Affimed GmbH

TURIN, Italy--( BUSINESS WIRE )-- ALKemist Bio , a biotechnology company dedicated to transforming the treatment of ALK-positive cancers, today announced the appointment of Dr. Adi Hoess to the company’s Board as an independent director. Dr. Hoess brings over three decades of leadership experience from across the biopharmaceutical industry and a significant commitment to the development of immuno-oncology therapeutics. As the former CEO of Affimed N.V., he played a pivotal role in advancing groundbreaking therapies that harness the immune system to combat cancer, aligning with ALKemist Bio’s mission to effectively target Anaplastic Lymphoma Kinase (ALK). ALK is a driver oncogene associated with several cancer types that often develop as an aggressive and recurrent disease after failure of ALK inhibition therapy. The addition of an experienced Board member strengthens the company’s ongoing preclinical evaluation and upcoming clinical development of its T cell-based therapies for ALK-positive tumors. “ Adi’s deep expertise in cellular therapies and impressive track record of driving biotech innovation and corporate development will be instrumental as ALKemist Bio enters its next phase of growth,” said Pietro Puglisi, Executive Chairman of ALKemist Bio. " With his guidance, we are well-positioned to achieve important progress in our pipeline and prepare for clinical evaluation, with the overall objective of bringing transformative therapies to patients with ALK-positive cancers.” “ The team at ALKemist Bio is developing groundbreaking ALK-specific cell therapies, which in preclinical testing eliminated ALK-positive cancer cells,” Dr. Hoess commented. “ ALK-positive tumors are aggressive and often relapse despite the availability of innovative kinase inhibitors, while T cell-based approaches offer the potential for more durable responses. I look forward to contributing to ALKemist’s growth and supporting its mission to improve outcomes for patients.” Dr. Adi Hoess has had a broad-ranging career in leading biotechnology companies through important value-building transitions, including advancing innovative drug candidates into clinical development and executing corporate and collaborative transactions. After leaving Nasdaq-listed Affimed, where he served as CEO for 13 years, Dr. Hoess joined ViaNautis Bio, a company pioneering targeted delivery solutions for genetic medicines, as CEO in October 2024. He was also Chief Commercial Officer of Jerini, which was acquired by Shire. He started his career at MorphoSys, attaining the title of Vice President Licensing and Business Development, where he oversaw multiple in- and out-licensing deals. Dr. Hoess holds a medical degree from the Technical University of Munich and a PhD in Chemistry and Biochemistry from Munich University. ALKemist Bio has achieved several key milestones over the past year. In December 2023, the company secured €6.9 million in funding through an investment round led by Claris Ventures, enabling the advancement of its first-in-class T Cell Receptor (TCR) cell therapy. Additionally, in July 2024, ALKemist Bio signed an exclusive license agreement with Boston Children’s Hospital, granting the company rights to develop and commercialize ALK-specific TCR therapies. These achievements underscore ALKemist Bio’s dedication to delivering innovative and life-changing solutions for patients with ALK-positive cancers. About ALKemist Bio ALKemist Bio’s mission is to change the treatment and prognosis of aggressive ALK-positive cancers by developing T cell-based immunotherapies that can eradicate ALK-positive cancer cells, overcome resistance and extend remissions for these patients. Leveraging deep collaborations with leading hospitals and research institutions, our objective is to prove the effectiveness of T cell-based therapies to radically extend the gains of ALK inhibition. By closing in on ALK, we aim to bring a sea change to cancer treatment that will mean hope for all patients with ALK-positive tumors.

MANNHEIM, Germany I December 09, 2024 I Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced the oral presentation of data on AFM28 at the 66th ASH Annual Meeting and Exposition. The data, derived from the first-in-human Phase 1 study of AFM28, showed promising results in R/R AML, with signs of clinical efficacy and a well-managed safety profile at doses up to 300 mg weekly. The study included 29 heavily pretreated R/R AML patients across six AFM28 dose levels. The median number of prior treatment lines was two and 86% of patients had an adverse risk profile according to the 2022 guidelines from the European LeukemiaNet (ELN2022). AFM28 was administered intravenously once a week across six dose levels, ranging from 25 mg to 300 mg. AFM28 was well tolerated, and the most common treatment-emergent adverse events were IRRs, observed in 45% of patients. All IRRs were mild to moderate (Grade 1 or 2). One patient demonstrated grade 1 cytokine release syndrome (CRS). No neurotoxicity or signs for immune-effector related side effects were seen. One of six patients treated at 250 mg showed a CR and stayed on treatment for 6.5 months. At the 300 mg dose level, 1 CR and 3 CRi were seen in 10 evaluable patients for a CRcR of 40%. Four of 10 patients are still on treatment with the option to deepen responses. “Achieving a 40% composite complete remission rate with AFM28 in R/R AML is a significant milestone, especially in this difficult-to-treat patient population. Importantly, we see activity independent of mutational status, including patients with negative prognostic molecular profiles. Safety has been manageable which provides the basis for further development of AFM28 either as single agent or in combination regimens,” said Dr. Andreas Harstrick, MD, Chief Medical Officer at Affimed. The AFM28 Phase 1 study is on-going. About AFM28 AFM28, a tetravalent, bispecific CD123- and CD16A-binding ICE ® , is designed to bring our immunotherapeutic approach to patients with acute myeloid leukemia (AML). It engages NK cells to initiate leukemic cell killing via antibody-dependent cellular cytotoxicity, even at low CD123 expression levels. AFM28 is currently in clinical development as monotherapy in patients with R/R AML (NCT05817058). About Affimed N.V. Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The Company’s innate cell engagers (ICE ® ) enable a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors. ICE ® are generated on the Company’s proprietary ROCK ® platform which predictably generates customized molecules that leverage the power of innate immune cells to destroy tumor cells. A number of ICE ® molecules are in clinical development, being studied as mono- or combination therapy. Headquartered in Mannheim, Germany, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by the bold vision to stop cancer from ever derailing patients’ lives. For more about the Company’s people, pipeline and partners, please visit: www.affimed.com . SOURCE: Affimed

Pfizer is enlisting another Flagship startup to help it create new obesity medicines. After June’s ProFound Therapeutics tie-up , Pfizer will work with the incubator’s Ampersand Biomedicines in the hunt for new biologics for obesity. The New York pharmaceutical company is also tapping into Flagship-founded Montai Therapeutics to find new small molecules for potentially treating lung cancer, the companies said Wednesday morning. The two pacts are part of Pfizer’s broader alliance with the Cambridge, MA-based Flagship, which recently reeled in about $3.6 billion in new funds as pharma partnerships become a “ bigger and bigger deal .” Pfizer has had an uneven few years in obesity, particularly with its danuglipron program . Last month, it revealed more details about its other early-stage bets: a GIP antagonist and a once-daily oral GLP-1. Ampersand hopes to help Pfizer create obesity treatments that go to a specific site in the body, rather than hitting healthy tissues or cells, so as to avoid side effects — like muscle loss and gastrointestinal concerns — and to make the drugs more potent. The startup, which emerged with $50 million in March 2023, uses computational methods to find “addresses” for drugs to go to and then creates an “actuator” to carry out the therapeutic function, Flagship general partner Avak Kahvejian told Endpoints News last year. In January, it bought antibody discovery tech startup AbCheck, an Affimed subsidiary, for $6 million. “We have addresses in virtually every tissue in the body, so you could think about virtually any disease,” CEO Jason Gardner said in an interview. Ampersand will likely make multiple other industry collaborations, he said, and it could form more tie-ups around obesity. It’s early days with the Pfizer partnership, and Gardner declined to disclose the specific pathway tissue that they’re looking at. Flagship’s work in obesity has also attracted the attention of Novo Nordisk. Its companies Metaphore Biotechnologies and Omega Therapeutics have both formed partnerships with the Danish drugmaker. In cancer, Pfizer’s new partnership with Montai will look at mechanisms that lead to lung cancer cell growth and find new small molecules that can potentially be turned into therapies. Pfizer has made oncology a core focus following its $43 billion Seagen acquisition last year. Montai emerged with $50 million in December 2022 and a high-profile CEO, Margo Georgiadis, who previously led Google’s Americas division and steered Ancestry.com to a nearly $5 billion exit to Blackstone. The startup scours through molecules already consumed by humans via foods, supplements and herbal medicines. Its computational tools have brought together nearly 200 million so-called “Anthromolecules” and their derivatives, Georgiadis said. The company’s name means “climbing mountains with AI,” she said. Georgiadis said in an interview that the company is trying to “create the first machine learning that enables us to decode that language of chemistry and how it connects to our biology.” “By doing that, it enables us to take advantage of this unbelievably rich and diverse chemistry set that pharma had kind of put to the side,” she said. “It’s how drug development started. It’s a super-proven source of drugs, but it was perceived as complex, hard to make, the challenges with polypharmacology.” Montai was working on a small molecule agonist for an undisclosed pathway in inflammation and immunology when Pfizer realized an antagonist of that pathway could be applied in lung cancer, Georgiadis said. The 65-employee company has created an internal pipeline of nine I&I therapies that are transcription factors and biologic replacements in dermatology, gastrointestinal and respiratory diseases, she said. The company is “developing partnerships” with more companies, Georgiadis said, as Montai’s work applies across immunology, oncology, neuro-inflammation and other areas.