Morgan Stanley Emerg Mkts Debt Fd Inc
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Morgan Stanley Emerg Mkts Debt Fd Inc is a diversified, closed-end management investment company. The Fund's primary investment objective is to produce high current income and as a secondary objective to seek capital appreciation, through investments mainly in debt securities of government and government-related issuers located in emerging countries, of entities organized to restructure the outstanding debt of such issuers and debt securities of corporate issuers in or organized under the laws of emerging countries.
AstraZeneca Showcases Groundbreaking Cancer Research at ASCO 2025 with Two Plenary Presentations
• AstraZeneca will present over 80 abstracts at ASCO 2025, including two plenary presentations featuring camizestrant for HR-positive breast cancer and IMFINZI for early gastric cancer, marking their seventh consecutive year with plenary data.
• The SERENA-6 trial is the first positive Phase III study for a next-generation oral SERD in first-line HR-positive breast cancer, pioneering the use of circulating tumor DNA to guide treatment decisions.
• DESTINY-Breast09 data shows ENHERTU plus pertuzumab is the first treatment in over a decade to demonstrate superiority over standard care in first-line HER2-positive metastatic breast cancer.
MSD Expands Opevesostat Clinical Program to Include Breast, Endometrial, and Ovarian Cancers
• MSD has initiated a new Phase 2 clinical trial to evaluate opevesostat (MK-5684) in women's cancers, expanding beyond its current prostate cancer program.
• Opevesostat, an oral, non-steroidal and selective CYP11A1 inhibitor discovered by Orion, will be tested for safety and efficacy in breast, endometrial, and ovarian cancers.
• The expansion represents a significant broadening of potential therapeutic applications for opevesostat, which is already in Phase 3 trials for metastatic castration-resistant prostate cancer.
Eisai to Present Long-Term LEAP-002 Data and Novel Pipeline Advances at ASCO 2025
• Eisai will showcase long-term follow-up data from the Phase 3 LEAP-002 study evaluating lenvatinib plus pembrolizumab versus lenvatinib monotherapy in first-line unresectable hepatocellular carcinoma treatment.
• The company will present research on E7386, a CBP/β-catenin interaction inhibitor, in combination with lenvatinib for patients with advanced or recurrent endometrial carcinoma, addressing significant unmet medical needs.
• Final analysis data from the Phase 3 LEAP-015 study examining lenvatinib plus pembrolizumab and chemotherapy in advanced gastroesophageal adenocarcinoma will be featured in an oral presentation.
Merck and Daiichi Sankyo Launch Phase 3 Trial of Novel B7-H3 Targeted ADC for Advanced Esophageal Cancer
• The IDeate-Esophageal01 Phase 3 trial has begun evaluating ifinatamab deruxtecan, a potential first-in-class B7-H3 directed antibody-drug conjugate, against standard chemotherapy in advanced esophageal squamous cell carcinoma.
• Esophageal squamous cell carcinoma accounts for 90% of global esophageal cancers with dismal survival rates of 15-20%, highlighting the urgent need for new treatment approaches after first-line therapy failure.
• The trial follows promising early-phase results and will enroll approximately 510 patients across Asia, Europe, and North America, with overall survival as the primary endpoint.
ROSALINE Trial: Neoadjuvant Letrozole/Entrectinib Shows Limited Efficacy in Invasive Lobular Breast Cancer
• The phase 2 ROSALINE trial found that combining entrectinib with letrozole failed to meet its primary endpoint, with no efficacy-evaluable patients achieving residual cancer burden (RCB) of 0 or 1 in invasive lobular breast cancer.
• Despite the primary endpoint failure, the treatment showed a 49% objective response rate by MRI assessment, with 10% complete responses and 39% partial responses among the 41 evaluable patients.
• ROSALINE represents the first neoadjuvant endocrine therapy trial dedicated exclusively to invasive lobular breast cancer, demonstrating the feasibility of subtype-specific trials while researchers continue biomarker analyses.
FDA Grants Cancer Drug Approvals to AbbVie and MSD, AbbVie Announces $335M ADARx Partnership
• The FDA has approved new cancer therapeutics from AbbVie and MSD, expanding treatment options for specific oncology indications.
• AbbVie has simultaneously announced a strategic collaboration with ADARx Pharmaceuticals, committing $335 million upfront to access ADARx's siRNA platform technology.
• The partnership aims to combine expertise in RNA technologies, antibody-drug conjugates (ADCs), and targeted delivery systems to accelerate development of novel cancer therapeutics.
FDA Approves Belzutifan as First Oral Treatment for Advanced Pheochromocytoma and Paraganglioma
• The FDA has approved belzutifan (Welireg) for adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma, based on promising phase 2 trial results.
• As a selective HIF-2α inhibitor, belzutifan demonstrated a 26% overall response rate with a median duration of response of 20.4 months, offering a novel mechanism of action compared to historically used treatments.
• This approval is particularly significant as previous treatment options were limited, with the only previously approved agent no longer commercially available and alternative therapies associated with concerning toxicity profiles.
Antengene to Showcase Six Innovative Cancer Therapies at AACR and ASCO 2025
• Antengene will present data from four preclinical studies at AACR 2025, featuring novel T-cell engagers and a synthetic lethality approach targeting MTAPnull cancers.
• The company's ATG-201 (CD19 x CD3 TCE) and ATG-042 (MTAPnull-selective PRMT5 inhibitor) demonstrated promising efficacy in preclinical models and are poised to enter clinical development in the second half of 2025.
• At ASCO 2025, Antengene will share clinical data on ATG-037 (CD73 inhibitor) in combination with pembrolizumab for anti-PD-1 resistant solid tumors, with encouraging preliminary results in melanoma and NSCLC.
Trodelvy-Keytruda Combination Shows Promising Results in First-Line Treatment for Triple-Negative Breast Cancer
• Gilead Sciences and Merck's phase 3 ASCENT-04/KEYNOTE-D19 trial demonstrated statistically significant improvement in progression-free survival with Trodelvy plus Keytruda compared to Keytruda with chemotherapy in metastatic TNBC patients.
• The novel combination of antibody-drug conjugate (Trodelvy) with immunotherapy (Keytruda) represents a potential paradigm shift in treatment approach for aggressive triple-negative breast cancer, potentially displacing conventional chemotherapy.
• Early data shows a positive trend toward improved overall survival, with detailed results to be presented at upcoming medical meetings and discussed with regulatory authorities.
BeiGene Discontinues Ociperlimab Development After Failed Phase III Lung Cancer Trial
• BeiGene has terminated development of its anti-TIGIT antibody ociperlimab following a futility analysis showing the drug was unlikely to meet overall survival endpoints in non-small cell lung cancer.
• The decision comes after Novartis ended its $300 million licensing partnership with BeiGene in July 2023, forcing the biotech to reevaluate the drug's development pathway.
• This setback adds to mounting challenges in the TIGIT inhibitor space, following Merck's recent discontinuation of two Phase III trials of its anti-TIGIT candidate vibostolimab due to safety and efficacy concerns.
Roche Expands Molecular Glue Portfolio with $2 Billion Monte Rosa Partnership
• Roche has signed a $2 billion partnership with Monte Rosa Therapeutics, including a $50 million upfront payment, to develop molecular glue therapies targeting previously "undruggable" proteins in cancer and neurological diseases.
• This marks Roche's second major molecular glue deal in a month, following a similar $2 billion alliance with Orionis Biosciences, demonstrating the company's strategic push to establish leadership in this emerging therapeutic category.
• Monte Rosa will lead discovery and preclinical activities using its QuEEN platform, with Roche taking over late-stage development of candidates that can potentially address the 80% of human proteins currently inaccessible to traditional drug development approaches.
FDA Grants Breakthrough Therapy Status to Radiprodil for GRIN-Related Seizure Treatment
• GRIN Therapeutics' radiprodil receives FDA Breakthrough Therapy designation for treating seizures in patients with GRIN-related neurodevelopmental disorder, showing 86% median reduction in seizure frequency during Phase 1b trials.
• The investigational drug demonstrated significant efficacy in Phase 1b Honeycomb study, with 71% of patients achieving over 50% reduction in countable motor seizures and most patients showing behavioral improvements.
• The company plans to initiate Phase 3 pivotal trials in mid-2025, backed by a $200M capital commitment from Blackstone Life Sciences, to evaluate radiprodil's impact on seizures and behavioral outcomes.
PADCEV-KEYTRUDA Combination Shows Sustained Survival Benefit in Advanced Urothelial Cancer Trial
• Phase 3 EV-302 trial demonstrates PADCEV plus KEYTRUDA reduces mortality risk by 49% compared to chemotherapy in advanced urothelial cancer patients, with median overall survival of 33.8 months versus 15.9 months.
• The combination therapy showed significant progression-free survival benefit of 12.5 months compared to 6.3 months with chemotherapy, representing a 52% reduction in disease progression risk.
• Extended 12-month follow-up data confirms sustained efficacy across all patient subgroups, including both cisplatin eligible and ineligible patients, with no new safety concerns identified.
BioNTech's BNT111 Cancer Vaccine Shows Promise in Advanced Melanoma Phase 2 Trial
• BioNTech's mRNA-based cancer vaccine BNT111, combined with Regeneron's Libtayo, demonstrated significant improvement in overall response rate for advanced melanoma patients who failed prior immunotherapy.
• The vaccine targets four melanoma-associated antigens (NY-ESO-1, MAGE-A3, tyrosinase, and TPTE) and has received FDA orphan drug and fast-track designations for treating resistant melanoma.
• This breakthrough represents a significant advancement in personalized cancer medicine, validating BioNTech's mRNA technology platform and combination therapy strategy.
FDA Issues Complete Response Letter for Checkpoint's Cosibelimab in Advanced Skin Cancer
• The FDA has rejected Checkpoint Therapeutics' application for cosibelimab in advanced cutaneous squamous cell carcinoma, citing manufacturing facility issues rather than safety or efficacy concerns.
• Clinical trials demonstrated promising results with a 55% overall response rate in locally advanced cSCC and 50% in metastatic disease, positioning cosibelimab as a potential low-cost alternative to existing treatments.
• Checkpoint Therapeutics plans to address the manufacturing concerns and resubmit their application, aiming for potential approval in 2024, though the news triggered a 45% drop in company stock.
European Commission Approves GSK's Jemperli Plus Chemotherapy for Advanced Endometrial Cancer
• The European Commission has approved Jemperli (dostarlimab) in combination with chemotherapy for first-line treatment of advanced or recurrent endometrial cancer.
• The approval expands the indication to include patients with mismatch repair proficient/microsatellite stable (MMRp/MSS) tumors, representing approximately 75% of cases.
• The RUBY trial demonstrated a 31% reduction in the risk of death with Jemperli plus chemotherapy compared to chemotherapy alone, with a median OS of 44.6 months.
• Jemperli, a PD-1 blocking antibody, is now an approved immuno-oncology-based treatment option for all patients with advanced endometrial cancer in the EU.
Evaxion Biotech Completes Dosing in Phase 2 Trial of Personalized Cancer Vaccine EVX-01 for Advanced Melanoma
• Evaxion Biotech has completed dosing in its Phase 2 trial of EVX-01, a personalized cancer vaccine, for advanced melanoma treatment.
• The trial evaluates EVX-01 in combination with MSD’s Keytruda (pembrolizumab), with each patient receiving a uniquely designed vaccine.
• Interim data from the Phase 2 trial presented at ESMO 2024 showed a 69% overall response rate and a positive correlation between AI predictions and immune responses.
• The company anticipates a full clinical data readout in the second half of 2025, with hopes that EVX-01 could become a new treatment option.
Enhertu Approved for HER2-Low and HER2-Ultralow Metastatic Breast Cancer
• The FDA has approved Enhertu for HR-positive, HER2-low or HER2-ultralow metastatic breast cancer after endocrine therapy progression.
• DESTINY-Breast06 trial data showed a 36% reduction in disease progression or death risk compared to chemotherapy.
• Patients on Enhertu had a median progression-free survival of 13.2 months versus 8.1 months on chemotherapy.
• This approval expands Enhertu's use to an earlier treatment setting and a broader patient population.
Gilead's Trodelvy Fails in Bladder Cancer Trial
Gilead Sciences' drug Trodelvy has not met its primary endpoint in a clinical trial for urothelial carcinoma, the most common form of bladder cancer, raising concerns over its effectiveness and future in the market.
Merck's Winrevair Receives UK Approval for Pulmonary Arterial Hypertension
• The UK's MHRA has approved Merck's Winrevair (sotatercept) for treating pulmonary arterial hypertension (PAH) in adults with moderate to marked physical activity limitations.
• Winrevair, used with other PAH medicines, improves exercise capacity by targeting the underlying causes of the narrowing of lung arteries.
• Clinical trials demonstrated that Winrevair significantly improved patients' ability to exercise, with a 40.8-meter increase in six-minute walk distance compared to placebo.
• The approval marks another regulatory win for Merck's Winrevair, already approved in the US and EU, with analysts projecting sales exceeding $1 billion in 2025.
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