On April 24, 2025 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported a strategic pipeline prioritization with workforce and cost reduction initiatives to focus resources on its lead oncology clinical programs CB-010 and CB-011, with clinical data disclosures now planned for H2 2025 (Press release, Caribou Biosciences, APR 24, 2025, View Source [SID1234652100]).

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"Broad patient access to life-changing CAR-T cell therapies is only achievable if healthcare systems have an off-the-shelf option. Caribou’s two lead Phase 1 clinical programs, CB-010 for large B cell lymphoma and CB-011 for multiple myeloma, continue to demonstrate encouraging efficacy and have the potential to serve this critical unmet need for individuals living with hematologic malignancies," said Rachel Haurwitz, PhD, Caribou’s president and CEO. "We recognize the challenges in the current market environment and believe the best approach is to present the most robust datasets for both programs. As a result, we now plan to disclose clinical data from CB-010 and CB-011 in the second half of this year."

"To ensure Caribou is strongly positioned to emerge from these challenging times and deliver these potentially value-generating datasets, we have made the difficult decision to strategically prioritize our resources on CB-010 and CB-011 for oncology indications," continued Dr. Haurwitz. "These strategic decisions resulted in a reduction in Caribou’s workforce, which include some of the industry’s most talented scientists and professionals. We are deeply grateful for their foundational contributions to Caribou’s technology and current clinical programs. We plan to honor that legacy as we work toward ushering in a new era of allogeneic CAR-T cell therapies that offer the potential for broad access and rapid availability to both patients and healthcare systems."

Clinical highlights
CB-010, a clinical-stage allogeneic anti-CD19 CAR-T cell therapy for B cell non-Hodgkin lymphoma
•Caribou is enrolling a 20-patient confirmatory cohort using the company’s HLA matching strategy in the ANTLER Phase 1 clinical trial in second-line large B cell lymphoma (2L LBCL). In H2 2025, Caribou expects to present data from this cohort with at least 6 months of follow up for the majority of patients.
•To date, data demonstrate that a single dose of CB-010 has the potential to drive outcomes that are on par with the safety, efficacy, and durability of approved autologous CAR-T cell therapies.
•Additionally, in H2 2025, Caribou expects to present data from a proof-of-concept cohort of CB-010 in up to 10 patients who have relapsed following any prior CD19-targeted therapy.

CB-011, a clinical-stage allogeneic anti-BCMA CAR-T cell therapy for multiple myeloma
•In the dose escalation portion of the CaMMouflage Phase 1 clinical trial for relapsed or refractory multiple myeloma (r/r MM), Caribou continues to observe encouraging efficacy in patients treated with CB-011 at multiple dose levels following a lymphodepletion regimen that includes a deeper dose of cyclophosphamide.
•Caribou is rapidly enrolling additional patients with the deeper lymphodepletion regimen to make a data-driven decision on the recommended doses for expansion. The company plans to present data in H2 2025 with at least three months of follow up on a minimum of 25 patients at multiple dose levels.

Pipeline prioritization with workforce and cost reduction initiatives
•Caribou is prioritizing its lead oncology programs, CB-010 and CB-011. Caribou is discontinuing the GALLOP Phase 1 trial of CB-010 for lupus prior to dosing the first patient. Caribou is also discontinuing the AMpLify Phase 1 clinical trial of CB-012 for relapsed or refractory acute myeloid leukemia (AML) as additional data would be needed to advance this program, taking time and resources that can be dedicated to CB-010 and CB-011. Patients treated in the AMpLify Phase 1 trial will continue to be followed as part of the company’s long-term follow up study. Additionally, the company is discontinuing preclinical research.
•The company is reducing its workforce by approximately 32%. Cash payments resulting from the reduction in force and strategic pipeline prioritization are estimated to be $2.5 to $3.5 million.
•These changes are expected to extend Caribou’s cash runway by one year, funding the company’s current operating plan into H2 2027, compared to into H2 2026 as previously reported.

Corporate update
$212.5 million in cash, cash equivalents, and marketable securities
•Based on preliminary unaudited financial information, Caribou expects to report $212.5 million in cash, cash equivalents, and marketable securities as of March 31, 2025.

2025 Anticipated milestones
•CB-010 ANTLER: Caribou plans to present data from both the additional 2L and prior CD19 relapsed LBCL patient cohorts in H2 2025 and is interacting with the FDA on a potential pivotal trial to be initiated following alignment. This update is expected to include:
◦Initial safety and efficacy data on the confirmatory cohort (20 patients) with partial HLA matching, with a minimum of six months of follow up for the majority of patients, as well as an update on the larger, maturing dataset presented previously.
◦Pivotal trial design and timeline, contingent on positive data and FDA alignment.
•CB-011 CaMMouflage: Caribou plans to present dose escalation data and share the recommended doses for expansion from the ongoing CaMMouflage Phase 1 clinical trial in r/r MM in H2 2025. This update is expected to include:
◦Initial safety and efficacy data on a minimum of 25 patients at multiple dose levels using the deeper lymphodepletion regimen with at least three months of follow up.
◦Recommended doses for expansion and plans for dose expansion.

About CB-010
CB-010 is an allogeneic anti-CD19 CAR-T cell therapy being evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) in the ongoing ANTLER Phase 1 clinical trial. To Caribou’s knowledge, CB-010 is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to enhance CAR-T cell activity by limiting premature CAR-T cell exhaustion. The FDA granted CB-010 Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, and Fast Track designations for B-NHL. Additional information on the ANTLER trial (NCT04637763) can be found at clinicaltrials.gov.

About CB-011
CB-011 is an allogeneic anti-BCMA CAR-T cell therapy being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM) in the CaMMouflage Phase 1 trial. To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to enable activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E fusion protein to blunt immune-mediated rejection. CB-011 has been granted Fast Track and Orphan Drug designations by the FDA. Additional information on the CaMMouflage trial (NCT05722418) can be found at clinicaltrials.gov.

On April 24, 2025 Bristol Myers Squibb (NYSE: BMY) reported results for the first quarter of 2025 (Press release, Bristol-Myers Squibb, APR 24, 2025, View Source [SID1234652099]).

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"Our strong execution in the first quarter drove continued momentum across our Growth Portfolio and meaningful progress in the pipeline," said Christopher Boerner, Ph.D., board chair and chief executive officer, Bristol Myers Squibb. "We are advancing our multi-year plan to become a more agile and efficient company, while strengthening the foundation for top-tier, long-term growth. Our strategy is clear, and our actions are accelerating the delivery of transformational medicines to patients."

First Quarter Results

$ in millions, except per share amounts

2025

2024

Change

Change
Excl. FX**

Total Revenues

$11,201

$11,865

(6)%

(4)%

Earnings/(Loss) Per Share – GAAP*

1.20

(5.89

)

N/A

N/A

Earnings/(Loss) Per Share – Non-GAAP*

1.80

(4.40

)

N/A

N/A

Acquired IPRD Charge and Licensing Income Net Impact on Earnings/(Loss) Per Share

(0.04

)

(6.30

)

N/A

N/A

*GAAP and Non-GAAP earnings/(loss) per share include the net impact of Acquired IPRD charges and licensing income.

**See "Use of Non-GAAP Financial Information".

FIRST QUARTER RESULTS
All comparisons are made versus the same period in 2024 unless otherwise stated.

Total revenues of $11.2 billion decreased 6%, or 4% Ex-FX.
U.S. revenues of $7.9 billion decreased 7%.
International revenues of $3.3 billion decreased 2%, or increased 2% Ex-FX.
Growth Portfolio revenues of $5.6 billion increased 16% on a reported basis, or 18% Ex-FX. Revenue growth was primarily driven byOpdivo, Breyanzi, Reblozyl andCamzyos and reflects the strong early U.S. launch ofCobenfy.
Legacy Portfolio revenues of $5.6 billion declined 20% on a reported basis and Ex-FX. The decline was driven by continued generic impact on Revlimid, Pomalyst, Sprycel andAbraxane, as well as the impacts from U.S. Medicare Part D redesign.
FIRST QUARTER PRODUCT REVENUE HIGHLIGHTS(d)

($ amounts in millions)

Quarter Ended March 31,
2025

% Change from Quarter
Ended March 31, 2024

% Change from
Quarter Ended
March 31, 2024
Ex-FX**

U.S.

Int’l

WW(c)

U.S.

Int’l

WW(c)

Int’l

WW(c)

Growth Portfolio

Opdivo

$ 1,332

$ 933

$ 2,265

15%

1%

9%

7%

12%

Opdivo Qvantig

8

—

9

N/A

N/A

N/A

N/A

N/A

Orencia

555

215

770

(3)%

(5)%

(4)%

(1)%

(2)%

Yervoy

394

230

624

7%

7%

7%

12%

9%

Reblozyl

390

89

478

33%

44%

35%

49%

36%

Opdualag

228

25

252

15%

>200%

23%

>200%

23%

Breyanzi

204

60

263

133%

>200%

146%

>200%

148%

Camzyos

126

33

159

63%

>200%

89%

>200%

90%

Zeposia

61

46

107

(16)%

22%

(3)%

26%

(2)%

Abecma

59

45

103

13%

47%

26%

54%

28%

Sotyktu

32

23

55

(5)%

138%

27%

146%

29%

Krazati

44

4

48

116%

>200%

125%

>200%

125%

Cobenfy

27

—

27

N/A

N/A

N/A

N/A

N/A

Other Growth Products(a)

174

229

403

13%

34%

24%

35%

25%

Total Growth Portfolio

3,633

1,930

5,563

18%

13%

16%

18%

18%

Legacy Portfolio

Eliquis

2,646

919

3,565

(6)%

2%

(4)%

5%

(3)%

Revlimid

809

127

936

(44)%

(41)%

(44)%

(39)%

(44)%

Pomalyst/Imnovid

537

122

658

(10)%

(55)%

(24)%

(53)%

(24)%

Sprycel

126

49

175

(56)%

(47)%

(53)%

(43)%

(53)%

Abraxane

40

65

105

(72)%

(10)%

(52)%

(6)%

(50)%

Other Legacy Products(b)

82

116

199

(14)%

(10)%

(12)%

(8)%

(11)%

Total Legacy Portfolio

4,240

1,398

5,638

(21)%

(17)%

(20)%

(14)%

(20)%

Total Revenues

$ 7,873

$ 3,328

$ 11,201

(7)%

(2)%

(6)%

2%

(4)%

**

See "Use of Non-GAAP Financial Information".

(a)

Includes Augtyro, Onureg, Inrebic, Nulojix, Empliciti and royalty revenue.

(b)

Includes other mature brands.

(c)

Worldwide (WW) includes U.S. and International (Int’l).

(d)

For the above table and all subsequent tables, certain totals may not sum due to rounding. Percentages have been calculated using unrounded amounts.

FIRST QUARTER COST & EXPENSES
All comparisons are made versus the same period in 2024 unless otherwise stated.

The table below presents selected line item information.

Three Months Ended March 31,
2025

Three Months Ended March 31,
2024

($ amounts in millions)

GAAP

Specified
Items**

Non-
GAAP

GAAP

Specified
Items**

Non-
GAAP

Cost of products sold

$

3,033

(14

)

$

3,018

$

2,932

(22

)

$

2,910

Gross margin(a)

72.9

%

73.1

%

75.3

%

75.5

%

Selling, general and administrative

1,584

(1

)

1,583

2,367

(378

)

1,989

Research and development

2,257

(21

)

2,235

2,695

(349

)

2,346

Acquired IPRD

188

—

188

12,949

—

12,949

Amortization of acquired intangible assets

830

(830

)

—

2,357

(2,357

)

—

Other (income)/expense, net

339

(489

)

(150

)

81

(235

)

(154

)

Effective tax rate

17.1

%

(2.1

)%

15.1

%

(3.4

)%

(5.6

)%

(9.0

)%

**See "Use of Non-GAAP Financial Information" and refer to the Specified Items schedule below for further detail.

(a) Represents revenue minus cost of products sold divided by revenue.

Gross margin decreased from 75.3% to 72.9% on a GAAP basis, and from 75.5% to 73.1% on a non-GAAP basis, primarily due to product mix.
Selling, general and administrative expenses of $1.6 billion decreased 33% on a GAAP basis, primarily due to one-time acquisition-related expenses in 2024 and results from our strategic productivity initiative in 2025. Non-GAAP selling, general and administrative expenses of $1.6 billion decreased 20%, primarily reflecting results from our strategic productivity initiative.
Research and development expenses of $2.3 billion decreased 16% on a GAAP basis, primarily from one-time acquisition-related expenses in 2024. Non-GAAP research and development expenses of $2.2 billion decreased 5%, primarily driven by results from our strategic productivity initiative.
Acquired IPRD charge of $188 million decreased from $12.9 billion on a GAAP and non-GAAP basis, primarily due to the prior year Karuna acquisition and SystImmune collaboration. Licensing income of $87 million increased from $12 million.
Amortization of acquired intangible assets of $830 million decreased 65% on a GAAP basis, primarily due to lower amortization expense related toRevlimid.
Effective tax rate in 2025 on a GAAP and non-GAAP basis was 17.1% and 15.1%, respectively. The 2024 GAAP and non-GAAP effective tax rate was impacted by the $12.1 billion one-time non-tax-deductible charge for the Karuna acquisition.
Reported net income attributable to Bristol Myers Squibb on a GAAP basis of $2.5 billion, or $1.20 per share, in the first quarter compared to a net loss of $11.9 billion, or $(5.89) per share, in the prior year. Non-GAAP net earnings attributable to Bristol Myers Squibb of $3.7 billion, or $1.80 per share, compared to a net loss of $8.9 billion, or $(4.40) per share, in the prior year.
PRODUCT AND PIPELINE UPDATES
Entries organized by date and inclusive of first quarter and recent updates.

Asset

Date
Announced

Milestone

CobenfyTM
(xanomeline and
trospium
chloride)

April 22

The Phase 3 ARISE trial evaluating Cobenfy as an adjunctive treatment to atypical antipsychotics in adults with schizophrenia did not meet the threshold for statistical significance for the primary endpoint.

Camzyos
(mavacamten)

April 17

The U.S. Food and Drug Administration (FDA) updated the U.S. Prescribing Information for Camzyos, simplifying treatment options for patients and physicians by reducing the required echo monitoring for eligible patients in the maintenance phase and expanding patient eligibility by reducing contraindications.

Camzyos

April 14

The Phase 3 ODYSSEY-HCM trial evaluating Camzyos for the treatment of adult patients with symptomatic New York Heart Association class II-III non-obstructive hypertrophic cardiomyopathy did not meet its dual primary endpoints.

Opdivo
(nivolumab) +
Yervoy
(ipilimumab)

April 11

The FDA approved Opdivo plus Yervoy as a first-line treatment for adult patients with unresectable or metastatic hepatocellular carcinoma (HCC).

Opdivo + Yervoy

April 8

The FDA approved Opdivo plus Yervoy as a first-line treatment of adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.

Opdivo

March 28

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of the perioperative regimen of Opdivo, in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo as monotherapy, as adjuvant treatment after surgical resection for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1%.

Subcutaneous
formulation of
Opdivo

March 28

The CHMP of the EMA recommended approval of a new Opdivo formulation associated with a new route of administration (subcutaneous use), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial).

Breyanzi
(lisocabtagene
maraleucel)

March 14

The European Commission (EC) granted approval to Breyanzi for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

Sotyktu
(deucravacitinib)

March 8

Announced positive data from the pivotal Phase 3 POETYK PsA-2 trial evaluating the efficacy and safety of Sotyktu in adults with active psoriatic arthritis.

Opdivo + Yervoy

March 7

The EC approved Opdivo plus Yervoy for the first-line treatment of adult patients with unresectable or advanced HCC.

Opdivo

February 19

Announced the final analysis of overall survival (OS) from the Phase 3 CheckMate -816 study. The results showed a statistically significant and clinically meaningful improvement in OS, a key secondary endpoint, compared to neoadjuvant chemotherapy alone.

Sotyktu

February 16

Announced new five-year results from the POETYK PSO long-term extension trial of Sotyktu treatment in adult patients with moderate-to-severe plaque psoriasis. The safety profile of Sotyktu remained consistent through five years with no new safety signals identified.

OpdualagTM
(nivolumab and
relatlimab-rmbw)

February 13

The Phase 3 RELATIVITY-098 trial evaluating Opdualag for the adjuvant treatment of patients with completely resected stage III-IV melanoma did not meet its primary endpoint of recurrence-free survival.

Breyanzi

February 10

Announced positive topline results from the Phase 2 TRANSCEND FL trial evaluating Breyanzi in adult patients with relapsed or refractory marginal zone lymphoma. The trial cohort met its primary endpoint of overall response rate and key secondary endpoint of complete response rate.

Financial Guidance
Bristol Myers Squibb is raising key 2025 non-GAAP line-item guidance assumptions as outlined below.

The company is increasing its full-year revenue guidance from approximately $45.5 billion to a range of approximately $45.8 billion to $46.8 billion, reflecting the strong performance of the Growth Portfolio, better-than-expected Legacy Portfolio sales in the first quarter of 2025, and a favorable impact of approximately $500 million related to foreign exchange rates.

In addition, full-year operating expense expectations remain approximately $16 billion, with an additional $200 million foreign exchange impact. The company now anticipates other income and expense in 2025 to be approximately $100 million of income due to higher-than-expected royalties and favorable interest income.

As a result of these changes, the company is raising the midpoint of its 2025 non-GAAP EPS guidance by $0.15 per share to an expected range of $6.70 to $7.00.

The stated guidance revisions include the estimated impact of current tariffs on U.S. products shipped to China, but do not account for any potential pharmaceutical sector tariffs.

Non-GAAP2,3

February
(Prior)

April
(Updated)

Total Revenues

(Reported & Ex-FX)

~$45.5 billion

~$45.8 – $46.8 billion

Gross Margin %

~72%

No change

Operating Expenses1

~$16 billion

~$16.2 billion

Other income/(expense)

~$30 million

~$100 million

Effective tax rate

~18%

No change

Diluted EPS

$6.55-$6.85

$6.70-$7.00

1 Operating Expenses = SG&A and R&D.

2 See "Use of Non-GAAP Financial Information."

3 February was calculated using foreign exchange rates as of January 9, 2025, and April was calculated using foreign exchange rates as of April 23, 2025.

The 2025 financial guidance excludes the impact of any potential future strategic acquisitions, divestitures, specified items that have not yet been identified and quantified, and the impact of future Acquired IPRD charges and licensing income. To the extent we have quantified the impact of significant R&D charges or other income resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights, we may update this information from time to time on our website www.bms.com, in the "Investors" section. Non-GAAP guidance assumes exchange rates as of the date noted. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this press release.

A reconciliation of forward-looking non-GAAP measures, including non-GAAP EPS, to the most directly comparable GAAP measures is not provided because comparable GAAP measures for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for such reconciliation. Namely, we are not, without unreasonable effort, able to reliably predict the impact of accelerated depreciation and impairment charges, legal and other settlements, gains and losses from equity investments and other adjustments. In addition, the company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. These items are uncertain, depend on various factors and may have a material impact on our future GAAP results. See "Cautionary Statement Regarding Forward-Looking Statements" and "Use of Non-GAAP Financial Information."

Conference Call Information
Bristol Myers Squibb will host a conference call today, Thursday, April 24, 2025, at 8:00 a.m. ET, during which company executives will review financial results with the investment community.

Investors and the general public are invited to listen to a live webcast of the call at View Source." target="_blank" title="View Source." rel="nofollow">View Source Materials related to the call will be available at View Source prior to the start of the conference call.

A replay of the webcast will be available at View Source approximately three hours after the conference call concludes.

On April 24, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported it will present data for selected assets from its diversified oncology pipeline, including mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting held in Chicago, Illinois from April 25-30, 2025 (Press release, BioNTech, APR 24, 2025, View Source [SID1234652098]). The oral and poster presentations underline both the progress of BioNTech’s advanced priority oncology programs as well as the execution of the Company’s combination strategy in oncology, with first data to be presented for the combination of the PD-L1xVEGF-A bispecific antibody candidate BNT3271 plus antibody-drug conjugates ("ADCs").

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"We believe that the future standard of care for the treatment of advanced cancers will be combinations with novel immuno-oncology backbones," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "Our data presentations at this year’s AACR (Free AACR Whitepaper) support our approach to combine complementary mechanisms of action with the aim of driving synergistic anti-tumor activity. The data we present indicate that we are well positioned to work towards our vision of improving outcomes for patients across the full continuum of cancer disease."

Highlights of BioNTech’s oncology programs to be presented at AACR (Free AACR Whitepaper) 2025:

BioNTech will present preclinical data characterizing the mode of action of BNT327. BNT327 is an investigational next-generation bispecific antibody combining PD-L1 checkpoint inhibition with VEGF-A neutralization. BNT327 showed a high binding affinity to PD-L1 and VEGF-A and efficient blocking of PD-1/PD-L1 and VEGF-A/VEGFR2 signaling. Anti-tumor activity superior to single PD-1/PD-L1 blockade or anti-VEGF-A treatment was observed in multiple tumor models.

First data for the combination of BNT327 with various ADC candidates, which are being jointly developed by BioNTech and Duality Biologics (Suzhou) Co. Ltd. ("DualityBio"), will be presented. The presentation will include preclinical evaluation of BNT327 plus ADCs, showing inhibition of tumor growth that is superior to each candidate alone. Further, early clinical data of the ongoing global Phase 1/2 trial (NCT05438329) of BNT327 in combination with BNT325/DB-1305, a TROP2-targeting ADC candidate, including safety and early efficacy data, will be presented in the poster session.

BioNTech will present data from the Phase 1 clinical trial LuCa-MERIT-1 (NCT05142189) for its mRNA cancer immunotherapy candidate BNT116 in combination with the anti-PD1 cemiplimab in an oral presentation. The update includes safety and clinical activity data, along with biomarker data from a cohort of frail patients with advanced or metastatic non-small cell lung cancer ("NSCLC") who were not eligible for platinum-based chemotherapy as first-line treatment. The preliminary data showed anti-tumor activity, consistent immune response induction, and a manageable safety profile.

Preclinical data for the EpCAMx4-1BB antibody candidate BNT314/GEN1059, which is being developed in collaboration with Genmab A/S ("Genmab"), will be presented in a poster session. BNT314/GEN1059 was evaluated in combination with PD-1 inhibition in a tumor model unresponsive to each single treatment. The data showed anti-tumor activity, delayed tumor outgrowth and prolonged survival for the combination treatment compared to both single treatments. The immunomodulatory activity of BNT314/GEN1059 was further potentiated in combination with PD-1 blockade.

BioNTech has established a diversified oncology portfolio including mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies, comprising ADCs and cell therapies, to develop novel treatment approaches for patients living with cancer. The Company is further maturing its clinical oncology pipeline across multiple solid tumor indications, including more than 20 active Phase 2 and Phase 3 clinical trials with a strategic focus on two pan-tumor priority programs: investigational mRNA cancer immunotherapies and the next-generation immunomodulator candidate BNT327. BioNTech expects multiple data readouts in 2025 and 2026 aimed at supporting its strategy and advancing the Company towards becoming a diversified multi-product oncology company.

The full abstracts are available on the AACR (Free AACR Whitepaper) Annual Meeting website. Click here for further information on BioNTech’s pipeline assets.

Full presentation details:

Oral presentation

Asset: BNT116
Session Title: "ADCs and Immunooncology-focused Biological Approaches"
Abstract Title: "Phase I trial evaluating BNT116, a TAA-encoding mRNA vaccine, in combination with cemiplimab in frail patients with advanced non-small cell lung cancer (NSCLC)"
Abstract Number: CT013
Location: Room S100 A (Grand Ballroom A)
Date: Sunday, April 27, 2025
Time: 4:20 PM – 4:30 PM CDT

Poster presentations

Asset: BNT327 + BNT325/DB-1305
Session Title: "Combination Immunotherapies"
Abstract Title: "Activity of BNT327/PM8002 (PD-L1 x VEGF-A bispecific antibody) in combination with BNT325/DB-1305 (TROP2 ADC) in solid tumors: Early preclinical and clinical evidence to support BNT327 + ADC combinations"
Poster Number: 648 / 14
Location: Section 28
Date: Sunday, April 27, 2025
Time: 2:00 PM – 5:00 PM CDT

Asset: BNT327
Session Title: "Antibodies 3: Multi-Target Checkpoint Inhibitors and Immune Activators"
Abstract Title: "Dual PD-L1 blockade and VEGF-A neutralization with the bispecific antibody BNT327/PM8002 shows potent antitumor activity in preclinical models"
Poster Number: 6061 / 2
Location: Section 37
Date: Tuesday, April 29, 2025
Time: 2:00 PM – 5:00 PM CDT

Asset: BNT314/ GEN1059
Session Title: "Antibodies 3: Multi-Target Checkpoint Inhibitors and Immune Activators"
Abstract Title: "The combination of an EpCAMx4-1BB bispecific antibody with PD-1 blockade exhibits antitumor activity in a murine tumor model unresponsive to each individual antibody"
Poster Number: 6075 / 16
Location: Section 37
Date: Tuesday, April 29, 2025
Time: 2:00 PM – 5:00 PM CDT

On April 24, 2025 Bio-Techne Corporation (NASDAQ: TECH), a global provider of cutting-edge life science tools, reported an Early Access Program for its latest advancement in spatial biology: a powerful new assay for in situ detection of protein proximity (Press release, Bio-Techne, APR 24, 2025, View Source [SID1234652097]). Built upon Advanced Cell Diagnostics RNAscope technology, this next-generation assay is designed to reveal functional interactions between proteins within intact tissues, delivering a spatial solution to explore how molecular signaling shapes disease processes — offering a truly integrated spatial multiomic view.

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"This new protein proximity assay opens the door to seeing functional interactions between proteins and not merely their presence in a tissue," said Dr. Matt McManus, President of Bio-Techne’s Diagnostics & Spatial Biology Segment. "It’s a powerful step forward in understanding the dynamic interplay within tissues that drives biology and disease."

Conventional methods for studying molecular interactions in tissues that separately measure proteins and RNA risk losing spatial fidelity, while bulk proximity assays provide no localization data. Bio-Techne’s proximity detection technology addresses these gaps with a clear visual signal at subcellular resolution, built to be compatible with the RNAscope Multiomic LS workflow on BOND RX. This capability is particularly valuable for research areas where context matters — such as assessing immune checkpoint dynamics, investigating bispecific antibodies and studying protein interactions at synaptic junctions.

The Early Access Program is available to select institutions and researchers interested in incorporating spatial protein proximity capabilities into their workflows. Proof-of-concept data and case studies will be shared at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, presented by Bio-Techne’s scientific team.

On April 24, 2025 Azitra, Inc. (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, reported that it has entered into a share purchase agreement (SPA) with Alumni Capital LP (Alumni), an institutional investor (Press release, Azitra, APR 24, 2025, View Source [SID1234652096]). Azitra anticipates that this partnership will provide Azitra with a flexible source of funding, enabling the Company to progress its pipeline of live biotherapeutic precision products delivered topically to treat rare and severe dermatologic conditions.

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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

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As Azitra works towards key clinical milestones, the Company anticipates the SPA will allow the Company to minimize dilution while creating and sustaining shareholder value, enabling Azitra to be judicious and plan for the timing and amount of any equity sales, which will be critical as it strategically develops its pipeline focused on Netherton Syndrome, a rare skin disorder and EGFRi associated rash, which impacts approximately 150,000 people in the U.S.

Under the terms of the agreement, Azitra has the right to sell, and Alumni has the obligation to purchase up to $20 million worth of common stock and warrants to purchase shares of common stock over a 20-month period at prices that are based on the market price at the time of each sale to Alumni. Azitra, at its sole discretion, controls the timing and amount of all sales of common stock and warrants associated with the SPA, subject to the limitations contained in the SPA.

The issuance of the shares of common stock to Alumni is being made pursuant to exemptions from the registration requirements of the federal and state securities laws. Pursuant to the SPA, the Company must register Alumni’s resale of the shares of the Company’s common stock purchased. The exercise of the warrants will be subject to shareholder approval.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, 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.