On January 5, 2022 Thermo Fisher Scientific Inc. (NYSE:TMO), the world leader in serving science, and PeproTech, Inc., a leading developer and manufacturer of recombinant proteins, reported that Thermo Fisher completed its acquisition of PeproTech on December 30, 2021 for a total cash purchase price of approximately $1.85 billion (Press release, Thermo Fisher Scientific, JAN 5, 2022, View Source,-a-Leader-in-Recombinant-Proteins [SID1234598302]).

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!

Based in Cranbury, New Jersey, PeproTech is a privately held provider of bioscience reagents known as recombinant proteins, including cytokines and growth factors. Recombinant proteins are used in the development and manufacturing of cell and gene therapies as well as in broader cell culture applications, especially for use in cellular research models. PeproTech’s recombinant proteins portfolio complements Thermo Fisher’s cell culture media products and will enable Thermo Fisher to provide customers significant benefits through an integrated offering.

"PeproTech will be an excellent strategic fit within our biosciences business and will allow us to even better serve our pharma and biotech customers by adding new capabilities to our existing offering," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "In combination with our proprietary bioprocessing and cell culture technologies, this complementary transaction positions us to partner with our customers to drive the evolution of the fast-growing market for cell and gene therapies. By leveraging our commercial reach, we will be able to efficiently grow the PeproTech business and generate attractive financial results all while furthering our Mission to enable our customers to make the world healthier, cleaner and safer."

Casper added, "With more than three decades of experience across a broad range of applications for drug development and therapeutic products, the PeproTech team has built long-standing customer relationships in pharma and biotech and life sciences research. We look forward to welcoming their incredibly talented team to Thermo Fisher."

Bob Goldman, president and co-founder of PeproTech, commented, "We are pleased to join Thermo Fisher given their team’s outstanding industry leadership and shared commitment to develop innovative therapies that improve patient outcomes. PeproTech’s reputation for unparalleled product consistency and quality directly aligns with that of Thermo Fisher’s, and we look forward to building on our success as part of the world leader in serving science."

PeproTech will become part of the biosciences business within Thermo Fisher and will be integrated into the Life Sciences Solutions Segment.

On January 5, 2022 Aileron Therapeutics (NASDAQ:ALRN), a chemoprotection oncology company that aspires to develop medicines to make chemotherapy safer and thereby more effective to save more patients’ lives, reported a business update and outlined the company’s strategic priorities for 2022 (Press release, Aileron Therapeutics, JAN 5, 2022, View Source [SID1234598195]).

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!

"All cancer patients undergoing chemotherapy – still the standard of care for most patients – experience chemotherapeutic side effects to varying degrees, from unpleasant to fatal. Utilizing a biomarker strategy, we are developing ALRN-6924 as a selective chemoprotective agent to shift the paradigm from accepting these side effects to preventing them for patients with p53-mutated cancer regardless of type of cancer or chemotherapy," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron. "In 2022, we expect several key milestones may propel us toward this vision, including our planned initiation of a clinical trial in breast cancer patients receiving neoadjuvant chemotherapy in the first half of the year with interim results in the fourth quarter, as well as planned interim and topline data readouts for our ongoing NSCLC trial in the second and fourth quarters, respectively."

Aileron is developing ALRN-6924 to selectively protect healthy cells in patients with p53-mutated cancers to reduce or eliminate chemotherapy-induced side effects. Nearly 1 million patients each year are diagnosed with a p53-mutated cancer in the US alone, and Aileron employs a precision medicine approach to exclusively treat those patients with p53-mutated cancers who are receiving chemotherapy. ALRN-6924 is designed to selectively protect these patients’ healthy cells from chemotherapy without protecting cancer cells. This novel concept is known as selective chemoprotection. The reduction or elimination of multiple chemotherapy-induced side effects is expected to enhance tolerability of chemotherapy, which is expected to result in fewer dose reductions and delays of chemotherapy, and that is expected to improve efficacy of chemotherapy.

2022 Strategic Priorities and Business Update

Initiate clinical trial in neoadjuvant (pre-operative) breast cancer in 1H22, with interim results in 4Q22. Aileron plans to initiate a new clinical trial in 1H22 to evaluate ALRN-6924 to protect against chemotherapy-induced bone marrow and other toxicities in ER+/HER2- breast cancer patients treated with a doxorubicin + cyclophosphamide and docetaxel chemotherapy regimen, also known as ‘AC-D’. The Phase 1b trial will enroll up to 30 patients in a parallel group design trial with a dose expansion cohort. Aileron will provide more details on the planned neoadjuvant breast cancer trial design at the time of trial initiation.
Advance ongoing NSCLC trial to interim (20-patient) and topline (60-patient) readouts, in 2Q22 and 4Q22, respectively. Aileron is currently enrolling patients in the US and EU with advanced p53-mutated NSCLC undergoing treatment with first-line carboplatin plus pemetrexed with or without immune checkpoint inhibitors. As previously guided, Aileron anticipates reporting interim results on 20 patients in 2Q22, and topline results on 60 patients in 4Q22. Aileron has dosed the first 10 patients in the trial and plans to conduct a blinded safety evaluation on these patients after one cycle in 1Q22, as previously guided.
Continue to progress ongoing Healthy Volunteer Study. Aileron is continuing to progress its ongoing Phase 1 pharmacology study which is evaluating ALRN-6924’s induction of p21-induced cell cycle arrest in healthy, normal bone marrow cells and other cell types in healthy volunteers receiving ALRN-6924. The company presented initial data from the study in 2021, confirming the drug’s novel p53 biomarker-driven mechanism of action, as well as its pharmacodynamic effects, including time to onset, magnitude and duration. The aim of the study is to develop a universal dosing regimen for ALRN-6924 for use as a chemoprotection agent across a range of chemotherapies and p53-mutated cancers. Aileron anticipates reporting additional findings from the study this year.

Expanded patent portfolio in 2021 with issuance of 11 new foreign and U.S. patents. Aileron was issued 7 new international patents and 4 U.S. patents over the past 12 months, including new patent protection for ALRN-6924 in China. These newly issued patents add to Aileron’s robust intellectual property portfolio, which includes over 170 U.S. and foreign patents, with another 47 applications in prosecution. These patents and applications include ALRN-6924 methods of manufacture, methods of use, drug product formulations, and compositions of matter (COM). The COM patent in the US expires in 2033 with up to 5 additional years subject to patent term extensions. Of note, Aileron maintains exclusive rights to its proprietary peptide drug technology and ALRN-6924 worldwide.

On January 5, 2022 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported a business update for 2022 (Press release, Eagle Pharmaceuticals, JAN 5, 2022, View Source [SID1234598213]):

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!

Near-Term Business Highlights:

Vasopressin: The Company will begin shipping its recently approved vasopressin product on Monday, January 17, 2022, with 180 days of marketing exclusivity. This is an important product for Eagle, as Vasostrict U.S. sales totaled $890 million for the LTM ended September 30, 2021.
PEMFEXY: On February 1, 2022, the Company will launch PEMFEXY, a ready-to-use liquid with a unique J-code. Eagle has been building inventory and believes this is a significant opportunity, as the Alimta U.S. market totaled $1.2 billion for the LTM ended September 30, 2021.
TREAKISYM: Eagle’s bendamustine franchise continues to grow, including the launch of the TREAKISYM ready-to-dilute ("RTD") formulation in Japan in the first quarter of 2021. Together with a potential approval of the rapid infusion ("RI") (50ml) liquid formulation, this could generate approximately $20 million of combined royalty and milestone revenue in 2022.
Fulvestrant: Based on discussions with the U.S. Food and Drug Administration ("FDA"), the Company will commence human pilot studies of its fulvestrant product candidate for the treatment of HR+/HER- advanced breast cancer shortly.
Landiolol: The Company is on track to submit a new drug application ("NDA") in the first half of 2022, seeking approval of Landiolol, a novel therapeutic, for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter.
CAL02: The Company is preparing to begin clinical trials for CAL02, a novel approach to the treatment of severe bacterial pneumonia, later this year.
"Our business is off to a very strong start this year. With our launch of vasopressin now and PEMFEXY on February 1, we believe that our products will do very well. We are advancing our other pipeline products as we expect to submit an NDA for Landiolol in the first half of this year and to begin our clinical studies for CAL02 later this year. We are also pleased to be moving forward with our fulvestrant product and expect to begin our next clinical studies soon," stated Scott Tarriff, President and Chief Executive Officer of Eagle.

"Importantly, our already-strong balance sheet and cash position will benefit from the two launches and position us well to deploy our cash strategically through additional in-licensing opportunities, as well as potential acquisitions of companies or products," concluded Tarriff.

On January 5, 2022 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported that Silverback management will participate in the H.C. Wainwright Bioconnect Conference from January 10-13, 2022 (Press release, Silverback Therapeutics, JAN 5, 2022, View Source [SID1234598239]).

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!

Laura Shawver, Ph.D., Silverback’s Chief Executive Officer, and Valerie Odegard, Ph.D., Silverback’s President and Chief Scientific Officer, will provide a corporate overview which will be available on Silverback’s Investor Relations website beginning on Monday, January 10, 2022, at 7:00 AM ET (4:00 AM PT).

On January 5, 2022 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that Manuel Litchman, M.D., President and Chief Executive Officer, will participate in three virtual investor conferences in January 2022 (Press release, Mustang Bio, JAN 5, 2022, View Source [SID1234598263]).

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!

Details of the events are as follows:

11th Annual LifeSci Partners Corporate Access Event: The company will host virtual one-on-one meetings during the conference on Wednesday, January 5 through Friday, January 7, 2022.
H.C. Wainwright Virtual BioConnect Conference: The company’s presentation will be available for on-demand viewing on Mustang’s website beginning Monday, January 10, 2022, at 7:00 a.m. EST.
B. Riley Securities’ Virtual Oncology Conference: The company’s fireside chat will take place on Friday, January 28, 2022, at 12:30 p.m. EST and will be available to all conference-registered institutional investors.
Webcasts of the H.C. Wainwright presentation and B. Riley fireside chat will be available on the Events page of the Investors Relations section of Mustang’s website, www.mustangbio.com, for approximately 30 days following each meeting.