Cybrexa Therapeutics Receives Green Light from FDA on Investigational New Drug Application for CBX-12 (alphalex™-exatecan)

NEW HAVEN, Conn., March 22, 2021 (GLOBE NEWSWIRE) — Cybrexa Therapeutics, an oncology-focused biotechnology company developing a new class of therapeutics through its alphalex™ Peptide Drug Conjugate (PDC) tumor targeting platform, today announced that the U.S. Food and Drug Administration (FDA) has provided the green light regarding the Investigational New Drug (IND) application for CBX-12 (alphalex™-exatecan), the company’s lead therapeutic candidate.

“The go ahead from the FDA on our IND application for CBX-12 is a major step in the clinical development of what we believe could be a game-changing therapeutic for many cancer patients,” said Per Hellsund, President and CEO of Cybrexa. “Preclinical studies of CBX-12 show a strong efficacy and safety profile, and we expect that the Phase I clinical trial will help us learn more about the potential applications of this therapeutic candidate. The clinical development of CBX-12 is important, not just as we move toward bringing this candidate to market, but in expanding the addressable patient populations with therapeutics that target a broader scope of solid tumors, allowing us to treat a greater number of patients.”

CBX-12 is a novel treatment for solid tumors that includes a highly potent topoisomerase I inhibitor payload that is in the same class as the payloads used by antibody-drug conjugates (ADCs) ENHERTU® and TRODELVY™. In contrast to these ADCs, CBX-12 is able to target cancer cells independent of antigen expression, which could greatly expand the addressable patient populations. The positive results from the GLP toxicology study of CBX-12 will serve as a guide for dosing regimen for the planned Phase I trial of CBX-12, which Cybrexa plans to initiate in April 2021.

About the alphalex™ Technology Platform
The Cybrexa alphalex™ technology platform – which consists of a pHLIP® peptide, linker, and small molecule anti-cancer agent (payload) – enables antigen-independent targeting of tumors and intracellular delivery of highly potent anticancer therapies, creating therapeutics that can revolutionize the standard of care. pHLIP® peptides are a family of pH-Low Insertion Peptides that target acidic cell surfaces. pHLIP® was developed at Yale University and the University of Rhode Island, and is exclusively licensed to pHLIP, Inc. alphalex™ represents the disruptive next generation in tumor targeting. View a video of the mechanism of action of the technology at www.cybrexa.com.

About Cybrexa
Cybrexa is a privately-held biotechnology company dedicated to developing next-generation tumor-targeted cancer therapies using its alphalex™ platform. The Company’s lead candidate, CBX-12, an alphalex™-exatecan conjugate, is expected to enter Phase I/II in 2021 in advanced solid tumors. Cybrexa also has other preclinical toxin conjugate programs as well as synthetic lethality programs. Cybrexa was founded by physician-scientists and has an experienced management team that has built numerous successful life sciences companies. For more information about Cybrexa, please visit www.cybrexa.com.

Contacts

Cybrexa Therapeutics
Lisa Rehm
Email: [email protected]

Investor Relations
Stephanie Carrington
Tel: 646-277-1282
Email: [email protected]

Media Relations
Mark Corbae
Tel: 203-682-8288
Email: [email protected]

Cybrexa Therapeutics Closes $25 Million Series B Financing

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Cybrexa Therapeutics Closes $25 Million Series B Financing

Source: Cybrexa Therapeutics

 

-Proceeds will advance the company’s lead program into clinical trials-

NEW HAVEN, Conn., March 10, 2021 (GLOBE NEWSWIRE) — Cybrexa Therapeutics, an oncology-focused biotechnology company developing a new class of therapeutics through its alphalex™ Peptide Drug Conjugate (PDC) tumor targeting platform, today announced the completion of its $25 million Series B financing. The financing included HighCape Capital and new investor Elm Street Ventures. Proceeds from the financing will be used to support the planned advancement of Cybrexa’s lead candidate CBX-12 (alphalex™-exatecan) into the clinic. The first patient dosing in the Phase 1 study is expected in the first half of 2021.

“We are pleased that our efforts continue to be recognized and supported by our investors. This funding is a testament to our company’s progress, execution and the strength of our alphalex™ platform technology,” said Per Hellsund, President & CEO of Cybrexa. “This round of financing will be deployed to support the planned Phase 1 study for CBX-12.”

CBX-12 is a novel treatment for solid tumors that includes a highly potent topoisomerase I inhibitor payload that is in the same class as the payloads used by antibody-drug conjugates (ADCs) ENHERTU® and TRODELVY™. In contrast to these ADCs, CBX-12 is able to target cancer cells independent of antigen overexpression, which should greatly expand the addressable patient populations. The positive results from the GLP toxicology study of CBX-12 will serve as a guide for the dosing regimen in the planned Phase I trial.

“We believe Cybrexa’s technology and science form the basis for a robust development platform, capable of producing multiple targeted therapeutic options, for a variety of oncology indications,” said Kevin Rakin, Partner of HighCape Capital. “We see the progress of CBX-12 into human trials as a significant milestone for the platform, as well as providing even more opportunities from a business perspective.”

About CBX-12

CBX-12 is a novel treatment for solid tumors that includes a highly potent topoisomerase I inhibitor payload that is in the same class as the payloads used by antibody-drug conjugates (ADCs) ENHERTU® and TRODELVY™. In contrast to these ADCs, CBX-12 is able to target cancer cells independent of antigen overexpression, which should greatly expand the addressable patient populations. Positive results from the GLP toxicology study of CBX-12 will serve as a guide for dosing regimen for the planned Phase I trial of CBX-12, as Cybrexa filed the IND on February 19, 2021. CBX-12 is currently being investigated in collaboration with NCI in pre-clinical safety and efficacy studies in the solid tumor landscape. This partnership will also explore its therapeutic potential to conduct trials in a wide number of indications and in combination with other therapies such as immune-oncology and PARP inhibitors.

About the alphalex™ Technology Platform
The Cybrexa alphalex™ technology platform – which consists of a pHLIP® peptide, linker, and small molecule anti-cancer agent (payload) – enables antigen-independent targeting of tumors and intracellular delivery of highly potent anticancer therapies, creating therapeutics that can revolutionize the standard of care. pHLIP® peptides are a family of pH-Low Insertion Peptides that target acidic cell surfaces. pHLIP® was developed at Yale University and the University of Rhode Island, and is exclusively licensed to pHLIP, Inc. alphalex™ represents the disruptive next generation in tumor targeting. View a video of the mechanism of action of the technology at www.cybrexa.com.

About Cybrexa
Cybrexa is a privately-held biotechnology company dedicated to developing next-generation tumor-targeted cancer therapies using its alphalex™ platform. The Company’s lead candidate, CBX-12, an alphalex™-exatecan conjugate, is expected to enter Phase I/II in 2021 in advanced solid tumors. Cybrexa also has other preclinical toxin conjugate programs as well as synthetic lethality programs. Cybrexa was founded by physician-scientists and has an experienced management team that has built numerous successful life sciences companies. For more information about Cybrexa, please visit www.cybrexa.com.

Contacts

Cybrexa Therapeutics
Lisa Rehm
Email: [email protected]

Investor Relations
Stephanie Carrington
Tel: 646-277-1282
Email: [email protected]

Media Relations
Mark Corbae
Tel: 203-682-8288
Email: [email protected]

Cybrexa Therapeutics Enters Cooperative Research and Development Agreement (CRADA) with U.S. National Cancer Institute to Develop CBX-12 (alphalex™- exatecan)

– Cybrexa and NCI to collaborate on clinical development of Cybrexa’s lead candidate, CBX-12, to assess the safety and efficacy in oncology patients with solid tumors –

NEW HAVEN, Conn., Feb. 24, 2021 (GLOBE NEWSWIRE) — Cybrexa Therapeutics, an oncology-focused biotechnology company developing a new class of therapeutics through its alphalex™ Peptide Drug Conjugate (PDC) tumor targeting platform, today announced that it has entered a Cooperative Research and Development Agreement (CRADA) with the U.S. National Cancer Institute (NCI), part of the National Institutes of Health. Under terms of the agreement, Cybrexa and the NCI will collaborate on pre-clinical and potential clinical development of Cybrexa’s lead therapeutic candidate, CBX-12 (alphalex™-exatecan).

“This research and development agreement with the NCI is not only a validation of Cybrexa’s technology, but may also allow us to significantly expand our clinical development program,” said Per Hellsund, President and CEO of Cybrexa. “Collaborating with the NCI on the development of CBX-12 may allow testing of its therapeutic potential by some of the world’s leading oncology researchers. This collaboration also dramatically expands our ability to conduct clinical trials in a wide number of indications, and in combination with other therapies such as immuno-oncology and PARP inhibitors.”

Cybrexa and the NCI will work together initially focusing on pre-clinical studies and move on to clinical development of CBX-12, if the preclinical studies support clinical development, to demonstrate its safety and efficacy in patients with a variety of solid tumors.

CBX-12 is a novel treatment for solid tumors that includes a highly potent topoisomerase I inhibitor payload that is in the same class as the payloads used by antibody-drug conjugates (ADCs) ENHERTU® and TRODELVY™. In contrast to these ADCs, CBX-12 is able to target cancer cells independent of antigen overexpression, which should greatly expand the addressable patient populations. The positive results from the GLP toxicology study of CBX-12 will serve as a guide for dosing regimen for the planned Phase I trial of CBX-12, as Cybrexa filed the IND on February 19, 2021.

About the alphalex™ Technology Platform
The Cybrexa alphalex™ technology platform – which consists of a pHLIP® peptide, linker, and small molecule anti-cancer agent (payload) – enables antigen-independent targeting of tumors and intracellular delivery of highly potent anticancer therapies, creating therapeutics that can revolutionize the standard of care. pHLIP® peptides are a family of pH-Low Insertion Peptides that target acidic cell surfaces. pHLIP® was developed at Yale University and the University of Rhode Island, and is exclusively licensed to pHLIP, Inc. alphalex™ represents the disruptive next generation in tumor targeting. View a video of the mechanism of action of the technology at www.cybrexa.com.

About Cybrexa
Cybrexa is a privately-held biotechnology company dedicated to developing next-generation tumor-targeted cancer therapies using its alphalex™ platform. The Company’s lead candidate, CBX-12, an alphalex™-exatecan conjugate, is expected to enter Phase I/II in 2021 in advanced solid tumors. Cybrexa also has other preclinical toxin conjugate programs as well as synthetic lethality programs. Cybrexa was founded by physician-scientists and has an experienced management team that has built numerous successful life sciences companies. For more information about Cybrexa, please visit www.cybrexa.com.

Contacts
Cybrexa Therapeutics
Lisa Rehm
Email: [email protected]

Investor Relations
Stephanie Carrington
Tel: 646-277-1282
Email: [email protected]

Media Relations
Mark Corbae
Tel: 203-682-8288
Email: [email protected]

Cybrexa Therapeutics Reports Positive Results from GLP Toxicology Study of Lead Candidate CBX-12 (alphalex™-exatecan)

– No Unexpected Safety Findings During the Course of the Study –

– On Track to File an IND in the First Quarter 2021 and Commence Phase I Trial by Mid Year 2021 –

NEW HAVEN, Conn., Jan. 28, 2021 (GLOBE NEWSWIRE) — Cybrexa Therapeutics, an oncology-focused biotechnology company developing a new class of therapeutics through its alphalex™ Peptide Drug Conjugate (PDC) tumor targeting platform, today announced that it has completed the GLP toxicology study of its lead candidate, CBX-12. The positive results for this study serve as a guide for dosing regimen for the planned Phase I trial of CBX-12 as Cybrexa intends to file the IND during the first quarter 2021.

“The successful completion of the GLP toxicology studies is an early, yet significant milestone in the development of our lead candidate CBX-12, a highly potent alphalex PDC conjugate that we believe has the potential to impact several types of solid tumors, both as a monotherapy and in combination with PD-1 inhibitors and other immuno-oncology drugs,” said Per Hellsund, President and CEO of Cybrexa. “Additionally, the study results are relevant to the development of our other pipeline candidates, as they suggest the utility of our alphalex PDC tumor targeting platform for targeted intracellular drug delivery, independent of surface antigens.”

In the GLP toxicology studies CBX-12 was delivered via IV infusion, and based on multiple parameters, including mortality, clinical observations, body weights and food consumption, the results established a significant therapeutic index of ~20X over exatecan for CBX-12. Additionally, in accordance with the FDA feedback from the pre-IND meeting, Cybrexa completed a rodent respiratory safety pharmacology study with no notable clinical observations, as well as a hemolytic potential and plasma compatibility study with no hemolysis or plasma incompatibility observed.

CBX-12 is a novel treatment for solid tumors that includes a highly potent topoisomerase I inhibitor payload that is in the same class as the payloads used by antibody-drug conjugates (ADCs) ENHERTU® and TRODELVY™. In contrast to these ADCs, CBX-12 is able to target cancer cells independent of antigen overexpression, which should greatly expand the addressable patient populations.

About the alphalex™ Technology Platform
The Cybrexa alphalex™ technology platform – which consists of a pHLIP® peptide, linker, and small molecule anti-cancer agent (payload) – enables antigen-independent targeting of tumors and intracellular delivery of highly potent anticancer therapies, creating therapeutics that can revolutionize the standard of care. pHLIP® peptides are a family of pH-Low Insertion Peptides that target acidic cell surfaces. pHLIP® was developed at Yale University and the University of Rhode Island, and is exclusively licensed to pHLIP, Inc. alphalex™ represents the disruptive next generation in tumor targeting. View a video of the mechanism of action of the technology at www.cybrexa.com.

About Cybrexa
Cybrexa is a privately-held biotechnology company dedicated to developing next-generation tumor-targeted cancer therapies using its alphalex™ platform. The Company’s lead candidate, CBX-12, an alphalex™-exatecan conjugate, is expected to enter Phase I/II in 2021 in advanced solid tumors. Cybrexa also has other preclinical toxin conjugate programs as well as synthetic lethality programs. Cybrexa was founded by physician-scientists and has an experienced management team that has built numerous successful life sciences companies. For more information about Cybrexa, please visit www.cybrexa.com.

Contacts

Cybrexa Therapeutics
Lisa Rehm
Email: [email protected]

Investor Relations
Stephanie Carrington
Tel: 646-277-1282
Email: [email protected]

Media Relations
Mark Corbae
Tel: 203-682-8288
Email: [email protected]

Cybrexa Therapeutics Expands Scientific Advisory Board With Appointment of Leader in Lung Cancer Research Roy Herbst, M.D., Ph.D.

Expansion of SAB in advance of IND submission for CBX-12 and start of Phase I/II study in solid tumors

New Haven, Conn., August 3, 2020 – Cybrexa Therapeutics, an oncology-focused biotechnology company developing a new class of therapeutics through its alphalex™ tumor targeting platform, today announced that it has expanded its Scientific Advisory Board with the appointment of Roy S. Herbst, M.D., Ph.D., Ensign Professor of Medicine, Professor of Pharmacology, Chief of Medical Oncology, Director of the Yale SPORE in Lung Cancer, and Associate Director for Translational Research at Yale Cancer Center (YCC) and Yale School of Medicine.

Dr. Herbst has worked over several decades as a pioneer of personalized medicine and immunotherapy to identify biomarkers and bring novel targeted treatments and immunotherapies to patients, serving as principal investigator for numerous clinical trials testing these agents in advanced stage lung cancers. This work led to the approval of several therapies (such as gefitinib, cetuximab, bevacizumab, axitinib, atezolizumab, and pembrolizumab), which have revolutionized the field and greatly enhanced patient survival. His work on “umbrella” trials has galvanized the field of targeted therapy and cancer drug approvals at the FDA. Nationally, he is at the forefront of personalized medicine and works closely with public-private partnerships to develop large clinical studies, such as Lung-MAP. The NCI Lung SPORE he leads has identified new mechanisms of sensitivity and resistance to immunotherapy.

Dr. Herbst has authored or co-authored more than 300 publications, including peer-reviewed journal articles, abstracts, and book chapters. His work has appeared in many prominent journals, such as the Journal of Clinical Oncology, Clinical Cancer Research, Lancet, and the New England Journal of Medicine. Work published in Nature was awarded the 2015 Herbert Pardes Clinical Research Excellence Award by the Clinical Research Forum.

Dr. Herbst was a member of the National Cancer Policy Forum, for which he organized an IOM meeting focused on policy issues in personalized medicine. He is a member of the Board of Directors of the American Association of Cancer Research, where he chairs the Tobacco Task Force, as well as the American Society of Clinical Oncology. Additionally, he is a member of the Board of Directors of the International Association for the Study of Lung Cancer (IASLC). He is a fellow of the American College of Physicians and an elected member of the Association of American Physicians. He is vice chair for developmental therapeutics for Southwestern Oncology Group’s (SWOG) Lung Committee and the Principal Investigator of the Lung-MAP master protocol. In 2015, his team at Yale was awarded a Lung Cancer SPORE by the NCI (renewed in 2020), and he serves as a principal investigator for an AACR/ Stand Up to Cancer Dream Team grant.

Dr. Herbst said, “I am excited to join Cybrexa’s scientific advisory board as CBX-12 approaches the clinic. I believe that the alphalexTM platform and programs have tremendous potential, particularly in solid tumor patients who are refractory to immunotherapy and in combination with immunotherapy drugs. I look forward to providing Cybrexa with guidance as they make the transition to become a clinical stage company over the next year.”

Per Hellsund, President and CEO of Cybrexa, added, “We are honored to have Dr. Herbst join our scientific advisory board. His contributions will be invaluable as we expand our clinical strategy in solid tumors.”

About the alphalex™ Technology Platform

The Cybrexa alphalex™ technology platform – which consists of a pHLIP® peptide, linker, and small molecule anti-cancer agent (payload) – enables antigen-independent targeting of tumors and intracellular delivery of highly potent anticancer therapies, creating therapeutics that can revolutionize the standard of care.  pHLIP® peptides are a family of pH-Low Insertion Peptides that target acidic cell surfaces.  pHLIP® was developed at Yale University and the University of Rhode Island, and is exclusively licensed to pHLIP, Inc.  alphalex™ represents the disruptive next generation in tumor targeting.  View a video of the mechanism of action of the technology at www.cybrexa.com.

About Cybrexa

Cybrexa is a privately-held biotechnology company dedicated to developing next-generation tumor-targeted cancer therapies using its alphalex™ platform. The Company’s lead candidate, CBX-12, an alphalex™-exatecan conjugate, is expected to enter Phase I/II in 2021 in advanced solid tumors. Cybrexa also has other preclinical toxin conjugate programs as well as synthetic lethality programs.  Cybrexa was founded by physician-scientists and has an experienced management team that has built numerous successful life sciences companies. For more information about Cybrexa, please visit www.cybrexa.com.

 

Media Contact

[email protected]

 

Investor Relations                                                                                   

Westwicke, an ICR Company

Stephanie Carrington

[email protected]

646-277-1282

Cybrexa Therapeutics Completes Successful Pre-IND Meeting With FDA for CBX-12 (alphalexTM-exatecan), a Novel Treatment for Solid Tumors

Positive pre-IND Meeting with FDA supports plan to file IND in fourth quarter 2020

New Haven, Conn., July 7, 2020 – Cybrexa Therapeutics, an oncology-focused biotechnology company developing a new class of therapeutics through its alphalex™ tumor targeting platform, today announced that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding its proposed IND and Phase I/II study for its lead candidate, CBX-12 (alphalexTM-exatecan).

Cybrexa plans to submit the IND application for CBX-12 during the fourth quarter of 2020 and to initiate a Phase I/II clinical trial evaluating CBX-12 in advanced solid tumors in the first half of 2021. The Phase I portion of the study will establish the safety profile and a recommended Phase II dose (RP2D).  This initial clinical trial will also evaluate efficacy across a number of solid tumors and establish proof of mechanism for the alphalexTM platform.

CBX-12 includes a highly potent topoisomerase I inhibitor payload that is in the same class as the payloads used by antibody-drug conjugates (ADCs) ENHERTU® and TRODELVY™.  In contrast to these ADCs, CBX-12 is able to target cancer cells independent of antigen overexpression. alphalexTM conjugates have efficacy in the substantial patient populations that cannot be effectively treated with ADCs, as ADCs can be used only in patients that overexpress antigens.

CBX-12 was selected based on its strong efficacy and solid safety profile in preclinical models. Preclinical efficacy and safety data for CBX-12 was recently presented in a poster at the American Association for Cancer Research (AACR) Virtual Annual Meeting II.

Per Hellsund, President and CEO of Cybrexa, said, “CBX-12 will be the first therapeutic generated from the alphalex™ platform to move into the clinic. Not only is this validating for our pipeline, but it also represents the first time a tumor selective drug that is antigen-independent, delivers payload intracellularly, and is capable of penetrating large tumor masses as well as treating small metastases, will enter into human studies.”

Vishwas Paralkar, PhD, Cybrexa Chief Scientific Officer, added “We are excited to prepare our IND filing and first-in-human study. We anticipate that CBX-12 will demonstrate efficacy in several solid tumors and believe there is potential for the drug in combination with immuno-oncology therapies as well.”

About the alphalex™ Technology Platform

The Cybrexa alphalex™ technology platform – which consists of a pHLIP® peptide, linker, and small molecule anti-cancer agent (payload) – enables antigen-independent targeting of tumors and intracellular delivery of highly potent anticancer therapies, creating therapeutics that can revolutionize the standard of care.  pHLIP® peptides are a family of pH-Low Insertion Peptides that target acidic cell surfaces.  pHLIP® was developed at Yale University and the University of Rhode Island, and is exclusively licensed to pHLIP, Inc.  alphalex™ represents the disruptive next generation in tumor targeting.  View a video of the mechanism of action of the technology at www.cybrexa.com.

About Cybrexa

Cybrexa is a privately-held biotechnology company dedicated to developing next-generation tumor-targeted cancer therapies using its alphalex™ platform. The Company’s lead candidate, CBX-12, an alphalex™-exatecan conjugate, is expected to enter Phase I/II in 2021 in advanced solid tumors. Cybrexa also has other preclinical toxin conjugate programs as well as synthetic lethality programs.  Cybrexa was founded by physician-scientists and has an experienced management team that has built numerous successful life sciences companies. For more information about Cybrexa, please visit www.cybrexa.com.

Media Contact

[email protected]

Investor Relations                                                                                                                    

Westwicke, an ICR Company

Stephanie Carrington

[email protected]

646-277-1282

Cybrexa Therapeutics to Present First Efficacy and Safety Data From its Lead Program CBX-12 and Initial Data From CBX-13 at the American Association for Cancer Research (AACR) Virtual Annual Meeting II

New Haven, Conn., May 15, 2020 – Cybrexa Therapeutics, an oncology-focused biotechnology company developing a new class of therapeutics through its alphalex™ tumor targeting platform, today announced that two posters featuring Cybrexa’s pipeline will be presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting II, which will be held June 22-24, 2020.

The following abstracts are now available on the AACR website at www.aacr.org.

  • Title: CBX-12: A low pH targeting alphalex™-exatecan conjugate for the treatment of solid tumors
  • Session Type: Poster Session
  • Session Title: Emerging Drug Delivery Systems
  • Abstract Number: 3222

 

  • Title: CBX-13: Development of alphalex™-toxin low pH targeting conjugates for the treatment of solid tumors
  • Session Type: Poster Session
  • Session Title: Emerging Drug Delivery Systems
  • Abstract Number: 3287

CBX-12, Cybrexa’s lead candidate, is a conjugate that includes the highly potent and toxic topoisomerase I inhibitor, exatecan. CBX-12 demonstrated remarkable efficacy across HER2-negative solid tumors in preclinical models. CBX-12 displays enhanced stability in plasma in vivo, undergoing only 0.002% warhead release over 30 hours in circulation and demonstrating exquisite selectivity for tumor over normal tissues in mouse tumor models.  “The tumor selectivity of this conjugate is critical to the long-lasting efficacy and safety profile CBX-12 demonstrated across preclinical models,” said Vishwas Paralkar, PhD, Chief Scientific Officer of Cybrexa. “CBX-12 shows tremendous potential across a number of solid tumors and avoids the bone marrow and gastrointestinal toxicities associated with the warhead.”

Cybrexa is also working on the CBX-13 program, a conjugate that includes the highly potent maytansine DM4. The poster presents data for potential CBX-13 candidates in HER2-negative xenograft models that are un-targetable by competing therapies. The candidates demonstrate single digit nanomolar potency in vitro.

Per Hellsund, President and CEO of Cybrexa, commented, “The preclinical results for CBX-12 and CBX-13 were striking and led us to accelerate the development of both programs. CBX-12 is on-track to enter IND-enabling studies shortly, and we look forward to testing the drug in a Phase I/II study in advanced solid tumors next year.”

About the alphalex™ Technology Platform

The Cybrexa alphalex™ technology platform – which consists of a pHLIP® peptide, linker, and small molecule anti-cancer agent (payload) – enables antigen-independent targeting of tumors and intracellular delivery of highly potent anticancer therapies, creating therapeutics that can revolutionize the standard of care.  pHLIP® peptides are a family of pH-Low Insertion Peptides that target acidic cell surfaces.  pHLIP® was developed at Yale University and the University of Rhode Island, and is exclusively licensed to pHLIP, Inc.  alphalex™ represents the disruptive next generation in tumor targeting.  View a video of the mechanism of action of the technology at www.cybrexa.com.

About Cybrexa

Cybrexa is a privately-held biotechnology company dedicated to developing next-generation tumor-targeted cancer therapies using its alphalex™ platform. The Company’s lead candidate, CBX-12, an alphalex™-exatecan conjugate, is expected to enter Phase I/II in 2021 in advanced solid tumors. Cybrexa also has other preclinical toxin conjugate programs as well as synthetic lethality programs.  Cybrexa was founded by physician-scientists and has an experienced management team that has built numerous successful life sciences companies. For more information about Cybrexa, please visit www.cybrexa.com.

 

Media Contact

[email protected]

 

Investor Relations                                                                                                               

Westwicke, an ICR Company

Stephanie Carrington

[email protected]

646-277-1282

Cybrexa Therapeutics to Present at BIO Digital and Sachs 6th Annual Digital Immuno-Oncology Innovation Forum

New Haven, Conn., May 7, 2020 – Cybrexa Therapeutics, an oncology-focused biotechnology company developing a new class of therapeutics through its alphalex™ tumor targeting platform, today announced Per Hellsund, President and Chief Executive Officer, will present at the 2020 BIO Digital Conference being held June 8-12, 2020.

Mr. Hellsund will present a corporate overview on the Company’s platform, pipeline, and lead candidate CBX-12 (alphalexTM-exatecan), which is expected to enter the clinic in advanced solid tumors in early 2021. He will also highlight the potential applications of alphalexTM to improve the therapeutic index of cancer therapeutics. The company presentation will be available on demand starting on June 8. Mr. Hellsund will also be one of the senior leaders speaking at the BIO Digital panel ‘Getting to the Tumor: Beyond the First Generation of Tumor Targeting Technologies’, which will be available on demand starting on June 8.

In addition, Cybrexa will present at the Sachs 6th Annual Digital Immuno-Oncology Innovation Forum that is being held May 26-27, 2020. Mr. Hellsund will also be a member of the ‘Latest Trends in C&G Therapeutics II: Focusing on Cancer Vaccines, Neo Antigens & Other Modalities’ panel which will be broadcast live on Wednesday, May 27, 2020 at 11am ET. Access to this conference is free for investors via the link: https://www.sachsforum.com/6ioif-registration.html

Members of the management team will be available for virtual meetings throughout BIO Digital and the 6th Annual Digital Immuno-Oncology Innovation Forum. To arrange a meeting with management, please contact Keely Zipp at [email protected] or visit the BIO One-on-One Partnering webpage or 6th Annual Digital Immuno-Oncology Innovation Forum webpage to schedule a meeting directly.

About the alphalex™ Technology Platform

The Cybrexa alphalex™ technology platform – which consists of a pHLIP® peptide, linker, and small molecule anti-cancer agent (payload) – enables antigen-independent targeting of tumors and intracellular delivery of highly potent anticancer therapies, creating therapeutics that can revolutionize the standard of care.  pHLIP® peptides are a family of pH-Low Insertion Peptides that target acidic cell surfaces.  pHLIP® was developed at Yale University and the University of Rhode Island, and is exclusively licensed to pHLIP, Inc.  alphalex™ represents the disruptive next generation in tumor targeting.  View a video of the mechanism of action of the technology at www.cybrexa.com.   

About Cybrexa

Cybrexa is a privately-held biotechnology company dedicated to developing next-generation tumor-targeted cancer therapies using its alphalex™ platform. The Company’s lead candidate, CBX-12, an alphalex™-exatecan conjugate, is expected to enter Phase I/II in 2021 in advanced solid tumors. Cybrexa also has other preclinical toxin conjugate programs as well as synthetic lethality programs.  Cybrexa was founded by physician-scientists and has an experienced management team that has built numerous successful life sciences companies. For more information about Cybrexa, please visit www.cybrexa.com.

Media Contact

[email protected]

 

Investor Relations

 Westwicke, an ICR Company

Stephanie Carrington

[email protected]

646-277-1282

Cybrexa Therapeutics Announces Arthur DeCillis, MD as Acting Chief Medical Officer to Support CBX-12’s Entry into the Clinic

Cybrexa Therapeutics Announces Arthur DeCillis, MD as Acting Chief Medical Officer to Support CBX-12’s Entry into the Clinic

New Haven, Conn., March 31, 2020 – Cybrexa Therapeutics, an oncology-focused biotechnology company developing a new class of therapeutics through its alphalex™ tumor targeting platform, today announced that Arthur DeCillis, MD, has joined the company as Acting CMO. Dr. DeCillis will be responsible for the development of the first-in-human study of Cybrexa’s lead program, CBX-12 (alphalexTM-exatecan), and early and late stage clinical programs for the Cybrexa portfolio.  Dr. DeCillis brings over 20 years of experience in pharma and biotech, having worked on multiple oncology products with over $1billion in sales.

Dr. DeCillis currently serves as the president of DeCillis Consulting LLC, a company that provides oncology strategic, medical, and operational consulting services to the pharmaceutical and biotechnology industries. Prior to forming his own consulting practice, Dr. DeCillis was the Chief Medical Officer for Eleven Biotherapeutics (now known as Sesen Bio Inc.), a late-stage clinical company developing next-generation antibody-drug conjugate (ADC) therapies. Previously, Dr. DeCillis was the Vice President of Clinical Research and then Vice President of Medical Affairs at Exelixis, Inc., an oncology-focused biotechnology company.  He also previously served as Executive Director of Oncology Development at Novartis and Group Director of Bristol-Myers Squibb. Arthur has been involved in the development of several commercialized oncology drugs including SPRYCEL® (dasatinib), AFINITOR® (everolimus), FARYDAK® (panobinostat), and CABOMETYX® (cabozantinib).  Dr. DeCillis holds an M.D. from University of Rochester and completed an internal medicine residency at Medical College of Virginia followed by a fellowship at University of Pittsburgh.

Per Hellsund, President and CEO of Cybrexa said, “We are privileged to have Art join the Cybrexa team.  His extensive expertise will help to optimize Cybrexa’s growing portfolio, particularly as we prepare for CBX-12 to enter the clinic in advanced solid tumors early next year.  We anticipate quickly growing into a company with multiple clinical-stage programs, and Art’s leadership will be a critical part of this transition.”

About the alphalex™ Technology Platform

 

The Cybrexa alphalex™ technology platform – which consists of a pHLIP® peptide, linker, and small molecule anti-cancer agent (payload) – enables antigen-independent targeting of tumors and intracellular delivery of highly potent anticancer therapies, creating therapeutics that can revolutionize the standard of care.  pHLIP® peptides are a family of pH-Low Insertion Peptides that target acidic cell surfaces.  pHLIP® was developed at Yale University and the University of Rhode Island, and is exclusively licensed to pHLIP, Inc.  alphalex™ represents the disruptive next generation in tumor targeting.  View a video of the mechanism of action of the technology at www.cybrexa.com.

 

About Cybrexa

 

Cybrexa is a privately-held biotechnology company dedicated to developing next-generation tumor-targeted cancer therapies using its alphalex™ platform. The Company’s lead candidate, CBX-12, an alphalex™-exatecan conjugate, is expected to enter Phase I in 2021 in advanced solid tumors. Cybrexa also has other preclinical toxin conjugate programs as well as synthetic lethality programs.  Cybrexa was founded by physician-scientists and has an experienced management team that has built numerous successful life sciences companies. For more information about Cybrexa, please visit www.cybrexa.com.

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Cybrexa Therapeutics Announces CBX-12 as Lead Development Program

New Haven, Conn., January 9, 2020 – Cybrexa Therapeutics, an oncology-focused biotechnology company developing a new class of therapeutics through its alphalex™ tumor targeting platform, today announced CBX-12 (alphalexTM-exatecan) as the new lead development program. CBX-12 is an alphalexTM conjugate that includes the highly potent topoisomerase I inhibitor exatecan.

CBX-12 has demonstrated strong efficacy and a solid safety profile in preclinical studies.  CBX-12 leverages the same class of payload used in the antibody-drug conjugate (ADC) ENHERTU® (fam-trastuzumab deruxtecan-nxki), which was recently approved by the U.S. Food and Drug Administration under Accelerated Approval in unresectable or metastatic HER2-positive breast cancer. Like ENHERTU®, CBX-12 delivers a highly potent topoisomerase I payload, but CBX-12 targets tumors without the need for a specific antigen and therefore has the potential to address a much broader patient population. CBX-12 has potential synergy with PD-1 inhibitors and other immuno-oncology drugs. Cybrexa plans to publish preclinical data for CBX-12 in the first half of 2020 and to advance the program into the clinic in 2021.

Per Hellsund, President and CEO of Cybrexa said, “CBX-12 has tremendous potential to change the treatment paradigm in multiple solid tumors, which remain hard to treat.  We are committed to moving this program rapidly into the clinic, and ultimately benefit as many patients as possible.  We look forward to reporting on CBX-12’s progress at upcoming high-profile medical conferences in 2020.”

Chief Scientific Officer Vishwas Paralkar, PhD, added, “The CBX-12 program has shown outstanding results in preclinical studies and showcases the potential and opportunity for the alphalexTM platform. We continue to make good progress with our other programs in the preclinical pipeline and look forward to advancing those candidates as we work to provide treatments to as many patients as possible.”

About the alphalex™ Technology Platform

The Cybrexa alphalex™ technology platform – which consists of a pHLIP® peptide, linker, and small molecule anti-cancer agent (payload) – enables antigen-independent targeting of tumors and intracellular delivery of highly potent anticancer therapies, creating therapeutics that can revolutionize the standard of care.  pHLIP® peptides are a family of pH-Low Insertion Peptides that target acidic cell surfaces.  pHLIP® was developed at Yale University and the University of Rhode Island, and is exclusively licensed to pHLIP, Inc.  alphalex™ represents the disruptive next generation in tumor targeting.  View a video of the mechanism of action of the technology at www.cybrexa.com.   

About Cybrexa

Cybrexa is a privately-held biotechnology company dedicated to developing next-generation tumor-targeted cancer therapies using its alphalex™ platform. The Company’s lead candidate, CBX-12, an alphalex™-exatecan conjugate, is expected to enter Phase I in 2021 in advanced solid tumors. Cybrexa also has other preclinical toxin conjugate programs as well as synthetic lethality programs.  Cybrexa was founded by physician-scientists and has an experienced management team that has built numerous successful life sciences companies. For more information about Cybrexa, please visit www.cybrexa.com.

Media Contact

Amanda Johnson

Phone: 202.930.4762 x407

Email: [email protected]