On April 26, 2022 Jubilant Therapeutics Inc., a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, reported the dosing of the first patient in a Phase I/II clinical trial of JBI-802 in patients with advanced solid tumors (Press release, Jubilant Therapeutics, APR 26, 2022, View Source [SID1234612999]). JBI-802 is a first-in-class, small-molecule, orally administered dual inhibitor of LSD1 and HDAC6 that has demonstrated synergistic anti-tumor activity in animal models.

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The Phase I/II trial is an open label, two-part dose escalation and expansion study designed to define the safety and tolerability, explore predictive biomarkers and assess preliminary activity of JBI-802 in more than 100 study participants with advanced solid tumors. More information on the clinical trial can be found at NCT05268666.

Hari S Bhartia, Chairman, Jubilant Therapeutics Inc. shared on the announcement, "We have come a long way from drug discovery to first-in-human dosing. We look forward to making a difference in patients’ lives. Our expertise in structure-based drug design and medicinal chemistry enables us to create differentiated precision therapeutics with truly innovative properties."

Syed Kazmi, Chief Executive Officer, Jubilant Therapeutics Inc. said, "JBI-802, effectively modulates two validated oncology targets with similar affinity and quick on/off exposure kinetics, leading to synergistic anti-tumour activity with a reduced risk of thrombocytopenia. This is our first internally developed product candidate to enter clinical development. Other advancing programs include an oral brain penetrant inhibitor of PRMT5, JBI 778, and an oral brain penetrant PDL1 inhibitor, JBI 2174, for neurological cancers among others."

About JBI-802

JBI-802 is novel, oral, potent and selective dual inhibitor of two epigenetic targets of the CoREST complex: LSD1 and HDAC6. It targets stem cell modulation by inhibiting LSD1 and modulates immune suppression with isoform selective HDAC6 inhibition. Preclinical research has demonstrated its synergistic anti-tumor activity, which is superior vs. either target alone and a favorable safety profile with no significant safety concerns or accumulation. It will be evaluated in both solid tumors, such as small cell lung cancer and neuroendocrine prostate cancer and hematological cancers such as acute myelogenous leukemia, myelodysplastic syndrome, and other myeloproliferative cancers.

On April 26, 2022 TC Biopharm (Holdings) PLC ("TC Biopharm" or the "Company") (NASDAQ: TCBP) (NASDAQ: TCBPW), a clinical stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and viral indications, reported that the company will be participating in several upcoming conferences (Press release, TC Biopharm, APR 26, 2022, View Source [SID1234612998]).

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TC BioPharm Co-founder and Executive Chariman, Michael Leek will participate in the Allogeneic Cell Therapies Summit, at the Hilton Boston Northshore between 9-11 May, 2022. Michael is scheduled to co-present the workshop on Supply Chain Management for Multicentered Clinical Trial Set-up (May 9) and chair sessions on Supply/Storage and Manufacturing (May 10 and 11 respectively).

He will also be speaking at the Advanced Therapies Conference at ExCel in London, May 24-25. The conference will explore the hottest topics in the advanced therapy medicinal products (ATMP) space alongside a faculty of industry leading speakers, whilst showcasing the latest technologies and advancements in the industry.

This June, Dr. Leek will be featured at the Next Generation CAR & T Cell Therapies 2022. The event takes place June 14-16, 2022 at the Mark Hopkins Hotel in San Francisco, California. Dr. Leek is scheduled to present and co-chair a workshop on on June 14th at 2:15 pm in a session entitled; TC Biopharm Case Study: Phase 3 Studies of Our Lead Product in Blood Cancers.

Additionally, Dr. Leek and Co-founder and Chief Operating Officer, Angela Scott will be speaking at the Onco Cell Therapy Summit. This seminar will be held June 29-30 at the Hynes Convention Center in Boston, Massachusetts. Michael Leek’s seminar is entitled: Using banked unmodified allogeneic gamma-delta T cells to treat cancer, while Angela Scott will speak to; Manufacture of GMP-grade frozen allogeneic cell therapies for phase 2/3 clinical studies’. The Onco Cell Therapy Summit (OCTS) is the only industry-led meeting covering the full range of autologous and allogeneic cell product advancements.

On April 26, 2022 Pheast Therapeutics, a company developing novel checkpoint therapies to fight cancer, reported it has raised $76 million in Series A funding round led by Catalio Capital Management and ARCH Venture Partners (Press release, Pheast Therapeutics, APR 26, 2022, View Source [SID1234612997]). Alexandria Venture Investments and Risk and Reward (R2) also participated. Pheast plans to use the funds to expand its management, scientific, and administrative teams, as well as towards R&D to advance its pipeline of innate immune checkpoint inhibitors towards the clinic.

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Pheast is led by scientific experts Dr. Amira Barkal, MD, PhD, Dr. Irving Weissman, MD, Dr. Ravi Majeti, MD, PhD, and Dr. Roy Maute, PhD. Drs. Weissman and Majeti were co-founders of Forty Seven Inc. (acquired by Gilead in 2020) and were instrumental in the discovery of CD47 as a "don’t eat me" signal and critical to the advancement of CD47-targeting clinical programs to treat multiple hematologic malignancies. Drs. Barkal and Weissman uncovered the role of CD24 as a "don’t eat me" signal and promising target for immunotherapy of solid tumors.

"While cancer immunotherapy has revolutionized the treatment of some tumors, many cancers, including ovarian and breast, have seen lackluster responses to existing immunotherapies, and patients are in dire need of new options," Dr. Amira Barkal, MD, PhD, Principal Founder, Scientific Director, and Interim CEO at Pheast. "With the help of this funding, we will be much better equipped to increase and expand our research efforts, and in doing so, hopefully bring meaningful responses for treatment-resistant cancers closer to reality."

"Pheast’s exceptional leadership and differentiated approach to leveraging macrophage checkpoints to develop life-changing cancer therapies have quickly positioned the company as a leader in the immunotherapy space," said George Petrocheilos co-founder and managing partner of Catalio.

"This investment is emblematic of Catalio’s strategy to identify and back breakthrough biomedical technology companies led by world-renowned, serial scientists with proven track records of launching category-defining businesses," said Dr. Jacob Vogelstein, co-founder and managing partner of Catalio, who will also be joining Pheast’s Board of Directors.

Spun out of Irv Weissman’s lab at Stanford University, Pheast is a pre-clinical stage immuno-oncology company focused on targeting immune evasion pathways to activate the innate immune system to fight cancer. However, unlike most cancer immunotherapies, which to date have focused on augmenting adaptive immune responses by targeting T-cells, Pheast’s approach is pioneering in the cancer immunotherapy space for three main reasons:

Pheast is focused on enhancing the innate immune response to cancer by targeting macrophage checkpoints, also called "don’t eat me" signals;
Pheast is targeting an entirely new signaling axis through their CD24 pipeline which has shown promise in animals for treating ovarian cancer, breast cancer, and other solid tumors;
Pheast’s team is developing therapeutic strategies to combine macrophage checkpoint inhibitors with existing anti-cancer therapies including existing immunotherapies, tumor-targeting antibodies, and chemotherapies.
The company’s primary program targets the surface protein CD24, a "don’t eat me" signal commandeered by many cancers, including ovarian and breast cancer, in order to avoid detection and clearance by intra-tumoral macrophages. Pheast is also leveraging its proprietary discovery platform to enable the development of additional novel tumor-specific cancer immunotherapies.

"The first macrophage checkpoint inhibitor discovered was CD47, a molecule upregulated by all cancers to block macrophages from eating and killing cancer cells, but later shown to be a general inhibitor of other disease-causing cells. By discovering how CD47 blocks macrophage eating, we developed general principles to discover other ‘don’t eat me’ signals, and we uncovered CD24 as a major ‘don’t eat me’ component of at least most ovarian and breast cancer cells" said Irv Weissman, co-discoverer of both molecules. "I have come to think about macrophages as micro-computing cells, each counting the sum of the ‘don’t eat me’ signals and ‘eat me’ signals coming from attached cancer cells, then acting if the ratio of ‘eat me’ to ‘don’t eat me’ is such that eating dominates. Our goal is to determine, with precision, how to assess the eat me and don’t eat me signals for each cancer, and to tip the balance to remove each human cancer. We are building the team to excel at achieving this goal."

"Through their research into macrophages and CD24, Pheast has already demonstrated that blockade of CD24 signaling can lead to impressive results in animal models of some of the most difficult-to-treat and aggressive malignancies, including ovarian cancer and breast cancer," said Dr. Steven Gillis, Managing Director at ARCH Venture Partners. "ARCH is excited to be a part of the Pheast team’s journey and we look forward to future developments at the company."

On April 26, 2022 Exact Sciences Corp. (Nasdaq: EXAS), a leader in advanced cancer diagnostics, reported that the company generated revenue of $486.6 million for the first quarter ended March 31, 2022, compared to $402.1 million for the same period of 2021 (Press release, Exact Sciences, APR 26, 2022, View Source [SID1234612996]).

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"The Exact Sciences team delivered outstanding results to start 2022, testing a record number of people with Cologuard and Oncotype DX," said Kevin Conroy, chairman and CEO. "We plan to fundamentally change the way cancer is diagnosed and treated, powered by our strong foundation in cancer screening and precision oncology, our deep pipeline of innovative tests, and a clear path to sustainable, profitable growth."

First quarter 2022 financial results

For the three-month period ended March 31, 2022, as compared to the same period of 2021 (where applicable):

Total revenue was $486.6 million, an increase of 21 percent
Total revenue, excluding COVID-19 testing, increased 24 percent
Screening revenue was $306.5 million, an increase of 28 percent
Excluding PreventionGenetics, Screening revenue was $296.8 million, an increase of 24 percent
Precision Oncology revenue was $152.6 million, an increase of 18 percent
COVID-19 testing revenue was $27.4 million, a decrease of 15 percent
Gross margin including amortization of acquired intangible assets was 68 percent, and non-GAAP gross margin excluding amortization of acquired intangible assets was 72 percent
Net loss was $180.9 million, or $1.04 per share, compared to a net loss of $31.2 million, or $0.18 per share
EBITDA was $(130.8) million and adjusted EBITDA was $(89.8) million
Cash, cash equivalents, and marketable securities were $817.0 million at the end of the quarter
Screening includes laboratory service revenue from Cologuard tests, PreventionGenetics, and immaterial revenue from Biomatrica products. Precision Oncology includes laboratory service revenue from global Oncotype products and therapy selection products, including oncomapTM and oncomapTM ExTra, formerly known as Oncotype MapTM and GEM ExTra, respectively.

2022 outlook

The company anticipates revenue of $1,985-$2,032 million during 2022, assuming:

Screening revenue of $1,350-$1,372 million, including $40-$42 million from PreventionGenetics,
Precision Oncology revenue of $595-$610 million, and
COVID-19 testing revenue of $40-$50 million.
Revenue guidance has been raised and narrowed toward the high end of the previously expected range of $1,975-$2,027 million, which assumed:

Screening revenue of $1,340-$1,367 million, including $40-$42 million from PreventionGenetics,
Precision Oncology revenue of $595-$610 million, and
COVID-19 testing revenue of $40-$50 million.
Non-GAAP Disclosure
In addition to the company’s financial results determined in accordance with U.S. GAAP, the company provides non-GAAP measures that it determines to be useful in evaluating its operating performance. The company presents EBITDA, adjusted EBITDA, as well as non-GAAP gross margin and non-GAAP gross profit. EBITDA and adjusted EBITDA consist of net loss after adjustment for those items shown in the table below. The company defines non-GAAP gross profit and non-GAAP gross margin as GAAP gross profit and GAAP gross margin, respectively, excluding amortization of acquired intangible assets. The amortization of acquisition-related intangible assets used in the calculation of non-GAAP gross profit and non-GAAP gross margin pertain only to the amortization associated with developed technology acquired and recorded through purchase accounting transactions. The amortization of these intangible assets will recur in future periods until such intangible assets have been fully amortized. The company believes that these non-GAAP measures are useful in evaluating the company’s operating performance. The company uses this non-GAAP financial information to evaluate ongoing operations and for internal planning and forecasting purposes. Non-GAAP financial information, when taken collectively, may be helpful to investors because it provides consistency and comparability with past financial performance. However, non-GAAP financial information is presented for supplemental information purposes only, has limitations as an analytical tool and should not be considered in isolation or as a substitute for financial information presented in accordance with U.S. GAAP. For example, non-GAAP gross margin and non-GAAP gross profit exclude the amortization of acquired intangible assets although such measures include the revenue associated with the acquisitions. For a reconciliation of these non-GAAP measures to GAAP, see below "EBITDA and Adjusted EBITDA Reconciliations" and "Non-GAAP Gross Profit and Non-GAAP Gross Margin Reconciliations."

First quarter conference call & webcast
Company management will host a conference call and webcast on Tuesday, April 26, 2022, at 5 p.m. ET to discuss first quarter 2022 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 888-330-2384 and international callers should dial +1-240-789-2701. The access code for both domestic and international callers is 4437608.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-770-2030 domestically or +1-647-362-9199 internationally. The access code for the replay of the call is 4437608. The webcast, conference call, and replay are open to all interested parties.

About Cologuard
The Cologuard test was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. The Cologuard test is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2021) and National Comprehensive Cancer Network (2016). The Cologuard test is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. The Cologuard test performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. Medicare and most major insurers cover the Cologuard test. For more information about the Cologuard test, visit www.cologuard.com. Rx only.

About Oncotype DX
The Oncotype DX portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. In breast cancer, the Oncotype DX Breast Recurrence Score test is the only test that has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention, and the Oncotype DX AR-V7 Nucleus DetectTM test helps determine which patients with metastatic castration-resistant prostate cancer (mCRPC) are resistant to androgen receptor (AR)-targeted therapies. The Oncotype DX AR-V7 Nucleus Detect test is performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego and offered exclusively by Exact Sciences. The Oncotype tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.

About Exact Sciences’ Therapy Selection Program
Exact Sciences’ therapy selection program includes two comprehensive genomic profiling (CGP) tests to help physicians identify the genomic mutations driving advanced cancers, leading patients to better care through targeted cancer treatments. The oncomap ExTra test, formerly known as GEM ExTra, detects damage in tumor genes and provides a complete biological picture of certain refractory, rare, or aggressive cancers. With an extensive panel of approximately 20,000 genes and 169 introns, the oncomap ExTra test is one of the most comprehensive genomic (DNA) and transcriptomic (RNA) panels available today. The oncomap ExTra test provides physicians, academic medical centers, and biopharma researchers with vital interpreted information to understand changes to a patient’s tumor genomic profile and recommend therapeutic treatment plans. For patients with advanced and metastatic cancer, the company offers the oncomap test, formerly known as Oncotype MAP, a rapid, comprehensive tumor profiling panel, which delivers results in three to five business days and allows physicians to understand a patient’s tumor profile and recommend actionable targeted therapies or clinical trials.

About PreventionGenetics
Founded in 2004 and located in Marshfield, Wisconsin, PreventionGenetics is a CLIA and ISO 15189:2012 accredited laboratory. PreventionGenetics delivers clinical genetic testing of the highest quality at fair prices with exemplary service to people around the world. PreventionGenetics has 25 PhD geneticists on staff and provides tests for nearly all clinically relevant genes including the powerful and comprehensive germline whole genome sequencing test, PGnome and whole exome sequencing test, PGxome. PreventionGenetics was acquired by Exact Sciences in December 2021.

On April 26, 2022 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported that the Company will present at the 2022 Bloom Burton & Co. Healthcare Investor Conference in Toronto, Ontario on Monday, May 2, 2022 at 3:30 p.m. ET (Press release, Fusion Pharmaceuticals, APR 26, 2022, View Source;co-healthcare-investor-conference-301533624.html [SID1234612995]). Presenting on behalf of Fusion will be Chief Executive Officer John Valliant, Ph.D.

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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors & Media" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 60 days following the presentation.