On August 31, 2021 Oxford BioDynamics Plc (AIM: OBD, the Company), a biotechnology company developing targeted clinical diagnostic tests for immune health utilizing its EpiSwitch 3D genomics technology, reported that it has been awarded an FNIH Partnership for Accelerating Cancer Therapies (PACT) Grant to use the EpiSwitch diagnostic platform for accurate prediction of a patient’s response to Immune Checkpoint Inhibitors (ICIs) from a routine blood sample (Press release, Oxford Biodynamics, AUG 31, 2021, View Source [SID1234587054]).

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The grant worth $910,000 (RFA #2021-PACT001) is executed by the Foundation for the National Institutes of Health (FNIH), a US not-for-profit organization managing the precompetitive collaboration between the National Institutes of Health (NIH), National Cancer Institute (NCI), US Food and Drug Administration (US-FDA), and 12 leading pharmaceutical companies comprising AbbVie, Amgen, Boehringer-Ingelheim, Bristol-Myers Squibb, Celgene, Genentech/Roche, Gilead, GlaxoSmithKline, Janssen, Novartis (NIBR), Sanofi, and Pfizer, as part of the Beau Biden Cancer Moonshot Initiative accelerating cancer research. PACT seeks to provide a systematic approach to cancer biomarker investigation in clinical trials by supporting development of standardized assays.

Immuno-oncology (IO) focuses on using an individual’s immune system to help fight their cancer using a class of drugs, ICIs, to target either of the immune regulatory proteins PD-1 or PD-L1. At present, of those deemed eligible to receive an ICI, less than 30% will benefit from these drugs[1]. Unfortunately, a similar number will experience significant and sometime fatal side effects when these therapies are used[2].

Current testing modalities cannot predict who will and won’t respond and generally require an invasive tumor biopsy. Development of a predictive test, one that only requires a small blood sample, will help oncologists to successfully deploy these drugs as well as enable the pharmaceutical companies to further understand and develop IO therapies to expand their benefits.

In Q4 2021, OBD expects to launch the "EpiSwitch ICI Response Test" as an LDT to allow access for oncologists who want to use it immediately and to start shaping the market.

The test, which is a predictive diagnostic of likely response in cancer patients considered for monotherapy treatment with immune checkpoint inhibitors, has been in full development since 2018. More than 800 blood samples from multiple cohorts of patients have been analyzed, including several studies where the outcomes were blinded to validate the predictive abilities of this technology. The aim of the test is to help oncologists deploy ICI drugs more successfully as well as enable pharmaceutical companies to further understand and develop IO therapies to expand their benefits.

The two-year $910,000 PACT Grant awarded to OBD will fund extended application of this technology to the analysis of primary and acquired resistance to ICI in several trials, including over 186 longitudinal samples from an observational trial, encompassing at least 4 separate ICI therapies and 7 common cancer types. The project will further validate this first-generation immune health assay for predicting response as well as monitoring resistance to ICI monotherapies. It will also evaluate key differences in predictive profiles of the patients treated with a combination therapy of ICI and an epigenetic drug.

In awarding the PACT grant, the reviewers highlighted the strengths of OBD’s success in applying the EpiSwitch platform for biomarker discovery, the prior experience of the team, the clinical practicality of non-invasive EpiSwitch testing from blood and the high relevance of the 3D genomic epigenetic modality.

OBD’s EpiSwitch 3D genomics platform is well-known amongst the consortium’s pharmaceutical companies and has been used for practical patient stratification in prognostic, predictive and early diagnostic applications across immuno-oncology, autoimmune and neurodegenerative indications[3-6].

Dr Stacey Adam, Associate Vice President, Research Partnerships at the FNIH, said:
"The PACT partners are pleased to support the development of a novel epigenetic biomarker platform that can be used in a non-invasive manner and across various clinical settings, thereby allowing for better assignment of patients to specific immunotherapies to treat their cancer."

Dr Jon Burrows, CEO of Oxford BioDynamics, said:
"The recognition of the EpiSwitch platform by the consortium of US federal agencies and top pharmaceutical stakeholders marks another significant validation of OBD’s ability via 3D genomics technology to address the clinical challenges of personalized medicine, cancer treatment and immune health."

On August 31, 2021 Immunolight, LLC, a clinical stage biopharmaceutical firm leading the way in advancing technologies to transform cancer treatment, reported it has received FDA clearance to enter phase 1 study in patients with breast, melanoma, sarcoma and head and neck cancers (Press release, Immunolight, AUG 31, 2021, View Source [SID1234587075]).

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The heart of the X-PACT (X-ray Psoralen Activated Cancer Treatment) system is psoralen, a naturally occurring compound which has been successfully used for decades in the treatment of autoimmune disease, skin disorders and certain skin and blood cancers. It has not, however, been able to be used to treat solid tumors due to the fact that UV light, which is needed to activate psoralen, cannot penetrate through tissue to reach the solid tumors. Immunolight has now made that possible.

Immunolight innovated materials that convert tissue penetrating energies, such as low dose X-ray, into UV light inside a solid tumor in the body. The energy converting materials are injected along with psoralen inside the solid tumor, then low dose x-ray energy is applied at the site. The energy converting materials convert the x-ray into UV light which activates the psoralen inside the solid tumor to kill the cancer.

"Transitioning into a clinical stage company represents a significant milestone in the company’s history and the potential beginning of a new era in cancer treatment," says Immunolight founder and CEO, Rick Bourke.

Currently in its 15th year of multidisciplinary research and development activities, Immunolight developed X-PACT in partnership with Duke University and Duke Medical Center with a team of over 30 scientists, physicians and engineers. "Our highest priority has been to translate this amazing science into a paradigm-changing cancer treatment in patients," Immunolight President Harold Walder says. "We are so excited to get this treatment into the clinic and potentially change patient’s lives and transform their treatment outcomes."

On August 31, 2021 Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to potentially create new treatments that make a meaningful difference in patients’ lives, reported that it has commenced an underwritten public offering of $400,000,000 of American Depositary Shares ("ADSs"), each of which represents one ordinary share of Ascendis (Press release, Ascendis Pharma, AUG 31, 2021, View Source [SID1234587039]). All of the ADSs are being offered by Ascendis. In addition, Ascendis expects to grant the underwriters a 30-day option to purchase up to an additional $60,000,000 of ADSs at the public offering price, less the underwriting commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, Evercore Group L.L.C. and SVB Leerink LLC are acting as joint book-running managers for the offering.

A shelf registration statement relating to these securities was filed with the U.S. Securities and Exchange Commission ("SEC") on May 27, 2021, and automatically became effective upon filing. This offering is being made solely by means of a prospectus. A copy of the preliminary prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained by contacting J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, or by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On August 31, 2021 Massive Bio reported it has entered a partnership with Veterans Prostate Cancer Awareness (VPCa), and Self-Care Catalysts to increase clinical trial and real-world evidence research participation in prostate cancer (Press release, Massive Bio, AUG 31, 2021, View Source [SID1234587056]). This will help put Massive Bio in a position to attract new patients and will provide Veterans Prostate Cancer Awareness and Self-Care Catalysts with new ways to help their members fight cancer. "Today there are over 500,000 Veterans with prostate cancer in the VHA system, over 16,000 of those are fighting a metastatic form of the disease where clinical trials can help. The partnership between Massive Bio, VPCa, and Self-Care Catalysts provide the patient search and navigation tool to effectively guide thousands of Veterans to new treatments and clinical trials," stated Mike "Bing" Crosby, Founder & CEO of VPCa.

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Massive Bio is known in the healthcare industry for its SYNERGY-Artificial Intelligence (AI) clinical trial matching program, as well as its Virtual Tumor Board. Massive Bio is a leader in AI-enabled patient-centric clinical trial enrollment whose mission is to provide cancer patients access to clinical trials regardless of their location or financial situation. "We are very excited for our partnership with VPCa, and Self-Care Catalysts," stated Selin Kurnaz, Co-Founder and CEO of Massive Bio. "Teaming up with both parties to provide prostate cancer patients with more access to clinical trials is an exciting development for our companies." "Our partnership with Veterans Prostate Cancer Awareness and Massive Bio brings together an unprecedented platform to drive real-world evidence research and outcome," said Grace Castillo-Soyao, Founder and CEO of Self Care Catalysts.

On August 31, 2021 Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, reported that Company management will participate in a fireside chat at the following virtual investor conferences (Press release, Certara, AUG 31, 2021, View Source [SID1234587040]):

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Morgan Stanley 19th Annual Global Healthcare Conference
Date and Time: Tuesday, September 14 at 9:30 a.m. ET
Speakers: William Feehery, chief executive officer, and Andrew Schemick, chief financial officer
Baird 2021 Global Healthcare Conference
Date and Time: Wednesday, September 15 at 4:55 p.m. ET
Speaker: Andrew Schemick, chief financial officer
Bank of America Securities 2021 Tech Solutions for Drug Discovery Conference
Date and Time: Monday, September 20 at 8:00 a.m. ET
Speakers: William Feehery, chief executive officer, and Andrew Schemick, chief financial officer
Live webcasts for each of the conferences will be available on Certara’s investor relations website at View Source and will be available for replay for at least 90 days thereafter.