Aravive to Present Updated Clinical Data from Batiraxcept Trials in Renal and Pancreatic Cancer at ESMO Congress 2023

On July 28, 2023 Aravive, Inc. (Nasdaq: ARAV, "the Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported the acceptance of two abstracts for poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, being held October 20-24, 2023 in Madrid, Spain (Press release, Aravive, JUL 28, 2023, View Source [SID1234633477]). Posters will feature clinical data from the Company’s ongoing Phase 1b/2 trials of batiraxcept in clear cell renal cell carcinoma (ccRCC) and pancreatic adenocarcinoma (PDAC).

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Presentation Details:

Title: Phase 1b/2 Study of Batiraxcept (BT, AVB-S6-500, an AXL pathway inhibitor) in Combination with Cabozantinib (Cabo) in Patients with Advanced Clear Cell Renal Cell Carcinoma (ccRCC) who Failed First Line (1L) Therapy
Presenter: Neil Shah, MBBS
Abstract Number: 2294

Title: Phase 1b/2 Study of Batiraxcept (AVB-S6-500, BT) plus Nab-paclitaxel (NP) and Gemcitabine (G) as first-line treatment (1L) for metastatic pancreatic adenocarcinoma (PDAC)
Presenter: Vaibhav Sahai, MBBS, MS
Abstract Number: 3218
Posters will be available on the "Publications" section of the Aravive website at the start of the meeting.

First Patient Dosed in Chemotherapy-Free Triple Combination Phase II Trial Targeting Soft Tissue Sarcoma

On July 28, 2023 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported the first patient has been enrolled and safely dosed in EFTISARC-NEO, the Phase II investigator-initiated trial of eftilagimod alpha (efti), a soluble LAG-3 protein and MHC Class II agonist, in combination with radiotherapy and the anti-PD-1 therapy KEYTRUDA (pembrolizumab) for patients with soft tissue sarcoma (Press release, Immutep, JUL 28, 2023, View Source [SID1234633468]). This chemo-free trial is the first to evaluate efti in a neoadjuvant setting.

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Soft tissue sarcoma (STS), an orphan disease, represents a high unmet medical need with a poor prognosis. The incidence of STS varies in different regions, with approximately 23,400 cases annually and a crude incidence of 4.7 per 100,000 in Europe, according to the RARECARE project. In the United States, the number of new cases is estimated to be 13,400 annually with 5,140 deaths, according to the American Cancer Society.

The open-label EFTISARC-NEO Phase II study, which will treat up to 40 patients, is being conducted by the Maria Skłodowska-Curie National Research Institute of Oncology (MSCNRIO) and is primarily funded with an approved grant from the Polish government awarded by the Polish Medical Research Agency program. The trial’s Principal Investigators are Dr. Katarzyna Kozak, M.D., Ph.D., and Paweł Sobczuk, M.D., Ph.D., medical oncologists at the Department of Soft Tissue/Bone Sarcoma and Melanoma at MSCNRIO.

Dr. Paweł Sobczuk stated: "Soft tissue sarcoma is a rare, aggressive disease in high need of new therapeutic approaches, and we are pleased to begin treating patients with this novel IO-IO-radiotherapy combination and look forward to evaluating the potential synergistic effects of this chemo-free therapy. In particular, efti’s sustained activation of antigen-presenting cells, leading to proliferation of activated CD8+ T cells and elevated interferon-gamma levels, may transform the immunosuppressed tumour microenvironment of soft tissue sarcomas into one that enables immune checkpoint inhibitors like pembrolizumab to exert their anti-cancer effect. Additionally, we see synergies between efti and radiotherapy to arm, activate, and proliferate cytotoxic T cells with radiotherapy-induced cancer antigens to target this difficult-to-treat tumour."

Immutep CSO, Frédéric Triebel, M.D., Ph.D, said: "We are pleased to see this trial, led by the expert team at the Maria Skłodowska-Curie National Research Institute, begin to enrol and dose patients. EFTISARC-NEO represents the first time efti will be evaluated in the neoadjuvant, non-metastatic cancer setting where patients will receive efti much earlier on in their cancer journey. Also, the neoadjuvant setting gives us the opportunity to assess in the surgical specimen the changes in the tumour microenvironment induced by efti. New information arising from this innovative trial may further broaden the future clinical development of efti and, in the end, bring even greater benefit to patients."

About Eftilagimod Alpha (Efti)

Efti is Immutep’s proprietary soluble LAG-3 clinical stage candidate that is a first-in-class antigen presenting cell (APC) activator that stimulates both innate and adaptive immunity for the treatment of cancer. Efti binds to MHC II molecules on APCs leading to activation/proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track Designation in 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).

Alexion, AstraZeneca Rare Disease, enters agreement with Pfizer to acquire a portfolio of preclinical rare disease gene therapies

On July 27, 2023 Alexion, AstraZeneca Rare Disease, reported that it has entered a definitive purchase and licence agreement for a portfolio of preclinical gene therapy programmes and enabling technologies from Pfizer Inc. (Pfizer) (Press release, AstraZeneca, JUL 28, 2023, View Source [SID1234633466]). The agreement furthers Alexion and AstraZeneca’s commitment to advancing next-generation genomic medicines with the addition of complementary pipeline assets and innovative technologies.

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As part of the agreement, the transaction will bring to Alexion a number of novel adeno-associated virus (AAV) capsids. AAV capsids have been shown to be an effective mechanism for delivering therapeutic gene cargos for gene therapy and gene editing.1 These new resources build on Alexion and AstraZeneca’s combined capabilities in genomic medicine, recently strengthened with the acquisition of LogicBio, with the objective to develop new genetic therapies with improved safety and efficacy profiles. Additionally, Alexion will seek to welcome talent from Pfizer associated with the portfolio.

Marc Dunoyer, Chief Executive Officer, Alexion, AstraZeneca Rare Disease, said: "Today’s announcement represents another major step forward in Alexion and AstraZeneca’s ambition to be an industry leader in genomic medicine, which has potential to be transformative and even curative for patients with devastating diseases. We look forward to continuing our work to develop enhanced platforms and technologies with broad therapeutic application while integrating best-in-class expertise to accelerate promising therapeutics into the clinic."

There are more than 7,000 known rare diseases, and around 80% of rare diseases are believed to be caused by a genetic mutation.2,3 Genomic medicines are designed to treat or cure these diseases by addressing the malfunctioning gene. This can be done through addition, alteration or inactivation of the gene to help the body fight the disease.4

Financial considerations
Under the agreement, Alexion will purchase and licence the assets of Pfizer’s early-stage rare disease gene therapy portfolio for a total consideration of up to $1bn, plus tiered royalties on sales.

Alexion plans to close the transaction in Q3 2023, subject to the satisfaction of closing conditions.

Genmab Updates 2023 Financial Guidance

On July 28, 2023 Genmab A/S (Nasdaq: GMAB) reported its preliminary first half 2023 financial results and its updated 2023 financial guidance (Press release, Genmab, JUL 28, 2023, View Source [SID1234633454]).

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Preliminary First Half 2023 Financial Results

In the first half of 2023, Genmab’s revenue increased by 34% and operating profit increased by 10%, compared to the first half of 2022 primarily due to higher product royalties. Operating expenses increased by 45%, reflecting continued focused investments in Genmab’s key priorities.

First Half First Half
(DKK million) 2023 2022 % Increase
Revenue 7,052 5,281 34%
Operating expenses (5,118) (3,520) 45%
Operating profit 1,934 1,761 10%

Updated 2023 Financial Guidance

Genmab expects its 2023 revenue to be in the range of DKK 15,500 – 16,500 million, an increase to the previous guidance of DKK 14,600 – 16,100 million, driven by the continued strong growth of DARZALEX net sales and higher total royalty revenues from DARZALEX and other marketed products. DARZALEX royalties are based on Genmab’s revised estimate of DARZALEX 2023 net sales of USD 9.8 – 10.0 billion compared to Genmab’s previous estimate of USD 9.4 – 10.0 billion.

Genmab anticipates its 2023 operating expenses to be in the range of DKK 10,400 – 10,900 million, an increase to the previous guidance of DKK 9,800 – 10,600 million, primarily related to increased and accelerated investment for epcoritamab clinical trials and progression of other pipeline products.

Genmab now expects its 2023 operating profit to be in the range of DKK 4,500 – 6,000 million, compared to the previous guidance of DKK 3,900 – 6,200 million, driven primarily by the items described above.


Revised Previous
(DKK million) Guidance Guidance
Revenue 15,500 – 16,500 14,600 – 16,100
Operating expenses (10,400) – (10,900) (9,800) – (10,600)
Operating profit 4,500 – 6,000* 3,900 – 6,200*
*Operating profit does not sum due to rounding

Genmab’s full financial results for the first half of 2023 will be published on August 3, 2023.

Boston Scientific Announces Results For Second Quarter 2023

On July 27, 2023 Boston Scientific Corporation reported net sales of $3.599 billion during the second quarter of 2023, growing 11.0 percent on a reported basis, 12.0 percent on an operational1 basis and 11.6 percent on an organic basis, all compared to the prior year period (Press release, Boston Scientific, JUL 27, 2023, View Source;_gl=1*3kubsm*_ga*NzE2MTY5ODI1LjE2OTM4ODk2ODg.*_ga_759NN7RMMK*MTY5Mzg4OTY4Ny4xLjEuMTY5Mzg5MDUwMC4wLjAuMA.. [SID1234634864]). The company reported GAAP net income attributable to Boston Scientific common stockholders of $261 million or $0.18 per share (EPS), compared to $246 million or $0.17 per share a year ago, and achieved adjusted3 EPS of $0.53 for the period, compared to $0.44 a year ago.

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"We had another quarter of excellent results fueled by our innovative portfolio, strong commercial execution and the high performance of our global team," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "We are excited about our long-term outlook and robust pipeline of unique innovations to address unmet patient needs."

Second quarter financial results and recent developments:

Reported net sales of $3.599 billion, representing an increase of 11.0 percent on a reported basis, compared to the company’s guidance range of 6.5 to 8.5 percent; 12.0 percent on an operational basis; and 11.6 percent on an organic basis, compared to the company’s guidance range of 7 to 9 percent, all compared to the prior year period.
Reported GAAP net income attributable to Boston Scientific common stockholders of $0.18 per share, compared to the company’s guidance range of $0.23 to $0.27 per share, and achieved adjusted EPS of $0.53 per share, compared to the guidance range of $0.48 to $0.50 per share.
Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 9.0 percent reported, 9.6 percent operational and 8.8 percent organic
Cardiovascular: 12.2 percent reported, 13.4 percent operational and organic
Achieved the following net sales growth in each region, compared to the prior year period:
U.S.: 9.1 percent reported and operational
EMEA (Europe, Middle East and Africa): 9.6 percent reported and 9.3 percent operational
APAC (Asia-Pacific): 18.0 percent reported and 24.5 percent operational
LACA (Latin America and Canada): 16.9 percent reported and 17.4 percent operational
Emerging Markets4: 18.8 percent reported and 24.2 percent operational
Late-breaking clinical science based on real-world outcomes from the EU-PORIA registry of the FARAPULSE Pulsed Field Ablation (PFA) System was presented at Heart Rhythm 2023, which demonstrated strong safety outcomes and high rates of freedom from recurrence of atrial fibrillation and atrial tachycardia at a median follow-up of one year.
Presented results from the FROZEN-AF IDE study of the POLARx Cryoablation System at Heart Rhythm 2023, which met the safety and effectiveness endpoints of the trial.
Completed enrollment in the WATCHMAN FLX Pro CT pilot study, a single-center study using multiple imaging modalities to assess post-procedural healing in the investigational WATCHMAN FLX Pro Left Atrial Appendage Closure Device for patients with non-valvular atrial fibrillation.
Received U.S. FDA 510(k) clearance for the EMBOLD Soft and Packing Coils, which, along with the EMBOLD Fibered Coil, complete the EMBOLD Detachable Coil System, a peripheral embolization platform for vessel occlusion designed to simplify operator workflow and streamline inventory for hospitals.
Received U.S. FDA 510(k) clearance for the OverStitch NXT System, a next-generation endoscopic suturing system that enables suture placement and soft tissue approximation during advanced endoscopic procedures.
Received U.S. FDA approval for the Vercise Neural Navigator 5 Software, which when used with the Vercise Genus deep brain stimulation systems can help provide clinicians with simple and actionable data for efficient programming in the treatment of people living with Parkinson’s disease or essential tremor.
Completed the purchase of a minority stake (9.9%) of M.I.Tech Co., Ltd, a publicly traded, Korea-based medical device manufacturer and distributor. M.I.Tech is the creator of HANAROSTENT technology, a family of conformable, non-vascular, self-expanding metal stents, which Boston Scientific has distributed in Japan since 2015.
Elected to the company’s board of directors Dr. Jessica L. Mega, co-founder of Verily Life Sciences LLC, and Susan E. Morano, former vice president of Business Development and Strategic Operations at Johnson & Johnson MedTech.
1. Operational net sales growth excludes the impact of foreign currency fluctuations.

2. Organic net sales growth excludes the impact of foreign currency fluctuations and net sales attributable to acquisitions and divestitures for which there are less than a full period of comparable net sales.

3. Adjusted EPS excludes the impacts of certain charges (credits) which may include amortization expense, goodwill and intangible asset impairment charges, acquisition/divestiture-related net charges (credits), investment portfolio gains and losses, restructuring and restructuring-related net charges (credits), certain litigation-related net charges (credits), EU MDR implementation costs, debt extinguishment charges, deferred tax expenses (benefits) and discrete tax items.

4.Periodically, we assess our list of Emerging Markets countries, and effective January 1, 2023, modified our list to include all countries except the United States, Western and Central Europe, Japan, Australia, New Zealand and Canada. We have revised prior year amounts to conform to the current year’s presentation.