On February 6, 2023 Presage Biosciences, a biotechnology company whose mission is understanding the complexity of drug response in the tumor microenvironment, reported that it has entered into a new research collaboration with Poland-based biopharmaceutical company Pure Biologics to evaluate two of Pure Biologics’ very early stage assets in a Phase 0 intratumoral microdosing study (Press release, Presage Biosciences, FEB 6, 2023, View Source [SID1234626894]). Presage’s CIVO platform will be used to evaluate drug mechanism of action, potential indicators of efficacy, and drug combinations.

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"We are excited to work with a forward-thinking partner who grasps the power of Phase 0 for cancer drug development and the insights we can gain from drug-exposed areas of the human tumor microenvironment," said Rich Klinghoffer, PhD, Presage CEO. "We see this partnership as a tremendous opportunity for Presage to continue innovating and delivering key pharmacodynamic insights into a partner’s early-stage oncology assets."

"The tumor microenvironment is complex and we are enthusiastic about Presage’s innovative approach to obtain information about the effectiveness of our compounds faster than traditional Phase I and Phase II trials," said Dr. Filip Jelen, Pure Biologics Co-Founder and President of the Management Board. "Their CIVO platform will allow us to introduce our novel agents directly into patient tumors and provide the first real clues about drug efficacy."

The collaboration with Pure Biologics comes on the heels of Presage’s recently completed Phase 0 clinical trials (NCT04065555 and NCT04541108) with Takeda Pharmaceutical Company evaluating immune-oncology drugs alone and in combination in head and neck cancer patients. The trials demonstrated that CIVO is able to deliver key spatial biology and mechanistic insights. Presage expects to publish the results from both studies later this year.

About CIVO
Comparative In Vivo Oncology (CIVO) is Presage’s patented platform that enables multiplexed intratumoral microdosing and generation of detailed tumor profiling. Presage’s CIVO technology and analysis capabilities are unparalleled at providing insight into drug-exposed areas of the intact tumor microenvironment. Presage is pairing the use of CIVO with molecular profiling technologies in both preclinical and Phase 0 trials in order to inform and de-risk oncology drug development.

On February 6, 2023 Dragonfly Therapeutics, Inc., a clinical stage biotechnology company developing novel immunotherapies, reported that it now owns all rights to develop DF6002, its novel interleukin-12 (IL-12) cytokine investigational immunotherapy program, which is in Phase 1 clinical development, with dose escalation progressing successfully in monotherapy and in combination with nivolumab, in the U.S. and in Europe (Press release, Dragonfly Therapeutics, FEB 6, 2023, View Source [SID1234626893]). Clinical development is currently being carried out by Bristol Myers Squibb, but will be transferred to Dragonfly over the coming weeks.

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"We are very excited to have the Dragonfly developed IL12 asset back," said Joseph Eid, MD, Dragonfly’s President of Research and Development, who previously led the pioneering clinical development of KEYTRUDA. "Given the encouraging profile we have seen both in preclinical models and in the clinic to date, we are accelerating DF6002’s development across a range of indications and combinations."

"We have great respect for Bristol Myers Squibb, whose broad range of oncology agents and talented, experienced and committed team have made it a strong partner," said Bill Haney, Co-founder and CEO of Dragonfly Therapeutics.

Since an original 2017 collaboration focusing on hematology malignancies, BMS and Dragonfly have entered multiple additional collaborations which include both oncology and neuroinflammation targets. BMS has licensed six Dragonfly TriNKET drug candidates and has two of them presently in the clinic. BMS licensed a TriNKET from Dragonfly for neuroinflammation in January 2023.

"We appreciate the BMS team’s hard work on the development of DF6002, the most advanced drug in Dragonfly’s rich cytokine pipeline," said Bill Haney. "And we are excited that Dr. Eid, who has had such an extraordinary career rapidly and effectively advancing drugs in oncology, will now take charge of accelerating DF6002 in the clinic."

About DF6002
DF6002, Dragonfly’s extended half-life IL12 cytokine, is an investigational immunotherapy being evaluated alone and in combination with nivolumab in participants with locally advanced or metastatic solid tumors [NCT04423029]. DF6002 is a monovalent IL12 immunoglobulin Fc fusion protein proposed to achieve strong anti-tumor efficacy by establishing an inflammatory tumor microenvironment necessary for productive anti-tumor responses. DF6002 has the potential to stimulate effective anti-tumor immunity in patients who are not eligible or not adequately responding to current therapies. DF6002 is the most advanced in a pipeline of cytokines that Dragonfly is developing to address the high unmet need in patients with advanced cancer.

On February 6, 2023 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a leader in the development of targeted radiotherapies, reported that it has entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes for Health (NIH), to develop Actimab-A for the treatment of patients with acute myeloid leukemia (AML) and other hematologic malignancies (Press release, US NCI, FEB 6, 2023, View Source [SID1234626892]). Under the terms of the CRADA, the NCI will serve as the regulatory sponsor for any clinical trials mutually approved by both parties to study Actimab-A while Actinium will be responsible for supplying and distributing Actimab-A to participating clinical sites and providing additional support as needed. The CRADA will provide broad support for the development of Actimab-A alone or in combination with chemotherapy, immunotherapy, targeted agents and other novel combinations, in line with Actinium’s strategy of leveraging Actimab-A’s targeted radiotherapy mechanism to elicit synergistic effects.

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The CRADA studies will be overseen by NCI in collaboration with Actinium’s clinical development team. Through the CRADA, Actimab-A will be available at over 2,000 clinical trial sites under the Experimental Therapeutics Clinical Trials Network (ETCTN) and the National Clinical Trials Network (NCTN) that includes leading oncology network groups such as Eastern Cooperative Oncology Group and the American College of Radiology Imaging Network (ECOG-ACRIN), Southwest Oncology Group (SWOG) and the Alliance for Clinical Trials in Oncology. Actimab-A studies may also be conducted through NCI’s MyeloMATCH program. NCI Cancer Therapy Evaluation Program (CTEP), which sponsors approximately two thirds of all combination cancer studies, will be accepting Letters of Intent (LOIs) or concepts for Phase 1, 2 or 3 studies of Actimab-A in AML and other hematological malignancies.

Sandesh Seth, Actinium’s Chairman and CEO, said, "We are incredibly honored to be collaborating with NCI and excited that they share our vision for Actimab-A’s potential for the treatment of AML and other blood cancers. The CRADA will allow Actimab-A’s broad applicability to be fully studied and developed by leading oncology network groups as well as NCI’s leading-edge MyeloMATCH program in ways Actinium could not do independently. NCI’s sponsorship will also allow us to accelerate novel Actimab-A combinations and broaden its use in AML and other hematological indications, while the collaboration with NCI, who funds and maintains the largest centralized clinical trial support systems in the United States, will help preserve our balance sheet for additional corporate priorities."

Dr. Avinash Desai, Chief Medical Officer of Actinium Pharmaceuticals, commented, "NCI’s broad support under the CRADA is a strong encouragement for us to together explore Actimab-A’s potential for the treatment of AML and other hematologic malignancies. As the only CD33 targeting radiotherapy in development, Actimab-A is uniquely positioned to address the challenges in treating relapsed or refractory AML patients who do not respond well to front line therapies and those whose disease stops responding to traditional cytotoxic or available targeted therapies. We are highly encouraged by the high rates of responses, minimal residual disease negativity and strong survival benefit at 1 and 2 years in heavily treated patients, including prior Venetoclax treatment and/or transplant, and those with adverse cytogenetics, including TP53 mutations, recently reported from the Actimab-A CLAG-M combination study. We look forward to working collaboratively with the NCI and all investigators through this CRADA to complete multiple clinical trials to further realize Actimab-A’s therapeutic potential."

On February 6, 2023 Oncotelic Therapeutics, Inc (OTCQB:OTLC) ("Oncotelic", the "Company" or "We"), a developer of treatments for rare and orphan indications, including Parkinson’s Disease, PDAC, DIPG, and COVID-19, reported the initiation of its second investigator initiated studies (IIS) in a series of planned clinical studies (Press release, Oncotelic, FEB 6, 2023, View Source [SID1234626891]).

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We have submitted to US FDA a protocol for the study with approximately 30 patients with non-small cell lung cancer in collaboration with the Fred Hutchinson Cancer Center and a large pharmaceutical company in the field of immuno-oncology (IO). The study will be combining our oligodeoxynucleotide OT-101 and a US FDA approved anti-PD-L1 checkpoint inhibitor.

Near term, the Company is planning to initiate up to 7 clinical studies in various oncology indications along with ‘Centers of Excellence’ and major pharmaceutical companies. The first trial as noted in a prior press release is planned to be in patients with metastatic pleural mesothelioma.

All studies will be assessing the tumor response to various combination studies assessing pre and post therapeutic biopsies measuring close to 800 genes, changes in phenotype and functionality, cytokines, suppressive immune cells; and their spatial distribution within the tumor.

"These studies are the result of careful planning with our collaborators in order to ensure the rigor and thorough assessment of changes within the tumor microenvironment resulting from combination immune-therapy and immune-oncology modalities" said Dr. Anthony Maida, Chief Clinical Officer – Translational Medicine.

For more information on the Fred Hutchinson Cancer Center and how you or someone you know can enroll in a trial, please visit: View Source

About OT-101

OT-101, is a first-in-class anti-TGF-β2 RNA therapeutic that exhibited single agent activity in some relapsed/refractory cancer patients in clinical trial settings. HGGs are characterized by a T-cell exhaustion signature and pronounced T-cell hypo responsiveness of their tumor microenvironment ("TME"). TGF-β2 has been implicated as a key contributor to the immunosuppressive landscape of the TME in HGG. OT-101 is designed to abrogate the immunosuppressive actions of TGF- β2. In a completed Phase 2 clinical study, OT-101 exhibited clinically meaningful single-agent activity and induced durable complete and partial responses in recurrent and refractory adult HGG patients, including young adults with Glioblastoma Multiforme or Amyloidosis.

OT-101 has been granted orphan designation by the FDA under the Orphan Drug Act ("ODA"). ODA provides for granting special status to a drug to treat a rare disease or condition upon request of a drug company. Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits for qualified clinical testing. OT-101 also been granted Rare Pediatric Designation for DIPG. The FDA grants rare pediatric disease designation for diseases with serious or life-threatening manifestations that primarily affect people aged from birth to 18 years, and that affect fewer than 200,000 people in the U.S. Under the FDA’s Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives an approval of a new drug application or biologics license application for a product for the prevention or treatment of a rare pediatric disease may be eligible for a voucher, which can be redeemed to obtain priority review for any subsequent marketing application and may be sold or transferred.

As previously reported, on March 31, 2022, we entered into a joint venture, or JV, with Dragon Overseas Capital Ltd. (Dragon Overseas) and GMP Biotechnology Ltd. (GMP Bio). The JV and Oncotelic will develop and ultimately market OT-101, individually and/or in combination with other products. Oncotelic would receive up to $50 million on sale of the RPD voucher, following marketing approval of OT-101 for diffuse intrinsic pontine glioma, or DIPG, by the US Food and Drug Administration.

On February 6, 2023 LIDDS AB (publ) ("LIDDS"or the "Company") reported the preliminary outcome of the righs issue with preferential rights for the shareholders (the "Rights Issue"), which subscription period ended today (Press release, Lidds, FEB 6, 2023, View Source [SID1234626890]). The subscription breakdown shows that 24,967,268 shares, corresponding to 35.0 MSEK or approximately 71.9 percent of the Rights Issue, were subscribed for with or without the exercise of subscription rights. The Rights Issue was secured to approximately 95.7 percent through issue gurantees and the Company will therefore obtain approximately 46.5 MSEK before issue costs.

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"I would like to thank all existing shareholders who have participated in the rights issue for your continued support and extend a warm welcome to new shareholders. The rights issue provides a significant reinforcement to the Company’s continued development of Nanodotax and Nanoimod and enables intensified work with the out-licensing of the Phase III project Liproca Depot", says Anders Månsson, CEO of LIDDS.

The subscription period in the Rights Issue ended today the 6 February 2023 and a preliminary breakdown shows that 24,967,268 shares, corresponding to 35.0 MSEK or approximately 71.9 percent of the Rights issue, were subscribed for with or without the exercise of subscription rights. No investors who have issued guarantees will preliminary be allocated any shares. The Rights Issue was secured to approximately 95.7 percent through issue guarantees and the Company will therefore obtain approximately 46.5 MSEK before issue costs.

The final outcome of the Rights Issue is expected to be announced on Wednesday 8 February 2023. Allocation of shares that were subscribed for without the exercise of subscription rights will be done according to the principles described in the prospectus that was prepared in connection with the Rights Issue and was published on 17 January 2023. Those who will be allocated shares without the support of subscription rights will be notified after the allocation meeting held by the Board of Directors on 8 February 2023 through contract note. Nominee shareholders will receive notification of allotment in accordance with the respective nominee’s routines. Allocated shares should be paid according to the instructions on the contract note.

Advisors
Erik Penser Bank AB is financial advisor to LIDDS in connection with the share issue and Setterwalls Advokatbyrå AB is legal advisor.