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Sandoz announces plans to further strengthen its antibiotics manufacturing setup in Europe

On May 18, 2021 Sandoz, a Novartis division, reported that plans to further strengthen its European antibiotics manufacturing network by further expanding production capabilities in Kundl, Austria and in Palafolls, Spain (Press release, Novartis, MAY 18, 2021, View Source [SID1234580190]). By modernizing and simplifying its manufacturing setup, Sandoz will improve its ability to consistently deliver high-quality medicines to patients, while remaining cost-competitive on the global market.

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In line with plans announced with the Austrian government in July 2020, Sandoz confirms that in a first step it will proceed to invest more than €100 million to introduce new manufacturing technology for the production of oral amoxicillin, an active pharmaceutical ingredient (API) for its leading penicillin product. This investment will allow Sandoz to leverage its position in Kundl as the hub and center of the only major end-to-end antibiotics supply chain in Europe, covering all production steps from API to Finished Dosage Forms (FDF) for many leading antibiotics.

In addition to the investment in Kundl, Sandoz announces plans for an expansion of its Palafolls site in Spain, planning to invest around €50 million in new production technology and increased capacity for the production of sterile penicillin APIs and sterile API mixtures.

As part of this network modernization plan, Sandoz will phase out the current production of oral APIs at the Les Franqueses site in Spain, which it plans to close in 2024. Sterile API production is planned to transfer from Kundl to the new facility at Palafolls in 2025. Sandoz is committed to its people and will offer full support to its associates who might be impacted.

Sandoz CEO Richard Saynor said: "Antibiotics are the backbone of modern healthcare and a key strategic pillar of our business. Despite a temporary drop in demand due to the pandemic, we remain as confident as ever in the mid- to long-term prospects for this segment, which meets a significant quantity of the global disease burden. This investment, which comes shortly after we announced plans to acquire GSK’s global cephalosporin antibiotics, confirms our commitment to securing the future of our leading global business".

Giovanni Barbella, Head of Sandoz Technical Operations, said: "Our goal is to produce and supply high-quality antibiotics at a cost-competitive price to patients around the world. The important investments announced today will enable our world-class manufacturing network in Europe to meet future requirements".

Sandoz is the global leader in generic antibiotics and operates the only vertically-integrated antibiotic network left in Europe, despite fierce competition from Asia.

Agenus and Bristol Myers Squibb Announce Exclusive Global License for Agenus’ Anti-TIGIT Bispecific Antibody Program

On May 18, 2021 Bristol-Myers Squibb Company (NYSE: BMY) and Agenus Inc. (NASDAQ: AGEN) reported that they have entered into a definitive agreement under which Bristol Myers Squibb will be granted a global exclusive license to Agenus’ proprietary bispecific antibody program, AGEN1777, that blocks TIGIT and a second undisclosed target (Press release, Agenus, MAY 18, 2021, View Source [SID1234580189]). AGEN1777 is an Fc-enhanced antibody in late preclinical development designed to target major inhibitory receptors expressed on T and NK cells to improve anti-tumor activity. In preclinical studies this approach has shown significant potential in tumor models where anti-PD-1 or anti-TIGIT monospecific antibodies alone are ineffective.

Under the agreement, Bristol Myers Squibb will become solely responsible for the development and any subsequent commercialization of AGEN1777 and its related products worldwide. Agenus will receive a $200 million upfront payment and up to $1.36 billion in development, regulatory and commercial milestones in addition to tiered double-digit royalties on net product sales. Agenus will retain options to conduct clinical studies under the development plan, to conduct combination studies with certain other Agenus pipeline assets, and also, upon commercialization, to co-promote AGEN1777 in the US. The agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

Agenus expects to file an Investigational New Drug ("IND") application for the development of AGEN1777 with the U.S. Food and Drug Administration in the second quarter of 2021. Bristol Myers Squibb intends to advance the research and development of AGEN1777 in immuno-oncology ("I-O") for high priority tumor indications including non-small cell lung cancer.

"AGEN1777’s differentiated mechanism of action provides the potential for potent anti-tumor activity; catalyzing our clinical TIGIT strategy aimed at serving more patients with unmet needs in cancer," said Debbie Law, D.Phil., Senior Vice President, Head of Tumor Microenvironment Thematic Research Center, Bristol Myers Squibb. "We look forward to working with Agenus to develop this important therapy as we continue to combat I-O resistance."

"We are pleased to partner with Bristol Myers Squibb to develop and commercialize AGEN1777. Their stellar record of success in this area has been an important determinant for our decision to enter into this transaction," said Garo Armen, PhD, Chairman and Chief Executive Officer of Agenus. "Through such transactions we are able to balance between advancing our portfolio with highly qualified collaborators, while retaining our other innovations for speedy development and commercialization by Agenus."

About AGEN1777

AGEN1777 is a potentially first-in-class bispecific anti-TIGIT antibody engineered with an enhanced Fc region for high binding affinity and improved T and NK cell activation.

Bristol Myers Squibb to Take Part in UBS Global Healthcare Virtual Conference

On May 18, 2021 Bristol Myers Squibb (NYSE: BMY) reported that the company will participate in a fireside chat at the UBS Global Healthcare Virtual Conference, which will be webcast on Tuesday, May 25, 2021 (Press release, Bristol-Myers Squibb, MAY 18, 2021, View Source [SID1234580188]). David Elkins, Executive Vice President, Chief Financial Officer and Samit Hirawat, M.D., Executive Vice President, Chief Medical Officer, Global Drug Development, will answer questions about the company at 1 p.m. ET.

Investors and the general public are invited to listen to a live webcast of the session at View Source An archived edition of the session will be available later that day.

AIM ImmunoTech Provides First Quarter 2021 Business Update

On May 18, 2021 AIM ImmunoTech Inc. (NYSE American: AIM) reported financial results for the first quarter ended March 31, 2021 (Press release, AIM ImmunoTech, MAY 18, 2021, View Source [SID1234580187]).

As of March 31, 2021, AIM had cash, cash equivalents and marketable securities of $63.6 million, compared to $54.4 million as of December 31, 2020.
Research and development expenses for the three months ended March 31, 2021 were $1.4 million, compared to $0.9 million for the three months ended March 31, 2020.
General and administrative expenses for the three months ended March 31, 2021 were $2.1 million, compared to $2.3 million for the three months ended March 31, 2020.
The net loss from operations for the three months ended March 31, 2021 was $3.6 million, or $0.08 per share, compared to $3.8 million, or $0.22 per share, for the three months ended March 31, 2020.
"I’m extremely proud of the progress we have made throughout the first quarter," commented Thomas K. Equels, CEO of AIM ImmunoTech. "We have established a strong foundation of pre-clinical and clinical data with respect to the development of therapeutics aimed to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19. With our solid financial standing, we intend to execute on our corporate strategy and aggressively move forward with our clinical programs that address critical unmet medical needs. We have reached many important milestones, are encouraged by the outlook for AIM and look forward to providing meaningful updates along the way."

Please refer to the full 10-Q for complete details. Additionally, please refer to AIM’s most recent Company Presentation for updates on ongoing clinical studies.

Abeona Therapeutics Reports First Quarter Financial Results

On May 18, 2021 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, reported financial results for the first quarter 2021 and recent business progress (Press release, Abeona Therapeutics, MAY 18, 2021, View Source [SID1234580186]).

"We are off to a fast start in 2021, reflecting our intense focus on execution," said Michael Amoroso, Chief Executive Officer of Abeona. "We are focused on completing enrollment in the EB-101 Phase 3 pivotal VIITAL study, gaining clarity on a regulatory path for ABO-102 in MPS IIIA, producing the first lot of Abeona-produced clinical grade product for ABO-102, and reporting additional neurocognitive and biomarker data from both the ABO-102 Transpher A and the ABO-101 Transpher B studies. We also have a robust preclinical pipeline, and we are conducting research assessing AAV capsids with the aim of IND-enabling studies in two to three eye indications. Importantly, our focus on building the right talent and experience on our leadership team positions us well to continue to advance our clinical programs toward delivering meaningful milestones later this year."

First Quarter and Recent Highlights

Corporate Updates

Appointed Michael Amoroso as President, Chief Executive Officer (CEO) and a member of the company’s Board of Directors.
Abeona strengthened its Board of Directors with the appointment of four new independent members who bring relevant operational leadership experience with life sciences companies, including in the areas of clinical development, manufacturing of cell therapy and gene therapy products, and corporate and financial compliance, to support the company’s focus on driving future growth and creating additional shareholder value.
EB-101 (Autologous, Gene-Corrected Cell Therapy)

Patient enrollment is ongoing for the EB-101 pivotal Phase 3 VIITAL study for RDEB. The company continues to expect to complete enrollment in the VIITAL study in 2021, depending upon the impact from the COVID-19 pandemic, including travel restrictions and safety concerns.
To support ongoing enrollment and commercial preparation, Abeona continues to work toward adding a second clinical site in the VIITAL study by the third quarter of 2021.
Presented data on long-term patient-reported outcomes following EB-101 treatment of RDEB wounds at the Society for Investigative Dermatology (SID) Virtual Meeting 2021, held from May 3-8, 2021. The results showed durable wound healing and reduction in pain through 6 years after treatment.
ABO-102 and ABO-101 (AAV-based Gene Therapies)

Presented new positive data from two ongoing Phase 1/2 clinical trials of ABO-102 in MPS IIIA and ABO-101 in MPS IIIB in late-breaking platform oral presentations at the 17th Annual WORLDSymposium in February 2021.
The FDA granted Abeona’s request and scheduled a Type B meeting in June 2021 to discuss the data-to-date from the ABO-102 Transpher A study and the potential path to a Biologics License Application (BLA) submission for ABO-102 in MPS IIIA.
Preclinical Pipeline

Presented new data supporting the potential of Cre-mediated dual AAV vector technology to enable delivery of large genes targeted for treatment of Stargardt disease during an oral presentation at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Annual Meeting, held virtually from May 1-7, 2021.
Abeona recently completed non-human primate (NHP) studies comparing several capsids with AAV8, the industry standard for intraocular administration, in order to further understand and characterize the company’s AAV capsids. The results showed that AAV204, part of Abeona’s in-licensed AIM capsid library, was superior to AAV8 using a recently developed route of ocular administration.
In a separate NHP experiment, the company’s AAV214 and AAVV214D5 capsids were tested versus AAV8 administered subretinally. Both capsids demonstrated nearly identical levels of transduction of photoreceptor and retinal pigmented epithelium (RPE) cells, which are the cell types most frequently affected in inherited retinal diseases, when compared with AAV8.
The results from the recently completed NHP studies support Abeona’s strategy to advance multiple preclinical eye programs into the clinic.
First Quarter Financial Results

Cash, cash equivalents and short-term investments totaled $86.8 million as of March 31, 2021, compared to $95.0 million as of December 31, 2020. Net cash used in operating activities was $13.6 million for the first quarter of 2021.

Research and development (R&D) expenses were $7.2 million for the first quarter of 2021, compared to $6.8 million in the comparable period in 2020. The increase in R&D expenses was primarily due to increased clinical and development work for the company’s gene and cell therapy product candidates, and increased salary and related costs. General and administrative (G&A) expenses were $6.6 million for the first quarter of 2021, compared to $6.4 million in the same period in 2020. The increase in G&A expenses was primarily due to increased professional fees, partially offset by decreased salary and related costs, and decreases in net other G&A expenses.

Net loss was $16.0 million for the first quarter of 2021, compared to net loss of $48.2 million for the comparable period in 2020. The decrease in net loss was primarily due to the non-cash impairment charge of $32.9 million related to the termination of the license agreement with REGENXBIO in the first quarter of 2020.

Conference Call Details

Abeona Therapeutics will host a conference call and webcast on Tuesday, May 25, 2021 at 8:30 a.m. ET, to discuss its first quarter 2021 financial results and business update. To access the call, dial 888-506-0062 (U.S. toll-free) or 973-528-0011 (international) and Entry Code: 552097 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at www.abeonatherapeutics.com. The archived webcast replay will be available for 30 days following the call.