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Asher Bio Appoints Andrea Pirzkall, M.D., as Chief Medical Officer

Industry veteran brings deep expertise in translational medicine and clinical development in oncology

South San Francisco, Calif., June 13, 2022 – Asher Biotherapeutics, Inc. (Asher Bio), a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, today announced the appointment of Andrea Pirzkall, M.D., as its first Chief Medical Officer. Dr. Pirzkall has a multi-disciplinary clinical background and a proven track record in developing cancer therapies from research to commercialization.

“We are delighted to welcome Andrea to the Asher Bio team at this pivotal time as we transition to a clinical-stage company. Her broad background spans early and late-stage development and includes both small molecule and biologic agents.  She has expertise in immunotherapies for cancer and is a successful leader of growing clinical teams.  Andrea is an ideal fit to our team as we continue to advance our pipeline,” said Craig Gibbs, Ph.D., Chief Executive Officer of Asher Bio. “Her expertise and hands-on style will be valuable assets as we implement clinical strategies to deliver our selective and differentiated immunotherapies for patients with cancer and other diseases.”

“I am very excited to join Asher Bio’s highly experienced senior management team and to build and lead the clinical development organization to deliver on the company’s promising pipeline of cis-targeted therapeutics,” said Dr. Pirzkall. “I am particularly intrigued by the potential of Asher Bio’s cis-targeting platform approach to overcome limitations and broaden the potential of existing immunotherapy by selectively targeting immune cell subsets, and thereby aiming to improve outcomes for patients. That includes Asher Bio’s lead cis-targeted IL-2 immunotherapy, AB248, which is approaching an IND filing and the start of a Phase 1 clinical trial. AB248 has been designed to selectively activate IL-2 signaling in CD8+ effector T cells, while avoiding systemic toxicities and limiting counterproductive pleotropic signaling that results from IL-2 binding to non-targeted cells. I look forward to working with the team to transition this compound into the clinic.”

Most recently, Dr. Pirzkall served as Chief Medical Officer at Replimune Group, Inc., where she was responsible for building, developing, and leading clinical development of the company’s pipeline of next-generation oncolytic immunotherapies. Prior to that, Dr. Pirzkall served as Executive Director of Clinical Development at BeiGene, Ltd., where she led and supported the development, startup and execution of several pivotal studies in lung cancer and head and neck cancers, which successfully led to approvals of tislelizumab (anti-PD1) in China and ongoing filings in other jurisdictions. She also served as the global clinical development lead on the BeiGene, Inc./Celgene Corporation joint development committee. Earlier in her career, Dr. Pirzkall spent 10 years at Genentech, Inc., where she held roles of increasing responsibility, including Principal Medical Director and Clinical Development Team Leader. In this role, she worked with cross-functional teams on therapeutics including Avastin, Tarceva, Perjeta, Cotellic and Tecentriq supporting these novel biologic agents through early to late stages of development in oncology as well as through exploratory and combination studies.

Prior to moving to industry, Dr. Pirzkall trained in radiation oncology and completed her dissertation at the University of Heidelberg and the German Cancer Research Center. She completed a fellowship in Medical Physics/Radiation Oncology at the University San Francisco (UCSF) and held academic positions as Associate Adjunct Professor of Radiation Oncology, Radiology, and Neurosurgery at UCSF. Dr. Pirzkall holds a Doctor of Medicine from Friedrich-Schiller University Jena, Germany.

About Asher Bio

Asher Bio is a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases. Its cis-targeting platform aims to enable selective activation of specific immune cell types, addressing the inherent limitations of otherwise pleiotropic immunotherapies that act on multiple cell types. Its approach has the potential to precisely direct different immune mediators against a range of target immune cell-types and create novel immunotherapies in cancer, autoimmune and infectious diseases. 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 Twitter @AsherBio and on LinkedIn.

 

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

 

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Asher Bio Announces Clinical Trial Collaboration with Merck to Evaluate AB248 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Locally Advanced or Metastatic Solid Tumors

— Trial evaluating AB248, a CD8+ T cell cis-targeted IL-2 immunotherapy, in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, aims to address unmet need for patients who are non-responsive to previous anti-PD-1 therapy or enhance current standard of care in an early line of therapy  —

South San Francisco, Calif., June 1, 2022 – Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, today announced that it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside of the United States and Canada) for a planned Phase 1a/1b dose escalation and expansion trial to evaluate AB248, Asher Bio’s novel investigational CD8-targeted interleukin 2 (IL-2), as a monotherapy and in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with locally advanced or metastatic solid tumors, including melanoma, renal cell carcinoma (RCC), non-small cell lung carcinoma (NSCLC) and squamous cell carcinoma of the head and neck (SCCHN). Under the terms of the agreement, Asher Bio is responsible for conducting the Phase 1a/1b trial, which it expects to initiate in the second half of 2022.

Mechanistically, IL-2 signaling is complementary to PD-1 checkpoint blockade: checkpoint inhibitors release the brakes on T cells, allowing them to kill cancer cells, while IL-2 pushes on the gas pedal driving an increase in the number and activity of T cells.  In the clinic, there have been studies conducted on high dose IL-2 as a monotherapy to treat PD-1 failures and on high dose IL-2 in combination with PD-1 checkpoint inhibitors in earlier lines of therapy that both demonstrated encouraging activity. However, despite high dose IL-2 efficacy in these settings, severe toxicities significantly hamper use of IL-2 in practice.

Asher Bio previously reported preclinical data from studies of a murine surrogate of AB248, which achieved significant anti-tumor activity as monotherapy and in combination with anti-PD1, without toxicity associated body weight loss. In comparison, treatment with a “not α” IL-2 achieved lower anti-tumor activity and was accompanied by body weight loss.

“We are looking forward to initiating this trial in collaboration with Merck to evaluate AB248 in combination with KEYTRUDA® in a range of cancers,” said Craig Gibbs, Ph.D., Chief Executive Officer of Asher Bio. “Treatment with PD-1 checkpoint blockade monotherapy or in combination with chemotherapy or another immunotherapy has become a recommended first line treatment in multiple indications. Yet for patients who failed to achieve a response or who relapse, treatment options are limited. In addition, there is a subset of first line patients where there is an opportunity to enhance the current standard of care. We believe that by precisely focusing the effect of IL-2 to the primary immune cell subset that drives anti-tumor efficacy, AB248 may have the potential to deliver a highly differentiated product profile that could become a backbone of immuno-oncology across a range of solid tumors.”

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

About AB248

AB248 is a novel CD8+ T cell selective IL-2, generated by fusing a reduced potency IL-2 mutein to a humanized IgG1 anti-CD8β antibody. It was specifically engineered to selectively and potently expand 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. In some preclinical studies, AB248 exhibits an approximately 1,000-fold preference for the activation of CD8+ T cells over NK cells and Tregs. In other nonclinical studies, AB248 has demonstrated potent anti-tumor activity both alone and in combination with PD-1 checkpoint blockade in a wide variety of murine tumor models.

About Asher Bio

Asher Bio is a biotechnology company developing precisely targeted immunotherapies for cancer and other diseases. Its cis-targeting platform aims to enable selective activation of specific immune cell types, addressing the inherent limitations of otherwise pleiotropic immunotherapies that act on multiple cell types. Its approach has the potential to precisely direct different immune mediators against a range of target immune cell-types and create novel immunotherapies in cancer, autoimmune and infectious diseases. 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 Twitter @AsherBio and on LinkedIn.

 

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

 

 

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Asher Bio to Present New Preclinical Data Demonstrating Differentiated Profile of AB248, its Lead Cis-targeted IL-2 Immunotherapy, at AACR Annual Meeting

Data presented at AACR showcase AB248’s selective CD8+ T cell targeting of IL-2 and differentiated profile —

— Investigational new drug (IND) application filing for AB248 expected 3Q 2022 —

South San Francisco, Calif., April 8, 2022 – Asher Biotherapeutics (Asher Bio), a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, today announced new preclinical data further demonstrating the profile of AB248, an engineered interleukin-2 (IL-2) immunotherapy that it intends to develop for the treatment of cancer. The data will be presented on Tuesday, April 12 in a poster session at the American Association for Cancer Research (AACR) Annual Meeting 2022, being held in New Orleans, Louisiana.

“We are pleased to share new preclinical data across our portfolio at AACR, including for AB248, our lead product candidate,” said Ivana Djuretic, Ph.D., Chief Scientific Officer and Co-founder of Asher Bio. “AB248 highlights our cis-targeting strategy, which optimizes the use of immunomodulators by selectively focusing their effect to specific immune cell types. By precisely activating only CD8+ T cells, the primary immune cell subset that drives anti-tumor efficacy in response to IL-2 pathway activation, we believe AB248 has the potential to deliver a highly differentiated product profile, that could become a backbone of immuno-oncology treatment across a range of solid tumors.”

High dose IL-2 was the first modern immunotherapy to show complete responses in a subset of cancer patients, however this and second-generation (“not α”) cytokine-based medicines are generally limited by off-target effects that both suppress anti-tumor responses and drive toxicity. In order to overcome these challenges, new approaches have emerged, which include targeting IL-2 to the tumor microenvironment or leveraging a cis-targeting approach to deliver IL-2 to specific immune cell subsets. AB248 is a cis-targeted immunotherapy, which was specifically engineered to selectively activate CD8+ T cells, which drive anti-tumor efficacy. AB248’s design allows for the avoidance of NK cells, which can act as a pharmacological sink and contribute to toxicity, as well as Tregs, which are immunosuppressive.

The new preclinical data to be presented at AACR detail these selective properties of AB248, underscoring key areas of differentiation compared to other molecules in development. In a poster presentation, titled “AB248 is a CD8+ T Cell Selective IL-2 Designed for Superior Safety and Anti-Tumor Efficacy,” lead author Kelly Moynihan, Ph.D., Director and AB248 Program Lead at Asher Bio, presents experiments showing that AB248 demonstrated selectivity, with an approximately 1000-fold preference for the activation of CD8+ T cells over NK cells and Tregs, and induced dose-dependent, selective expansion of CD8+ T cells in non-human primates.

Laboratory data also demonstrated that AB248 avoided the NK cell-dependent IFNg secretion by cultured human peripheral blood mononuclear cells (PBMCs) that has been observed with first-generation IL-2 or second-generation “not α” IL-2s. In addition, data demonstrated that AB248 augments effector cytokine production in CD8+ T cells that also receive a T cell receptor signal. Unlike NK cells, CD8+ T cells do not produce inflammatory cytokines following an IL-2 signal alone.

“This new data demonstrates our ability to deconvolute complex biology by separating cell types essential for anti-tumor activity, like CD8+ T cells, from those that are key drivers of toxicity, and to leverage this understanding to develop potentially best-in-class molecules,” said Dr. Djuretic. “Together with the results of preclinical studies we’ve shared previously, the new data presented at AACR substantiate our belief in the clinical potential of AB248. We look forward to advancing AB248 into human testing later this year, where we plan to evaluate it in multiple solid tumor indications as both a single and combination agent.”

Asher Bio continues to advance AB248 through preclinical studies. Asher Bio expects to file an IND application with the U.S. Food and Drug Administration in the third quarter of 2022 and plans to initiate a Phase 1 clinical trial before year-end.

The poster presentation is now available in the “Presentations and Posters” section of Asher Bio’s website: https://asherbio.com/pipeline/presentations-publications/.

About Asher Bio

Asher Bio is a biotechnology company developing precisely targeted immunotherapies for cancer and other diseases. Its cis-targeting platform aims to enable selective activation of specific immune cell types, addressing the inherent limitations of otherwise pleiotropic immunotherapies that act on multiple cell types. Asher Bio believes its approach has the potential to precisely direct different immune mediators against a range of target immune cell-types and create best-in-class immunotherapies in cancer, autoimmune and infectious diseases. Asher Bio was founded by Ivana Djuretic and Andy Yeung with support from Third Rock Ventures and is located in South San Francisco.

 

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

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Asher Bio to Unveil Two New Immunotherapy Programs, a CD8+ T Cell Targeted IL-21 and a Cis-Targeted IL-2 for Cell Therapy Augmentation, at AACR Annual Meeting

– New preclinical data support advancement of AB821 as a CD8+ T cell targeted IL-21; investigational new drug (IND) application filing expected 2H 2023 –

– New preclinical data provide foundational proof-of-concept for cis-targeted IL-2 augmentation of engineered T cell therapies –

–  Growing pipeline demonstrates versatility and broad applicability of cis-targeting technology platform —

South San Francisco, Calif., April 8, 2022 – Asher Biotherapeutics (Asher Bio), a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, today announced preclinical data for AB821, its CD8+ T cell cis-targeted interleukin-21 (IL-21) cytokine, which was designed to promote the function, survival, and reduced exhaustion of CD8+ T cells, and for its cis-targeted interleukin-2 (IL-2) fusion molecules, which were developed to specifically target engineered cells such as CAR-T cells, while exhibiting minimal effects on non-engineered or endogenous cells. The data will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2022, being held in New Orleans, Louisiana, April 8-13, 2022.

“We are pleased to announce two new development programs today, reflecting the versatility and broad applicability of our cis-targeting technology, as well as its ability to rapidly produce highly selective molecules that target two different cytokines to two different cell types,” said Ivana Djuretic, Ph.D., Chief Scientific Officer and Co-founder of Asher Bio. “Including AB248, we have now validated in nonclinical studies three distinct programs in under three years since our founding, each of which has demonstrated over 100 to 1000x selectivity for its intended immune cell target. Importantly, and consistent with our foundational hypothesis that cis-targeted immunotherapies might overcome the clinical limitations of existing immune-based medicines, this selectivity has translated into improved activity and tolerability across an array of preclinical models. We look forward to advancing each of these programs, while further leveraging the modularity of our platform, with the goal of building a differentiated portfolio of product candidates for the treatment of cancers, autoimmune and infectious diseases.”

AB821: a CD8+ T Cell Targeted IL-21

Asher Bio designed AB821 to overcome the historical challenges of IL-21, including pleiotropic activation of multiple lymphoid and myeloid immune cell subsets, by focusing the IL-21 activity of AB821 to only CD8+ T cells – the immune cell type primarily responsible for anti-tumor efficacy – while avoiding activation of non-CD8 cells which may dampen overall anti-tumor efficacy and contribute to adverse effects. IL-21 can have beneficial effects on anti-tumor immune responses due to its ability to activate STAT3, a master transcription factor involved in a broad spectrum of adaptive and innate immune functions. Previously, wild-type IL-21 has demonstrated promising signs of efficacy in early clinical studies, but its utility has been hindered by toxicities and pleiotropic effects, such as suppression of antigen presentation in myeloid cells.

Asher Bio’s presentation at AACR provides an overview of AB821, a cis-targeted and charge-modified IL-21.  In a poster titled “Selective activation of CD8+ T cells by a CD8-targeted IL-21 results in enhanced anti-tumor efficacy and safety,” Renee Greer, Ph.D., Senior Scientist, Immunology at Asher Bio, shared foundational nonclinical proof-of-concept data, demonstrating that AB821 exhibits greater than 1000-fold selectivity for CD8+ T cells over other cell types.  In addition, a single dose of murine CD8-IL21 surrogate demonstrated activity in multiple syngeneic tumor models without inducing body weight loss. In the MC38 tumor model, for example, treatment with a single dose of CD8-IL21 as low as 0.1 mg/kg induced complete regression of established tumors without toxicity and, in cynomolgus monkeys, treatment with CD8-IL21 demonstrated improved exposure and tolerability over untargeted IL-21.

“We are excited to share the first preclinical data for AB821, our CD8+ T cell targeted IL-21 and the second product candidate in our pipeline,” said Andy Yeung, Ph.D., Chief Technology Officer and Co-founder of Asher Bio. “Though early, these data buoy our confidence that AB821 fits our desired product profile as an IL-21 therapy that can selectively activate STAT3 signaling in CD8+ T cells to promote functionality, memory cell differentiation, and survival, all of which are complementary to the proliferation signal provided by IL-2 induced STAT5 activation. We believe AB821 could address unmet needs across tumor types that may have sub-optimal responsiveness to IL-2 and/or PD-1 therapies, and we look forward to advancing this program toward our planned IND filing in the second half of 2023.”

In addition to exploring AB821 as a monotherapy, Asher Bio intends to evaluate AB821 with AB248, its engineered interleukin-2 (IL-2) immunotherapy. Asher Bio believes the combination of AB248 and AB821 could enhance efficacy by combining AB248’s proliferation signal with AB821’s non-overlapping and complementary mechanism of action, which optimizes functionality and prevents T cell exhaustion.

Cis-Targeted IL-2 for Cell Therapy Augmentation

Asher Bio designed its highly selective cis-targeted IL-2 fusion molecules to specifically target engineered cells such as CAR-T cells, while exhibiting minimal effects on non-engineered or endogenous cells, enabling superior activity and durability. Positive clinical outcomes of commercially available CAR-T cell therapies in the treatment of some hematological malignancies, as well as the promising results with T cell therapies observed in solid tumors, have stimulated further interest in these treatment approaches. Building on these findings, important efforts in T cell engineering are underway to improve key properties including engraftment, persistence, and expansion in the tumor microenvironment. Preclinical studies have demonstrated that the co-administration of an IL-2 therapy can enhance engineered T cell engraftment, persistence, and functionality. However, the clinical potential of utilizing IL-2 in combination with engineered T cell therapies is limited using current molecules due to the severe toxicity of high-dose IL-2 and the inadequate selectivity of existing engineered IL-2 variants, which expand multiple endogenous cell types in addition to transferred T cells.

Asher Bio will present new data at AACR characterizing two IL-2 fusions, CAR-IL2 and EGFRt-IL2, and detailed their in vivo activity in tumor-bearing NSG mice infused with human CAR-Ts. CAR-IL2 and EGFRt-IL2 are distinct fusion molecules, both of which leverage cis-targeting to enable CAR-T cell restricted IL-2 signaling. CAR-IL2 targets the FMC63 CAR directly without blocking CD19 antigen recognition, enabling targeting of approved anti-CD19 CAR-T products. EGFRt-IL2 targets an EGFR tag co-expressed with the CAR.

In a poster titled, “CAR-targeted IL-2 drives selective CAR-T cell expansion and improves anti-tumor efficacy,” Nathan Mathewson, Ph.D., Senior Scientist at Asher Bio, will demonstrate the specificity of CAR-IL2 and EGFRt-IL2. Both fusion molecules selectively induce phospo-STAT5 signaling resulting in greater than 100-fold preferential STAT5 activity in CAR-expressing cells, compared to CAR-negative cells. The ability of the fusion molecules to selectively expand CAR-Ts in vitro and in vivo was shown through a substantial and specific expansion of the infused CAR-Ts, with the CAR-T fraction increasing from approximately 50% of infused T cells to over 93% of T cells. Re-dosing with either CAR-IL2 or EGFRt-IL2 resulted in a significant re-expansion of CAR-T cells by over 500-fold after a long rest period in vivo. In addition, treatment with the CAR-IL2 molecule augmented the anti-tumor activity of CAR-T therapy in a preclinical model of leukemia, converting a suboptimal dose of CAR-T cells into a curative therapy by meaningfully expanding the low number of transferred CAR-T cells.

“Durable complete responses and survival in CAR-T-treated patients is correlated with CAR-T engraftment and expansion. The new data that will be presented at AACR provide foundational proof-of-concept for our strategy of selectively boosting CAR-T cells post-adoptive transfer, in order to drive significantly better CAR-T expansion and, therefore, improved activity and durability,” said Dr. Djuretic. “In addition, selective support of CAR-T cells and other engineered T cells may provide other benefits, such as decreasing the number of engineered T cells required at infusion, reducing the need for preconditioning, and allowing temporal control over cell activation. We are eager to advance our program forward, as we aim to deliver bespoke cis-targeted cytokines that can augment existing cell therapies without requiring the retrofitting of a novel receptor or other construct, and ultimately optimize therapeutic outcomes.”

Both poster presentations are now available in the “Presentations and Posters” section of Asher Bio’s website: https://asherbio.com/pipeline/presentations-publications/.

About Asher Bio

Asher Bio is a biotechnology company developing precisely targeted immunotherapies for cancer and other diseases. Its cis-targeting platform aims to enable selective activation of specific immune cell types, addressing the inherent limitations of otherwise pleiotropic immunotherapies that act on multiple cell types. Asher Bio believes its approach has the potential to precisely direct different immune mediators against a range of target immune cell-types and create best-in-class immunotherapies in cancer, autoimmune and infectious diseases. Asher Bio was founded by Ivana Djuretic and Andy Yeung with support from Third Rock Ventures and is located in South San Francisco.

 

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

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Asher Bio to Showcase Continued Progress with Lead Program AB248 and Growing Pipeline of Precisely-Targeted Immunotherapies at AACR Annual Meeting 2022

New preclinical data highlight differentiated efficacy and safety profile of AB248, a CD8-targeted IL-2 —

— First preclinical data for AB821, a CD8-targeted IL-21, and CAR-T cell-targeted IL-2 demonstrate versatility and broad applicability of cis-targeting technology —

South San Francisco, Calif., March 8, 2022 – Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, today announced plans to present new data for multiple research programs across its portfolio of cis-targeted immunotherapies at the American Association for Cancer Research (AACR) Annual Meeting 2022, being held in New Orleans, Louisiana, April 8-13, 2022.

The presentations provide additional data supporting the best-in-class potential of AB248, Asher Bio’s CD8-targeted IL-2 immunotherapy, and further validate the company’s cis-targeting platform, demonstrating its ability to rapidly generate highly selective molecules that target multiple immunomodulators to a diverse set of immune cell types. Asher Bio expects to file an investigational new drug application for AB248, its CD8-targeted IL-2 immunotherapy, in the third quarter of 2022 and for AB821, its CD8-targeted IL-21 immunotherapy, in the second half of 2023.

Details of the poster presentations are as follows:

Presentation Title: AB248 is a CD8+ T cell selective IL-2 designed for superior safety and anti-tumor efficacy
Session Title: Immunomodulatory Agents and Interventions 2
Session Date & Time: Tuesday, April 12, 2022 from 1:30 p.m. – 5:00 p.m. CT (11:30 a.m. – 3:00 p.m. PT)
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 37
Abstract Number: 3518 

Title: Selective activation of CD8+ T cells by a CD8-targeted IL-21 results in enhanced anti-tumor efficacy and safety
Session Title: Therapeutic Antibodies 1
Session Date & Time: Tuesday, April 12, 2022 from 9:00 a.m. – 12:30 p.m. CT (7:00 a.m. – 10:30 a.m. PT)
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 37
Abstract Number: 2882 

Title: CAR-targeted IL-2 drives selective CAR-T cell expansion and improves anti-tumor efficacy
Session Title: Adoptive Cell Therapy 1
Session Date & Time: Sunday, April 10, 2022 from 1:30 p.m. – 5:00 p.m. CT (11:30 a.m. – 3:00 p.m. PT)
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 36
Abstract Number: 561 

The abstracts are now available on the AACR conference website.

About Asher Bio

Asher Bio is a biotechnology company developing precisely targeted immunotherapies for cancer and other diseases. Our cis-targeting platform aims to enable selective activation of specific immune cell types, addressing the inherent limitations of otherwise pleiotropic immunotherapies that act on multiple cell types. Our approach has the potential to precisely direct different immune mediators against a range of target immune cell-types and create best-in-class immunotherapies in cancer, autoimmune and infectious diseases. 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 Twitter @AsherBio and on LinkedIn.

 

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

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Asher Bio Appoints Ian T. Clark to its Board of Directors

South San Francisco, Calif., February 14, 2022 – Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, today announced the appointment of Ian T. Clark to its Board of Directors. Mr. Clark most recently served as Chief Executive Officer (CEO) and a member of the Board of Directors at Genentech.

“We are pleased to welcome Ian as a member of our board,” said Craig Gibbs, Ph.D., Chief Executive Officer of Asher Bio. “Ian dedicated his career to developing novel medicines for cancer and other diseases with high unmet need and, in addition to his track record as a corporate executive, he has served on several different boards, supporting early-stage biotechnology companies in their development efforts and corporate growth. With his deep global expertise, Ian will bring important perspective to Asher Bio, and we look forward to his many contributions as we build clinical and corporate strategies to deliver our precision immunotherapies to patients, while also cultivating a supportive and collaborative culture.”

“I am honored to serve on Asher Bio’s Board. I am inspired by Asher Bio’s patient-focused mission and look forward to working with the team to harness the power of cis-targeting to overcome the limitations of existing immune-based therapies,” said Mr. Clark. “In just a couple of years, Asher Bio has developed a pipeline of highly differentiated immunotherapies, including its lead program AB248, a CD8-targeted IL-2, AB821, a CD8-targeted IL-21, and a CART-targeted IL-2, which together demonstrate the ability of the company’s platform to rapidly generate new molecules targeting different immunomodulators to a diverse set of immune cells. I am eager to share my expertise as the company advances its first programs into Phase 1 studies and we seek to establish the clinical utility of cis-targeted immunotherapies.”

Mr. Clark has more than 35 years of experience in the biopharma industry. Until his retirement in 2016, Mr. Clark served as CEO of Genentech. During his seven-year tenure as CEO, Mr. Clark and his team brought 11 new medicines to market for patients living with rheumatoid arthritis, idiopathic pulmonary fibrosis and various types of cancer. In addition, Mr. Clark was named among the highest rated CEOs by Glassdoor, recognized as the Bay Area’s most admired CEO by the San Francisco Business Times awarded the Honorable Mentor of the Year by the Healthcare Businesswomen’s Association. Prior to assuming his role as CEO, Mr. Clark held several senior management positions across Genentech, including Head of Global Product Strategy, Chief Marketing Officer, Senior Vice President, General Manager of BioOncology and Executive Vice President, Commercial Operations.  Before joining Genentech, Mr. Clark spent over two decades in the pharmaceutical industry in senior roles at Novartis, Ivax Pharma and Sanofi in the United Kingdom, France and Eastern Europe. He began his career in sales and marketing at Searle, a subsidiary of Monsanto Corporation.

Mr. Clark currently serves on the boards of several private and public biopharmaceutical and biotechnology companies, including Agios Pharmaceuticals, Inc., Guardant Health Inc., Olema Oncology, and Takeda Pharmaceutical Company Limited . He is also on the BioFulcrum Board of the Gladstone Institute. Mr. Clark previously served on the Boards of Forty Seven Inc., Kite Pharma, Inc., and Shire Pharmaceuticals Inc. He was also on the Board of Biotechnology Industry Association and on the Economic Advisory Council of the 12th District of the Federal Reserve. Mr. Clark received his B.S. in Biological Sciences and an Honorary Doctorate of Science, both from Southampton University.

About Asher Bio

Asher Bio is a biotechnology company developing precisely targeted immunotherapies for cancer and other diseases. Our cis-targeting platform aims to enable selective activation of specific immune cell types, addressing the inherent limitations of otherwise pleiotropic immunotherapies that act on multiple cell types. Our approach has the potential to precisely direct different immune mediators against a range of target immune cell-types and create best-in-class immunotherapies in cancer, autoimmune and infectious diseases. 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 Twitter @AsherBio and on LinkedIn.

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

 

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Asher Bio to Present at Upcoming Investor Conferences

South San Francisco, Calif., February 4, 2022 – Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, today announced that company management will participate in the following upcoming investor conferences:

4th Annual Guggenheim Oncology Conference
Craig Gibbs, Ph.D., will present a corporate overview on Friday, February 11, 2022 at 1:00 p.m. ET (10:00 a.m. PT). Company management will also participate in 1×1 meetings on Friday, February 11, 2022. 

SVB Leerink 11th Annual Global Healthcare Conference
Company management will participate in 1×1 meetings on Monday, February 14 and Tuesday, February 15, 2022.

About Asher Bio
Asher Bio is a biotechnology company developing precisely targeted immunotherapies for cancer and other diseases. Our cis-targeting platform aims to enable selective activation of specific immune cell types, addressing the inherent limitations of otherwise pleiotropic immunotherapies that act on multiple cell types. Our approach has the potential to precisely direct different immune mediators against a range of target immune cell-types and create best-in-class immunotherapies in cancer, autoimmune and infectious diseases. 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 Twitter @AsherBio and on LinkedIn.

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

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Asher Bio Expands Leadership Team with Three Key Appointments

Industry Veterans Bolster Company’s Business and Regulatory Functions —

South San Francisco, Calif., January 24, 2022 – Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, today announced the expansion of its executive leadership team with the appointments of Don O’Sullivan, Ph.D., M.B.A., as Chief Business Officer, James Cross, Ph.D., as Vice President, Regulatory Affairs and Florence Zhu, CPA, as Vice President, Finance. Together, these leaders will support the company’s growth and further enhance its ability to advance a growing pipeline of highly differentiated precision immunotherapies through research and development.

“We are delighted to welcome Don, Jamie and Florence to Asher Bio,” said Craig Gibbs, Ph.D., Chief Executive Officer of Asher Bio. “Each is a highly talented industry veteran, with experience building high quality and successful biotechnology companies and advancing clinical pipelines in oncology in a manner consistent with our core values. We look forward to their many contributions as we continue to make significant progress across our business, with the potential to advance two oncology programs into clinical development over the next two years, while collaborating to broaden our cis-targeted programs into the areas of cell therapy augmentation, autoimmune and infectious diseases.”

Don O’Sullivan, Ph.D., M.B.A., Chief Business Officer 

Dr. O’Sullivan brings nearly 15 years of leadership experience in biotechnology and pharmaceutical business development. Dr. O’Sullivan joins Asher Bio from Roche and Genentech, where he served most recently as Vice President, Global Head of Oncology Partnering, with responsibility for all oncology pipeline business development activities. Earlier, Dr. O’Sullivan held positions of increasing responsibility at Genentech, including leading partnering efforts for gRED’s Immunology and Infectious Disease R&D groups. Dr. O’Sullivan holds a Ph.D. in Molecular Biology from the University of Cambridge, an M.B.A. in Healthcare and Finance from the Wharton School at the University of Pennsylvania, and a B.Sc. in Biochemistry from Imperial College London.

“I am incredibly excited by the modularity of Asher Bio’s platform, which enables the rapid generation and de-risking of new molecules against a diverse set of immune cell types, spanning multiple therapeutic areas,” said Dr. O’Sullivan. “Over the course of my career, I have developed a deep appreciation of the need for more selective medicines for the treatment of cancer, autoimmune and infectious diseases, which can deliver robust efficacy without introducing significant off-target toxicity. I am eager to leverage my experience to maximize the reach of Asher Bio’s cis-targeted technology and ultimately enable many more patients to achieve better clinical outcomes.”

James Cross, Ph.D., Vice President, Regulatory Affairs 

Dr. Cross is an established industry veteran, with nearly 20 years of experience working in industry, academia and at the U.S. Food and Drug Administration (FDA). Prior to Asher Bio, Dr. Cross founded and served as the principal regulatory consultant of Cross BioStrategies, LLC, where he assisted companies with product development strategies, regulatory filings, and regulatory leadership.  Earlier, he served as Executive Director of Regulatory Affairs at Halozyme Therapeutics, leading product strategy for assets in global late-stage oncology development, and as Head of Regulatory Affairs at Forty Seven Inc. (acquired by Gilead Sciences, Inc.), where he supported the clinical program expansion for the company’s lead asset, magrolimab, while managing the regulatory, quality assurance and medical writing functions. Dr. Cross started his industry career in roles of increasing responsibility at Genentech, after working for five years at the FDA. Dr. Cross holds a Ph.D. in Health Outcomes Research from the University of Washington, an M.S. in Immunology from the University of California at Davis, and a B.S. in Biology and French from Tufts University.

“I am honored to join the talented team at Asher Bio at this important moment, as the company prepares to file its first investigational new drug application to advance AB248 into clinical development,” said Dr. Cross. “I am impressed by the compelling anti-tumor activity that has been observed across multiple preclinical models and believe AB248 may offer a best-in-class IL-2 immunotherapy. I look forward to partnering with the team on a clinical and regulatory strategy for AB248 that efficiently advances this program through development for the benefit of patients and their doctors.”

Florence Zhu, CPA, Vice President, Finance

Ms. Zhu brings over 20 years of finance, financial reporting and public company management experience in the life sciences industry. Prior to joining Asher Bio, Ms. Zhu was the Vice President of Finance and Corporate Controller at Olema Oncology, where she made significant contributions to their public company transition and the establishment of their finance team. Earlier, she served as Senior Director, Corporate Controller at Forty Seven, Inc. (acquired by Gilead Sciences, Inc.) and at Five Prime Therapeutics (acquired by Amgen), and in roles of increasing responsibility at Codexis, Inc., Maxygen Inc., Varian Inc. and Guidant Corporation. Ms. Zhu is a Certified Public Accountant and holds a B.A. in Accounting from the State University of New York at New Paltz.

“Over the last two years, Asher Bio has assembled an incredible team of industry leaders with a shared belief in the breakthrough potential of cis-targeted immunotherapies, as well as a strong investor syndicate to support the advancement of its lead product candidates,” said Ms. Zhu. “I am delighted to join Asher Bio and look forward to working with the team to establish a robust business organization that can serve as a foundation for long-term growth.”

About Asher Bio

Asher Bio is a biotechnology company developing precisely targeted immunotherapies for cancer and other diseases. Our cis-targeting platform aims to enable selective activation of specific immune cell types, addressing the inherent limitations of otherwise pleiotropic immunotherapies that act on multiple cell types. Our approach has the potential to precisely direct different immune mediators against a range of target immune cell-types and create best-in-class immunotherapies in cancer, autoimmune and infectious diseases. 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 Twitter @AsherBio and on LinkedIn.

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

 

 

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Asher Bio to Present at 40th Annual J.P. Morgan Healthcare Conference

South San Francisco, Calif., January 5, 2022 – Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, today announced that Craig Gibbs, Ph.D., Chief Executive Officer of Asher Bio, will present a corporate overview at the 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12, 2022 at 3:30 p.m. ET (12:30 p.m. PT).

About Asher Bio

Asher Bio is a biotechnology company developing precisely targeted immunotherapies for cancer and other diseases. Our cis-targeting platform aims to enable selective activation of specific immune cell types, addressing the inherent limitations of otherwise pleiotropic immunotherapies that act on multiple cell types. Our approach has the potential to precisely direct different immune mediators against a range of target immune cell-types and create best-in-class immunotherapies in cancer, autoimmune and infectious diseases. 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 Twitter @AsherBio and on LinkedIn.

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

 

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Asher Bio Showcases Versatility and Broad Applicability of Cis-Targeting Technology for Precision Immunotherapies at Antibody Engineering Conferences

Proprietary platform enables discovery of novel cis-targeted therapies leveraging a diverse set of immunomodulators to selectively activate different immune cell types —

— To-date, achieved preclinical proof-of-concept for three programs, using two different cytokines and targeting two different immune cell types–

South San Francisco, Calif., December 15, 2021 – Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer, autoimmune, and infectious diseases, today provided an overview of its cis-targeting platform and growing pipeline of highly differentiated precision immunotherapies. The update follows presentations by Asher Bio on its cis-targeting technology at PEGS Europe: Protein & Antibody Engineering Summit, held November 2-4, 2021 in Barcelona, and the Antibody Engineering & Therapeutics (AET) Conference, held December 12-16, 2021 in San Diego.

“We were delighted to present additional details on our cis-targeting technology at recent scientific conferences,” said Andy Yeung, Ph.D., Chief Technology Officer and Founder of Asher Bio. “Our platform enables us to build a broad pipeline of potentially best-in-class precision immunotherapies, each of which engages both an immunomodulatory receptor and a specific target on the same cell. By focusing our potent immunomodulators selectively on only the desired immune cell type, we believe we can deliver improved clinical outcomes, offering patients more efficacious medicines that carry a reduced risk of off-target toxicities. Importantly, our approach can be applied systematically to target multiple classes of immunomodulators to a diverse set of immune cell types, creating numerous opportunities to generate new immunotherapies for a range of cancers, autoimmune and infectious diseases.”

As outlined in Asher Bio’s presentations at PEGS Europe and AET, the company’s proprietary cis-targeting platform yields immunotherapies that selectively activate specific immune cell subsets, in order to avoid the pleiotropic effects that characterize the systemic delivery of existing cytokines and immunotherapies. Asher Bio is applying its modular toolkit, which includes a library of targeting arms and engineered cytokines that can be readily recombined to generate new molecules, to rapidly build and de-risk a portfolio of drug candidates for treatments in multiple disease areas.

“Since our founding, we progressed our three most advanced programs – all of which leverage our discoveries in IL-2 and other cis-targeted cytokines for the treatment of oncology – through preclinical proof-of-concept, demonstrating the reproducibility of our approach and providing the foundation for us to build a portfolio of potentially best-in-class immunotherapies,” said Ivana Djuretic, Ph.D., Chief Scientific Officer and Founder of Asher Bio. “We look forward to building on this momentum as we advance our existing programs toward the clinic and apply our proprietary cis-targeting technology to discover, develop and, ultimately, deliver novel molecules with the potential to restore hope, health and happiness to many more patients.”

The presentations at PEGS Europe and AET provide additional detail on Asher Bio’s cis-targeting technology and support the company’s emerging pipeline of cis-targeted immunotherapies:

  • Asher Bio’s lead program, AB248, is a fusion protein that selectively activates the interleukein-2 (IL-2) receptor pathway on CD8+ T cells. In preclinical studies, AB248 has demonstrated highly compelling anti-tumor activity across multiple mouse tumor models, showing superior efficacy and tolerability compared to wild-type IL-2 and other not-α IL-2 therapies currently in clinical development. Asher Bio expects to file an investigational new drug application with the U.S. Food and Drug Administration in the third quarter of 2022.
  • Beyond AB248, Asher Bio is advancing two additional programs for the treatment of cancer, both of which have achieved preclinical proof of concept:
    • A cis-targeted cytokine that selectively activates STAT3 signaling in CD8+ T cells, promoting cytotoxicity, memory cell differentiation and survival, all of which are signals potentially complementary to the proliferation signal provided by IL-2 and STAT5 activation.
    • A CAR-T cis-targeted IL-2 that selectively expands CAR-Ts post-adoptive transfer, supporting better engraftment, peak expansion and persistence, all of which have been correlated with improved clinical efficacy and outcomes.

The scientific overview presented at PEGS Europe and AET is now available in the “Presentations and Posters” section of Asher Bio’s website: https://asherbio.com/pipeline/presentations-publications/. 

About Asher Bio

Asher Bio is a biotechnology company developing precisely targeted immunotherapies for cancer and other diseases. Our cis-targeting platform aims to enable selective activation of specific immune cell types, addressing the inherent limitations of otherwise pleiotropic immunotherapies that act on multiple cell types. Our approach has the potential to precisely direct different immune mediators against a range of target immune cell-types and create best-in-class immunotherapies in cancer, autoimmune and infectious diseases. 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 Twitter @AsherBio and on LinkedIn.

 

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

 
 

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