On August 26, 2020 Kintara Therapeutics, Inc. (formerly DelMar Pharmaceuticals, Inc.) ("Kintara" or the "Company") (Nasdaq: KTRA) reported that Saiid Zarrabian, Chief Executive Officer of Kintara, will give a virtual corporate presentation at the LD Micro 500 taking place online on Thursday, September 3, 2020 at 4:00 PM ET followed by a live Q&A session with registered investors and other conference attendees (Press release, Kintara Therapeutics, AUG 26, 2020, View Source [SID1234564057]).

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Webcast link: View Source

In addition, Mr. Zarrabian will be available for virtual one-on-one meetings from September 1-4, 2020. To schedule a meeting please contact Eric Lahiji at [email protected].

On August 26, 2020 Can-Fite BioPharma Ltd. (NYSE American:CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that it will be presenting at the 12th annual LD 500 on Tuesday, September 1, 2020 at 9:20 AM EST / 6:20 AM PST (Press release, Can-Fite BioPharma, AUG 26, 2020, View Source [SID1234564056]). The LD 500 will take place on September 1st through the 4th. Investors interested in viewing the presentation may register here: https://ld-micro-conference.events.issuerdirect.com/

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Can-Fite CEO Dr. Pnina Fishman will present to a live public audience, and management will conduct private 1×1 meetings with registered investors. LD Micro expects 20,000 attendees and 300 featured companies. Can-Fite plans to update investors on its advanced clinical pipeline including two ongoing Phase III trials in rheumatoid arthritis and psoriasis, an upcoming pivotal Phase III study in liver cancer, and two upcoming clinical trials in the treatment of COVID-19 and NAFLD/NASH.

Chris Lahiji, Founder of LD stated, "We have been waiting for this moment all year long. Due to COVID, it has been nearly impossible for physical conferences to even take place. I want to show the world that you can still learn, have a great time, and see some of the most unique companies in the capital markets today. All without having to step foot outside. For the first time, LD Micro is accessible to everyone, and we are honored to welcome you to one of the most trusted platforms in the space."

Can-Fite’s profile for the conference may be viewed here: View Source

Profiles powered by LD Micro – News Compliments of ACCESSWIRE

About LD Micro

Back in 2006, LD Micro began with the sole purpose of being an independent resource to the microcap world. What started as a newsletter highlighting unique companies, has transformed into the pre-eminent event platform in the space. The upcoming "500" in September is the Company’s most ambitious project yet, and the first event that is accessible to everyone. For those interested in attending, please contact David Scher at [email protected] or visit www.ldmicro.com for more information.

On August 26, 2020 Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built proteins known as DARPin therapeutics, reported its corporate highlights and unaudited financial results for the first half-year of 2020 (Press release, Molecular Partners, AUG 26, 2020, View Source [SID1234564053]).

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"Molecular Partners progressed and expanded our diverse portfolio in the first half of 2020. As a therapeutics innovator developing an entirely new class of drugs, COVID-19 represented an opportunity to deliver a highly differentiated therapeutic solution. We have rapidly advanced a novel anti-COVID-19 program, supported by strong preclinical data, and secured manufacturing capacity for initial clinical and commercial need. In parallel, we have advanced our immuno-oncology clinical recruitment and shared first proof-of-concept for our novel peptide-MHC program, an area that has been incredibly challenging for other biologic modalities," said Patrick Amstutz, Ph.D., Chief Executive Officer of Molecular Partners. "We remain supportive of our ophthalmology partnership with AbbVie and, as we look forward, Molecular Partners is more strongly positioned than ever before to create value through our continual expansion of DARPin platform technologies that leverage the unique advantages of this class."

Antiviral program: Rapid development of highly differentiated anti-COVID-19 multi-DARPin candidates with unique advantages for addressing a global viral pandemic

In April 2020, the Company leveraged its rapid discovery and candidate design capabilities to deliver multi-target binding DARPin proteins that neutralized the SARS-CoV-2 virus in vitro. Tri-specific DARPin candidates, including MP0420, were selected with the ability to inactivate the virus through multiple mechanisms simultaneously – cooperative target binding – and generate stronger antiviral effects through these synergies. These candidates exhibit among the highest potency in inhibiting SARS-CoV-2 live virus reported to-date, and in August 2020 the Company disclosed strong preliminary in vivo findings.

The DARPin technology offer a differentiated approach to treating COVID-19 through a single molecule that can engage with the spike protein of the SAR-CoV-2 virus with three DARPin modules simultaneously to neutralize the virus. This offers potentially broader efficacy – across both therapeutic and prophylactic settings – and reduced potential for the development of viral drug resistance which can result from selection pressure on any single molecular target. DARPin candidates are also produced through rapid, high-yield microbial fermentation for potential speed and cost advantages over mammalian cell production typically employed for antibodies.

In July 2020, the Company announced a partnership with AGC Biologics, a global biopharmaceutical contract development and manufacturing organization to secure initial clinical and commercial-scale manufacturing capacity for the COVID-19 program. In August 2020, the Company announced the reservation by the Swiss Federal Office of Public Health: Bundesamt für Gesundheit (FOPH-BAG) of up to 3.2 million doses of MP0420, if the candidate is approved in Switzerland. Under the terms of the agreement, the Company immediately received a reservation fee in the mid to high single digit millions of Swiss Francs.

In August 2020 the Company submitted a paper to the biology research preprint server bioRxiv which recapped the Company’s anti-COVID-19 research program and disclosed strong preliminary in vivo findings, including dose-dependent trends for reduction of viral titer as well as protection against body weight loss and lung lesions. The paper is titled "Highly potent anti-SARS-CoV-2 multi-DARPin candidates".

Molecular Partners plans to initiate clinical studies for its COVID-19 program in Q4 2020.

Immuno-oncology programs: Continued recruitment and proof-of-concept for peptide-MHC DARPin binders

In partnership with Amgen, the Company continued strong recruitment of patients with solid tumors in the phase 1 dose escalation study of AMG 506 (MP0310), a novel tumor-localized immune agonist. This phase 1 trial is evaluating AMG 506 (MP0310) as a single agent in patients with advanced solid tumors. Molecular Partners expect to report initial data from this study in H2 2020. Data from the dose escalation cohorts will be used to inform potential Ph1b combination studies with Amgen assets and will be conducted by Amgen. Additionally, the Company presented preclinical data at the American Academy for Cancer Research (AACR) (Free AACR Whitepaper) describing the research supporting the optimal dose for this candidate in the ongoing clinical study.

For MP0317, the Company’s second tumor-localized immune agonist, IND-enabling work continues to advance. MP0317 includes localizer (FAP) and stimulator (CD40) DARPin domains, which respectively provide tumor-specificity and immune activation. The Company presented preclinical data at AACR (Free AACR Whitepaper) strongly supporting the intended profile and mechanism of this candidate and anticipates filing an IND by the end of 2020.

For MP0274, recruitment for its phase 1 trial has concluded. MP0274 is a multi-specific DARPin product candidate being developed for the treatment of solid tumors with strong expression of the highly validated target protein HER2. Molecular Partners anticipates reporting initial data from this study in H2 2020.

As of April 30, 2020, patients in the ongoing phase 2 study of MP0250 in combination with the proteasome inhibitors (PIs) bortezomib (Velcade) and dexamethasone will be monitored per protocol and no additional patients will be enrolled into the study.

Finally, at AACR (Free AACR Whitepaper) the Company also presented proof-of-concept data for its peptide-MHC DARPin program. The constructed DARPin proteins were observed to effectively activate T cells at a range of concentrations and to carry out highly targeted cell killing exclusively on those cells that were positive for the peptide target. This demonstrated proof-of-concept for the ability of DARPin therapeutics to effectively drug specific peptide-MHC complexes.

Ophthalmology: AbbVie receipt of CRL for abicipar and further regulatory engagement

In June, AbbVie received a Complete Response Letter (CRL) for the Biologics License Application (BLA) of abicipar. AbbVie has withdrawn its filings for abicipar with both the European Medicines Agency and the Japanese Regulatory Agency and is committed to working with these agencies to determine appropriate next steps and requirements for potential resubmissions for abicipar.

There is substantial need for better treatment options for nAMD and the Company remains confident in the totality of data supporting abicipar’s clinical profile for this indication, and continues to support AbbVie as it determines next steps.

Financial highlights: Private placement extends cash runway into 2022

Molecular Partners remains solidly funded to capture upcoming value inflection points. In the first six months of 2020, Molecular Partners recognized total revenues of CHF 7.5 million (H1 2019: CHF 13.6 million) and incurred total operating expenses of CHF 30.6 million (H1 2019: CHF 26.0 million). This led to an operating loss of CHF 23.1 million for the first six months in 2020 (H1 2019: Operating loss of CHF 12.4 million). In the first six months in 2020 the Company accounted for a net financial loss of CHF 1.6 million (H1 2019: Net financial loss of CHF 0.3 million). This resulted in a net loss of CHF 24.7 million for H1 2020 (H1 2019: Net loss of CHF 12.7 million).

The net cash outflow from operating activities during the first six months in 2020 was CHF 27.9 million (2019: net cash inflow of CHF 27.0 million). Including time deposits, the cash and cash equivalents position decreased by CHF 30.7 million vs. year-end 2019 to CHF 64.4 million as of June 30, 2020 (December 31, 2019: CHF 95.1 million).

Total shareholders’ equity stood at CHF 31.0 million as of June 30, 2020, a decrease of CHF 23.1 million (December 31, 2019: CHF 54.1 million). As of June 30, 2020, the Company employed 144 FTEs (full time equivalents), up 12% year-on-year. About 85% of the employees are employed in R&D-related functions.

Early July 2020, the Company was able to reinforce its solid cash position with a private placement financing, raising gross proceeds of CHF 80.2 million. This further increases Molecular Partner’s financial flexibility to capture multiple value-creating inflection points into 2022. To continue building its capacity to deliver innovative new therapeutic candidates and manage a growing clinical portfolio, the Company plans to invest in both its clinical programs as well as an expanded workforce.

Business outlook and priorities
In the second half of 2020, Molecular Partners will focus on advancing its immuno-oncology and antiviral programs. For the COVID-19 program, the Company plans to initiate clinical trials of MP0420 in Q4 2020 and advance additional candidate towards the clinic.

Molecular Partners expects to present additional data from its ongoing phase 2 trial of MP0250 in patients with multiple myeloma in combination with Velcade (PI) in H2 2020. For AMG 506 (MP0310), following the planned reporting of initial data from the phase 1 study in H2 2020, these data will be used to inform potential Ph1b combination studies with Amgen assets to be conducted by Amgen. For MP0317, IND submission is anticipated around the end of 2020. The Company also plans to publish or present multiple updates across its portfolio at select scientific venues.

Financial outlook 2020
For the full year 2020, at constant exchange rates, the Company expects total expenses in the range of CHF 65-75 million (previously CHF 60-70 million), of which around CHF 6.0 million will be non-cash effective costs. This slightly increased guidance reflects the Company’s additional investments into its Covid-19 programs. Capital expenditures in FY 2020 are expected to be approximately CHF 3.0 million.

Documentation
The results presentation, this press release and the half-year 2020 report will be made available on www.molecularpartners.com after 7:00am (CET) on August 26, 2020.

H1 2020 conference call
Molecular Partners will hold a conference call and audio webcast on August 26, 2020, 2:00pm CET (1:00pm GMT, 8:00am EST).

In order to register for the H1 2020 conference call, please dial the following numbers approximately 10 minutes before the start of the presentation:

Audio webcast
The H1 20 results presentation will be webcast live and will be made available on the Company’s website under the investor section. The replay will be available for 90 days following the presentation.

Financial Calendar
October 29, 2020 Interim Management Statement Q3 2020
December 2020 R&D Day in New York
The latest timing of the above events can always be viewed on the investor section of the website.

About DARPin therapeutics
DARPin therapeutics are a new class of custom-built protein therapeutics based on natural binding proteins that open a new dimension of multi-functionality and multi-target specificity in drug design. A single DARPin candidate can engage more than five targets, and its flexible architecture and small size offer benefits over conventional monoclonal antibodies or other currently available protein therapeutics. DARPin therapeutics have been clinically validated through to the registrational stage. The DARPin platform is a fast and cost-effective drug discovery engine, producing drug candidates with optimized properties for development and very high production yields. DARPin is a registered trademark owned by Molecular Partners AG.

On August 26, 2020 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that the U.S. Food and Drug Administration (FDA) approved the FoundationOne Liquid CDx, Foundation Medicine’s comprehensive liquid biopsy test for all solid tumors with multiple companion diagnostic indications, including for Rubraca (rucaparib) tablets, recently approved for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.i,ii FoundationOne Liquid CDx is intended for use by health care professionals to help inform cancer treatment decisions in accordance with FDA-approved labeling and professional guidelines for patients with solid tumors (Press release, Clovis Oncology, AUG 26, 2020, View Source [SID1234564052]).

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FoundationOne Liquid CDx is intended to be used as a companion diagnostic to identify patients who may benefit from treatment with specific FDA-approved targeted therapies, including Rubraca, the first PARP inhibitor approved for the treatment of BRCA1/2-mutant mCRPC.

"Tumors with BRCA mutations are by far the most responsive to PARP inhibitors in metastatic castration-resistant prostate cancer, and when we started development of Rubraca for mCRPC, we knew it was important to develop a plasma-based companion diagnostic for physician and patient ease of use," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "What we could not have foreseen was how important a plasma-based test would be in this COVID-19 environment, in which even important procedures, such as tissue-based biopsies, can be difficult to schedule for patients. We are pleased that the FDA has approved a plasma-based companion diagnostic to identify mCRPC patients who may benefit from treatment with Rubraca."

The objective response rate in BRCA positive patients as determined by FoundationOne Liquid CDx was 46% (95% CI, 31-63), comparable to 44% (95% CI, 31-57) as determined by clinical trial assays for patients enrolled in TRITON2, highlighting the utility and consistency of using a liquid biopsy test for patient selection.i,iii

"Now that we have drugs that specifically benefit patients with BRCA mutations, the ability to identify who has these mutations is paramount," said Professor Celestia S. Higano, MD FACP, University of Washington School of Medicine. "In contrast to tissue biopsy, a liquid biopsy is a blood-plasma test that is less invasive than a tissue biopsy for assessing germline or somatic BRCA mutations. The FDA’s approval of liquid biopsy tests represents a significant advancement for clinicians and patients to make timely decisions about treatment options."

Foundation Medicine expects the FoundationOne Liquid CDx to be commercially available on Friday, August 28, 2020.

About Prostate Cancer

The American Cancer Society estimates that nearly 192,000 men in the United States will be diagnosed with prostate cancer in 2020iv, and the GLOBOCAN Cancer Fact Sheets estimated that approximately 450,000 men in Europe were diagnosed with prostate cancer in 2018.v Castration-resistant prostate cancer has a high likelihood of developing metastases. Metastatic castration-resistant prostate cancer, or mCRPC, is an incurable disease, usually associated with poor prognosis. Approximately 43,000 men in the U.S. are expected to be diagnosed with mCRPC in 2020.vi According to the American Cancer Society, the five-year survival rate for mCRPC is approximately 30 percent.vii Approximately 12 percent of patients with mCRPC harbor a deleterious germline and/or somatic mutation in the genes BRCA1 and BRCA2. These molecular markers may be used to select patients for treatment with a PARP inhibitor.viii

Rubraca U.S. FDA Approved Indication

Rubraca is indicated for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy.

This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Select Important Safety Information

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) has occurred in patients treated with Rubraca, and are potentially fatal adverse reactions. In 1146 treated patients, MDS/AML occurred in 20 patients (1.7%), including those in long term follow-up. Of these, 8 occurred during treatment or during the 28 day safety follow-up (0.7%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 53 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA damaging agents. In TRITON2, MDS/AML was not observed in patients with mCRPC (n=209) regardless of homologous recombination deficiency (HRD) mutation.

Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1). Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics. If MDS/AML is confirmed, discontinue Rubraca.

Based on findings in genetic toxicity and animal reproduction studies, advise male patients with female partners of reproductive potential or who are pregnant to use effective methods of contraception during treatment and for 3 months following last dose of Rubraca. Advise male patients not to donate sperm during therapy and for 3 months following the last dose of Rubraca.

Most common adverse reactions in TRITON2 (≥ 20%; Grade 1-4) were fatigue/asthenia (62%), nausea (52%), anemia (43%), AST/ALT elevation (33%), decreased appetite (28%), rash (27%), constipation (27%), thrombocytopenia (25%), vomiting (22%), and diarrhea (20%).

Co-administration of rucaparib can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring.

Click here for full Prescribing Information for Rubraca.

You may also report side effects to Clovis Oncology, Inc. at 1-415-409-7220 (US toll) or 1-844-CLVS-ONC (1-844-258-7662; US toll-free).

About Accessing Rubraca

Rubraca is available in the United States through specialty pharmacies and distributors. Clovis is committed to ensuring Rubraca access for patients and offers eligible patients financial and reimbursement support through Rubraca Connections. More information about Rubraca Connections is available at RubracaConnections.com or by calling 1-844-779-7707 between 8 a.m. and 8 p.m. Eastern Time, Monday through Friday.

About Rubraca (rucaparib)

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

On August 26, 2020 GlaxoSmithKline plc reported the European Commission has granted conditional marketing authorisation for BLENREP (belantamab mafodotin) as monotherapy for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy (Press release, GlaxoSmithKline, AUG 26, 2020, View Source [SID1234564051]). BLENREP is a first-in-class humanised anti-BCMA (B-cell maturation antigen) treatment for these patients whose disease has progressed despite the current standard of care.

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Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "The approval of BLENREP marks an important step forward for patients in Europe where nearly 50,000 new cases of multiple myeloma are diagnosed each year. Unfortunately, most of these patients will relapse or stop responding to current therapies so I am pleased that today’s news will give patients with limited treatment options access to the first approved anti-BCMA therapy."

The approval is based on data from the pivotal DREAMM-2 (DRiving Excellence in Approaches to Multiple Myeloma) study, including 13-month follow-up data. These data demonstrated that treatment with single-agent BLENREP, administered as a 2.5 mg/kg dose every three weeks (Q3W), resulted in an overall response rate of 32%. The median duration of response was 11 months and median overall survival was 13.7 months.

The safety and tolerability profile were consistent with previously reported data on BLENREP. The most commonly reported adverse events in the 2.5 mg/kg arm (greater than or equal to 20%) were keratopathy/microcyst-like epithelial changes or MECs (71%), thrombocytopenia (38%), anaemia (27%), blurred vision events (25%), nausea (25%), pyrexia (23%), increased aspartate aminotransferase (AST) (21%), infusion-related reactions (21%), and lymphopenia (20%).

Dr Katja Weisel, Deputy Director and Associate Professor of Haematology/Oncology in the Department of Oncology, Haematology and Bone Marrow Transplantation with Department of Pneumonology, University Medical Centre Hamburg-Eppendorf in Germany and an investigator for the DREAMM-2 trial, said: "Despite advances in treatment, multiple myeloma remains incurable and patients continue to cycle through therapies, with their prognosis worsening with each relapse. The approval of BLENREP, with its novel mechanism of action, represents a new class of treatment that patients can turn to when their cancer stops responding to other standard of care options."

BLENREP employs a multi-faceted mechanism of action and is directed toward BCMA, a cell-surface protein that plays an important role in the survival of plasma cells and is expressed on multiple myeloma cells.[1]

Dr Brian G.M. Durie, Chairman of the Board of the International Myeloma Foundation, said: "The EC approval of BLENREP is good news for patients with refractory multiple myeloma whose cancer continues to progress and are in dire need of new treatment options. We appreciate GSK’s efforts to bring this new therapy to patients in the EU and for the commitment to addressing the needs of the multiple myeloma community."

BLENREP was granted PRIME designation in 2017 and the Conditional Marketing Authorisation Application was reviewed under European Medicines Agency’s accelerated assessment procedure, which is given if the EMA’s Committee for Medicinal Products for Human Use determines the treatment is of major interest from a public health perspective and represents a therapeutic innovation.

Earlier this month, the US Food and Drug Administration approved BLENREP as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent, following a priority review for the company’s Biologics License Application.

About DREAMM-2
DREAMM-2 is an open label study of BLENREP. Patients in the trial had actively progressing multiple myeloma that had worsened despite current standard of care and were randomised to two arms to receive either 2.5 mg/kg or 3.4 mg/kg BLENREP Q3W. Overall, patients in DREAMM-2 had more advanced disease, poorer prognosis and performance status and also had a greater number of prior lines of therapy in comparison with patients in DREAMM-1, the first time in human study of BLENREP.

About multiple myeloma
There are approximately 48,000 new cases of multiple myeloma diagnosed each year across Europe.[2] Research into new treatments is needed as most patients will relapse or become refractory to available therapies.[3]

About B-cell maturation antigen (BCMA)
The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines.[4]

About BLENREP
BLENREP is an antibody drug conjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa.

Important information for BLENREP in the EU
Indication

BLENREP is indicated as monotherapy for the treatment of multiple myeloma in adult patients, who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

Important safety information
Contraindications: Hypersensitivity to the active substance or to any of the excipients

Warnings and precautions: Corneal adverse reactions have been reported with BLENREP (keratopathy or microcyst-like epithelial changes in corneal epithelium with or without changes in visual acuity, blurred vision, and dry eye symptoms). Ophthalmic examinations including assessment of visual acuity and slit lamp examination, should be performed at baseline, before the subsequent 3 treatment cycles and during treatment as clinically indicated. Patients experiencing corneal adverse reactions may require dose modifications or treatment discontinuation based on severity of findings. Cases of corneal ulcer (ulcerative and infective keratitis) have been reported with BLENREP. These should be managed promptly and treatment with BLENREP should be interrupted until the corneal ulcer has healed. Due to the risk of thrombocytopenic events, complete blood counts should be obtained at baseline and monitored during treatment. Patients on concomitant anticoagulant treatments may require more frequent monitoring and should be managed with a dose delay or reductions. If a moderate or severe infusion-related reaction occurs, interrupt infusion and provide supportive treatment. Once symptoms resolve, resume at a lower infusion rate. If anaphylactic or life-threatening infusion reaction, BLENREP should be permanently discontinued.

Undesirable effects: The most commonly-reported adverse reactions were keratopathy and thrombocytopenia. The most commonly reported serious adverse reactions were pneumonia, pyrexia and infusion related reactions.

Very common (≥1/10): Pneumonia, thrombocytopenia, anaemia, lymphopenia, leukopenia, neutropenia, keratopathy, blurred vision events, dry eye, nausea, diarrhoea, pyrexia, fatigue, increased aspartate aminotransferase, increased gamma glutamyltransferase and infusion related reactions.

Common (≥1/1000 to <1/10): Upper respiratory tract information, photophobia, eye irritation, vomiting and increased creatine phosphokinase

Refer to the BLENREP Prescribing Information for a full list of adverse events and the complete important safety information.

GSK in Oncology
GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics, and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.