On April 8, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company plans to release its first quarter 2021 financial results after the close of the U.S. financial markets on May 4, 2021 (Press release, Exact Sciences, APR 8, 2021, View Source [SID1234577716]). Following the release, company management will host a webcast and conference call at 5 p.m. EDT to discuss financial results and business progress.

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First quarter 2021 webcast & conference call details

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 5789488. The webcast, conference call and replay are open to all interested parties.

On April 8, 2021 Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) reported that Jeffrey L. Wade, Lexicon’s executive vice president, corporate and administrative affairs and chief financial officer, will participate in a live fireside chat at the 20th Annual Needham Virtual Healthcare Conference on Thursday, April 15, 2021 at 10:15 a.m. ET (Press release, Lexicon Pharmaceuticals, APR 8, 2021, View Source [SID1234577732]).

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A webcast of the event will be available in the "Events" section of the Lexicon website at www.lexpharma.com. An archived version of the webcast will be available on the website for two weeks.

On April 8, 2021 Volastra Therapeutics reported that Co-founder Samuel Bakhoum, M.D., Ph.D., and Scientific Advisory Board Member David Pellman, M.D., will both deliver plenary presentations at the April session of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 (Press release, Volastra Therapeutics, APR 8, 2021, View Source [SID1234577748]).

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The plenary session, titled "Mechanisms, Impact, and Exploitation of Cancer Chromosomal Instability," is dedicated to exploring a key driver of tumor progression. Volastra is building on this groundbreaking work into the biology of chromosomal instability, which will be shared throughout the plenary session, to develop new therapies for metastatic cancer.

"Volastra is at the forefront of identifying novel techniques to measure and modulate chromosomal instability for the future treatment of patients with advanced cancers, and we’re delighted to be sharing the most current insights into this important field with the scientific community," said Charles Hugh-Jones, M.D., Chief Executive Officer at Volastra.

The session will feature four presentations. Dr. Pellman, HHMI Investigator, Professor of Cell Biology and Pediatrics at Harvard Medical School and the Dana-Farber Cancer Institute, will lead off the plenary session, focusing on the mechanisms driving the rapid evolution of cancer genomes. Dr. Bakhoum, a radiation oncologist and faculty member at Memorial Sloan Kettering Cancer Center, will follow, presenting on the role of chromosomal instability in tumor evolution.

"We have known about chromosomal instability for decades, but only now do we fully understand its critical role in tumor progression. Its importance to the future of cancer treatment is underscored by AACR (Free AACR Whitepaper)’s decision to devote a leading plenary session to the topic," said Dr. Bakhoum. "I’m honored to be participating in the plenary with leading researchers from around the world, and I’m proud to be translating these insights into groundbreaking drug discovery programs at Volastra."

The plenary session, which will include several discussion periods, will be available as a live stream for registered conference attendees. Presentation details can be found below:

Session PL06: Discovery Science Plenary: Mechanisms, Impact, and Exploitation of Cancer Chromosomal Instability
April 10, 2021
9:30 – 11:30 a.m. ET

On April 8, 2021 Secura Bio, Inc. (Secura Bio) – (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, reported that it has completed enrollment, with 101 patients, into the PRIMO study, which is evaluating COPIKTRA for the treatment of patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL) (Press release, Secura Bio, APR 8, 2021, https://www.prnewswire.com/news-releases/secura-bio-announces-enrollment-completion-of-the-copiktra-duvelisib-study-primo-in-peripheral-t-cell-lymphoma-301264723.html [SID1234577765]). The completion of study enrollment is an important milestone in the continued development of COPIKTRA to treat T-cell lymphomas, a disease category for which it is not currently indicated.

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The PRIMO study is a global, multi-center, open-label, parallel cohort registration-directed Phase 2 study. In the dose optimization portion of the study, patients were randomized to receive COPIKTRA 25mg twice daily (cohort 1) or COPIKTRA 75mg twice daily continuously (cohort 2) until disease progression or unacceptable toxicity. Based on the dose optimization results, an expansion group was added in which COPIKTRA was dosed at 75mg twice daily for two cycles, followed by 25mg twice daily, until disease progression or unacceptable toxicity. The primary endpoint in the expansion phase of the study is independent review committee assessed overall response rate (ORR). Secondary endpoints include duration of response (DOR) and safety.

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and gamma pathways, which are involved in the proliferation and sustenance of malignant cells.

"Secura Bio will continue to aggressively support the development of COPIKTRA in the treatment of T-cell malignancies, because these patients often have limited therapeutic options and generally poor outcomes, and because PI3K inhibition appears to be a relevant, safe and promising mechanism of action" said Dr. David Cohan, Chief Medical Officer of Secura Bio.

For the treatment of PTCL, COPIKTRA monotherapy has received Fast Track status and Orphan Drug Designation, and investigations are imminently planned in combination with other proven anti-cancer agents.

"Secura Bio now has two meaningful oncology drugs with novel modes of action that offer the potential to build a broad portfolio of indications in hematologic and solid malignancies. We will also fully explore the combination of COPIKTRA with FARYDAK (panobinostat), Secura Bio’s pan-HDAC inhibitor" said Joseph M. Limber, President and CEO of Secura Bio.

Interim results of the PRIMO study are expected to be published later in 2021.

On April 8, 2021 Morphogenesis, Inc. ("Morphogenesis"), a clinical stage biotechnology company specializing in the development of cell and gene therapy products to treat chronic diseases such as cancer, reported that the United States Food and Drug Administration (FDA) has granted the Company’s lead clinical stage candidate, IFx-Hu2.0, Fast Track drug designation for the treatment of patients with advanced skin cancer (Press release, Morphogenesis, APR 8, 2021, View Source [SID1234578994]). Specifically, these are patients with unresectable or metastatic cutaneous melanoma who have not responded to, or have stopped responding to, FDA-approved immune checkpoint inhibitors. Most advanced skin cancer patients who receive immune checkpoint inhibitors do not respond to these therapies. Based on the data amassed to date and its mechanism of action, IFx-Hu2.0 has the potential to change that. The FDA previously granted Orphan Drug Designation to IFx-Hu2.0 for the same indication.

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Fast Track is a designation issued by the FDA for products that have the potential to treat patients with a serious disease and who have an unmet medical need. Morphogenesis provided the FDA with epidemiologic data as well as pre-clinical and clinical evidence to support IFx-Hu2.0’s mechanism of action. IFx-Hu2.0 is an immunomodulator that as well as initiating a significant anti-tumor response in previously untreated patients, also has the potential to re-sensitize patients to immune checkpoint inhibitors. More people have skin cancer than all the other primary cancers in the United States combined. Advanced melanoma’s aggressiveness and high mortality rate make it the deadliest type of skin cancer.

"We believe that being able to initiate a broad anti-tumor response in late-stage melanoma patients with a 30-second intralesional injection of IFx-Hu2.0 fulfills an unmet medical need of these patients," said Patricia D. Lawman, PhD, Chief Executive Officer of Morphogenesis.

"Fast Track designation for IFx-Hu2.0 signifies the FDA’s recognition that patients suffering from this life-threatening disease remain in dire need of effective treatment options even with all the therapies that are being developed for melanoma. IFx-Hu2.0 holds promise to effectively treat these patients," said Michael J.P. Lawman, PhD, President of Morphogenesis.

The FDA is committed to facilitating the development and to expediting the review of IFx-Hu2.0 to treat patients with advanced skin cancer, thereby potentially addressing a significant unmet medical need. Morphogenesis is advancing the clinical development of IFx-Hu2.0, a highly differentiated cancer immunotherapy drug candidate, especially since IFx-Hu2.0 is now eligible for accelerated approval and priority review if relevant criteria are met.

"With IFx-Hu2.0’s Fast Track designation, we look forward to having expert guidance and frequent communication with the FDA throughout the entire drug development and review process," said Christopher Konig, PharmD, Regulatory Affairs Manager at Morphogenesis. "In the past, this quality and frequency of communication with the FDA has led to earlier drug approval and access by patients."