On March 30, 2022 Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company with a Research & Development ("R&D") innovation engine that aims to discover, develop and ultimately deliver impactful medicines to patients, reported financial results for the fourth quarter and year ended December 31, 2021 and provided a business update (Press release, Centessa Pharmaceuticals, MAR 30, 2022, View Source [SID1234611220]).

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"We have strengthened our strategic focus on innovative, high impact rare disease and immuno-oncology assets. Lixivaptan for ADPKD and SerpinPC for hemophilia are entering into registrational studies while LB101, our PD-L1xCD47 LockBody, is advancing toward the clinic," said Saurabh Saha, MD, PhD, Chief Executive Officer. "We are in a strong financial position to make significant clinical progress towards our ‘4×24’ goal of having four programs in registrational trials in 2024."

"We believe that our LockBody programs have the potential to become the cornerstone for a multi-product immuno-oncology franchise. We look forward to sharing initial preclinical data at ASCO (Free ASCO Whitepaper) 2022 for the first program, LB101, which is designed to selectively drive potent CD47 effector function activity while avoiding systemic toxicity," said Antoine Yver, MD, MSc, Chairman of Development.
"The breadth of our rare disease programs provides us multiple opportunities to develop drugs which can potentially impact the lives of thousands of patients living with debilitating diseases such as ADPKD, hemophilia, alpha-1-antitrypsin deficiency, pulmonary arterial hypertension, and narcolepsy, among others," added Javad Shahidi, MD, MSc, Chief Medical Officer.

2021 Highlights and Recent Business Updates

Clinical Development Updates
•SerpinPC: Recently completed pre-IND interactions with the FDA regarding the planned registrational studies for SerpinPC. Based on the FDA feedback, the Company is proceeding with a streamlined, integrated registrational development plan initially for Hemophilia B, with and without inhibitors. The FDA discussions followed the announcement in September 2021 of positive topline data from a proof-of-concept study of SerpinPC in severe Hemophilia A and B subjects not on prophylaxis.
•Lixivaptan: Commenced dosing in the pivotal Phase 3 clinical trial ("ACTION Study") evaluating lixivaptan as a potential treatment for autosomal dominant polycystic kidney disease ("ADPKD"). In addition, a key US patent was issued on February 8, 2022, which covers the use of lixivaptan for the treatment of ADPKD. The patent term expires June 8, 2038, before considering possible patent term extensions or adjustments.
•ZF874: Announced proof-of-mechanism data from the first three PiMZ subjects dosed in the Phase 1 Part B study evaluating ZF874 for the treatment of AATD demonstrating that a pharmacological chaperone has the potential to achieve clinically significant Z-A1AT serum increases in individuals with AATD.
Business Updates
•Further strengthened the leadership team with multiple key appointments, including Antoine Yver, MD, MSc, Executive Vice President and Chairman of Development; Javad Shahidi, MD, MSc, Chief Medical Officer; and David Grainger, PhD, Chief Innovation Officer.
•Dosing of the first subject with lixivaptan in the Phase 3 ACTION Study in February 2022 triggered settlement of the contingent value rights ("CVRs") originally issued to the former shareholders and option holders of Palladio Biosciences in connection with its acquisition by Centessa in January 2021.
•Entered into financing agreement with funds managed by Oberland Capital Management LLC ("Oberland Capital") and received initial $75 million funding in October of 2021.
•As part of ongoing portfolio management, the Company has recently decided to discontinue the small molecule EGFR inhibitor discovery program; evaluate strategic options, including potential divestment, for imgatuzumab; and discontinue internal funding for the lead dual-STAT3/5 degrader program.
•Announced ‘4×24’ portfolio goal with the aim of having four registrational programs in 2024.

Upcoming Program Milestones
Registrational: Programs currently in or expected to enter registrational trials this year:
•Lixivaptan, vasopressin V2 receptor antagonist for ADPKD: Lixivaptan is currently being administered in the Phase 3 registrational ACTION Study to investigate its potential to treat ADPKD and avoid safety issues associated with the only drug currently approved for the treatment of ADPKD. The ACTION Study is expected to enroll ~1,350 subjects across>200 sites in

over 20 countries. The Company anticipates completing enrollment in the second half of 2023 and, if results are supportive, plans to submit a New Drug Application after completion of the one-year double-blind portion of the study.
•SerpinPC, an activated protein C inhibitor for Hemophilia: In the second half of 2022 the Company expects to launch two registrational studies. The first study will enroll ~120 subjects and evaluate the efficacy and safety of prophylactic SerpinPC in subjects with severe Hemophilia B without inhibitors and will include subjects with severe Hemophilia A to add to the safety database. The second registrational study is planned with fewer than 20 subjects to evaluate the efficacy and safety of SerpinPC in subjects with severe Hemophilia B with inhibitors. Registrational plans for Hemophilia A are in development. The Phase 2a open label extension study is ongoing, and we expect to report data on the 48-week flat dose portion of that study and interim results from the following 24-week high dose portion in the fourth quarter of 2022.
Emerging: Programs / platforms with expected clinical proof of concept in the next 18 months
•LB101 and LB201 in Solid Tumors: LB101, a PD-L1xCD47 LockBody, is designed to selectively drive potent CD47 effector function activity while avoiding systemic toxicity. We anticipate sharing foundational preclinical data at ASCO (Free ASCO Whitepaper) 2022, with an IND for LB101 planned for late 2022. LB201, a PD-L1xCD3 LockBody, is designed to selectively drive potent CD3 effector function activity while avoiding systemic toxicity. IND for LB201 is planned for 2023.
•ZF874 in Alpha-1 Antitrypsin Deficiency (AATD): Small molecule folding corrector of the Z variant of alpha-1-antitrypsin. We expect to share Phase 1 data from multiple dose cohorts with PiMZ and PiZZ subjects in 2H 2022.
•MGX292 in Pulmonary Arterial Hypertension (PAH): Recombinant modified BMP9 replacement protein designed to overcome the deficiency in BMP9 signaling in PAH. IND is planned for early 2023.
•OX2R Agonists (Oral and Intranasal) in Narcolepsy Type 1 (NT1): Selective orexin receptor 2 agonists targeting the underlying pathophysiology of orexin neuron loss in NT1. INDs/CTAs are planned for 2023.
Exploratory: Programs with expected clinical proof of concept beyond 18 months
•CBS001 in Inflammatory / Fibrotic Diseases: High-affinity anti-LIGHT antibody. Phase 1 clinical trial in healthy volunteers is expected to begin in the second quarter of 2022.
•CBS004 in Autoimmune Diseases: Humanized mAb targeting BDCA2. IND is planned for late 2022.

Fourth Quarter and 2021 (period January 30 through December 31, 2021) Successor Financial Results
•Cash and Cash Equivalents: $595.1 million as of December 31, 2021 which the Company expects will fund operations, based on current non-risk adjusted plans, into early 2024, without drawing on the remaining available tranches under the Oberland facility.

•R&D Expenses: $41.5 million for the Company for the quarter ended December 31, 2021, $95.7 million for the Successor for 2021.
•General & Administrative Expenses: $13.0 million for the Company for the quarter ended December 31, 2021, $42.9 million for the Successor for 2021.
•Net Loss Attributable to Ordinary Shareholders: $60.8 million for the quarter ended December 31, 2021, $381.1 million for the Successor for 2021 (which includes two special, non-cash expenses: a $220 million charge for acquired in-process R&D associated with the Centessa subsidiary acquisitions; and a $15 million fair value adjustment to the CVRs).

On March 30, 2022 Bolt Biotherapeutics, Inc. (NASDAQ: BOLT) a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported financial results for the fourth quarter and full year ended December 31, 2021, and provided an update on recent business highlights (Press release, Bolt Biotherapeutics, MAR 30, 2022, View Source [SID1234611219]).

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"In 2021, we demonstrated for the first time that our HER2-targeting Boltbody ISAC can increase myeloid cell infiltration and repolarize macrophages in the tumor microenvironment, and thereby, established proof of mechanism for our pioneering Boltbody ISAC platform. In our Phase 1/2 study, BDC-1001 was well tolerated at all dose levels tested with no dose-limiting toxicities. At the lower dose levels evaluated to date, we have seen stable disease in multiple different tumor types and a partial response that has now persisted for more than 60 weeks," said Randall C. Schatzman, Ph.D., Chief Executive Officer of Bolt Biotherapeutics. "We continue to explore dose levels expected to achieve our targeted higher drug exposures, and look forward to determining the recommended Phase 2 dose for BDC-1001 as monotherapy and in combination with Opdivo."

Recent Business Highlights

•Initiation of BDC-1001 combination arm with Bristol Myers Squibb’s PD-1 checkpoint inhibitor OPDIVO (nivolumab) in ongoing Phase 1/2 clinical trial for the treatment of patients with HER2-expressing solid tumors – In December 2021, Bolt Biotherapeutics dosed the first patient in a new combination arm of the ongoing multi-center, multi-dose Phase 1/2 clinical trial of BDC-1001.
•Reported interim Phase 1/2 monotherapy data for BDC-1001 in HER2-expressing solid tumors at ESMO (Free ESMO Whitepaper) I-O 2021 – In December 2021, Bolt Biotherapeutics presented a poster at the European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Congress 2021 detailing new safety, pharmacokinetic, and pharmacodynamic results from 57 subjects, 40 of whom were evaluable for efficacy, in the ongoing monotherapy dose-escalation portion of the Phase 1/2 trial. BDC-1001 demonstrated a favorable safety and tolerability profile. BDC-1001 also demonstrated early signs of clinical activity in the lower doses evaluable for efficacy with corresponding biomarker changes in the tumor microenvironment. The Company expects to determine the recommended Phase 2 dose for expansion trials in 2022.
•Advanced BDC-2034, a Boltbody ISAC targeting CEA, into IND-enabling studies with clinical development expected to begin in 2022 – Bolt Biotherapeutics is conducting IND-enabling studies with the goal of initiating clinical development in 2022. Data presented to date demonstrated tumor cell killing and innate immune activation in cellular and in vivo models of CEA-expressing cancers. Systemic administration in tumor-bearing animals was shown to result in dose-dependent anti-tumor activity.
•Presented preclinical data demonstrating progress of three novel anti-cancer therapeutic candidates at SITC (Free SITC Whitepaper) 2021 – In November 2021, Bolt Biotherapeutics presented three posters highlighting Bolt Biotherapeutics’ pipeline including BDC-2034, a PD-L1 Boltbody ISAC, and BDC-3042, an agonist antibody targeting Dectin-2, a novel target for tumor macrophage reprogramming in cancer immunotherapy.
•Expanded Bolt Biotherapeutics executive leadership team and board of directors with multiple appointments and promotions – The Company added Nicole Onetto, M.D., Brian O’Callaghan, and Frank Lee to the board of directors, bringing deep industry experience in clinical development and commercial strategy within oncology drug development. Jim Healy, M.D., Ph.D., assumed the role of Lead Independent Director. Additionally, Bolt Biotherapeutics promoted Bruce Hug, M.D., Ph.D., to Senior Vice President, Clinical Development & Translational Medicine, Nathan Ihle, Ph.D., to Senior Vice President, Pharmaceutical Operations, and Brian Safina, Ph.D., to Senior Vice President, Discovery Research.
•Cash, cash equivalents, and marketable securities were $271.6 million as of December 31, 2021, which is expected to fund operations and the advancement of the Company’s oncology product pipeline to achieve multiple key milestones into 2024.

Upcoming Events

•At the upcoming 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, the Company will present three posters highlighting preclinical research, demonstrating anti-tumor activity and supporting future clinical development for these novel, early-stage pipeline programs.
oWilliam G. Mallet, Ph.D., will present a poster entitled, "The CEA-targeted ISAC, BDC-2034, shows preclinical efficacy associated with innate immune activation, phagocytosis, and myeloid reprogramming" on Tuesday, April 12, 2022, from 9:00 a.m. – 12:30 p.m. CT.

oShelley E. Ackerman, Ph.D., will present a poster entitled, "Dectin-2 agonist antibodies reprogram tumor-associated macrophages to drive anti-tumor immunity" on Tuesday, April 12, 2022, from 9:00 a.m. – 12:30 p.m. CT.

oJustin Kenkel, Ph.D., will present a poster entitled, "PD-L1-targeted ISAC combines myeloid cell activation, immune-checkpoint inhibition and ADCP to improve anti-tumor efficacy over anti-PD-L1 antibodies in preclinical models" on Wednesday, April 13, 2022, from 9:00 a.m. – 12:30 p.m. CT.

•At the 21st Annual Needham & Co Virtual Healthcare Conference, management will be available for meetings with the investment community on Thursday, April 14, 2022, with a live virtual corporate presentation at 3:45 p.m. ET.

Fourth Quarter and Full Year 2021 Financial Results

Cash Position – Cash, cash equivalents, and marketable securities were $271.6 million as of December 31, 2021, compared to $22.8 million as of December 31, 2020. Bolt Biotherapeutics expects its cash balance to fund operations into 2024.

Collaboration Revenue – Revenue was $0.5 million for the quarter and $1.3 million for the full year ended December 31, 2021, compared to zero and $0.2 million for the same quarter and year in 2020. Revenue in 2021 was generated from services performed under the newly initiated R&D collaboration with Genmab A/S.

Research and Development Expenses – R&D expenses were $22.5 million for the quarter and $75.7 million for the full year ended December 31, 2021, compared to $14.9 million and $40.4 million for the same quarter and year in 2020, primarily due to increase in manufacturing and clinical trial expenses related to BDC-1001 and BDC-2034 and increase in personnel expenses relating to an increase in headcount.

General and Administrative Expenses – G&A expenses were $5.1 million for the quarter and $18.4 million for the full year ended December 31, 2021, compared to $2.1 million and $9.1 million for the same quarter and year in 2020, primarily due to increased expenses related to being a public company, including higher personnel expenses relating to increased headcount and an increase in professional services expenses.

Loss from Operations – Loss from operations was $27.1 million for the quarter and $92.8 million for the full year ended December 31, 2021, compared to $16.9 million and $49.2 million for the same quarter and year in 2020.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform

ISACs are a new category of immunotherapy combining the precision of antibody targeting with the strength of the innate and adaptive immune systems. Boltbody ISACs comprise three primary components: a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant to activate the patient’s innate immune system. By initially targeting a single marker on the surface of a patient’s tumor cells, an ISAC can create a new immune response by activating and recruiting myeloid cells. The activated myeloid cells start a feed-forward loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This reprograms the tumor microenvironment and invokes an adaptive immune response that targets the tumor, which can lead to the conversion of immunologically "cold" tumors to "hot" tumors with the goal of durable responses for patients with cancer.

On March 30, 2022 Keymed Biosciences Inc. (HKEX Code: 02162) reported 2021 annual results (Press release, Keymed Biosciences, MAR 30, 2022, View Source [SID1234611212]).

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BUSINESS HIGHLIGHTS

On July 8, 2021, Keymed was listed on the HKEX. During the Reporting Period, the Company continued proceeding the R&D of products and made the following progress with respect to pipeline and business operation:

Rapid development of in-house discovered products
Core product CM310 (IL-4Rα antibody):

The Company has initiated and completed the Phase IIb clinical trial for moderate-to-severe AD in adults, with the results disclosed in November 2021. And the Phase III clinical study has been rapidly initiated in the first quarter of 2022.
Phase II clinical trial for patients with CRSwNP was initiated in the first half of 2021 and the enrollment was completed in September 2021, and the results were disclosed in March 2022. The Company plans to initiate the Phase III study for CRSwNP in the second half of 2022.
Core product CM326 (TSLP antibody):

The Company has initiated and completed the Phase I trial in healthy persons in 2021, with the results disclosed in November 2021.
Phase Ib/IIa clinical trials of CM326 in adults with moderate to severe AD have been initiated in the first quarter of 2022.
Phase Ib/IIa clinical trials in patients with CRSwNP are about to be initiated.
Core product CMG901 (Claudin 18.2 ADC):

Phase I clinical trial of CMG901 in subjects with solid tumors was proceeded in 2021, which is currently in the dose-escalation phase. The Company expects to initiate the dose-expansion stage of trial in solid tumors in China in the second quarter of 2022.
In March 2021, Keymed received the FDA IND clearance of CMG901 for the Phase I clinical trial in gastric and GEJ cancers in the U.S.
CM313 (CD38 antibody):

The Phase I clinical trial for hematologic malignancies including RRMM and lymphoma was initiated and proceeded in 2021. The dose-escalation trial is expected to be completed in the first half of 2022.
In January 2022, Keymed submitted a clinical trial application to the NMPA for the indication of CM313 in the treatment of SLE.
Rapid expansion of workforce and production facilities
By the end of 2021, the Company had more than 320 employees, including over 120 employees engaging in clinical development and operations.
In addition to the headquarters in Chengdu, the Company has offices in Shanghai, Beijing, Wuhan, Guangzhou, etc.
In 2021, the Company initiated the construction of a new plant in Chengdu, and the first production line is expected to be put into operation in mid-2022 with capacity of 16,000 L. The designs of all facilities are in compliance with the requirements of cGMP of the NMPA and FDA.
Actively cooperation with external parties

In 2021, Keymed entered into cooperation with CSPC in respect to the interests in China (excluding Hong Kong, Macau and Taiwan) of CM310 and CM326 in respiratory disease indications such as moderate-to-severe asthma and COPD. In September 2021, the Company strategically allied with CSPC to jointly identify, research, develop and commercialize one or more nervous system disease-related products.

In 2021, Keymed entered into a strategic collaboration agreement with InnoCare to develop first-in-class large-molecule innovative drugs.

Financial Position

As of December 31, 2021, the Company’s R&D investment totaled RMB360 million; the collaboration income is RMB110 million, which was mainly derived from the cooperation with CSPC and InnoCare.
As of December 31, 2021, the Company’s cash in hand is approximately RMB3.5 billion.

On March 30, 2022 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported the initiation of a Phase 1 trial evaluating its novel chimeric antigen receptor T-cell (CAR-T) therapy in ovarian cancer (Press release, Anixa Biosciences, MAR 30, 2022, View Source [SID1234611211]). The CAR-T approach used for Anixa’s therapy is known as chimeric endocrine receptor T-cell (CER-T) since the target of the engineered T-cells is an endocrine receptor. The Phase 1 trial at Moffitt Cancer Center will evaluate the safety and efficacy of Anixa’s therapy in patients with ovarian cancer. Anixa holds an exclusive, worldwide license for the technology, which was developed at the Wistar Institute.

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While CAR-T therapy has shown efficacy in some hematological tumors, reproducing the same results with solid tumors, such as ovarian cancer, has proven challenging. One of the reasons for this difficulty is that effective CAR-T therapy needs a specific antigen to recognize that is only present on target cancer cells in order to avoid negatively affecting healthy cells. The CER-T therapy being evaluated in Anixa’s Phase 1 study differs from traditional CAR-T in that it targets the follicle stimulating hormone receptor (FSHR), which research indicates is exclusively expressed on ovarian cells in healthy adult females.

"We are thrilled to have partnered with world-class scientists at Moffitt Cancer Center to advance our CER-T platform and feel that this partnership provides a critical opportunity to make a significant impact on the treatment of solid tumors," said Dr. Amit Kumar, President, CEO and Chairman of Anixa Biosciences. "We strongly believe that our unique targeting approach differentiates our CER-T platform from traditional CAR-T approaches and that CER-T has potential to work in solid tumors where other therapies have failed."

Jose R. Conejo-Garcia, M.D., Ph.D., Chair of the Department of Immunology at Moffitt Cancer Center and co-inventor of the CER-T technology, added, "CAR-T therapies are rapidly becoming an important player in cancer therapy, and our lab has developed a technology that has the potential to target tumors by using an existing biological mechanism that is well understood. If our CER-T approach is successful, it could serve as a model for future targeted CAR-T therapies in other cancer types. The goal in cancer therapy has always been to kill cancer cells with limited damage to healthy tissue, and we look forward to seeing how this CER-T therapy may be able to accomplish that in solid tumors, which have historically proven challenging to eradicate with cell therapy."

Robert Wenham, M.D., MS, FACOG, FACS, the trial’s lead investigator and Chair of the Department of Gynecologic Oncology at Moffitt Cancer Center, added, "There are limited treatment options for recurrent, chemo-resistant ovarian cancer, and this platform holds immense promise to change that. I am hopeful that this program represents a unique opportunity for us to potentially make a truly game-changing impact for patients with ovarian cancer and other solid tumors."

About Anixa’s CER-T Approach (Follicle Stimulating Hormone Receptor-Mediated CAR-T technology)
Anixa’s chimeric antigen receptor T-cell (CAR-T) technology approach is an autologous cell therapy comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is known as CER-T (chimeric endocrine receptor T-cell) therapy, a new type of CAR-T.

On March 30, 2022 Sutro Biopharma, Inc. ("Sutro" or the "Company") (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation cancer therapeutics, reported that the company presented on advances with its novel immunostimulatory antibody-drug conjugate (iADC) modality at the 12th Annual World ADC conference taking place virtually and in London, from March 29 through April 1, 2022 (Press release, Sutro Biopharma, MAR 30, 2022, View Source [SID1234611210]).

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Sutro’s novel iADC modality was generated with Sutro’s proprietary and integrated cell-free protein synthesis platform and site-specific conjugation platform. The molecule allows for a single therapy to target tumors with conjugated toll-like receptor (TLR) agonist in addition to a conjugated cytotoxic warhead. The iADC modality provides for dual mechanisms to attacking the tumor, through cytotoxic killing as well as potentially building a protective immune response. Using dual conjugations to deliver both components as systemic therapy potentially broadens the types of tumors that can be treated.

"This novel iADC modality is a further confirmation of the fruitful journey at Sutro, building upon a decade of research working with precisely conjugated ADCs," commented Trevor Hallam, Ph.D., President of Research and Chief Scientific Officer of Sutro. "Sutro’s novel iADC technology has therapeutic potential in difficult-to-treat cancers by both directly targeting cancer cells and activating the patient’s own immune system through the dual mechanism of action. With this technology, we can potentially develop an off-the-shelf therapy that aims to program a patients natural immune response to treat cancer and protect against future disease."

Dr. Hallam presented virtually at a session during the pre-conference seminar titled, "A New Molecular Class to target Tumor Immunity by both disrupting the tumor and enabling the immune system" on Tuesday, March 29, 2022.

Arturo Molina, M.D., M.S., FACP, Chief Medical Officer of Sutro, presented a session titled "Targeting FolRα in Gynecologic Cancers & other Solid Tumours with the Novel Antibody-Drug Conjugate, STRO-002," on Wednesday, March 30. The talk examined nonclinical and clinical data of STRO-002 in ovarian, endometrial, and other cancers, including the previously disclosed interim dose-expansion data of STRO-002-GM1.

The presentations will be accessible through the News & Events page of the company’s website at www.sutrobio.com.