On January 25, 2022 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company dedicated to delivering targeted therapies for rare cancers, reported that it intends to offer and sell $100.0 million of shares of its common stock in an underwritten public offering (Press release, Sierra Oncology, JAN 25, 2022, View Source [SID1234606788]). The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the offering. In addition, Sierra Oncology intends to grant the underwriters a 30-day option to purchase up to $15.0 million of additional shares of its common stock. Sierra Oncology intends to use the net proceeds of the offering to prepare for potential commercialization of momelotinib, clinical development activities of its other product candidates, research, clinical and process development and manufacturing of its product candidates, working capital, and capital expenditures and other general corporate purposes.

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Jefferies and Cantor are acting as the joint book-running managers for the proposed offering. LifeSci Capital, Oppenheimer & Co. and H.C. Wainwright & Co. are acting as lead managers for the proposed offering.

A shelf registration statement on Form S-3 relating to the common stock offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on November 5, 2021 and declared effective by the SEC on November 12, 2021. A preliminary prospectus supplement and the accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this proposed offering may also be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, New York, New York 10022, or by email at [email protected].

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

On January 25, 2022 Gilead Sciences Inc. (Nasdaq: GILD) reported that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on studies evaluating the combination of magrolimab plus azacitidine due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions (SUSARs) between study arms (Press release, Gilead Sciences, JAN 25, 2022, View Source [SID1234606787]). While no clear trend in the adverse reactions or new safety signal has been identified by Gilead at this time, the partial clinical hold is being implemented by Gilead across all ongoing magrolimab and azacitidine combination studies worldwide in the best interests of patients as additional data is gathered and analyzed to address the concerns raised by FDA.

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During the partial clinical hold, screening and enrollment of new study participants will be paused in any study investigating the combination of magrolimab with azacitidine. Patients already enrolled in these clinical studies may continue to receive magrolimab and azacitidine, or placebo, and continue to be closely monitored according to the current study protocol. Gilead is currently notifying clinical investigators and global regulatory authorities about the partial clinical hold. Other magrolimab studies, or cohorts, that are not studying the combination of magrolimab plus azacitidine, will continue without any impact by the partial clinical hold.

"The safety and well-being of people enrolled in our studies is our top priority. We will share more information with the medical and patient community as soon as we can," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "Considering the high unmet need for new medicines in myelodysplastic syndrome and acute myeloid leukemia, we will work closely with regulatory authorities worldwide to continue the magrolimab development program appropriately. We remain confident in the potential of magrolimab across a broad range of tumors, including the other, ongoing magrolimab studies. We are grateful to those participating in our studies, their families, and the investigators for their continued contributions to the clinical program for magrolimab."

Gilead is working with regulatory authorities to determine next steps to release the partial clinical hold for new patient enrollment for the affected studies.

The studies impacted by this partial clinical hold include:

Phase 3 ENHANCE study in myelodysplastic syndrome (MDS; NCT04313881)
Phase 3 ENHANCE-2 study in acute myeloid leukemia (AML; TP53 mutated patients; NCT04778397)
Phase 3 ENHANCE-3 study in unfit AML (NCT05079230)
Phase 1b study in MDS (NCT03248479)
Phase 2 study in myeloid malignancies (NCT04778410) *only the azacitidine combination cohorts
The studies not impacted include:

Phase 2 study in diffuse large B-cell lymphoma (NCT02953509)
Phase 2 study in multiple myeloma (NCT04892446)
Phase 2 study in head and neck squamous cell carcinoma (NCT04854499)
Phase 2 study in solid tumors (NCT04827576)
Phase 2 study in triple-negative breast cancer (NCT04958785)
Phase 2 study in colorectal cancer, planned and not currently recruiting
About Magrolimab

Magrolimab is a potential, first-in-class investigational monoclonal antibody against CD47 and a macrophage checkpoint inhibitor that is designed to interfere with recognition of CD47 by the SIRPα receptor on macrophages, with the goal of blocking the "don’t eat me" signal used by cancer cells to avoid being ingested by macrophages. Magrolimab is being developed in several hematologic cancers, including myelodysplastic syndrome (MDS), as well as solid tumor malignancies.

More information about clinical trials with magrolimab is available at www.clinicaltrials.gov.

On January 25, 2022 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported a presentation at the 2nd Annual TGFβ for Immuno-Oncology Drug Development Summit (January 25-27, 2022) (Press release, Scholar Rock, JAN 25, 2022, View Source [SID1234606786]).

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"Development of a Comprehensive Biomarker Strategy to Support DRAGON, a Phase 1 Clinical Trial of SRK-181, the latent TGFβ1 Inhibitor" will be presented on January 27th, 2022, at 11:00 AM EST. The presentation, led by Si Tuen Lee-Hoeflich, Director, Translational Sciences at Scholar Rock, will discuss the SRK-181 biomarker strategy in relation to the DRAGON Phase 1 proof-of-concept trial (NCT04291079). The goal of the trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SRK-181 administered alone and in combination with an anti-PD-(L)-1 in adult patients with locally advanced or metastatic solid tumors. The biomarker strategy will focus on the evaluation of biomarkers relevant to the mechanism of action of SRK-181 to facilitate the clinical development of Scholar Rock’s immuno-oncology (IO) program and to identify the next wave of IO biomarkers that correlate with anti-tumor response.

"We are excited to be presenting at the TGFβ for Immuno-Oncology Drug Development Summit on our biomarker strategy for SRK-181 in support of DRAGON," said Gregory Carven, Ph.D., Chief Scientific Officer. "Our biomarker efforts play an important role in advancing our understanding of the mechanisms of action of selective inhibition of TGFβ1 and for facilitating the development of SRK-181, which we hope will positively impact the lives of those affected by cancers that are resistant to checkpoint blockade."

Initial Part A data from the ongoing DRAGON trial in patients with locally advanced or metastatic solid tumors were presented by Scholar Rock at the 36th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November 2021, supporting dose selection and advancement into Part B. Part B will assess SRK-181 in combination with an approved anti-PD-(L)1 therapy across multiple solid tumor cohorts to test proof of concept. To learn more about DRAGON, visit clinicaltrials.gov.

For Summit information, visit: www.tgf-beta-summit.com

About SRK-181

SRK-181 is a selective inhibitor of TGFβ1 activation and is an investigational product candidate being developed to overcome primary resistance to checkpoint inhibitor therapy, such as anti-PD-(L)1 antibodies. TGFβ1 is the predominant TGFβ isoform expressed in many human tumor types. Based on analyses of various human tumors that are resistant to anti-PD-(L)1 therapy, data suggest TGFβ1 is a key contributor to the immunosuppressive tumor microenvironment, excluding and preventing entry of cytotoxic T cells into the tumor, thereby inhibiting anti-tumor immunity (1). Scholar Rock believes SRK-181, which specifically targets the latent TGFβ1 isoform, has the potential to overcome this immune cell exclusion and induce tumor regression when administered in combination with anti-PD-(L)1 therapy while potentially avoiding toxicities associated with non-selective TGFβ inhibition. The DRAGON Phase 1 proof-of-concept clinical trial (NCT04291079) in patients with locally advanced or metastatic solid tumors is ongoing. The efficacy and safety of SRK-181 have not been established. SRK-181 has not been approved for any use by the FDA nor any other regulatory agency.

(1) Martin et al., Sci. Transl. Med. 12: 25 March 2020

On January 25, 2022 Iterative Scopes, a pioneer in the development of precision-based gastrointestinal disease technologies, reported that it has entered into a collaboration with Janssen Research & Development, LLC (Janssen) in which Iterative Scopes will work with the Janssen Data Science and Immunology teams to augment Janssen’s clinical trials for inflammatory bowel disease (IBD) with the deployment of cutting-edge artificial intelligence (AI) and computer vision tools (Press release, Janssen Research & Development, JAN 25, 2022, View Source [SID1234606785]).

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Patient recruitment and clinical trial workflow inefficiencies are ongoing challenges for gastrointestinal clinical researchers and drug developers. Through this agreement, Iterative Scopes and Janssen will work together to integrate computational gastroenterology solutions to enhance assessment and interpretation of endoscopic video images, facilitating recruitment of eligible patients for Janssen’s IBD clinical trials. This collaboration has significant potential to addressing the bottlenecks in IBD clinical research, helping identify the right patients for each trial, reducing unnecessary screening costs, and accelerating trials.

"Our team at Iterative Scopes is thrilled to be collaborating with Janssen, to help solve some of the toughest problems facing drug development for Inflammatory Bowel Disease with artificial intelligence," said Jonathan Ng, Founder and CEO of Iterative Scopes.

Johnson & Johnson Innovation – JJDC, Inc., the strategic venture capital arm of Johnson & Johnson, participated with other investors in Iterative Scopes’ $30 million Series A financing, which closed in August 2021, as well as their $150 million Series B financing, which closed in December 2021.

On January 25, 2022 Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, reported an update to the Proprietary Laboratory Analyses (PLA) code for its comprehensive genomic profiling test, PGDx elio tissue complete (Press release, Personal Genome Diagnostics, JAN 25, 2022, View Source [SID1234606784]). The Centers for Medicare & Medicaid Services (CMS) finalized a national reimbursement rate of $2,919.60 for the PLA code (0250U) that PGDx obtained for the test.

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"We are thrilled that CMS has responded to PGDx’s advocacy efforts, agreeing with our crosswalk recommendation for the previously obtained PLA code," said PGDx CEO Megan Bailey. "The PGDx elio tissue complete test enables rapid and actionable genomic insights for patients living with advanced cancers, and the national reimbursement rate as determined by CMS will allow for more patients to receive targeted insights and informed treatment options that could improve outcomes."

The new Medicare payment rate went into effect on January 1, 2022. More information can be found in the latest Medicare Clinical Laboratory Fee Schedule Files.

The PGDx elio tissue complete solution is an in-house comprehensive genomic profiling (CGP) test that identifies key genomic alterations and guideline supported biomarkers in solid tumors using a 500+ gene panel. PGDx elio tissue complete is the industry’s first and only NGS diagnostic kit for comprehensive tumor profiling that is FDA cleared and CE-IVD marked for use in labs worldwide.