Asher Bio Closes $55 Million Series C Financing to Advance Lead Program into Phase 1b Clinical Trials

Rhea-AI Summary

Asher Biotherapeutics closes $55 million Series C financing led by RA Capital Management to advance lead program AB248 into Phase 1b Clinical Trials with support from AstraZeneca and Bristol Myers Squibb.

Positive

• Asher Bio closes a $55 million Series C financing round to further develop AB248, a CD8-targeted IL-2 immunotherapy.
• RA Capital Management leads the financing round with participation from AstraZeneca and Bristol Myers Squibb.
• AB248 is designed to activate only desired immune cell types to maximize efficacy and limit off-target toxicities.
• The financing will support AB248's clinical development to generate tumor response data and dose escalation in combination with a PD-1 checkpoint inhibitor.
• AB248 shows promising early data in Phase 1a/1b clinical trials, demonstrating potent and selective CD8+ T cell activation with initial evidence of anti-tumor activity and a well-tolerated safety profile.

Negative

• None.

Financial Analyst

Asher Bio's recent $55 million Series C financing signals healthy investor confidence, especially with giants like AstraZeneca and Bristol Myers Squibb getting on board. Such a capital injection is important not just for the further development of AB248, but also as an endorsement of Asher Bio's technological potential in the competitive immunotherapy market. This funding might facilitate a smoother transition through the clinical trial phases, potentially speeding up the timeline for FDA approval and market entry, key milestones that can impact Asher Bio's valuation and investor returns. However, the risks inherent in drug development such as trial failures, regulatory hurdles, or unforeseen side effects cannot be ignored. Investors should closely monitor the progression of AB248's trials for any signs that could hint at both prosperous outcomes or cautionary hurdles.

Biotech Industry Analyst

The biopharmaceutical landscape is increasingly embracing targeted immunotherapies like AB248 due to their potential to enhance treatment efficacy while minimizing side effects. Asher Bio's approach, focusing on CD8+ T cell activation, differentiates it from therapies that inadvertently affect NK or Treg cells, leading to toxicity. This specificity could lead to a competitive advantage in the market for cancer treatments, provided the clinical data continues to support efficacy and safety claims. The involvement of established oncology players as investors adds a layer of credibility to Asher Bio's methodologies and may indicate a strategic interest in potential partnerships or acquisitions. Investors should appraise Asher Bio's pipeline and technology within the broader context of the immunotherapy sector's trajectory, which has been marked by significant interest and growth potential.

Clinical Trials Expert

The transition from Phase 1a to 1b trials is a significant step in clinical drug development. AB248's selective activation mechanism could represent a notable advancement in reducing adverse effects common in immunotherapies. The Phase 1b trial's focus on assessing safety and anti-tumor activity, particularly in combination with pembrolizumab, will be a key determinant of the drug's future. Positive results can lead to enhanced investment and partnership opportunities, while negative outcomes could stymie development. Given the investment from pharmaceutical heavyweights, AB248 appears promising, but investors should keep an eye on forthcoming trial data, as these will heavily influence regulatory success and commercial viability. The clinical landscape is fickle and the ultimate test comes down to whether the therapy can consistently demonstrate a strong safety profile alongside robust efficacy.

– Proceeds will fund further development of AB248, a highly differentiated CD8-targeted IL-2 immunotherapy, through Phase 1b monotherapy expansion data, as well as initial safety and efficacy results from the ongoing combination with pembrolizumab –

– Financing led by RA Capital Management with participation from existing investors and additional new investors, including AstraZeneca and Bristol Myers Squibb –

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, today announced the closing of a Series C financing, which raised $55 million. The financing was led by RA Capital Management, and included new investors AstraZeneca (LSE/STO/Nasdaq: AZN) and Bristol Myers Squibb, along with existing investors Janus Henderson Investors, Third Rock Ventures, Wellington Management and Boxer Capital and other undisclosed institutional investors.

“We are delighted to have the continued support of RA Capital, and excited to add two top biopharmaceutical companies and experts in oncology to our investor syndicate,” said Craig Gibbs, Ph.D., Chief Executive Officer of Asher Bio. “We are committed to delivering a new class of highly selective cis-targeted immunotherapies for cancer, which are designed to activate only the desired immune cell type to potentially maximize efficacy and limit off-target toxicities. We are pleased to have investors with deep and hands-on expertise in the cytokine space recognizing our early clinical data and our differentiated approach. This Series C financing generated robust demand and positions us well to continue AB248’s clinical development to generate tumor response data from monotherapy expansion cohorts, as well as data from dose escalation and expansion in combination with a PD-1 checkpoint inhibitor.”

Asher Bio plans to use the proceeds from this financing to advance the clinical development of its lead program, AB248, a novel CD8+ T cell selective IL-2, generated by fusing a reduced potency IL-2 mutein to an anti-CD8β antibody. AB248 is currently being investigated in a Phase 1a/1b study, which is evaluating AB248 as a monotherapy and in combination with KEYTRUDA^® (pembrolizumab), in patients with recurrent locally advanced or metastatic solid tumors, including melanoma, renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN), previously treated with a PD1 or PD-L1 checkpoint inhibitor.

AB248 was specifically engineered to selectively and potently activate CD8+ T-cells, while avoiding natural killer (NK) cells, which can act as a pharmacological sink and contribute to toxicity, and regulatory T (Treg) cells, which are immunosuppressive. Initial pharmacokinetic and pharmacodynamic data from the ongoing Phase 1a/1b clinical trial support AB248’s proof of mechanism and activity with a highly differentiated clinical profile. Early data shows potent and selective CD8+ T cell activation without substantial changes to Treg and NK cell numbers and initial evidence of anti-tumor activity, with a generally well-tolerated safety profile.

“Asher’s groundbreaking cis-targeting platform offers a highly differentiated approach to immunotherapy, with the potential to overcome the limitations of other immune-based treatments by maximizing efficacy and limiting off-target toxicities,” said Jake Simson, RA Capital Management. “The company has produced promising preclinical and early clinical data to date and we are excited to continue to support Asher as they further advance their lead program in the clinic.”

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About Asher Bio

Asher Bio is a biotechnology company developing therapies to precisely engage specific immune cells to fight cancer, chronic viral infection and autoimmune disease. We utilize our proprietary cis-targeting platform to develop therapies engineered to overcome limitations of other immune-based treatments by selectively activating specific immune cell types with validated disease fighting functionality. Our candidates feature an antibody connected to a modified immunomodulatory protein, such as a cytokine. Our candidate design is intended to enable our candidates to selectively activate the desired immune cells and not other cells that contribute to toxicity or immune suppression. Our lead program AB248, an investigational IL-2 molecule specifically targeted to CD8+ effector T cells, is currently in Phase 1 trials for oncology. Our broader portfolio includes AB821, a CD8-targeted IL-21 immunotherapy, and early-stage programs targeting CAR-T cells, myeloid cells and CD4+ T cells. Asher Bio was founded by Ivana Djuretic and Andy Yeung with support from Third Rock Ventures and is located in South San Francisco. For more information, please visit www.asherbio.com and follow us on X (formerly Twitter) @AsherBio and on LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240416383585/en/

Media Contact

Kathryn Morris, The Yates Network

914-204-6412

kathryn@theyatesnetwork.com

Investor Contact

Hannah Deresiewicz, Stern Investor Relations, Inc.

212-362-1200

hannah.deresiewicz@sternir.com

Source: Asher Biotherapeutics

What is the purpose of the $55 million Series C financing raised by Asher Biotherapeutics?

The financing will fund further development of AB248, a CD8-targeted IL-2 immunotherapy, through Phase 1b monotherapy expansion data and initial safety and efficacy results from the ongoing combination with pembrolizumab.

Who led the Series C financing round for Asher Biotherapeutics?

RA Capital Management led the financing round.

Which companies participated as new investors in the Series C financing?

AstraZeneca and Bristol Myers Squibb participated as new investors.

What is the focus of AB248, the lead program of Asher Biotherapeutics?

AB248 is a novel CD8+ T cell selective IL-2 designed to activate only desired immune cell types to potentially maximize efficacy and limit off-target toxicities.

In which types of cancer is AB248 being investigated?

AB248 is being investigated in patients with recurrent locally advanced or metastatic solid tumors, including melanoma, renal cell carcinoma, non-small cell lung cancer, and squamous cell carcinoma of the head and neck.