On June 15, 2021 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology company pioneering the development of monoclonal antibodies targeting treatment of various cancers and viral infections, reported to highlight the publication of an in-depth analyst research report on Nascent Biotech by equity research firm, Marble Arch Research, Inc, which rated NBIO a "Speculative Buy" under its tiered rating system, and specified a price target of between $0.39-$1.99 (Press release, Nascent Biotech, JUN 15, 2021, View Source [SID1234584175]).

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 report concludes, "We believe that there is a reasonable investment thesis at hand to indicate that the company’s market value can rise significantly as its lead development drug, PTB, progresses through its clinical study journey, which has just begun. We rate the stock a Speculative BUY."

‘In its comprehensive report, Marble Arch Research highlights the progress we have made this year as we cross critical milestones on the path toward potential eventual commercialization of our primary platform asset, pritumumab," commented Sean Carrick, CEO of Nascent Biotech. "Now that we are well into clinical trials, we look forward to gaining a deeper understanding of how our research can make the greatest possible positive impact for those suffering from the cancers and viral infections we are targeting. And we continue to seek to protect and reward our shareholders for their loyalty, patience and commitment along the way."

On June 15, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune(R) T-cell activating technology, reported the pricing of its previously announced underwritten public offering of 5,294,118 shares of its common stock at a public offering price of $8.50 per share(Press release, PDS Biotechnology, JUN 15, 2021, View Source [SID1234584097]). The gross proceeds to PDS Biotech, before deducting the underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $45.0 million. All of the shares of common stock to be sold in the offering are being offered by PDS Biotech. PDS Biotech has granted the underwriters a 30-day option to purchase up to an additional 794,117 shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about June 17, 2021, subject to customary closing conditions.

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!

Cantor Fitzgerald & Co. is acting as sole bookrunner for the offering.

PDS Biotech intends to use a portion of the net proceeds from this offering for the development of our clinical pipeline and for general corporate purposes including working capital.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission (the "SEC") and became effective on July 31, 2020. A preliminary prospectus supplement relating to the offering has been filed with the SEC and a final prospectus supplement relating to the offering will be filed with the SEC. Copies of the final prospectus supplement and accompanying prospectus may be obtained from Cantor Fitzgerald & Co., 499 Park Avenue, 4th Floor, New York, NY 10022, Attn: Capital Markets Department, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On June 15, 2021 Actinium Pharmaceuticals reported data from its pivotal Phase 3 SIERRA trial for Iomab-B in an oral presentation at the 2021 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, which is to be held virtually from June 11th – 14th (Press release, Actinium Pharmaceuticals, JUN 15, 2021, View Source [SID1234584091]). Iomab-B is radiotherapy that targets cells expressing CD45, a protein found only on blood cancer cells and immune cells including bone marrow stem cells, with the radioisotope iodine-131 and is intended to be a targeted conditioning agent to enable potentially curative bone marrow transplant (BMT). The SIERRA trial is the only randomized Phase 3 trial to offer potentially curative BMT as an option for patients with active, relapsed or refractory acute myeloid leukemia (r/r AML) age 55 and above, a patient population not considered eligible for BMT with standard non-targeted conditioning regimens.

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!

Dr. Mark Berger, Actinium’s Chief Medical Officer, said, "Our enthusiasm for Iomab-B continues to grow at every safety and feasibility update from the pivotal Phase 3 SIERRA trial. With consistently strong engraftment data through 75% of patient enrollment, we believe Iomab-B has the potential to unlock a paradigm shift in the treatment of patients with relapsed and refractory AML. Despite 9 approved drugs for patients with AML since 2017, many of which are targeted agents, AML remains one of the most difficult to treat blood cancers with the lowest 5-year survival rate. In developing Iomab-B our goal is to improve patient outcomes by enabling potentially curative BMT for a large portion of the AML patient population."

SNMMI Presentation Title: Relationship of Marrow Radiation Dose and Timing of Engraftment for Targeted Radioimmunotherapy with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] in Patients with Active Relapsed or Refractory Acute Myeloid Leukemia

Presenter: Susan Passalaqua, MD, Banner MD Anderson Cancer Center

SNMMI Presentation Highlights:

100% BMT and engraftment rate for patients receiving a therapeutic dose of Iomab-B compared to 18% of patients receiving physician’s choice of salvage therapy on the control arm
79% of all patients enrolled on SIERRA were able to proceed to BMT despite being a patient population not considered eligible for BMT with standard approaches
Iomab-B delivers high amounts of targeted radiation to the bone marrow with minimal impact on other organs resulting in lower rates and severity of adverse events

About Iomab-B
Iomab-B (I-131 apamistamab) is an Antibody Radiation Conjugate (ARC) that is intended to condition or prepare patients for a potentially curative bone marrow transplant (BMT) in a targeted manner with the goal of reducing adverse events and increasing patent access to BMT. Via the monoclonal antibody apamistamab, Iomab-B targets CD45, an antigen widely expressed on leukemia and lymphoma cancer cells, immune cells and stem cells. Apamistamab is linked to the radioisotope iodine-131 (I-131) and once its attached to its target cells, it emits energy that travels about 100 cell lengths, destroying a patient’s cancer cells and ablating their bone marrow. By carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B can avoid the side effects of radiation on most healthy tissues while effectively killing the patient’s cancer and marrow cells.

Iomab-B is currently being studied in the pivotal Phase 3 SIERRA (Study of Iomab-B in Relapsed or Refractory AML) trial, a 150-patient, randomized controlled clinical trial in patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are age 55 and above. The SIERRA trial is being conducted at preeminent transplant centers in the U.S. with the primary endpoint of durable Complete Remission (dCR) at six months and a secondary endpoint of overall survival. Upon approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, in a potentially safer and more efficacious manner than the non-targeted intensive chemotherapy conditioning that is the current standard of care in bone marrow transplant conditioning. A bone marrow transplant is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Additional information on the Company’s Phase 3 clinical trial in R/R can be found at www.sierratrial.com.

On June 15, 2021 Actinium Pharmaceuticals reported safety data from its ongoing pivotal Phase 3 SIERRA trial of Iomab-B in patients with relapsed or refractory Acute Myeloid Leukemia (r/r AML) were presented at the 2021 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting which was held virtually June 11th – 14th (Press release, Actinium Pharmaceuticals, JUN 15, 2021, View Source [SID1234584090]). The presentation highlighted Iomab-B’s targeting ability and corresponding safety data from 113 patients, representing 75% of patient enrollment on the SIERRA trial.
Iomab-B targets CD45, an antigen expressed on leukemia and lymphoma cancer cells and immune cells including bone marrow stem cells but not on cells outside of the blood forming or hematopoietic system. This allows high amounts of radiation to be delivered to the bone marrow via Iomab-B while sparing critical organs. As a result, statistically significant lower rates of sepsis were reported as well as lower rates of febrile neutropenia, mucositis and non-relapse transplant related mortality in patients receiving Iomab-B and bone marrow transplant (BMT) compared to patients that received salvage therapy and a BMT. In addition, patients who crossed over to receive Iomab-B and went to BMT after receiving salvage therapy but not achieving a complete response also had lower rates of sepsis, febrile neutropenia, mucositis and non-relapse transplant related mortality.
Dr. Mark Berger, Actinium’s Chief Medical Officer, commented, "Relapsed and refractory AML in older patients is a particularly challenging disease to treat. Patients are heavily pretreated making their disease resistant to most standard therapies and often have comorbidities that limit treatment options, particularly bone marrow transplant. It is highly encouraging to us that in the SIERRA trial thus far, Iomab-B has enabled all patients receiving a therapeutic dose to proceed to BMT, the only curative treatment option for this patient population. Importantly, Iomab-B has been well tolerated and we are elated with the safety data from 75% of patient enrollment in the SIERRA trial. Given the targeted nature of Iomab-B, we can spare non-targeted organs like GI tract and deliver higher amounts of radiation to the bone marrow, the target organ. We are thrilled to be able to highlight results of the SIERRA trial through 75% of patient enrollment at SNMMI and look forward to future opportunities to present topline data from the full study."

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!

About Iomab-B
Iomab-B (I-131 apamistamab) is an Antibody Radiation Conjugate (ARC) that is intended to condition or prepare patients for a potentially curative bone marrow transplant (BMT) in a targeted manner with the goal of reducing adverse events and increasing patent access to BMT. Via the monoclonal antibody apamistamab, Iomab-B targets CD45, an antigen widely expressed on leukemia and lymphoma cancer cells, immune cells and stem cells. Apamistamab is linked to the radioisotope iodine-131 (I-131) and once its attached to its target cells, it emits energy that travels about 100 cell lengths, destroying a patient’s cancer cells and ablating their bone marrow. By carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B can avoid the side effects of radiation on most healthy tissues while effectively killing the patient’s cancer and marrow cells.

Iomab-B is currently being studied in the pivotal Phase 3 SIERRA (Study of Iomab-B in Relapsed or Refractory AML) trial, a 150-patient, randomized controlled clinical trial in patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are age 55 and above. The SIERRA trial is being conducted at preeminent transplant centers in the U.S. with the primary endpoint of durable Complete Remission (dCR) at six months and a secondary endpoint of overall survival. Upon approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, in a potentially safer and more efficacious manner than the non-targeted intensive chemotherapy conditioning that is the current standard of care in bone marrow transplant conditioning. A bone marrow transplant is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Additional information on the Company’s Phase 3 clinical trial in R/R can be found at www.sierratrial.com.

On June 15, 2021 Autolus Therapeutics, a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported that it has received innovative licensing and access pathway (ILAP) designation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for AUTO1 (obecabtagene autoleucel, obe-cel), the company’s CAR T cell therapy being investigated in the ongoing FELIX Phase 1b/2 study in relapsed / refractory (r/r) adult B-cell Acute Lymphocytic Leukemia (ALL) in patients 18 years and older (Press release, Autolus, JUN 15, 2021, View Source [SID1234584088]).

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 ILAP designation for obe-cel, alongside the recent PRIority MEdicines (PRIME) designation from the European Medicines Agency (EMA), is another step forward in accelerating the review process of this promising therapy," said Dr. Christian Itin, chief executive officer of Autolus. "Obe-cel continues to show the potential to be differentiated on efficacy, durability and safety from other CAR T cell products and could change standard of care by offering a potentially curative therapy for r/r ALL."

About ILAP
ILAP was announced in December 2020 and launched at the start of 2021 in order to accelerate the development and access to promising medicines and is geared toward medicines that are in the early stages of development. The pathway, part of the UK’s plan to attract life sciences development in the post-Brexit era, features enhanced input and interactions with MHRA and other stakeholders including the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC). (RELATED: MHRA sheds light on pathway to accelerate R&D, Regulatory Focus 24 December 2020).

The innovation passport designation is the first step in the ILAP process and triggers the MHRA and its partner agencies to chart a roadmap for regulatory and development milestones with the goal of early patient access in the UK. Other benefits of ILAP include access to range of development tools, such as the potential for a 150-day accelerated Marketing Authorization Application (MAA) assessment, rolling review and a continuous benefit risk assessment.