On August 2, 2021 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported the Company will release second quarter and first half 2021 financial results after the market closes on Monday, August 9, 2021 (Press release, Precigen, AUG 2, 2021, View Source [SID1234585556]). The Company will host a conference call that day at 4:05 PM ET to discuss financial results and provide a general business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The conference call may be accessed by dialing 1-888-317-6003 (Domestic US), 1-866-284-3684 (Canada) or 1-412-317-6061 (International) and providing the participant access code 5004322. Participants are asked to dial in 10-15 minutes in advance of the scheduled call time to facilitate timely connection to the call.

Participants may register and access the webcast through Precigen’s website in the Events & Presentations section at investors.precigen.com/events-presentations.

On August 2, 2021 Nuvalent, Inc., a biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported the closing of its upsized initial public offering of 11,212,500 shares of common stock, consisting of 10,612,500 shares of Class A common stock and 600,000 shares of Class B common stock, which includes 1,462,500 shares of Class A common stock sold pursuant to the exercise in full by the underwriters of their option to purchase additional shares, each at a price to the public of $17.00 per share (Press release, Nuvalent, AUG 2, 2021, View Source [SID1234585555]). The gross proceeds of the offering were approximately $190.6 million, before deducting underwriting discounts and commissions and other offering expenses. The Class A common stock began trading on The Nasdaq Global Select Market under the ticker symbol "NUVL" on July 29, 2021. All shares in the offering were offered by Nuvalent.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

J.P. Morgan, Cowen and Piper Sandler are acting as joint book-running managers for the offering.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on July 28, 2021. The offering was made only by means of a written prospectus. Copies of the final prospectus relating to the initial public offering can be obtained, when available, from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone (866) 803-9204 or by email at [email protected]; Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; and Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at (800) 747-3924, or by email at [email protected].

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 registration or qualification under the securities laws of any such state or jurisdiction.

On August 2, 2021 Jacobio Pharmaceuticals (1167.HK) reported the first patient was dosed in a Phase I/II clinical trial of KRAS G12C inhibitor JAB-21822 in China (Press release, Jacobio Pharmaceuticals, AUG 2, 2021, View Source [SID1234585554]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

JAB-21822 is Jacobio’s innovative in-house small molecule anti-cancer drug, which is designed to target the KRAS G12C mutation. It will be used to treat advanced solid tumors with KRAS G12C mutation, including but not limited to non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other advanced solid tumors. The global incidence of the KRAS G12C mutation in patients with NSCLC, ovarian cancer, CRC and pancreatic cancer reached approximately 295,000 in 2019.

JAB-21822 has best-in-class potential among KRAS G12C inhibitors. Internal pre-clinical head-to-head animal studies comparisons have shown JAB-21822 to have a superior pharmacokinetic (PK) profile and favorable tolerability as well as potential for a superior dosing profile in comparison with its competitors.

The Phase I/II trial is a multi-center, open label study of assessing the safety and tolerability of JAB-21822 in patients with advanced solid tumors and the efficacy of JAB-21822 in patients with non-small lung cancer harboring KRAS G12C mutation.

"KRAS is the first oncogene discovered by scientists, it has long been considered ‘undruggable’ for its smooth surface so that it’s hard to bind with small molecule anti cancer drug. We hope that JAB-21822 will benefit more patients with better treatment choice", said Professor Lin Shen of the Beijing Cancer Hospital.

"JAB-21822 is our in-house innovative drug candidate with promising pre-clinical data. We will continue to advance clinical trials with researchers, so that we can bring hope to patients," said Dr. Yinxiang Wang, Chairman and CEO of Jacobio.

The clinical study of JAB-21822 has been initiated after the IND (investigational new drug) approval by the US FDA in May 2021.

On August 2, 2021 PharmaCyte Biotech, Inc. (OTCQB: PMCBD) (PharmaCyte or Company), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that The Nasdaq Stock Market LLC (Nasdaq) has approved the listing of the Company’s common stock on Nasdaq (Press release, PharmaCyte Biotech (BioStrat), AUG 2, 2021, View Source [SID1234585552]). The Company’s common stock will be listed on Nasdaq under the symbol "PMCB." PharmaCyte also announced that it intends to offer and sell, subject to market and other conditions, shares of its common stock (or pre-funded warrants to purchase common stock in lieu of common stock) and warrants to purchase shares of common stock in an underwritten public offering.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

With respect to the proposed public offering, the Company expects to grant the underwriter a 30-day option to purchase additional shares of its common stock and/or warrants to purchase shares of its common stock at the public offering price, less the underwriting discounts and commissions. All of the securities to be sold in the offering are to be offered by PharmaCyte.

H.C. Wainwright is acting as sole book-running manager for the proposed offering.

The Company’s common stock will continue to trade on the OTC Markets quotation system on the OTCQB Venture Market until trading commences on Nasdaq, which the Company expects to occur following the pricing of the proposed public offering. The offering, however, is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

PharmaCyte intends to use the net proceeds of this offering (i) to complete activities requested by the U.S. Food and Drug Administration (FDA) in order to address the FDA’s clinical hold on its Investigational New Drug application (IND) with respect to the Company’s planned Phase 2b clinical trial in locally advanced, inoperable, pancreatic cancer (LAPC), including conducting several additional preclinical studies and assays and providing the FDA with the additional information it requested, (ii) to begin to fund and conduct the Phase 2b clinical trial in LAPC, if and when the clinical hold on the IND is lifted, and (iii) for general working capital purposes.

The securities described above are being offered by PharmaCyte pursuant to a shelf registration statement on Form S-3 (File No. 333-255044) that was previously filed with and subsequently declared effective by the Securities and Exchange Commission (SEC) on April 14, 2021. The securities may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying base prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Electronic copies of the preliminary prospectus supplement and the accompanying base prospectus relating to the offering, when available, may also be obtained by contacting H.C. Wainwright & Co., LLC, at 430 Park Ave., New York, New York 10022, by telephone at (212) 856-5711, or by email at [email protected].

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. Any offer, if at all, will be made only by means of the prospectus supplement and the accompanying prospectus forming a part of the registration statement.

On August 2, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced translational genomics and diagnostics for cancer, reported the publication of its study "Prediction of immunotherapy response in melanoma through combined modeling of neoantigen burden and immune-related resistance mechanisms,"(1) in Clinical Cancer Research, a journal published by the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Personalis, AUG 2, 2021, View Source [SID1234585551]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study details the development of the Personalis Neoantigen Presentation Score (NEOPS), a novel composite biomarker for predicting response to cancer immunotherapy. Enabled by comprehensive tumor immunogenomic profiling from the Personalis NeXT Platform, NEOPS simultaneously models both neoantigen burden and immune-related resistance mechanisms to better predict immunotherapy response in a cohort of late-stage melanoma patients. In this study, NEOPS was more strongly predictive of therapy response than other standard single analyte and investigational biomarkers tested, including tumor mutational burden. Performance of this composite biomarker was initially tested on a cohort of late-stage melanoma patients receiving immune checkpoint blockade therapies and later validated on an independent dataset of similarly treated late-stage melanoma patients.

"Given the varied response to immunotherapy as well as the potential toxicities associated with treatment, there is a need for improved biomarker approaches to better predict which patients will respond to therapy," said Richard Chen, MD, Personalis CMO. "Our findings suggest that integrative, multi-omic biomarkers like NEOPS can be stronger predictors of response than simpler, single-analyte approaches, especially in the setting of new cancer therapies where the underlying biological mechanisms governing response are highly complex. We feel that NEOPS and other composite biomarkers will be important, sharper tools for enabling precision oncology."

NEOPS utilizes technology that Personalis has been developing since 2015 to better predict neoantigens and identify associated escape mechanisms such as HLA LOH. Our ImmunoID NeXT, and clinical NeXT Dx tests make this advanced capability, including NEOPS, available to pharmaceutical researchers and clinicians for clinical trials and investigational use, and additional clinical studies with other tumor types are planned.