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Ligand Pharmaceuticals Incorporated (LGND)
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Almost got a positive article from Zacks...
Of note, "Management believes that the (OmniAb) platform can generate $500 million to $1 billion of annual royalties beginning 2030." A ballpark gross PE imputes a $20B market cap for OmniAb (in 2030) - 8x Ligand's current market cap.
Of course, it's Zacks, so they had to add "If *any* of LGND”s partners fails to receive regulatory approvals or terminates a deal, its prospects would be severely hit."
No, no they wouldn't.
Can someone explain the convertible note to me? The conversion price is $248/share. Does this mean that ligand has to pay the equivalent of $248/share to unwind this deal? Regardless of stock price? The conversion date is Nov ‘22. What implications for the stock price as this unwinds? Does this note preclude the IPO of OmniAb? Seems like the note would have to be retired prior to the IPO?
APVO436 news: Aptevo Therapeutics reports complete remission with APVO436+chemo combo in acute myeloid leukemia. APTV up more than 100% on the news. APVO436 is an OmniAb derived bispecific CD3xCD123 mAb:
"Aptevo Therapeutics Reports First Complete Remission, Providing Clinical Update for Its Phase 1b Multi Center, Multi Cohort Expansion Trial in the Treatment of Acute Myeloid Leukemia
Tue, November 23, 2021, 5:05 AM
In this article:
SEATTLE, WA / ACCESSWIRE / November 23, 2021 / Aptevo Therapeutics Inc. ("Aptevo" or the "Company") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, today announced a clinical update for the Company's Phase 1b Expansion trial evaluating APVO436 in the treatment of acute myeloid leukemia (AML). Preliminary data observed to date includes one complete remission.
A high-risk AML patient treated in Cohort 1 with a combination of chemotherapy plus APVO436 achieved a complete remission (CR) after one cycle of therapy. The chemotherapy regimen included the standard leukemia drugs Mitoxantrone, Etoposide, and Cytarabine. The patient tolerated treatment without evidence of overt toxicity.
The overarching goal of the Phase 1b expansion phase study is to determine if APVO436 treatments can improve the quality of remission in high-risk AML patients by reducing the residual chemotherapy-resistant measurable residual disease (MRD) burden. The quality of remission will be assessed using state-of-the art multiparameter flow cytometry methods for quantitative MRD assessment in a centralized laboratory.
MRD, previously known as minimal residual disease, in AML refers to leukemia cells that are present at very low numbers but can be detected using highly sensitive flow cytometric or genomic methods. A recent systematic review of the clinical significance of MRD in over 10,000 AML patients has demonstrated that achievement of MRD negativity is associated with superior leukemia-free survival and overall survival. Therefore, MRD status has emerged as an attractive and clinically meaningful end point that may allow for accelerated evaluation of novel therapies in AML (reference: Short et al., Association of Measurable Residual Disease with Survival Outcomes in Patients with Acute Myeloid Leukemia: A Systematic Review and Meta-analysis. JAMA Oncol. 2020 Dec 1;6(12):1890-1899. Click here to view the publication:
Aptevo believes that APVO436 has the potential to help AML patients achieve complete remissions without MRD and thereby reduce their risk of leukemic relapses. Aptevo also believes that the use of APVO436 for targeting MRD in AML may be associated with a very low risk of cytokine release syndrome (CRS) as well as an increased likelihood of responses as both CRS as well as responses are inversely correlated with the leukemia burden of the patients. If successful, deepening the remission to an MRD-negative remission using this strategy could translate into an improved overall survival in AML.
The Company recently published information about the compound's favorable safety profile, characterized by a low incidence of CRS, and promising single agent activity of APVO436 in two back-to-back peer-reviewed publications in the prestigious oncology journal Cancers (Basel):
1. Uckun, F.M.; Lin, T.L.; Mims, A.; Patel, P.; Lee, C.; Shahidzadeh, A.; Shami, P.; Cull, E.; Cogle, C.R.; Watts, J. A Clinical Phase 1B Study of the CD3xCD123 Bispecific Antibody APVO436 in Patients with Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplasia. Cancers (Basel)2021, 13, Aug 15;13(16):4113. Click here to view the publication:
2. Uckun FM, Watts J, Mims AS, Patel P, Wang E, Shami PJ, Cull E, Lee C, Cogle CR, Lin TL. Risk, Characteristics and Biomarkers of Cytokine Release Syndrome in Patients with Relapsed/Refractory AML or MDS Treated with CD3xCD123 Bispecific Antibody APVO436. Cancers (Basel) 2021; 13(21):5287. Click here to view the publication:
Overexpression of CD123 is the hallmark of many forms of leukemia. Aptevo's lead proprietary drug candidate, APVO436 is a bispecific CD3xCD123 ADAPTIR that is designed to redirect the immune system of the patient to destroy leukemia cells expressing the target CD123 molecule on their surface. This antibody-like recombinant protein therapeutic is designed to engage both leukemia cells and T-cells of the immune system and bring them closely together to trigger the destruction of leukemia cells. APVO436 has been engineered using Aptevo's proprietary and enabling bioengineering methods and is designed to reduce the likelihood and severity of CRS. APVO436 has received orphan drug designation ("orphan status") for AML according to the Orphan Drug Act.
Sugemalimab news: EQRx announces Sugemalimab commercialization partnership for ROW (Middle East, Africa and Turkey). EQRx holds commercial rights to US+EU+ROW. CStone Pharma has rights to China. Sugemalimab approval in China is imminent- I expect it in the next few days. LGND will receive royalties on global Sugemalimab revenues:
"November 22, 2021
EQRx Announces Partnership Agreement with Abdul Latif Jameel Health to Commercialize Lead Oncology Programs in Middle East, Turkey and Africa
EQRx, a new type of pharmaceutical company committed to developing and delivering important new medicines to patients at radically lower prices, today announced a strategic collaboration agreement with Abdul Latif Jameel Health, part of international diversified family business Abdul Latif Jameel. Through the agreement, Abdul Latif Jameel Health will become EQRx’s regulatory and commercial partner for aumolertinib and sugemalimab, if approved, in selected markets throughout the Middle East region, as well as in Turkey and all of Africa.
Aumolertinib, an epidermal growth factor receptor (EGFR) inhibitor, and sugemalimab, an anti-PD-L1 antibody, have both shown promising Phase 3 data for the treatment of patients with advanced non-small cell lung cancer (NSCLC).
“This strategic collaboration aims to expand the commercial reach of our lead oncology programs throughout the Middle East, Turkey and Africa and provide millions of people with access to affordable new cancer treatments,” said Melanie Nallicheri, chief executive officer of EQRx. “We are excited to partner with Abdul Latif Jameel Health which brings extensive regulatory and commercial expertise in these vast regions as we continue to work to create sustainable access to innovative medicines globally.”
“This agreement comes as we forge ahead in our mission to source, collaborate with and fund innovators within the medical world that are re-examining how to improve the current healthcare landscape by disrupting existing methods and working to accelerate the wider inclusivity of healthcare throughout the world,” said Akram Bouchenaki, chief executive officer, Abdul Latif Jameel Health. “It’s our joint mission with EQRx to change that, a mission that is aligned with the values of the Jameel Family.”
About Lung Cancer
Every 15 seconds, a person across the world is diagnosed with lung cancer, and every 18 seconds, a person dies of the disease, making it the second most commonly diagnosed cancer and leading cause of cancer death worldwide. In 2020, an estimated 2.2 million people were diagnosed with lung cancer.1 NSCLC is the most common type of lung cancer, accounting for 84% of all lung cancer diagnoses.2
Sugemalimab is an investigational monoclonal antibody targeting programmed death-ligand 1 (PD-L1) discovered by CStone Pharmaceuticals. Authorized by the U.S.-based Ligand Corporation, sugemalimab is developed by the OmniRat® transgenic animal platform, which can generate fully human antibodies in one stop. As a fully human, full-length anti-PD-L1 monoclonal antibody, sugemalimab mirrors the natural G-type immunoglobulin 4 (IgG4) human antibody, which reduces the risk of immunogenicity and potential toxicities in patients, a potential advantage during treatment. Currently, sugemalimab is being investigated in a number of ongoing clinical trials including four Phase 3 registration studies in Stage III NSCLC (GEMSTONE-301), Stage IV NSCLC (GEMSTONE-302), gastric cancer, and esophageal cancer. Both the GEMSTONE-301 and GEMSTONE-302 studies met their primary endpoints of progression free survival and results were recently presented at global medical congresses. In November 2020, the National Medical Products Administration (NMPA) of China accepted the New Drug Application for sugemalimab combined with chemotherapy for the first-line treatment of advanced squamous and non-squamous NSCLC patients. EQRx holds the development and commercialization rights to sugemalimab outside of Greater China and plans to pursue regulatory discussions in multiple countries...."
OmniAb spinoff: informative article on LGND's spinoff initiative. OmniAb currently has 50 partners with 200 Ab programs, and close to 20 programs are in clinical development. OmniAb has $1 Billion in contracted milestones in the 200 currently partnered programs:
"Ligand Pharma antibody spinoff plan sets up competition with AbCellera, Adimab
Ligand Pharmaceuticals has turned a series of antibody discovery acquisitions into a growing business unit. Ligand now wants to spin it off as a separate company, but that new company will compete head to head against established antibody players AbCellera and Adimab.
By FRANK VINLUAN
Antibodies are part of the wave of new biological drugs that are bringing new treatment options for patients and blockbuster sales for companies. As a growing number of biopharma companies look to beef up their antibody discovery capabilities, Ligand Pharmaceuticals believes that its antibody technologies unit, which has developed internally for the past six years, is now ready to stand on its own.
San Diego-based Ligand, which provides an array of technologies and services that biopharmaceutical industry customers use for drug discovery and development, announced plans for the spinoff of its OmniAb antibody unit after the market close Tuesday. The split will leave two publicly traded entities, each with a distinct business focus and base of customers. OmniAb will have to fend for itself, competing against AbCellera and Adimab, two established players in the antibody discovery space.
The OmniAb platform that Ligand provides to its biopharmaceutical industry customers offers capabilities to find antibodies that have the potential for therapeutic applications. The platform is the product of a series of acquisitions, beginning in 2016 with the $178 million buyout of Palo Alto-based Open Monoclonal Technology (OMT), a company with antibody generation technology. The following year, Ligand paid $27.2 million to acquire Crystal Bioscience. In 2019, it bought the computational antigen technology company Ab Initio for $12 million. Last year, the company paid $12 million total for two privately held antibody discovery companies, xCella Biosciences and Taurus Biosciences.
Speaking on a conference call, Ligand CEO John Higgins said that when his company acquired OMT, it only had 15 partners, all of them at the discovery stage. Currently, OmniAb has more than 50 partners spanning more than 200 programs. Nearly 20 of those programs are in clinical development. Disclosed partners include Amgen, Pfizer, and Takeda Pharmaceutical.
By comparison, AbCellera Biologics has 33 disclosed partners that have begun 60 programs. The Vancouver, British Columbia-based company, which was founded in 2012, went public last year, raising $483 million. Lebanon, New Hampshire-based Adimab was founded in 2015. It has 80 partners, though a Ligand corporate presentation noted that the privately held company does not disclose how many programs have been started by those partners, nor does it say whether programs and partnerships are ongoing or have been terminated.
The business model of Ligand revolves around striking deals. The company licenses its technologies, as well as some of its internally discovered drug programs, to other parties. Fees and milestone payments from these deals provide revenue. Additional dollars come from milestones payments and royalties paid to Ligand as discoveries and out-licensed products progress in their development. In 2020, Ligand reported $186.4 million in revenue, a nearly 55% increase over total revenue in the prior year. The company does not break out financials for the OmniAb unit, but the company said in the presentation that the antibody unit has nearly $1 billion in contracted milestones.
Royalty revenue from an OmniAb antibody is coming soon. In August, authorities in China approved the Gloria Biosciences drug zimberelimab, a monoclonal antibody discovered with the OmniAb technology. The Gloria Bio drug is designed to block the checkpoint protein PD-1 to treat classical Hodgkin’s lymphoma. Ligand is set to receive royalties from product sales. A regulatory decision for another OmniAb-discovered antibody is expected by the end of the year.
“Simply put, the OmniAb business is bigger, better, and further along than we expected just a few years ago,” Higgins said.
OmniAb’s growth comes as antibody research progresses across the entire sector. In the corporate presentation, Ligand said that the antibody drug market is expected to grow from $150 billion today to more than $250 billion in five years. The company also noted that 42 antibodies are now blockbuster sellers, up from 36 two years ago....."
Reproxalap news: Aldeyra Therapeutics confirms NDA submission for anti-inflammatory Reproxalap in 1Q'22; PIII TRANQUILITY trial enrollment completed:
"Aldeyra Therapeutics Announces Completion of Enrollment in Phase 3 TRANQUILITY Trial in Patients with Dry Eye Disease and Reiterates New Drug Application (NDA) Submission Guidance
Top-Line Results from TRANQUILITY Expected This Quarter
Together with Recently Completed Phase 2 Clinical Trial, Positive Ocular Redness Results from TRANQUILITY Could Satisfy NDA Submission Requirements as Pivotal Trials for Improvement in an Objective Sign of Dry Eye Disease
Completed Phase 3 RENEW-Part 1 and Formulation Phase 2 Clinical Trials to be Submitted as Pivotal Trials in Satisfaction of NDA Symptom Requirements
Anticipated NDA Submission Expected in Early 2022
LEXINGTON, Mass., November 09, 2021--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra or the Company), a biotechnology company developing novel immune-modulating therapies to treat ocular and systemic diseases, today announced completion of enrollment in the Phase 3 TRANQUILITY Trial of 0.25% reproxalap ophthalmic solution (reproxalap) for the treatment of patients with dry eye disease.
"Following the recent announcement of top-line results from our Phase 2 clinical trial, which achieved the primary endpoint of ocular redness and which we intend to submit as a pivotal trial, completion of enrollment in TRANQUILITY is a significant milestone as we advance reproxalap toward an anticipated NDA submission early next year for the treatment of dry eye disease," stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. "If the primary endpoint of ocular redness in TRANQUILITY is achieved, and in conjunction with two previously announced clinical trials demonstrating improvement in ocular dryness symptoms, we believe that the efficacy requirements for NDA submission will have been met."
The multi-center, double-masked, parallel-group TRANQUILITY Trial enrolled 300 patients randomized equally to receive either reproxalap or vehicle. Patients received four doses one day prior to, and two doses on the day of exposure to, a 90-minute dry eye chamber with minimal humidity, high airflow, and forced visual tasking. The primary endpoint of the TRANQUILITY Trial is ocular redness. Top-line results from the trial are expected this quarter.
Based on the results of the recently completed Phase 2 clinical trial, which enrolled 158 patients and achieved statistical significance in the primary endpoint of ocular redness, TRANQUILITY is at least 90% powered to detect a statistically significant difference in ocular redness. TRANQUILITY is one of two identically designed Phase 3 clinical trials Aldeyra is conducting in patients with dry eye disease. Enrollment in the second trial, TRANQUILITY-2, is ongoing. If successful, either TRANQUILITY or TRANQUILITY-2 could complete NDA submission requirements for demonstration of improvement in an objective sign of dry eye disease.
Per draft U.S. Food and Drug Administration (FDA) guidance, to be considered for regulatory approval in the United States, a product candidate for the treatment of dry eye disease must demonstrate efficacy in an objective sign in at least two clinical trials and efficacy in a subjective symptom in at least two clinical trials. For satisfaction of symptom efficacy requirements, Aldeyra intends to submit two previously completed adequate and well-controlled symptom trials that pre-specified patient-reported ocular dryness score as a primary endpoint, the RENEW-Part 1 Trial and the Formulation Phase 2 clinical trial. For satisfaction of the sign efficacy requirements, Aldeyra intends to submit the recently completed Phase 2 clinical trial and, if positive, either TRANQUILITY or TRANQUILITY-2, all of which pre-specify ocular redness as a primary endpoint.
"With its safety and efficacy profile—demonstrated in clinical trials encompassing more than 1,300 patients in aggregate—reproxalap has the potential to provide relief to the estimated 34 million adults in the U.S. who suffer from persistently disturbing symptoms and ocular redness caused by dry eye disease," Dr. Brady stated.
More information on TRANQUILITY can be found on
Reproxalap, an investigational new drug, is a novel small-molecule immune-modulating covalent inhibitor of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease. Reproxalap’s mechanism of action has been validated with the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications. Reproxalap is currently in Phase 3 clinical development as a 0.25% ophthalmic solution for the treatment of dry eye disease and allergic conjunctivitis, two ocular inflammatory diseases that often occur together.
With the omicron variant, I have a feeling the Remy run isn't going to be over as soon as we thought...
down 7.50 on 22k shares
dividing the company plan hasn't helped the way this trades
Kyprolis (carfilzomib) news: FORTE clinical trial results show Kyprolis provides significantly improved efficacy compared to bortezomib (current standard-of-care) both as induction and maintenance treatment in newly diagnosed multiple myeloma patients eligible for transplantation. Kyprolis projected to do $1.2 Billion in revenue in '21. LGND ascending royalties 1.5-3% from global sales; threshold for 3% is at $750 Million in Kyp revenue:
(Abstract is very long, providing the Conclusion here.)
Lancet Oncol. 2021 Nov 11;S1470-2045(21)00535-0. doi: 10.1016/S1470-2045(21)00535-0. Online ahead of print.
Carfilzomib with cyclophosphamide and dexamethasone or lenalidomide and dexamethasone plus autologous transplantation or carfilzomib plus lenalidomide and dexamethasone, followed by maintenance with carfilzomib plus lenalidomide or lenalidomide alone for patients with newly diagnosed multiple myeloma (FORTE): a randomised, open-label, phase 2 trial
Interpretation: Our data show that KRd plus ASCT showed superiority in terms of improved responses compared with the other two treatment approaches and support the prospective randomised evaluation of KRd plus ASCT versus standards of care (eg, daratumumab plus bortezomib plus thalidomide plus dexamethasone plus ASCT) in transplant-eligible patients with multiple myeloma. Carfilzomib plus lenalidomide as maintenance therapy also improved progression-free survival compared with the standard-of-care lenalidomide alone.
11/15 Lasofoxifene news: Sermonix raises $40 Million in financing to advance Lasofoxifene through late stage clinical development for the treatment of ESR1-mutated metastatic breast cancer. LGND will receive royalties on an ascending scale of 6-10% of global sales:
Sermonix Pharmaceuticals Closes $40 Million Series A3 Financing Round Led by Perceptive Xontogeny Ventures Fund II
Sermonix Pharmaceuticals LLC
Mon, November 15, 2021, 7:00 AM
Funds will be used to further advance lasofoxifene through late-stage clinical development as a next-generation oral SERM to treat women with increasingly prevalent ESR1 breast cancer mutations
Initial data from both Phase 2 clinical trials is expected in H1 2022
COLUMBUS, Ohio, Nov. 15, 2021 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to treat ESR1-mutated metastatic breast and gynecological cancers, today announced that it successfully closed a $40 million Series A3 financing round led by Perceptive Xontogeny Ventures Fund II (PXV Fund). Existing investors also participated in the financing.
As part of the agreement, Fred Callori and Ben Askew, Ph.D., partners in the PXV Fund, were appointed to the Sermonix Board of Directors.
“We are excited to welcome investors who share our passion as we work to leverage a precision medicine approach to address a significant unmet need in the metastatic breast cancer setting,” said David Portman, M.D., Sermonix founder and chief executive officer. “This is a pivotal moment for Sermonix. With a strengthened balance sheet and both our ELAINE Phase 2 studies fully enrolled and progressing, we have set the stage for a catalyst-rich 2022, with initial data from each trial expected in the first half.”
The PXV Fund team brings significant scientific, business, operational and investment expertise to the Sermonix team, with a singular goal of shepherding lasofoxifene through compelling and rigorously designed clinical proof-of-concept studies.
“We are pleased to announce our support for Sermonix Pharmaceuticals in their endeavors to develop an effective treatment for the approximately 40% of breast cancer patients who develop ESR1 mutations and progress following endocrine therapy,” said Mr. Callori. “We believe lasofoxifene, if approved, may become a treatment of choice for oncologists and many of their patients with this challenging disease. The accomplished team at Sermonix recognizes the acute medical need and will be executing effectively on these strategies.”
Sermonix recently announced significant progress in the advancement of its ELAINE (Evaluation of Lasofoxifene in ESR1 Mutations) Phase 2 clinical program for lasofoxifene:
In August, Sermonix announced completion of enrollment in its Phase 2 ELAINE 1 trial (NCT03781063), which is evaluating lasofoxifene versus the current standard of care, fulvestrant, for the treatment of ER+/HER2- breast cancer in patients with an ESR1 mutation. Sermonix expects topline data from the trial, which enrolled a total of 100 patients, in the first half of 2022.
In June, Sermonix announced completion of enrollment in its Phase 2 Elaine 2 trial (NCT04432454), which is evaluating lasofoxifene in combination with Eli Lilly and Company’s FDA-approved CDK 4 and 6 inhibitor, abemaciclib. Initial data from the trial is expected in the first half of 2022.
LifeSci Capital acted as placement agent for Sermonix on this transaction."
Rylaze news: 3Q'21 Jazz Pharma reports $20.7 Million Rylaze sales in Q. Excellent numbers considering Jul 15'21 launch! JAZZ plans filing for marketing approval in EU and Japan in '22. LGND will receive an additional $155 Million in milestones as Rylaze receives regulatory and marketing approvals in EU+Japan+ROW. Royalties on global Rylaze sales are on ascending scale from ca. 3%-6%:
"Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):
Rylaze net product sales were $20.7 million in 3Q21, following commercial launch on July 15, 2021.
The Company has been granted Real-Time Oncology Review by FDA and plans to submit a supplemental Biologics License Application (sBLA) with additional data in support of a Monday/Wednesday/Friday (M/W/F) intramuscular dosing schedule in early 2022.
The Company is presenting data, for the first time, from the Phase 2/3 study of Rylaze in patients with ALL/LBL who developed hypersensitivity or silent inactivation to a long-acting E. coli–derived asparaginase, at the 63rd American Society of Hematology (ASH) Annual Meeting, which will be held December 11-14, 2021.
The Company anticipates that data from the current development program will support regulatory filings in Europe in mid-2022, with potential for approval in 2023. The Company is also working with a partner to advance the program for potential filing, approval and launch in Japan.
Rylaze is the only recombinant Erwinia asparaginase manufactured product that maintains a clinically meaningful level of asparaginase activity throughout the entire duration of treatment. It was developed by the Company to address the needs of patients and healthcare providers for an innovative, high-quality Erwinia asparaginase with reliable supply."
interesting with LGND partner ALDX submission for NDA ALDX stock dropping toward 52 week low.
good chance for their have 3 results any day now
Good news this morning from Arcus Biosciences.
-- Gilead Exercises Options to Arcus’s Anti-TIGIT Program (Domvanalimab and AB308), Etrumadenant (A2a/A2b Adenosine Receptor Antagonist) and Quemliclustat (Small Molecule CD73 Inhibitor) --
Zimberelimab is the backbone of most of the Arcus studies involving the above mentioned mab and small molecules.
CASI reports sales increase of evomela to $8.1 million in latest quarter. Ligand gets 20% royalty plus captisol sales.
11/15 Pharma Intelligence Informa report: MRK projects pneumococcal vaccine market of $10 Billion by '25. Vaxneuvance expected to capture approx 30% of PV market for ~$3.3 Billion/yr. LGND will receive royalties in the low single digits on global Vaxneu sales:
"...Merck forecasts the global pneumococcal vaccine market will reach $10bn in 2025 and $13bn by 2030 but acknowledged much of the opportunity remains in the pediatric pneumococcal market, where Merck has a limited presence. Roughly 70% of global revenues come from the pediatric market while 30% are attributed to adults, according to Merck...."
APVO436 News: Aptevo Therapeutics announces presentation of updated clinical results for APVO436 in relapsed/refractory AML and MDS leukemia patients. Robust and durable efficacy reported in these patients who have failed all other treatment options:
"Aptevo Therapeutics Announces the Presentation of Two Abstracts at the Upcoming American Society of Hematology Annual Meeting
Mon, November 15, 2021
In this article:
SEATTLE, WA / ACCESSWIRE / November 15, 2021 / Aptevo Therapeutics Inc. ("Aptevo" or the "Company") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, today announced that the Company will present two abstracts at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition, which will be held virtually and in-person in Atlanta, Ga. December 11-14, 2021.
Details of the presentations are as follows:
Title: "Tolerability and Single Agent Anti-Neoplastic Activity of the CD3xCD123 Bispecific Antibody APVO436 in Patients with Relapsed/Refractory AML or MDS"
Lead Author: Justin M. Watts, M.D., Sylvester Comprehensive Cancer Center and University of Miami Health System, Miami, Florida
Date/Time: Monday, December 13, 2021, 6:00 PM-8:00 PM
Title: "Risk and Severity of Cytokine Release Syndrome in Patients with Relapsed/Refractory AML or MDS Treated with CD3xCD123 Bispecific Antibody APVO436"
Lead Author: Tara L. Lin, M.D., University of Kansas Cancer Center, Westwood, Kansas
Date/Time: Monday, December 13, 2021, 6:00 PM-8:00 PM
Overexpression of CD123 is the hallmark of many forms of leukemia. Aptevo's lead proprietary drug candidate, APVO436 is a bispecific ADAPTIR that targets CD123 x CD3 and is designed to redirect the immune system of the patient to destroy leukemia cells expressing the target CD123 molecule on their surface. This antibody-like recombinant protein therapeutic is designed to engage both leukemia cells and T-cells of the immune system and bring them closely together to trigger a rapid and complete destruction of leukemia cells.
Paper: Tolerability and Single Agent Anti-Neoplastic Activity of the CD3xCD123 Bispecific Antibody APVO436 in Patients with Relapsed/Refractory AML or MDS
Short interest is deflating somewhat..
SETTLEMENT DATE SHORT INTEREST AVG. DAILY SHARE VOLUME DAYS TO COVER
11/15/2021 1,588,319 157,977 10.0
10/29/2021 1,659,088 82,835 20.0
Let's go to 208 ! It's coming !
Warren Buffett's Berkshire just took a position in Royalty Pharma.
They bought the rights to Promacta from Ligand.
Maybe Warren might recognize the potential in LGND?
Report out: interim analysis from GMMG-CONCEPT trial reported; testing combo of Isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd) as front line treatment in high risk multiple myeloma patients. Outstanding efficacy with 100% ORR and 40% CR. Carfilzomib already a blockbuster drug and this will boost revenue potential significantly. LGND receives ascending royalties up to 3% depending on sales:
Published: 03 November 2021
MULTIPLE MYELOMA, GAMMOPATHIES
Isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd) in front-line treatment of high-risk multiple myeloma: interim analysis of the GMMG-CONCEPT trial
Lisa B. Leypoldt, Britta Besemer, Anne Marie Asemissen, Mathias Hänel, Igor Wolfgang Blau, Martin Görner, Yon-Dschun Ko, Hans Christian Reinhardt, Peter Staib, Christoph Mann, Raphael Lutz, Markus Munder, Ullrich Graeven, Rudolf Peceny, Hans Salwender, Anna Jauch, Manola Zago, Axel Benner, Diana Tichy, Carsten Bokemeyer, Hartmut Goldschmidt & Katja C. Weisel
The continuous implementation of novel agents in the treatment of multiple myeloma (MM) has led to significant improvement in survival. Especially the addition of monoclonal antibodies directed against CD38 to standard of care regimens led to significantly deepening responses and improved survival outcomes . However, treatment of high-risk (HR) MM remains challenging with still markedly impaired survival, and risk-adapted treatment concepts are rare [2, 3]. Even aggressive approaches resulted in two-year median progression-free survival (PFS) rates of approximately 50% . The GMMG-CONCEPT trial (NCT03104842) investigates the quadruplet regimen isatuximab, carfilzomib, lenalidomide, and dexamethasone (Isa-KRd) in front-line treatment of solely HRMM. Here, we report the interim analysis (IA) focusing on best response during induction and presenting first data on PFS of the first 50 patients.
The IA reports on the first 50 patients included in this phase II, open-label, two-arm, multi-center clinical trial with planned recruitment of 246 patients. Patients were eligible if they had ND symptomatic MM according to international consensus criteria with HR features, defined by the presence of del17p (≥10% of purified cells) or t(4;14) or t(14;16) or > 3 copies of 1q21. Furthermore, all patients had to have ISS II or III stage disease . Prior MM-specific treatment was allowed as emergency treatment with a maximum of one cycle of any anti-MM first-line treatment. All patients received ECG and ECHO at screening.
Forty-four of 50 patients completed induction, seven patients discontinued treatment due to progressive disease (n = 3), death (n = 3) or patient’s request (n = 1). Average dose intensities were 95.7% for isatuximab, 95.2% for dexamethasone, 91.6% for carfilzomib, and 87.9% for lenalidomide. With regards to the goal of this IA reporting on best response during induction, all patients (50/50; ORR = 100%) responded to the induction treatment showing at least a partial response (PR) as best response. 45/50 patients (90%) showed a VGPR or better, 20/50 patients (40%) a complete response (CR) and three patients (6%) a stringent complete response (sCR) (Table 1).
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