Advanced Sarcoma

LEXINGTON, Mass.--( BUSINESS WIRE )--Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in developing novel immunological agents to treat various cancers, presented data today at the European Society for Medical Oncology (ESMO) Congress held in Barcelona, Spain. The data from a Phase 1 study of botensilimab (BOT), an investigational Fc-enhanced CTLA-4 inhibitor, in combination with balstilimab (BAL), an investigational PD-1 antibody, showed clinical activity in patients with refractory sarcomas, a population with limited treatment options. "The continued activity with additional patients and longer follow-up of BOT/BAL in this study reinforces it's potential as an important treatment option for patients with sarcomas," said Dr. Breelyn A Wilky, University of Colorado Cancer Center. "The deep and durable responses we are observing, particularly in late line patients with poorly immunogenic or ‘cold’ sarcomas like visceral angiosarcoma, leiomyosarcoma, and dedifferentiated liposarcoma, are significant. These findings highlight the potential of BOT/BAL to deliver extended survival and a meaningful clinical benefit for patients who previously had very limited options." Study Highlights 64 patients with relapsed/refractory sarcomas (median of 3 prior lines of therapy) were treated with 1 or 2 mg/kg BOT + 3 mg/kg BAL. 52 patients were efficacy evaluable with at least one post-baseline 6-week imaging scan. ORR and DOR reporting will be based on the unconfirmed response in this cohort. Majority of sarcoma subtypes included angiosarcoma (39%) and leiomyosarcoma (34%). Clinical Findings 23% overall response rate (ORR) was observed in the full sarcoma cohort, with a median duration of response (DOR) of 21.7 months. 12-month overall survival (OS) was 69% and the median OS was not reached. 39% ORR achieved in the angiosarcoma subtype (33% in cutaneous and 44% in visceral), with a median DOR of 21.7 months. 12-month OS was 64% and the median OS was not reached. A representative patient with visceral angiosarcoma achieved a durable response, ongoing beyond 3 years, that has been maintained off-therapy. The adverse event profile of BOT+ BAL was manageable and reversible with no new safety signals identified. "The updated sarcoma data presented at ESMO underscore the transformative potential of botensilimab and balstilimab for patients with refractory sarcomas who have exhausted other treatment options," said Dr. Steven O’Day, Chief Medical Officer at Agenus. "Seeing these metastatic sarcoma patients experience tumor reduction, with significant and durable responses is incredibly encouraging. BOT/BAL not only offers hope to patients with sarcoma but also holds promise for redefining the standard of care across other historically IO-resistant cancers." The presentation is available on the Agenus website at https://agenusbio.com/publications . About Botensilimab Botensilimab is an investigational human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 1,100 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316. About Agenus Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission is to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2023, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

The first Colors of SM artworks were unveiled at a gallery show in Indianapolis during the Mast Cell Disease Society’s MastCellCon conference earlier this month, featuring the visual representations of six patients’ stories. A new initiative from Blueprint Medicines is adding some color to the experiences of people with systemic mastocytosis (SM).SM is a rare disease in which an abundance of mast cells build up in the body, causing a range of painful inflammatory symptoms similar to those of an allergic reaction, which may in turn lead to anaphylaxis, organ damage, a reduction in bone density and other serious conditions throughout the body.Blueprint’s “Colors of SM” project was created in collaboration with the arts-focused patient support organization Twist Out Cancer. It paired up SM patients with artists who, after spending time with the patients and hearing their stories, were tasked with creating an original artwork that reflected those experiences.The idea came from a desire to find a new and powerful medium that could express the diverse stories of SM patients and “communicate that true lived experience where, unfortunately, sometimes words were not getting close to where they needed to go,” according to Fatima Scipione, Blueprint’s vice president of global patient affairs.The program was designed “to promote empowerment, to ensure that their voices were not only heard but also validated and to create a safe space where these unique stories could be shared, could be celebrated, bringing together patients, caregivers, healthcare professionals in a meaningful way,” she told Fierce Pharma Marketing in an interview.The first Colors of SM works were unveiled at a gallery show in Indianapolis during the Mast Cell Disease Society’s MastCellCon conference earlier this month, featuring the visual representations of six patients’ stories.Scipione said the program has been met with an overwhelmingly positive response from patients and physicians alike. In addition to citing viewers who have praised its message of empowerment, she also shared a testimonial from one of the patients involved, who reflected fondly on the process of telling her story to her assigned artist and said the resulting artwork brought her to tears, “because I really didn’t expect to see a work that so well captured all of the things we had discussed.”Applications are already open for SM patients hoping to participate in next year’s program, and Scipione reported that among the many individuals who have already expressed a desire to join in was a participant in this year’s edition who wants another go-round.“The feedback has been tremendous,” she said. “It’s a rare disease; many of these folks feel unseen. And so to be able to capture it in an unexpected way with art—it’s been really positive.” Blueprint is the maker of Ayvakit, a drug that was approved by the FDA in 2021 to treat advanced SM, before earning another nod last year that expanded its use to the more common “indolent” form of the disease. But Scipione said the Colors of SM program is less about advertising the drug and more about raising awareness of the disease itself and patients’ experiences.“The diagnostic journey is long, it’s frustrating, and it’s marked by feelings of being unseen and misunderstood. They often see multiple specialists—I spoke to one patient who said they had seen 72 specialists before they were diagnosed. There’s a ton of different tests that are done, and patients do face confusion and uncertainty,” she said.It can take years to reach a definitive diagnosis of SM, and even after that, per Scipione, many patients may continue to face “a lack of compassion or understanding” from their family, friends and healthcare professionals as they grapple with the physical and emotional effects of often unpredictable and debilitating symptoms, which can prevent them from participating in everyday activities.Raising awareness and improving education around SM among all of those groups, then, “is absolutely critical to hopefully get patients to an accurate diagnosis, to hopefully get them to better care,” she said. To ensure the Colors of SM artworks and the program’s overarching message reach as many people as possible, in addition to sharing the six pieces of art on a dedicated website, Scipione said Blueprint invited influencers with mast cell diseases to the gallery show and also gathered video content there to be shared via social media.Meanwhile, the company also plans to reach more doctors by bringing the art to conferences across the country, she said: “Healthcare professionals can see it, can understand the stories, and hopefully go back to their offices with a deeper understanding of the lived experience that can translate into either a shared decision-making conversation or more empowered conversation … about what is the best path forward to treat.” Scipione said initiatives like Colors of SM are a crucial complement to Blueprint’s work to develop powerful new drugs.“Our goal is, we certainly want to bring forward life-altering, lifesaving medicines with respect to mast cell disease,” she said. “Centered in that is an individual who’s living with this disease. So, our commitment beyond medicine is also to understand how we can support them, how we can provide them with the skills, the courage and the knowledge to navigate to a diagnosis and through a diagnosis.”She continued, “We have an obligation and an opportunity to really help this community be seen, help this community to understand their disease and to understand how best to advocate for their own best path forward as it relates to treatment, as it relates to advocacy, as it relates to, really, living.”That holds true even if the support doesn’t lead a patient to one of Blueprint’s treatments. As Scipione noted, “Patients who have the education and the understanding of this disease can have different conversations with their physician, and in those conversations, that leads to a shared decision-making. If Ayvakit is the right choice, fantastic; if it’s not, but the patient gets the treatment that they need or the directions that they need to change their circumstance, fantastic.”Whatever the result, Blueprint’s strategy focuses on empowerment, education and community-building—all of which are covered by Colors of SM, she said.“We do envision Colors of SM as a symbol of hope, a symbol of strength,” she said. “Our goal is that these shared stories and the artwork, that they not only resonate deeply, but also spark significant changes in healthcare and personal choices. And we do hope that with this initiative we’re building compassion and a supportive community for those who are impacted by systemic mastocytosis.”

Aldoxorubicin Returns to LadRx LOS ANGELES -- (BUSINESS WIRE)-- LadRx Corporation (OTCQB: LADX) (“LadRx” or the “Company”), a biopharmaceutical innovator focused on research and development of life-saving cancer therapeutics, is pleased to announce that the Company and NantCell, Inc. (“NantCell”), together with NantCell’s parent company ImmunityBio, Inc. (“ImmunityBio”), have agreed to a mutual termination of the license of aldoxorubicin entered into in 2017. With the termination of the license agreement between LadRx and NantCell, LadRx regains control of aldoxorubicin. In 2023, LadRx transferred the royalty and milestone rights of arimoclomol and aldoxorubicin to XOMA Corporation (NASDAQ: XOMA) (“XOMA”) in exchange for $5 million in upfront gross proceeds, up to an additional $2 million for milestones related to arimoclomol and $5 million for milestones related to aldoxorubicin. XOMA consented to the mutual termination of the LadRx-NantCell agreement in order to facilitate the return of the program to LadRx. In parallel, LadRx and XOMA have amended their 2023 Royalty Purchase Agreement to provide XOMA with a low-single-digit synthetic royalty on aldoxorubicin and a mid-single-digit percentage of any economics derived by LadRx from future out-license agreements related to aldoxorubicin. The agreement between LadRx and XOMA regarding future royalties and milestones associated with arimoclomol is not affected by the termination of the aldoxorubicin license between LadRx and NantCell. Stephen Snowdy, PhD, CEO of LadRx commented, “We are excited to have aldoxorubicin back in-house. Aldoxorubicin is the first LADR-based drug to reach the clinic and was shown in multiple clinical studies to have lower cardiotoxicity compared to doxorubicin while showing promise of efficacy in a Phase II trial in advanced soft tissue sarcoma. Aldoxorubicin also proved the premise of LADR-based drugs that targeting chemotoxins via the LADR backbone allows for several-fold higher dosing of chemotherapeutic drugs.” Dr. Snowdy continued, “We congratulate ImmunityBio on their recent successes with their immunity-based products and certainly understand their going-forward focus on those modalities. Over the coming months, we will be reviewing the pre-clinical and clinical data for aldoxorubicin and plotting a path forward for its continued clinical development. Meanwhile, we continue to march LADR-7 towards the clinic and remain on track for filing an IND application for LADR-7 in the third or fourth quarter of 2024.” Forward-Looking Statements This press release may contain certain statements relating to future results which are forward-looking statements, including whether the company’s strategic review will be successful and whether the stock split will help the company be more successful in evaluating strategic alternatives. These statements are not historical facts, but instead represent only LadRx’s belief regarding future events, many of which, by their nature, are inherently uncertain and outside of LadRx’s control. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements; and other risks and uncertainties described in the most recent annual and quarterly reports filed by LadRx with the SEC, including disclosures under the heading “Risk Factors,” and current reports filed since the date of the LadRx’s most recent annual report. All forward-looking statements are based upon information available to LadRx on the date the statements are first published. LadRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. About LadRx LadRx Corporation (OTCQB: LADX) is a biopharmaceutical company developing new therapeutics to treat patients with cancer. LadRx Corporation’s website is . View source version on businesswire.com: Contacts Longacre Square Partners Greg Marose / Charlotte Kiaie ladrx@longacresquare.com Source: LadRx Corporation View this news release online at: