On November 2, 2022 Alterome Therapeutics, Inc., a biopharmaceutical company pioneering the development of alteration-specific targeted therapies for the treatment of cancer, reported that it has raised more than $35 million in a Series A2 financing, bringing total funds raised to nearly $100 million (Press release, Alterome Therapeutics, NOV 2, 2022, View Source [SID1234622828]). Colt Ventures and OrbiMed co-led the round, with participation from all Series A investors including Nextech Invest, Vida Ventures, and Boxer Capital. The original round of $64 million closed in January 2022.

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The proceeds will be used to advance Alterome’s pipeline of three next-generation precision oncology programs designed using "The Kraken," its in-house computational chemistry platform. The Kraken provides precise, atomic-level insights into molecular interactions and enables ligand activity and binding mode predictions that inform the company’s expert team of medicinal chemists with approaches to design novel, exquisitely selective, alteration-specific therapies.

"We are very pleased to welcome Colt Ventures to our investor syndicate and are grateful to our existing investors for their continued support of our vision to relentlessly push the boundaries of cancer treatments to transform the lives of patients, one alteration at a time," said Eric Murphy, Ph.D., founder, CEO and CSO of Alterome Therapeutics. "Our unique blend of computational chemistry, medicinal chemistry, and translational biology experience combined with next-generation drug discovery technologies enable the discovery of therapeutics that address well-known oncogenic drivers while increasing the safety profile."

Sundeep Agrawal, M.D., General Partner at Colt Ventures said, "By bringing the latest advances in chemistry, biology, pharmacology, and genomics to bear on genomically-defined alterations, we believe that Alterome can make a meaningful impact on patients with cancers where too few treatment options exist. We are thrilled to lead this funding round and believe Alterome’s experienced leadership team is well-positioned to deliver a truly transformational approach to precision cancer therapeutics."

On November 2, 2022 GlycoMimetics, Inc. (Nasdaq: GLYC), reported that it will host a conference call and webcast to report third quarter financial results on Wednesday, November 9, 2022, at 8:30 a.m. ET (Press release, GlycoMimetics, NOV 2, 2022, View Source [SID1234622827]).

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To access the call by phone, please go to this registration link and you will be provided with dial in details. Participants are encouraged to connect 15 minutes in advance of the scheduled start time.

A live webcast of the call will be available on the "Investors" tab on the GlycoMimetics website. A webcast replay will be available for 30 days following the call.

On November 2, 2022 Peak Bio Co., Ltd. ("Peak Bio"), a clinical-stage biopharmaceutical company focused on developing the next-generation of therapeutics to treat oncology and inflammatory diseases, reported the completion of its business combination (the "Business Combination") with Ignyte Acquisition Corp. (Nasdaq: IGNY) ("Ignyte"), a special purpose acquisition company (Press release, Peak Bio, NOV 2, 2022, View Source [SID1234622826]).

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The transaction was approved at a special meeting of Ignyte’s stockholders held on October 25, 2022 (the "Special Meeting"). Ignyte’s stockholders also voted to approve all other proposals presented at the Special Meeting. Ignyte’s Board of Directors had previously approved the business combination and recommended that its stockholders vote in favor of it and all of the proposals relating to the Business Combination.

The combined company will operate under the name "Peak Bio, Inc." (the "Combined Company") under the direction of Hoyoung Huh, M.D., Ph.D., founder and Chairman, and Stephen LaMond, PharmD, MBA, Chief Operating Officer. Commencing at the open of trading on or about November 2, 2022, on NASDAQ, the Combined Company’s common stock and public warrants will trade under the new trading symbols "PKBO" and "PKBOW," respectively.

"We believe that Peak Bio is now well positioned to succeed in the public markets and look forward to updating the entire investment community on our progress in our differentiated approach in both oncology and rare inflammatory diseases," said Hoyoung Huh, M.D., Ph.D., Chairman and founder of Peak Bio.

On November 2, 2022 Bluestar Genomics, Inc., an early cancer detection company leading the development and commercialization of next-generation liquid biopsy tests focused on non-invasive detection of high-mortality cancers in high-risk patient populations, reported the results of a validation study for its early pancreatic cancer detection test (Press release, Bluestar Genomics, NOV 2, 2022, View Source [SID1234622825]).

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Based on the positive study results, Bluestar Genomics initiated a physician experience program to enable patients to gain access to the Bluestar Genomics test, designed specifically for pancreatic cancer detection in people at high risk of developing the disease due to various factors, such as a recent Type 2 diabetes diagnosis.

"Despite the alarming statistics associated with pancreatic cancer, current diagnostics offerings have limited clinicians’ ability to identify patients with pancreatic cancer at the earliest stages of the disease, when treatments can still be effective," said Dave Mullarkey, chief executive officer at Bluestar Genomics. "With our focus on high-mortality cancer detection in high-risk patients, we can finally start changing this paradigm by offering clinicians and their patients a better way to identify the disease during its treatable stage."

Bluestar Genomics’ epigenomics-based pancreatic cancer signal detection test assesses whether an individual has an abnormal DNA signal associated with pancreatic cancer by measuring levels of the biomarker 5-hydroxymethylcytosine (5hmC). The 5hmC biomarker is stable, sensitive, and precise enough to detect not just the presence of cancer, but to also specify the location.

The results from the recently completed case-control validation study show the Bluestar Genomics test performing at 67% sensitivity and 97% specificity in a population of 2,150 patients over age 50. Its study cohort included patients recently diagnosed with Type 2 diabetes, a population with eight times the risk of developing pancreatic cancer. The full data will be shared during an oral presentation at the American Pancreatic Association annual meeting on November 4 in Orlando, Fla.

"Pancreatic cancer remains one of the leading causes of cancer death in the United States, largely due to its frequent diagnosis in later stages when it is less treatable. In fact, the vast majority (65%) of pancreatic cancers are not detected until they have already spread," said Michelle Welch, M.D., practicing endocrinologist at Diabetes and Metabolism Specialists, San Antonio in San Antonio, Texas. "By testing people recently diagnosed with Type 2 diabetes – a known risk factor for pancreatic cancer – we hope to identify this cancer earlier for this group of patients at high risk of the disease."

Bluestar Genomics has built a body of scientific and clinical evidence demonstrating the scientific validity and clinical application of its 5hmC-based approach to pancreatic cancer detection. Based on these findings, the company announced the availability of its pancreatic cancer signal detection test for recently diagnosed Type 2 patients aged 50 and older. This physician experience program aims to make the Pancreatic Cancer Signal Detection test available to more patients at high risk for developing pancreatic cancer, leading to broader availability in coming months. To learn more about participation, visit: View Source

On November 2, 2022 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, reported that following an interim analysis of its randomized controlled Phase II clinical study comparing TG4001 in combination with avelumab to avelumab alone in patients with HPV16-positive anogenital tumors (NCT: 03260023), the Independent Data Monitoring Committee (IDMC) has recommended the study continue (Press release, Transgene, NOV 2, 2022, View Source [SID1234622824]).

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Based on positive signals observed in the interim analysis, the trial is now expected to enroll an additional 66 patients, for a total trial size of 120 patients compared to the previously announced target of 150 patients. Transgene anticipates the last patient to be randomized in the trial in H1 2024.

Hedi Ben Brahim, CEO, and Dr. Maud Brandely, Chief Medical Officer, MD, PhD, will host an analyst and investor call to discuss the interim analysis at 6:00 pm CET (1:00 pm EST) today (see details below).

The Phase II study is evaluating TG4001, an investigational therapeutic cancer vaccine, in combination with avelumab compared to avelumab alone in patients with HPV16-positive anogenital tumors without liver metastases, through a continuing collaboration with the alliance of Merck KGaA, Darmstadt, Germany, and Pfizer, which is supplying avelumab.

"We are very pleased with the outcome of this interim analysis," said Hedi Ben Brahim, Chief Executive Officer of Transgene. "The IDMC’s recommendation to continue the study reinforces our confidence in TG4001, which follows promising data from our earlier Phase Ib/II trial. This also enables us to reduce the number of patients randomized in the trial. We are looking forward to completing this trial in H1 2024 and communicating itsresults when they are available. We expect that positive final results from this trial will allow us to launch a registration trial to further confirm the benefit of our therapeutic vaccine candidate. TG4001 aims to provide a new solution to patients who currently have very limited treatment options."

The interim analysis was triggered per protocol, by a predefined number of PFS events. Based on the interim results, the IDMC’s objective was to provide a recommendation on the continuation of the trial and on the final sample size using adaptive sample size re-estimation modeling approach. To date, the treatment has been well tolerated. Adverse events are consistent with previous observations made in the Phase Ib/II trial. TG4001 is based on a MVA (Modified Vaccinia Ankara) vector, which is engineered to express HPV16 antigens (E6 & E7) and interleukin 2 (IL-2). TG4001 is designed to alert the immune system specifically to cells presenting the HPV16 E6 and E7 antigens that can be found in HPV16-related tumors and to induce a specific cellular immune response against these cancer cells. Phase II trial aims to show superiority of TG4001 + avelumab over avelumab monotherapy The trial is enrolling patients in the USA and in Europe (France and Spain).

It focuses on patients with recurrent or metastatic HPV16-positive anogenital cancer without liver metastases, including cervical, vulvar, vaginal, penile, and anal cancer. Patients are randomized to either receive the combination regimen of the therapeutic vaccine TG4001 and avelumab or avelumab alone. The primary endpoint of the trial is progression-free survival (PFS) according to RECIST 1.1. Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS) and a series of immunological parameters.

About the trial The multi-center, open label, randomized Phase II trial (NCT03260023) is designed to compare the efficacy of the combination of TG4001 and avelumab versus avelumab alone in patients with advanced, recurrent and/or metastatic HPV16-positive anogenital cancers who have disease progression after a maximum of one line of systemic treatment, or who are not eligible for first-line chemotherapy. Page 3/4 Prof. Christophe Le Tourneau, M.D., PhD, Head of the Department of Drug Development and Innovation (D3i) at the Curie Institute, is the Principal Investigator of the study. The trial is being conducted in collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE), which are providing avelumab for the trial. Avelumab is codeveloped and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc.

Transgene will continue to be the sponsor of the trial and conduct the trial. Avelumab is not approved alone or in combination for the treatment of HPV16-positive anogenital tumors in any region. Patients will receive TG4001 at the dose of 5×107 pfu, SC, weekly for 6 weeks, every 2 weeks up to six months, and every 12 weeks thereafter, in combination with avelumab or avelumab alone at 800 mg, IV every two weeks, until disease progression. The primary endpoint of the trial is progression-free survival (PFS) according to RECIST 1.1. Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS) and other immunological parameters. The trial will enroll 120 patients.

About the Phase Ib/II data of TG4001 + avelumab (single arm trial) The combination of TG4001 and avelumab demonstrated anti-tumor activity (22% ORR) in patients with previously treated recurrent and/or metastatic HPV-related cancers (including patients with oropharyngeal cancers and anogenital cancers). Presence of liver metastases had a profound impact on the outcome in terms of ORR and PFS. In patients without liver metastases, an ORR of 32%, a median PFS of 5.6 months and a median OS of 13.3 months were achieved. The treatment induced HPV-specific T-cell responses and was associated with increased levels of immune cell infiltration in the tumors and expression of genes associated with activation of the immune system.

The results from the Phase Ib/II parts of the trial combining TG4001 with avelumab in HPV16-positive recurrent and/or metastatic malignancies have been updated in a R&D day held in September 2022 by Transgene. A first set of data had been presented at SITC (Free SITC Whitepaper) 2020 and ESMO (Free ESMO Whitepaper) IO 2020 [1,2]. About TG4001 TG4001 is an investigational therapeutic vaccine based on a non-propagative, highly attenuated Vaccinia vector (MVA), which is engineered to express HPV16 antigens (E6 & E7) and an adjuvant (IL-2).

TG4001 is designed to have a two-pronged antiviral approach: to alert the immune system specifically to cells presenting the HPV16 E6 and E7 antigens, that can be found in HPV16-related tumors, and to further stimulate the infection-clearing activity of the immune system through interleukin 2 (IL-2). TG4001 has been administered to more than 350 individuals, demonstrating good safety and promising efficacy results [1, 2,]. Its mechanism of action and good safety profile make TG4001 an excellent candidate for combinations with other therapies in HPV-mediated solid tumors.