On May 24, 2022 PanTher Therapeutics (PanTher), a clinical-stage oncology company developing next-generation targeted therapies for solid tumors, reported that a methods-of-use patent for a deployable anticancer drug-eluting stent, exclusively licensed to PanTher, has been issued by the United States Patent and Trademark Office (USPTO) (Press release, PanTher Therapeutics, MAY 24, 2022, View Source [SID1234614997]). The patent increases the potential applicability of PanTher’s proprietary Sagittari treatment platform, which focuses on direct, localized, and sustained delivery of proven and novel therapeutic agents to attack cancer at the source.

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The newly awarded patent covers methods of treating a tumor using a drug-eluting stent that incorporates a degradable polymer film containing a chemotherapeutic drug. The drug is released from the film when the stent is deployed into a biliary or pancreatic duct or tissue site of the pancreas, biliary system, gallbladder, liver, small bowel, or colon.

"The patent validates the novelty and breadth of the Sagittari platform and increases our potential market, while enhancing the value of our intellectual property portfolio," said Laura Indolfi, PhD, chief executive officer of PanTher Therapeutics. "It also supports our investigational strategy of applying our technology to multiple solid tumor types, which facilitates the selection of our follow-on assets."

The Sagittari️ platform is an optimized system for precisely transporting therapeutics to the tumor site, leveraging interventional oncology to design superior localized cancer treatments. PanTher’s lead candidate, PTM-101, the first product to emerge from the Sagittari platform, is currently in Phase 1 of clinical development for the treatment of localized non-metastatic pancreatic cancers.

PanTher also announced the appointment of Dan Wildman as a strategic advisor to the company. A seasoned executive with more than 35 years of experience in the MedTech industry, Mr. Wildman is president and chief executive officer of the strategic consulting company Wildman Ventures, LLC. He previously led the Digital Surgery Strategy initiative at Johnson & Johnson and served as worldwide president of Depuy Synthes Spine and Ethicon Biosurgery. While at Ethicon Biosurgery, Mr. Wildman led the development and commercialization of a novel combination product based on a biomaterial and biologic formulation. As strategic advisor to PanTher, Mr. Wildman will apply this expertise and his decades of experience to advancing the clinical development program for PTM-101 and selecting and prioritizing other Sagittari platform product candidates.

"I am excited to join PanTher at such a pivotal moment in the company’s trajectory, with its first asset in the clinic and a newly issued patent that positions the company very competitively in a crowded space," commented Mr. Wildman. "I look forward to contributing to the growth and expansion of the company and helping realize the tremendous market potential of its pipeline."

On May 24, 2022 Calidi Biotherapeutics, Inc., a clinical-stage biotechnology company pioneering the development of stem cell-based delivery of oncolytic viruses, reported that it has been granted a new patent (No. US 11,285,194, Combination immunotherapy approach for treatment of cancer) by the U.S. Patent and Trademark Office (USPTO) related to its proprietary SuperNova (SNV) technology platform (Press release, Calidi Biotherapeutics, MAY 24, 2022, View Source [SID1234614996]). The enhanced oncolytic virotherapy delivery platform was designed to provide and improve therapeutic treatments for multiple cancer indications. Calidi’s product candidates are in the early stages of development and have not yet been approved by the U.S. Food and Drug Administration (FDA).

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The SNV platform is composed of allogeneic, adipose-derived mesenchymal stem cells (AD-MSC) loaded with an oncolytic agent, such as the vaccinia virus, and is anticipated to be used in combination with various immunotherapy agents, including blocking antibodies. The SNV platform is designed to shield oncolytic viral payloads from the immune system, thereby efficiently delivering immuno-oncology therapy directly to tumor sites.

"Calidi’s Supernova platform has been developed through years of research in stem cell delivery and potentiation of oncolytic viruses and has the potential to revolutionize the treatment of solid tumors," said Allan J. Camaisa, CEO and Chairman of Calidi. "The addition of this patent further strengthens our intellectual property position and solidifies the opportunity to use our platform technology in advancing therapeutic discovery and development through the FDA approval process."

The Calidi approach aims to induce a durable anti-tumor immune response. In pre-clinical studies, Calidi’s SNV platform-based product candidates have been shown to shield the oncolytic viruses from destruction by the patient’s immune system, supporting efficient viral replication within the stem cells prior to delivery to tumor sites. Once there, the viral payload selectively destroys tumor cells and stimulates the patient’s immune system to attack the tumor.

"Our outstanding team of doctors and scientists have invested years of intensive research and groundbreaking work to develop Calidi’s SNV platform technology," said Boris Minev, M.D., President, Medical and Scientific Affairs at Calidi, and a patent inventor. "This patent represents the culmination of their impressive expertise, dedication, and passion, and will help the company continue to advance its novel discovery programs."

On May 24, 2022 City of Hope, one of the largest cancer research and treatment organizations in the United States and a national leader in providing cancer patients with best-in-class, integrated supportive care programs, reported that it has received a $10 million gift from The Sheri and Les Biller Family Foundation (Press release, City of Hope, MAY 24, 2022, View Source [SID1234614995]). The partnership between City of Hope and The Sheri and Les Biller Family Foundation will support City of Hope’s efforts to give patients across its cancer care system expanded access to its evidence-based supportive care medicine offerings and to advocate for establishing supportive care as a standard practice for cancer care in the United States.

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Beginning at intake, City of Hope’s supportive care program provides cancer patients with comprehensive physical, psychological, social and practical support services that improve outcomes and enable them to maximize their personal and family strengths. Offerings include care navigation, survivorship programs, specialists in cancer and aging, psychological and spiritual counseling, pain management, and integrative medicine like yoga, massage, meditation and more.

"Cancer diagnoses and treatments bring tremendous stress to families, with challenges that are uniquely personal. Providing patients with access to supportive care programs has a direct impact on their treatment outcomes and our ability to deliver value-based medical care. It results in a reduction in the length of inpatient stays, hospital readmissions and ICU stays, and an improved quality of life and patient satisfaction," said Robert Stone, City of Hope’s president and chief executive officer and the Helen and Morgan Chu Chief Executive Officer Distinguished Chair. "We are grateful for the ongoing and generous support and partnership of The Sheri and Les Biller Family Foundation. Together, our vision is to lead the way in expanding supportive care programs to cancer patients and their families early in their road to recovery — no matter where they live or where they receive care."

As a leader in the field, the Department of Supportive Care Medicine at City of Hope was the first in the United States to fully integrate across supportive care specialties and into the patient’s clinical care and is one of the largest programs of its kind today. City of Hope’s evidence-based supportive care model has been outlined at academic meetings and in textbooks as exemplary; yet, despite its proven benefits, supportive care programs are not widely available at cancer centers and hospitals around the country. City of Hope has heard the call of patients and providers and is working to train experts and expand access to evidence-based supportive care programs.

The gift supports two focus areas: (1) Bolster City of Hope’s efforts to train providers in delivery of supportive care, drive research to inform care guidelines and develop digital, scalable tools that can be easily adapted by other health care providers; and (2) expand supportive care by convening and educating stakeholders, including patients, policymakers, insurance companies and health care providers on the importance of establishing supportive care programs as a standard practice for cancer and other life-threatening conditions.

"Our shared belief at The Sheri and Les Biller Family Foundation and at City of Hope is that supportive care should be an essential part of cancer care for every patient and family. Having lost two close friends — women I referred to as sisters — to breast cancer, I’ve seen firsthand the immense toll that cancer takes on patients and their loved ones, and I have come to understand the relief that truly integrated and meaningful supportive care can provide," said The Sheri and Les Biller Family Foundation President Sheri Biller. "Our aim is to leverage the power of our partnership with City of Hope to propel and advance supportive care medicine in oncology for all cancer patients. With scalable care models and training, this gift will amplify over time, expanding access to the best supportive care programs to cancer patients who have otherwise often faced racial, gender, age, economic and geographical barriers."

Audrey Haberman, CEO of The Sheri and Les Biller Family Foundation, added, "It is equally important to us to evolve the supportive care model within City of Hope’s expanded cancer care system and also improve access for patients and their families so that wherever they go for cancer treatment, they have access to high-quality supportive care programs that improve their lives and outcomes."

Because more than half of all cancer patients and nearly 70% of cancer survivors are older than 65, City of Hope has focused on leading the national effort to improve cancer and aging care with personalized treatment based on the individual’s age.

"Older populations, people of color and economically disadvantaged communities face unique burdens and barriers to cancer care. Supportive care programs can level the playing field in health equity, giving all patients the care they deserve," said Edward Kim, M.D., M.B.A., professor of medical oncology and physician-in-chief at City of Hope Orange County. "We work with patients and their loved ones, from the very beginning, to understand their greatest concerns and challenges. Then we tailor our support to meet the specific needs of patients and family members at every step along the way."

The efforts to expand access to City of Hope’s supportive care programs will encompass patients in the organization’s recently acquired Cancer Treatment Centers of America sites, contributing to City of Hope’s goal of democratizing cancer care and extending world-class care to more patients, families and communities.

An earlier donation from The Sheri and Les Biller Family Foundation supported the creation of the Sheri & Les Biller Patient and Family Resource Center at City of Hope’s Los Angeles campus, which serves as a hub to facilitate easy access to supportive care programs. Later this year, City of Hope will open a second Sheri & Les Biller Patient and Family Resource Center on its new campus in Irvine, California.

The Sheri and Les Biller Family Foundation’s philanthropic partnership with City of Hope has also supported programming, including patient navigators, the development of City of Hope-led trainings for health care professionals throughout the country, and City of Hope’s SupportScreen technology, a touch-screen application that asks patients a wide range of questions to address physical and psychosocial concerns common to their diagnosis.

"Nearly 15 years ago, Sheri and Les Biller saw an unmet need to better support patients and families on their cancer journey. Their visionary generosity helped City of Hope build on one of the best supportive care medicine programs in the country — a compassionate, integrated model now deeply embedded in our culture," said Kristin J. Bertell, chief philanthropy officer at City of Hope. "Now, they are leading the way once more with a gift that will accelerate our efforts to reach more people than ever before. For that, we are truly grateful."

On May 24, 2022 LIDDS AB (publ) reported that Interim Report January – March 2022 (Press release, Lidds, MAY 24, 2022, View Source [SID1234614994])

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Net sales amounted to 0.6 (0.6) MSEK
The operating result for the period was -9.8 (-10.8) MSEK
The net result was -9.8 (-10.8) MSEK corresponding to earnings per share of SEK -0.29 (-0.36)
Cash flow from operating activities amounted to -6.1 (-11.7) MSEK
Cash and cash equivalents amounted to 27.5 (23.3) MSEK

Significant events January – March
The R&D project with J&J has moved into the next phase.
A financing agreement of up to 40.8 MSEK signed with Nice&Green

Significant events after the reporting period
Max Mitteregger and Johan Lund are proposed as new member of LIDDS Board of Directors. Max Mitteregger will in connection with the appointment to LIDDS’ Board of Directors acquire shares at a total value of 4.5 MSEK. It is proposed that this will be done through a directed share issue of 750,000 shares at a subscription price of 6 SEK, which corresponds to LIDDS’ share price at Nasdaq First North Growth Market at the time for a binding commitment to subscribe for the shares. The directed share issue is subject to approval by the Annual General Meeting of shareholders.

CEO comment
In the beginning of 2022, we have had several important announcements. Early January, we announced that the research collaboration with Johnson & Johnson Enterprise Innovation Inc (J&J) continued into the next stage. It is of utmost importance that the cooperation continues to develop well. The collaboration with J&J is an important part of our development goals to be able to offer drugs that make an important difference in patients’ lives. We want to be part of developing products that improves the situation for patients, caregivers and society at large through improved treatment results, increased quality of life and efficient use of resources.

We also presented the next step in the development of our project nanodotax which isNanoZolid-formulated docetaxel. We will conduct a shorter clinical study to evaluate the immunological effects observed in the clinical Phase I study NZ-DTX-001. The study showed activation of systemic inflammatory biomarkers that are believed to improve conditions for treatment with so-called checkpoint inhibitors. Preliminary results indicate that local treatment with nanodotax could stimulate patients’ immune systems in such a way that it could attack even distant metastases. Based on the positive results in the phase I study, we chose to take over the sponsorship of the previously approved investigator sponsored trial in patients with prostate cancer. We expect to be able to start recruiting patients quite soon and I look forward to the results as the study will provide important insights into the mechanism of action and how the project will be further advanced in the clinical development regarding patient group and indication.

I note that there is great interest in TLR9-targeted treatment as Regeneron Pharmaceuticals has announced its intention to acquire Checkmate Pharmaceuticals. Checkmate’s product in development is a TLR9 agonist which is basically the same as our nanoimod product but without the long-lasting effect. We are convinced that the solution for good treatment results lies in a long-acting and continuous TLR9 activation. The deal is a good indication of the interest among pharmaceutical companies for intratumoral administration in general and more specifically of TLR9-targeted treatment as a new tool in the treatment of various cancers.

In order to be able to continue the positive development of the project portfolio, secured financing is of great importance. Therefore, we announced in February that LIDDS has entered into a convertible loan agreement with Nice & Green, a Swiss specialist investor with valuable experience from the life science sector. The agreement stipulates that Nice & Green has committed to subscribe for convertibles with a nominal value of up to SEK 40.8 million. The agreement gives LIDDS the opportunity, but no obligation, to use the agreed financing for the next 18 months. This is very important for the company because it gives us flexibility.

I am happy to have been able to meet both shareholders and other stakeholders during the first months of the year. We did this both at the Fight Cancer Day organized by Redeye in January and at the much-appreciated Capital Markets Day (CMD) that we held in March. The focus at the CMD was on our research and development – the heart of the company. I appreciate your commitment and interest and look forward to meeting you again. In June, we will have reason to spread the word about LIDDS further as we attend the US BIO International Convention in San Diego. The conference is one of the most important industry congresses with internationally renowned keynote speakers and brings together a large number of market-leading players from around the world. As a further step in strengthening the knowledge about LIDDS, the website has also been updated with new design, content and better functions to make it easier for our visitors.

My focus in the future is to manage the good foundation we carefully laid out for the company in 2021 and the beginning of 2022. We will accelerate the work of developing effective solutions for local drug administration and develop projects that generate the greatest opportunities for future collaborations and agreements.

On May 24, 2022 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of therapeutics designed to activate immune response to cancers and infections, reported that its innate/adaptive immune activator, botensilimab, will be the subject of a late-breaking oral presentation at the upcoming ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer in Barcelona, Spain (Press release, Agenus, MAY 24, 2022, View Source [SID1234614993]). In addition, Agenus also announced broad efficiencies expected to reduce costs by 20% and drive botensilimab’s accelerated development.

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"MSS colorectal cancer is one of the tumor types where single agent checkpoint inhibitors targeting PD-1/PD-L1 have not shown significant activity; in contrast, we are seeing deep and durable responses using botensilimab and balstilimab in these heavily pretreated MSS colorectal patients," said Anthony El-Khoueiry, MD, Phase I Program Director at the USC Norris Comprehensive Cancer Center, Keck Medicine of USC. "The activity noted with this combination warrants advancing the program with further trials".i

"The clinical activity of the combination of botensilimab and balstilimab in heavily pretreated metastatic MSS colorectal cancer is remarkable," said Dr. Steven O’Day, CMO of Agenus. "Prior PD1 and PDL1 antibodies, with or without CTLA-4, have failed in this same setting. These data in MSS CRC are further supported by emerging clinical data in a wide range of poorly responsive solid tumors. We look forward to advancing botensilimab alone and in combination in the second half of 2022."

Botensilimab is an immunotherapy with the potential to transform the treatment landscape. A growing body of evidence supports botensilimab’s broad activity in indications inadequately addressed by currently approved treatments, and Agenus is focusing additional resources to accelerate its development. In this regard, Agenus will:

Prioritize its clinical development programs.
Automate and implement Vision and AI capabilities, as part of effort to streamline discovery and development.
These measures will reduce Agenus’ operating expenses and allow the company to prioritize its high potential programs, while continuing to pursue creative financing mechanisms and/or potential partnerships.

Agenus will also continue to advance clinical collaborations designed to increase the potential value of botensilimab and other clinical programs in new indications and combinations. These studies are sponsored and executed by our partners, with drug supply and scientific support provided by Agenus. Internally, the company will continue to focus on botensilimab combinations which inform its use as a foundational therapy; these combinations include Agenus’ balstilimab (anti-PD-1), AGEN2373 (anti-CD137), and AGEN1571 (anti-ILT2) antibodies, as well as chemotherapy.

"As we enter a period of unprecedented regulatory and financial challenges for the biotech industry, Agenus is poised to differentiate our capabilities and comprehensive portfolio. The enthusiasm GI experts have shown, as evidenced by a prominent presentation at ESMO (Free ESMO Whitepaper) GI, is very heartening, as is the accelerated patient enrollment in our clinical trials. We believe the value of botensilimab to be unmatched relative to existing therapies and known development candidates, and we are moving with speed to bring this potentially revolutionary treatment to patients in need," CEO of Agenus, Dr. Garo Armen.

Agenus’ plans include initiation of three phase 2 studies in 2022 (MSS colorectal cancer, melanoma and pancreatic cancer).

About Botensilimab
Botensilimab (also known as AGEN1181) is a next-generation, Fc-enhanced, immunoglobulin G1 (IgG1) antibody which has shown significant activity in activating both the innate and adaptive immune response. It is also designed to block CTLA-4 (cytotoxic T-lymphocyte associated antigen 4) inhibitory function from interacting with its ligands CD80 and CD86. The Fc region of the antibody was engineered to enhance immune activation and tumor killing, improve safety, and benefit a broader patient population versus first-generation anti CTLA-4 antibodies which act as a negative regulator of immune activation that is considered a foundational mechanism.