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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"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.

On February 6, 2023 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, and Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported that, as part of their existing strategic collaboration, they have mutually selected the first program combining an Atreca-discovered antibody with Xencor’s XmAb bispecific Fc domain and a cytotoxic T-cell binding domain (CD3) (Press release, Xencor, FEB 6, 2023, View Source [SID1234626889]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of their 2020 collaboration, Atreca generates novel, tumor-binding antibodies from the immune responses of cancer patients and identifies the antibodies’ targets. Xencor then engineers Atreca’s antibodies into T-cell engaging bispecific antibodies that bind to and activate the CD3 co-receptor on T cells, and characterizes these novel XmAb bispecific antibodies to identify candidates for further development. The program announced today is the first of up to two joint programs that can be mutually selected for further development and commercialization, with each partner sharing 50% of costs and profits. Atreca will lead clinical development, regulatory and commercialization activities for this program, and the second potential joint program would be advanced by Xencor. In addition, the agreement allows for each partner to pursue up to two programs arising out of the collaboration independently.

The joint program announced today is based on APN-346958, an Atreca-discovered antibody. APN-346958 targets a novel RNA-binding protein and is tumor-reactive in at least 50% of samples for six tumor types evaluated, including: colorectal, thyroid, head and neck, urothelial, melanoma and brain cancer. In preclinical studies, the XmAb bispecific antibodies engineered against APN-346958’s target have demonstrated potent anti-tumor activity. Atreca and Xencor expect to name a candidate from the program later this year, and Atreca targets an investigational new drug (IND) submission by early 2025.

"The advancement of this program into joint development is a key milestone in our collaboration with Xencor," said Stephen Gould, Ph.D., Chief Scientific Officer of Atreca. "We continue to believe that our respective approaches have the potential to be highly complementary, given the abundance of novel antibody-target pairs generated by Atreca’s discovery platform and the plug-and-play nature of Xencor’s XmAb bispecific antibody platform. We are excited to continue working with Xencor to advance this program and generate additional programs combining Atreca antibodies and Xencor CD3 bispecific engineering."

"We are using our modular protein engineering platforms to create a new generation of XmAb bispecific antibodies that can act directly and selectively against solid tumors with cytotoxic T cell engagement," said John Desjarlais, Ph.D., Senior Vice President and Chief Scientific Officer at Xencor. "Today’s announcement speaks to the productivity of our ongoing collaboration with Atreca, and we look forward to evaluating additional molecules engineered with antibodies presented by Atreca’s unique and differentiated discovery platform."

On February 6, 2023 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that Vincerx’s management team will present the company’s corporate overview and participate in one-on-one investor meetings at the SVB Securities Global Biopharma Conference, to be held virtually from February 14-16, 2023 (Press release, Vincerx Pharma, FEB 6, 2023, View Source [SID1234626888]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

SVB Securities Global Biopharma Conference Presentation Details
Date: Thursday, February 16, 2023
Time: 1:40 p.m. ET
Webcast: View Source

An archived webcast will be accessible in the Investors section of the Company’s website for approximately 90 days following the event.