Affimed Therapeutics B.V. - AFMD
Die bisherige, schon länger bekannte Aussage in der Monothearpie bei T-Zell Lymphoma war ein 50% ORR (d.h. CR + PR) in dieser AFM13 Studie und auch der Grund für die weiteren Untersuchungen.
Mein Verständnis, keine Handelsempfehlung.
Mr. Smith has broad biopharmaceutical industry experience including financial strategy, capital markets, business development and operations. He joins Affimed from Rockwell Medical, Inc., where he served as Chief Financial Officer.
“We are pleased to welcome Mr. Smith who adds extensive US capital markets expertise,” said Dr. Adi Hoess, Affimed’s CEO. “His biopharmaceutical industry experience and track record of financial execution for life sciences companies will help ensure that Affimed is well positioned as we enter the next stage of rapid growth.”
“This is an exciting time to join Affimed and I look forward to contributing to the success of the company as it progresses its clinical and pre-clinical programs,” said Mr. Smith. “I look forward to applying my experience in late-stage pharmaceuticals in order to evolve the company and accelerate our ability to bring much needed therapeutics to cancer patients who deserve more options.”
Prior to Rockwell, a biopharmaceutical company focused on developing and commercializing therapies for anemia, Mr. Smith served as Senior Vice President, Chief Business Officer and Principal Financial Officer at Pernix Therapeutics, a specialty pharmaceutical company focused on the acquisition, development and commercialization of prescription drugs.
Mr. Smith began his career in healthcare investment banking, having served as a Director in the Healthcare Investment Banking Group at Cantor Fitzgerald. During his nearly decade-long investment banking tenure, Mr. Smith focused on providing strategic and financial advice to life sciences and healthcare companies. He has worked on a substantial number of transactions across the healthcare sector with an aggregate transaction value of more than $15 billion.
Mr. Smith holds a B.A. in Mathematical Economics from Colgate University.
Vielleicht erfährt man ja bald aus den Meldeschwellen Überschreitungen, wer da investiert (oder verkauft) hat.
Damit dürften es jetzt rund 13 Millionen Aktien zu rund 42 Millionen US-Dollar sein.
Wenn diese Transaktionen bei Affimed per ATM in die Kasse geflossen sind, wäre es eine nette Verbesserung der Finanzlage und hätte dem Investor (so es kein Tauschgeschäft zwischen Grossinvestoren ist) eine meldepflichtige Beteiligung von über 5% eingebracht - warten wir mal die nächsten Tage ab.
Meine Meinung - KEINE Handelsempfehlung.
Roche / Genentech hat eine klinische Studie zum BCMA Engager (ehemals AFM26) mit 4 Studienorten initiert und ist in Dänemark schon in der Rekrutierung von Patienten.
Da sollte Affimed am 23-ten wohl etwas zu berichten haben.
Meine Meinung - KEINE Handelsempfehlung.
AFM24, designed to activate innate immunity to broadly target EGFR-expressing solid tumors regardless of mutational status, has the potential to improve efficacy and safety over currently available EGFR-targeted therapies
AFM24 is the first innate cell redirecting immuno-oncology therapeutic dosed in solid tumor patients
The 2nd dose cohort is open for patient recruitment
Heidelberg, Germany, June 17, 2020 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced the successful completion of the first dose cohort in a Phase 1/2a clinical trial of AFM24. This first-in-human study evaluates AFM24 as monotherapy in patients with advanced solid EGFR expressing malignancies whose disease has progressed after treatment with previous anticancer therapies. AFM24, a tetravalent, bispecific epidermal growth factor receptor (EGFR)- and CD16A-binding innate cell engager, is novel due to its activation of innate immunity to kill solid tumors, inducing both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). Other therapies rely heavily on signal or checkpoint inhibition.
The company reports that no dose limiting toxicity was observed and the study is cleared to proceed the next dose level (cohort 2). No efficacy yet was observed, however, efficacy was not expected at this dose level.
“As we progress to the 2nd dose cohort, we take another step closer to giving patients a new treatment option with a distinctive mechanism that mobilizes the innate immune system to attack cancer cells” said Dr. Andreas Harstrick, Chief Medical Officer of Affimed. “The innate immune system is inherently powerful, yet it has been largely untapped as a therapeutic approach to fight cancer. With the clinical progress we are making we are hopeful that AFM24 will become an important option to provide long-lasting, multilayered tumor control.”
AFM24 has demonstrated preclinically the ability to bridge NK cells and macrophages to EGFR-expressing tumor cell lines, and to induce lysis through ADCC and ADCP, respectively, independent of RAS or BRAF mutational status.
The study is an open-label, non-randomized, multi-center, multiple ascending dose escalation/expansion study to evaluate AFM24 as monotherapy in adult patients with advanced solid malignancies known to be EGFR-positive. The aim of the dose escalation phase is the determination of the maximum tolerated dose and the establishment of a recommended Phase 2a dose. The dose expansion phase is intended to collect preliminary evidence of efficacy and to further confirm the safety of AFM24. For more information including eligibility criteria, visit www.clinicaltrials.gov, using Identifier NCT04259450.
About AFM24
AFM24 is a tetravalent, bispecific EGFR- and CD16A-binding innate cell engager generated from Affimed’s fit-for-purpose ROCK® platform. AFM24 uses the cytotoxic potential of the innate immune system by redirecting and activating NK cells and macrophages to kill EGFR-positive cancer cells through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), respectively. Due to its unique mechanism of action, AFM24 is potentially not limited to patient subtypes based on mutational status. Toxicology studies in cynomolgus monkeys with AFM24 showed a favorable safety profile, even when the animals were treated at high dose levels, demonstrating AFM24’s potential to have lower toxicities in humans compared to other EGFR-targeted therapies.
Data Presented at AACR Virtual Annual Meeting II demonstrate that Affimed’s ROCK® platform has the ability to produce diverse Innate Cell Engagers for a multitude of hematologic and solid tumor cancers with consistent profiles in tumor lyses and safety
Data on both Affimed’s AFM24 (CD16A/EGFR) and Genentech’s RO797089 (CD16A/BCMA) show potent killing in tumor cell lines at low target expression in the relevant pre-clinical models
Both Innate Cell Engagers show dual Mode of Action through activation of CD16A on NK cells and macrophages, inducing ADCC and ADCP respectively
In cynomolgus monkeys both AFM24 and RO7297089 demonstrate a promising safety profile
Heidelberg, Germany, June 22, 2020 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that data from two investigational Innate Cell Engagers (ICE) developed from its fit-for-purpose ROCK® platform were presented as posters at the American Association for Cancer Research (AACR) Virtual Annual Meeting II. Affimed researchers presented data on AFM24, a bispecific EGFR/CD16A ICE with the potential to overcome resistance to current targeted treatments for EGFR-positive malignancies. Researchers from Genentech, a member of the Roche Group, presented preclinical data on the pharmacology and safety of RO7297089, a novel anti-BCMA/CD16A bispecific antibody for the treatment of multiple myeloma built from the ROCK® platform; Affimed researchers contributed as co-authors on the poster.
“The data presented at AACR on AFM24 and RO7297089 further confirm the importance of activating the innate immune system to deliver transformative medicines to patients,” said Dr. Arndt Schottelius, Affimed’s Chief Scientific Officer. “Moreover, it is very exciting to see that both molecules show potent and targeted killing of tumor cells in vitro without high levels of cytokine release. With AFM24, we have already progressed to the 2nd dose cohort in our Phase 1/2A clinical study and very much look forward to seeing continued consistent safety profile and early signs of activity in future cohorts.“
AFM24 activates innate immunity to kill solid tumors, inducing both ADCC and ADCP
The data presented on Affimed’s AFM24 further elucidated its preclinical profile as a novel ICE that harnesses the innate immune system to induce potent tumor cell killing via ADCC and ADCP. Due to its distinctive mechanism of action (MOA), AFM24 is potentially eligible for treatment of EGFR-positive tumors, regardless of EGFR-pathway mutations and EGFR receptor density. Unlike other EGFR targeted therapies, EGFR is used as a docking site only, AFM24’s cytotoxicity is independent of EGFR functionality and the downstream signal cascade. The pre-clinical data suggest that AFM24 is well tolerated with no toxicity in cynomolgus monkeys. Based on its preclinical profile, AFM24 shows promising therapeutic benefit for a broad set of patients with hard-to-treat EGFR-expressing cancers. AFM24 is currently being studied in a Phase1/2A study.
RO7297089 shows potent cell killing of BCMA positive tumor cell lines employing NK cells and macrophages
The data presented on Genentech’s RO7297089 provided preclinical characterization of a novel BCMA/CD16A ICE, also based on the ROCK® platform, for the treatment of multiple myeloma. It was shown that RO7297089 is a potent therapeutic agent in vitro and selectively kills BCMA expressing multiple myeloma tumor cells by activating innate immunity (ADCC and ADCP). The in vitro assessment demonstrated that, unlike T cell redirecting therapies, RO7297089 is unlikely to have a risk of acute cytokine release. In a one-month repeat-dose study in cynomolgus monkeys, RO7297089 was well tolerated, and there were no test article-related adverse effects at up to 50 mg/kg, with no significant cytokine release. RO7297089 represents a novel and promising MOA with a favorable safety profile, distinct from the T cell-based BCMA-targeting modalities in the clinic.
More details about the program for the AACR Virtual Annual Meeting II including the abstracts and poster presentations on AFM24 and RO7297089 are available online at www.aacr.org.
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Wertpapier: Affimed NV |
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Insbesondere ex-Genentech, ex-Morphosys CSO Dr. Arndt Schotteluis mit Details zur Biologie der Immune-Cell-Engagers and CMO Dr. Andreas Harstrick als klinischer Experte speziell zu den Möglichkeiten von AFM-24. Der CMO hatte leider auch schlechte Nachrichten zum Start der NK-Zell Kombinationsstudien wegen der schwiergien COVID19 Situation am MD Anderson Cancer Center.
Der bald anfangende CFO Angus Smith wurde noch vertreten durch Michael Wolf, der über eine gute gefüllte Kasse von 107 Millionen Euro einschliesslich der 18.8 Millionen Euro aus dem ATM berichtete, die insbesondere zur Beschleunigung von AFM24 eingesetzt werden sollen.
Für mich eine gut geführte, für Neulinge sehr informative Pressekonferenz mit Enthusiasmus aber ohne Übertreibung oder übertriebene Versprechungen.
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