On February 14, 2023 Therapeutic Solutions International (TSOI) reported paradigm shifting findings leveraging the age-old immunological paradigm that cancer is an uncontrolled replica of pregnancy (Press release, Therapeutics Solutions International, FEB 14, 2023, View Source [SID1234627226]). Pregnancy has historically been regarded as an immunological mystery due to the survival of the offspring, which contains foreign paternal derived proteins in the mother. Founders of Res Nova have previously published that vaccination with placental tissues results in immune mediated tumor regression in animal models and have been previously granted FDA clearance for clinical trials.

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Data disclosed and patented today reveal that specific formulations of RU-486, the original abortion pill, can enhance the therapeutic effects of multiple immunotherapies. The Company has created the "FloraVax" platform which comprises various formulations and combinations of RU-486 and cancer targeting antigens which has been shown to enhance effects of therapies which function in whole or in part through immune modulation.

"From a biological perspective cancer and pregnancy share many similarities such as the ability to escape immune attack and metastasis in that fetal cells invade maternal tissues and can be found even in the mother’s skin, as well as rapid growth," said Dr. James Veltmeyer, Chief Medical Officer, and co-inventor of the patent. "While it has previously been shown that vaccinating with placental tissues has an anticancer effect, we were shocked at the profound responses we have observed when combining the abortion pill active ingredient with our immune modulating approach."

"It is generally accepted that cancer and pregnancy both utilize molecules such as VEGF to produce new blood vessel, IL-10 and HLA-G to suppress immune attack, and matrix metalloproteases to invade tissues," said Timothy Dixon, President, and CEO of Therapeutic Solutions International, the founding company of Res Nova. "This is not the first time that agents which stimulate breakdown of the maternal-fetal immune tolerance also possess anticancer activity. This has been seen with inhibitors of indolamine 2,3 dioxygenase, as well as several checkpoint inhibitors."

"From the regulatory perspective, RU-486 formulations fall under the 505b2 pathway which significantly shortens time to commercialization," said Famela Ramos, CEO of Res Nova Bio. "I find it very interesting that a compound with such a controversial history appears to be on the path for repositioning to something that everyone can agree on."

On February 14, 2023 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported that Janux management will participate in a Novel Immuno-Oncology (IO) panel discussion at Cowen’s 43rd Annual Health Care Conference and be available for 1×1 meetings from March 6 to 8, 2023 in Boston (Press release, Janux Therapeutics, FEB 14, 2023, View Source [SID1234627224]). Details of the presentations are as follows:

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Cowen’s 43rd Annual Health Care Conference
Date: Monday, March 6
Time: 9:10am to 10:10am Eastern Time
Location: Boston Marriott Copley Place
Forum: Novel IO Panel

Presentations and subsequent archived replay may be accessed via the Investors & Media section of Janux’s website. An archived replay of the webcast will be available on the website for approximately 90 days following the presentation.

On February 14, 2023 Halda Therapeutics, a biotechnology company developing a novel class of cancer therapies called RIPTAC (Regulated Induced Proximity TArgeting Chimeras) therapeutics, reported the first public presentation of data for a RIPTAC therapeutic from its pipeline at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (ASCO GU) Cancers Symposium being held in San Francisco on February 16-18 (Press release, Halda Therapeutics, FEB 14, 2023, View Source [SID1234627223]). The poster presentation will describe preclinical data of an orally-available RIPTAC therapeutic for the treatment of prostate cancer, demonstrating anti-tumor activity superior to the standard of care agent in prostate cancer, enzalutamide, in an in vivo rodent model of enzalutamide insensitive prostate cancer, as well as demonstrating broad in vitro activity across prostate cell lines.

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Halda has raised $76 million to date from investors, including Canaan Partners, Access Biotechnology, Elm Street Ventures, and Connecticut Innovations, to pioneer the new RIPTAC drug modality to treat cancer. Proceeds from the funding have enabled the company to build a robust platform and pipeline of small molecule, anti-cancer drug candidates, including two lead programs for major solid tumor types to overcome common drug resistance and to address significant unmet treatment needs for cancer patients.

The company’s scientific founder, Craig Crews, PhD, Professor of Molecular, Cellular, and Developmental Biology at Yale University, is a pioneer of induced proximity biology that led to the invention of PROteolysis Targeted Chimeras (PROTAC), a class of heterobifunctional small molecule protein degrader therapeutics. Professor Crews is scientific founder of multiple biopharmaceutical companies, including Proteolix, Inc. (acquired by Onyx Pharmaceuticals) and Arvinas, Inc. Crews subsequently set the vision for RIPTAC therapeutics as another class of heterobifunctional small molecules which were invented by Halda.

"Halda’s new RIPTAC modality is an evolution of my lab’s multi-decade interest in heterobifunctional drugs," said Professor Crews. "RIPTAC therapeutics address a shortcoming shared by most current pharmaceutical modalities, namely, the reliance on oncogenic driver proteins which can result in drug resistance. This modality offers an oral, selective, and widely applicable cancer cell-killing mechanism that can overcome drug resistance and can be used in advanced cancer where resistance has emerged, as well as potentially in early-stage cancer."

RIPTAC therapeutics work by a novel "hold and kill" mechanism, bringing together two proteins, a cancer-specific protein, and a protein with essential function, resulting in abrogation of the essential cell function, and subsequently, cancer cell death. The two proteins targeted with Halda’s prostate cancer program are Androgen Receptor (AR) as the tumor-specific protein to selectively deliver the RIPTAC therapeutic to tumors, and an essential protein involved in transcriptional regulation. This therapeutic induces a prostate cancer specific protein-protein interaction between AR and a protein with essential function, which abrogates an essential function and results in cancer cell killing. The novel mode of action is designed to overcome the known bypass mechanisms of resistance that evolve during a course of therapy, which is a common limitation of today’s precision oncology medicines.

"We are excited to unveil the first data for our lead pipeline candidate demonstrating the unique mechanism of the RIPTAC modality, as well as preclinical activity in models of prostate cancer," said Kat Kayser-Bricker, PhD, Chief Scientific Officer of Halda Therapeutics. "Novel drug mechanisms are desperately needed to better address prostate cancer and the emergence of resistance to standard of care. The cancer cell-killing mechanism of our prostate cancer RIPTAC therapeutic is uniquely designed to leverage AR as a targeting protein, independent of its driver status, while overcoming limitations of the current prostate cancer treatments and the heterogeneity of resistance."

The poster presentation, with lead author Kanak Raina, Senior Director of Biology at Halda, entitled "An Oral RIPTAC Therapeutic for Prostate Cancer," will take place on Thursday, February 16 at 11:30 a.m.-1:00 p.m. PT and at 5:45-6:45 p.m. PT in Poster Session A: Prostate Cancer in Level 1 West Hall. The abstract for the ASCO (Free ASCO Whitepaper) GU poster presentation can be found here. Highlights from the presentation include the following results:

In castrated mice bearing VCaP xenografts, the prostate cancer RIPTAC therapeutic resulted in tumor growth inhibition superior to enzalutamide, the standard of care agent for prostate cancer as well as broad in vitro activity across prostate cell lines.
In castrated mice bearing VCaP xenografts, the prostate cancer RIPTAC therapeutic induced AR:RIPTAC:EP ternary complex formation in the tumor at a low oral dose, resulting in tumor‑specific abrogation of the essential protein.
The RIPTAC therapeutic demonstrated pharmacokinetic properties suitable for oral administration.
Lead molecules utilizing AR as a tumor protein formed a ternary complex between AR and an essential protein involved in transcriptional regulation across prostate cancer cell lines, leading to abrogation of the essential protein and consequent cancer cell killing.
About Prostate Cancer and mCRPC

Prostate cancer is the most common non-skin cancer in men. In the U.S., 1 in 8 men will be diagnosed with prostate cancer in his lifetime.1 Prostate cancer depends on the androgen receptor (AR), a transcription factor critical for prostate cancer growth and progression. Treatment initially relies on androgen deprivation therapy, as well as AR signaling inhibitors (ARSIs). However, resistance to antiandrogen interventions eventually emerges, and is driven by many heterogenous bypass mechanisms including genomic alterations in AR. The long-term prognosis for patients with metastatic castration resistant prostate cancer (mCRPC) is poor, with a relatively short overall survival. In the mCRPC form of the disease, more than 80% of patients harbor amplifications of the AR gene or the upstream enhancer region of DNA.2 AR remains expressed in tumors even if they are no longer AR dependent, dramatically reducing effectiveness of ARSIs, thus representing a vast unmet need.

On February 14, 2023 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage cell and gene therapy company advancing a new class of treatments for patients with cancer and rare diseases, reported that the Company’s Chief Executive Officer, Mark Gergen, will participate in a fireside chat at the H.C. Wainwright Cell Therapy Virtual Conference on February 28, 2023, at 11:00 AM ET (Press release, Poseida Therapeutics, FEB 14, 2023, View Source [SID1234627222]).

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A webcast of the presentation will be available on the Investors & Media Section of Poseida’s website, www.poseida.com. A replay of the webcast will be available for approximately 90 days following the presentation.

On February 14, 2023 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company"), a leader in the development of targeted radiotherapies, reported its presence at the upcoming Tandem Meetings: Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) being held February 15 – 19, 2023 at the World Center Marriott in Orlando, Florida (Press release, , FEB 14, 2023, View Source;cellular-therapy-tandem-meetings-on-saturday-february-18-2023-301745923.html [SID1234627219]). Actinium will host an investor conference call and webcast to present full topline results from its pivotal Phase 3 SIERRA trial of Iomab-B at 6:00 PM EST on Saturday, February 18, 2023. The investor conference call will follow the late-breaker presentation of the full Phase 3 SIERRA trial results. In addition, Iomab-B will be highlighted in a CME Event titled, "The Convergence of Innovative Therapy and AlloHCT in AML: Applying Current Evidence to Improve Outcomes Across Patient Populations.

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Investor Conference Call and Webcast Details:

Time / Date:

6:00 PM EST on Saturday, February 18, 2023

Presenters:

Sandesh Seth, Chairman & CEO, Madhuri Vusirikala M.D., Vice President, Clinical Development – Transplant & Cellular Therapy, Avinash Desai, M.D., Chief Medical Officer, Caroline Yarbrough, Chief Commercial Officer

Dial-in:

1-877-407-0784 (toll-free domestic) or 1-201-689-8560 (international) or by clicking on this link and requesting a return call

Live webcast:

To access the live webcast of the call with slides please visit the Investors section of Actinium’s website View Source or View Source;tp_key=580722640c

An archived webcast will be available on the Actinium’s website (click here) after the event.

TCT Iomab-B SIERRA Trial Late-Breaker Presentation Details:

Presentation Title:

Efficacy and Safety Results of the SIERRA Trial: A Multicenter, Pivotal Phase 3 Study of Iomab-B Prior to Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care in Older Patients with Active, Relapsed or Refractory Acute Myeloid Leukemia

Date: Saturday, February 18, 2022

Time: 5:00 PM EST

Presenter: Dr. Sergio Giralt, Memorial Sloan Kettering Cancer Center

Location: World Center Marriott, Cypress 3

CME Event Details:

Title: The Convergence of Innovative Therapy and AlloHCT in AML: Applying Current Evidence to Improve Outcomes Across Patient Populations

Date: Thursday, February 16, 2023

Time: 12:45 PM EST

Location: World Center Marriott, Cypress 3

About Iomab-B and the Pivotal Phase 3 SIERRA Trial

Iomab-B is a first-in-class targeted radiotherapy intended to improve patient access to potentially curative BMT by simultaneously and rapidly depleting blood cancer, immune and bone marrow stem cells that uniquely express CD45. Multiple studies have demonstrated increased survival in patients receiving BMT, however, an overwhelming majority of patients with blood cancers do not receive BMT as current approaches do not produce a remission, which is needed to advance to BMT, or are too toxic. Studied in over 400 patients, prior studies with Iomab-B have demonstrated nearly universal access to BMT, increased survival and tolerability in multiple clinical trials including the recently completed pivotal Phase 3 SIERRA trial in patients with active (leukemic blasts >5%), relapsed or refractory acute myeloid leukemia (r/r AML) age 55 and above. The SIERRA trial produced positive topline results, meeting its primary endpoint of durable Complete Remission (dCR) of 6 months with statistical significance (p<0.0001). Actinium intends to submit a Biologics License Application (BLA) seeking approval for Iomab-B to address patients age 55+ with r/r AML who cannot access BMT with currently available therapies. Iomab-B has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and has patent protection into 2037.

The pivotal Phase 3 SIERRA (Study of Iomab-B in Elderly relapsed or refractory AML) is a 153-patient, randomized, multi-center clinical trial, studying Iomab-B compared to the control arm of physician’s choice of salvage therapy. Control arm options included chemotherapies like cytarabine and daunorubicin and targeted agents such as a Bcl-2 inhibitor (Venetoclax), FLT3 inhibitors and IDH 1/2 inhibitors. The SIERRA control arm reflects real-world treatment of r/r AML patients with over 20 single agents or combination of agents as no standard of care exists for this patient population. Data from full patient enrollment presented at the Transplantation & Cellular Therapy Tandem Meetings in April 2022 showed that 100% of patients receiving Iomab-B accessed BMT and engrafted without delay. Iomab-B was also shown to be well tolerated given its targeted nature, consistent with its previous clinical data. The SIERRA trial enrolled patients at 24 leading transplant centers in the United States and Canada that perform over 30% of AML BMTs.

Developed at the Fred Hutchinson Cancer Research Center, a pioneer in the field of BMT, Iomab-B is supported by data in six disease indications including leukemias, lymphomas and multiple myeloma, which afflict over 100,000 patients annually. Actinium intends to pursue additional indications for Iomab-B beyond AML. Actinium also intends to pursue international regulatory approvals independently and through partnerships. In April 2022, Actinium licensed the European, Middle East and North African commercial rights for Iomab-B to Immedica AB, a fully-fledged independent pharmaceutical company headquartered in Sweden. In exchange, Actinium received an upfront payment of $35 million USD with the potential for an additional $417 million USD in regulatory and sales milestones and mid-twenty percent royalties. Europe represents a commercial opportunity double the size of the United States by number of patients with AML receiving BMT. Iomab-B has been granted Orphan Drug Designation by the European Medicines Agency (EMA) and has received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the EMA indicating that the Phase 3 SIERRA trial design, primary endpoint and planned statistical analysis are acceptable as the basis for a Marketing Authorization Application.