Metastatic Colorectal Carcinoma

Versavo® (bevacizumab) is indicated for the treatment of several types of cancers including metastatic colorectal cancer, advanced non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, advanced cervical cancer, ovarian cancer and metastatic breast cancer Versavo® is the first Dr. Reddy’s biosimilar product to be approved and launched in the UK Previously, Dr. Reddy’s launched Versavo® in India in 2019 and subsequently in other countries such as Thailand, Ukraine, Nepal and Jamaica. In Colombia, the product was launched under the brand name Persivia®. HYDERABAD, India--(BUSINESS WIRE)-- Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; hereafter referred to as “Dr. Reddy’s”), a global pharmaceutical company, announced the launch of Versavo® (bevacizumab) in the United Kingdom (UK). Dr. Reddy’s Versavo® is a (bevacizumab) biosimilar of Avastin®1 and indicated for the treatment of several types of cancers, including metastatic colorectal cancer, advanced non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, advanced cervical cancer, ovarian cancer and metastatic breast cancer2. Versavo® is the first Dr. Reddy’s biosimilar product to be approved and launched in the UK. It is available in strengths of 100mg and 400mg single use vials. Dr. Reddy’s launched Versavo® in India in 2019. Subsequently, Versavo® was introduced in other markets such as Thailand, Ukraine, Nepal, and Jamaica under the same brand name. In Colombia, the product was launched under the brand name Persivia®. Dr. Jayanth Sridhar, Global Head of Biologics at Dr. Reddy’s, said: “The launch of Versavo® in a highly regulated market underscores our capability for global clinical development of high-quality biosimilar products. Versavo® is a potential treatment option for patients with different types of cancers. This launch reinforces our commitment to bring more biosimilar and other critical biological products to meet the unmet needs of patients, and strengthens our focus on oncology.” About Dr. Reddy’s Versavo®: Versavo® is bevacizumab biosimilar from Dr. Reddy's. Bevacizumab is the first antiangiogenic therapy proven to slow metastatic disease progression in patients with cancer. It is a humanized recombinant antibody that targets human vascular endothelial growth factor (VEGF), leading to deterred angiogenesis and tumor growth3. About Dr. Reddy’s biosimilars programme: Dr. Reddy’s biosimilars business is part of our key strategic initiatives expected to drive both near-term and long-term growth. Over the last 25 years, our Biologics team has developed into a fully integrated organisation with robust capabilities in the development, manufacture and commercialisation of a range of biosimilar products in oncology and immunology. We have a current portfolio of six commercial products marketed in India, with some products marketed in more than 25 other countries. In addition, we have several products in the pipeline in oncology and auto-immune diseases in various stages of development for global launches across regulated as well as emerging markets. We are also ramping up manufacturing capacity to support our global expansion plans. In July 2023, our proposed rituximab biosimilar application was accepted for review by the USFDA, EMA and MHRA. About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, we are committed to providing access to affordable and innovative medicines. Driven by our purpose of ‘Good Health Can’t Wait’, we offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Our major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in businesses of the future. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: . Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2023. The company assumes no obligation to update any information contained herein. 1 Avastin® is a registered trademark of Roche. 2 3 View source version on businesswire.com: Contacts INVESTOR RELATIONS RICHA PERIWAL richaperiwal@drreddys.com MEDIA RELATIONS USHA IYER ushaiyer@drreddys.com Source: Dr. Reddy’s Laboratories Ltd. View this news release online at:

ADELAIDE, Australia, March 18, 2024 (GLOBE NEWSWIRE) -- Carina Biotech Limited (Carina), a clinical stage cell therapy immuno-oncology company, today announced three poster presentations from studies of its LGR5-targeting CAR-T program in colorectal cancer and ovarian cancer at the American Association for Cancer Research (AACR) Annual Meeting 2024 that will take place in San Diego, California, on April 5-10. “We are looking forward to sharing data related to our LRG-5 targeted CAR-T program in three poster presentations at the upcoming AACR annual meeting. One of the posters will highlight the GMP manufacturing and testing findings for our lead LGR5-targeted CAR-T cell therapy candidate CNA3103, that is currently being evaluated in a Phase 1/2 clinical trial for the treatment of adult patients with metastatic colorectal cancer,” stated Deborah Rathjen, PhD, Carina’s Chief Executive Officer. “Our research team will also be presenting preclinical data that demonstrate the potential to develop our LGR5-targeting CAR-T cells as a novel immunotherapy for ovarian cancer and that expand the preclinical body of evidence across a diverse range of cancer families, including ovarian, brain, liver, and stomach, where LGR5-targeting CAR-T cells may be harnessed.” Poster Presentation Details Title: Preclinical in vivo characterization underpinning LGR5-targeting CAR-T cells as a cancer immunotherapyLead Author: Jade Foeng, PhD, Chemokine Biology Laboratory, Department of Molecular and Biomedical Science, The University of Adelaide, South AustraliaSession Category: ImmunologySession Title: Adoptive Cell Therapies: CAR-T CellsSession Date and Time: Sunday, April 7, 2024 1:30 pm PT – 5:00 pm PTLocation: Poster Section 2Poster Board Number: 24Published Abstract Number: 56 Title: CAR-T cells targeting LGR5: An effective treatment for chemotherapy resistant ovarian cancerLead Author: Wanqi (Jady) Wang, Robinson Research Institute, The University of Adelaide, South AustraliaSession Category: Clinical ResearchSession Title: Adoptive Cell Therapy 2Session Date and Time: Tuesday, April 9, 2024 1:30 pm PT – 5:00 pm PTLocation: Poster Section 40Poster Board Number: 11Published Abstract Number: 6320 Title: From bench to bedside: GMP manufacturing and testing of LGR5-targeting CAR-T against colorectal cancerLead Author: Veronika Bandara, PhD, Molecular Immunology Laboratory, Robinson Research Institute, The University of Adelaide, South AustraliaSession Category: Clinical ResearchSession Title: Adoptive Cell Therapy 2Session Date and Time: Tuesday, April 9, 2024 1:30 pm PT – 5:00 pm PTLocation: Poster Section 40Poster Board Number: 22Published Abstract Number: 6311 About Carina BiotechClinical stage immuno-oncology company Carina Biotech is developing CAR-T and other adoptive cell therapies for the treatment of solid cancers. In addition to its LGR5-targeted CAR-T cell therapy CNA3103 for advanced colorectal cancer, Carina has a deep pipeline of CAR-T programs. Using its proprietary chemokine receptor platform, Carina aims to improve access to and infiltration of solid cancers by CAR-containing cells, resulting in more potent and specific cancer killing and reduced off-target effects. Carina also has a fully integrated, proprietary manufacturing process that has reduced manufacturing time and improved CAR-T cell quality, with the potential to deliver robust “serial-killing” CAR-T cells to patients. About CNA3103Carina’s proprietary CNA3103 CAR-T cell targets LGR5, a cancer stem cell marker that is highly expressed on advanced colorectal cancer and some other cancers. In colorectal cancer patients, LGR5 expression has been correlated with poor prognosis. Cancer stem cells are a small sub-population of cells within a tumor with the ability to self-renew, differentiate into the many cell types of a tumor, initiate new tumors, and resist chemotherapy and radiotherapy (leading to relapses). By targeting cancer stem cells, it is anticipated that this therapy will reduce the tumor’s ability to generate new cancer cells, resulting in durable tumor suppression and preventing the relapses that are common in patients with colorectal cancer. Carina’s preclinical studies of CNA3103 have shown promising results with complete tumor regression and no tumor recurrence following a single administration. CNA3103 has also demonstrated impressive tumor access and prolonged survival enabling the rejection of new tumors. For more information please contact: Rudi MichelsonMonsoon Communications+61 (0)3 9620 3333rudim@monsoon.com.au Stephanie CarringtonICR Westwicke+1 646 277 1282stephanie.carrington@westwicke.com

FDA Grants Fast Track designation for BOT/BAL in metastatic, refractory colorectal cancer (CRC) patients who have failed 1st and 2nd line standard of care treatments Data from Phase 1 of BOT/BAL in refractory CRC showed durable ORR of 24% in patients with non-active liver metastases (NLM); Completed enrollment of randomized Phase 2 trial (n=230) Clinical data sets path for expansion opportunities in pancreas, lung, neoadjuvant CRC, and melanoma LEXINGTON, Mass.--(BUSINESS WIRE)-- Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, today provided a corporate update and reported financial results for the fourth quarter and full year 2023. “In 2023, Agenus made significant advances across our BOT/BAL development program. Our first target indication is metastatic, refractory colorectal cancer that is not MSI-H/dMMR, for which we are focused on pursuing accelerated approval,” said Garo Armen, Ph.D., Chief Executive Officer. “We are also pursuing multiple strategies to capitalize the company through this important path in our efforts to bring BOT and BOT/BAL to the forefront of solid tumor cancer treatment. Our vision is to maximize BOT's utility to benefit patients in combination with other immune therapies as well as current standards of care for patients with both early and late-stage tumors.” 2023 Highlights on Botensilimab Colorectal Cancer: Received Fast Track designation for patients with metastatic colorectal cancer that is not MSI-H/dMMR and who do not have liver metastases, and who were previously treated with standard combination chemotherapy, anti-VEGF and anti-EGFR if RAS wild type (“refractory MSS mCRC NLM”) Completed enrollment of patients with refractory MSS mCRC NLM in a Phase 1 (n=150) and randomized Phase 2 (n=230) in October 2023. Clinical data reported by Agenus in October 2023 revealed: Among the 70 efficacy evaluable ("EE") patients in the refractory MSS mCRC NLM treatment setting, a 24% RECIST v1.1 response rate was observed in those treated with the BOT/BAL combination. Based on literature review, the response rate in a similar population treated with standard of care therapies ranges from 1% to 6.1%1, 2. The 12-month overall survival (OS) rate is 74% with median OS not yet reached. Topline data from the ongoing Phase 2 study are expected in 2H 2024. The most common safety observations are immune-related diarrhea and colitis, which are managed in accordance with standard therapies. Grade 3 treatment related diarrhea/colitis occurred in approximately 14% of patients. Neoadjuvant CRC: Clinical data presented at ASCO-GI January 2024: In an investigator sponsored trial (IST) led by Dr. Pashtoon Kasi at Weill-Cornell Medicine, patients diagnosed with resectable localized colon or rectal cancer were treated with one dose of BOT and two doses of BAL approximately 4 weeks prior to planned surgery. After surgery, pathologic analysis reported significant tumor shrinkage. 3/3 patients (100%) with MSI-H CRC experienced major pathological responses (>90% tumor shrinkage) in less than 4 weeks, while 6/9 (67%) MSS CRC patients had tumor shrinkage of 50% or more. IST is expanding to 24 patients with an extended follow-up time (6-8 weeks); Agenus plans to prioritize neoadjuvant development and is evaluating study designs for subsequent pivotal trials. 2L Metastatic Pancreatic: In patients with metastatic pancreatic cancer who have failed or don’t respond to FOLFIRINOX (2L Pancreatic) and received treatment with BOT in combination with gemcitabine+nab-paclitaxel, significant tumor marker reductions were observed in 4 of 5 patients, all with liver metastases. Two (2) of the 4 patients achieved PRs at 16 weeks (target lesion reductions of 47% (confirmed) and -37% (pending confirmation). Two other patients showed stable disease at their first 8-week scan with tumor reductions of -20% and -13%. A Phase 2 randomized study is in progress, with preliminary data expected to be available mid-year. CTLA-4/PD-1 Relapsed Refractory Advanced Melanoma (“2L+ Melanoma”): Phase 1b expansion cohort in 2L+ Melanoma reported a 30% ORR and 60% disease control rate (n=10; 2/8 BOT responses and 1/2 BOT/BAL responses); all patients had failed anti-PD-1 therapy and 8/10 had failed both anti-PD-1/CTLA-4 therapy. In the Phase 2 study in 2L+ Melanoma, data from the fully enrolled BOT monotherapy arm and a cohort of patients on BOT/BAL (n=30) are anticipated in 2H2024. Refractory Non-Small Cell Lung Cancer (NSCLC): In the PD(L)-1 refractory cohort, a 56% ORR and an 89% disease control rate were observed in patients treated with the BOT/BAL combination (n=9). In a TKI-refractory cohort, 2 out of 7 patients experienced complete confirmed objective responses after treatment with BOT/BAL*. Advanced Sarcomas: Updated findings from a Phase 1b study of 41 efficacy evaluable patients treated with BOT/BAL showed durable responses with an ORR of 20%, a median response duration of 19.4 months (iRECIST), and a 6-month progression-free survival rate of 40%. A higher ORR was observed by dose level, with 29% at 2 mg/kg BOT compared to 15% at 1 mg/kg BOT. Refractory Ovarian: In a total of 24 evaluable patients treated with BOT/BAL, with a median of four prior lines of therapy, an overall response rate of 33% was observed. The disease control rate was 67% and the median Duration of Response (DOR) was not yet reached. Finance $25 million milestone payment from BMS triggered by the commencement of a Phase 2 study with BMS-986442 in December 2023. Advancing in our discussions on monetizing non-strategic assets, royalty monetization, and project financing, with the potential to yield $100-200 million in cash proceeds. Currently we are in active discussions with several potential biopharma partners for potential co-development and co-commercialization of BOT/BAL. Fourth Quarter and Full Year 2023 Financial Results For the year ended December 31, 2023, we recognized revenue of $156 million and incurred a net loss of $257 million, or $0.69 per share. For the fourth quarter ended December 31, 2023, we recognized revenue of $84 million and incurred a net loss of $49 million or $0.13 per share. Revenue primarily includes revenue under our collaboration agreements, including milestones achieved, and revenue related to non-cash royalties earned. We ended the year with a $76.1 million cash balance; subsequent to which in January 2024 we received the $25 million milestone payment from BMS triggered by the commencement of a Phase 2 study with BMS-986442, the AGENUS discovered TIGIT bispecific antibody. Additionally, we've progressed in monetizing non-strategic assets and future milestones and royalties from ongoing partnerships. These efforts are expected to yield significant cash proceeds by mid 2024. Accordingly, we anticipate being funded through 2024. In parallel, we're pursuing potential partnership discussions with several biopharmaceuiticsl parties to further expand our cash resources. December 31, 2023 2022 Cash, cash equivalents and short-term investments $ 76,110 $ 193,358 Three months ended December 31, Year ended December 31, 2023 2022 2023 2022 Revenues, research and development $ 30,249 $ 3,755 $ 38,764 $ 16,975 Revenues, non-cash royalty 53,038 18,284 114,572 45,285 Revenues, royalty sales milestone - - - 25,250 Revenues, other 514 6,347 2,978 10,514 Total Revenue 83,801 28,386 156,314 98,024 Research and development expenses 66,723 53,279 234,569 186,691 General and administrative expenses 21,177 25,036 78,739 81,007 Cost of service revenue 260 7,693 3,111 10,568 Other income (193 ) (3,918 ) (2,663 ) (10,944 ) Non-cash interest expense 44,574 18,326 100,551 62,955 (Gain) loss related to debt - 1,937 - (782 ) Non-cash contingent consideration fair value adjustment (158 ) 135 (556 ) (815 ) Net loss $ (48,582 ) $ (74,102 ) $ (257,437 ) $ (230,656 ) Net loss per share attributable to Agenus Inc. common stockholders $ (0.13 ) $ (0.24 ) $ (0.69 ) $ (0.78 ) Cash used in operations $ 40,590 $ 47,338 $ 224,202 $ 175,373 Non-cash operating expenses $ 56,455 $ 32,777 $ 139,015 $ 96,286 Conference Call Date: March 14th, 2024, 8:30 a.m. ET To access dial-in numbers, please register here. Conference ID: 73242 Webcast A live webcast and replay of the conference call will be accessible on the company’s website at and via . References 1 Prager et. al NEJM 2023 2 Grothey et al. Lancet 2013 * Investigator reported, subject to change About Botensilimab Botensilimab is an investigational multifunctional anti-CTLA-4 immune activator (antibody) designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 900 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316. About Agenus Agenus is a leading immuno-oncology company targeting cancer and infectious diseases with a comprehensive pipeline of immunological agents. The company’s mission is to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus is headquartered in Lexington, MA. For more information, visit or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding a its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Quarterly Report on Form 10-Q or Annual Report on Form 10-K filed with the Securities and Exchange Commission and available on our website at . Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.