Tizona Therapeutics, Inc.

The top-line data also saw statistically significant and clinically meaningful improvement in overall survival (OS). Credit: Shutterstock / NMK-Studio. Pfizer ’s metastatic colorectal cancer (mCRC) combination therapy has met one of the primary endpoints of improving progression-free survival (PFS) in a Phase III trial, further supporting a full approval. The company’s active-controlled, open-label BREAKWATER trial (NCT05217446) evaluating a combination of Pfizer’s Braftovi (encorafenib), Eli Lilly’s Erbitux (cetuximab) and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) met one of its dual primary endpoints, improving PFS. The trial investigated the combination in mCRC patients living with a BRAF V600E mutation who are treatment-naive. The top-line data also saw statistically significant and clinically meaningful improvement in overall survival (OS). Additionally, the company has added that no new safety signals have been observed. In December 2024, the US Food and Drug Administration (FDA) granted accelerated approval to the combination therapy of Braftovi, Erbitux and mFOLFOX6. Although it is waiting on full analysis of the final results, Pfizer intends to present its findings in a meeting with the FDA to support full approval. Speaking ahead of World Cancer Day on 4 February, Pfizer’s chief oncology officer Roger Dansey said: “We are extremely pleased with the clinically meaningful PFS and OS results from the BREAKWATER study, which have the potential to be practice-changing for this patient population that has historically had limited treatment options and poor outcomes. “The Braftovi regimen is emerging as a new standard of care as the first targeted therapy approved for use as early as first-line for patients with mCRC with a BRAF V600E mutation.” The multi-centre BREAKWATER trial is also the first trial to be launched under the regulatory body’s Project FrontRunner, an initiative aimed at encouraging sponsors to seek approval for drugs for patients in an earlier stage of clinical treatment. This is as opposed to seeking approval for treatments designed for patients who have already undergone several therapies or treatment options. In the BREAKWATER trial patients were randomised to receive either 300mg of Braftovi and Erbitux alone or in combination with mFOLFOX6. The active control group received mFOLFOX6, FOLFOXIRI (Folinic acid, fluorouracil, oxaliplatin and irinotecan), or CAPOX (capecitabine and oxaliplatin) with or without bevacizumab. A BRAF mutation is a form of cancer in which the BRAF gene begins to cause certain cells to continue dividing without ever receiving a signal to stop. The V600E variant is one of the more common forms of BRAF mutation with the name defining the location and nature of the condition. While some BRAF mutations are susceptible to different forms of targeted therapy, other BRAF mutations are not. Elsewhere in the treatment of mCRC, Tizona Therapeutics has expanded its ongoing Phase Ib clinical trial of TTX-080, a novel antibody targeting human leukocyte antigen-G (HLA-G), in patients with the condition. Meanwhile, Johnson & Johnson has reported a 49% overall response rate in a colorectal cancer study with RYBREVANT.

LEBANON, N.H.--( BUSINESS WIRE )--Adimab, LLC, the global leader in the discovery and engineering of fully human monoclonal and multispecific antibodies, today announced that five therapeutic products containing molecules discovered or optimized by Adimab have been approved for commercial sale. Adimab’s first partnered program to receive approval was Innovent’s TYVYT ® (sintilimab injection), which is currently marketed by Innovent and Lilly in China for seven cancer indications. Other commercial products containing molecules from Adimab include: Innovent’s SINTBILO ® (tafolecimab injection), a PCSK9 program approved in China for the treatment of adult patients with primary hypercholesterolemia and mixed dyslipidemia. IASO Bio’s FUCASO ® (equecabtagene autoleucel), a BCMA CAR-T program approved in China for the treatment of patients with multiple myeloma. Invivyd’s PEMGARDA™ (pemivibart), a SARS-CoV-2 monoclonal antibody approved for prophylactic emergency use to prevent COVID-19 infection in the United States. Checkpoint Therapeutic’s UNLOXCYT™ (cosibelimab) received BLA approval December 2024 in the United States for multiple myeloma. There are 11 additional Adimab-associated programs that are currently in Phase II or Phase III (pivotal) trials. The total number of Adimab-associated clinical programs initiated by our partners has now reached 78. "Helping our partners get new therapies on the market to treat patients has been our goal from day one," explained Ryan McGovern, Chief Financial Officer of Adimab. “Given our high number of currently-approved and late-stage programs, we made the decision in 2024 to move royalty rights on our more advanced assets into a separate business unit called Adimab Royalty Company (ARC), which provides a unique opportunity for investors interested in an advancing, diversified portfolio of royalty-bearing assets. The rapid clinical and commercial advancement of so many exciting therapies is driving the value of ARC in addition to validating our core business at Adimab, which remains focused on generating new therapeutic candidates for our partners.” “Therapeutic product development has many challenges, and it is truly meaningful when programs are approved and reach patients. Over time, we have succeeded in building a valuable, sustainable business because of our relentless focus on high-quality execution for our partners without the distraction and conflict of an internal development pipeline. Also critical to our success are our continuous investment in improving the Adimab platform, our discipline on the expense side, our highly talented and committed employees, and our supportive investor base,” said Philip T. Chase, Chief Executive Officer of Adimab. “We have been a reliable collaborator since 2009 and those looking to discover protein-based therapeutics know that we will continue to be a dependable resource for years to come.” Adimab partners have exercised more than 115 commercial licenses to option rights to advance programs into clinical development. In 2024, 11 partners exercised commercial options including BMS, NextPoint, Regeneron, REGiMMUNE, SixPeaks Bio, Santa Ana Bio, Triveni Bio, and Werewolf, among others. Technologies Antibody Discovery: Adimab discovers therapeutic antibodies in IgG and VHH formats through our proprietary yeast-based technology. Adimab can utilize its fully human synthetic diversity as well as additional diversities from in vivo sources. Antibodies from Adimab have exquisite specificity and are utilized in a variety of modalities, including monoclonal and multispecific formats, CAR-Ts, ADCs, etc. Engineering: Adimab has developed and refined its engineering capabilities over thousands of lead antibody optimization efforts. The process starts with one or more partner-selected lead antibodies with the goal of optimizing potency, specificity, and/or developability. In addition to Adimab-discovered antibodies, engineered antibodies can originate from outside sources, typically to fix undesirable properties of antibodies from in vivo and phage-based technologies. Adimab also applies its engineering expertise to cytokines, TCRs, and other proteins. Multispecifics: Adimab has extensive bispecific and multispecific know-how and capabilities, including proprietary solutions for both Fc (HC:HC) and Fab (HC:LC) heterodimerization, to allow for the generation of numerous bispecific and multispecific product designs with excellent developability properties. Additionally, Adimab can perform common light chain and fragment-based discovery and engineering necessary for certain partner-desired formats. T Cell Engagers: Adimab has a highly characterized suite of functional and diverse CD3 (both IgG and VHH binders) and CD28 antibodies to generate bi- and multi-specific T cell engagers. Adimab has partnered this program non-exclusively with more than 25 partners, to date. Complex Targets: Certain membrane-obligate proteins (e.g., GPCRs and ion channels) are often poorly behaved outside their native membrane environment. For these targets, Adimab has developed proprietary in vitro and in vivo discovery workflows that rely solely on the target being expressed in its native membrane and without the need for antigen mimetics. The company has employed these workflows numerous times to generate robust panels of functional and specific antibodies to these classically difficult targets, which are then further extensively engineered with our yeast platform. About Adimab Adimab is the leading provider of therapeutic antibody discovery and engineering technologies. This includes naïve discovery from synthetic libraries in yeast or B cells (mice and humans), antibody engineering and optimization, multispecific antibody engineering, and a portfolio of proprietary CD3 and CD28 antibodies licensed non-exclusively for bispecific applications. Adimab focuses solely on its partners and not on developing an internal product pipeline. Since 2009, Adimab has partnered with over 130 pharmaceutical and biotechnology companies, generating more than 600 therapeutic programs, over 75 clinical programs, and multiple approved products. The Adimab technology has been transferred and implemented at Biogen, GSK, Lilly, Merck, Novo Nordisk, and Takeda. Funded discovery partners include leading pharmaceutical companies, such as Alnylam, Bristol Myers Squibb, Novartis, Regeneron, Vertex and others. Adimab has also partnered with many early-stage venture-backed companies, including Dragonfly, NextPoint, Santa Ana Bio, Tizona, TRex Bio and others, as well as mid-size public biopharmaceutical companies such as Alector, Cullinan Therapeutics, Innovent, iTeos, Mersana, Scholar Rock, and others. Adimab’s integrated antibody discovery and engineering platform provides unprecedented speed from antigen to purified, full-length human IgGs. Adimab offers fundamental advantages by delivering diverse panels of therapeutically relevant antibodies that meet the most demanding standards for affinity, epitope coverage, species cross-reactivity, and developability. Adimab enables its partners to rapidly expand their biologics pipelines through a broad spectrum of technology access arrangements. For more information, visit http://www.adimab.com .

LEBANON, N.H.--( BUSINESS WIRE )--Adimab, LLC, the global leader in the discovery and engineering of fully human monoclonal and multispecific antibodies, today announced that it entered into partnership agreements with 17 new companies in 2024. In addition, Adimab announced the expansion of eight of its current partnerships and the achievement of 51 technical and development milestones across numerous collaborations. Adimab has partnered with over 130 companies to discover therapeutic programs, to date. New alliances for 2024 include collaborations with Candid Therapeutics, Champlain Bio, GV.M1, Helicore Biopharma, Incendia Therapeutics, Inc., Leyden Labs, Remunix, Sedare Biosciences, Inc., Stipple Bio, Meiji Seika Pharma and Treeline Biosciences, among others. In addition, Adimab expanded its collaborations with eight partners, including Alnylam, Cullinan Therapeutics, GSK, iOmx, Novartis, Santa Ana Bio, and Werewolf. In 2024, Adimab and its partners initiated discovery on 62 new therapeutic programs, bringing the total number of royalty-bearing programs commenced to over 600. Many partners retain the contractual rights to initiate additional royalty-bearing programs with Adimab in the future. "Adimab’s platform stands out in the field of protein-based therapeutic discovery due to our unique ability to leverage a highly proprietary eukaryotic discovery system and a vast human antibody library in an IgG format, yielding exceptional specificity and developability in our output," said Guy Van Meter, Chief Business Officer of Adimab. "Across more than 600 therapeutic programs to date, no project has ever been discontinued for developability issues, which is an achievement unmatched by any other technology in the field. This reflects the unparalleled robustness and reliability of our platform." "Our competitive edge extends beyond technology; it lies in the unmatched experience of our team. At Adimab, we foster a culture where every employee is motivated by the success of our partners, which has allowed us to attract and retain some of the best talent in the industry. With the wisdom gained from hundreds and hundreds of therapeutic programs, we bring a level of expertise that ensures success in every new project. This is another reason why Adimab stands as the most successful antibody technology company in the industry — enabling our partners to bring better therapeutic programs to patients," said Philip T. Chase, Chief Executive Officer of Adimab. Technologies Antibody Discovery: Adimab discovers therapeutic antibodies in IgG and VHH formats through our proprietary yeast-based technology. Adimab can utilize its fully human synthetic diversity as well as additional diversities from in vivo sources. Antibodies from Adimab have exquisite specificity and are utilized in a variety of modalities, including monoclonal and multispecific formats, CAR-Ts, ADCs, etc. Engineering: Adimab has developed and refined its engineering capabilities over thousands of lead antibody optimization efforts. The process starts with one or more partner-selected lead antibodies with the goal of optimizing potency, specificity, and/or developability. In addition to Adimab-discovered antibodies, engineered antibodies can originate from outside sources, typically to fix undesirable properties of antibodies from in vivo and phage-based technologies. Adimab also applies its engineering expertise to cytokines, TCRs, and other proteins. Multispecifics: Adimab has extensive bispecific and multispecific know-how and capabilities, including proprietary solutions for both Fc (HC:HC) and Fab (HC:LC) heterodimerization, to allow for the generation of numerous bispecific and multispecific product designs with excellent developability properties. Additionally, Adimab can perform common light chain and fragment-based discovery and engineering necessary for certain partner-desired formats. T Cell Engagers: Adimab has a highly characterized suite of functional and diverse CD3 (both IgG and VHH binders) and CD28 antibodies to generate bi- and multi-specific T cell engagers. Adimab has partnered this program non-exclusively with more than 25 partners, to date. Complex Targets: Certain membrane-obligate proteins (e.g., GPCRs and ion channels) are often poorly behaved outside their native membrane environment. For these targets, Adimab has developed proprietary in vitro and in vivo discovery workflows that rely solely on the target being expressed in its native membrane and without the need for antigen mimetics. The company has employed these workflows numerous times to generate robust panels of functional and specific antibodies to these classically difficult targets, which are then further extensively engineered with our yeast platform. About Adimab Adimab is the leading provider of therapeutic antibody discovery and engineering technologies. This includes naïve discovery from synthetic libraries in yeast or B cells (mice and humans), antibody engineering and optimization, multispecific antibody engineering, and a portfolio of proprietary CD3 and CD28 antibodies licensed non-exclusively for bispecific applications. Adimab focuses solely on its partners and not on developing an internal product pipeline. Since 2009, Adimab has partnered with over 130 pharmaceutical and biotechnology companies, generating more than 600 therapeutic programs, over 75 clinical programs, and multiple approved products. The Adimab technology has been transferred and implemented at Biogen, GSK, Lilly, Merck, Novo Nordisk, and Takeda. Funded discovery partners include leading pharmaceutical companies, such as Alnylam, Bristol Myers Squibb, Novartis, Regeneron, Vertex and others. Adimab has also partnered with many early-stage venture-backed companies, including Dragonfly, NextPoint, Santa Ana Bio, Tizona, TRex Bio and others, as well as mid-size public biopharmaceutical companies such as Alector, Cullinan Therapeutics, Innovent, iTeos, Mersana, Scholar Rock, and others. Adimab’s integrated antibody discovery and engineering platform provides unprecedented speed from antigen to purified, full-length human IgGs. Adimab offers fundamental advantages by delivering diverse panels of therapeutically relevant antibodies that meet the most demanding standards for affinity, epitope coverage, species cross-reactivity, and developability. Adimab enables its partners to rapidly expand their biologics pipelines through a broad spectrum of technology access arrangements. For more information, visit http://www.adimab.com .