On December 7, 2020, GenScript ProBio and Initium Therapeutics reported that Initium Therapeutics has launched a single B-cell based antibody development platform through collaboration with GenScript ProBio (Press release, Initium Therapeutics, DEC 7, 2020, View Source [SID1234629627]). Initium Therapeutics is a US biotechnology company, a spin-off from South Korean biotech company Tiumbio, seeking antibody-based therapeutics for patients who are suffering from unaddressed incurable and rare diseases. The strategic collaboration between the two companies will allow Initium Therapeutics to expand their antibody drug pipeline using GenScript ProBio’s ultra-rapid, high-efficient Berkeley Lights Beacon platform. Furthermore, their partnership will potentially be extended to GenScript ProBio’s cutting edge therapeutic antibody development platforms, including bispecific antibody platform, human antibody transgenic mouse and/or downstream therapeutic antibody development and manufacturing processes. Through this partnership, Initium Therapeutics expects to significantly accelerate their therapeutic antibody pipeline development.

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"We are very pleased to announce that through the strategic collaboration with GenScript ProBio, we will expand our therapeutic antibody pipeline in fibrosis, immuno-oncology and hemophilia," said Dr. Huntaek Kim, CEO of Initium Therapeutics/TiumBio. "Initium Therapeutics was established to develop innovative antibody-based therapeutics focusing on unaddressed rare diseases. Our deep scientific and drug development expertise have allowed us to recognize new therapeutic targets in fibrosis, immuno-oncology and hemophilia, and I believe the partnership with GenScript ProBio will strengthen our therapeutic antibody platform and expand our antibody pipeline in more rapid and highly efficient ways."

"We are very glad to cooperate with Initium Therapeutics and help them expand their therapeutic antibody pipeline in fibrosis, immuno-oncology and hemophilia by utilizing GenScript ProBio’s Berkeley Lights Beacon platform," said Dr. Brian Min, CEO of GenScript ProBio. "Our Single B cell screening platform dramatically expedites and enables unparalleled B cell diversity. We will continue fueling Initium’s first-rate research capabilities and look forward to further collaboration to bring diverse treatment options to patients in rare diseases," he added.

On December 7, 2020 Teneobio, Inc., a clinical stage biotech company focused on discovery and development of novel multi-specific biotherapeutic antibodies, reported initial results of a Phase I trial (View Source) evaluating TNB-383B in Relapsed Refractory Multiple Myeloma (R/R MM) on December 5 at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Conference (Press release, TeneoBio, DEC 7, 2020, View Source;utm_medium=rss&utm_campaign=teneobio-reports-initial-data-phase-study-of-tnb-383b-in-relapsed-refactory-multiple_myeloma [SID1234572319]). TNB-383B is a fully human bispecific antibody that targets BCMA on the surface of multiple myeloma (MM) cells and CD3 on the surface of T cells in order to trigger lysis of MM cells in MM patients. The ongoing open-label multi-center trial is designed to assess the safety, pharmacokinetics and preliminary efficacy of TNB-383B administered intravenously once every 21 days.

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TNB-383B demonstrated a favorable safety profile in patients with R/R MM and achieved an overall response rate (ORR) of 80% at doses ≥ 40 mg every three weeks (QW3). The most common adverse events were cytokine release syndrome (CRS), fatigue, headache, anemia, infection, and nausea. Notably, at all doses, CRS was limited to Grade 1-2, with no patient experiencing a Grade 3 CRS. No step-dosing or dose splitting was necessary in any patient. Among the responders, over 75% had very good partial response (VGPR) or better. The median Time to Response (TTR) was 3 weeks (1 cycle) and responses deepened with additional time on therapy. The multi-center escalation and expansion cohorts are ongoing so that the median Duration of Response (DOR) has not been reached.

"Immunotherapy represents the next frontier in the management of myeloma, with many different approaches being explored in clinical trials. The results with TNB-383B have been very promising with high response rates in patients with relapsed refractory myeloma and very manageable toxicity that allows for outpatient management of these patients," said Dr. Shaji Kumar of Mayo Clinic, Rochester, and one of the Principal Investigators on this trial. "We are pleased to announce these compelling initial results. The safety profile and response rates we have seen in this initial trial validate our differentiated CD3 platform and support further development of TNB-383B in R/R MM patients," said Ben Buelow, Teneobio’s Chief Medical Officer. "In addition to TNB-383B, we look forward to advancing multiple CD3 engaging bi-specific antibodies into the clinic, both in hematologic malignancies and solid tumors."

About TNB-383B

TNB-383B is a fully human bispecific monoclonal antibody being developed for MM. TNB-383B was designed to bind to BCMA with high affinity and simultaneously result in T-cell binding/activation to cause destruction of tumor cells accompanied by markedly attenuated cytokine production. TNB-383B is being developed in collaboration with AbbVie Inc.

On December 7, 2020 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported that it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell $200,000,000 of shares of its common stock (Press release, Kura Oncology, DEC 7, 2020, View Source [SID1234572337]). In connection with the offering, Kura expects to grant the underwriters a 30-day option to purchase up to an additional $30,000,000 of the shares of common stock offered in the public offering. All of the shares in the proposed offering will be offered by Kura. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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SVB Leerink, Credit Suisse, Barclays and Stifel are acting as joint bookrunning managers in the offering.

The securities described above are being offered by Kura pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed by Kura with and became effective by rule of the Securities and Exchange Commission (the "SEC") on December 7, 2020. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, 6933 Louis Stephens Drive, Morrisville, NC 27560, by telephone at (800) 221-1037, or by email at [email protected]; Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected], or by telephone at (888) 603-5847; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, or by email at [email protected], or by telephone at (415) 364-2720.

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 December 7, 2020 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company") reported that 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 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting (Press release, Actinium Pharmaceuticals, DEC 7, 2020, View Source [SID1234572353]). The oral presentation highlighted Iomab-B’s targeting ability and corresponding safety data from 110 patients from the SIERRA trial for which detailed safety data was available. Iomab-B targets CD45, an antigen expressed on leukemia and lymphoma cancer cells and immune cells including bone marrow stem cells but not 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 healthy 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 that 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.

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Dr. Mark Berger, Actinium’s Chief Medical Officer, commented, "We are pleased that the engraftment and safety profile of Iomab-B remains positive and consistent with prior interim safety results at 75% of patient enrollment in SIERRA and also consistent with the large body of historical data from Iomab-B. Collectively, this data gives excitement as we approach the upcoming ad hoc interim analysis for SIERRA that will be completed by year-end and the ultimate potential of Iomab-B for patients with R/R AML and other blood cancers as a targeted conditioning regimen."

Safety data presented in ASH (Free ASH Whitepaper) oral presentation are highlighted in the table below:

ASH Oral Presentation: High Doses of Targeted Radiation with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Do Not Correlate with Incidence of Mucositis, Febrile Neutropenia or Sepsis in the Prospective, Randomized Phase 3 Sierra Trial for Patients with Relapsed or Refractory Acute Myeloid Leukemia

Adverse Event

1 Adverse Event data available for 46 of 47 evaluable patients

2 Adverse Event data available for 27 of 30 evaluable patients

3 Iomab-B arm: 4 patients unevaluable. Conventional Care Arm: 4 patients unevaluable

Patient Group

No. of
Patients

Radiation dose delivered to
the Marrow. Median (range)

Radiation dose to GI tract.
Median (range)

Iomab-B

Vijay Reddy, Vice President, Clinical Development and Head of BMT, "The targeted nature of Iomab-B makes it highly differentiated from current BMT conditioning regimens that are largely comprised of non-targeted cytotoxic chemotherapies. These data from SIERRA showing higher rates of sepsis, neutropenia and mucositis in patients receiving chemotherapy are consistent with the literature and unfortunately what we expected but hope to address with Iomab-B. Particularly, chemotherapy’s effect on the GI tract and resulting mucositis, which we believe is leading to the higher rates of sepsis seen in the control arm. We are highly encouraged by the lower rates of adverse events and the universal engraftment reported from SIERRA and excited for the potential of targeted conditioning could have an BMT access, patient outcomes and quality of life."

About Iomab-B

Iomab-B (I-131 apamistamab) via the monoclonal antibody apamistamab, targets CD45, an antigen widely expressed on leukemia and lymphoma cancer cells, B cells and stem cells. Apamistamab is linked to the radioisotope iodine-131 (I-131) and once attached to its target cells 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 will 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 at one year. 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 December 7, 2020 OncoMyx Therapeutics, a privately-held oncolytic immunotherapy company, reported that The University of Western Ontario (Western) has assigned to OncoMyx the technology and patent rights associated with pioneering research on the use of myxoma virus in the treatment of cancer (Press release, OncoMyx Therapeutics, DEC 7, 2020, View Source [SID1234572370]). This research was led by OncoMyx cofounder Grant McFadden, Ph.D., when he was a Professor at Western and the Robarts Research Institute.

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Lisa Cechetto, the Executive Director of WORLDiscoveriesTM, the technology transfer office for Western, Robarts Research Institute, and Lawson Research Institute, said, "We are pleased to assign these patents to OncoMyx, as it is important that the outputs of pioneering research, such as Dr. McFadden’s use of myxoma virus to create novel oncolytic therapies, be further developed to improve the lives of cancer patients or others who may benefit."

"The assignment of this technology and intellectual property to OncoMyx further reinforces our IP portfolio protecting our use of myxoma virus and our pipeline of myxoma virotherapies for the treatment of cancer," said Steve Potts, Ph.D., MBA, cofounder and chief executive officer of OncoMyx. "The myxoma virus has a number of important attributes that we are leveraging to develop potentially impactful oncolytic immunotherapies with the goal of increasing the number of cancer patients who could benefit from immunotherapies."

"Oncolytic viruses are emerging as a new pillar of cancer care with the potential to expand the effectiveness of immunotherapies, such as immune checkpoint inhibitors," said Dr. McFadden. "I am pleased that OncoMyx has been assigned the patent rights associated with the pioneering myxoma research that was done at Western, as the myxoma virus is unique as a technology platform to build oncolytic immunotherapies."

About Myxoma Virotherapy for the Treatment of Cancer

The myxoma virus is highly immuno-interactive and can selectively infect and kill a broad range of cancer cell types. Because myxoma virus is not pathogenic to humans, myxoma virotherapy does not have to overcome pre-existing immunity. As a large dsDNA poxvirus, myxoma is engineerable to express multiple transgenic payloads, such as immunomodulatory proteins, to target multiple points in the cancer immunity cycle. The company’s preclinical data demonstrates efficacy of multi-armed myxoma virotherapies via intravenous (IV) and intratumoral (IT) delivery in a number of tumor models across multiple cancer indications and supports a pan-tumor approach to expand the therapeutic effectiveness of immunotherapies.