On September 11, 2024 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported the pricing of a best-efforts offering of 12,325,000 common shares (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof), priced at-the-market under Nasdaq rules (Press release, BriaCell Therapeutics, SEP 11, 2024, View Source [SID1234646518]). Each common share (or Pre-Funded Warrant) is being sold at an offering price of $0.69 per share (inclusive of the Pre-Funded Warrant exercise price). All of the common shares and Pre-Funded Warrants in the offering are being offered by the Company. Total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $8.5 million. The offering is expected to close on September 12, 2024, subject to satisfaction of customary closing conditions. The Company is relying upon the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as Nasdaq.

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The Company intends to use the net proceeds from the offering for working capital requirements, general corporate purposes, and the advancement of business objectives.

ThinkEquity is acting as sole placement agent for the offering.

The securities described above are being offered and sold by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-276650), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on January 22, 2024 and declared effective on January 31, 2024. The offering is being made only by means of a written prospectus. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and can be accessed for free on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

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

On September 11, 2024 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat cancers, reported that Jim Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic, presented at the H.C. Wainwright 26 th Annual Global Investment Conference (Press release, Xenetic Biosciences, SEP 11, 2024, https://ir.xeneticbio.com/news/detail/150/xenetic-biosciences-inc-presents-at-the-h-c-wainwright-26th-annual-global-investment-conference [SID1234646517]).

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The video webcast of the presentation is now accessible on the Events page in the Investors section of the Company’s website (www.XeneticBio.com) and will be archived for 90 days.

On September 11, 2024 Xencor, Inc. ("Xencor") (Nasdaq: XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and other serious diseases, reported the pricing of its underwritten public offering of (i) 6,635,112 shares of its common stock at a price to the public of $18.00 per share and (ii) pre-funded warrants to purchase up to an aggregate of 3,088,888 shares of common stock at a price to the public of $17.99 per pre-funded warrant (Press release, Xencor, SEP 11, 2024, View Source [SID1234646516]). The pre-funded warrants will be immediately exercisable and will have an exercise price of $0.01 per share. The gross proceeds from the offering, before deducting underwriting discounts and commissions and offering expenses, are expected to be approximately $175 million. Xencor has also granted the underwriters a 30-day option to purchase up to 1,458,600 additional shares of its common stock. All of the shares of common stock and pre-funded warrants in the offering are to be sold by Xencor. The offering is expected to close on or about September 12, 2024, subject to the satisfaction of customary closing conditions.

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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

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Leerink Partners, Raymond James and RBC Capital Markets are acting as joint book-running managers for the proposed offering. Wedbush PacGrow is acting as a co-manager for the offering.

Xencor currently intends to use the net proceeds from the offering for general corporate purposes, which may include research and development, capital expenditures, working capital and general and administrative expenses.

The public offering is being made pursuant to an automatic shelf registration statement on Form S-3 (File No. 333-270030), previously filed with the Securities and Exchange Commission (the "SEC") on February 27, 2023, and which automatically became effective upon filing. The securities may be offered only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus, and when available, copies of the final prospectus supplement and accompanying prospectus relating to the offering may also be obtained by contacting Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863, or by email at [email protected]; or from RBC Capital Markets, LLC, Attention: Equity Capital Markets, Brookfield Place, 200 Vesey Street, 8th Floor, New York, New York 10281, by telephone at (877) 822-4089 or by email at [email protected].

This press release shall 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 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.

On September 11, 2024 Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), reported that it will host a Research Forum to highlight its pipeline of next-generation ADCs (Press release, Sutro Biopharma, SEP 11, 2024, View Source;utm_medium=rss&utm_campaign=sutro-biopharma-to-host-research-forum-highlighting-next-generation-adc-innovation-and-near-term-pipeline-on-october-10-2024 [SID1234646515]). The live webcast will be held on Thursday, October 10, 2024, starting at 1:30 p.m. PT / 4:30 p.m. ET.

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Webcast Information:
To access the live audio webcast on Thursday, October 10, at 1:30 p.m. PT / 4:30 p.m. ET, please go to View Source

An archived replay of the webcast will be available on the Company’s website following the live presentation.

On September 11, 2024 Pfizer Inc. (NYSE: PFE) reported to showcase potential practice-changing research and next-generation candidates across its robust Oncology portfolio at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2024, being held September 13-17 in Barcelona (Press release, Seagen, SEP 11, 2024, View Source [SID1234646514]). Data from more than 50 company-sponsored, investigator-sponsored and collaborative research abstracts, including more than 10 oral and mini-oral presentations, will be presented across the company’s tumor areas and core scientific modalities, as well as a potential treatment for a cancer-related condition.

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"At this year’s ESMO (Free ESMO Whitepaper), we are looking forward to demonstrating our progress toward delivering next-generation biologics and novel combinations that have the potential to be new standards of care for patients," said Chris Boshoff, Chief Oncology Officer and Executive Vice President, Pfizer. "Our key data presentations highlight our scientific leadership in developing targeted therapies, including small molecules and antibody-drug conjugates, across our core tumor areas, including breast, bladder and thoracic cancers."

"At ESMO (Free ESMO Whitepaper), Pfizer will share important data highlighting our commitment to transforming outcomes for patients living with lung cancer, including longer-term follow-up results from the BRAFTOVI + MEKTOVI PHAROS study in BRAF V600E-mutated metastatic non-small cell lung cancer," said Karin Tollefson, Chief Oncology Medical Officer, Pfizer. "We are also looking forward to sharing progress on our industry-leading pipeline of new molecules, including encouraging early results for two novel, investigational antibody-drug conjugates and preliminary data on a novel combination of Pfizer’s next-generation CDK inhibitors."

Key research includes a late-breaking presentation of updated results from the pivotal Phase 2 PHAROS* study of BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) in patients with BRAF V600E-mutant metastatic non-small cell lung cancer (mNSCLC). Longer-term efficacy and safety data will be presented, following the initial primary overall response results (ORR) that supported the FDA approval for BRAFTOVI + MEKTOVI in this indication in 2023 and the recent approval by the European Commission in August 2024. Further, Pfizer will share updated data from the safety lead-in of the ongoing Phase 3 BREAKWATER trial, showing antitumor activity of BRAFTOVI + cetuximab + FOLFIRI in patients with untreated BRAF V600E-mutant metastatic colorectal cancer (mCRC) in a mini-oral presentation.

Additionally, Pfizer will present a late-breaking Proffered Paper Presentation on the Phase 2 efficacy and safety results for its GDF-15 inhibitor, ponsegromab, in patients with cancer-associated cachexia, highlighting the company’s commitment to improving the treatment journey for people living with cancer. Cancer cachexia is a common, life-threatening wasting condition characterized by severe weight loss. The condition affects patients with advanced cancers and can greatly impact a patient’s ability to tolerate cancer treatment and quality of life. Despite its severity, there are no FDA-approved treatments for cachexia. i,ii

Pfizer will also present early clinical-stage research for a number of priority pipeline areas, including encouraging Phase 1 results of the potential first-in-class antibody-drug conjugate (ADC) candidate SGN-PDL1V (PF-08046054) in NSCLC and head and neck squamous cell carcinoma (HNSCC); initial data for the investigational ADC disitamab vedotin in combination with KEYTRUDA (pembrolizumab) in human epidermal growth factor receptor 2 (HER2)-expressing locally advanced or metastatic urothelial cancer (la/mUC); and the first data combining atirmociclib, our highly-selective cyclin-dependent kinase 4 (CDK4) inhibitor (CDK4i), with a novel CDK2 inhibitor (CDK2i) in hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer (MBC) from a Phase 1 dose-escalation study.

Key ESMO (Free ESMO Whitepaper) Presentations

Genitourinary Cancer

PADCEV + KEYTRUDA**: additional analysis from the pivotal EV-302 trial continues to support the combination as a new standard of care for patients with previously untreated la/mUC. An exploratory analysis shows PADCEV + KEYTRUDA showed consistent progression free survival (PFS), overall survival (OS), and ORR versus chemotherapy regardless of Nectin-4 or PD-L1 expression.
Disitamab Vedotin: preliminary efficacy and safety data for disitamab vedotin in combination with KEYTRUDA highlights Pfizer’s continued commitment to developing novel therapeutics to meet the needs of patients with bladder cancer. Results from the safety run-in of the ongoing Phase 2 trial showed encouraging early efficacy and a safety profile consistent with previously presented data in treatment-naive patients with HER2-expressing la/mUC.
Thoracic Cancer

SGN-PDL1V (PF-08046054): encouraging Phase 1 results will be presented for PDL1V, a novel, investigational vedotin ADC directed to PD-L1-expressing solid tumors. Data from the dose-escalation and dose optimization cohorts of the ongoing Phase 1 study show PDL1V as monotherapy was generally well tolerated with no unexpected adverse events, and encouraging antitumor activity was observed in patients with heavily pretreated NSCLC and HNSCC.
Breast Cancer

Atirmociclib (PF-07220060) + PF-07104091 : initial data from a dose-escalation study evaluating the innovative combination of atirmociclib, a potential first-in-class CDK4-selective inhibitor, with PF-07104091, a novel CDK2-selective inhibitor, showed a manageable safety profile and encouraging efficacy in patients with heavily pretreated HR+/HER2- breast cancer. These early results highlight the potential of Pfizer’s strategy to advance atirmociclib as a future CDK inhibitor backbone therapy that may address treatment resistance with first generation CDK4/6i, subject to clinical success and regulatory approval. The CDK4i+2i combination is continuing to be explored in an ongoing Phase 1b/2 dose escalation and dose expansion study (NCT05262400).
Additional information on the Pfizer-sponsored abstracts, including date and time of presentation, follow in the chart below.

Pfizer is continuing its commitment to help non-scientists understand the latest findings with the development of abstract plain language summaries (APLS) for company-sponsored research being presented at ESMO (Free ESMO Whitepaper), which are written in non-technical language. Those interested in learning more can visit www.Pfizer.com/apls to access the summaries starting September 16, 2024.

BREAST CANCER

Mini Oral Presentation (Abstract 618MO)
Saturday, September 14, 2:45 PM-4:15 PM CEST

Phase 1b/2 first-in-class novel combination trial of next generation CDK4-selective inhibitor PF-07220060 and next generation CDK2-selective inhibitor PF-07104091 in HR+ HER2- metastatic breast cancer and advanced solid tumors

Yap et al

Poster Presentation (Abstract 413P)
Monday, September 16, 9:00 AM-5:00 PM CEST

Longitudinal circulating tumor DNA (ctDNA) dynamics in Phase 1/2a study of the first-in-class CDK4-selective inhibitor, PF-07220060, in combination with endocrine therapy in patients with HR+/HER2− metastatic breast cancer (mBC) who progressed on prior CDK4/6 inhibitors

Yap et al

Poster Presentation (Abstract 359P)
Monday, September 16, 9:00 AM-5:00 PM CEST

Overall survival of palbociclib (PAL) + endocrine therapy (ET) in Japanese patients with hormone receptor-positive (HR+)/ human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) in the 1st line (1L) or 2nd line (2L) setting: A multicenter observational study

Nakayama et al

Poster Presentation (Abstract 354P)
Monday, September 16, 9:00 AM-5:00 PM CEST

Synergistic preclinical efficacy through combination of the CDK4 and CDK2 selective inhibitors, PF-07220060 and PF-07104091, respectively, in HR+ HER2- breast cancer

Anders et al

Poster Presentation (Abstract 356P)
Monday, September 16, 9:00 AM-5:00 PM CEST

Real-world effectiveness in subgroups of palbociclib + endocrine therapy in HR+/HER2- ABC patients: Interim Results of the PERFORM study

Pfeiler et al

EARLY PIPELINE

Oral Presentation, Proffered Paper (Abstract 607O)
Friday, September 13, 4:00 PM-5:30 PM CEST

Interim results of a Phase 1 study of SGN-PDL1V (PF-08046054) in patients with PDL1-expressing solid tumors

Oliva Bernal et al

GASTROINTESTINAL CANCER

Mini Oral Presentation (Abstract 515MO)
Saturday, September 14, 2:45 PM-4:15 PM CEST

Encorafenib + cetuximab (EC) + FOLFIRI for BRAF V600E-mutant metastatic colorectal cancer (mCRC): updated results from the BREAKWATER safety lead-in (SLI)

Tabernero et al

GENITOURINARY CANCER

Mini Oral Presentation (Abstract 1966MO)
Sunday, September 15, 8:30 AM-10:00 AM CEST

EV-302: Exploratory analysis of nectin-4 expression and response to 1L enfortumab vedotin (EV) + pembrolizumab (P) in previously untreated locally advanced or metastatic urothelial cancer (la/mUC)

Powles et al

Poster Presentation (Abstract 1968P)
Sunday, September 15, 9:00 AM-5:00 PM CEST

Study EV-103 dose escalation/cohort A (DE/A): 5y follow-up of first-line (1L) enfortumab vedotin (EV) + pembrolizumab (P) in cisplatin (cis)-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC)

Rosenberg et al

Poster Presentation (Abstract 2001P)
Sunday, September 15, 9:00 AM-5:00 PM CEST

Epidemiology and treatment patterns of patients with locally advanced or metastatic urothelial cancer in France: a non-interventional database study

Joly et al

Poster Presentation (Abstract 1638P)
Sunday, September 15, 9:00 AM-5:00 PM CEST

Enzalutamide (ENZA) with or without leuprolide in patients (pts) with high-risk biochemically recurrent (hrBCR) prostate cancer (PC): EMBARK post hoc analysis by age

Shore et al

Poster Presentation (Abstract 1626P)
Sunday, September 15, 9:00 AM-5:00 PM CEST

Incidence of hematologic toxicities in the homologous recombination repair (HRR)-deficient population of the TALAPRO-2 trial and their potential association with germline vs somatic origin of HRR gene alterations

Azad et al

Poster Presentation (Abstract 1637P)
Sunday, September 15, 9:00 AM-5:00 PM CEST

Efficacy of talazoparib and enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) patients previously treated with androgen receptor pathway inhibitors (ARPI) or docetaxel – post hoc analysis from both cohorts in TALAPRO-2 study

Agarwal et al

Poster Presentation (Abstract 1633P)
Sunday, September 15, 9:00 AM-5:00 PM CEST

Phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) vs placebo (PBO) + ENZA as first-line (1L) treatment in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): TALAPRO-2 (TP-2) China cohort

Zeng et al

Mini Oral Presentation (Abstract 1967MO)
Sunday, September 15, 8:30 AM-10:00 AM CEST

Preliminary efficacy and safety of disitamab vedotin (DV) with pembrolizumab (P) in treatment (Tx)-naive HER2-expressing, locally advanced or metastatic urothelial carcinoma (la/mUC): RC48G001 Cohort C

Galsky et al

MELANOMA

Poster Presentation (Abstract 1071TiP)
Saturday, September 14, 9:00 AM-5:00 PM CEST

Phase 1 study of the investigational CD228 x 4-1BB costimulatory antibody Anticalin bispecific SGN-BB228 (PF-08046049) in advanced melanoma and other solid tumors

Dummer et al

SUPPORTIVE AND PALLIATIVE CARE

Oral Presentation, Proffered Paper (Abstract LBA82)
Saturday, September 14, 2:45 PM-4:25 PM CEST

Efficacy and safety of ponsegromab, a first-in-class, monoclonal antibody inhibitor of growth differentiation factor-15, in patients with cancer cachexia: A randomized, placebo-controlled, Phase 2 study

Crawford et al

THORACIC CANCER

Mini Oral Presentation (Abstract LBA56)
Saturday, September 14, 10:15 AM-11:45 AM CEST

Updated efficacy and safety from the Phase 2 PHAROS study of encorafenib plus binimetinib in patients with BRAF V600E-mutant metastatic NSCLC (mNSCLC)

Riely et al

Poster Presentation (Abstract 1398TiP)
Saturday, September 14, 9:00 AM-5:00 PM CEST

Be6A Lung-01, a Phase 3 study of sigvotatug vedotin (SV), an investigational antibody-drug conjugate (ADC) versus docetaxel in patients (pts) with previously treated non-small cell lung cancer (NSCLC)

Peters et al

Poster Presentation (Abstract 1279P)
Saturday, September 14, 9:00 AM-5:00 PM CEST

First-line lorlatinib vs crizotinib in Asian patients with ALK+ non-small cell lung cancer (NSCLC): 5-year outcomes from the CROWN study

Wu et al

*The PHAROS trial is conducted with support from Pierre Fabre.

**Pfizer and Astellas have a clinical collaboration agreement with Merck to evaluate the combination of PADCEV and KEYTRUDA in patients with previously untreated metastatic urothelial cancer.

Prescribing Information for Pfizer Medicines

Please see full Prescribing Information for PADCEV.

Please see full Prescribing Information for BRAFTOVI and full Prescribing Information for MEKTOVI.