On May 14, 2024 Sonnet Biotherapeutics presented its corporate presentation (Presentation, Sonnet BioTherapeutics, MAY 14, 2024, View Source [SID1234643238]).

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On May 14, 2024 Scorpius Holdings, Inc. (NYSE American: SCPX), ("Scorpius", or the "Company"), an integrated contract development and manufacturing organization (CDMO), reported the pricing of its underwritten public offering of 60,000,000 common units and/or pre-funded units in lieu thereof (Press release, Scorpius BioManufacturing, MAY 14, 2024, View Source [SID1234643237]). Each common (or pre-funded) unit is being offered at a public offering price of $0.10 per unit (inclusive of the pre-funded warrant exercise price) and consists of one share of common stock (or pre-funded warrant to purchase one share of common stock in lieu thereof) and a common warrant to purchase one share of common stock. The common warrants will have an exercise price of $0.12 per share and will be immediately exercisable upon issuance for a period of five years following the date of issuance. The gross proceeds to the Company from the offering are expected to be approximately $6,000,000, before deducting underwriting discounts and offering expenses. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 9,000,000 shares of common stock (and/or pre-funded warrants) and/or up to an additional 9,000,000 common warrants solely to cover over-allotments, if any. All of the shares of common stock (and/or pre-funded warrants) and associated common warrants are being offered by the Company. The offering is expected to close on May 16, 2024, subject to satisfaction of customary closing conditions.

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The Company intends to use the net proceeds of the offering to fund working capital, general corporate purposes, and the repayment of a $750,000 non-convertible promissory note, plus accrued and unpaid interest.

ThinkEquity is acting as sole book-running manager for the offering.

A registration statement on Form S-1 (File No. 333-279092), as amended, including a preliminary prospectus, relating to the securities being offered was filed with the Securities and Exchange Commission ("SEC") and became effective on May 13, 2024. This offering is being made only by means of a prospectus. Copies of the preliminary prospectus and final prospectus, when available, may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. The final prospectus will be filed with the SEC and will be available on the SEC’s website located at View Source

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On May 14, 2024 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical stage company focused on developing next generation therapeutics to target difficult-to-treat cancers, reported financial results for the first quarter ended March 31, 2024, and provided a corporate update (Press release, Pyxis Oncology, MAY 14, 2024, View Source [SID1234643236]).

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PYX-201, a first-in-concept tumor stroma targeting antibody-drug conjugate (ADC) against the stromal Extradomain-B Fibronectin (EDB+FN) target, has dosed 42 patients in 8 cohorts since initiating the Phase 1 trial in March 2023 with continued enthusiasm for this agent by global investigators.

"Based on encouraging early responses with late-stage patients across multiple tumor types, we are actively studying dose ranges from 5.4 mg/kg to 8 mg/kg, refining our understanding of PYX-201’s therapeutic window. We are on track to report the comprehensive dataset in the fall of 2024, and we look forward to the potential future robust development plan supported by our strong balance sheet," said Lara S. Sullivan, M.D., President and CEO of Pyxis Oncology.

Dr. Sullivan added, "We plan to dose an additional 16 patients with a focus on five tumor types of interest based on an assessment of factors including immunohistochemistry target expression, stromal volume, unmet medical need, and clinical judgment. Patient recruitment at these dose levels focuses on head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), ovarian cancer, soft tissue sarcoma, and pancreatic ductal adenocarcinoma cancer (PDAC). We look forward to sharing the monotherapy development path for PYX-201 this fall alongside the dose escalation phase 1 dataset presentation. PYX-201 safety data continues to support go-forward monotherapy and potential combination development strategies."

Pyxis Oncology continues to expand our understanding of PYX-201, and we were excited to share our latest preclinical data at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in San Diego, California, held from April 5 to 10, 2024. The preclinical data presented (Figure 1. Abstract #742) supports that PYX-201 is designed to have improved plasma stability, better potency, and tumor permeability due to optimized auristatin payload (Aur-0101) and improved linker stability through site-specific conjugation to engineered cysteine residues for a target DAR of 4. Across a panel of approximately 100 preclinical patient-derived xenograft (PDX) models representing ten tumor types, PYX-201 demonstrated broad, deep, and durable anti-tumor activity.

Another poster (Figure 2. Abstract #2908) Pyxis Oncology presented on PYX-201 detailed the development of an immunohistochemistry (IHC) assay to detect our novel EDB+FN protein target and shared our scoring method to quantify expression in tumor stroma. This research further supports that EDB+FN is broadly and predominantly expressed in tumor-induced stroma across multiple cancer indications (10 tumor types) with virtually no expression in healthy tissues.

Given the observed anti-tumor activity for our non-internalizing mechanism of action, Pyxis Oncology also had the opportunity to review insights from a legacy 2014 AACR (Free AACR Whitepaper) poster (Figure 3. Abstract #4837) on the extracellular cleavage of ADCs that promotes bystander cell killing. This poster described mechanisms of extracellular proteolytic cleavage of ADCs and, for an EDB+FN-targeted ADC specifically, the release of Aur-0101 payload capable of bystander cell killing, which provides support for our novel mechanistic approach of payload cleavage in the extracellular matrix.

In summary, Pyxis Oncology’s preclinical data provides insights into the mechanism associated with this novel agent observed across multiple solid tumors. PYX-201 has potential applications in both monotherapy and combination therapy and maintains a well-tolerated safety profile based on the lack of EDB+FN expression in healthy cells.

Concurrently, Pyxis Oncology is actively enrolling our Phase 1 study evaluating PYX-106, a fully human immunotherapy antibody candidate aimed at inhibiting Siglec-15 activity in non-small cell lung cancer, colorectal cancer, breast cancer, and other tumors of interest. We plan to share the initial PYX-106 clinical results in the second half of 2024 after our PYX-201 results.

Pyxis Oncology is also delighted to announce the appointment of Stephen Worsley as its new Chief Business Officer. With a wealth of experience in the biotechnology and pharmaceutical sectors, Stephen brings invaluable expertise to Pyxis Oncology’s leadership team.

In his role, Stephen will oversee Pyxis Oncology’s business development strategies and forge partnerships to advance the company’s assets, PYX-201 and PYX-106. His proven track record in fostering successful collaborations and executing strategic initiatives aligns seamlessly with Pyxis Oncology’s mission to develop breakthrough treatments for patients with difficult-to-treat cancers. As a business development executive, Stephen has led negotiations of transformative and award-winning technology and clinical product partnerships for leading therapeutics companies, focused primarily on oncology with antibody and ADC modalities. These include global co-development agreements on behalf of Abgenix with Immunex/Wyeth (led to acquisition by Amgen for $2.7B) with Vectibix (panitumumab); on behalf of Peregrine a deal with Oncologie Inc. for clinical Phase III level bavituximab; on behalf of Zosano Pharmaceutical with Asahi Kasei Pharma Corporation (AKP) Asahi Kasei Pharma Corporation (AKP) on ZP-PTH; on behalf of Raven Biotechnologies with B7-H3 & B7-H4 mAbs with Macrogenics (leading to the merger of the two companies); and also on behalf of Raven with Abbott (AbbVie) a collaboration focused on five key mAbs (for ADC development) programs.

"We are thrilled to welcome Stephen to Pyxis Oncology as our Chief Business Officer," said Dr. Sullivan. "Stephen’s extensive experience, proven track record of transaction execution, and strategic vision will be instrumental as we continue the clinical development of our lead asset, PYX-201, a first-in-concept tumor stroma targeting ADC against EDB-fibronectin."

"Joining Pyxis Oncology is an extraordinary opportunity to contribute to a company that stands at the forefront of ADC research and development," said Stephen. "I am excited to work with the team to build on their strong foundation and to help drive the development of transformative cancer treatments that could significantly impact patients’ lives."

Stephen joins Pyxis Oncology from Lytix Biopharma, where he was the Chief Business officer and led numerous successful business development endeavors. His appointment underscores Pyxis Oncology’s commitment to attracting top talent to drive its mission of transforming cancer care through innovation.

Program and Corporate Updates

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PYX-201 in the PYX-201-101 trial: To date, 42 subjects have been dosed, and the Company will enroll an additional 16 patients. Pyxis Oncology expects to report study results, including efficacy, safety, pharmacokinetics (PK), preclinical insights, further development plans, and the expected timing of the next anticipated milestones in the fall of 2024.
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PYX-106 in the PYX-106-101 trial: This is a phase 1 trial focusing on NSCLC and other tumor types. Study dosing is ongoing, with 24 subjects dosed to date. Preliminary data are anticipated in 2H 2024.
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AACR Poster Presentations. Presented new PYX-201, PYX-106 and PYX-102 preclinical data at the AACR (Free AACR Whitepaper) Annual Meeting.
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Expanded Executive Leadership Team with the appointment of Stephen Worsley as Senior Vice President, Chief Business Officer.

Anticipated Upcoming Milestones

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PYX-201: Report preliminary Phase 1 data and PK/PD results in fall of 2024
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PYX-106: Report preliminary Phase 1 data and PK/PD results in 2H 2024, following the release of PYX-201 results

First Quarter 2024 Financial Results

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As of March 31, 2024, Pyxis Oncology had cash and cash equivalents, including restricted cash, and short-term investments of $158.5 million. During Q1 2024, the Company raised gross proceeds of $10.8 million via an at-the-market ("ATM") offering, completed a $50 million private placement, and sold the Company’s rights to royalties from the commercialization of Beovu (brolucizumab-dbll) and another asset for a one-time payment of $8 million to Novartis. Pyxis Oncology expects to have the cash runway to fund operations into 2H 2026.
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Revenues for the quarter ended March 31, 2024 were $16.1 million, compared to $0 for the quarter ended March 31, 2023. During the quarter, we entered into a settlement agreement with Novartis, pursuant to which we transferred our rights to future royalties on the net sales of Beovu to Novartis for a one-time amount of $8.0 million and Novartis also agreed to forgo its right to reclaim royalties previously paid of $8.1 million to us and Apexigen. Both of these amounts were recognized as revenues, upon execution of the settlement agreement during the quarter ended March 31, 2024.
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Research and development expenses were $13.0 million for the quarter ended March 31, 2024, compared to $11.9 million for the quarter ended March 31, 2023. The period-over-period increase was primarily due to increased clinical trial-related expenses for our ongoing Phase 1 clinical trials of PYX-201 and PYX-106.
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General and administrative expenses were $8.2 million for the quarter ended March 31, 2024, compared to $9.1 million for the quarter ended March 31, 2023. The period-over-period decline was primarily due to lower professional and consultant fees.
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Net loss was $3.3 million, or ($0.06) per common share, for the quarter ended March 31, 2024, compared to $19.2 million, or ($0.54) per common share, for the quarter ended March 31, 2023. Net losses for the quarters ended March 31, 2024 and 2023 included $4.3 million and $4.9 million, respectively, related to non-cash stock-based compensation expense.
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As of May 13, 2024, the outstanding number of shares of Common Stock of Pyxis Oncology was 58,888,473.

On May 14, 2024 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage allogeneic cell therapy and genetic medicines company advancing differentiated non-viral treatments for patients with cancer and rare diseases, reported updates and financial results for the first quarter ended March 31, 2024 (Press release, Poseida Therapeutics, MAY 14, 2024, View Source [SID1234643235]).

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"We see 2024 as a breakout year for Poseida as we make great strides across our cell therapy and genetic medicine programs and continue to cultivate and expand high value collaborations that highlight Poseida’s role as the partner of choice in allogeneic CAR-T," said Kristin Yarema, Ph.D., President and Chief Executive Officer of Poseida Therapeutics. "The promising updates from our BCMA program at AACR (Free AACR Whitepaper) 2024 reinforce our belief that P-BCMA-ALLO1 has the potential to treat a broad range of patients with multiple myeloma, including those who are BCMA-therapy naïve and those who have relapsed or are refractory to BCMA-targeted therapies such as autologous CAR-T or T-cell engaging bispecifics. We continue to advance our MUC1-C solid tumor and CD19CD20 B-cell malignancy programs and are on track to provide updates across our wholly owned and Roche-partnered CAR-T programs in the second half of 2024."

"The proprietary and powerful genetic engineering toolkit that we have used ex vivo to deliver our allogeneic CAR-T programs demonstrates compelling potential for the development of in vivo genetic medicines. Moving forward, we are focusing our gene therapy pipeline on fully nonviral approaches, highlighted by our lead gene editing and gene insertion programs, P-KLKB1-101 and P-FVIII-101. New preclinical data supporting the advancement of both programs was recently presented at the ASGCT (Free ASGCT Whitepaper) annual meeting, further confirming their potential to address significant unmet patient need."

Recent Accomplishments

Cell therapy

Announced strategic research collaboration and license agreement with Astellas’ wholly owned subsidiary, Xyphos Biosciences, to develop novel cell therapies for solid tumors. The collaboration will utilize Poseida’s proprietary allogeneic CAR-T platform with Xyphos’ ACCEL technology to create one Poseida-developed CAR-T construct to form the basis of two convertibleCAR product candidates in areas beyond Poseida’s core pipeline focus. Under the research agreement, Poseida is receiving $50 million upfront plus potential development and sales milestones and contingency payments of up to $550 million in total and will be reimbursed for costs incurred as part of the research agreement. Poseida is eligible for up to low double digit tiered royalties as a percentage of net sales. This new collaboration expands the strategic relationship between the companies, which began in 2023 with Astellas’ $25 million equity investment in Poseida and concurrent one-time $25 million payment for a right of exclusive negotiation and first refusal to license Poseida’s P-MUC1C-ALLO1 program also targeting solid tumors.

Presented new allogeneic CAR-T data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from the Company’s Phase 1 study of P-BCMA-ALLO1 as well as a comparison of lymphodepletion needs in hematologic vs. solid tumor settings.

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The P-BCMA-ALLO1 data presented at AACR (Free AACR Whitepaper) 2024 builds on the Company’s earlier ASH (Free ASH Whitepaper) 2023 data, which demonstrated a 100% overall response rate in patients who had not been previously treated with a BCMA-targeted therapy who received adequate lymphodepletion. This new data from a subset of patients in the ongoing Phase 1 study showed that three of five (60%) patients with relapsed/refractory multiple myeloma (RRMM) who had progressed following one or more prior BCMA-targeted therapies achieved clinical responses with P-BCMA-ALLO1. Overall, P-BCMA-ALLO1 was well tolerated, and findings suggest that P-BCMA-ALLO1 could be an appropriate treatment for a broad range of patients with multiple myeloma, including BCMA-naïve patients and those with relapsed/refractory disease whose cancer progressed following prior BCMA-targeted therapy.
•
Following efforts to optimize its allogeneic CAR-T therapies, Poseida presented new data underscoring the need for higher lymphodepletion chemotherapy doses when treating solid tumors vs. hematologic malignancies. Drawing from these insights, the Company is exploring higher lymphodepletion regimens in its Phase 1 clinical trial of P-MUC1C-ALLO1 for solid tumors.
P-BCMA-ALLO1 granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma, highlighting the potential of TSCM-rich allogeneic CAR-T therapies to offer the optimal combination of clinical results, on-demand availability, and high-volume production, while supporting broad access to off-the-shelf allogeneic CAR-T therapies.

Advanced Roche partnership including completion of certain program-related development milestones that resulted in the receipt of a $30 million payment in the first quarter of 2024 and the anticipated receipt of an additional $15 million milestone payment in May 2024. Looking forward, Poseida will continue to have responsibility for the expanded Phase 1 trial of P-BCMA-ALLO1 and the related operational activities, for which Roche will provide reimbursement.

Genetic medicine

Poseida’s gene therapy platform technologies, which are based in part on experience developing the Company’s allogeneic CAR-T platform, demonstrate significant potential to support the development of in vivo genetic medicines. The Company highlighted these scientific advancements and its pipeline strategy during a virtual Gene Therapy R&D Day, including its fully non-viral approach to genetic medicine employing differentiated gene delivery, gene editing and gene insertion technology.

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The key advantages of Poseida’s fully non-viral approach include low immunogenicity, lower oncogenic risks, integrated and stable expression, personalized titratable dosing, and a favorable cost of goods compared to viral gene therapies.
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Poseida is focused on advancing its two fully non-viral lead programs in rare disease with significant unmet patient need: P-KLKB1-101 for Hereditary Angioedema (HAE), which is the Company’s first in vivo gene editing program using Cas-CLOVER, and P-FVIII-101, which is the Company’s gene insertion program for the treatment of Hemophilia A.
•
Poseida’s hybrid programs remain promising for applications where high levels of editing in liver cells are required and Poseida may opportunistically consider partnering transactions.
Presented multiple presentations at the American Society of Gene and Cell Therapy 27th Annual Meeting (ASGCT) (Free ASGCT Whitepaper) featuring lead genetic medicine approaches, P-KLKB1-101 and P-FVIII-101.

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P-KLKB1-101 interim data in a non-human-primate model showed that the Cas-CLOVER nuclease formulation was well tolerated and yielded levels of editing approaching therapeutic efficacy in early read-out doses. Studies in human cells and rodent models show high fidelity and high efficiency KLKB1 editing within a target range for correction of HAE. P-KLKB1-101 demonstrated a highly controlled dose-dependent reduction in kallikrein protein and confirmatory studies revealed minimal off-target editing.
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P-FVIII-101 preclinical data support advancing to non-human primate studies based on sustained FVIII expression over 13 months from a single dose, along with data supporting mitigated immunogenicity and ability to fine tune FVIII expression levels via repeat dosing and/or Poseida’s proprietary modulator switch.
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Additional data describing the Company’s advancements in lipid nanoparticle (LNP) technology, intracellular targeting agents and nuclease fidelity.
Anticipated Milestones

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P-BCMA-ALLO1 in RRMM: clinical update planned for the second half of 2024 subject to coordination with Roche.
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P-MUC1C-ALLO1 in solid tumors: clinical update planned for the second half of 2024.
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P-CD19CD20-ALLO1 in B-cell malignancies: interim data update anticipated in the second half of 2024 subject to coordination with Roche.

Other Operational Updates

Leadership Updates

Poseida appointed Syed Rizvi, M.D., as Chief Medical Officer in April 2024. Dr. Rizvi is a seasoned executive with over 20 years of experience across all stages of drug development, including clinical strategy, execution, and commercialization. He most recently served as Chief Medical Officer of Caribou Biosciences, where he was responsible for overall strategy and execution of all clinical development programs, and also held leadership positions at Chimeric Therapeutics, Legend Biotech, and Celgene.

Financial Results for the First Quarter 2024

Revenues

Revenues were $28.1 million for the first quarter ended March 31, 2024, compared to $10.3 million for the same period in 2023. The increase was primarily due to revenue recognized from the Astellas strategic investment and an increase in Roche-related collaboration activity.

Research and Development Expenses

Research and development expenses were $42.9 million for the first quarter ended March 31, 2024, compared to $38.1 million for the same period in 2023. The increase was primarily due to an increase in allogeneic clinical stage programs, driven mainly by an increase in overall enrollment of our allogeneic programs and the initiation of our third allogeneic clinical trial, P-CD19CD20-ALLO1.

General and Administrative Expenses

General and administrative expenses were $9.8 million for the first quarter ended March 31, 2024, compared to $11.8 million for the same period in 2023. The decrease was primarily due to lower personnel expenses, mainly caused by a decrease in stock-based compensation expense driven by a one-time expense associated with the resignation of our former Executive Chairman in 2023.

Net Loss

Net loss was $24.3 million for the first quarter ended March 31, 2024, compared to net loss of $38.8 million for the same period of 2023.

Cash Position

As of March 31, 2024, the Company’s cash, cash equivalents and short-term investments balance was $198.6 million. In addition, the Company will receive $50 million from the recent Astellas research collaboration and $15 million from a recent milestone achievement within the Roche collaboration. The Company expects that its cash, cash equivalents and short-term investments together with these and other remaining near-term milestones and other payments from Roche will be sufficient to fund operations into the second half of 2025. Potential additional payments under the Roche Collaboration Agreement and/or potential additional business development could further extend cash runway.

On May 14, 2024 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported that it has expanded its collaboration with MSD (Merck & Co., Inc., Rahway, NJ, USA) to include a clinical trial collaboration and supply agreement for a phase 2 trial evaluating Nykode’s wholly-owned lead candidate, VB10.16, in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) (Press release, Nykode Therapeutics, MAY 14, 2024, View Source [SID1234643233]). This study will enroll HPV16-positive high-risk patients with locally advanced cervical cancer undergoing chemoradiotherapy.

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VB10.16 is a potentially first-in-class off-the-shelf therapeutic cancer vaccine specifically designed to treat HPV16-induced malignancies. The cancer vaccine is built on Nykode’s technology platform of targeting antigens to antigen presenting cells. Nykode has reported promising data from the phase 2 VB C-02 trial (NCT04405349) in heavily pre-treated cervical cancer patients receiving VB10.16 in combination with atezolizumab with a median overall survival not yet reached (estimated to 25 months at the time of analysis). These data support Nykode’s ongoing efforts with the phase 2 VB-C-04 trial (NCT06099418) in second-line recurrent/metastatic cervical cancer. Furthermore, the VB10.16 clinical development program is expanding into new indications, including head and neck cancer, for which Nykode has an existing clinical trial collaboration and supply agreement with MSD for the ongoing VBC-03 trial (NCT06016920) evaluating VB10.16 in combination with KEYTRUDA in patients with HPV16-positive, PD-L1-positive, recurrent or metastatic head and neck squamous cell carcinoma.

Agnete Fredriksen, EVP, Chief Scientific Officer and Business Development, commented, "We are excited to expand our clinical development to include earlier stages of cervical cancer where there is a significant unmet medical need, and we see a huge potential for cancer vaccines. We are thrilled to continue building on our already established, highly valued collaboration with the experienced and talented team at MSD, a global leader in immuno-oncology."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.