On December 6, 2021 bioAffinity Vice President of Research David Elzi, Ph.D., reported that it will discuss how bioAffinity successfully uses RNA interference to knock down expression of two genes that results in killing cancer cells with little or no effect on normal cells at Cell Bio, a joint meeting of the American Society for Cell Biology (ASCB) and European Molecular Biology Organization (EMBO), held virtually Dec. 6-11, 2021 (Press release, BioAffinity Technologies, DEC 6, 2021, View Source [SID1234596519]).

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"bioAffinity’s research expands the use of RNAs in the fight against cancer."

Dr. Elzi will present a poster titled "Silencing of two LDL-family receptors, CD320 and LRP2, results in cancer cell toxicity, while normal cells seem unaffected" and will be available for questions from meeting participants on Monday, Dec. 6, at 4 p.m. CST. A video presentation by Dr. Elzi will be available for viewing throughout the conference.

"bioAffinity’s discovery of a fundamental vulnerability of cancer opens the way to new therapies that kill cancer without harm to normal tissue," Dr. Elzi said. "In particular, bioAffinity’s research shows how the Company has designed and used siRNAs to kill multiple cancers at the cellular level, including prostate, lung, breast, brain and skin cancers, without harm to normal cells."

"Recent scientific discoveries related to RNAs and their application in medicine have been astonishing, leading to life-saving therapies including the use of mRNA vaccines to eradicate the SARS-Cov-2 virus causing the COVID-19 pandemic," said bioAffinity President and CEO Maria Zannes. "bioAffinity’s research expands the use of RNAs in the fight against cancer."

Cell Bio, the joint meeting of ASCB and EMBO, showcases the diverse global community engaged in cell biology by focusing on scientific discovery, research, education, professional development, and diversity and inclusion.

On December 6, 2021 MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that it has closed the previously announced underwritten public offering of 20,125,000 shares of its common stock, which includes 2,625,000 shares of common stock sold as a result of the full exercise by the underwriters of an option to purchase additional shares of common stock, at $2.60 per share for total gross proceeds, before underwriting commissions and estimated expenses, of approximately $52,325,000 (Press release, MEI Pharma, DEC 6, 2021, View Source [SID1234596518]).

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The Company plans to use the net proceeds of the offering, together with other available funds, to progress its clinical development programs, prepare for and support the commercial launch of zandelisib, subject to receiving FDA marketing approval, and for other general corporate purposes.

Jefferies, Stifel and Wells Fargo Securities acted as joint book-running managers for the offering. LifeSci Capital and H.C. Wainwright & Co. acted as co-managers for the offering.

The securities described above are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus supplement and accompanying base prospectus.

When available, copies of the final prospectus supplement and accompanying base prospectus relating to the offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022 or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at 415-364-2720 or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, New York 10001 at 833-690-2713 or email a request to [email protected]. An electronic copy of the final prospectus supplement and accompanying base prospectus relating to the offering will also be available on the website of the SEC at www.sec.gov.

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

On December 6, 2021 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported the closing of its previously announced underwritten public offering of 17,486,364 shares of its common stock, which reflects the exercise in full by the underwriters of their option to purchase up to 5,850,000 additional shares of common stock, and pre-funded warrants to purchase 27,363,636 shares of its common stock (Press release, ImmunoGen, DEC 6, 2021, View Source [SID1234596517]). The shares of common stock were sold at a price of $6.60 per share and the pre-funded warrants were sold at a price of $6.59 per pre-funded warrant, which represents the per share public offering price for the common stock less the $0.01 per share exercise price for each such pre-funded warrant, in each case before underwriting discounts and commissions. All of the shares of common stock and pre-funded warrants in the offering were sold by ImmunoGen.

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The total gross proceeds from the offering (before deducting the underwriting discounts and offering expenses) were $295.7 million.

ImmunoGen intends to use the net proceeds of the offering to fund its operations, including, but not limited to, commercialization activities, clinical trial activities, supply of drug product, business development activities, capital expenditures, and working capital.

Jefferies, Cowen, and Guggenheim Securities acted as joint book-running managers for the offering. Canaccord Genuity acted as lead manager for the offering.

The securities described above were offered by ImmunoGen pursuant to a shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC) and became effective upon filing. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, 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. A final prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388; Cowen and Company, LLC c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY, 11717, by email at [email protected] or by telephone at (833) 297-2926; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, or by email at [email protected] or by telephone at (212) 518-9544.

On December 6, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company using its ARCUS genome editing platform to develop allogeneic CAR T and in vivo gene editing therapies, reported it will review interim data results presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from the PBCAR0191 CD19 allogeneic CAR T program and provide other CAR T program updates during a company-hosted webcast and conference call on Saturday, December 11, 2021 at 7:30 PM ET (Press release, Precision Biosciences, DEC 6, 2021, View Source [SID1234596516]).

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Precision previously announced that abstracts accepted by ASH (Free ASH Whitepaper) are now available at www.hematology.org, and the following two abstracts will be presented during oral presentation sessions:

Oral Presentation: #626. Allogeneic CAR-T PBCAR0191 with Intensified Lymphodepletion is Highly Active in Subjects with Relapsed/Refractory B-cell Malignancies (Abstract #302)
Presenting Author: Bijal Shah, M.D., Moffitt Cancer Center
Date/Time/Location: Saturday, December 11, 2021 at 4:15 PM ET in the Georgia World Congress Center, B401-B402

Oral Presentation: #704. Preliminary Safety and Efficacy of PBCAR0191, an Allogeneic ‘Off-the-Shelf’ CD19-Directed CAR-T for Patients with Relapsed/Refractory (R/R) CD19+ B-ALL (Abstract #650)
Presenting Author: Nitin Jain, M.D., The University of Texas MD Anderson Cancer Center
Date/Time/Location: Monday, December 13, 2021 at 10:45 AM ET in the Georgia World Congress Center, Sidney Marcus Auditorium

Company-Hosted Webcast and Conference Call Information
Precision will host a conference call and webcast on Saturday, December 11, 2021 at 7:30 PM ET to discuss interim data results for PBCAR0191 presented at the ASH (Free ASH Whitepaper) annual meeting, as well as additional updates regarding its allogeneic CAR T pipeline. This event is not an official program of the ASH (Free ASH Whitepaper) annual meeting. The dial-in conference call numbers for domestic and international callers are (866) 996-7202 and (270) 215-9609, respectively. The conference ID number for the call is 1178837. Participants may access the live webcast, and accompanying presentation materials, as well as the archived webcast on Precision’s website in the Investors section under Events & Presentations: View Source

December 6, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported it will present new data demonstrating the benefits of using the Guardant360 liquid biopsy test to help guide targeted therapy options for patients with advanced breast cancer at the 2021 San Antonio Breast Cancer Symposium (SABCS) on December 7-11 (Press release, Guardant Health, DEC 6, 2021, View Source [SID1234596514]). These studies were based on data from the GuardantINFORM real-world clinical genomic platform, which features extensive de-identified genomic data and aggregated commercial payer claims from advanced cancer patients who received the Guardant360 liquid biopsy assay.

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Data from one study (Abstract P5-13-29) confirmed that patients with BRCA1/2 reversion mutations, thought to cause acquired therapeutic resistance, experienced worse survival outcomes when treated with a PARP inhibitor as compared to patients without reversion mutations. The study also validates recent advancements in homologous recombination deficiency (HRD) assessment in the Guardant360 lab developed test (LDT), detecting additional inactivating alterations in BRCA1/2, including copy number loss and large genomic rearrangements. These data further demonstrate the Guardant360 test’s ability to reliably identify patients with advanced breast cancer who are most likely to benefit from PARP inhibitor treatment.

Another study (Abstract P1-18-07) using the GuardantINFORM platform demonstrated that, for advanced breast cancer patients with PIK3CA mutations identified using the Guardant360 liquid biopsy and subsequently treated with alpelisib, there was no significant difference in treatment outcomes regardless of whether they had clonal or subclonal PIK3CA mutations. This suggests patients with these mutations may benefit from alpelisib targeted therapy irrespective of mutation clonality.

"These studies further support the tremendous value that our Guardant360 liquid biopsy test and GuardantINFORM real-world clinical genomic platform bring to physicians, and most importantly the patients they treat," said Helmy Eltoukhy, Guardant Health Co-CEO. "Guardant360 identifies mutations driving the cancer, which enables the physician to match a patient with the right precision therapy without the need for a tissue biopsy, which can be difficult and time-consuming, potentially delaying treatment for patients with advanced breast cancer."

Full List of Guardant Health Presentations:

Analytical and clinical validation of a ctDNA assay for detecting copy number loss and structural rearrangement variants contributing to homologous recombination and repair (HRR) deficiency (Abstract Number: P5-13-29)
Impact of PIK3CA mutation (PIK3CA-mt) clonality on alpelisib (ALP) activity based on real-world evidence (RWE) following liquid biopsy testing (Abstract Number: P1-18-07)
SOLTI-1903 HOPE: Real-world clinical practice study to assess the impact of using genomic data on the next treatment decision making-choice in patients with locally advanced or metastatic breast cancer in Spain (Abstract Number: OT2-06-01)
Early changes in circulating tumor DNA and its effect on clinical outcomes in patients with advanced breast cancer receiving the CDK4/6 inhibitor palbociclib: Genotyping results from POLARIS (Abstract Number: P1-18-05)
The full abstracts can be found at the official SABCS website here.

About the Guardant360 Liquid Biopsy Test

The Guardant360 liquid biopsy test is part of the market leading Guardant360 portfolio that offers oncologists end-to-end testing solutions from treatment selection to treatment response monitoring. Since it was first introduced, the Guardant360 liquid biopsy test has become widely accepted for blood-based comprehensive genomic profiling (CGP) with more than 250 peer-reviewed publications including over 60 clinical outcomes studies. It has been trusted by more than 9,000 oncologists with more than 200,000 tests performed to date.

About GuardantINFORM

The GuardantINFORM clinical-genomic platform is intended to help accelerate research and development of the next generation of cancer therapeutics by offering biopharma partners an in-silico platform that combines de-identified longitudinal clinical information and genomic data collected from the Guardant360 liquid biopsy test. With data from more than 160,000 patients diagnosed with locally advanced and metastatic cancers, this robust dataset offers real-world insights into anti-cancer therapy use in the clinic, tumor evolution, and treatment resistance throughout each patient’s treatment journey for many advanced solid tumor cancers, including non-small cell lung, breast, colon, and prostate.