On April 10, 2023 Ultima Genomics, Inc. and Genome Insight, Inc. have signed an agreement to collaborate to bring affordable whole genome sequencing solutions to cancer patients (Press release, Ultima Genomics, APR 10, 2023, https://www.prnewswire.com/news-releases/ultima-genomics-and-genome-insight-collaborate-to-bring-affordable-whole-genome-sequencing-to-cancer-patients-301792800.html [SID1234629924]). As part of the agreement, Genome Insight will join the early access program for Ultima’s high-throughput NGS instrument platform, the UG 100, and develop an optimized version of its whole genome bioinformatics solution for Ultima’s sequencing technology. The combination of Genome Insight’s proprietary bioinformatics with Ultima’s low-cost sequencing will make whole genome sequencing an affordable reality for cancer patients.

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Although cancer is a disease caused by alterations to the genome, conventional NGS approaches typically use targeted panels that examine only a small fraction of this information. Insights into the whole genome can expand the understanding of cancer biology and provide important information for physicians in formulating a treatment strategy for each patient. Genome Insight’s proprietary bioinformatics platform translates a cancer patient’s genome into medically meaningful insights. Optimizing this platform for Ultima’s high-throughput, low-cost sequencing architecture will enable delivery of curated whole genome sequencing reports to patients and physicians at a very low cost – even cheaper than conventional NGS panels.

"We are excited to partner with Ultima to bring affordable whole genome sequencing to cancer patients," said Young Seok Ju, CEO of Genome Insight. "The ability to analyze the entire genome at a low cost is a game-changer in cancer treatment, and we are proud to be at the forefront of this revolution. This collaboration is an important step towards our vision of using whole genome sequencing to improve patient outcomes."

"We founded Ultima Genomics to help overcome the tradeoffs scientists and clinicians are forced to make between the breadth, depth and frequency with which they use genomic information," said Gilad Almogy, CEO of Ultima Genomics. "Genome Insight’s focus on whole genome sequencing is a perfect example of this, and we are excited to collaborate on this development."

On April 10, 2023 CTRL Therapeutics Inc., a biotechnology company developing a next-generation cell therapy platform for solid tumors, reported a $10M seed financing led by General Catalyst with participation from Intermountain Health, FACIT and other investors (Press release, CTRL Therapeutics, APR 10, 2023, View Source [SID1234629923]).

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"The field of cell therapy has been limited by the lack of tools to isolate and expand tumor-reactive cells that are efficacious against solid tumors." said Shana Kelley, Ph.D., Founder and Chief Technology Officer at CTRL Therapeutics. "This funding enables further optimization and validation of our proprietary technology platform and expansion of our team to support our mission to deliver curative therapies for all individuals living with cancer."

CTRL Therapeutics is leveraging a next-generation platform with the potential to address the challenges of existing cell therapy technologies by extracting circulating tumor-reactive lymphocytes (cTRLs) from blood. It builds on the advantages of tumor-infiltrating lymphocyte (TIL) therapies while providing greater efficacy by improving the immune-phenotype, quality and consistency of therapeutic cells harvested. This method may enable broader patient access by avoiding invasive and costly surgery, while delivering superior cost-effectiveness and simplified manufacturing.

The company’s approach is highlighted in a landmark publication featured in Nature Biomedical Engineering, titled "Isolation of tumor-reactive lymphocytes from peripheral blood via microfluidic immunomagnetic cell sorting." The study validates CTRL’s high-throughput cell processing platform to harvest tumor-reactive immune cells from the blood, which exhibited significant levels of antitumor activity when tested against solid tumors in mice.

"CTRL combines high impact, pioneering science that harnesses natural biology with experienced leadership that is well versed in platform optimization and clinical development," said Elena Viboch, Partner at General Catalyst. "We are excited to partner with the CTRL team to propel the development of next-generation cellular therapy for solid tumors, and to ultimately bring accessible, safe and effective therapeutics to patients affected by cancer.

On April 10, 2023 Sumitomo Pharma Oncology, Inc., a clinical-stage company focused on novel cancer therapeutics, reported the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for TP-1287, an investigational oral CDK9 inhibitor, for the treatment of Ewing sarcoma (Press release, Sumitomo Pharmaceuticals, APR 10, 2023, View Source [SID1234629922]).

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"We are delighted to have received this designation for TP-1287 which underscores the need for additional treatment options for patients with Ewing sarcoma," said Patricia S. Andrews, Chief Executive Officer and Global Head of Oncology, Sumitomo Pharma Oncology, Inc. "We recognize the unmet need for novel treatments in this disease state and are excited to contribute to the advancement of this research with the goal of helping to improve patient outcomes."

The FDA’s Orphan Drug Designation is granted to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the United States.1 Ewing sarcoma is a rare type of cancer that occurs in bones or in the soft tissue around the bones. The disease occurs when a cell develops changes in its DNA that cause the cell to multiply quickly, resulting in a tumor of abnormal cells that is capable of invading and destroying healthy body tissue. The abnormal cells can break away and metastasize throughout the body. Ewing sarcoma can occur at any age, but it is more likely to occur in children and teenagers.2

"TP-1287 exhibits potent inhibition of intracellular kinases including CDK9. Inhibition of CDK9 leads to downregulation of key antiapoptotic proteins such as MCL-1, which in turn has been shown to inhibit tumor growth in preclinical models of hematologic malignancies and several tumor types,"3-6 detailed Jatin J. Shah, M.D., Chief Medical Officer of Sumitomo Pharma Oncology, Inc.

TP-1287 was also granted Rare Pediatric Disease Designation from the FDA for the treatment of Ewing sarcoma. A rare pediatric disease is one that is serious or life-threatening in which the serious or life-threatening manifestations primarily affect patients from birth to 18 years old.7

TP-1287 is currently being evaluated in a Phase 1, first-in-human study of oral TP-1287 in patients with advanced metastatic or progressive solid tumors who are refractory to, or intolerant of, established therapy known to provide clinical benefit for their condition, which is being conducted in the United States. To learn more about the study and eligibility for enrollment, visit clinicaltrials.gov (NCT03604783).

This is the fourth Orphan Drug Designation Sumitomo Pharma Oncology, Inc. has received in the last year. DSP-5336, the company’s proprietary investigational small molecule inhibitor against the binding of menin and mixed-lineage leukemia (MLL) protein, was granted Orphan Drug Designation for the treatment of acute myeloid leukemia (NCT04988555). TP-3654, the company’s proprietary investigational oral inhibitor of PIM kinases, was granted Orphan Drug Designation for the treatment of myelofibrosis (NCT04176198). DSP-0390, an investigational emopamil-binding protein (EBP) inhibitor, was also granted Orphan Drug Designation for the treatment of brain cancer (NCT05023551). These designations showcase the strength and diversity of SMP Oncology’s pipeline and commitment to oncology research and development.

About TP-1287
TP-1287 is an investigational oral phosphate prodrug of the CDK9 inhibitor alvocidib.8 TP-1287 is hydrolyzed enzymatically to yield alvocidib.8,9 Alvocidib binds at the ATP-binding site of CDK9, stopping phosphorylation by CDK9.3 This binding prevents productive transcription and causes reduction of messenger RNA (mRNA) in genes such as c-MYC and MCL-1.3 Downregulation of c-MYC and MCL-1 transcription leads to apoptosis in a variety of tumor cells.3 TP-1287 is currently being evaluated in a Phase 1, open-label, dose-escalation, dose-expansion, safety, pharmacokinetics and pharmacodynamic study, with a purpose of determining the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-1287 in patients with advanced metastatic or progressive solid tumors who are refractory to, or intolerant of, established therapy known to provide clinical benefit for their condition (NCT03604783).

On April 10, 2023 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its first quarter 2023 financial results on Monday, May 1, 2023 after the financial markets close (Press release, Vertex Pharmaceuticals, APR 10, 2023, View Source [SID1234629921]). The company will host a conference call and webcast at 4:30 p.m. ET. To access the call, please dial (877) 270-2148 (U.S.) or +1(412) 902-6510 (International) and reference the "Vertex Pharmaceuticals First Quarter 2023 Earnings Call."

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The conference call will be webcast live and a link to the webcast can be accessed through Vertex’s website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website.

On April 10, 2023 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec"), a clinical-stage biotechnology company developing intratumoral immunotherapies to stimulate the patient’s immune system to target cancer cells and eradicate disease, reported that it has entered into a definitive agreement for the purchase and sale of an aggregate of 1,582,932 shares of its common stock (or common stock equivalents in lieu thereof), at a purchase price of $1.25 per share (or common stock equivalent in lieu thereof), in a registered direct offering priced at-the-market under Nasdaq rules (Press release, OncoSec Medical, APR 10, 2023, View Source [SID1234629920]). The Company has also agreed to issue in a concurrent private placement unregistered warrants to purchase up to an aggregate of 1,582,932 shares of common stock. The warrants will have an exercise price of $1.12 per share, are immediately exercisable upon issuance, and will expire five and one-half years from the date of issuance. The closing of the offering is expected to occur on or about April 12, 2023, subject to the satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The gross proceeds to the Company from the offering are expected to be approximately $2 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering as working capital for general corporate purposes.

The securities described above (excluding the warrants and the shares of common stock underlying the warrants) are being offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333-260850) that was originally filed with the Securities and Exchange Commission (the "SEC") on November 8, 2021, and declared effective on November 15, 2021. The offering of such securities in the registered direct offering is being made only by means of a prospectus supplement that forms a part of the effective registration statement. A final prospectus supplement and the accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying base prospectus may also be obtained, when available, from H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at [email protected].

The warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying such warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and the underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities 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.