On December 13, 2021 Biosion, Inc. ("Biosion"), a global, clinical stage biotechnology company, reported that Biosion and OBI Pharma Inc. (4174.TWO) ("OBI Pharma") have signed an exclusive license agreement under which OBI Pharma will be granted a global exclusive license to Biosion’s proprietary anti-Trop2 humanized monoclonal antibody, BSI04702, for developing next generation biologics (Press release, Biosion, DEC 13, 2021, View Source;and-other-derivative-products-301442963.html [SID1234597014]). The license agreement enables OBI Pharma to conduct further preclinical and clinical development, registration, and commercialization of BSI04702 as an Antibody Drug Conjugate and other derivative products. Under the terms of the agreement, OBI Pharma will pay license fees to Biosion, including an upfront payment, future development milestones and net sales royalties. The specific terms of the agreement were not disclosed.

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"Biosion has been driving innovation to deliver breakthrough therapies for cures. The licensing of our anti-TROP-2 mAb to OBI Pharma for global development further exhibits the strength of our discovery engine and proprietary SynTracerTM HT-endocytosis platform to identify superior mAbs, ideal as ADCs" said Dr. Hugh Davis, Chief Operating Officer of Biosion, Inc. and President of Biosion USA. "We are looking forward to partnering with OBI Pharma to advance BSI-04702 into the clinical stage as fast as possible and making a difference for patients worldwide."

BSI04702 was created through Biosion’s proprietary SynTracerTM HT-endocytosis platform, a high-throughput endocytosis screening application that can identify antibody candidates with high internalization rates- a critical parameter for lead antibody success in next generation ADC development.

On December 13, 2021 Zetagen Therapeutics, Inc., a private, clinical-stage, biopharmaceutical company dedicated to driving breakthrough innovation in the treatment of metastatic bone cancers and osteologic interventions, reported it has received a two year, $2 million USD grant from the National Cancer Institute of the National Institutes of Health (NIH) (Press release, Zetagen Therapeutics, DEC 13, 2021, View Source [SID1234643706]). The grant will be used for the Phase 2 clinical and commercial development of its ZetaMet (Zeta-BC-003) technology. ZetaMet (Zeta-BC-003) is a synthetic, small-molecule, inductive biologic technology being developed to target and resolve metastatic bone lesions while inhibiting future tumor growth and regenerating bone..

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"This support from the NCI marks a key milestone and will facilitate the continued development of ZetaMet (Zeta-BC-003) for the use in treating metastasis in bone," said Bryan S. Margulies, PhD,chief scientific officer of Zetagen Therapeutics. "Preclinical trials have successfully demonstrated ZetaMet (Zeta-BC-003)’s ability to resolve existing metastatic bone lesions, inhibit pain and stimulate targeted bone regeneration. If these results hold true in the next phase of study, ZetaMet (Zeta-BC-003) could offer an entirely new treatment for patients living with certain late-stage cancers where present therapies do not offer desired results."

ZetaMet (Zeta-BC-003) works through a mechanism of action (MOA) which is a novel and patented molecular pathway. The small molecule, precisely-dosed, delivered to the affected area through a proprietary drug-eluting carrier, stimulates stem cells, activating cells to grow healthy bone known as "osteoblasts", and inhibits cells associated with bone degradation called "osteoclasts".

Bone metastases are common among cancer patients and occur when cells from the primary cancerous tumor relocate to the bone. When these cancers relocate, they can cause changes to the bone, damaging it in a process called osteolysis. Osteolysis can cause small holes within the bone, weakening it and increasing the risk of breakage. These holes are called "lytic lesions." Among cancers which metastasize to bone, Breast and Prostate are most prevalent, amounting to approximately 70-percent of cases.[1]

"We know there are hundreds of thousands of patients living with late-stage cancers which involve painful, debilitating metastatic bone lesions," said Joe C. Loy, CEO of Zetagen Therapeutics. "This recognition from the NCI further reinforces our commitment to developing breakthrough therapies that will make a tangible difference in quality of life as they battle these devastating diseases."

Earlier this year, ZetaMet (Zeta-BC-003) received Breakthrough Device designation from the Centers for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA). The first human clinical trial using ZetaMet (Zeta-BC-003) in Stage 4 breast cancer patients is being targeted for early 2022.

On December 13, 2021 Bristol Myers Squibb (NYSE: BMY) reported that on December 10, 2021, its Board of Directors approved an increase in the quarterly dividend and authorized an additional multi-year share repurchase program (Press release, Bristol-Myers Squibb, DEC 13, 2021, View Source [SID1234596913]).

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"The company’s financial position is strong, and we remain committed to a consistent, balanced capital allocation strategy," said Giovanni Caforio, board chair and chief executive officer, Bristol Myers Squibb. "With significant free cash flow of $45 billion to $50 billion expected between 2021 and 2023, investment in business development continues to be a key priority for the company in driving innovation and sustained growth as we return capital to shareholders through the dividend increase and expanded share repurchase authorization. We remain committed to maintaining a strong investment grade credit rating and reducing our debt."

Increase in 2022 Dividend

The Board of Directors has declared a quarterly dividend of fifty-four cents ($0.54) per share on the $.10 par value common stock of the company. The dividend is payable on February 1, 2022 to stockholders of record at the close of business on January 7, 2022.

This amount represents a 10.2% increase in the quarterly dividend over last year’s quarterly rate of forty-nine cents ($0.49) per share. At this quarterly dividend rate, subject to the normal quarterly review by the Board of Directors, the annual dividend rate for the fiscal year 2022 is $2.16 per share. This marks the thirteenth consecutive fiscal year that Bristol Myers Squibb increased its dividend payouts.

In addition, the Board of Directors has declared a quarterly dividend of fifty cents ($0.50) per share on the company’s $2.00 convertible preferred stock, payable March 1, 2022 to stockholders of record at the close of business on February 1, 2022.

Multi-Year Share Repurchase Authorization

The Board of Directors also authorized the repurchase of an additional $15 billion of the company’s common stock. With this increase, the company’s total outstanding share repurchase authorization is approximately $15.2 billion. This multi-year authorization enables management to execute repurchases at its discretion.

The timing and amount of any share repurchases under the authorization will be determined by management at its discretion and based on market conditions and other considerations. Share repurchases under the authorizations may be made through a variety of methods, which may include open market purchases, pursuant to pre-set trading plans meeting the requirements of Rule 10b-1 under the Securities Exchange Act of 1934, in privately negotiated transactions, block trades, accelerated share repurchase transactions, or any combination of such methods. The program does not obligate Bristol Myers Squibb to acquire any particular amount of its common stock, and the repurchase program may be suspended or discontinued at any time at the company’s discretion.

On December 13, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported its inaugural issuance of a $1 billion sustainability bond, which was part of an $8 billion underwritten public offering of notes that closed on Dec. 10, 2021 (Press release, Merck & Co, DEC 13, 2021, View Source [SID1234596930]).

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Merck’s environmental, social and governance (ESG) efforts are grounded in the core values that have always guided the company’s mission to invent for life, with a responsibility to patients and animals in need of medicines and vaccines, and with respect, inclusion and accountability to its employees. The company’s 130-year legacy has been built on the understanding that operating responsibly, enabling access to health for the patients and communities it serves, investing in and cultivating the company’s employees, and reducing its impact on the environment underpins the success and long-term sustainability of its business.

"Today’s announcement is an important step to further integrate ESG into the core of our business, accelerate the achievement of our ESG goals, and measure and continue to be transparent about our progress," said Caroline Litchfield, chief financial officer, executive vice president, Merck.

Merck intends to use the net proceeds from this bond offering to support projects and partnerships in the company’s priority ESG areas and contribute to the advancement of the United Nations Sustainability Development Goals. These company projects and partnerships include:

Access to essential services – health care, such as medicines and vaccines, maternal health programs, health care system strengthening, product donations, medical outreach, disaster and emergency relief, and patient assistance programs
Infectious disease research and development that includes antimicrobial resistance, neglected and emerging diseases, and sexual and reproductive health
Socioeconomic advancement and empowerment, particularly for minority and women-owned business enterprise (MWBE) suppliers, employee diversity and inclusion initiatives, and health literacy programs which serve people of all ages, races, incomes and education levels
Renewable energy generation projects such as new onsite or offsite solar or wind generating capacity, as well as electricity generated from renewable sources
Energy efficiency expenditures related to the company’s operations, such as energy-efficient heating, ventilation, air conditioning, refrigeration, lighting, roofing or electrical equipment, energy monitoring, control solutions and energy assessments, including smart meters and control automation devices
Green buildings, including the design, development, construction and certification costs for new/existing facilities to meet LEED Gold or Platinum standards (or equivalent), as well as those which achieve at least a 30% improvement in energy use or GHG emissions
Sustainable water and wastewater management to improve water quality or water efficiency, such as wastewater treatment, recycling and harvesting, overall reductions and reuse
Pollution prevention and control projects to reduce and manage emissions to air or water, as well as recycling projects and efforts to divert non-hazardous and/or hazardous waste away from landfills
The bond transaction is in line with Merck’s newly introduced Sustainability Financing Framework, which facilitates the company’s use of sustainable capital markets to finance or refinance eligible projects that align with its ESG commitments. This framework addresses the core components and key recommendations of the Social Bond Principles (2021), Green Bond Principles (2021), and Sustainability Bond Guidelines (2021), all of which are administered by the International Capital Markets Association (ICMA). V.E., a Moody’s affiliate, provided a second party opinion (SPO) on Merck’s Sustainability Financing Framework.

Merck has committed to annual reporting on the allocation of bond net proceeds to actual spend by social and/or environmental category, along with the remaining balance of unallocated proceeds. Where feasible, Merck will report estimated social and/or environmental quantitative impact metrics and provide qualitative case studies on eligible projects. For eligible social projects, Merck will seek to report impact metrics by target population to show how expenditures are enhancing access to the stated target population.

For more information on Merck’s ESG performance, policies and initiatives, please view the company’s 2020/2021 ESG Progress Report.

On December 13, 2021 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or the "Company"), a leader in the development of targeted radiotherapies for patients with unmet needs reported that positive data from the fully enrolled pivotal Phase 3 SIERRA trial of Iomab-B was presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (ASH) (Free ASH Whitepaper) that is being held December 11 – 14, 2021 in Atlanta, Georgia and virtually (Press release, Actinium Pharmaceuticals, DEC 13, 2021, View Source [SID1234596955]). Iomab-B is an antibody radiation conjugate (ARC) targeting CD45 with the Iodine-131 radioisotope payload that is intended to be a targeted conditioning regimen to enable patients to access a bone marrow transplant (BMT). The pivotal Phase 3 SIERRA trial is the only randomized Phase 3 trial for patients age 55 and above with active, relapsed or refractory acute myeloid leukemia (r/r AML) where BMT, the only potentially curative treatment option for this patient population, is feasible. SIERRA is a randomized trial that will compare outcomes of patients receiving Iomab-B and a BMT to those of patients on the control arm receiving physician’s choice of salvage therapy including recently approved targeted agents venetoclax (Bcl-2), midostaurin and giltiritinib (FLT-3), and ivosidenib (IDH) who can potentially receive a BMT if they achieve a remission.

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BMT Engraftment Rates in Evaluable Patients Throughout the SIERRA Trial

BMT Engraftment

25% enrollment
(n=38)

50% enrollment
(n=76)

75% enrollment
(n=113)

100% enrollment
(n=151)

SIERRA

100%

100%

100%

100%*

Conventional
Care

21%

18%

17.5%

17%

Iomab-B
Crossover

100%

100%

100%

100%

• Does not include data from 6 Iomab-B patients for which BMT engraftment and 100-day non-relapse transplant mortality data is still maturing

Dr. Avinash Desai, Actinium’s Chief Medical Officer, said, "The remarkably consistent and high rates of BMT engraftment together with the low rates of non-relapse transplant related mortality at day 100 with Iomab-B through 100% enrollment give us great confidence in SIERRA. Despite 9 AML therapies approved since 2017, many of which are targeted, outcomes for relapsed or refractory patients remain dismal and potentially curative bone marrow transplant is rarely accessible, especially for older patients with active disease like those in SIERRA. This is supported by the fact that only 17% of patients were able to go to transplant in the control arm, which included many of the newly approved targeted therapies. We are highly encouraged that the separation in the number of patients potentially evaluable for the primary endpoint of six-month durable complete remission has remained at approximately 5-times or greater through all data analyses and now at full enrollment."

Grade > 3 Adverse Events

Adverse Event

Iomab-B (n=75)

N (%)

Control Arm (n=76)

N (%)

Sepsis p=0.002

4 (5.3%)

18 (23.7%)

Febrile neutropenia

25 (33.3%)

34 (44.7%)

SIERRA Patient Demographics Through 100% Enrollment

Patients in the Iomab-B arm were a median age of 64 (range: 55-77) and had a median blast count of 30% (range: 2-97) while patients in the control arm were a median age of 65.5 (range: 55-76) and had a median blast count of 20% (range: 3-97)
Over 60% of patients in SIERRA had adverse cytogenetics and over 32% had intermediate risk cytogenetics
Over 50% of patients were primary induction failures, approximately 25% had early relapse (less than 6 months) and the remaining patients were relapsed or refractory or second relapse
66% of patients enrolled in SIERRA received and failed targeted therapies with 66% of patients receiving venetoclax (Bcl-2) based treatment
47% of patients randomized to the control arm in SIERRA received targeted therapies with 81% of patients receiving Venetoclax-based treatment
Dr. Desai continued, "Given the advanced age, high-risk cytogenetic profile, poor disease status and florid active disease of the SIERRA patient population, it is remarkable that Iomab-B has enabled BMT engraftment in 100% of all evaluable patients receiving a therapeutic dose. We are also highly encouraged by the safety and tolerability profile of Iomab-B, which we believe is the result of its targeted nature. We have shown that Iomab-B can deliver high amounts of radiation to the bone marrow but spare vital organs such as the GI tract. We believe this has resulted in the significantly lower rate of sepsis in the Iomab-b arm compared to the control arm, which is a leading cause of transplant related mortality. In addition, lower rates of other adverse events – such as febrile neutropenia combined with the lower rates of 100-day non-relapse transplant related mortality – in the SIERRA arm is exciting. With the final Iomab-B patient receiving their BMT in November 2021, we can confirm our expectation for topline data in the third quarter of 2022. We look forward to presenting additional BMT engraftment, safety and 100-day non-relapse transplant related mortality data from the fully matured data set at a medical conference in early February."

Sandesh Seth, Actinium’s Chairman and CEO, added, "Data from the SIERRA trial have continuously validated our enthusiasm for Iomab-B and its potential to improve patient outcomes. We are struck by not only the consistency of the universal BMT engraftment rates at 25%, 50%, 75% and now 100% enrollment but also the consistency of the SIERRA data with the multiple studies conducted at the Fred Hutchinson Cancer Research Center, which drove our decision to license Iomab-B. As data from the SIERRA trial evolved, the vision to drive a paradigm shift in BMT conditioning, which currently relies on decades old, non-targeted chemotherapy-based regimens that limit access and hinder outcomes, by bringing Iomab-B forward as a targeted conditioning regimen became clear. It is an incredibly exciting time for Actinium to have completed SIERRA trial enrollment and to be on the cusp of producing data to support a BLA filing with the FDA and potential approval. If approved, we will be in a position to execute our vision of leading the paradigm shift to make targeted conditioning for BMT a reality."

The ASH (Free ASH Whitepaper) SIERRA presentation can be accessed on Actinium’s investor relations page View Source

About the SIERRA Phase 3 Trial

The SIERRA trial is a 150-patient, randomized clinical trial, studying Iomab-B compared to the control arm of physician’s choice of salvage therapy in patients with active, relapsed or refractory acute myeloid leukemia (r/r AML) age 55 and above. In SIERRA, patients receiving Iomab-B, those achieving a remission after salvage therapy or those patients not achieving remission after salvage therapy that crossed over to receive Iomab-B were offered a bone marrow transplant (BMT), which is the only treatment option with curative potential for patients with active r/r AML. The SIERRA trial is the only randomized Phase 3 trial intended to offer BMT to this patient population. The control arm of SIERRA included over 20 single agents or combination treatment options based on physician’s choice which include salvage chemotherapy and recently approved targeted agents including Bcl-2 inhibitor (Venetoclax), FLT3 inhibitors and IDH 1/2 inhibitors as there is no standard of care for this patient population. The SIERRA trial was conducted at 24 sites in the United States and Canada.

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, immune cells and bone marrow 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 may avoid the side effects of radiation on most healthy tissues while effectively killing the patient’s cancer (induction) and marrow cells (myeloablation) including those in bone marrow niches due to the "crossfire" effect enabled by the I-131 radioisotope.

Iomab-B was licensed from the Fred Hutchinson Cancer Research Center where it was studied in nearly 300 patients, in multiple clinical trials in 6 blood cancer indications. Iomab-B is 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 was conducted at 24 preeminent transplant centers in the U.S. and Canada. 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 Iomab-B and the Phase 3 SIERRA clinical trial can be found at www.sierratrial.com.