Corvus Pharmaceuticals Announces Initiation of Phase 1b/2 Clinical Trial of Ciforadenant as Potential First Line Treatment for Patients with Renal Cell Cancer

On October 25, 2022 Corvus Pharmaceuticals, Inc. (Corvus or the Company) (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported the initiation of a Phase 1b/2 clinical trial evaluating ciforadenant as a potential first line therapy for metastatic renal cell cancer (RCC) in combination with ipilimumab (anti-CTLA-4) and nivolumab (anti-PD-1) (Press release, Corvus Pharmaceuticals, OCT 25, 2022, View Source [SID1234622343]). The Phase 1b/2 study is being conducted by the Kidney Cancer Research Consortium (KCRC) and is led by The University of Texas MD Anderson Cancer Center, one of seven partner institutions that make up the KCRC. The study is expected to enroll up to 60 patients at KCRC partner institutions.

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"Ciforadenant is one of the most studied adenosine receptor antagonists and we have presented encouraging clinical data in very advanced refractory patients with renal cell cancer, demonstrating its anti-tumor activity as a monotherapy and in combination with anti-PD-L1 therapy," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "In addition, we published preclinical data in Cancer Immunology Research in 2018 that showed that ciforadenant combined with anti-CTLA-4 and anti-PD-1 therapy is highly active, which resulted in complete elimination of tumors, even in the setting of treatment of established tumors. Further laboratory studies have uncovered a novel mechanism of action that we believe may synergize with anti-CTLA-4 therapy. Together we believe this provides strong rationale for this Phase 1b/2 clinical trial in first line renal cell cancer and we are excited to partner with the Kidney Cancer Research Consortium, who is leading the clinical trial. And given this is an open-label study, we hope to have preliminary results relatively early in the trial."

About the Ciforadenant Phase 1b/2 Trial
The open-label Phase 1b/2 clinical trial is expected to enroll up to 60 patients with newly diagnosed or recurrent stage IV clear cell RCC that have not received any prior systemic therapy. Patients will receive ciforadenant 100 mg oral, twice-daily in combination with ipilimumab (anti-CTLA-4) 1mg/kg given once every three weeks for twelve weeks (4 doses) and nivolumab (anti-PD-1) 3mg/kg given once every three weeks. In the Phase 1b portion of the clinical trial (N=8), the primary endpoints are safety, tolerability and anti-tumor activity. In the Phase 2 portion of the clinical trial, the primary endpoint is the percent of patients that achieve a deep response, defined as complete response or depth of partial response of >50% tumor reduction. Historical data has shown that deep responses correlate with prolonged progression free survival and is seen in approximately 35% of patients receiving ipilimumab and nivolumab. The trial design is based on Corvus’ preclinical research published in 2018 in Cancer Immunology Research, which demonstrated antitumor control and complete elimination of tumors in several animal models using ciforadenant in combination with anti-CTLA4 and anti-PD1.

bioAffinity Technologies Announces Award of Therapeutic Patents in China, Mexico and Australia

On October 25, 2022 bioAffinity Technologies, Inc. (NASDAQ: BIAF; BIAFW) reported the People’s Republic of China awarded a Certificate of Patent to the Company’s wholly owned subsidiary OncoSelect for its patent "Porphyrin Compounds and Compositions Useful for Treating Cancer" that is directed to novel compounds in which porphyrins are conjugated to chemotherapeutics for selective delivery of cancer treatment (Press release, BioAffinity Technologies, OCT 25, 2022, View Source [SID1234622342]).

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bioAffinity Technologies also announced that Mexico and Australia recently awarded the Company therapeutic patents with claims directed to novel compounds of porphyrin conjugates for selective delivery of cancer treatment. The patents grant protection to 2037.

"An estimated 4.5 million people are expected to receive a cancer diagnosis this year in China, and more than 3 million people are expected to die. Cancer is the leading cause of death in China," said Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies. "Nearly 200,000 Mexicans are diagnosed annually with cancer, and an estimated one in 18 Australians are expected to have a personal history of cancer by 2040. The award of these patents in China, Mexico and Australia is further evidence that bioAffinity Technologies can be a leader in advancing novel approaches for both diagnosing and treating this deadliest of diseases."

bioAffinity’s therapeutic discoveries are the result of research related to advancing its non-invasive lung cancer diagnostic CyPath Lung which has shown 92% sensitivity and 87% specificity in detecting lung cancer in people at high risk for the disease and who have small nodules less than 20 millimeters. CyPath Lung uses a specific fluorescent porphyrin that labels cancer cells in a patient’s lung sputum sample for detection using flow cytometry. The intellectual property associated with CyPath Lung was licensed and has been developed as a laboratory developed test by Precision Pathology Services for sale to physicians.

"bioAffinity’s research led to an accurate, patient-friendly test to detect early-stage lung cancer. Our research also uncovered novel approaches being developed to treat cancer. The selectivity of porphyrins for cancer makes them excellent candidates for drug delivery and diagnostic products," Zannes said.

The Company and its subsidiary OncoSelect hold patents in the U.S., Australia, Canada, China, France, Germany, Hong Kong, Italy, Mexico, Spain, Sweden, and the United Kingdom.

Triumvira Immunologics Appoints Life Sciences Industry Leader Robert Williamson as President and Chief Business Officer

On October 25, 2022 Triumvira Immunologics ("Triumvira"), a clinical-stage company developing novel, targeted autologous and allogeneic T cell therapeutics that co-opt the natural biology of T cells to treat patients with cancer, reported the appointment of Robert Williamson as President and Chief Business Officer (Press release, Triumvira Immunologics, OCT 25, 2022, View Source [SID1234622341]). Mr. Williamson will lead business development and strategy for Triumvira, and will work within Triumvira’s leadership team to establish new value-creating partnerships, drive long-term strategic plans, and advance fundraising activities.

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Mr. Williamson brings more than 25 years of experience in the biotechnology sector, leading company business development and financing efforts through partnerships, private funding, and public capital markets. His accomplishments include orchestrating the exits of numerous biotech companies, including guiding the growth, IPO, financing, commercial ramp-up and sale of Pharmasset to Gilead for $11 billion.

"We are delighted to welcome Rob to the team and look forward to working together to advance Triumvira’s mission on the heels of our recent clinical accomplishments and as we advance our robust pipeline," said Paul Lammers, M.D., M.Sc., Chief Executive Officer of Triumvira. "Rob has a long track record of building companies and delivering value for various stakeholders, and he brings tremendous experience and perspective to our leadership team."

Diffusion Pharmaceuticals Announces Strategic Review Process to Evaluate Value-Enhancing Alternatives including Opportunities to Better Leverage TSC

On October 25, 2022 Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) ("Diffusion" or the "Company"), a biopharmaceutical company developing novel therapies that may enhance the body’s ability to deliver oxygen to areas where it is needed most, reported that its Board of Directors (the "Board") has authorized a thorough review and evaluation of a range of potential strategic opportunities in the interest of enhancing stockholder value including transactional opportunities to better leverage the potential of trans sodium crocetinate ("TSC") and the Company’s other assets (Press release, Diffusion Pharmaceuticals, OCT 25, 2022, View Source [SID1234622340]).

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As part of the Company’s previously disclosed, ongoing efforts to identify acquisition and partnership transactions that complement, supplement or de-risk the Company’s current development programs and the Board’s commitment to enhancing stockholder value, the Board has determined to expand its evaluation to a broader range of options which could include a joint venture, licensing, sale or divestiture of some of the Company’s proprietary technologies or a sale of the Company, in addition to the previously announced opportunities under consideration. The Company has retained Canaccord Genuity LLC as its financial advisor and Dechert LLP as its legal counsel to assist in the review process.

"Over the past two years, we have obtained encouraging data on the potential effects of TSC on oxygenation, including the results of our Altitude, TCOM, and COVID-19 Trials. We continue to believe TSC has potential benefits for patients, particularly as an adjuvant treatment to standard of care therapy for hypoxic solid tumors, like glioblastoma multiforme," said Robert J. Cobuzzi, Jr., Ph.D., President and Chief Executive Officer of Diffusion. "We continue to seek opportunities to leverage our cash position and the significant skills and experience of our team to opportunistically identify novel product candidates that may deliver additional value for our stockholders. This includes strategic transactions that may increase the likelihood of TSC’s successful development and simultaneously allow for a more effective and efficient use of our other resources."

There is no timeline for this review and there is no assurance that the Board’s review will result in any transaction being consummated. Diffusion does not intend to comment on the process or make further disclosures until it determines an update is appropriate.

Recursion Announces $150 Million Private Placement to New and Existing Investors, led by Kinnevik AB

On October 25, 2022 Recursion (NASDAQ: RXRX), the clinical-stage biotechnology company industrializing drug discovery by decoding biology, reported that it has entered into a stock purchase agreement for the sale of an aggregate of approximately 15.3 million shares of its Class A common stock in a private placement, led by Kinnevik AB, with participation by Baillie Gifford, Mubadala Investment Company, Laurion Capital Management, Invus, and Platinum Asset Management (Press release, Recursion Pharmaceuticals, OCT 25, 2022, View Source [SID1234622339]). The price per share of $9.80 reflects an approximate 7% discount to the volume weighted average share price of Recursion’s Class A common stock over the five trading days ended on October 24, 2022.

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Gross proceeds of the private placement are expected to be approximately $150 million, led by Kinnevik with a $75 million investment, before deducting placement agent fees and other expenses payable by Recursion. Morgan Stanley is acting as lead placement agent for the private placement. Berenberg, KeyBanc Capital Markets and Needham & Company are acting as co-placement agents for the private placement.

Recursion currently intends to use the net proceeds from this private placement, together with existing cash and cash equivalents, for general corporate purposes, which may include strategic investments in advancing of existing clinical and preclinical programs, including Recursion’s new clinical program in AXIN1/APC mutant cancers with an initial focus in hepatocellular carcinoma and ovarian cancer for which a Phase 2 trial is being planned, digital chemistry technologies, automated chemical microsynthesis technologies, industrialized validation and translation, and scientific and technical personnel as well as runway extension and other purposes.

"We are proud to be supported by this esteemed group of new and existing investors, and delighted to welcome Kinnevik, who have joined us in our mission as company-building thought partners," said Christopher Gibson, Ph.D., co-founder and Chief Executive Officer of Recursion. "This investment shows conviction in our approach as a leader within technology-enabled drug discovery across our pipeline, partnerships, and massive relatable datasets which ultimately enables us to create a more efficient path to new and better medicines."

Natalie Tydeman, Senior Investment Director at Kinnevik commented: "Recursion’s mission to decode biology to radically improve lives fits squarely into Kinnevik’s strategy of backing challengers that leverage disruptive technology to upend whole industries, and builds on Kinnevik’s successful track record of healthcare investing. We look forward to being long-term partners to Recursion’s visionary and ambitious management team on its journey to advance the future of medicine."

The securities being issued and sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state’s securities laws, and are being issued and sold pursuant to an exemption from registration provided for under the

Securities Act. The securities 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 Securities Act. Recursion has agreed to file a registration statement (or a prospectus supplement to an effective registration statement on Form S-3ASR) with the Securities and Exchange Commission ("SEC") registering the resale of the shares of its Class A common stock issued and sold in the private placement. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities described herein, 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.