MEDICAL

Be Bio and Resilience Announce Strategic Collaboration to Manufacture Engineered B Cells, a New Class of Cellular Medicines

Be Bio | May 20, 2022

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Be Biopharma, Inc. (“Be Bio”) and National Resilience, Inc. (Resilience) today announced a strategic collaboration to advance initial programs in Be Bio’s rare disease pipeline. Be Bio’s proprietary engineered B Cell Medicines (BeCM) platform is harnessing the power of the human B cell to create a new class of autologous and allogeneic cellular medicines that durably and redosably produce therapeutic proteins in vivo without toxic pre-conditioning.

The two companies are investing to drive innovation and reliability in cell therapy manufacturing, a critical success factor for broad and meaningful patient impact. As part of this unique partnership, Resilience will dedicate personnel solely to produce and supply Good Manufacturing Practices (GMP)-grade viral vector and cell therapy drug product for the initial programs in Be Bio’s rare disease pipeline. Through a creative cost and risk-sharing model, Resilience will be responsible for manufacturing costs and receive potential future milestones and royalties.

Over the past year, Be Bio has built a strong foundation with our BeCM platform, pipeline, team, and recent $130 million financing. Manufacturing is critical to rapidly progress our BeCMs to the clinic and we have built non-GMP manufacturing capabilities in our Cambridge facility. This deal allows us to drive GMP manufacturing with an outstanding partner, and in a capital efficient manner, Resilience’s broad manufacturing capabilities, strong collaborative spirit and dedicated resources to our platform, make them an ideal partner for our BeCM programs.”

Joanne Smith-Farrell, Ph.D., Chief Executive Officer at Be Bio.

Resilience will lead clinical GMP manufacturing of both the viral vector and the cell therapy drug product for Be Bio’s initial rare disease programs to support first-in-human clinical trials. Resilience will apply its pioneering bioprocessing solutions and network of cell therapy sites, including facilities in Research Triangle Park, NC, Philadelphia, PA, Waltham, MA and Marlborough, MA to conduct the work.

This collaboration shows our excitement for the promising science of Be Bio’s proprietary BeCM platforms, and our confidence in their expertise to deliver transformative cell therapies, By working alongside Be Bio early in the drug development process, we aim to accelerate the development of their B cell medicines with the potential to unlock a pipeline of product candidates across a variety of serious diseases.”

Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience.

About B Cells – A New Class of Cellular Medicines
Imagine what could “Be?” In nature, a single B cell engrafts in the bone marrow and can produce thousands of proteins per second at constant levels over decades. B cells are nature’s exquisite medicine factories, manufacturing proteins to fight disease and maintain health. Unleashing the power of B cells is driving a new class of cellular medicines – Engineered B Cell Medicines (BeCM). BeCMs have the potential to be durable, allogeneic, redosable and administered without toxic conditioning. The promise of BeCMs could transform therapeutic biologics with broad application — across protein classes, patient populations and therapeutic areas.

About Be Biopharma
Be Biopharma (“Be Bio”) is pioneering Engineered B Cell Medicines (BeCM) to dramatically improve patients’ lives who are living with cancer, rare diseases and other serious conditions. With eyes locked on the patient, our team of purpose-driven scientists, technologists, manufacturing experts and business builders collaborate to create a bold new class of cell therapies. Be Bio was founded in October 2020 by Longwood Fund and B cell engineering pioneers David Rawlings, M.D., and Richard James, Ph.D. from Seattle Children’s Research Institute. Be Bio is backed by ARCH Venture Partners, Atlas Venture, RA Capital Management, Alta Partners, Longwood Fund, Bristol Myers Squibb and Takeda Ventures. Since our founding, Be Bio’s investors have committed over $180 million to enable the Company to re-imagine medicine based on the power of B cell therapy.

About Resilience
Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives by continuously advancing the science of biopharmaceutical manufacturing and development.

Spotlight

The digital revolution in manufacturing began with an explosion in monitoring, analytics, and new computing capabilities. Combined with advances such as artificial intelligence (AI), automation, and robotics, digital is changing manufacturing concepts such as product development, factory operations, and materials supply. This evolution also connects product and process designers and leaders in manufacturing engineering. Digital manufacturing is a reality that will change industry.

Spotlight

The digital revolution in manufacturing began with an explosion in monitoring, analytics, and new computing capabilities. Combined with advances such as artificial intelligence (AI), automation, and robotics, digital is changing manufacturing concepts such as product development, factory operations, and materials supply. This evolution also connects product and process designers and leaders in manufacturing engineering. Digital manufacturing is a reality that will change industry.

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INDUSTRIAL IMPACT

iNtRON Confirms Efficacy of CDL200 Against CDI Clinical Isolates

iNtRON Biotechnology | July 12, 2022

iNtRON Biotechnology announced that CDL200, a novel biological drug candidate under the development of the world's first enteric colon-targeted capsule formulation for the treatment of intractable and recurrent CDI confirmed the strong efficacy against clinical isolates from CDI patients. A company official explained that the antibacterial activity of CDL200 was evaluated for 20 clinical isolates from patients in Europe and Korea, and rapid lysis effect within few minutes after treatment was confirmed from all of the tested strains. In particular, even though majority of the tested strains are resistant strains to the commonly used antibiotics such as Metronidazole, Vancomycin, and Rifaximin, CDL200 showed very potent and rapid bactericidal activity. CDL200 is an endolysin-based novel biological drug candidate for the treatment of Clostridioides difficile infection, a hard-to-treat and recurrent bowel diseases. CDL200 has innovative drug properties that can eradicate bacteria much faster than the conventional antibiotics in the market, and also can be used for the infection caused by antibiotic-resistant bacteria and/or highly virulent bacteria. CDI patient population has been increasing globally and resulting in high mortality rate due to resistance to the existing antibiotics and serious complications such as toxic megacolon, sepsis, and intestinal perforation. Although there is growing interest in refractory CDI that does not respond well to primary treatment, there are only few studies on effective treatment yet. The more serious problem is the frequency of recurrent CDI is increasing, since the risk of subsequent recurrence is over 45% in patients who have had at least one recurrence. The conventional treatment based on Metronidazole and Vancomycin is not effective for CDI with severe intractability and repeating recurrence. And the recently attempted FMT (fecal microbiota transplantation), that is, the treatment of administering donor feces to the patient's intestinal tract, has advantages such as not suppressing the intestinal flora and not creating resistant strains, but the treatment brings objection to the general public and is limited in that there is a possibility that other pathogens from the donor may be transmitted. The mortality rate of CDI was about 3-4% in the past, but due to intensification of antibiotic-resistant bacteria and the emergence of highly virulent strain (NAP1/027), the recent mortality rate has been rapidly increased to over 10%, which makes global awareness growing. Dr. KANG, Sang Hyeon, CTO of iNtRON, said, "We have a number of new endolysin pipelines under the development utilizing our unique itLysin® technology for the serious infection that the development of effective therapeutic agents are urgently needed." "Based on the development experience of SAL200, we will strive to enhance the value of our rich itLysin® pipelines and will continue to secure global competitiveness in the endolysin field." Mr. YOON, Kyung Won, CEO of iNtRON About CDL200 CDL200 is a novel endolysin-based anti- Clostridioides difficile causes an infection of the large intestine which is often referred to as C. difficile or C. diff. CDL200 showed potent and rapid activity against 100% clinical isolates from multi-nation and has no disturbance of the normal flora in human's gut. The potential clinical usage and indications are CDI and IBD (Inflammatory Bowel Disease), and the targeted administration route of CDL200 is oral in capsule formulation. CDL200 is under non-clinical stage development and IND enabling studies will be conducted throughout the year. About iNtRON Biotechnology, Inc. iNtRON is a leader in bacteriophage-based technology with aim to develop and investigate into the 'Immune & Immunotherapeutics' market. While pursuing global research and business development investments since their foundation and accelerated development after entering its IPO in KOSDAQ, the company honed in on innovating BIO New Drugs by developing various 'First-in-Concept' bio-drugs and conducting clinical studies in phases. The Company is committed to development of innovative innovation in the infectious diseases and 'Immune & Immunotherapeutics' area. About iNtODEWORLD, Inc. iNtRON has established its wholly owned US subsidiary, iNtODEWORLD, Inc. in 2017. iNtODEWORLD was initially registered in Delaware and the headquarter office is currently located in Boston. iNtODEWORLD provides news, updates and platform development progresses of iNtRON to its potential global partners and collaborators along with its own R&BD works in the US.

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CELL AND GENE THERAPY

Sesen Bio and Carisma Therapeutics Announce Merger Agreement

Sesen Bio and Carisma Therapeutics | September 22, 2022

Sesen Bio, Inc. and Carisma Therapeutics Inc. a privately held, clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, announced that they have entered into a definitive merger agreement to combine the companies in an all-stock transaction. The combined company will focus on the advancement of Carisma’s proprietary cell therapy platform that utilizes engineered macrophages and monocytes to potentially transform the treatment of cancer and other serious disorders. Carisma is pioneering the development of chimeric antigen receptor macrophage therapies and is believed to be the only company developing CAR-M therapies with demonstrated proof of mechanism and safety data in clinical trials. The combined company is expected to operate under the name Carisma Therapeutics Inc. and trade on Nasdaq under the ticker symbol “CARM”. Carisma has also secured commitments from a syndicate of investors for a $30 million financing, including HealthCap, AbbVie, Wellington Partners, SymBiosis, Penn Medicine, TPG Biotech, MRL Ventures Fund, the therapeutics-focused corporate venture arm of Merck & Co., Agent Capital, Solasta, Livzon, Pictet Alternative Advisors and 4Bio, which is expected to close concurrently with the completion of the merger. With the cash expected from both companies at closing and the proceeds of the concurrent financing, the combined company is expected to have approximately $180 million in cash, cash equivalents and marketable securities. These cash resources are expected to be used to advance Carisma’s pipeline through multiple ongoing and planned key data readouts across several clinical trials and to fund operating expenses and capital expenditure requirements through 2024. The merger and related financing are expected to close in the next three to four months. “The proposed merger represents an exciting opportunity for shareholders of each company, and we believe it gets us one step closer to our goal of revolutionizing the field of immunotherapy. This transaction will provide us with financial strength to not only continue to develop our lead candidate CT-0508, but also allow us to accelerate the growth of our platform and pipeline within and outside of oncology and develop additional strong strategic partnerships beyond those we already have with Moderna and Novartis. Carisma is focused on delivering cutting-edge technology for patients in a way that has never been done before, and we look forward to advancing this important mission.” Steven Kelly, President and Chief Executive Officer of Carisma “This transaction represents the result of a thoughtful and careful review of strategic alternatives over the past four months, during which Carisma’s clinical programs, management team, and corporate strategy stood out amongst the 42 bids reviewed,” said Dr. Thomas Cannell, President and Chief Executive Officer of Sesen Bio. “Carisma is an exciting clinical-stage company with groundbreaking science and an impressive management team, which we believe makes them the optimal partner to provide value for our shareholders. Our mission at Sesen Bio has always been to save and improve the lives of patients with cancer, and we believe Carisma has the science and the unwavering patient focus required to make that mission a reality.” About the Proposed Merger Pre-merger Sesen Bio stockholders are expected to own approximately 41.7% and pre-merger Carisma stockholders are expected to own approximately 58.3% of the combined company, in each case before giving effect to the concurrent financing described above and the conversion of the outstanding Moderna convertible note. Under the terms of the merger agreement, stockholders of Carisma will receive newly issued shares of Sesen Bio common stock pursuant to an exchange ratio formula set forth in the merger agreement. The percentage of the combined company that Sesen Bio stockholders will own upon the closing of the merger is further subject to adjustment based on the amount of Sesen Bio’s net cash at the time of closing. Immediately prior to the closing of the proposed merger, Sesen Bio stockholders of record will be issued a contingent value right (CVR) for each outstanding share of Sesen Bio common stock held by such Sesen Bio stockholder as of such date, representing the right to receive certain cash payments from proceeds received by Sesen Bio related to the Roche Asset Purchase Agreement, if any, subject to customary deductions, including for expenses and taxes. SVB Securities is acting as exclusive financial advisor to Sesen Bio for the transaction and Hogan Lovells US LLP is serving as its legal counsel. Evercore Group LLC is serving as lead financial advisor to Carisma for the transaction and BofA Securities, Inc. is also serving as financial advisor to Carisma for the transaction. Wilmer Cutler Pickering Hale and Dorr LLP is serving as legal counsel to Carisma. BofA Securities, Inc. and Evercore Group L.L.C. are serving as co-placement agents for Carisma’s concurrent financing and Shearman & Sterling LLP is serving as the placement agents’ legal counsel. About Sesen Bio Sesen Bio, Inc. is a late-stage clinical company focused on targeted fusion protein therapeutics for the treatment of patients with cancer. Sesen Bio’s most advanced product candidate, Vicineum™, also known as VB4-845, is a locally-administered targeted fusion protein composed of an anti-epithelial cell adhesion molecule antibody fragment tethered to a truncated form of Pseudomonas exotoxin A for the treatment of non-muscle invasive bladder cancer. On July 15, 2022, Sesen Bio made the strategic decision to voluntarily pause further development of Vicineum in the US. The decision was based on a thorough reassessment of Vicineum, which included the incremental development timeline and associated costs for an additional Phase 3 clinical trial, following Sesen Bio’s discussions with the United States Food and Drug Administration. Sesen Bio has turned its primary focus to assessing potential strategic alternatives with the goal of maximizing shareholder value. Additionally, Sesen Bio intends to seek a partner for the further development of Vicineum. About Carisma Therapeutics Carisma Therapeutics Inc. is a biopharmaceutical company dedicated to developing a differentiated and proprietary cell therapy platform focused on engineered macrophages, cells that play a crucial role in both the innate and adaptive immune response. The first applications of the platform, developed in collaboration with the University of Pennsylvania*, are autologous chimeric antigen receptor (CAR)-macrophages for the treatment of solid tumors. Carisma Therapeutics is headquartered in Philadelphia, PA.

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INDUSTRIAL IMPACT

SIGA Announces Oncology Collaboration with KaliVir Immunotherapeutics

SIGA Technologies Inc. | July 16, 2022

SIGA Technologies, Inc. a commercial-stage pharmaceutical company focused on the health security market, today announced a collaboration with KaliVir Immunotherapeutics to make TPOXX® available for use with KaliVir’s proprietary oncolytic vaccinia immunotherapy platform. This novel oncolytic platform includes multiple proprietary genetic modifications that can be combined to generate a unique oncolytic virus that has been optimized for systemic delivery and anti-tumor immune stimulation. Under this partnership, SIGA is providing its TPOXX oral capsules to support future clinical programs. “KaliVir is an innovator in the creation of oncolytic viral immunotherapies, and we are excited to enter into this collaboration with them. TPOXX is a powerful antiviral drug to vaccinia and allows the safe use of higher doses of vaccinia vectors; there is also the potential it could increase immunotherapeutic outcomes. This collaboration helps bring new levels of assurance to physicians, regulators, and especially patients receiving these promising investigational therapies.” Dr. Phil Gomez, CEO of SIGA “We are pleased to announce this collaboration with SIGA Technologies,” said Helena Chaye, Ph.D., J.D., CEO of KaliVir. “Pairing oncolytic immunotherapies with an effective antiviral agent is a critical part of the development of new treatments, and we look forward to enhancing our groundbreaking oncolytic immunotherapy programs with the support of SIGA’s TPOXX.” On July 13, 2018, the U.S. Food and Drug Administration (FDA) approved oral TPOXX for the treatment of smallpox to mitigate the impact of a potential outbreak or bioterror attack. In preclinical studies, TPOXX has been shown to be active against most orthopoxviruses, including vaccinia The unique mechanism of action of TPOXX coupled with published efficacy in animal studies, make it an important addition to development programs focused on vaccinia-based cancer therapies. In 2020, SIGA entered into numerous collaborations, including a partnership with Turnstone Biologics to supply TPOXX to support Turnstone’s clinical oncolytic vaccinia immunotherapy programs. In 2021, SIGA entered into a preclinical research collaboration with Bioarchitech to investigate TPOXX enabling higher doses of vaccinia vectors when used in combination with Bioarchitech’s oncolytic vaccinia-based immunotherapy platform. ABOUT SIGA TECHNOLOGIES, INC. and TPOXX® SIGA Technologies, Inc. is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies for emerging infectious diseases, and health preparedness. Our lead product is TPOXX®, also known as tecovirimat and ST-246®, an orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. TPOXX is a novel small-molecule drug and the US maintains a supply of TPOXX under Project BioShield. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox in 2018. The full label is available by clicking here. Oral tecovirimat received approval from the European Medicines Agency (EMA) in 2022. The EMA approval includes labeling for oral tecovirimat indicating its use for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox. The full label is available by clicking here. In September 2018, SIGA signed a contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, for additional procurement and development related to both oral and intravenous formulations of TPOXX. ABOUT KALIVIR IMMUNOTHERAPEUTICS. KaliVir Immunotherapeutics is a privately held biotech company developing cutting-edge, next-generation oncolytic viral immunotherapy programs. The company has developed a unique vaccinia virus-based platform that can generate potent novel oncolytic vaccinia viruses with modifications to maximize viral replication and to enhance intravenous delivery and spread (Vaccinia Enhanced Template “VET” Platform). VET™ platform utilizes the large transgene capacity of the vaccinia virus to deliver therapeutics matched to tumor immunophenotypes to stimulate patients’ immune systems and modify the tumor microenvironment. KaliVir’s oncolytic product candidates are designed to be safe, potent and systemically deliverable to treat cancer patients across multiple tumor types. KaliVir is in the process of advancing multiple therapeutic candidates toward the clinic.

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