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Archives: Press Releases

Cybrexa Strengthens Drug Development Capabilities with the Addition of Laurie Kenvin to the Company’s Leadership Team and Nick Saccomano to the SAB

Cybrexa is focused on leveraging its expertise to further build out the organization as it continues to strive towards the next generation of cancer therapeutics

NEW HAVEN, Conn., Feb. 01, 2023 (GLOBE NEWSWIRE) — Cybrexa Therapeutics, a clinical-stage oncology biotechnology company developing a novel class of tumor-targeting peptide drug conjugate (PDC) therapeutics, today announced the appointments of Laurie Kenvin as Vice President of Clinical Operations and Nick Saccomano, Ph.D., to the Company’s Scientific Advisory Board (SAB).

“We are excited to be strengthening our organization with the addition of Laurie and Nick,” said Per Hellsund, President and CEO, Cybrexa. “They bring over 50 years combined therapeutic and clinical expertise; both critical to the expansion of our leadership and advisory teams as we expand our CBX-12 clinical development program into Phase 2 clinical trials and further advance our other important pipeline assets.”

Laurie Kenvin brings more than 20 years of global clinical operations expertise as a therapeutic industry veteran including clinical, regulatory, and product lifecycle management experience. Before joining Cybrexa, she spent 13 years at Celgene as Senior Director of Global Clinical Projects. Ms. Kenvin’s background in leading large-scale, international phase II-IV clinical trials will help implement and drive organizational strategies to advance ongoing clinical trial efforts and execute Cybrexa’s pipeline objectives.

Nick Saccomano joins the Cybrexa advisory board with over 35 years of research, development, and management experience across a multitude of therapeutic areas. Nick most recently served as Chief Science Officer and Site Head at Pfizer Boulder R & D, formally Array BioPharma Inc., where he grew and advanced a portfolio of small molecule oncology programs from inception to proof-of-concept. Over his varied career, Dr. Saccomano has guided the discovery and development of dozens of molecules resulting in several commercial introductions. Nick’s appointment will complement the strengths of Cybrexa’s existing advisory team while contributing deep insights into strategic development and clinical applications going forward.

About the alphalex™ Technology Platform 
The Cybrexa alphalex™ technology is a novel antigen-independent, peptide-drug conjugate (PDC) platform that enables targeted delivery of highly potent anticancer treatments and aims to revolutionize the standard of care in oncology. The platform consists of a pH-Low Insertion Peptides (pHLIPs®) peptide, linker, and small molecule anti-cancer agent. 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., and Cybrexa is a sublicensee of pHLIP, Inc.

About Cybrexa
Cybrexa is a privately held clinical-stage biotechnology company pioneering novel antigen-independent tumor-targeting peptide drug conjugate (PDC) therapeutics. The company is led by a dynamic team of highly successful life science entrepreneurs and veteran drug development scientists. Cybrexa investors include Advantage Capital Connecticut, Connecticut Innovations, Elm Street Ventures and HighCape Capital. It is on a mission to create therapeutics that revolutionize the standard of care in oncology. Cybrexa’s robust pipeline aims to combat breast, ovarian, non-small cell lung cancer and a range of other tumors. Its assets are built on Cybrexa’s alphalex™ technology platform, which enables intracellular delivery of highly potent anticancer treatments. Cybrexa is based in New Haven, Conn. and was founded in 2017. For more information about Cybrexa, please visit www.cybrexa.com or follow us on LinkedIn and Twitter.

Investors Contact:
Stephen Basso
CFO/COO
Cybrexa Therapeutics
475-655-7952
[email protected]

Media Contact:
Tara DiMilia
TellMed Strategies
908-884-7024
[email protected]

Cybrexa Therapeutics Announces the Appointment of Michael N. Needle, MD, as Senior Vice President and Chief Medical Officer

Industry veteran most recently from Aveo Oncology joins clinical stage oncology company as it accelerates into Phase 2

NEW HAVEN, Conn., Dec. 15, 2022 (GLOBE NEWSWIRE) — Cybrexa Therapeutics, a clinical-stage oncology biotechnology company developing a novel class of tumor-targeting peptide drug conjugate (PDC) therapeutics, today announced the appointment of Michael N. Needle, MD as Chief Medical Officer. A board-certified hematologist/oncologist, Dr. Needle will be responsible for overseeing and strategizing the continued development of Cybrexa’s advancing pipeline. The Company recently presented positive findings from its first-in-human study of lead candidate, CBX-12 (alphalex™-exatecan) at the annual EORTC-NCI-AACR (ENA) Symposium in October 2022.

“As we advance our clinical programs and progress our early-stage pipeline, Mike’s extensive background and expertise bring valuable insights to the clinical strategy and development,” said Per Hellsund, President & CEO, Cybrexa. “Mike will be replacing Chief Medical Officer Arthur DeCillis, MD who will be transitioning back into a consulting role. Art’s leadership over the last two and a half years has been invaluable to the process of getting CBX-12 into the clinic and through its FIH study, and I am confident that Mike will be instrumental in furthering Cybrexa’s goal of bringing hope to cancer patients with few or no treatment options.”

Dr. Needle brings more than 20 years of industry experience in clinical, business development, regulatory, and safety. Prior to joining Cybrexa, he served as CMO for Aveo Oncology, Array BioPharma, Multiple Myeloma Research Foundation and Consortium, and was also Vice President, Pediatric Strategy at Celgene. He holds a Doctor of Medicine from State University of New York, Downstate Medical Center, and a Bachelor of Arts in physics from Binghamton University.

About the alphalex™ Technology Platform 
The Cybrexa alphalex™ technology is a novel antigen-independent peptide-drug conjugate (PDC) platform that enables targeted delivery of highly potent anticancer treatments and aims to revolutionize the standard of care in oncology. The platform consists of a pH-Low Insertion Peptides (pHLIPs®) peptide, linker, and small molecule anti-cancer agent. 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., and Cybrexa is a sublicensee of pHLIP, Inc.

About Cybrexa
Cybrexa is a privately held clinical-stage biotechnology company pioneering novel antigen-independent tumor-targeting peptide drug conjugate (PDC) therapeutics. The company is led by a dynamic team of highly successful life science entrepreneurs and veteran drug development scientists. Cybrexa investors include Advantage Capital Connecticut, Connecticut Innovations, Elm Street Ventures and HighCape Capital. It is on a mission to create therapeutics that revolutionize the standard of care in oncology. Cybrexa’s robust pipeline aims to combat breast, ovarian, non-small cell lung cancer and a range of other tumors. Its assets are built on Cybrexa’s alphalex™ technology platform, which enables intracellular delivery of highly potent anticancer treatments. Cybrexa is based in New Haven, Conn. and was founded in 2017. For more information about Cybrexa, please visit www.cybrexa.com or follow us on LinkedIn and Twitter.

Investors Contact:
Stephen Basso
CFO/COO
Cybrexa Therapeutics
475-655-7952
[email protected]

Media Contact:
Tara DiMilia
TellMed Strategies
908-884-7024
[email protected]

Exelixis and Cybrexa Therapeutics Establish Exclusive Collaboration Providing Exelixis the Right to Acquire CBX-12, a Potential First-in-Class Peptide-Drug Conjugate of Exatecan

  • CBX-12 has potential to improve efficacy and reduce toxicity over systemic topoisomerase inhibitor
  • Deal reflects Exelixis’ strategic focus on expanding its clinical pipeline and building upon its growing biotherapeutics expertis

November 01, 2022 04:06 PM Eastern Daylight Time – ALAMEDA, Calif. & NEW HAVEN, Conn.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq: EXEL) and Cybrexa Therapeutics (Cybrexa) today announced that the companies have entered into an exclusive collaboration agreement providing Exelixis the right to acquire CBX-12 (alphalex™ exatecan), a clinical-stage, first-in-class peptide-drug conjugate (PDC) that utilizes Cybrexa’s proprietary alphalex technology to enhance delivery of exatecan to tumor cells. CBX-12 is designed to increase the efficacy and reduce the toxicity of topoisomerase I inhibition by delivering exatecan, a highly potent, second-generation topoisomerase I inhibitor, directly to the tumor cells. This collaboration underscores Exelixis’ commitment to expanding its clinical pipeline building upon its biotherapeutics and targeted drug therapy expertise.

“Cybrexa is focused on developing the next generation of cancer therapeutics that specifically target tumors and their underlying biology”

CBX-12 is composed of a pH-Low Insertion Peptide (pHLIP®), a linker and exatecan. As an antigen-independent therapy, CBX-12 may have broad utility in patients who are not eligible for antigen-targeted therapies, including monoclonal antibodies and antibody-drug conjugates (ADCs), and has potential for use in combination regimens with other anti-cancer agents and immunotherapies. Data from the ongoing phase 1 trial of CBX-12 in patients with metastatic solid tumors, reported in an oral presentation during a plenary session at the EORTC-NCI-AACR (ENA) 2022 Symposium on October 28, 2022, demonstrated preliminary anti-tumor activity in a heavily pretreated patient population. This included a complete response in a patient with ovarian cancer.

“This agreement aligns with Exelixis’ goal of acquiring first- or best-in-class clinical-stage assets that may provide differentiated benefits to patients with cancer. Today’s announcement further highlights our ongoing strategy to leverage our balance sheet to gain access to new assets with compelling potential upside in a risk-sharing model, where we can work with partners to further establish proof of concept before investing more heavily,” said Michael Morrissey, Ph.D., President & CEO, Exelixis. “Robust preclinical data and initial clinical data from the ongoing phase 1 trial suggest that CBX-12 may provide differentiated clinical benefit in several solid tumors. Similar to our interest in antibody-drug conjugates, we believe this novel peptide-drug conjugate has transformative clinical potential, and this collaboration affords us the opportunity to expand our clinical pipeline with a best-in-class exatecan therapy if additional CBX-12 clinical data demonstrate enhanced safety and efficacy.”

Cybrexa’s proprietary alphalex technology is designed to increase the therapeutic index of potent anti-cancer compounds by targeting their delivery to tumor cells, thus reducing systemic exposure and thereby reducing toxicity. Importantly, this targeting is achieved through an antigen-independent mechanism, making the alphalex technology potentially applicable to diverse tumor types and providing a complementary approach to traditional ADCs. The alphalex technology platform utilizes pHLIPs combined with a linker to deliver anti-cancer compounds directly to tumor cells. In the acidic (low pH) tumor microenvironment, the pHLIP forms an alpha-helical structure that inserts itself into and across the tumor cell membrane. It is well established that many tumors have an altered metabolism that results in excretion of lactic acid into the tumor microenvironment, thereby reducing the local pH. The linker is cleaved within the cell, releasing the anti-cancer agent into the cell’s cytoplasm. The alpha-helical structure of the peptide (pHLIP) does not form in the physiologic pH surrounding normal cells, preventing delivery to these cells and reducing toxicity.

“Cybrexa is focused on developing the next generation of cancer therapeutics that specifically target tumors and their underlying biology,” said Per Hellsund, President & CEO, Cybrexa. “With its expanding portfolio of biotherapeutics, including ADCs, Exelixis and its partner network have significant and expanding expertise in PDC chemistries and development. Our alphalex PDC technology is an important complement to ADCs and other targeted therapies, and we are excited to bring Exelixis’ insights and resources to the development of CBX-12.”

Financial Considerations

Under the terms of the agreement, Exelixis will pay Cybrexa an upfront fee of $60 million in exchange for the right to acquire CBX-12 pending certain Phase 1 results and to fund certain development and manufacturing expenses incurred by Cybrexa to advance an agreed development plan. Cybrexa may also be eligible to receive up to an additional $642.5 million, including development, regulatory, and commercial milestone payments, as well as a fee for the acquisition of CBX-12 upon evaluation of a pre-specified clinical data package.

Please see Exelixis’ disclosure in today’s Form 10-Q filed with the Securities and Exchange Commission for additional details of the terms of the collaboration agreement.

About the alphalex™ Technology Platform

The Cybrexa alphalex™ technology is a novel antigen-independent peptide-drug conjugate (PDC) platform that enables targeted delivery of highly potent anticancer treatments and aims to revolutionize the standard of care in oncology. The platform consists of a pH-Low Insertion Peptides (pHLIPs®) peptide, linker, and small molecule anti-cancer agent. 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., and Cybrexa is a sublicensee of pHLIP, Inc.

About Cybrexa

Cybrexa is a privately held clinical-stage biotechnology company pioneering novel antigen-independent tumor-targeting peptide drug conjugate (PDC) therapeutics. The company is led by a dynamic team of highly successful life science entrepreneurs and veteran drug development scientists. Cybrexa investors include Advantage Capital Connecticut, Connecticut Innovations, Elm Street Ventures and HighCape Capital. It is on a mission to create therapeutics that revolutionize the standard of care in oncology. Cybrexa’s robust pipeline aims to combat breast, ovarian, non-small cell lung cancer and a range of other tumors. Its assets are built on Cybrexa’s alphalex™ technology platform, which enables intracellular delivery of highly potent anticancer treatments. Cybrexa is based in New Haven, Conn. and was founded in 2017. For more information about Cybrexa, please visit www.cybrexa.com or follow us on LinkedIn and Twitter.

About Exelixis

Founded in 1994, Exelixis, Inc. (Nasdaq: EXEL) is a commercially successful, oncology-focused biotechnology company that strives to accelerate the discovery, development and commercialization of new medicines for difficult-to-treat cancers. Following early work in model system genetics, we established a broad drug discovery and development platform that has served as the foundation for our continued efforts to bring new cancer therapies to patients in need. Our discovery efforts have resulted in four commercially available products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO® (esaxerenone), and we have entered into partnerships with leading pharmaceutical companies to bring these important medicines to patients worldwide. Supported by revenues from our marketed products and collaborations, we are committed to prudently reinvesting in our business to maximize the potential of our pipeline. We are supplementing our existing therapeutic assets with targeted business development activities and internal drug discovery — all to deliver the next generation of Exelixis medicines and help patients recover stronger and live longer. Exelixis is a member of the Standard & Poor’s (S&P) MidCap 400 index, which measures the performance of profitable mid-sized companies. For more information about Exelixis, please visit www.exelixis.com, follow @ExelixisInc on Twitter or like Exelixis, Inc.on Facebook.

Exelixis Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements related to: the therapeutic potential of CBX-12 to improve efficacy and reduce toxicity over systemic topoisomerase inhibitors; the potential for CBX-12 to be a first-in-class PDC of exatecan, with broad utility in patients with diverse tumor types who are not eligible for antigen-targeted therapies, including monoclonal antibodies and ADCs, and the potential for use in combination regimens with other anti-cancer agents and immunotherapies; Exelixis’ ongoing strategy to leverage its balance sheet to gain access to new assets with compelling potential upside in a risk-sharing model, where Exelixis can work with partners to further establish proof of concept before investing more heavily; Exelixis’ belief that CBX-12 has transformative clinical potential and may provide differentiated clinical benefit in several solid tumors, and that the collaboration with Cybrexa aligns with Exelixis’ strategic goals by affording Exelixis an opportunity to expand its clinical pipeline with a best-in-class clinical-stage asset; Exelixis’ immediate and future financial and other obligations under the exclusive collaboration agreement with Cybrexa; and Exelixis’ plans to reinvest in its business to maximize the potential of the company’s pipeline, including through targeted business development activities and internal drug discovery. Any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements and are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the level of costs associated with Exelixis’ commercialization, research and development, in-licensing or acquisition of product candidates, and other activities; uncertainties inherent in the drug discovery and product development process; Exelixis’ dependence on its relationship with Cybrexa, including Cybrexa’s adherence to its obligations under the exclusive collaboration agreement; complexities and the unpredictability of the regulatory review and approval processes in the U.S. and elsewhere; Exelixis’ and Cybrexa’s continuing compliance with applicable legal and regulatory requirements; Exelixis’ and Cybrexa’s ability to protect their respective intellectual property rights; market competition; changes in economic and business conditions, including as a result of the COVID-19 pandemic and other global events; and other factors affecting Exelixis and its product pipeline discussed under the caption “Risk Factors” in Exelixis’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 9, 2022, and in Exelixis’ future filings with the SEC, including, without limitation, Exelixis’ Quarterly Report on Form 10-Q expected to be filed with the SEC on November 1, 2022. All forward-looking statements in this press release are based on information available to Exelixis as of the date of this press release, and Exelixis undertakes no obligation to update or revise any forward-looking statements contained herein, except as required by law.

Exelixis, the Exelixis logo, CABOMETYX and COMETRIQ are registered U.S. trademarks of Exelixis.

COTELLIC is a registered trademark of Genentech, Inc.

MINNEBRO is a registered trademark of Daiichi Sankyo Company, Limited.

Contacts

Exelixis Investors Contact:
Varant Shirvanian
Associate Director, Investor Relations
Exelixis, Inc.
650-837-7917
[email protected]

Exelixis Media Contact:
Hal Mackins
For Exelixis, Inc.
415-994-0040
[email protected]

Cybrexa Therapeutics Investors Contact:
Stephen Basso
CFO/COO
Cybrexa Therapeutics
475-655-7952
[email protected]

Cybrexa Therapeutics Media Contact:
Tara DiMilia
For Cybrexa, Inc.
908-884-7024
[email protected]

Cybrexa Therapeutics Presents Findings from First-in-Human Study of CBX-12 as a Plenary Oral Presentation at 34th EORTC-NCI-AACR Symposium

  • Positive FIH safety and tolerability data supports advancing CBX-12 into multiple Phase II studies
  • Results show early signs of efficacy with a favorable safety profile

NEW HAVEN, Conn., Oct. 28, 2022 (GLOBE NEWSWIRE) — Cybrexa Therapeutics, a clinical-stage oncology biotechnology company developing a novel class of tumor-targeting peptide drug conjugate (PDC) therapeutics, today presented findings as a plenary oral presentation at the annual EORTC-NCI-AACR (ENA) Symposium on molecular targets and cancer therapeutics. This first-in-human study of CBX-12, an alphalex™ PDC in patients with advanced or metastatic solid tumors, demonstrates tolerability, safety and single-agent anti-tumor activity including two confirmed responses for patients receiving CBX-12.

“In this phase I study, CBX-12 demonstrated safety and tolerability, without significant gastrointestinal toxicity. We also saw signal of antitumor activity in multiple tumor types,” said principal investigator, Funda Meric-Bernstam, M.D., Chair of the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center.

Of the 18 response-evaluable patients in this heavily treated patient population with advanced or metastatic cancers, one patient with ovarian cancer achieved complete response (CR), one patient with breast cancer achieved partial response (PR), and 13 patients maintained stable disease (SD). The ongoing study is evaluating safety and tolerability, and these data have provided insights which will inform the recommended phase II dose. The study is also evaluating plasma pharmacokinetics (PK), anti-drug antibodies, and intratumoral levels of CBX-12 and exatecan, anti-tumor activity.

“This study’s data provides us with important early signs of clinical viability of Cybrexa’s alphalex technology platform, which opens the door for us to move forward rapidly with the development of our pipeline,” said Arthur DeCillis, M.D., Chief Medical Officer, Cybrexa Therapeutics.

CBX-12 is a PDC that includes the highly potent topoisomerase I inhibitor exatecan. The asset leverages Cybrexa’s alphalex technology platform, which is a novel antigen-independent PDC platform that enables targeted delivery of highly potent anticancer treatments. The alphalex technology platform consists of a pHLIP® peptide, a linker, and a small molecule anti-cancer agent (payload) and enables intracellular delivery of highly potent anticancer treatments. Further development of CBX-12 by Cybrexa will occur in the company’s New Haven, Conn.-based labs.

About the Presentation

Abstract title: CBX-12-101: A first-in-human study of CBX-12, an alphalex peptide drug conjugate (PDC) in patients with advanced or metastatic solid tumors

Time and date: Friday, 28 October, 15:15 – 15:25

Symposium information: www.eortc.org/ena

About the Trial

Patient cohorts in the Phase I trial were treated with escalating doses of CBX-12 on three dosing schedules, which were 5x daily every three weeks (Schedule A); 3x daily every three weeks (Schedule B); and once weekly (Schedule C). Evaluable patients included those with ovarian, testicular, appendiceal, breast, colorectal, small cell lung, gastric, salivary gland, pancreatic, or endometrial cancers.

About Cybrexa

Cybrexa is a privately held clinical-stage biotechnology company pioneering novel antigen-independent tumor-targeting peptide drug conjugate (PDC) therapeutics. The company is led by a dynamic team of highly successful life science entrepreneurs and veteran drug development scientists. Cybrexa investors include Advantage Capital Connecticut, Connecticut Innovations, Elm Street Ventures and HighCape Capital. It is on a mission to create therapeutics that revolutionize the standard of care in oncology. Cybrexa’s robust pipeline aims to combat breast, ovarian, non-small cell lung cancer and a range of other tumors. Its assets are built on Cybrexa’s alphalex technology platform, which consists of a pHLIP peptide, linker, and small molecule anti-cancer agent (payload) and enables intracellular delivery of highly potent anticancer treatments. 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. Cybrexa is based in New Haven, Conn. and was founded in 2017. For more information about Cybrexa, please visit www.cybrexa.com or follow us on LinkedIn and Twitter.

Contacts

Cybrexa Therapeutics Investor Relations
Stephen Basso
[email protected]

Cybrexa Therapeutics Media Relations
Tara DiMilia
[email protected]

Cybrexa Therapeutics to Present at Upcoming Investor Conferences in June

NEW HAVEN, Conn., June 02, 2022 (GLOBE NEWSWIRE) — Cybrexa Therapeutics, a clinical-stage oncology biotechnology company developing a novel class of tumor-targeting peptide drug conjugate (PDC) therapeutics, today announced that the Company’s Chief Executive Officer, Per Hellsund, is scheduled to present at the upcoming conferences:

Jefferies Healthcare Conference, June 8-10, 2022
Date: Friday, June 10, 2022
Time: 10:30am ET
Location: Marriott Marquis, New York, NY

JMP Securities 2022 Life Sciences Conference, June 15-16, 2022
Date: Thursday, June 16, 2022
Time: 1:30pm ET
Location: Lotte New York Palace, New York, NY

About the alphalex™ Technology Platform 
The Cybrexa alphalex™ technology is a novel antigen-independent peptide drug conjugate (PDC) platform that enables targeted delivery of highly potent anticancer treatments and aims to revolutionize the standard of care in oncology. The platform consists of a pHLIP® peptide, linker, and small molecule anti-cancer agent. 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 clinical-stage biotechnology company pioneering novel antigen-independent tumor-targeting peptide drug conjugate (PDC) therapeutics. The company is led by a management team experienced in building successful life science companies and driven by scientists with an expertise in drug development. Cybrexa’s alphalex™ technology platform enables intracellular delivery of highly potent anticancer treatments, creating therapeutics aimed at revolutionizing the standard of care in oncology. The company’s robust pipeline aims to combat breast, ovarian, non-small cell lung cancer and a range of other tumors. For more information about Cybrexa, please visit www.cybrexa.com.

Contacts

Cybrexa Therapeutics:
Stephen Basso
[email protected]

Media Relations:
Caitlin Henderson
TellMed Strategies
[email protected]

Investor Relations:
Alex Lobo
Stern Investor Relations
[email protected]

Cybrexa is Disrupting the ADC Market with Peptide Drug Conjugate Therapeutics

Published: Jan 17, 2022 By Alex Keown

JPM Series Graphic 3

Despite all of the advances made in treating different cancers over the past several years, there is still significant room for improvement in oncology.

That’s the thinking of the leadership team at Connecticut-based Cybrexa Therapeutics who touted the potential of their novel class of tumor-targeting peptide drug conjugate (PDC) therapeutics at the annual J.P. Morgan Health Care Conference. Cybrexa Chief Executive Officer Per Hellsund told BioSpace that the company’s alphalex technology platform is designed to boost the target opportunity within cancer treatment programs.

Hellsund described the company’s approach as a way to “improve the therapeutic index.” Unlike antibody-drug conjugates (ADCs) that focus on antigens, PDCs are able to target the tumor microenvironment that has universal features across solid tumors.

Cybrexa CEO Per Hellsund_company courtesy“It provides opportunities for broad targets,” Hellsund said. “We plan to disrupt the ADC market by expanding the reach of the molecules being targeted. We can take payloads that have been proven by ADCs and expand them into new patient populations.”

The company’s lead asset is CBX-12 (alphalex-exatecan), which is in Phase I development as a potential treatment for solid tumors. CBX-12 is an alphalex conjugate that includes the highly potent topoisomerase I inhibitor exatecan. The inhibitor is in the same class as payloads used by two well-known and approved ADCs, AstraZeneca’s Enhertu and Gilead Sciences’ Trodelvy. Hellsund explained that unlike the ADCs, CBX-12 is able to target cancer cells independently of the overexpression of antigens that the ADCs target. The company believes CBX-12 has potential synergy with PD-1 inhibitors and other immuno-oncology drugs.

In October, the company released interim data for the study that showed “robust efficacy signals and tolerability” in patients who have been diagnosed with metastatic cancer. So far, the data seen from the early study is serving as a key demonstration of the company’s alphalex technology, an antigen-independent PDC tumor-targeting platform, Hellsund said.

In data released so far, one patient with ovarian cancer demonstrated a complete response to CBX-12. There has also been a partial response in one patient, and another heavily pretreated patient has achieved stable disease.

“There’s a real belief that this technology can help patients,” Hellsund said. “The clinical benefits we’ve seen, including complete response and low incidence of serious adverse effects related to CBX-12, reinforce our belief that CBX-12 could dramatically change the lives of patients who have few or no therapeutic options.”

Cybrexa has plans to investigate CBX-12 in different solid tumors, including breast, ovarian and non-small cell lung cancer. The company is on track to accelerate the development of CBX-12 and is eying multiple Phase II studies that are expected to be initiated in the second half of 2022.

“So far the data looks very promising,” Hellsund said of CBX12. “We’re very happy with what we’re seeing with proof of mechanism to date. We’re really excited about this platform and the potential to help patients.”

The Phase I study is expected to be completed later this year. Data garnered from the study will ultimately guide the future plans at Cybrexa, Hellsund noted. He added that the data generated in the study will also go a long way to validate the targeting mechanism of action of the PDC platform.

“If we can get the drug into the tumor and spare the tissue, we know it will work,” he said.

Unlike several large trials over the past two years, Hellsund said their clinical program has not been negatively impacted by COVID-19. He admits the company has been fortunate that its program has not been delayed and said he hopes that good fortune will continue as the company begins to position its two other assets, CBX15 and CBX13, for the clinic.

Coinciding with the advancement of Cybrexa’s platform is a need for additional fundraising. Chief Financial Officer Stephen Basso said the $25 million raised last year in a Series B financing round provided the company with enough funding to support operations through the end of this year. Basso said they anticipate securing additional funding that will support the launch of expansion cohorts for CBX-12 and begin clinical trials for the company’s other top candidates. Basso said they are looking at a crossover financing round of $75 million that will finance the company for another two years. He hinted that this will allow the company to broaden its investor based and eventually position it for a possible initial public offering.

The J.P. Morgan conference typically brings companies face-to-face with multiple investors. While that mode is usually preferable for both investor meetings and potential partnering opportunities, Basso and Hellsund said they are being proactive with their time setting up the necessary meetings to share the Cybrexa story.

“Our objectives are to meet new investors and we are always looking to maintain relationships with bankers and strategic partners,” Hellsund said. He added that the company is excited to share information about its technology and the possible disruption of the ADC market the company envisions.

Cybrexa Therapeutics Announces Data Demonstrating Early Signals of Efficacy and Powerful Potential of Antigen-Independent Tumor Targeting

NEW HAVEN, Conn., Oct. 26, 2021 (GLOBE NEWSWIRE) —

  • CBX-12, Cybrexa’s lead therapeutic candidate for solid tumors, demonstrates anti-tumor activity and robust efficacy signals in a heavily pretreated patient population
  • CBX-12 and IO therapeutics combination trial expected to initiate late 2022
  • Plans for accelerated approval in ovarian and NSCLC to be evaluated based on Phase 2 expansion cohorts to start in late 2022

Cybrexa Therapeutics, a clinical-stage oncology biotechnology company developing a novel class of tumor-targeting peptide drug conjugate (PDC) therapeutics, today announced favorable early Phase 1 data for its lead therapeutic candidate, CBX-12 (alphalex™-exatecan). The initial data show robust efficacy signals and tolerability in patients with metastatic cancer. These data also serve as a key demonstration of mechanism for Cybrexa’s antigen-independent PDC tumor targeting platform, alphalex™. Cybrexa intends to investigate CBX-12 in patients with breast, ovarian and non-small cell lung cancer.

“Having clear signals of efficacy at this early stage in our development program underscores the potential of our approach,” said Per Hellsund, Chief Executive Officer of Cybrexa. “The clinical benefits we’ve seen, including complete response and low incidence of serious adverse effects related to CBX-12, reinforce our belief that CBX-12 could dramatically change the lives of patients who have few or no therapeutic options.”

Of the three response-evaluable patients enrolled in the study, one patient’s disease met the criteria for a partial response at the first on-treatment assessment and became a complete response at the second assessment. Another heavily pre-treated patient who had received five previous treatment regimens, including a topoisomerase 1 inhibitor, experienced stable disease. Response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. All patients were over age 60 with stage four cancer.

In addition, on-treatment tumor biopsies confirmed delivery of drug, both as full conjugate and free exatecan, in the tumors for all patients with on-treatment biopsies.

“Based on data to date, we believe CBX-12 has the potential to be a disruptive tumor targeting platform technology in the clinic, as it is already showing clear initial signs of efficacy,” said Vishwas Paralkar, Ph.D., Chief Scientific Officer of Cybrexa.

Cybrexa is on track to accelerate the development of CBX-12 with multiple additional Phase 2 studies expected to be initiated in late 2022.

“It is exciting to see that CBX-12 is demonstrating anti-tumor activity and we are very hopeful of its continued success as we expand our dose-escalation program and look to accelerate the development of CBX-12 with multiple additional Phase 2 studies,” said Arthur DeCillis, M.D., Chief Medical Officer of Cybrexa.

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, has entered a Phase 1/2 clinical trial in patients with advanced or metastatic 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]

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

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

Cybrexa Therapeutics to Present at AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics

NEW HAVEN, Conn., Sept. 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, announced today that it will present the results of a preclinical study of CBX-12 (alphalex™-exatecan), the company’s lead therapeutic candidate for solid tumors, at the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics, taking place from October 7-10, 2021.

Cybrexa Therapeutics Associate Director of Biology Sophia Gayle will present results of a study evaluating the efficacy of CBX-12 in combination with PD-1- and CTLA4-targeted immune checkpoint inhibitors in preclinical cancer models. The presentation will be viewable beginning at 9:00AM ET on Thursday, October 7, to registered attendees of the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics.

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. In May, Cybrexa initiated a Phase 1/2 clinical trial to evaluate CBX-12 in patients with advanced or metastatic refractory solid tumors to determine its safety and tolerability, maximum tolerated doses and dose limiting toxicities, and to establish the recommended Phase 2 dose.

Additional meeting information is available on AACR’s website.

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, has entered a Phase 1/2 clinical trial in patients with advanced or metastatic 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]

Westwicke, an ICR Company
Investor Relations
Stephanie Carrington
Tel: 646-277-1282
Email: [email protected]

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

Cybrexa Therapeutics to Present Virtually at H.C. Wainwright 23rd Annual Global Investment Conference September 10, 2021 09:57 ET | Source: Cybrexa Therapeutics

NEW HAVEN, Conn., Sept. 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, announced today that management is scheduled to deliver a virtual presentation at the H.C. Wainwright 23rd Annual Global Investment Conference. The presentation will be available on demand throughout the conference from September 13-15.

Update 9/30/21: Click here to view the presentation

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, has entered a Phase 1/2 clinical trial in patients with advanced or metastatic 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]

Westwicke, an ICR Company
Investor Relations
Stephanie Carrington
Tel: 646-277-1282
Email: [email protected]

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

Cybrexa Therapeutics to Present at BTIG Virtual Biotechnology Conference 2021

NEW HAVEN, Conn., Aug. 04, 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, announced today that management is scheduled to deliver a company presentation at BTIG Virtual Biotechnology Conference 2021 on Monday, August 9th at 9:00 am ET. The team will also host one-on-one investor meetings throughout the conference.

Per Hellsund, President and CEO of Cybrexa, will provide an overview of CBX-12 (alphalex™-exatecan), the company’s lead therapeutic candidate for solid tumors, and the recently initiated Phase 1/2 trial in patients with advanced or metastatic refractory 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 expression, which could 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, has entered a Phase 1/2 clinical trial in patients with advanced or metastatic 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]

Westwicke, an ICR Company
Investor Relations
Stephanie Carrington
Tel: 646-277-1282
Email: [email protected]

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

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