NIH Awards Bound Therapeutics LLC $300,000 in Grant Funding

On June 13, 2023 Bound Therapeutics reported the US National Cancer Institute has awarded Bound Therapeutics LLC a Small Business Technology Transfer grant starting 15 June for $300,000 to develop "microRNA-21 Blockade of Triple Negative Breast Cancer" (Press release, Bound Therapeutics, JUN 13, 2019, View Source [SID1234637827]).

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"Triple negative breast cancer strikes younger women, tragically killing half the patients within 4 years," said Dr. Yuan-Yuan Jin, Chief Operating Officer of Bound Therapeutics LLC. "Surgery, chemotherapy, and radiation are the current standard of care for triple negative breast cancer."

"To provide effective molecular therapy that will keep patients alive with a good quality of life, we have designed a cancer cell-targeted drug that will block a tiny strand of ribonucleic acid, called microRNA-21," explained Dr. Eric Wickstrom, Professor of Biochemistry and Molecular Biology at Thomas Jefferson University, a partner in the award.

Dr. Miguel Castro, President and CEO of Bio-Synthesis Inc., another research partner, said that "The RNA analogs and peptide analogs that we are making to treat triple negative breast cancer cells are extraordinarily specific and safe in mammalian models."

Our clinical collaborator, Dr. Edith Mitchell, Clinical Professor of Medicine and Medical Oncology at Thomas Jefferson University, commented that "Patients with triple negative disease have limited treatment options compared to patients with more common forms of breast cancer. There is an urgent need for targeted treatments in this area." Dr. Mitchell serves as the Director of the Jefferson Center to Eliminate Cancer Disparities in diagnosis, treatment, and survival of patients with different ancestries, and is a past President of the National Medical Association.

GT BIOPHARMA GTB-1550

On June 13, 2019 GT Biopharma, Inc. (OTCQB: GTBP) (GTBP.PA) an immuno-oncology company reported that developing GTB-1550, a novel multi-target bispecific drug conjugate therapy for the treatment of chemotherapy-refractory B-cell malignancies (Press release, GT Biopharma , JUN 13, 2019, View Source [SID1234539511]).

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Today, Bloomberg discussed antibody-drug conjugates (ADC) as effective cancer therapies having the potential to replace traditional chemotherapy. ADCs are essentially a "trojan horse" therapeutics which have several advantages over traditional chemotherapy including less toxicity and higher efficacy due to a more precise targeting of cancer cells compared to non-cancer cells.

An ADC is composed of an antibody which specifically identifies cancer cells and a cytotoxic agent (the payload) which has been grafted onto the antibody. When injected into patients, the ADC traffics through the patient’s body to find the targeted cancer cells. Upon binding to the cancer cell, the ADC is internalized by the cancer cell, and the cytotoxic payload kills the cancer cell.

Anthony Cataldo (CEO GT Biopharma, Inc.) said, "The Bloomberg article points out the excitement that big pharma is now realizing as the potential for ADC’s as a realistic alternative to Chemo Therapies. What differentiates our ADC Bispecific GTB-1550, is the ability for our drug to hit multiple target sites of B-cell malignancies as opposed to the one target ADC’s represented in the Bloomberg article. We are happy to see the attention of the large pharmaceuticals moving in this direction."

GTB-1550 is a novel, multi-target bispecific cytotoxic therapeutic agent consisting of diphtheria toxin and bispecific single-chain variable fragments (scFV) of antibodies targeting human CD19 and CD22. By simultaneously targeting cancer cells that express either CD19 or CD22 or both, GTB-1550 is capable of killing a broader variety of hematological malignancies than either a traditional a CD19 antibody drug conjugate or a CD19 CAR-T immunotherapy which are only able to target and attack CD19 expressing hematological malignancies. Simultaneously targeting multiple cancer targets such as CD19 and CD22 using a single therapeutic agent potentially makes GT Biopharma’s multi-target bispecific drug conjugate therapy the next generation of advanced cancer therapies.

To date, GTB-1550 has completed one dose escalation Phase I-II expansion clinical trial, and one fixed dose Phase I-II expansion clinical trial which collectively enrolled a combined 43 patients.

Top-line Consolidated Results:

Two patients exhibited a Complete Remission (CR) with one patient currently disease-free at 50 months post treatment.
Five patients exhibited Stable Disease (SD) with the longest response lasting 12 months post treatment.
Two patients with transformed lymphoma showed transient tumor shrinkage, however, therapy was discontinued due to dose-limiting toxicities after the 1st cycle.
Greater than 50% of evaluable patients receiving 60 mg/kg dose had positive clinical response defined as stable disease, partial remission, or complete remission.

I-Mab Announces IND Approval for Its Proprietary TJC4, A Potentially Differentiated CD47 Antibody, to Initiate Clinical Trials in China

On June 13, 2019 I-Mab Biopharma ("I-Mab"), a clinical stage biotech company exclusively focusing on discovery and development of innovative biologics in immuno-oncology and autoimmune diseases, reported that the National Medical Products Administration (NMPA) has approved its investigational new drug (IND) application for TJC4, a differentiated fully human CD47 monoclonal antibody internally developed for the treatment of advanced malignant tumors (Press release, I-Mab Biopharma, JUN 13, 2019, View Source [SID1234537516]). Previously on June 24, 2019, I-Mab announced the first patient dosing of TJC4 in a phase I clinical study in the US.

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As a pivotal drug candidate from I-Mab’s innovative pipeline, TJC4 is a potential global best-in-class CD47 Monoclonal Antibody. Unlike other known CD47 antibodies under development, it binds to a unique epitope on CD47 that leads to minimal red blood cell binding, resulting in neither hemagglutination in vitro nor anemia in cynomolgus monkeys in toxicological studies.

"We are delighted to receive the IND clearance of TJC4 from the NMPA to start clinical studies in China. This is another significant progress after we initiated the phase 1 study in the United States," Expressed by Dr. Joan Shen, Head of R&D at I-Mab, "By design and from the pre-clinical data, we believe TJC4 has the great potential to become a best-in-class agent treating cancer patients worldwide."

About CD47 and TJC4
CD47 is a glycoprotein over-expressed in a wide variety of cancers and delivers a "don’t eat me" signal to tumor-engulfing macrophage through its ligand known as SIRPα. Blockade of CD47 by TJC4 enables macrophage to engulf cancer cells as a potential treatment option for cancers. TJC4 also known as TJ011133 is a differentiated CD47 monoclonal antibody and designed to minimize inherent binding to normal red blood cells by this class of monoclonal antibodies yet preserve its strong anti-tumor activities. TJC4 recognizes a unique epitope on CD47 and exhibits a minimal binding to red blood cells. The hematologic safety advantage of TJC4 has been demonstrated in a series of robust pre-clinical and toxicological studies including those in cynomolgus monkeys, while it maintains superb anti-tumor activities.

Savara to Present at the JMP Securities Life Sciences Conference

On June 13, 2019 Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, reported that the Company’s Chief Executive Officer, Rob Neville, and Chief Operating Officer, Taneli Jouhikainen, will present at the JMP Securities Life Sciences Conference on Wednesday, June 19, 2019 at 11:30 a.m. Eastern Time / 8:30 a.m. Pacific Time in the Fontainebleau room, The St. Regis, New York (Press release, Savara, JUN 13, 2019, View Source [SID1234537090]).

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Interested parties can access a live audio webcast on the Investors page of the Savara website at www.savarapharma.com/investors/events-presentations/. Please connect to the Company’s website at least 15 minutes prior to the start of the presentation to ensure sufficient time for any software download that may be required for the webcast. An archived presentation will be available on Savara’s website for 30 days.

Unum Therapeutics Strengthens and Expands Leadership Team

On June 13, 2019 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of cellular immunotherapies to treat cancer based on its novel T cell technology platforms, reported new additions to its leadership team. Matthew Osborne will be joining as Chief Financial Officer, effective June 24, 2019 (Press release, Unum Therapeutics, JUN 13, 2019, View Source [SID1234537075]). Jessica Sachs, M.D., will become Chief Medical Officer, effective July 15, 2019, replacing Michael Vasconcelles, M.D., who is transitioning to a clinical advisory role and departing the company . Mert Aktar has been appointed to the newly created role of Head of Business and Corporate Development. Each new executive has a proven track record of excellence and adds decades of experience to the Unum leadership team.

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"We are excited to welcome Matt, Jessica, and Mert to the leadership team at Unum. They each bring deep experience to their respective functions, and their contributions will be important to our work building our pipeline of engineered T cell therapies across a broad range of cancers," said Chuck Wilson, President and Chief Executive Officer of Unum. "I would also like to thank Mike Vasconcelles for his enormous contributions at Unum over the last several years, and I look forward to continuing to work with him as he transitions into an advisory role."

"I’ve supported many companies throughout my career helping to bring innovative and transformative new therapies to patients, and am excited about Unum’s cutting-edge T cell therapy platforms, ACTR and BOXR, with potential best-in-class product profiles in lymphoma and myeloma, and expanding these platforms in solid tumors," said Mr. Osborne. "I look forward to joining the talented leadership team at Unum and working together to make a difference in the lives of patients with cancer."

Mr. Osborne joins Unum with over 20 years of biotechnology capital markets and corporate industry experience from past roles as an equity research analyst on Wall Street and as a highly-respected corporate communications and investor relations professional in the biotechnology industry. Most recently, he was vice president of corporate affairs, communications and investor relations at Voyager Therapeutics, and he also served as global head of investor relations at Shire plc (now Takeda) during its acquisitions of Baxalta Inc. and Dyax Corp., vice president of corporate communications and investor relations at Synageva BioPharma from its public inception through its acquisition by Alexion Pharmaceuticals, and investor relations at Vertex Pharmaceuticals as part of an Institutional Investor highly-ranked investor relations team. On Wall Street as a biotechnology sell-side analyst, he covered small-to-large cap biotechnology companies at Lazard Capital Markets and Leerink Swann (now SVB Leerink) analyzing the development of several blockbuster drugs across multiple therapeutic areas. Mr. Osborne received a B.S. in Biology from Syracuse University and M.B.A. from the D’Amore-McKim School of Business at Northeastern University.

Dr. Sachs has over 16 years of experience in oncology and pediatrics, including a decade in industry. She has been serving as Vice President of Clinical Sciences at Unum since 2017, where she has been responsible for the clinical development strategy and medical and translational oversight of the Unum portfolio. Prior to joining Unum, Dr. Sachs spent several years at Takeda/Millennium where she led multiple clinical programs in oncology and transplantation, and at Genzyme Corporation, where she was responsible for post-marketing safety surveillance and risk management activities for a variety of oncology products. Dr. Sachs has been a faculty member of the Harvard Medical School since 2007 and is an Assistant in Pediatrics in the Division of Pediatric Hematology/Oncology at the Massachusetts General Hospital. She completed her fellowship in pediatric hematology and oncology at the Dana Farber Cancer Institute and Children’s Hospital Boston. She received her M.D. from Washington University in St. Louis and her B.S. from Duke University.

Mr. Aktar has 19 years of multinational experience in pharmaceuticals and biotechnology, including leadership roles in business development and technical operations. He joins Unum from Shire plc (now Takeda) where he most recently served as global head of hematology and immunology business development. While at Shire, Mr. Aktar led a team responsible for identification, evaluation and execution of global business development opportunities and facilitated the company’s acquisitions of Baxalta Inc. and Dyax Corp. Prior to Shire, Mr. Aktar held positions of increasing responsibility at Biogen, ensuring clinical and commercial supply of biologics across diverse therapeutic areas. Mr. Aktar received a B.S. in Chemical Engineering from Worcester Polytechnic Institute, M.S. in Engineering Management from Tufts University, and M.B.A. from the Massachusetts Institute of Technology Sloan School of Management.