On May 3, 2023 2seventy bio, Inc. (Nasdaq: TSVT), a leading immuno-oncology cell therapy Company, reported financial results and recent highlights for the first quarter ended March 31, 2023 (Press release, 2seventy bio, MAY 3, 2023, View Sourcenews-releases/news-release-details/2seventy-bio-reports-first-quarter-financial-results-and-0" target="_blank" title="View Sourcenews-releases/news-release-details/2seventy-bio-reports-first-quarter-financial-results-and-0" rel="nofollow">View Source [SID1234630898]).

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"We are off to a strong start in 2023, with a sharp focus on timely execution across our commercial business, clinical programs, and research pipeline," said Nick Leschly, chief kairos officer, 2seventy bio. "Abecma revenue remains on a strong growth trajectory as we continue to successfully execute with BMS on manufacturing scale-ups to deliver Abecma to myeloma patients. The successful steps taken to date to increase vector and drug product manufacturing support the achievement of the upper end of our U.S. revenue guidance range. With the recent FDA acceptance of our Abecma sBLA based on our KarMMa-3 study, we look forward to the opportunity to offer this transformational product to patients in earlier lines of treatment and, if approved, will enable us to serve thousands of additional patients in the U.S. We have made significant progress across our pipeline, and we plan to share initial clinical data from our SC-DARIC33 program for acute myeloid leukemia at the ASGCT (Free ASGCT Whitepaper) Annual Meeting. We also look forward to providing a more in-depth look into both Abecma and our pipeline programs, including promising pre-clinical data in our in-vivo gene editing hemophilia A program, at our upcoming R&D Deep Dive. We believe 2023 will be a transformative year for 2seventy as we continue in our mission to deliver more time for patients living with cancer."

SELECT COMMERCIAL AND FINANCIAL HIGHLIGHTS

First quarter Abecma U.S. revenues, as reported by Bristol Myers Squibb (BMS), were $118 million, representing 26% growth over the prior quarter and 111% growth over the same quarter last year. Based on strong first quarter performance, the Company believes Abecma will achieve the upper end of U.S. revenue guidance of $470-570 million.
2seventy bio and BMS share equally in all profits and losses related to development, manufacturing, and commercialization of Abecma in the U.S. 2seventy reported collaborative arrangement revenue of $23.0 million for the three months ended March 31, 2023, and share of collaboration loss of $5.4 million for the three months ended March 31, 2022.
Abecma was cash-flow positive in the first quarter and the Company expects the Abecma collaboration to be cash flow positive throughout 2023 and to generate between $200 and $300 million of operating income for 2seventy bio during the 2024-2025 period, based on management’s current operating plans.
The Company believes Abecma has potential peak U.S. revenues of $2 to 3 billion.
2seventy bio successfully completed an equity financing in the first quarter, raising approximately $117 million in net proceeds.
The Company ended the first quarter of 2023 with cash, cash equivalents and marketable securities of $341.4 million. 2seventy bio believes that this cash position, combined with growing Abecma cashflow and disciplined expense management, provides financial runway into 2026 and potentially beyond.
Abecma Manufacturing Progress

During the first quarter, the Food and Drug Administration (FDA) approved a second adherent vector manufacturing suite, which will further increase vector capacity.
The FDA approved the Company’s plan for establishing comparability between adherent lentiviral vector and suspension-based lentiviral vector (sLVV) manufacturing processes. BMS and 2seventy continue to accelerate the introduction of sLVV manufacturing processes and we expect commercial introduction of sLVV in the first half of 2024.
BMS recently entered into an agreement for a manufacturing facility to produce viral vectors which is in line with our dual sourcing strategy, leveraging external partners as well as internalizing vector. BMS expects the Libertyville, Illinois site to be contributing by 2025. The combination of this new facility coupled with progress toward transitioning to suspension vector supports bringing more products to patients.
A successful step-up in drug product manufacturing capacity was completed in the first quarter and additional ramp-ups are planned for later this year.
Abecma Clinical and Regulatory Highlights

The FDA has accepted BMS and 2seventy bio’s supplemental Biologics License Application (sBLA) for Abecma in adult patients with triple-class exposed relapsed or refractory multiple myeloma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 16, 2023.
The sBLA was based on interim results from the KarMMa-3 study evaluating Abecma compared with standard combination regimens. The KarMMa-3 study population represents heavily pretreated triple-class exposed patients with high unmet need in their 3rd to 5th line of therapy.
In this difficult-to-treat population, Abecma delivered a 51% risk reduction and clinical benefit compared to the standard of care arm.
Data from KarMMa-3 were published in The New England Journal of Medicine in February 2023.
Initiation of KarMMa-9 study in patients with newly-diagnosed multiple myeloma is anticipated later this year.
NOVO NORDISK COLLABORATION

The joint 2seventy bio and Novo Nordisk collaborative research program focused on an in vivo gene editing treatment for hemophilia A achieved positive proof of concept data triggering a $15 million milestone payment to 2seventy bio from Novo Nordisk.
This program represents a natural extension of the Company’s gene editing capabilities which are also being applied to its oncology programs, including the bbT369 clinical program for non-Hodgkin lymphoma.
Proof of concept data to be disclosed during the Company’s R&D Deep Dive on May 19, 2023.
ASGCT ABSTRACTS ACCEPTED

The American Society of Gene & Cell Therapies (ASGCT) (Free ASGCT Whitepaper) released the abstract titles for its 2023 Annual Meeting which will include new data from 2seventy bio’s portfolio of preclinical and clinical programs:
Late-Breaking Oral Presentation [#3092]: First in human studies show activation of SC-DARIC33, a rapamycin-regulated anti-CD33 CAR T cell therapy, in patients with AML
Oral Presentation [#148]: Enhanced anti-AML potency of DARIC33 by iSynPro-IL-15*: an IL-15 expression module driven by a tightly regulated synthetic promoter activated by antigen receptor signaling
Poster Presentation [#585]: bbT369, a clinical-stage dual-targeted and CBLB gene edited autologous CAR T product for non-Hodgkin Lymphoma, shows edit driven enhanced activity in preclinical in vitro and in vivo models
Poster Presentation [#612]: A novel TGFb switch receptor drives robust MAGE-A4 TCR anti-tumor activity with a favorable safety profile
Poster Presentation [#608]: RESET: a novel TCR coupled antigen receptor displaying superior targeting sensitivity and pharmacologically controlled anti-tumor activity
UPCOMING ANTICIPATED PIPELINE MILESTONES

Data update from Phase I CRC-403 study of bbT369 in patients with relapsed and/or refractory B cell non-Hodgkin lymphoma (B-NHL) anticipated by the end of 2023
Data update from Phase I PLAT-08 study of SC-DARIC33 in patients with acute myeloid leukemia anticipated by the end of 2023
Submission of an Investigational New Drug (IND) application for MUC-16 program in ovarian cancer, being developed in partnership with Regeneron anticipated by end of 2023
Led by JW Therapeutics, initiation of an investigator-initiated study in China of 2seventy bio’s potency enhanced MAGE-A4 T cell receptor (TCR) program in solid tumors anticipated by end of 2023
SELECT FIRST QUARTER FINANCIAL RESULTS

Total 2seventy bio revenues were $41.6 million for the three months ended March 31, 2023, compared to $8.4 million for the three months ended March 31, 2022. The increase for the three-month period was primarily driven by an increase in collaborative arrangement revenue recognized under our collaboration with BMS, as discussed in further detail above.
Research and development expenses were $68.2 million for the three months ended March 31, 2023, compared to $65.9 million for the three months ended March 31, 2022.
Selling, general and administrative expenses were $20.7 million for the three months ended March 31, 2023, compared to $23.9 million for the three months ended March 31, 2022. The decrease for the three-month period reflects cost containment measures across overhead and business functions.
Net loss was $47.0 million for the three months ended March 31, 2023, compared to $85.7 million for the three months ended March 31, 2022.
RESEARCH & DEVELOPMENT (R&D) DEEP DIVE
2seventy bio will host a virtual R&D Deep Dive on Friday, May 19, from 10:00 a.m. – 11:30 a.m. ET to highlight the Company’s R&D pipeline, including updates following the 2023 ASGCT (Free ASGCT Whitepaper) Annual Meeting, as well as an Abecma commercial update and additional details from the hemophilia A program. Registration and access to the live webcast may be found by visiting the "Events and Presentations" page in the Investors and Media section of the Company’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source A replay will be archived on the 2seventy bio website for 30 days following the event.

Conference Call Information
2seventy bio will host a conference call and live webcast today, May 3, at 4:30 p.m. ET to discuss 1Q 2023 financial results and recent business highlights. To join the live conference call, please register at: https://register.vevent.com/register/BI458c3098c2a64310b49e967327a906e7. Upon registering, each participant will be provided with call details and access codes. The live webcast may be accessed by visiting the event link at: View Source A replay of the webcast may be accessed from the "News and Events" page in the Investors and Media section of the Company’s website at View Source and will be available for 30 days following the event.

On May 3, 2023 Imugene Limited (ASX: IMU), a clinical stage immunooncology company, reported its onCARlytics technology, in combination with Eureka Therapeutics’ Artemis T cell platform, has been presented as part of an abstract at the American Society of Gene and Cell Therapy’s Annual Meeting (ASGCT) (Free ASGCT Whitepaper) (Press release, Imugene, MAY 3, 2023, View Source [SID1234630865]).

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The abstract, titled ‘Effective combination immunotherapy using onCARlytics and Artemis CD19 T cells against hepatocellular carcinoma’, investigates the combination in the most primary type of liver cancer and sixth most common cancer worldwide.

While hepatocellular carcinoma (HCC) has systemic therapies and curative treatment options, CD19 targeting CAR T cell therapy has shown positive clinical outcomes, despite some ongoing challenges in bringing effective results into solid cancers.

The abstract presented at ASGCT (Free ASGCT Whitepaper) noted that the combination of onCARlytics and Artemis CD19 T cells demonstrated impressive in vivo anti-tumour responses in a human xenograft HepG2 model. It also stated that the combination strategy can be applied to otherwise target-less tumours such as HCC, and this shows the potential this could be applicable to a wide array of solid cancers as an effective immunotherapy approach.

The ASGCT (Free ASGCT Whitepaper) event is now in its 26th year and attracts a range of professionals in the area of gene and cell therapy, who observe new scientific research and technologies alongside peers in the industry. It is being held 16-20 May 2023 at the Los Angeles Convention Center, CA, USA.

The full abstract can be viewed at: View Source

On May 3, 2023 Medigene AG (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, reported financial results for the first quarter of 2023 (Press release, MediGene, MAY 3, 2023, View Source [SID1234630860]). The full Quarterly Statement Q1 2023 can be downloaded here: View Source

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"Since the beginning of 2023, we have been making significant progress on our strategy in addressing the unmet needs in treating solid tumors. We have expanded the technologies in our end-to-end technology platform through our research collaboration with the National Cancer Institute as well as with the addition of a second exclusive costimulatory switch receptor CD40L-CD28, designed to optimize both the efficacy and safety profiles of TCR-T therapies. I remain convinced that our unique end-to-end platform and our approach to its continued innovation will be the key differentiators for Medigene allowing us to develop new, best-in-class therapies," said Selwyn Ho, Chief Executive Officer of Medigene. "Further, our internal programs MDG1015 and MDG10xx as well as our partnerships with BioNTech and 2seventy bio have continued to advance well, further validating our end-to-end platform. Finally, we continue to explore options to extend our cash reach beyond 4Q 2024 in order to meet these planned future milestones and create further shareholder value."

Financial and Corporate Development

The financial performance in Q1 2023 was in line with the Executive Management Board’s expectations. Revenues amounted to EUR 1.5 million, primarily from the partnership with BioNTech. Reflecting the strong commitment towards advancing the pipeline, R&D expenses amounted to EUR 2.3 million. The Company maintains strong liquidity of EUR 32.1 million, with cash & cash equivalents in the amount of EUR 21.1 million and time deposits of EUR 11.0 million as of March 31, 2023.

The Management Board therefore maintains its guidance for fiscal year 2023 published in the annual report 2022 on March 29, 2023, in its entirety. Management is confident to achieve further progress with partnerships, potentially generating additional milestone payments and revenues.

As previously announced, Medigene moves forward with a strengthened leadership team. During the first quarter, Pamela Keck joined as Head of Investor Relations and Corporate Communications with more than 15 years of experience in the field, as well as Kirsty Crame, MD, who brings more than 10 years of experience in drug development and clinical operations, focused primarily in immuno-oncology and in cell therapy development, into her role as Head of Clinical Research & Development.

Scientific progress

Presented at the American Academy of Cancer Research (AACR) (Free AACR Whitepaper) in April 2023, pre-clinical data for the Company’s lead program MDG1015 highlighted the potential for significant benefits of MDG1015 in improving long-term anti-tumor effects by mitigating the immunosuppressive tumor microenvironment (TME) that currently limits solid tumor therapies. Specifically, the findings demonstrate that the combination of a NY-ESO-1-specific T cell receptor (TCR) combined with co-expression of Medigene’s chimeric PD1-41BB switch receptor on the TCR-T cell surface significantly increases anti-tumor activity, compared to T cells expressing the TCR alone.

Just after the end of Q1, Medigene entered into a cooperative R&D agreement with the U.S. National Cancer Institute to evaluate the use of Medigene’s proprietary TCRs in novel cell constructs. Also subsequent to the end of the quarter, as announced on May 2, Medigene has partnered with Helmholtz Munich to acquire the exclusive, worldwide rights to the CD40L-CD28 costimulatory switch receptor.

On May 2, 2023 Xspray Pharma AB reported a rights issue of units amounting to approximately SEK 300 million (the "Rights Issue"), with two warrant series approximately amounting together up to an additional SEK 300 million upon full exercise (Press release, Xspray, MAY 2, 2023, View Source [SID1234650111]). The Board of Director’s resolution on the Rights Issue was based on the authorization granted by the extraordinary general meeting held on 25 May 2023. Today, Xspray hereby announces the outcome of the Rights Issue. Through the Rights Issue, Xspray will receive total proceeds of approximately SEK 251 million before transaction costs.

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"It is a sign of strength that we have been able to successfully complete this rights issue in a challenging market. We now have sufficient funds to launch our innovative first product Dasynoc in the US market within the next 12 months, thus transforming Xspray Pharma from a research company into a commercial, profitable pharmaceutical company. I want to extend a warm thank you to all long-term and new investors for your trust." comments Per Andersson, CEO of Xspray Pharma.

The outcome of the Rights Issue shows that 2,718,687 units, equivalent to approximately 72 percent of the Rights Issue, were subscribed with the support of unit rights. In addition, 25,015 units were subscribed for without the support of unit rights, of which 25,015 units, equivalent to approximately 1 percent of the Rights Issue, were allocated to investors who subscribed without the support of unit rights. 389,244 units, corresponding to approximately 10 percent of the Rights Issue, have been allotted to the parties who entered into guarantee undertakings in the Rights Issue. The Rights Issue is thus subscribed to approximately 83 percent and Xspray will receive proceeds amounting to approximately SEK 251 million before transaction costs.

The purpose of the Rights Issue is primarily to finance the pre-launch activities for Dasynoc in the US as well as general corporate purposes, ongoing operating costs, and the continued development of product candidates XS003 nilotinib and XS008 axitinib.

Notice of allotment of units subscribed without the support of unit rights will be sent through a settlement note around 28 June 2023. Subscribed and allocated units are to be paid in cash in accordance with the instructions on the settlement note. The allocation of units subscribed without preferential rights has been carried out in accordance with the allocation principles stated in the prospectus published by Xspray on 30 May 2023. Nominee-registered shareholders will receive information regarding allocation and payment according to the procedures of the nominee.

Through the Rights Issue, Xspray’s share capital will increase by approximately SEK 6,265,892, from approximately SEK 22,680,408 to approximately SEK 28,946,300, and the number of shares in Xspray will increase by 6,265,892 shares, from 22,680,408 shares to 28,946,300 shares.

The BTU (Sw. "Betald Tecknad Unit") will be tradable on Nasdaq Stockholm until the Rights Issue has been registered with the Swedish Companies Registration Office and the BTUs have been converted into shares and warrants. The last day of trading with BTUs is expected to take place on or around 11 July 2023.

Shares subscribed with the support of unit rights are expected to be registered with the Swedish Companies Registration Office around 6 July 2023 and are expected to start trading on Nasdaq Stockholm around 17 July 2023.

Shares subscribed without the support of unit rights are expected to be registered with the Swedish Companies Registration Office around 6 July 2023 and are expected to start trading on Nasdaq Stockholm around 17 July 2023.

The first day of trading for the warrants of series TO5 and TO6 is expected to be 17 July 2023.

On May 2, 2023 Alloy Therapeutics, a biotechnology ecosystem company, reported it is collaborating with Lundbeck, a global pharmaceutical company specializing in brain diseases, in the discovery of novel biologics therapies (Press release, Alloy Therapeutics, MAY 2, 2023, View Source [SID1234642129]).

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Through this agreement, Lundbeck will gain access to Alloy’s Antibody Discovery Services and its SeqImmune discovery module, which is a sequence-first workflow for early-on repertoire capture and generation of maximum initial diversity.

Lundbeck has licensed Alloy’s ATX-Gx humanized transgenic mouse platform since 2020, and this partnership reflects a deepening of the relationship between the companies, with Lundbeck looking to Alloy for complementing capabilities to its biologics discovery efforts.

"We have been impressed with Alloy’s innovative mindset and shared commitment to its partners’ success, and we are excited to complement Lundbeck’s internal scientific expertise with Alloy’s sophistication around biologics discovery," said Allan Jensen, Vice President of Biotherapeutic Discovery at Lundbeck.

Alloy started in 2017 with a mission to democratize foundational, pre-competitive biologics discovery technologies and expertise to enable the global scientific community to make better medicine together, starting with the ATX-Gx platform. Alloy quickly followed with its Antibody Discovery Service organization to enable its collaborators to fully outsource their discovery services needs to the foremost experts on the ATX-Gx platform.

Alloy’s Antibody Discovery Service is committed to finding its partners the best therapeutic antibodies against their target and delivering each campaign a sophisticated data package with the option for additional value-add offerings around machine-learning-driven affinity maturation and optimization, bispecific engineering, translational medicine, and advanced antibody production.

Alloy is committed to reinvesting 100 percent of its revenue back into innovation, and as a result is continuously improving and expanding the technologies and protocols deployed in its discovery campaigns.

Biotherapeutic Discovery at Lundbeck is focused on restoring brain health through the discovery and development of antibodies and biologics. The unique biology and additional complexities associated with the treatment of brain disease set highly stringent specifications on potential drug lead candidates.

"The ability to discover highly diverse antibody repertoires is key to finding the few potential drug leads, and the SeqImmune discovery module on top of the ATX-Gx platform holds that promise," said Allan Jensen, Vice President Biotherapeutic Discovery at Lundbeck.

"Our relationship with Lundbeck is a reflection of how we work to support the global scientific community in their mission to advance the best medicines for patients," said Errik Anderson, Alloy Therapeutics Founder and CEO. "We are grateful that Lundbeck has been collaborating with us for years on our platform technology and have put their trust in us as an extension of their discovery services team with this expanded partnership leveraging our SeqImmune antibody discovery workflow."