On June 15, 2021 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that on June 11, 2021 it approved non-statutory stock options to purchase an aggregate of 118,350 shares of its common stock and 30,835 restricted stock units ("RSUs"), each representing the right to receive one share of its common stock upon vesting, to 66 new employees(Press release, PTC Therapeutics, JUN 15, 2021, View Source [SID1234584037]). The awards were made pursuant to the NASDAQ inducement grant exception as a component of the new hires’ employment compensation.

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The inducement grants were approved by PTC’s Compensation Committee on June 11, 2021 and are being made as an inducement material to each employee’s acceptance of employment with the Company in accordance with NASDAQ Listing Rule 5635(c)(4).

All stock option awards have an exercise price of $42.95 per share, the closing price of PTC’s common stock on June 11, 2021, the date of the grant. The stock options each have a 10-year term and vest over four years, with 25% of the original number of shares vesting on the first anniversary of the applicable employee’s new hire date and 6.25% of the original number of shares vesting at the end of each subsequent three-month period thereafter until fully vested, subject to the employee’s continued service with the Company through the applicable vesting dates. The RSUs each will vest over four years with 25% of the original number of shares vesting on each annual anniversary of the applicable employee’s new hire date until fully vested, subject to the employee’s continued service with the Company through the applicable vesting dates.

On June 15, 2021 Quirem Medical reported that A first clinical QuiremSpheres patient procedure took place with radioactive holmium-166 microspheres that were activated at the BR2 reactor in Mol, Belgium (Press release, Quirem Medical, JUN 15, 2021, View Source [SID1234584001]). QuiremSpheres is an innovative product for treating liver cancer patients. In 2020, primary liver cancer was the 7th most common cancer worldwide, responsible for 905,677 new cases. This equates to 4.7% of all cancers diagnosed in 2020. Primary liver cancer became fatal that year for 830,180 patients worldwide, making liver cancer the third most deadly cancer of 2020, accounting for 8.3% of all cancer-related deaths.

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"We are very pleased that after a period of extensive testing and validation, we can now use the BR2 reactor for clinical productions." says Jan Sigger, CEO of Quirem Medical. "SCK CEN has proven to be a strong partner and we value their commitment during the development process leading up to this first clinical case. With the high reliability of the BR2 reactor, we are confident we can meet the strongly increasing demand for our products throughout Europe and beyond."

"The Belgian Nuclear Research Centre (SCK CEN) is a global leader in the field of nuclear research, services and education. SCK CEN is operating the BR2 reactor and has a long-standing tradition of partnering with healthcare companies to secure the global supply of medical radioisotopes. We are excited that we are now also able to support the production of holmium-166 microspheres for the treatment of liver cancer." says Bernard Ponsard, Stakeholder Manager of the BR2 reactor for radioisotope production and silicon doping.

QuiremScout is a unique product that allows for screening of patients that are candidates for Selective Internal Radiation Therapy (SIRT). QuiremScout is unique, as it is the only CE-marked product on the market for that purpose. It is more predictive than the current standard, Tech-99m-MAA.

QuiremSpheres, the next generation of radio-embolization microspheres, is the only commercially available SIRT product that contains holmium-166 microspheres. Unlike the widely adopted yttrium-90 microspheres, holmium-166 microspheres can be visualized in low concentrations by means of Single Photon Emission Computed Tomography (SPECT) and Magnetic Resonance Imaging (MRI). This allows clinicians to quantitatively assess the distribution of microspheres in the liver, enabling accurate evaluation of treatment directly after the radio-embolization procedure.

On June 15, 2021 Caris Life Sciences, a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine, and Elevation Oncology, a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported a strategic collaboration to jointly identify oncogenic fusions and mutations that are driver alterations (Press release, Elevation Oncology, JUN 15, 2021, https://elevationoncology.com/caris-life-sciences-and-elevation-oncology-announce-joint-discovery-and-development-collaboration-focused-on-oncogenic-fusions-and-driver-mutations/?utm_source=rss&utm_medium=rss&utm_campaign=caris-life-sciences-and-elevation-oncology-announce-joint-discovery-and-development-collaboration-focused-on-oncogenic-fusions-and-driver-mutations [SID1234584018]). Together, Caris and Elevation Oncology will discover and develop therapeutics targeting these newly identified alterations.

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Under the terms of the agreement, Caris and Elevation Oncology will jointly evaluate potential targets, some of which are not currently actionable by an existing therapeutic, identified on an ongoing basis by analyzing Caris’ Whole Transcriptome Sequencing (WTS) and Whole Exome Sequencing (WES) data. The companies can then elect to initiate a novel drug discovery program for those targets, or pursue licensing or product acquisitions, while retaining exclusive access to all targets selected by the parties.

"Caris is dedicated to advancing precision oncology for patients. We are thrilled to build upon our strategic relationship with Elevation Oncology and deepen the connection between molecular diagnostics and clinical development," said David Spetzler, M.S., Ph.D., MBA, President and Chief Scientific Officer of Caris Life Sciences. "By pairing our unique insight into potential genomic driver alterations gained through Caris’ market-leading molecular profiling capabilities with Elevation Oncology’s strength in executing innovative clinical oncology programs in genomically-defined populations, we aim to further close the gap between target identification and clinical investigation for potential new therapeutics."

"Through this collaboration between Elevation Oncology and Caris, we hope to demonstrate how biopharmaceutical and molecular medicine companies can work hand in hand to realize visions that are shared across the precision oncology community," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "At Elevation Oncology, we believe every cancer patient deserves the opportunity to be matched with an actionable, purposely selected therapeutic that is precisely targeted to their tumor’s unique genomic biomarkers. In Caris, we have found a collaborator who both shares this vision as a leader in genomic testing and who can provide real-world insights into emerging or underserved genomically-defined patient populations. Together, we believe we are pioneering a platform to accelerate the development of precision therapeutics and build toward a future where patients have the option of a matched therapy for every driver alteration – no matter how rare."

Caris Molecular Intelligence, the company’s proprietary, comprehensive tumor profiling approach assesses all 22,000 genes in both DNA and RNA, and proteins – unique to an individual’s cancer – to reveal a molecular blueprint in order to guide more precise and individualized treatment decisions. Caris’ CODEai is the most comprehensive data solution in the industry, with cancer treatment information and clinical outcomes data for over 244,000 patients covering over 1,000,000 data points per patient. The analysis of oncogenic fusions and mutations that are driver alterations for assessment under the collaboration will be conducted on both the historical dataset that has been compiled by Caris, and on an ongoing basis from the future tumor profiling data routinely generated from Caris’ platforms over the term of the agreement.

Therapeutics selected by the parties, and subsequent companion diagnostics, will be developed on a cost-sharing basis with revenue being shared on any approved therapeutics.

On June 15, 2021 Actinium Pharmaceuticals reported safety data from its ongoing pivotal Phase 3 SIERRA trial of Iomab-B in patients with relapsed or refractory Acute Myeloid Leukemia (r/r AML) were presented at the 2021 Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting which was held virtually June 11th – 14th (Press release, Actinium Pharmaceuticals, JUN 15, 2021, View Source [SID1234584090]). The presentation highlighted Iomab-B’s targeting ability and corresponding safety data from 113 patients, representing 75% of patient enrollment on the SIERRA trial.
Iomab-B targets CD45, an antigen expressed on leukemia and lymphoma cancer cells and immune cells including bone marrow stem cells but not on cells outside of the blood forming or hematopoietic system. This allows high amounts of radiation to be delivered to the bone marrow via Iomab-B while sparing critical organs. As a result, statistically significant lower rates of sepsis were reported as well as lower rates of febrile neutropenia, mucositis and non-relapse transplant related mortality in patients receiving Iomab-B and bone marrow transplant (BMT) compared to patients that received salvage therapy and a BMT. In addition, patients who crossed over to receive Iomab-B and went to BMT after receiving salvage therapy but not achieving a complete response also had lower rates of sepsis, febrile neutropenia, mucositis and non-relapse transplant related mortality.
Dr. Mark Berger, Actinium’s Chief Medical Officer, commented, "Relapsed and refractory AML in older patients is a particularly challenging disease to treat. Patients are heavily pretreated making their disease resistant to most standard therapies and often have comorbidities that limit treatment options, particularly bone marrow transplant. It is highly encouraging to us that in the SIERRA trial thus far, Iomab-B has enabled all patients receiving a therapeutic dose to proceed to BMT, the only curative treatment option for this patient population. Importantly, Iomab-B has been well tolerated and we are elated with the safety data from 75% of patient enrollment in the SIERRA trial. Given the targeted nature of Iomab-B, we can spare non-targeted organs like GI tract and deliver higher amounts of radiation to the bone marrow, the target organ. We are thrilled to be able to highlight results of the SIERRA trial through 75% of patient enrollment at SNMMI and look forward to future opportunities to present topline data from the full study."

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About Iomab-B
Iomab-B (I-131 apamistamab) is an Antibody Radiation Conjugate (ARC) that is intended to condition or prepare patients for a potentially curative bone marrow transplant (BMT) in a targeted manner with the goal of reducing adverse events and increasing patent access to BMT. Via the monoclonal antibody apamistamab, Iomab-B targets CD45, an antigen widely expressed on leukemia and lymphoma cancer cells, immune cells and stem cells. Apamistamab is linked to the radioisotope iodine-131 (I-131) and once its attached to its target cells, it emits energy that travels about 100 cell lengths, destroying a patient’s cancer cells and ablating their bone marrow. By carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B can avoid the side effects of radiation on most healthy tissues while effectively killing the patient’s cancer and marrow cells.

Iomab-B is currently being studied in the pivotal Phase 3 SIERRA (Study of Iomab-B in Relapsed or Refractory AML) trial, a 150-patient, randomized controlled clinical trial in patients with relapsed or refractory Acute Myeloid Leukemia (AML) who are age 55 and above. The SIERRA trial is being conducted at preeminent transplant centers in the U.S. with the primary endpoint of durable Complete Remission (dCR) at six months and a secondary endpoint of overall survival. Upon approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, in a potentially safer and more efficacious manner than the non-targeted intensive chemotherapy conditioning that is the current standard of care in bone marrow transplant conditioning. A bone marrow transplant is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Additional information on the Company’s Phase 3 clinical trial in R/R can be found at www.sierratrial.com.

On June 15, 2021 RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases, reported the pricing of its previously announced underwritten public offering of 3,787,879 shares of its common stock at a price to the public of $33.00 per share (Press release, RAPT Therapeutics, JUN 15, 2021, https://investors.rapt.com/news-releases/news-release-details/rapt-therapeutics-announces-pricing-public-offering-common-stock [SID1234585135]). All of the shares of common stock are being offered by RAPT. Gross proceeds to RAPT from the offering are expected to be approximately $125 million, before deducting underwriting discounts and commissions and estimated offering expenses. In addition, the underwriters have been granted a 30-day option to purchase up to an additional 568,181 shares of common stock on the same terms and conditions. The offering is expected to close on June 18, 2021, subject to customary closing conditions.

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J.P. Morgan, SVB Leerink and Piper Sandler are acting as joint lead book-running managers for the offering. Cantor is acting as book-running manager for the offering. H.C. Wainwright & Co. and Roth Capital Partners are acting as co-lead managers for the offering.

The offering is being made pursuant to a shelf registration statement, including a base prospectus, filed by RAPT with the Securities and Exchange Commission (SEC), which was declared effective by the SEC on November 16, 2020. The offering may be made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. When available, electronic copies of the final prospectus supplement and the accompanying prospectus may also be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by email at [email protected] or by telephone at (866) 803-9204; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by email at [email protected] or by telephone at (800) 808-7525, ext. 6105; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by email at [email protected] or by telephone at (800) 747-3924.

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 offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.