Avenge Bio, Inc.

Company announces appointments of Dr. Claudio Dansky Ullmann as CMO and Ms. Karen Andreas as VP, Clinical Operations Appointments support the development of the Company’s two clinical-stage T cell engaging assets to treat solid tumors PHILADELPHIA, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing medicines for solid tumors, today announced the appointment of Claudio Dansky Ullmann, M.D. as Chief Medical Officer (“CMO”) and Karen Andreas, M.S. as Vice President, Clinical Operations. “We are thrilled to welcome Dr. Dansky Ullmann and Ms. Andreas to our team at this exciting time as the Company advances its product candidates, CTIM-76 and CT-95, into Phase 1 clinical trials,” said Martin Lehr, CEO of Context. “Dr. Dansky Ullmann and Ms. Andreas are industry veterans with deep expertise in oncology and T cell therapies, and a proven track record of advancing programs through clinical development.” Dr. Dansky Ullmann brings over 30 years of experience in early and late-stage oncology therapeutics development. Most recently, he was the CMO at Avenge Bio, where Dr. Dansky Ullmann guided the clinical advancement of AVB-001 allogeneic cell therapy for ovarian cancer. Prior to Avenge, Dr. Dansky Ullmann was CMO at MaxCyte where he was responsible for the development of the CARMA™ chimeric antigen receptor (CAR) therapy program, including MCY-M11, a mesothelin-targeting CAR therapy. Previously, he was the Senior Vice President, Head of Clinical Development at Infinity Pharmaceuticals, where he led the development of Copiktra® through FDA approval and eganelisib through first in human studies. Earlier, he was Global Clinical Lead in the Oncology Therapy Area Unit at Takeda Pharmaceuticals. Before, Dr. Dansky Ullmann was a Senior Investigator in the Cancer Therapy Evaluation Program at the National Cancer Institute, where he was involved in the strategic development of novel agents through Phase 1-3 clinical trials. Dr. Dansky Ullmann earned his M.D. at the School of Medicine, Universidad de Buenos Aires and completed his medical oncology training at Guemes Private Hospital, Buenos Aires. “I am excited to join the leadership team at Context, which is focused on building an innovative portfolio of clinical stage T cell engaging bispecific therapeutics,” said Dr. Dansky Ullmann. “I look forward to contributing to the team to help bring potential best-in-class and first-in-class treatments to patients in need.” Ms. Andreas’ biopharma career spans almost 20 years in multiple cross-functional roles across the drug development process, maintaining a primary focus in oncology at small to midsize companies. Prior to joining Context, Ms. Andreas was Vice President, Clinical Operations at Avenge Bio where she was responsible for oversight of all clinical trial activities, clinical operations strategy, planning, and execution for a first in human allogeneic cell therapy for ovarian cancer. Previously, at Boston Pharmaceuticals, Ms. Andreas led clinical operations and program management for zeteletinib through proof of concept and other oncology assets through early development. Ms. Andreas also spent 10 years with Merrimack Pharmaceuticals in various roles advancing multiple oncology and immunology-focused assets and three years at ArQule advancing the company's first early-stage studies. Ms. Andreas holds a bachelor’s degree in biology from Colby College and a Master of Science from Tufts University School of Medicine. Ms. Andreas stated, “I look forward to working with the entire Context team and utilizing my clinical operations background to support the advancement of the Company’s two clinical stage assets, CTIM-76 and CT-95.” Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) In connection with the employment of Dr. Dansky Ullmann, the Company will grant a non-qualified stock option award in an amount of 202,170 shares of the Company's common stock as an inducement material to him accepting employment with the Company. Such stock option will have an exercise price equal to the closing price of the Company’s common stock as reported by Nasdaq as of the close of market on August 1, 2024, which will be the date of grant. The Company also hired an additional employee on August 1, 2024 and anticipates two additional hires starting on August 12, 2024. These employees will be granted non-qualified stock option awards in an aggregate amount of 115,237 shares of the Company's common stock as an inducement material to each of them accepting employment with the Company, with an exercise price equal to the closing price of the Company’s common stock as reported on Nasdaq as of the close of market on the date of commencement of such employee’s employment. All such stock options will vest as to 25% of the shares on the first anniversary of the date of grant and in successive equal monthly installments over the subsequent three years, subject to continued employment with the Company and the terms and conditions in the stock option agreement. All such stock options are respectively granted as an inducement award pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. About Context Therapeutics®Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing medicines for solid tumors that is building an innovative portfolio of clinical-stage T cell engaging bispecific therapeutics. Product candidates include CTIM-76, a Claudin 6 x CD3 bispecific antibody, and CT-95, a mesothelin x CD3 bispecific antibody. Context is headquartered in Philadelphia. For more information, please visit www.contexttherapeutics.com or follow the Company on X (formerly Twitter) and LinkedIn. Forward-looking StatementsThis press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “look forward,” “plan,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) the ability of the new appointments to support the Company and the advancement of its product candidates; (ii) the potential benefits, characteristics, safety and side effect profile of our product candidates, (iii) the ability of our product candidates to have benefits, characteristics, manufacturability, and a side effect profile that is differentiated and/or better than third party product candidates, (iv) the likelihood data will support future development of our product candidates, and (v) the likelihood of obtaining regulatory approval for our product candidates. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we therefore cannot assure you that our plans, intentions, expectations, or strategies will be attained or achieved. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise. Investor Relations Contact:Jennifer Minai-AzaryContext TherapeuticsIR@contexttherapeutics.com

NATICK, Mass. and QUINCY, Mass., Nov. 20, 2023 /PRNewswire/ -- Avenge Bio, Inc. ("Avenge" or the "Company"), a biotechnology company developing the LOCOcyte™ Immunotherapy platform for the precision administration of potent immune effector molecules to treat solid tumors, today announced Michael Heffernan, Founder and Chief Executive Officer, will present at the Piper Sandler 35th Annual Healthcare Conference in New York. In September 2023, Avenge Bio received FDA Fast Track designation for AVB-001. AVB-001 is an encapsulated cell product engineered to produce native human interleukin-2 (hIL-2) and is delivered intraperitoneally (IP) to patients. Avenge is currently enrolling patients in a First-in-Human, Phase 1/2, multicenter clinical trial (NCT05538624) designed to evaluate the safety and efficacy of AVB-001. The Company has advanced through multiple dose levels in a dose escalation cohort and expects to initiate a Phase 2 dose expansion trial in 1H 2024. Presentation Details: Date: Tuesday, November 28, 2023 Location: The Lotte New York Palace | Harlem Track | Kennedy 2, 4th Floor Time: 10:30-10:50 AM ET About LOCOcyte™ Platform Our LOCOcyte™ allogeneic cell-based immunotherapy platform enables potent localized modulation of the immune system which also precipitates a systemic immune response, allowing us to treat previously intractable cancers. The technology leverage three unique advantages: Potent immune effector molecules are generated by synthetically engineering allogeneic cells creating a ready-to-use therapy, Therapy is localized in proximity to the primary tumor site and generates innate and adaptive immune response, and The immunomodulator trains the patient's immune system generating a robust immune response that seeks and eradicates distal metastasis without systemic toxicity. About Avenge Bio Avenge Bio, Inc. ("Avenge") is an oncology-focused biotechnology company developing transformative cell-based immunotherapeutic products for the treatment of intractable solid tumors by incorporating its LOCOcyte™ platform. The LOCOcyte™ platform leverages proprietary engineered cells delivered to the local tumor environment that generate high concentrations of immune effector molecules in proximity to the tumor. This initiates a robust, local, and durable systemic immune response while avoiding toxicities associated with systemic immunotherapies. Avenge's most advanced product candidate, AVB-001, produces native IL-2 immunotherapy and is initially being studied in metastatic peritoneal cancers such as ovarian cancer. Avenge has additional pipeline candidates for the treatment of a wide range of cancers including pancreatic, lung and breast cancers. Avenge was founded in 2019 base upon technology developed in the laboratory of Omid Veiseh, Ph.D. and has an exclusive license from Rice University for this technology. To learn more about Avenge visit: and follow us on LinkedIn , X, or Instagram. SOURCE Avenge Bio, Inc.

NATICK, Mass. and QUINCY, Mass., Oct. 24, 2023 /PRNewswire/ -- Avenge Bio, Inc. ("Avenge" or the "Company"), a biotechnology company developing the LOCOcyte™ Immunotherapy platform for the precision administration of potent immune effector molecules to treat solid tumors, today announced their poster presentation at the Society of Immunotherapy of Cancer 38th Annual Meeting (SITC 2023) on November 1-5, 2023, in San Diego, California. In September 2023, Avenge Bio received FDA Fast Tack designation for AVB-001. AVB-001 is an encapsulated cell product engineered to produce native human interleukin-2 (hIL-2) and is delivered intraperitoneally (IP) to patients. Avenge is currently enrolling patients in a First-in-Human, Phase 1/2, multicenter clinical trial (NCT05538624) designed to evaluate the safety and efficacy of AVB-001. The Company has advanced through multiple dose levels in a dose escalation cohort and expects to initiate a Phase 2 dose expansion trial in 1H 2024. Abstract #: 1045 Poster Title: Overcoming immunosuppressive tumors by stimulating the adaptive and innate immune systems Presenting Author: Guillaume Carmona, PhD Location: Exhibit Halls A and B1 Date: Friday, November 3, 2023 Time: 9:00 AM-7:00 PM PDT The poster will present how a single administration of either AVB-001 or AVB-002, engineered to produce native human IL-2 or native human IL-12 respectively, demonstrated complete responses as monotherapy and provided sustained eradication in various mouse tumor models. In addition, the poster will also present the commonalities and differences between AVB-001 and AVB-002 in modulating the innate and adaptive anti-tumor immune response. The poster will be available on the Presentations and Publications section of following the conference. About LOCOcyte™ Platform Our LOCOcyteTM allogeneic cell-based immunotherapy platform enables potent localized modulation of the immune system which also precipitates a systemic immune response, allowing us to treat previously intractable cancers. The technology leverages three unique advantages: (1) Potent immune effector molecules are generated by synthetically engineering allogeneic cells creating a ready-to-use therapy, (2) Therapy is localized in proximity to the primary tumor site and generates innate and adaptive immune response, and (3) The immunomodulator trains the patient's immune system generating a robust immune response that seeks and eradicates distal metastasis without systemic toxicity. About Avenge Bio Avenge Bio, Inc. ("Avenge") is an oncology-focused biotechnology company developing transformative cell-based immunotherapeutic products for the treatment of intractable solid tumors by incorporating its LOCOcyte™ platform. The LOCOcyte™ platform leverages proprietary engineered cells delivered to the local tumor environment that generate high concentrations of immune effector molecules in proximity to the tumor. This initiates a robust, local, and durable systemic immune response while avoiding toxicities associated with systemic immunotherapies. Avenge's most advanced product candidate, AVB-001, produces native IL-2 immunotherapy and is initially being studied in metastatic peritoneal cancers such as ovarian cancer. Avenge has additional pipeline candidates for the treatment of a wide range of cancers including pancreatic, lung and breast cancers. Avenge was founded in 2019 base upon technology developed in the laboratory of Omid Veiseh, Ph.D. and has an exclusive license from Rice University for this technology. To learn more about Avenge visit: and follow us on LinkedIn , X, or Instagram. SOURCE Avenge Bio, Inc.