal Care Solutions increased in the mid-single digits with strong growth in acute therapies.
Neuroscience Portfolio
The Neuroscience Portfolio includes the Cranial & Spinal Technologies (CST), Specialty Therapies, and Neuromodulation divisions. Neuroscience first quarter revenue of $2.204 billion increased 29% as reported and 26% organic, with high-thirties growth in Neuromodulation and Specialty Therapies and high-teens growth in CST, all on an organic basis.

Cranial & Spinal Technologies first quarter revenue of $1.123 billion increased 19% as reported and 17% organic. Spine & Biologics grew in the low-double digits and Neurosurgery increased in the low-twenties, as spine surgeons continue to adopt the Medtronic ecosystem of spine implants and enabling technology, including Mazor robotics, StealthStation navigation, O-arm imaging, and Midas Rex powered surgical instruments.
Specialty Therapies first quarter revenue of $641 million increased 42% as reported and 37% organic. Neurovascular increased in the high-single digits and ENT increased in the mid-thirties. Pelvic Health increased 134%, driven by continued strong adoption of the InterStim Micro sacral neuromodulation system.
Neuromodulation first quarter revenue of $440 million increased 40% as reported and 37% organic. Brain Modulation increased in the high-thirties, driven by the launch of the Percept PC deep brain stimulation system. Pain Therapies increased in the low-forties, with Targeted Drug Delivery revenue more than doubling on the backlog recovery of replacement procedures, and Pain Stim revenue growing in the mid-twenties on strong uptake of Intellis with DTM SCS therapy. Interventional grew in the low-twenties.
Diabetes
Diabetes first quarter revenue of $572 million increased 2% as reported and declined 3% organic. Diabetes quarterly revenue performance was driven by high-single digit growth in durable pumps, including strong growth in international markets on the continued launch of the MiniMed 780G system. This was offset by mid-teens declines in U.S. sales of consumables and continuous glucose monitoring (CGM) products.

Guidance
The company today reiterated its revenue growth guidance and raised the lower end of its EPS guidance range for fiscal year 2022.

The company continues to expect revenue growth in its fiscal year 2022 to approximate 9% on an organic basis. If current exchange rates hold, revenue growth in fiscal year 2022 would be positively affected by approximately $100 to $200 million.

The company increased its fiscal year 2022 diluted non-GAAP EPS guidance from the prior range of $5.60 to $5.75 to the new range of $5.65 to $5.75, including an estimated 5 to 10 cent positive impact from foreign currency exchange versus a 10 to 15 cent positive impact previously.

"We’re reiterating our revenue guidance for the year while increasing the lower end of our EPS range on the back of our first quarter results," said Karen Parkhill, Medtronic chief financial officer. "We remain focused on accelerating our long-term revenue growth and generating strong returns for our shareholders. In addition to growing our dividend, we are increasing our investments at the front end of major product launches, growing our R&D spend broadly across the company, and executing disciplined tuck-in acquisitions."

Webcast Information
Medtronic will host a webcast today, August 24, at 8:00 a.m. EDT (7:00 a.m. CDT) to provide information about its businesses for the public, investors, analysts, and news media. This webcast can be accessed by clicking on the Investor Events link at investorrelations.medtronic.com(opens new window) and this earnings release will be archived at news.medtronic.com(opens new window). Medtronic will be live tweeting during the webcast on its Newsroom Twitter account, @Medtronic. Within 24 hours of the webcast, a replay of the webcast and transcript of the company’s prepared remarks will be available by clicking on the Investor Events link at investorrelations.medtronic.com(opens new window).

Medtronic plans to report its fiscal year 2022 second, third, and fourth quarter results on November 23, 2021, February 22, 2022, and May 26, 2022, respectively. Confirmation and additional details will be provided closer to the specific event.

On August , 2022 April Bio reported that the company had signed a technology license and joint research and development contract with Yuhan Corp. to develop a new drug candidate (Press release, AprilBio, AUG 23, 2022, View Source [SID1234643379]).

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!

Under the accord, the two companies will conduct joint research to develop a new treatment candidate for a dual- and long-acting fusion protein substance applicable to intractable solid cancer based on April Bio’s serum albumin fragment associated (SAFA) platform technology and Yuhan’s new drug R&D capabilities.

April Bio will receive contracted technology fees from Yuhan when they achieve certain milestones, including a down payment. In addition, if approved, April Bio can also receive its share of annual net sales as a recurring technology fee.

If Yuhan enters into a license agreement with a third party, a certain percentage of the proceeds may also be distributed.

However, the two companies did not disclose the investment amount, citing contractual reasons.

"By combining our SAFA platform and dual-action anticancer drug development technology with Yuhan’s immunotherapy development know-how, we plan to develop a substance that can safely and effectively remove cancer cells," April Bio CEO Cha Sang-hoon said. "Our company will focus on research to provide new treatment options to patients suffering from various intractable solid cancers."

Yuhan CEO Cho Wook-je said, "Through this joint research, we anticipate a synergistic effect of the technologies of the two companies and will derive innovative drug candidates from diseases that have unmet needs."

Cho added that the company would continue to promote active open innovation for new drug development.

April Bio entered the KOSDAQ stock market in July after passing the preliminary examination in May. Yuhan participated in April Bio as a strategic investor (SI) to hold a 10.25 percent stake, making it the second largest shareholder.