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Affimed Shifts Attention To Risky Combination Therapy With NK Cells For T-Cell Lymphoma

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Natural slayer cells attacking a crab cell

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Introduction

Affimed (NASDAQ:AFMD), a clinical-stage immuno-oncology company, precocious announced that it will nary longer prosecute monotherapy successful peripheral T-cell lymphoma (PTCL) and alternatively will attraction connected testing AFM13 successful operation pinch Artiva's AB-101 earthy slayer (NK) compartment product. This determination was made pursuing nan results of Affimed's shape 2 REDIRECT study, which investigated AFM13 monotherapy successful patients pinch advanced-stage refractory and relapsed PTCL.

In this article, we will analyse nan reasons down Affimed's displacement from monotherapy to operation therapy successful peripheral T-cell lymphoma. Furthermore, we will measure nan company's imaginable successful nan aftermath of investors' unfavorable guidance to this strategical shift.

Financials

Let's first reappraisal nan company's latest financials. As of September 30, 2022, Affimed had $260.7 cardinal successful rate and rate equivalents, which is expected to support operations until mid-2024. The 4th ended September 30, 2022, saw a full revenue of $17.6 million, chiefly from collaborations pinch Genentech and Roivant. Research and improvement expenses accrued by 27% to $29.1 million, while wide and administrative expenses accrued by 19% to $9.1 million. Net finance income accrued by 84% to $3.1 cardinal owed to rate fluctuations. The nett nonaccomplishment for nan 4th was $19.2 million, aliases $0.13 nonaccomplishment per communal share. Affimed is presently weighted beneath its rate and rate equivalents, displaying nan disappointment and debased expectations from nan market.

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Affimed Reports Topline Data from Phase 2 REDIRECT Study successful Peripheral T-Cell Lymphoma, Decides to Focus connected Combination Therapy pinch AFM13 and NK Cells.

Affimed's shape 2 REDIRECT study's superior efficacy measures included an nonsubjective consequence complaint (ORR) of 32.4% and a complete consequence (CR) complaint of 10.2%. Secondary and exploratory result measures included safety, durability of response, progression-free endurance (PFS), and wide endurance (OS). The information floor plan of AFM13 was accordant pinch antecedently reported information from anterior and ongoing objective studies. The median long of consequence (DOR) was 2.3 months, nan median PFS was 3.5 months, and nan median OS was 13.8 months.

According to Dr. Adi Hoess, CEO of Affimed, these information are "remarkable" and corroborate that nan activation of innate immunity tin lead to robust objective activity. However, nan institution believes that nan operation of AFM13 pinch NK cells has a higher probability of delivering accrued anti-tumor activity and a much durable objective use to reside nan unmet request successful this diligent population. Consequently, Affimed will attraction its finance connected objective improvement successful nan operation of AFM13 pinch AB-101 NK cells.

Peripheral T-Cell Lymphomas: A Highly Aggressive and Difficult-to-Treat Form of Lymphoma pinch Limited Therapeutic Options

Peripheral T-cell lymphomas are highly fierce and 1 of nan astir difficult to dainty forms of lymphoma pinch mediocre prognosis for patients. They relationship for astir 10-15% of each non-Hodgkin lymphomas and are often refractory to chemotherapy.

The pathophysiology of PTCL is not good understood, but it is known to beryllium a heterogeneous illness pinch various familial and epigenetic alterations. PTCL is characterized by nan overexpression of nan CD30 antigen, a personnel of nan tumor necrosis facet receptor superfamily, which is besides expressed successful Hodgkin lymphoma. This makes CD30 an charismatic target for therapy successful PTCL.

Currently, location are respective curen options disposable for PTCL, including chemotherapy, radiation therapy, stem compartment transplantation, and targeted therapies. However, nan efficacy of these treatments is limited, and immoderate patients relapse aliases create refractory disease.

The Potential of Combining AFM13 and AB-101 NK Cells successful nan Treatment of PTCL: Benefits, Limitations, and Risks

AFM13 is simply a bispecific antibody that targets CD30 connected tumor cells and CD16A connected NK cells. This allows for nan selective activation of NK cells, starring to nan demolition of CD30-positive tumor cells. AFM13 has shown promising activity successful PTCL, some arsenic a monotherapy and successful operation pinch allogeneic NK cells. The operation of AFM13 pinch AB-101 NK cells is expected to amended nan durability of consequence and build connected nan already meaningful activity seen successful nan REDIRECT study.

The operation of AFM13 and Artiva's AB-101 NK cells has nan imaginable to supply a synergistic effect successful nan curen of PTCL. This is because AFM13 targets nan CD30 antigen connected lymphoma cells and activates nan innate immune strategy to onslaught them. The AB-101 NK cells are earthy slayer cells that tin admit and destruct crab cells done nonstop cytotoxicity and nan merchandise of cytokines.

Furthermore, nan operation of AFM13 and AB-101 NK cells has nan imaginable to supply a much durable consequence compared to monotherapy pinch AFM13. This is because NK cells person a longer half-life (as agelong arsenic a week) compared to monoclonal antibodies (19 hours for AFM13) and can, thus, persist successful nan assemblage for a longer play of time, providing ongoing immune surveillance against crab cells.

While nan operation of AFM13 and AB-101 NK cells seems promising, location are imaginable limitations and risks associated pinch this approach. One awesome limitation is nan imaginable for toxicity aliases adverse events. As pinch immoderate operation therapy, location is ever a consequence of accrued toxicity, which could limit nan wide effectiveness of nan treatment. In particular, nan usage of NK cells could lead to cytokine merchandise syndrome, a perchance vulnerable inflammatory consequence that tin beryllium fatal successful terrible cases. This consequence will request to beryllium cautiously monitored during objective trials.

There is besides nan consequence that nan operation therapy whitethorn not beryllium arsenic effective arsenic anticipated. While nan preclinical and early objective information for AFM13 and AB-101 NK cells looks promising, it is still early days for this approach. The operation therapy whitethorn not activity arsenic good successful nan larger, much divers diligent organization that will beryllium enrolled successful early objective trials.

Challenges and Competitive Landscape successful Advancing Combination Therapy for PTCL

Although focusing connected operation therapy presents challenges, Affimed believes nan imaginable benefits of combining AFM13 pinch AB-101 NK cells are worthy pursuing. However, combining different narcotics aliases therapies tin beryllium difficult owed to varying dosing schedules, broadside effects, and interactions. Getting operation therapies FDA-approved and to marketplace tin besides beryllium much difficult, arsenic nan FDA requires extended testing and information to show their information and efficacy.

The competitory scenery successful PTCL curen whitethorn person besides influenced nan determination to wantonness monotherapy and attraction connected operation therapy. Brentuximab vedotin (Adcetris), recombinant chimeric mAb directed against CD30, + chemotherapy and pralatrexate (Folotyn) are 2 examples of FDA-approved therapies for PTCL.

Adcetris and chemotherapy is nan preferred induction therapy for CD30-positive PTCL, achieving an ORR of 87% and a CR of 68% without further toxicity successful a pivotal objective trial. Folotyn was approved successful 2009 for relapsed aliases refractory PTCL, pinch an ORR of 29%, CRR of 11%, and median DOR of 10.1 months. However, Folotyn is associated pinch important toxicity and is typically reserved for patients who person grounded different treatments.

Given nan support of these narcotics and nan crowded marketplace for PTCL treatments, Affimed whitethorn person felt their monotherapy results were not beardown capable to compete. The operation of AFM13 pinch AB-101 NK cells whitethorn connection a much compelling curen option, arsenic nan AFM13-104 proceedings showed an ORR of 89% and a CRR of 59% successful patients pinch relapsed aliases refractory Hodgkin lymphoma. While nan results surely cannot beryllium extrapolated to PTCL, they propose that combining AFM13 pinch NK cells whitethorn beryllium a much effective curen approach.

Challenges of Developing Combination Therapies successful Cancer Treatment: Understanding Investor's Negative Response to Affimed's Decision to Abandon Monotherapy successful PTCL.

Investors' antagonistic consequence to Affimed's determination to wantonness monotherapy successful PTCL is understandable fixed nan challenges associated pinch processing and gaining FDA support for operation therapies. Combination therapies impact nan usage of 2 aliases much narcotics aliases therapies successful nan curen of a disease, pinch nan purpose of improving efficacy and/or reducing toxicity. While location person been immoderate successful examples of operation therapy successful crab treatment, nan improvement and FDA support of operation therapies tin beryllium a agelong and difficult process.

One illustration of nan challenges associated pinch processing operation therapies is nan lawsuit of ipilimumab and nivolumab, which are some checkpoint inhibitors that person been approved by nan FDA for nan curen of melanoma. While these narcotics person shown promising results successful combination, their improvement and FDA support was a lengthy process that progressive respective objective trials. In addition, nan operation therapy has been associated pinch increased toxicity, which has constricted its usage successful immoderate patients.

Another illustration is nan operation therapy of chemotherapy and radiotherapy successful nan curen of caput and cervix cancer. While this operation has shown committedness successful immoderate patients, location are still galore unknowns astir really nan 2 therapies interact pinch each other, and nan optimal timing and dosing of nan 2 therapies is still being investigated.

In nan lawsuit of PTCL, location person been immoderate past attempts astatine operation therapy, but nary person been wide adopted arsenic modular treatment. For example, nan operation of chemotherapy and radiation therapy has been utilized successful nan past, but this has been associated pinch important toxicity and has not shown important betterment successful wide survival. In addition, nan operation of chemotherapy and stem compartment transplantation has been utilized successful immoderate patients, but this is simply a high-risk process that is not suitable for each patients.

Conclusion

In summary, Affimed's determination to pivot from monotherapy to operation therapy for peripheral T-cell lymphoma is simply a strategical 1 intended to summation nan likelihood of AFM13's success. While nan monotherapy results were promising, nan operation attack is expected to beryllium much effective and competitive. However, advancing operation therapy is simply a difficult process that requires extended objective tests and regulatory approvals. Additionally, achieving occurrence pinch AFM13 and AB-101 NK cells successful nan look of Adcetris and chemotherapy successful operation therapy is simply a long-shot. Affimed is starting from scratch to prosecute a challenging goal, and its resources are limited. Investors are understandably cautious, arsenic Affimed and AFM13 are still a agelong measurement from being market-ready, and nan institution will request to agelong its resources to execute its objectives. It is worthy noting that biotechnology stocks whitethorn waste and acquisition nether their rate value, but that does not needfully make them undervalued aliases cheap. As agelong arsenic Affimed remains active, it is apt to pain done astatine slightest $75 cardinal annually and edifice to dilutive capital-raising measures and debt. Although AFM13 for PTCL is Affimed's superior and most-advanced focus, nan institution besides has different prospects, specified arsenic AFM24. However, since these assets are successful nan preclinical aliases shape 1 stage, it is challenging to find their value.

This article was written by

Stephen Ayers floor plan picture

As a practicing Registered Nurse pinch a Bachelor of Science successful Nursing (BSN), I person a keen liking successful biotechnology and bask researching and penning astir it. Drawing from my nonstop acquisition pinch patients and my analytical skills, I connection unsocial perspectives connected nan topic. My superior attraction is connected late-stage/approved drugs, evaluating curen options and determining wherever a caller supplier whitethorn beryllium champion suited, arsenic good arsenic expanding consciousness of nan risks associated pinch objective proceedings outcomes and marketplace performance.

Disclosure: I/we person nary stock, action aliases akin derivative position successful immoderate of nan companies mentioned, and nary plans to initiate immoderate specified positions wrong nan adjacent 72 hours. I wrote this article myself, and it expresses my ain opinions. I americium not receiving compensation for it (other than from Seeking Alpha). I person nary business narration pinch immoderate institution whose banal is mentioned successful this article.

Additional disclosure: This article intends to supply informational penetration and not individual finance advice. The accusation presented is intended to beryllium factual, but readers are encouraged to independently verify nan accusation and see their ain financial situation, consequence tolerance, portfolio diversification, etc. earlier making an finance decision. Some of nan articles screen biotechnology companies pinch constricted aliases nary revenue, which makes nan stocks speculative and prone to volatility. While nan prospects whitethorn look attractive, it's important to support successful mind that nan early is unpredictable and location is simply a imaginable for important losses.

Editor: Naga



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